Court Opinion

ID: 2687562
Source: CourtListenerOpinion
Date Created: 2014-07-31 21:42:11.516847+00
Date Added: 2024-06-11T13:16:53.049901
License: Public Domain

IN THE SUPREME COURT OF IOWA
                                  No. 12–0596

                            Filed July 11, 2014

THERESA HUCK,

      Appellant,

vs.

WYETH, INC. d/b/a WYETH; SCHWARZ PHARMA, INC.;
and PLIVA, INC.,

      Appellees.

      On review from the Iowa Court of Appeals.

      Appeal from the Iowa District Court for Sac County, Gary L.

McMinimee, Judge.

      Plaintiff seeks further review of court of appeals decision affirming

summary judgments dismissing her personal injury claims against

pharmaceutical companies.          DECISION OF COURT OF APPEALS

VACATED; DISTRICT COURT JUDGMENTS AFFIRMED IN PART,

REVERSED IN PART, AND REMANDED WITH INSTRUCTIONS.

      Terrence     J.   Donahue    Jr.   of   McGlynn   Glisson   &   Mouton,

Baton Rouge, Louisiana, and James R. Van Dyke of Eich, Van Dyke,

Werden & Steger PC, Carroll, for appellant.
                                   2

      Henninger S. Bullock and Andrew J. Calica of Mayer Brown LLP,

New York, New York, and Carl J. Summers of Mayer Brown LLP,

Washington, DC, for appellee Schwarz Pharma, Inc.

      Jeffrey F. Peck, Linda E. Maichl, Joseph P. Thomas of Ulmer &

Berne LLP, Cincinnati, Ohio, and Gregory M. Lederer of Lederer Weston

Craig PLC, Cedar Rapids, for appellee PLIVA, Inc.

      Kevin C. Newsom and Lindsey C. Boney IV of Bradley Arant Boult

Cummings LLP, Birmingham, Alabama, for appellee Wyeth, Inc.

      Richard J. Sapp and Ryan G. Koopmans of Nyemaster, Goode,

West, Hansell & O’Brien, P.C., Des Moines, for appellees Wyeth, Inc. and

Schwarz Pharma, Inc.
                                     3

WATERMAN, Justice.

      This products liability action against pharmaceutical companies

presents several issues involving the interplay between state tort law and

federal prescription drug regulation. This case is one of many litigated in

state and federal courts nationwide alleging severe side effects from

prolonged use of metoclopramide, sold under the brand name Reglan

and as a competing generic formulation. The plaintiff in this case used

only the generic product. After developing a neurological disorder, she

sued the manufacturer of the generic drug as well as the manufacturers

of the branded formulation.

      The district court dismissed all of plaintiff’s claims in several

summary judgment rulings. The district court, relying on PLIVA, Inc. v.

Mensing, 564 U.S. ___, ___, 131 S. Ct. 2567, 2580–81, 180 L. Ed. 2d 580,

595 (2011), ruled plaintiff’s claims against the generic manufacturer were

preempted by federal law that requires conformity with the brand

manufacturers’ warning labels approved by the Food and Drug

Administration (FDA). The district court granted summary judgment for

the brand manufacturers based on Mulcahy v. Eli Lilly & Co., which

requires proof the defendant manufactured or supplied the product that

caused plaintiff’s injury. 386 N.W.2d 67, 76 (Iowa 1986). The court of

appeals affirmed. We granted plaintiff’s application for further review.

      For the reasons explained below, we hold plaintiff’s state common

law tort claims against the generic manufacturer based on inadequate

warnings are not preempted to the extent that the generic manufacturer

failed to implement a stronger warning approved by the FDA in 2004.

We decline, however, to alter long-standing Iowa products liability law to

allow recovery against a manufacturer for injuries caused by use of its

competitor’s product.    We thereby join the overwhelming majority of
                                     4

courts, including every federal circuit court of appeals, in holding Reglan

brand manufacturers are not liable to plaintiffs who consumed only the

competing generic formulation.    Accordingly, we vacate the decision of

the court of appeals, affirm the district court’s summary judgment for the

brand manufacturers, reverse in part the summary judgment for the

generic manufacturer, and remand for further proceedings against that

defendant alone.

       I. Background Facts and Proceedings.

       We begin with a discussion of federal drug labeling regulation to

provide the necessary context for the fighting issues. In 1984, Congress

passed the Hatch-Waxman Amendments to the Food, Drug, and

Cosmetics Act (FDCA) in order to expand access to affordable generic

drugs by reducing barriers to generic market entry.            Drug Price

Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-

417, 98 Stat. 1585 (codified in relevant part at 21 U.S.C. § 355 (1988));

see also Mensing, 564 U.S. at ___, 131 S. Ct. at 2574, 180 L. Ed. 2d at

588.   Prior federal law compelled virtually all companies to file a new

drug application—requiring costly clinical trials—to receive FDA approval

to market a drug.    Mensing, 564 U.S. at ___, 131 S. Ct. at 2574, 180

L. Ed. 2d at 588.    Hatch-Waxman eliminated this requirement for a

generic drug applicant, instead requiring the applicant to demonstrate its

product’s chemical and biological equivalence to a previously approved

drug—i.e., a brand manufacturer’s drug.      See id. at ___, 131 S. Ct. at

2574, 180 L. Ed. 2d at 588; see also 21 U.S.C. § 355(j)(2)(A) (2006).

       When a brand manufacturer first files a new drug application, the

FDA must approve the accuracy and adequacy of a drug’s label. See 21

U.S.C. § 355(a), (b)(1), (d); Wyeth v. Levine, 555 U.S. 555, 566–67, 129

S. Ct. 1187, 1195, 173 L. Ed. 2d 51, 61 (2009). After the initial approval
                                     5

of the new drug application, a brand manufacturer may update its label

by filing an application with the FDA to “add or strengthen a

contraindication, warning, precaution, or adverse reaction” or to “add or

strengthen an instruction about dosage and administration that is

intended to increase the safe use of the drug product,” but it need not

wait for FDA approval. 21 C.F.R. § 314.70(c)(6)(iii)(A), (C) (2006); see also

Levine, 555 U.S. at 567–68, 129 S. Ct. at 1196, 173 L. Ed. 2d at 62. The

equivalence of brand-name and generic drugs is the foundation of the

generic drug approval process, and accordingly, federal regulations

“require that the warning labels of a brand-name drug and its generic

copy must always be the same—thus, generic drug manufacturers have

an ongoing federal duty of ‘sameness.’ ” Mensing, 564 U.S. at ___, 131

S. Ct. at 2574–75, 180 L. Ed. 2d at 589; see also, e.g., 21 U.S.C.

§ 355(j)(2)(A)(v), (4)(G); 21 C.F.R. §§ 314.94(a)(8), .127(a)(7); Abbreviated

New Drug Application Regulations, 57 Fed. Reg. 17950–01, 17961 (Apr.

28, 1992) (“[T]he [generic drug’s] labeling must be the same as the listed

drug product’s labeling because the listed drug product is the basis for

[generic drug] approval.”). The requirement that generic labeling mirrors

that of the brand drug ensures generic manufacturers do not mislead

consumers by “inaccurately imply[ing] a therapeutic difference between

the brand and generic drugs.” Mensing, 564 U.S. at ___, 131 S. Ct. at

2576, 180 L. Ed. 2d at 590. Manufacturers—both brand and generic—

are required to propose stronger warning labels to the FDA if they believe

such warnings are needed. Id. at ___, 131 S. Ct. at 2576, 180 L. Ed. 2d

at 591.

      The United States Supreme Court decisions of Levine and Mensing

set parameters for when state-law failure-to-warn claims are preempted

by federal prescription drug labeling regulations. First, Levine held that
                                      6

federal drug regulations do not preempt state-law failure-to-warn claims

against   brand     manufacturers    because    federal   law   allows   brand

manufacturers to unilaterally strengthen their warnings.          555 U.S. at

573, 129 S. Ct. at 1199, 173 L. Ed. 2d at 65 (concluding requiring brand

drug manufacturers to comply with a state-law duty to warn would not

obstruct the purposes and objectives of federal drug labeling regulation).

“The Court did not find it significant that the FDA has authority to reject

unilateral labeling changes . . . finding it ‘difficult to accept’ that the FDA

would not have permitted a change to a stronger warning.” Fulgenzi v.

PLIVA, Inc., 711 F.3d 578, 582 (6th Cir. 2013) (quoting Levine, 555 U.S.

at 570, 129 S. Ct. at 1197, 173 L. Ed. 2d at 63).         After Levine, some

courts reasoned that generic drug manufacturers would then also be

subject to state-law failure-to-warn claims. See, e.g., Demahy v. Actavis,

Inc., 593 F.3d 428, 430 (5th Cir. 2010) (“[Levine] shadows our conclusion

that the federal regulatory regime governing generics is also without

preemptive effect.”), rev’d sub nom. Mensing, 564 U.S. at ___, 131 S. Ct.

at 2573, 180 L. Ed. 2d at 587); Mensing v. Wyeth, Inc., 588 F.3d 603, 607

(8th Cir. 2009) (“After [Levine], we must view with a questioning mind the

generic defendants’ argument that Congress silently intended to grant

the manufacturers of most prescription drugs blanket immunity from

state tort liability when they market inadequately labeled products.”),

rev’d sub nom. Mensing, 564 U.S. at ___, 131 S. Ct. at 2573, 180

L. Ed. 2d at 587.

      But, the Supreme Court held otherwise in Mensing, a case

involving generic manufacturers of metoclopramide. 564 U.S. at ___, 131

S. Ct. at 2572, 180 L. Ed. 2d at 586. The five-justice majority noted the

FDA interprets its regulations “to allow changes to generic drug labels

only when a generic drug manufacturer changes its label to match an
                                     7

updated brand-name label or to follow the FDA’s instructions.”        Id. at

___, 131 S. Ct. at 2575, 180 L. Ed. 2d at 590 (emphasis added).

Otherwise, a generic manufacturer is obligated to copy the brand

manufacturer’s approved label. See id. at ___, 131 S. Ct. at 2575, 180

L. Ed. 2d at 590.       Accordingly, the Court agreed with the FDA’s

interpretation of its regulations that “changes unilaterally made to

strengthen a generic drug’s warning label would violate the statutes and

regulations requiring a generic drug’s label to match its brand-name

counterpart’s.” Id. at ___, ___, 131 S. Ct. at 2575, 2580, 180 L. Ed. 2d at

590, 595 (emphasis added) (highlighting that “[b]efore the Manufacturers

could satisfy state law, the FDA—a federal agency—had to undertake

special effort permitting them to do so”). Due to this conflict, the Court

held federal law categorically preempts state-law failure-to-warn claims

against generic manufacturers. Id. at ___, 131 S. Ct. at 2580–81, 180

L. Ed. 2d at 595.   “The Court distinguished the situation in [Levine],

which it characterized as holding that ‘the possibility of impossibility’

(i.e., possible FDA subsequent denial) was not enough for impossibility

preemption from the case at hand, which concerned ‘the possibility of

possibility’ (i.e., possible FDA prior approval).” Fulgenzi, 711 F.3d at 583

(quoting Mensing, 564 U.S. at ___ n.8, 131 S. Ct. at 2581 n.8, 180

L. Ed. 2d at 596 n.8). The Mensing Court acknowledged “the unfortunate

hand that federal drug regulation has dealt” those whose pharmacies

filled their prescriptions with generic metoclopramide instead of Reglan.

Mensing, 564 U.S. at ___, 131 S. Ct. at 2581, 180 L. Ed. 2d at 596.

      In response to Mensing, the FDA proposed a rule to amend generic

labeling regulations.    Supplemental Applications Proposing Labeling

Changes for Approved Drugs and Biological Products, 78 Fed. Reg.

67985–02 (proposed Nov. 13, 2013) [hereinafter Proposed Rule] (setting
                                        8

deadline of January 13, 2014, for comments). The proposed rule “would

create parity” between brand and generic manufacturers, granting both

the ability to unilaterally improve labeling and then seek approval from

the FDA. Id. at 67986.

      Against this backdrop, we now turn to the facts of this case. In

1980, the FDA approved the new drug application for metoclopramide

tablets, which are designed to treat digestive tract problems, including

gastroesophageal reflux disease (acid reflux). This FDA approval allowed

for the manufacture and distribution of a patented formulation of the

drug, which was branded Reglan. Wyeth, Inc. came to own the Reglan

brand in approximately 1989 1 and later sold the rights and liabilities

associated with Reglan to Schwarz Pharma, Inc. in December 2001. 2 In

addition to the Reglan tablets marketed by Wyeth and Schwarz

[hereinafter referred to collectively as the brand defendants], a generic

formulation of the drug was manufactured and distributed by PLIVA, Inc.

      In February 2004, Theresa Huck’s physician prescribed Reglan to

treat her reflux. Her physician relied upon information published by the

brand defendants in the Physician’s Desk Reference, which contained the

FDA-approved labeling for the drug.             Huck’s pharmacy filled this
prescription with the PLIVA generic.

      The FDA-approved labeling at the time Huck began taking

metoclopramide stated “Therapy longer than 12 weeks has not been

evaluated and cannot be recommended.”             The label also contained a

warning about possible side effects, including tardive dyskinesia.

      1A.H.  Robinson Company, Inc. obtained the original FDA approval for Reglan.
Wyeth is the successor in interest to A.H. Robinson.
      2Schwarz  then manufactured and distributed Reglan until February 2008, when
the brand was again sold.
                                     9

Tardive dyskinesia is a severe, often irreversible neurological disorder

resulting in involuntary and uncontrollable repetitive body movements of

slow or belated onset.    Symptoms include “grotesque facial grimacing

and open-mouthed, uncontrollable tongue movements, tongue thrusting,

[and] tongue chewing.”    Fisher v. Pelstring, 817 F. Supp. 2d 791, 802

(D.S.C. 2011).    There is no known treatment or cure for tardive

dyskinesia.   The FDA-approved warning stated that tardive dyskinesia

was expected to occur in one in every five hundred patients.

      In July 2004, approximately five months after Huck began taking

metoclopramide, the FDA approved additional label warning language

requested by Schwarz.     Printed in bold on the first line of both the

“Indications and Usage” and “Dosage and Administration” sections of the

label, the new language indicated, “Therapy should not exceed 12

weeks in duration.”      While this language appeared on the label for

Reglan, it was not published in the Physicians’ Desk Reference.

Although required by federal regulations to mirror the brand defendant’s

label, PLIVA did not update its metoclopramide packaging to include the

new warning approved in 2004.      The record is silent as to why PLIVA

failed to add that warning.    Neither the brand defendants nor PLIVA

communicated the new label information to Huck or her physician.

Huck testified she never would have taken metoclopramide had she been

warned its possible side effects included a neurological disorder.

      Taking an average of 2.7 pills per day, Huck continued to refill her

PLIVA generic prescription until March 2006. Though Huck had been

experiencing symptoms of tardive dyskinesia for some time, she was not

diagnosed with the disease until June 6, 2006.

      Based on growing evidence that prolonged use of metoclopramide

causes tardive dyskinesia, on February 26, 2009, the FDA imposed
                                         10

heightened warnings for the drug’s packaging.             The FDA required the

following black-box warning—its strongest—for metoclopramide:

              Chronic treatment with metoclopramide can cause
       tardive dyskinesia, a serious movement disorder that is often
       irreversible. The risk of developing tardive dyskinesia
       increases with the duration of treatment and the total
       cumulative dose. * * *
             There is no known treatment for tardive dyskinesia;
       however, in some patients symptoms may lessen or resolve
       after metoclopramide treatment is stopped. * * *
             Prolonged treatment (greater than 12 weeks) with
       metoclopramide should be avoided in all but rare cases
       where therapeutic benefit is thought to outweigh the risks to
       the patient of developing tardive dyskinesia.

       On May 27, 2008, Huck filed suit against the brand defendants,

PLIVA, and several other defendants no longer involved in the case. 3 Her

petition did not distinguish between the brand defendants and PLIVA,

instead referring to them collectively as “manufacturing defendants.” In

total, Huck pled thirteen claims against these manufacturing defendants:

(1) strict products liability, (2) strict liability for a manufacturing defect,

(3) strict liability for a design defect, (4) breach of express warranty, (5)

breach of implied warranties (based on inadequate warnings), (6)

negligence       (based    on     inadequate       warnings),      (7)    negligent
misrepresentation, (8) breach of undertaking a special duty, (9) fraud

and    misrepresentation,       (10)   constructive     fraud,   (11)    fraud    by

concealment, (12) violation of the Iowa Unfair Trade Practices Act, and

(13) intentional infliction of emotional distress.

       3Huck’s petition also named as defendants two of her physicians, Trimark
Physicians Group, and Barr Laboratories (PLIVA’s parent company). The district court
granted summary judgment in favor of Barr Laboratories after Huck failed to serve the
company with original notice. Huck’s physicians and Trimark Physicians Group were
later granted summary judgment based on Huck’s failure to timely file expert
designations. Huck did not appeal the summary judgments for those parties.
                                            11

       Huck filed a “Notice of Product Identification” on October 6

admitting she ingested only generic metoclopramide manufactured by

PLIVA.        In response, the brand defendants moved for summary

judgment.       Huck filed no resistance.          On March 2, 2009, the district

court granted the brand defendants’ unresisted motion for summary

judgment on all claims. The district court noted it was undisputed that

the brand defendants “did not manufacture or sell the generic

metoclopramide ingested by [Huck]” and, citing Mulcahy, concluded

Huck’s claims against the brand defendants therefore failed as a matter

of law.    Huck did not file a motion for reconsideration or immediately

appeal the ruling.

       For the next two and one-half years, Huck pursued her claims

against PLIVA, the only remaining defendant.                  On February 26, 2010,

PLIVA filed two motions for summary judgment, one arguing no genuine

issues of material fact existed and the other arguing Huck’s claims were

preempted by federal law.             On April 12, the district court ruled on

PLIVA’s motions.         First, the district court rejected PLIVA’s preemption

argument.       The district court also ruled that a factual dispute existed

relating to whether Huck would not have ingested metoclopramide had

she received (or, if the learned intermediary doctrine is applied, her

physician received 4) an adequate warning.                   The district court then

dismissed several of Huck’s claims, 5 but her common law claims for

       4The   learned intermediary doctrine is not at issue in this appeal.
       5The   district court dismissed the following claims: strict liability for failure to
warn, strict liability for design defect, design defect, strict liability for manufacturing
defect, breach of express warranty, breach of implied warranty (excluding breach of
implied warranty of merchantability), fraud (to the extent they are not based on
nondisclosure), breach of undertaking a special duty, the Unfair Trade Practice Act,
intentional infliction of emotional distress. Huck does not appeal the dismissal of those
claims.
                                         12

breach of the implied warranty of merchantability, negligence (based on

failure    to     warn),     negligent        misrepresentation,    fraud      and

misrepresentation, constructive fraud, and fraud by concealment were

allowed to proceed. Trial was set for February 7, 2011.

      On December 14, 2010, PLIVA moved to stay all deadlines and

continue the trial based on the United States Supreme Court’s grant of

certiorari in Mensing, which consolidated two lawsuits involving state

tort-law claims against generic metoclopramide manufacturers. 564 U.S.

___, 131 S. Ct. 2572–73, 180 L. Ed. 2d 586–87.               The district court

granted the stay, acknowledging that two of the cases it had relied on in

its denial of PLIVA’s preemption motion were at issue in the Mensing

appeal. See id. at ___, 131 S. Ct. at 2573, 180 L. Ed. 2d at 587.

      After Mensing held federal preemption precluded plaintiffs’ failure-

to-warn claims, see id. at ___, 131 S. Ct. at 2580–81, 180 L. Ed. 2d at

595, PLIVA again moved to dismiss Huck’s claims based on federal

preemption. Additionally, on September 26, 2011, Huck filed a “Motion

for Relief” from the 2009 summary judgment dismissing the brand

defendants. Huck invoked the district court’s “inherent power to correct

interlocutory     errors”   and   argued      Mensing’s   holding   that    generic

manufacturers do not have the ability to unilaterally strengthen drug

labels necessarily shifted responsibility for generic manufacturers’

insufficient labeling to brand manufacturers, who are able to unilaterally

strengthen labels.      Asserting the Mensing decision overturned prior

precedent, Huck asked the court to reinstate her claims against the

brand defendants.

      On January 9, 2012, the district court ruled on the pending

motions.        Regarding Huck’s motion for relief, the district court

highlighted that it granted the brand defendants’ summary judgment
                                     13

“based upon the rule in Iowa ‘that a Plaintiff in a products liability action

bears the burden of proving the Defendant manufactured or supplied the

product that caused the injury.’ Mulcahy v. Eli Lilly & Co., 386 N.W.2d

67, 69 (Iowa 1986).”     The court further concluded Huck’s argument

based on Mensing was meritless and denied the motion for relief as to the

brand defendants. The district court granted PLIVA summary judgment

on grounds of federal conflict preemption.

      Huck appealed both the district court’s grant of summary

judgment in favor of PLIVA and its denial of her motion for relief against

the brand defendants. We transferred the case to the court of appeals,

which affirmed the district court’s rulings.    The court of appeals held

Huck’s claims against PLIVA “attack the adequacy of the labeling” and

therefore are preempted because they “fall[] within Mensing’s sphere.”

The court of appeals specifically rejected Huck’s argument that PLIVA

can be held liable for failing to update its label to provide the additional

bolded warning approved in 2004, reasoning federal law prohibits private

attempts to enforce a generic manufacturer’s obligation to match the

brand manufacturer’s label.     As to the brand defendants, the court of

appeals noted Huck failed to resist their motion for summary judgment,

file a postjudgment motion, or immediately appeal the summary

judgment.    Consequently, the court of appeals concluded the only

preserved issue relating to that summary judgment ruling is the issue

explicitly decided by the district court: whether the brand defendants

owed Huck a duty under Iowa law when she did not ingest a product

manufactured or sold by them. The court of appeals held Mensing did

not alter state-law principles requiring the dismissal of a claim brought

against a defendant whose product plaintiff never used.

      We granted Huck’s application for further review.
                                       14

       II. Standard of Review.

       We review rulings that grant summary judgment for correction of

errors at law.   Parish v. Jumpking, Inc., 719 N.W.2d 540, 542 (Iowa

2006).    Summary judgment is appropriate when there is no genuine

issue of material fact and the moving party is entitled to judgment as a

matter of law. Iowa R. Civ. P. 1.981(3). “A fact is material if it will affect

the outcome of the suit, given the applicable law.” Parish, 719 N.W.2d at

543.     “An issue of fact is ‘genuine’ if the evidence is such that a

reasonable finder of fact could return a verdict or decision for the

nonmoving party.” Id. We view the evidence in the light most favorable

to the nonmoving party.      Id.   Summary judgment is properly granted

when the moving party shows “the nonmoving party has no evidence to

support a determinative element of that party’s claim.” Id.

       We may review the issues actually decided in a ruling granting an

unresisted motion for summary judgment when the nonmoving party

filed a postjudgment motion that gave the district court the opportunity

to correct the alleged error. See Cooksey v. Cargill Meat Solutions Corp.,

831 N.W.2d 94, 98–99 (Iowa 2013); id. at 107 (Mansfield, J. dissenting);

Otterberg v. Farm Bureau Mut. Ins. Co., 696 N.W.2d 24, 28 (Iowa 2005)

(noting the party moving for summary judgment has the burden “to show

the district court that there was no genuine issue of material fact and

that it was entitled to a judgment as a matter of law”); Bill Grunder’s

Sons Constr., Inc. v. Ganzer, 686 N.W.2d 193, 197–98 (Iowa 2004) (“[T]he

nonmovant must at least preserve error by filing a motion following entry

of [the unresisted summary] judgment, allowing the district court to

consider the claim of deficiency.”).
                                    15

      III. Analysis.

      A. Whether Any of Huck’s Claims Against PLIVA Survive

Mensing. We must decide whether the district court correctly ruled that

all of Huck’s claims against PLIVA are preempted by Mensing. Applying

Mensing, the district court ruled Huck’s claims against PLIVA are

preempted because it was impossible for PLIVA to alter its label.      The

court of appeals agreed. Huck argues Mensing preempts only claims that

require the generic manufacturer to vary its labeling from that of the

branded drug.    She points out that PLIVA failed to update its label in

2004 to include the FDA-approved warning stating, “Therapy should

not exceed 12 weeks in duration.”        Mensing did not decide whether

that claim is preempted. The Court of Appeals for the Sixth Circuit in

Fulgenzi, however, recently adjudicated this very issue and squarely held

Mensing does not preempt claims based on the generic manufacturer’s

failure to update its label warning with the language the FDA approved in

2004. Fulgenzi, 711 F.3d at 584. As the Sixth Circuit observed, “not

only could PLIVA have independently updated its labeling to match [the

warning added in 2004], it had a federal duty to do so.”      Id. (citation

omitted).   We find Fulgenzi persuasive and hold Huck’s claims survive

preemption to the extent they are based on PLIVA’s failure to adopt the

additional warning language approved by the FDA in 2004.

      The federal preemption doctrine derives from the Supremacy

Clause of the Federal Constitution. See Ackerman v. Am. Cyanamid Co.,

586 N.W.2d 208, 211 (Iowa 1998).         Under the doctrine of conflict

preemption, “[when] state and federal law directly conflict, state law must

give way.” Mensing, 564 U.S. at ___, 131 S. Ct. at 2577, 180 L. Ed. 2d at

592 (internal quotation marks omitted). But, “[t]here is a presumption

against preemption which counsels a narrow construction of preemption
                                          16

provisions.” Ackerman, 586 N.W.2d at 213. We must evaluate each of

Huck’s     surviving     claims 6—breach        of   the    implied     warranty      of

merchantability, negligence (based on failure to warn), negligent

misrepresentation, fraud and misrepresentation, constructive fraud, and

fraud by concealment—“to determine if it is impossible for PLIVA to

comply with both the state-law duties underlying those claims and its

federal labeling duties” or if state law “would obstruct the purposes and

objectives of federal drug labeling regulation.” See Levine, 555 U.S. at

568, 573, 129 S. Ct. at 1196, 1199, 173 L. Ed. 2d at 62, 65.

       We will first evaluate her claims to determine if they make it

impossible for PLIVA to comply with both state and federal law. Next, we

will decide if her claims pose an obstacle to the purposes and objectives

of Congress.      Finally, we will consider PLIVA’s argument that Huck’s

claims violate a federal law prohibiting private enforcement of the FDCA. 7

       6PLIVA  argues Huck preserved error only as to her failure-to-warn and breach-
of-implied-warranty claims. When PLIVA moved for summary judgment in the wake of
Mensing, Huck resisted this motion and argued her claims were still viable. On
January 5, 2012, the district court dismissed all of Huck’s remaining claims as
preempted by Mensing. In her motion for reconsideration, Huck mentioned only her
failure-to-warn claims and breach-of-implied-warranty claims.        Nevertheless, we
consider error preserved as to the additional claims because Huck resisted summary
judgment and argues those claims on appeal.
       7PLIVA argues that Huck cannot base her failure-to-warn claim on the 2004

label update because she has asserted the label was inadequate even with the
additional language. The court of appeals agreed, concluding, “Iowa law does not
provide a cause of action for failing to disseminate allegedly inadequate warnings.” This
mischaracterizes the issue. This argument—that “there is no such thing as a ‘failure to
inadequately warn’ ”—was rejected by the Sixth Circuit. Fulgenzi, 711 F.3d at 587–88.
As that court observed:
       It may well be more difficult to prove proximate causation in a case
       where the warning that the defendant failed to provide was also legally
       inadequate. But there is no reason to believe that a severely inadequate
       warning would never cause an injury that a moderately inadequate
       warning would have prevented. A plaintiff need not prove that the
       alternative warning would have been objectively reasonable, only that it
       would most likely have prevented the injury in this case.
                                           17

       1. Impossibility preemption.          We first consider Huck’s negligence

claim based on PLIVA’s failure to warn. Huck concedes her failure-to-

warn claim is preempted to the extent it required PLIVA to adopt a label

different than that of the approved brand label, but argues she can base

her common law negligence claim on PLIVA’s failure to adopt the

language approved in the 2004 warning against use of metoclopramide

for longer than twelve weeks. We agree.

       The facts of this case present a narrow path around Mensing

preemption. Once the additional warning language was approved by the

FDA in July 2004, PLIVA needed only to go through the “changes being

effected” process to revise its label to match the updated brand-name
___________________________
              . . . [I]t is sufficiently plausible that the use of a neutral warning
       disavowing approval instead of a bold-faced warning affirmatively
       discouraging long-term use proximately caused [plaintiff’s] injury.
       Whether in fact these allegations are true is a matter for further
       proceedings.
Id. We agree with the Fulgenzi court’s reasoning.
          The court of appeals also stated, “Huck has not argued these [2004 updated]
warnings—providing what she argued is faulty information—would have prevented the
harm she suffered.” We do not find Huck has conceded that issue. To the contrary,
Huck successfully resisted PLIVA’s motion for summary judgment, in which PLIVA
argued Huck was unable to prove that if she or her physician “had received an adequate
warning, she would not have ingested the drug.” The district court denied PLIVA’s
motion, finding that based on the record provided fact issues precluded summary
judgment. Cf. Clinkscales v. Nelson Sec., Inc., 697 N.W.2d 836, 841 (Iowa 2005) (“[W]e
reiterate the well-settled maxim that questions of negligence or proximate cause are
ordinarily for the jury—only in exceptional cases should they be decided as a matter of
law.”); Lovick v. Wil-Rich, 588 N.W.2d 688, 700 (Iowa 1999) (affirming denial of directed
verdict on failure-to-warn claim; noting “proximate cause can be established by showing
a warning would have altered the plaintiff’s conduct so as to avoid injury”); see also
Restatement (Third) of Torts: Prods. Liab. § 2 cmt. i, illus. 11, at 31 (1998) (“Whether
the warning actually given was reasonable in the circumstances is to be decided by the
trier of fact.”); cf. In re Prempro Prods. Liab. Litig., 586 F.3d 547, 569 (8th Cir. 2009)
(“ ‘[[T]]he vast majority of jurisdictions hold that where a warning is inadequate, the
plaintiff is entitled to a rebuttable presumption that an adequate warning would have
been heeded if one had been given.’ ” (quoting Thom v. Bristol–Myers Squibb Co., 353
F.3d 848, 855 (10th Cir. 2003)). We decide today only the preemption issue as to
Huck’s claims against PLIVA and leave for further proceedings issues concerning the
adequacy of PLIVA’s warnings and whether an updated warning in 2004 would have
reached Huck or her physicians and altered her behavior.
                                        18

label. See Mensing, 564 U.S. at ___, 131 S. Ct. at 2575, 180 L. Ed. 2d at

589–90 (citing the FDA’s interpretation of 21 C.F.R. § 314.94(a)(8)(iv) )).

This process allows manufacturers to update their label without waiting

for FDA approval. Id. at ___, 131 S. Ct. at 2575, 180 L. Ed. 2d at 589.

Though the FDA could have rejected PLIVA’s request after the fact, such

a rejection would have been unlikely. Cf. Levine, 555 U.S. at 571, 129

S. Ct. at 1198, 173 L. Ed. 2d at 64 (“[A]bsent clear evidence that the FDA

would not have approved a change to [defendant’s] label, we will not

conclude that it was impossible for [defendant] to comply with both

federal and state requirements.”). Accordingly, it was not impossible for

PLIVA to update its label and send informational letters consistent with

the updated language, warning health care professionals and consumers

that metoclopramide therapy should not exceed twelve weeks.                 To the

contrary, PLIVA had a federal duty to match its label to Wyeth’s. See 21

U.S.C. § 331(a) (prohibiting the introduction into interstate commerce

any drug that is misbranded); 21 C.F.R. §§ 314.94(a)(8)(iii) (requiring

generic   applicant     to   match     label   of   brand    drug);    21   C.F.R.

§ 314.150(b)(10) (providing FDA may withdraw drug approval if the

generic’s label “is no longer consistent with that for [the brand-name]”);

see also Fulgenzi, 711 F.3d at 584 (“[C]ompliance with federal and state

duties was not just possible; it was required.”). We therefore conclude

Huck’s state-law negligent failure-to-warn claim is not preempted by

federal labeling regulations to the extent it is based on PLIVA’s failure to

adopt the additional warning language approved in 2004.                 A growing

number of courts have reached the same conclusion. 8

       8These courts include: Neeley v. Wolters Kluwer Health, Inc., No. 4:11-CV-325
JAR, 2013 WL 3929059, at *9 (E.D. Mo. July 29, 2013); Phelps v. Wyeth, Inc., 938
F. Supp. 2d 1055, 1061 (D. Or. 2013); Johnson v. Teva Pharm. USA, Inc., No. 2: 10 CV
404, 2012 WL 1866839, at *3 (W.D. La. May 21, 2012); Cooper v. Wyeth, Inc., No. 09–
                                          19

       Moving to Huck’s remaining claims, we note at the outset that

“there is no general, inherent conflict between federal pre-emption [sic] of

state warning requirements and the continued vitality of state common-

law damages actions.” Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 518,

112 S. Ct. 2608, 2618, 120 L. Ed. 2d 407, 424 (1992). “Of course any

direct challenge to the adequacy of a label or warning is preempted.”

Ackerman, 586 N.W.2d at 213. But, “[w]e also examine whether a claim

is merely another way of alleging the label or warning was inadequate.

Such an indirect challenge is also preempted.”               Id.   If Huck’s claims

against PLIVA do not require the company to change its labeling to differ

from that of the approved label, they are not preempted. See id. (“[O]ur

task remains to identify whether [plaintiff’s] claims are predicated upon

labeling and packaging requirements in addition to and different from

those required by [federal law].”).

       Huck argues her claims for negligent testing and postmarket

surveillance thus are not preempted. But, “merely to call something a

design or testing claim does not automatically avoid [the] preemption

clause.” Id. at 214. The line between a claim for mislabeling and a claim

for negligent testing is “razor thin.” See id.

___________________________
929–JJB, 2012 WL 733846, at *4 (M.D. La. Mar. 6, 2012); Lyman v. Pfizer, Inc.,
No. 2:09-cv-262, 2012 WL 368675, at *5–6 (D. Vt. Feb. 3, 2012); Couick v. Wyeth, Inc.,
No. 3:09–cv–210–RJC–DSC, 2012 WL 79670, at *5 (W.D.N.C. Jan. 11, 2012); Del Valle
v. PLIVA, Inc., No. B:11–113, 2011 WL 7168620, at *5 (S.D. Tex. Dec. 21, 2011); Fisher,
817 F. Supp. 2d at 805; In re Reglan Litig., No. 289, 2012 WL 1613329 (N.J. Super. Ct.
Law Div. May 4, 2012); Hassett v. Dafoe, 74 A.3d 202, 216 (Pa. Super. Ct. 2013); see
also Teva Pharm. USA, Inc. v. Super. Ct., 158 Cal. Rptr. 3d 150, 158 (Ct. App. 2013)
(relying on Fulgenzi to hold failure-to-warn claim not preempted when generic
manufacturers of alendronate sodium did not mirror the branded Fosamax label). In
contrast, the Court of Appeals for the Fourth Circuit recently affirmed a summary
judgment dismissing all claims against PLIVA based on Mensing’s impossibility or
conflict preemption, while expressly noting the 2004 update theory was not timely made
in that case. Drager v. PLIVA USA, Inc., 741 F.3d 470, 474–76 (4th Cir. 2014).
                                       20
      [T]he rule is that a claim based on negligent or inadequate
      testing will not be considered a disguised label-based
      challenge if adequate testing would have caused the
      manufacturer to alter the product itself. Conversely, the rule
      is that if defendant could remedy any problems with its
      product, that it learned about through adequate testing, by
      altering the product’s label rather than by changing the
      product, then any challenge concerning negligent testing is
      preempted.

Wright v. Am. Cyanamid Co., 599 N.W.2d 668, 673 (Iowa 1999).

      Federal drug regulation adds a wrinkle to the application of this

rule: generic manufacturers are prohibited from altering the composition

of a drug because they must mirror the formulation of the brand-

manufacturer drug.          See, e.g., 21 U.S.C. § 355(j)(2)(A) (requiring

bioequivalence); id. § 355(j)(2)(A)(ii), (iii) (requiring generic drug to have

the same “active ingredients,” “route of administration,” “dosage form,”

and   “strength”     as   its   brand-name   counterpart);   id.   § 355(j)(8)(B)

(requiring the same “rate and extent of absorption”).         Moreover, both

generic and brand manufacturers are prohibited from making major

changes to the “qualitative or quantitative formulation of the drug

product, including active ingredients, or in the specifications provided in

the approved application” after their drug is approved.              21 C.F.R.

§ 314.70(b)(2)(i).

      In light of these regulations, the only way for PLIVA to avoid

liability for negligent testing would be to withdraw from the market. This

issue is addressed by Mutual Pharmacy Co. v. Bartlett, 570 U.S. ___, ___

133 S. Ct. 2466, 2477, 186 L. Ed. 2d 607, 622–23 (2013). In Bartlett, the

Supreme Court rejected the “stop selling” argument because “if the

option of ceasing to act defeated a claim of impossibility, impossibility

pre-emption [sic] would be ‘all but meaningless.’ ” Id. at ___, 133 S. Ct.

at 2477–78, 186 L. Ed. 2d at 622 (quoting Mensing, 564 U.S. at ___, 131

S. Ct., at 2579, 180 L. Ed. 2d at 594) (noting “[j]ust as the prospect that
                                    21

a regulated actor could avoid liability under both state and federal law by

simply leaving the market did not undermine the impossibility analysis

in [Mensing], so it is irrelevant to our analysis here”). But, as with her

failure-to-warn   claim,   we   conclude   Huck’s   negligent-testing   and

postmarket-surveillance claims avoid preemption to the extent the claims

are based on PLIVA’s failure to adopt the 2004 label change. Cf. Wright,

599 N.W.2d at 675 (concluding negligent testing claim was “a disguised

label-based claim” preempted by federal law).

      Huck next argues her claim of breach of the implied warranty of

merchantability based on warning defects escapes Mensing preemption

because (1) metoclopramide was unfit “for the ordinary purposes for

which such goods are used”—namely, for prolonged therapy; (2) PLIVA

did not include the revised 2004 label limiting the duration of use to

twelve weeks; and (3) metoclopramide did not conform to the statements

of fact that appear on its label.   See Iowa Code § 554.2314(c), (e), (f)

(2005). Once more, we agree this claim may proceed if she is able to

ground it on PLIVA’s failure to adopt the 2004 additional approved

warning. See Fisher, 817 F. Supp. 2d at 821 (denying PLIVA’s motion for

summary judgment on implied warranty of merchantability because “the

Court does not find as a matter of law that long-term use was not an

ordinary purpose for which metoclopramide was used”); see also Wright

v. Brooke Grp. Ltd., 652 N.W.2d 159, 182 (Iowa 2002) (citing the

Restatement (Third) of Torts: Prods. Liab. § 2(b)–(c), at 14 (1998) as

authority to allow breach of the implied warranty of merchantability

claim based on inadequate warnings); cf. Ackerman, 586 N.W.2d at 213–

14 (dismissing claim of breach of implied warranty of merchantability

based on federal preemption).
                                          22

       Finally, Huck appeals the dismissal of her claims alleging fraud,

misrepresentation, constructive fraud, and fraud by concealment. Our

common law recognizes fraud claims by a consumer against a product

manufacturer who “made misleading statements of fact intended to

influence consumers” or “made true statements of fact designed to

influence consumers and subsequently acquire[d] information rendering

the prior statements untrue or misleading.”                Brooke Grp. Ltd., 652

N.W.2d at 177 & n.4 (declining to decide whether such claims were

preempted). We conclude her fraud and misrepresentation claims escape

preemption to the extent they are based on the additional 2004 warning

language PLIVA failed to adopt.

       2. Purposes and objectives analysis.             Next, we must consider

whether state tort suits against generic manufacturers would frustrate

the purposes and objectives of Congress, thus warranting preemption.9

In Levine, the Court held suits against Reglan manufacturers would not

obstruct the purposes and objectives of federal drug labeling regulation.

Levine, 555 U.S. at 573, 129 S. Ct. at 1199, 173 L. Ed. 2d at 65. We

reach the same conclusion with respect to Huck’s claims against PLIVA.

       Levine recognized that Congress has not provided a federal remedy
for consumers harmed by prescription drugs and, as such, “state law

offers an additional, and important, layer of consumer protection that

complements FDA regulation.” Id. at 574, 579, 129 S. Ct. at 1200, 1202,

173 L. Ed. 2d at 66, 69 (noting additionally that, “[i]f Congress thought

state-law suits posed an obstacle to its objectives, it surely would have

       9Because  defendants in Mensing argued only that it was impossible for a generic
manufacturer to unilaterally strengthen its label without running afoul of federal law,
the Mensing opinion did not consider the purposes and objectives prong of the conflict
preemption analysis. 564 U.S. at ___, 131 S. Ct. at 2587, 180 L. Ed. 2d at 602–03
(Sotomayor, J., dissenting).
                                    23

enacted an express pre-emption [sic] provision at some point during the

FDCA’s 70–year history”); see also Bates v. Dow Agrosciences LLC, 544

U.S. 431, 451, 125 S. Ct. 1788, 1802, 161 L. Ed. 2d 687, 707 (2005)

(“Private remedies that enforce federal misbranding requirements would

seem to aid, rather than hinder, the functioning of [federal law].”). The

Levine Court’s reasoning on this issue applies to state tort claims against

both generic and brand manufacturers:

      State tort suits uncover unknown drug hazards and provide
      incentives for drug manufacturers to disclose safety risks
      promptly. They also serve a distinct compensatory function
      that may motivate injured persons to come forward with
      information. Failure-to-warn actions, in particular, lend
      force to the FDCA’s premise that manufacturers, not the
      FDA, bear primary responsibility for their drug labeling at all
      times.

555 U.S. at 579, 129 S. Ct. at 1202, 173 L. Ed. 2d at 68–69.

      The Sixth Circuit’s decision in Fulgenzi reinforces our conclusion

that Huck’s claims against PLIVA do not frustrate congressional goals.

In Fulgenzi, the court considered the differences between brand and

generic manufacturers, singling out the “promotion of generic drugs, and

the attendant reduction in costs” as “[t]he most easily identifiable policy”

of the FDCA.    711 F.3d at 585.     “Permitting state tort actions to go

forward against generic-drug manufacturers [as opposed to brand

manufacturers], the argument goes, would increase costs and reduce

usage.” Id. Yet, the Fulgenzi court held this hypothetical difference does

not justify preemption. Id. Citing the Mensing dissenters’ observation

that “the inability to sue for inadequate warnings may actually reduce

consumer demand,” Fulgenzi reasoned “[t]his is an empirical question,

and we should not affirmatively answer on the basis of mere speculation

about Congressional purposes.” 711 F.3d at 585. The court concluded:
                                    24
      It is hard to see how permitting state tort suits to go forward
      against sameness-violating generic defendants frustrates
      federal policies where permitting suits against FDA-compliant
      branded defendants does not. A vague policy of encouraging
      use of generic drugs, untethered from the structure of the
      Act, is not enough to support purposes-and-objectives
      preemption.

Id. at 586 (citation omitted). We agree with this analysis and hold Huck’s

claims survive impossibility preemption.

      3. Private right of action. PLIVA argues Huck’s claims are merely

attempts to enforce the FDCA, which 21 U.S.C. § 337(a) disallows. The

court of appeals and district court agreed.     That section states: “[A]ll

such proceedings for the enforcement, or to restrain violations, of this

chapter shall be by and in the name of the United States.” 21 U.S.C.

§ 337(a). This provision ensures private suits do not “deprive the [FDA]

of the ability to use its enforcement authority to achieve a delicate

balance of statutory objectives.” Fulgenzi, 711 F.3d at 586. PLIVA reads

§ 377(a) to mean “private litigants are barred from asserting claims

involving violations of the FDCA or FDA’s implementing regulations.” We

disagree and instead conclude Huck’s claims—as limited by our decision

today—are based on traditional state tort law principles that supplement

federal requirements.

      This case presents us with a “situation[] implicating ‘federalism

concerns and the historic primacy of state regulation of matters of health

and safety,’ ” a situation governed by a presumption against preemption.

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S. Ct.

1012, 1017, 148 L. Ed. 2d 854, 861 (2001) (quoting Medtronic, Inc. v.

Lohr, 518 U.S. 470, 485, 116 S. Ct. 2240, 2250, 135 L. Ed. 2d 700, 715

(1996)). “Where [a] claim is based on traditional state-tort-law principles,

the lack of a private cause of action within a federal regulatory scheme

will not preempt the claim for damages (even if state regulations might be
                                           25

preempted).” Fulgenzi., 711 F.3d at 586; accord Silkwood v. Kerr-McGee

Corp., 464 U.S. 238, 255, 104 S. Ct. 615, 625, 78 L. Ed. 2d 443, 457

(1984) (“[T]raditional principles of state tort law . . . apply with full force

unless they [are] expressly supplanted.”). Likewise, an independent state

law cause of action that parallels federal requirements is permissible.

See Riegel v. Medtronic, Inc., 552 U.S. 312, 330, 128 S. Ct. 999, 1011,

169 L. Ed. 2d 892, 906 (2008) (“[The express preemption provision in the

Medical Device Amendments to the FDCA] does not prevent a State from

providing a damages remedy for claims premised on a violation of FDA

regulations; the state duties in such a case ‘parallel,’ rather than add to,

federal requirements.”); Lohr, 518 U.S. at 495, 116 S. Ct. at 2255, 135

L. Ed. 2d at 721 (“Nothing in [the statute] denies Florida the right to

provide a traditional damages remedy for violations of common-law

duties when those duties parallel federal requirements.”).        “But if the

claims ‘exist solely by virtue of’ the regulatory scheme, they are

preempted.” Fulgenzi, 711 F.3d at 586 (quoting Buckman, 531 U.S. at

353, 121 S. Ct. at 1020, 148 L. Ed. 2d at 864 (finding “fraud on the FDA”

claim preempted because “the existence of . . . federal enactments is a

critical element” of plaintiff’s case)).

      Huck’s petition does not attempt to allege a prohibited private

federal cause of action under the FDCA.             Rather, she alleges state

common law tort and warranty theories that exist regardless of whether

the FDCA required a duty of sameness.             Indeed, Huck could try her

claims without reference to the FDCA.           Cf. Fulgenzi, 711 F.3d at 588

(noting “the logic of Buckman would encourage exclusion of evidence of

federal-law violations where possible”). Fundamentally, with variations

on a theme, she asserts:
                                           26
       (1) PLIVA had a duty to warn her that she should not take
       metoclopramide for longer than twelve weeks. 10
       (2) PLIVA breached this duty.
       (3) Huck took metoclopramide for longer than twelve weeks
       because she was not instructed otherwise.
       (4) Huck suffered damages as a result                       of   ingesting
       metoclopramide for more than twelve weeks.

Neither the federal duty of sameness nor the duty to report safety risks to

the FDA are “critical element[s]” of her state law claims. 11 See Buckman,

531 U.S. at 353, 121 S. Ct. at 1020, 148 L. Ed. 2d at 864. Federal law

has limited the way in which she can frame her claim: she cannot raise a

claim based on labeling that would require PLIVA to unilaterally

strengthen its label. She has managed to avoid that difficulty because

PLIVA did not include the additional 2004 approved language. In sum,

Huck’s claims fit into a “narrow gap”: she is suing for conduct that

violates the FDCA, but she is not suing because the conduct violates the

FDCA. See In re Medtronic, Inc., 623 F.3d 1200, 1204 (8th Cir. 2010)

(internal quotation marks omitted).

       B. The Brand Defendants. We next address whether the district

court correctly entered summary judgment dismissing Huck’s claims

       10This is distinct from the duty of label sameness imposed by federal law. If
Huck premised her claim upon the duty of sameness, it would be preempted as an
attempt to enforce federal law. See Fulgenzi, 711 F.3d at 588–89. Yet, we do not expect
Huck to try her case without reference to the fact that the FDA approved a warning
against prolonged use in 2004. We agree with the Fulgenzi court:
       Although federal-law violations here are not as relevant as they would be
       in a negligence per se case, references to federal law will inevitably arise.
       To avoid Mensing preemption, [plaintiff] must use the language of the
       2004 FDA-approved label in her proximate-cause argument, not (or not
       merely) the fact of the failure to update. Federal standards are also likely
       to arise in determining the adequacy of PLIVA’s warning, since FDA
       approval and industry practices may be relevant to the state duty of care.
Id.
       11In  contrast, “[f]ailure to update from one adequate warning to another would
violate the FDCA, but not [state] law.” Fulgenzi, 711 F.3d at 586–87.
                                          27

against the brand defendants based on the undisputed fact that Huck

consumed       only    the    generic    formulation      sold    by   PLIVA—their

competitor—and never used Reglan. The district court granted the brand

defendants’ unresisted motion for summary judgment, applying our

decision in Mulcahy.         The court of appeals affirmed, stating, “To the

minimal extent Huck argues Mulcahy is either distinguishable or not

applicable, we disagree and find the district court’s application of

Mulcahy is correct.”

       Mulcahy applied a well-settled requirement of Iowa law—the

plaintiff must prove injury caused by a product sold or supplied by the

defendant.     386 N.W.2d at 76.         This long-standing requirement bars

Huck’s recovery from the manufacturers of a brand she never used.12

Under Iowa law, manufacturers owe duties to those harmed by use of

their products. We decline to change Iowa law to impose a new duty on

manufacturers to those who never used their products and were instead

harmed by use of a competitor’s product.             The FDA has responded to

Mensing through a proposed rule to allow generic manufacturers to

update their labeling on their own, regardless of the brand manufacturer

labeling. See Proposed Rule, 78 Fed. Reg. at 67985. The rule change
would vitiate the preemption defense of generic manufacturers. This is

the appropriate way to address the unfairness resulting from Mensing,

rather than turning Iowa tort law upside down.

        12Our preservation-of-error rules permit us to review issues the district court

actually decided when granting an unresisted motion for summary judgment.
Otterberg, 696 N.W.2d at 27–28. The brand defendants agree error is preserved to
review whether the district court correctly entered summary judgment in their favor
based on Mulcahy. Huck gave the district court the opportunity to revisit the issue in
light of Mensing when she filed her motion for relief from judgment. See Ganzer, 686
N.W.2d at 197–98 (requiring postjudgment motion to preserve error for appellate review
of unresisted summary judgment). Accordingly, we conclude error is preserved.
                                      28

      Huck argues we should reinstate her claims against the brand

defendants because PLIVA was required to use the same warnings that

accompanied Reglan. An overwhelming majority of courts adjudicating

this issue have affirmed judgments or granted dispositive motions

dismissing claims against the brand defendants when the plaintiff used

only the generic formulation.       See, e.g., In re Darvocet, Darvon and

Propoxyphene Prods. Liab. Litig., ___ F.3d ___, ___, 2014 WL 2959271,

*17–18 (6th Cir. June 27, 2014) (affirming dismissal of claims against

brand defendants when plaintiffs consumed only generic painkiller;

applying laws of twenty-two states in a multidistrict litigation action with

sixty-eight lawsuits); Moretti v. Wyeth, Inc., ___ Fed. Appx. ___, ___, 2014

WL 2726886, at *1 (9th Cir. June 17, 2014) (affirming summary

judgment for brand defendants based on Nevada law); Lashley v. Pfizer,

Inc., 750 F.3d 470, 476–78 (5th Cir. 2014) (affirming summary

judgments for brand defendants because plaintiffs ingested only generic

metoclopramide); Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 406

(6th Cir. 2013) (noting “every federal court of appeals to consider this

issue has held that brand-name manufacturers are not liable to plaintiffs

who are injured by a generic manufacturer’s drug”); Schrock v. Wyeth,

Inc., 727 F.3d 1273, 1284–86 (10th Cir. 2013) (stating “the courts of

other states have overwhelmingly rejected the very theory advanced by

the Schrocks”); Guarino v. Wyeth, LLC, 719 F.3d 1245, 1252 (11th Cir.

2013) (“[T]he overwhelming national consensus—including . . . the vast

majority of district courts around the country to consider the question—

is that a brand-name manufacturer cannot be liable for injuries caused

by the ingestion of the generic form of a product.”); Bell v. Pfizer, Inc., 716

F.3d 1087, 1092–94 (8th Cir. 2013) (affirming summary judgment for

brand defendants because Bell never used Reglan and noting “ ‘[a]n
                                         29

overwhelming majority of courts considering this issue,’ including the

Eighth Circuit, have rejected Bell’s theory of liability” (quoting Mensing,

588 F.3d at 613)); Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th

Cir. 1994) (“There is no legal precedent for using a name brand

manufacturer’s statements about its own product as a basis for liability

for injuries caused by other manufacturers’ products, over whose

production the name brand manufacturer had no control.”). As the Sixth

Circuit     Court   of   Appeals   summarized,      “almost   every   court   has

. . . reason[ed] that a brand manufacturer does not owe a duty to a

consumer unless the consumer actually used the brand manufacturer’s

product.”     Darvocet ___ F.3d at ___, 2014 WL 2959271, at *4 (citing

Victor E. Schwartz, et. al., Warning: Shifting Liability to Manufacturers of

Brand–Name Medicines When the Harm Was Allegedly Caused by Generic

Drugs Has Severe Side Effects, 81 Fordham L. Rev. 1835, 1857–58 (2013)

[hereinafter Schwartz], which catalogs cases following the majority

trend).

      The Court of Appeals for the Tenth Circuit recently discussed three

principal     rationales    used    by    courts,   concluding    “brand-name

manufacturers are not liable to consumers of generic drugs”:

      First, they based their view on traditional common law tort
      principles under which a manufacturer is liable for injuries
      caused by its own product. See, e.g., Mensing, 588 F.3d at
      604, 613 (holding name brand manufacturers liable for harm
      caused by generic manufacturers “stretches the concept of
      foreseeability too far” (quotation and alteration omitted)).
      Second, they reason that brand-name manufacturers’
      warnings and representations do not create a basis for
      liability to consumers of competitors’ products because
      brand-name manufacturers only “intend[] to communicate
      with their customers, not the customers of their
      competitors.” Id. at 613 n.9; see also Stanley v. Wyeth, Inc.,
      991 So. 2d 31, 34 (La. Ct. App. 2008) (“A manufacturer
      cannot reasonably expect that consumers will rely on the
      information it provides when actually ingesting another
      company’s drug.”). Finally, they conclude that public policy
                                    30
      considerations   weigh     against    holding   name-brand
      competitors liable for injuries caused by their generic
      competitor’s drug. See, e.g., Foster, 29 F.3d at 170 (citing
      the expense in development, research, and promotion
      undertaken by name-brand manufacturers not undertaken
      by generic manufacturers).

Schrock, 727 F.3d at 1285. We agree with each rationale.

      In Mulcahy, we squarely held that “under Iowa common law a

plaintiff in a products liability case must prove that the injury-causing

product was a product manufactured or supplied by the defendant.” 386

N.W.2d at 76.    The brand defendants correctly argue this “product-

identification requirement is decisive here because it is undisputed

[Huck] did not use brand defendants’ product, but instead used a generic

equivalent product that was manufactured and sold by another

company”—PLIVA—their competitor.         We see no indication Congress

intended to alter common law principles of causation to create liability

for injuries caused by use of a competitor’s product. See Norfolk Redev.

& Hous. Auth. v. Chesapeake & Potomac Tel. Co. of Va., 464 U.S. 30, 35,

104 S. Ct. 304, 307, 78 L. Ed. 2d 29, 34 (1983) (“It is a well-established

principle of statutory construction that ‘[t]he common law . . . ought not

to be deemed to be repealed, unless the language of a statute be clear

and explicit for this purpose.’ ” (quoting Fairfax’s Devisee v. Hunter’s

Lessee, 11 U.S. (7 Cranch) 603, 623, 3 L. Ed. 453, 459–60 (1812))).

“Absent clearer indications, we cannot impute to Congress an intent to

repeal, sub silentio, this deeply-rooted legal principle.”   State Eng’r v.

S. Fork Band of Te-Moak Tribe of W. Shoshone Indians of Nev., 339 F.3d

804, 814 (9th Cir. 2003) (citing Norfolk, 464 U.S. at 35–36, 104 S. Ct. at

307, 78 L. Ed. 2d at 34, and discussing common law doctrine of prior

exclusive jurisdiction). We have never relaxed the product-identification

causation requirement to impose liability for injuries caused by the use
                                     31

of a competitor’s product, and we decline to do so here. Cf. Mulcahy, 386

N.W.2d at 76 (“The imposition of liability upon a manufacturer for harm

that it may not have caused . . . is an act more closely identified as a

function assigned to the legislature under its power to enact laws.”).

      Huck contends the product-identification causation requirement

does not apply to her negligent misrepresentation and fraud claims. We

disagree. The plaintiffs in Mulcahy sued pharmaceutical companies for

personal injuries resulting from the ingestion of DES, a synthetic

estrogen compound.      Id. at 69.   The plaintiffs “set forth theories of

recovery against the defendants based upon strict liability, negligence,

misrepresentation, breach of warranties, alternate liability, enterprise

liability, market share liability, and concert of action.”   Id. (emphasis

added).    We held the product-identification causation requirement

applied “ ‘[r]egardless of the theory which liability is predicated upon.’ ”

Id. at 72–73 (quoting Annotation, Products Liability: Necessity and

Sufficiency of Identification of Defendant Manufacturer or Seller of Product

Alleged to Have Caused Injury, 51 A.L.R.3d 1344 § 2[a], at 1349 (1973)).

      Moreover, the tort of negligent misrepresentation does not apply to

sellers of products but rather is limited to those in the business or

profession of supplying information for the guidance of others. See Pitts

v. Farm Bureau Life Ins. Co., 818 N.W.2d 91, 111–12 (Iowa 2012). “We

have found accountants, appraisers, school guidance counselors and

investment brokers all fall within this class of potential defendants.” Id.

at 112 (collecting cases). “However, we have refused to allow a suit for

negligent misrepresentation where the defendant was a retailer in the

business of selling and servicing merchandise . . . .” Id. Federal courts

applying Iowa law likewise hold the tort of negligent misrepresentation

does not apply to sellers of products:
                                    32
             Even if Plaintiff’s negligence actions were not barred by
      the contract’s limitation of remedies, Defendant would be
      entitled to summary judgment on Plaintiffs’ negligent
      misrepresentation claim. Plaintiffs concede that Meier v.
      Alfa–Laval, Inc., 454 N.W.2d 576 (Iowa 1990) applies in this
      case. The Meier court held that liability based on the tort of
      negligent misrepresentation was limited to those persons in
      the business of supplying information versus persons who
      give information incidental to selling goods. Id. at 581.
      Clearly Defendant’s business is more accurately described as
      selling goods than it is supplying information. In addition,
      even if Defendant were in the business of providing
      information, Plaintiffs’ claim would fail in that Defendant did
      not supply “false information for the guidance of others in
      their business transactions.” Restatement (Second) of Torts
      § 552(1) [(1965)]. Thus, summary judgment is appropriate
      as to Plaintiffs’ negligent misrepresentation claim.

Nelson v. DeKalb Swine Breeders, Inc., 952 F. Supp. 622, 628 (N.D. Iowa

1996), aff’d sub nom. Brunsman v. DeKalb Swine Breeders, Inc., 138 F.3d

358, 360 (8th Cir. 1998).

      Courts in the Reglan litigation have applied the same limiting

principles to dismiss negligent misrepresentation claims against brand

name manufacturers when the plaintiff used only the generic product.

See, e.g., Baymiller v. Ranbaxy Pharm., Inc., 894 F. Supp. 2d 1302, 1309–

10 (D. Nev. 2012) (noting that Nevada law “limited the application” of

section 552 to business transactions and concluding that because

plaintiff did not purchase the brand-name product, there was no

business transaction and section 552 did not apply); Strayhorn v. Wyeth

Pharm., Inc., 882 F. Supp. 2d 1020, 1030 (W.D. Tenn. 2012) (rejecting

plaintiffs’ claims of negligent and fraudulent representation against

brand manufacturers when the Tennessee Supreme Court had declined

to apply section 552 to fraudulent misrepresentation or in products

liability actions previously), aff’d, 737 F.3d 378, 383 (6th Cir. 2013);

Mosley v. Wyeth, Inc., 719 F. Supp. 2d 1340, 1345–46 (S.D. Ala. 2010)

(finding that section 552 did not apply in a products liability action
                                    33

against brand manufacturers and stating, “Under the restatement, drug

manufacturers cannot be classed, at least not in the same sense as

accountants and real estate appraisers, as ‘persons [who] make it a part

of their business . . . to supply information for the guidance of others in

their business transactions,’ ” and concluding, “under the facts of this

case Wyeth and Schwarz did not engage in any business transaction with

the Mosleys” (alternation in original) (citations omitted); see also

Darvocet, ___ F.3d at ___, 2014 WL 2959271, at *16–18 (“After

conducting a state-by-state Erie analysis, we conclude that the highest

courts in each of the 22 implicated states would not recognize Plaintiffs’

misrepresentation claims under their respective state laws.”).     We too

decline to extend the tort of negligent misrepresentation to the brand

defendants when Huck used only the generic drug sold by their

competitor.

      We did not retreat from the product-identification causation

requirement for fraud cases in Brooke Group Ltd., as Huck argues.

Rather, we noted the general rule that “a manufacturer’s failure to warn

or to disclose material information does not give rise to a fraud claim.”

Id. at 177. We noted two exceptions: “where the manufacturer (1) has

made misleading statements of fact intended to influence consumers, or

(2) has made true statements of fact designed to influence consumers

and subsequently acquires information rendering the prior statements

untrue or misleading.”      Id. (citing Restatement (Second) of Torts

§ 551(2)(b)–(c), at 119 (1977)). But, the exceptions were expressly based

on the existence of the relationship between the “customer/buyer and

manufacturer,” a relationship that created a duty. Id. We never held or

suggested a fraud claim could be brought by a plaintiff against a

manufacturer who owed the plaintiff no duty, as we conclude is the case
                                         34

here. Our decision in Brooke Group Ltd. also forecloses another liability

theory urged by Huck on appeal: “Good Samaritan” liability for a

voluntary undertaking.           See id. at 177–78 (holding marketing and

advertising on the health effects of smoking are not an “undertaking”

within the scope of Restatement (Second) of Torts section 323)).

      Huck argues we should revisit Mulcahy in light of our adoption of

section 7 13 of the Restatement (Third) of Torts: Liability for Physical and

Emotional Harm, at 77 (2010) in Thompson v. Kaczinski, 774 N.W.2d

829, 835 (Iowa 2009).           We disagree.    Thompson was not a products

liability case, and we have not applied section 7 of the Restatement

(Third) of Torts in products liability actions. Rather, in products liability

actions, we turn to the Products Restatement. See Brooke Group Ltd.,

652 N.W.2d at 167. Huck cannot evade the proof requirements of Iowa

products liability law merely by labeling her claim as a common law

negligent failure-to-warn theory. Her claims arise from injuries from her

use of a product—PLIVA’s generic metoclopramide. Products liability law

broadly refers to the legal responsibility for injury resulting from the use

of a product. Bingham v. Marshall & Huschart Mach. Co., 485 N.W.2d 78,

79 (Iowa 1992). It encompasses the theories of negligence, strict liability

and breach of warranty. Id. Although each is a separate and distinct

theory of recovery, the same facts often give rise to all three claims. See

id.   “The underlying theories ordinarily concern improper design,

inadequate warnings, or mistakes in manufacturing.” Smith v. Air Feeds,

      13Section   7 provides:
            (a) An actor ordinarily has a duty to exercise reasonable care
      when the actor's conduct creates a risk of physical harm.
              (b) In exceptional cases, when an articulated countervailing
      principle or policy warrants denying or limiting liability in a particular
      class of cases, a court may decide that the defendant has no duty or that
      the ordinary duty of reasonable care requires modification.
                                     35

Inc., 519 N.W.2d 827, 830 (Iowa Ct. App. 1994) (emphasis added). Thus,

the Products Restatement applies to this case and its specific provisions

control over general tort principles found in the Restatement (Third) of

Torts provisions adopted in Thompson.

      Moreover, section 7 of the Restatement (Third) of Torts addresses

duty, not causation. See Restatement (Third) of Torts: Liab. for Physical

Harm § 7, at 77.     We have never applied section 7 to eliminate the

requirement that the plaintiff prove her injuries were caused by a

product sold or supplied by the defendant or to impose liability for

injuries caused by a competitor’s product. Nor has any other appellate

court in the country. The product-identification requirement applied in

Mulcahy remains good law. The Sixth Circuit Court of Appeals, applying

Nebraska law, expressly rejected the argument that section 7 supported

imposing liability on brand defendants for injuries of consumers of the

generic competing product. Darvocet, ___ F.3d at ___, 2014 WL 2959271,

at *27–28.

      Huck points to no provision of the Products Restatement that

would eliminate Mulcahy’s product-identification causation requirement

or that would impose liability on a defendant whose product the plaintiff

never used. We adopted sections 1 and 2 of the Products Restatement in

Brooke Group Ltd., 652 N.W.2d at 169. Those provisions require proof

the defendant’s product injured the plaintiff. Section 1 provides, “One

. . . who sells or distributes a defective product is subject to liability for

harm to persons or property caused by the defect.” Restatement (Third)

of Torts: Prods. Liab. § 1, at 5.     Section 2 defines defect to include
                                            36

inadequate warnings or instructions. 14                 Id. § 2, at 14.      Section 6

specifically addresses prescription drugs and imposes “liability for harm

to persons caused by the defect.” Id. § 6(a), at 144. Section 15 provides,

“Whether a product defect caused harm to persons or property is

determined by the prevailing rules and principles governing causation in

tort.”     Id. § 15, at 231.        The prevailing rule requires cause-in-fact

causation.      See Restatement (Third) of Torts: Liab. for Physical Harm

§ 26, at 346 (“Conduct is a factual cause of harm when the harm would

not have occurred absent the conduct.”). Cause-in-fact is lacking when

the plaintiff used only a competitor’s product, not the defendant’s. See

Mulcahy, 386 N.W.2d at 76. As noted above, the overwhelming majority

of courts apply this product-identification causation requirement in

Reglan litigation to reject claims against brand defendants for injuries

caused by use of a competitor’s generic drug.

         We are not persuaded by the two outlier appellate decisions cited

by Huck: Wyeth, Inc. v. Weeks, ___ So. 3d ___, ___, 2013 WL 135753, at

*19, reargument granted (June 13, 2013) (Ala. Jan. 11, 2013) (applying

Alabama law); Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 304–05 (Ct.

App. 2008) (applying California law). 15              Both concluded the product-

         14Section   2(c) states:
         [A product] is defective because of inadequate instructions or warnings
         when the foreseeable risks of harm posed by the product could have been
         reduced or avoided by the provision of reasonable instructions or
         warnings by the seller or other distributor, or a predecessor in the
         commercial chain of distribution, and the omission of the instructions or
         warnings renders the product not reasonably safe.
Restatement (Third) of Torts: Prods. Liab. § 2(c), at 14.
       15Huck cites several unpublished trial court decisions allowing claims to proceed

against brand defendants when plaintiffs used only the generic formulation, and one
published district court decision, Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010).
Kellogg applied Vermont law that, unlike Iowa’s, permits recovery for harm inflicted by a
competitor’s product. See 762 F. Supp. 2d at 708–09. Kellogg is at odds with Mulcahy.
The unpublished decisions cited by Huck are similarly at odds with Mulcahy and lack
                                          37

identification causation requirement for strict liability claims did not

apply to fraud and negligent misrepresentation theories under the

applicable state law. Weeks, ___ So. 3d at ___, 2013 WL 135753, at *19;

Conte, 85 Cal. Rptr. 3d at 317–18.             Iowa law differs.      As we held in

Mulcahy, a plaintiff seeking recovery for the side effects of a prescription

who sues a pharmaceutical company under any theory, including

misrepresentation, must prove she was injured by using the prescription

drug manufactured or supplied by that defendant. 386 N.W.2d at 69,

72–73, 76.       Additionally, the Alabama Supreme Court subsequently

granted Wyeth’s application for rehearing and reset Weeks for a second

oral argument heard in September 2013.                Lorelei Laird, Generic drugs

leave a bad taste for patients filing tort suits, ABA Journal (Feb. 1, 2014),

http://www.abajournal.com/magazine/article/generic_drugs_leave_a_

bad_taste_for_patients_filing_tort_suits/.          Judge Murdock, in his well-

reasoned dissent from the initial decision, observed:

       [A]lmost every one of the 47 reported cases decided before
       the United States Supreme Court’s decision in [Mensing],
       including cases decided by two United States Circuit Courts
       of Appeals, hold that a manufacturer of a brand-name drug
       has no duty to the consumer of a generic drug manufactured
       and sold by another company. (Only three courts, including
       the court certifying the question in this case, have held
       otherwise.) Since the Supreme Court’s 2011 decision in
       PLIVA, every one of the 11 cases that have addressed the
       issue, including decisions by three United States Circuit
       Courts of Appeals, has reached this same conclusion.

___________________________
precedential value. A more recent Court of Appeals for the Seventh Circuit case, In re
GlaxoSmithKline LLC, No. 14–2051, 2014 WL 2506461, at *1 (7th Cir. June 4, 2014),
provided by Huck subsequent to oral argument is also unpersuasive. Though the
plaintiff in that case ingested only a generic medication, the district court denied the
brand manufacturer’s motion for summary judgment. Id. The brand manufacturer
petitioned the Seventh Circuit for a writ of mandamus to correct that ruling. Id. The
Seventh Circuit acknowledged “that a majority of federal courts has ruled in favor of the
[brand] manufacturer,” but denied the brand manufacturer’s petition for a writ of
mandamus, reasoning that the legal issue could be resolved on appeal from a final
judgment. Id.
                                          38
            As these numbers indicate, the Supreme Court’s
      holding in [Mensing]—that state-law claims against generic-
      drug manufacturers are preempted by the federal regulatory
      scheme—did nothing to undermine the essential rationale in
      the plethora of pre- and post-[Mensing] decisions holding
      that brand-name manufacturers are not liable for injuries
      caused by deficient labeling of generic drugs they neither
      manufactured nor sold. In fact, as discussed below, the
      opinion in [Mensing] expressly says as much, and opinions
      in post-[Mensing] cases are even more explicit in saying so.

Weeks, ___ So. 3d at ___, 2013 WL 135753, at *21 (Murdock, J.

dissenting). It remains to be seen how the Alabama Supreme Court will

ultimately decide whether brand defendants may be held liable under

Alabama law to consumers who used only the generic formulation sold

by a competitor.

      Not     only   is   Huck   unable        to   satisfy    Mulcahy’s    causation

requirement, she cannot establish that the brand defendants owed her a

duty. Cf. Hoyt v. Gutterz Bowl & Lounge L.L.C., 829 N.W.2d 772, 775

(Iowa 2013) (“[T]he determination of whether a duty is owed under

particular     circumstances     is   a    matter      of     law   for   the   court’s

determination.”). We have made clear that our adoption of section 7 of

the Restatement (Third) of Torts in Thompson did not supersede our

precedent limiting liability based on the relationships between the

parties.     McCormick v. Nikkel & Assocs., 819 N.W.2d 368, 374 (Iowa

2012) (noting general duty of care under section 7(a) is “subject to ‘an

articulated countervailing principle or policy’ ” in section 7(b), which

“ ‘may be reflected in longstanding [sic] precedent’ ” (quoting Restatement

(Third) of Torts: Liab. for Physical Harm § 7(b) & cmt. a, at 77–78)). In

McCormick, we discussed how the law of duty remains intact in

important ways after Thompson:

            Historically, the duty determination focused on three
      factors: the relationship between the parties, the
      foreseeability of harm, and public policy. [Thompson, 774
                                    39
      N.W.2d] at 834. In Thompson, we said that foreseeability
      should not enter into the duty calculus but should be
      considered only in determining whether the defendant was
      negligent. Id. at 835. But we did not erase the remaining
      law of duty; rather, we reaffirmed it. Id. at 834–36. In short,
      a lack of duty may be found if either the relationship
      between the parties or public [policy] considerations
      warrants such a conclusion.

McCormick, 819 N.W. 2d at 371. We reiterated “our previous law of duty

was otherwise still alive and well.” Id. We affirmed summary judgment

for the defendant electrical subcontractor under the control rule that

predated Thompson.     McCormick, 819 N.W.2d at 375; see also Feld v.

Borkowski, 790 N.W.2d 72, 76–77 & n.1 (Iowa 2010) (applying contact-

sports rule that predated Thompson to tort claim arising from injury to

player during high school intramural softball game because the

Restatement (Third) of Torts “expresses the notion that a reasonable-care

duty applies in each case unless a special duty, like the contact-sports

exception, is specifically recognized” (citing Restatement (Third) of Torts:

Liab. for Physical Harm § 7 cmt. a, at 77)).

      Due to the unique nature of the relationship between generic and

brand manufacturers, a “ ‘countervailing principle or policy warrants

denying liability in [this] particular class of cases.’ ” Thompson, 774

N.W.2d at 835 (quoting Restatement (Third) of Torts: Liab. for Physical

Harm § 7(b), at 90) (Proposed Final Draft No. 1, 2005); accord Kelly v.

Wyeth, No. Civ.A.MICV20003314B, 2005 WL 4056740, at *4 (Mass.

Super. May 6, 2005) (concluding “strong social policy reasons” weigh

against finding brand manufacturers owe a duty to generic consumers).

As we concluded in Mulcahy, to expand tort liability to those who did not

make or supply the injury-causing product used by the plaintiff involves

policy choices and “social engineering more appropriately within the

legislative domain.”    386 N.W.2d at 76.        Congress has created a
                                    40

symbiotic relationship between brand and generic drug manufacturers.

In this relationship,

      [n]ame brand manufacturers undertake the expense of
      developing pioneer drugs, performing the studies necessary
      to obtain premarketing approval, and formulating labeling
      information. Generic manufacturers avoid these expenses
      by duplicating successful pioneer drugs and their labels.
      Name brand advertising benefits generic competitors
      because generics are generally sold as substitutes for name
      brand drugs, so the more a name brand drug is prescribed,
      the more potential sales exist for its generic equivalents.

Foster, 29 F.3d at 170.    The Foster court recognized that, as between

these competing pharmaceutical companies, it would be “especially

unfair” to find brand manufacturers have a duty to those who take

generic drugs “when, as here, the generic manufacturer reaps the

benefits of the name brand manufacturer’s statements by copying its

labels and riding on the coattails of its advertising.” Id.; see also Kelly,

2005 WL 4056740, at *4 (highlighting that “[the drug] approval process

can be a very time consuming and costly endeavor [for brand

manufacturers], as the manufacturer bears the cost of research and

development, as well as performing clinical studies of the drug’s safety

and effectiveness” while “[t]he makers of generic drugs, by contrast, do

not have to expend the same amount of resources”).

      Through carefully crafted legislation, Congress has made policy

choices that impact the economics of prescription drug sales to increase

access to medication.     Huck cites nothing in the text of the Hatch-

Waxman Amendments or congressional record suggesting Congress

intended to render brand defendants liable to consumers of generic

products. To impose such liability would alter the relationship between

generic and brand manufacturers.         Specifically, extending liability to

brand manufacturers for harm caused by generic competitors would
                                    41

discourage investments necessary to develop new, beneficial drugs by

increasing the downside risks.    See Schwartz, 81 Fordham L. Rev. at

1870–72 (elaborating reasons why “expanding liability for a competitor’s

product is not sound health policy”).

      Economic and public policy analyses strongly disfavor imposing

tort liability on brand manufacturers for harm caused by generic

competitors. See generally Richard A. Epstein, What Tort Theory Tells Us

About Federal Preemption: The Tragic Saga of Wyeth v. Levine, 65 N.Y.U.

Ann. Surv. Am. L. 485 (2010) [hereinafter Epstein]. As Professor Epstein

observed:

      The powerful influence of common law decisions creates
      gratuitous expense and uncertainty that feed their way back
      into the cycle of drug development, testing, and marketing.
      Properly understood, the entire duty-to-warn apparatus has
      become a tax on drugs, which, in some instances, may drive
      both old and new products off the market and, in most
      instances, will increase drug cost and reduce the levels of
      beneficial patient use.

Id. at 514. Professor Epstein further noted:

             The judicial failure to understand the historical arc of
      the law of torts leads to a second set of unsound judgments
      on matters of institutional competence . . . .        There is
      nothing that erratic and expensive juries can do to make
      accurate scientific judgments that will allow people to plan
      their conduct in advance.        Stability of expectations is
      indispensable in marketing dangerous compounds, and, for
      all its manifest failings, the FDA is better at this task than
      juries.

Id. at 522. As Professor Epstein elaborated:

      The FDA, for all its flaws, does have one advantage over a
      system of tort liability: It makes its judgments on the overall
      effects of drug use, not on the particulars of individual cases
      where the question of proper warning is compromised in a
      number of ways.
                                          42
Id. at 488 (footnote omitted). 16
       Huck fails to articulate any persuasive case that public health and

safety would be advanced through imposing tort liability on brand

defendants for injuries caused by generic products sold by competitors.

We agree with Professor Epstein that courts are not institutionally

qualified to balance the complex, interrelated, and divergent policy

considerations in determining labeling and liability obligations of brand

and generic pharmaceuticals. Courts deal ad hoc with the record made

by private litigants.     By contrast, the FDA, with its four billion dollar
budget, engages in public rulemaking allowing transparent input from all

interest groups, guided by its own staff of qualified scientists.

       Fundamental tort principles of risk apportionment further support

a no-duty holding in this case. Liability generally follows control in our

tort law. Cf. McCormick, 819 N.W.2d at 374 (noting the party in control

“is best positioned to take precautions to identify risks and take

measures to improve safety”). But, the brand defendants “d[id] not place

[the generic product] in commerce, ha[d] no ability to control the quality

of the product or the conformance of the product with its design, and

d[id] not have the opportunity to treat the risk of producing the product
as a cost of production against which liability insurance can be

obtained.”    See Am. L. Prod. Liab. 3d § 5:10 (noting that, under these

circumstances, “the defendant has not undertaken and assumed [a]

special responsibility toward the consuming public”).               Accordingly, the

brand defendants cannot be classified as the sellers of the generic

       16Epstein  favors preemption of state law failure-to-warn claims against brand
defendants brought by consumers of Reglan, Epstein, 65 N.Y.U. Ann. Surv. Am. L. 485,
a view rejected in Levine. See Levine, 555 U.S. at 581, 129 S Ct. at 1204, 173 L. Ed. 2d
at 70. Yet his policy arguments apply with greater force to efforts to extend state tort
liability to brand defendants for injuries to consumers who used only the competing
generic drug.
                                   43

metoclopramide Huck ingested. See Restatement (Third) of Torts: Prods.

Liab. § 1, at 5.

      A brand manufacturer cannot ensure that a generic manufacturer

complies with federal law—the two are, after all, competitors. The brand

defendants had no control over whether PLIVA used their improved

warning language approved by the FDA in 2004. Indeed, in this case

PLIVA failed to update its label to conform to the improved warnings by

the brand defendants approved by the FDA in 2004. Huck will have her

day in court against PLIVA.     We adopted products liability to place

responsibility for the harm caused by a product on the party who profits

from its manufacture and sale. See Brooke Grp. Ltd., 652 N.W.2d at 164

(noting our purpose in adopting principles of products liability was to

ensure “ ‘that the costs of injuries resulting from defective products are

borne by the manufacturers that put such products on the market’ ”)

(quoting Hawkeye-Sec. Ins. Co. v. Ford Motor Co., 174 N.W.2d 672, 683

(Iowa 1970))). PLIVA, not the brand defendants, profited from its sale of

the generic formulation that harmed Huck.

      We reject Huck’s argument based on Bredberg v. PepsiCo, Inc., 551

N.W.2d 321 (Iowa 1996).     Huck relies on Bredberg to argue Iowa law

permits liability on a party who designs, but does not manufacture or

sell, the product that injured the plaintiff.   In Bredberg, plaintiff was

injured by an exploding glass bottle of Diet Mountain Dew. Id. at 323.

He sued the retailer, PepsiCo, Inc. (which made and sold the Diet

Mountain Dew concentrate), as well as Pepsi Cola General Bottlers, Inc.

(which bottled and distributed the soft drink under a license agreement).

Id. at 323 & n.1.    The bottler was “required to mix the concentrate

pursuant to a formula provided by PepsiCo.”         Id. at 323 n.1.   The

defendants moved for a directed verdict on grounds the evidence was
                                      44

insufficient to prove the bottle was defective. Id. at 324. Importantly for

present purposes, PepsiCo did not move for a directed verdict on grounds

it did not manufacture or sell the bottle. The jury returned a verdict for

plaintiff and allocated fault fifty percent to plaintiff, five percent to the

retailer, twenty-five percent to the bottler, and twenty percent to PepsiCo.

Id. at 325. The district court entered judgment for half the damages, and

PepsiCo and the bottler appealed. Id. at 325. We transferred the case to

the court of appeals, which reversed.        Id.    We granted Bredberg’s

application for further review.     Id. at 326.    In a footnote, we stated

“PepsiCo contends that its licensing agreement with [the bottler] Pepsi

Cola is not sufficient to impute liability on it as a manufacturer.” Id. at

326 n.4.         We declined to follow a case based on a Georgia statute

because it “says nothing about whether PepsiCo could be held liable as a

product ‘designer,’ as alleged by plaintiff against PepsiCo in the present

case.”     Id.    We went on to review the evidence and conclude it was

sufficient to support the verdict that the bottle was defective. Id. at 326–

29.   We held the district court correctly denied defendants’ posttrial

motions and affirmed the judgment for plaintiff on that basis. Id. at 329.

         The fighting issue in Bredberg was whether there was substantial

evidence the bottle that exploded was defective. See id. at 327–28. That

was the basis of the rulings on the directed verdict motion and the

motion for JNOV, rulings our holding affirmed. Id. at 324–25. PepsiCo

supplied the concentrate and, therefore, was a component parts supplier

of the completed product—the full bottle of carbonated soft drink. See

id. at 323 n.1. PepsiCo essentially outsourced the manufacture of the

glass bottle and distribution of the finished product to its licensee, the

bottler. PepsiCo controlled part of the manufacturing (mixing) process

for the very product that injured plaintiff. See id. PepsiCo was thus in
                                          45

the chain of distribution of the injury-causing product, with significant

control over the process for which it profited. PepsiCo was held liable for

injuries caused by the Pepsi™ product, consistent with Mulcahy—not for

injuries from an exploding Coca-Cola bottle sold by a competitor. 17

       By contrast, the brand defendants control the brand label, but do

not otherwise control PLIVA. As we noted, PLIVA failed to adopt the new

warning language used by the brand defendants in 2004.                        And, the

brand defendants, who incurred the costs to develop Reglan, do not

profit from PLIVA’s sale of the competing generic formulation.

       Judge Murdock observed that limiting liability to the defendant

that made the drug used by the plaintiff is consistent with “bedrock

principles of tort law and of economic realities underlying those

principles”:

              From the beginning, what Alexander Hamilton referred
       to as “[t]he spirit of enterprise, which characterizes the
       commercial part of America,” has animated Americans to
       work hard to produce innovative goods and services that
       have benefited not only themselves, but also their children,
       their communities, and America as a whole. An enterprising
       spirit alone, however, is not enough. The law must protect
       the fruits of enterprise and create a climate in which trade
       and business innovation can flourish. Concomitantly, the

        17Huck does not attempt to support her innovator liability theory against the

brand defendants by relying on our court’s professional malpractice decisions in which
defective plans or specifications caused harm. See, e.g., Schiltz v. Cullen-Schiltz &
Assocs., Inc., 228 N.W.2d 10, 12 (Iowa 1975). In Schiltz, a professional engineering firm
was paid to design plans for the construction of a sewage treatment plant. Id. at 12.
The general contractor built the facility in accordance with the engineer’s design, which
failed to provide for a dike for flood protection. Id. at 12–13. A nearby creek flooded
and damaged the facility. Id. at 13. The contractor sued the engineering firm for
negligently designing the facility without adequate flood protection, and the jury
ultimately found for the plaintiff-contractor. Id. at 12–13. We affirmed the submission
of the negligence theory. Id. at 18. Schiltz does not support imposing liability on brand
defendants. The defendant engineer was hired and paid to design the facility built by
the plaintiff. The engineer provided a service, not a product. Schiltz is not a case in
which a different engineer copied and sold the design made by defendant for another
project. There was no attempt in Schiltz to impose liability on a remote designer who
was not retained and paid for the construction project at issue.
                                      46
      law must justly allocate risks that are a function of that free
      trade and innovation.
             These dual needs have resulted in an economic and
      legal system that always has coupled the rewards from the
      sale of a good or service with the costs of tortious injury
      resulting from the same. Indeed, this and the corollary
      notion that parties are responsible for their own products,
      not those of others, are so organic to western economic and
      legal thought that they rarely find need of expression.

Weeks, ___ So. 3d at ___, 2013 WL 135753, at *20 (Murdock, J.

dissenting) (alteration in original) (footnote omitted).

      We adhere to these bedrock principles today, and join the

multitude of courts that have concluded brand defendants owe no duty

to consumers of generic drugs. See, e.g., Darvocet ___ F.3d at ___, 2014

WL 2959271, at *17–18 (affirming dismissals of claims against brand

defendants on no-duty grounds); Lashley, 750 F.3d at 476 (“[B]ecause

Appellants did not ingest the brand manufacturers’ products, these

defendants have no common-law duty to them.”); Strayhorn, 737 F.3d at

405 (acknowledging that “ ‘[a]lthough a product manufacturer generally

has a duty to warn of the dangers of its own products, it does not have a

duty to warn of the dangers of another manufacturer’s products’ ”

(quoting Barnes v. Kerr Corp., 418 F.3d 583, 590 (6th Cir. 2005)));

Schrock, 727 F.3d at 1282 (recognizing “[w]hether or not a duty exists

depends on the relationship between the parties” and “brand-name

manufacturers do not have any relationship” with the plaintiff who

ingested a generic drug (alteration in original) (internal quotation marks

omitted)); Bell, 716 F.3d at 1093 (“[N]othing in Arkansas law . . .

supports extending such a duty of care to the customer of a competitor

using a competing product.”); Foster, 29 F.3d at 171 (concluding “Wyeth

has no duty to the users of other manufacturers’ products”).
                                      47

      We are unwilling to make brand manufacturers the de facto

insurers for competing generic manufacturers. Cf. Schwartz, 81 Fordham

L. Rev. at 1871 (“Deep-pocket jurisprudence is law without principle.”) It

may well be foreseeable that competitors will mimic a product design or

label. But, we decline Huck’s invitation to step onto the slippery slope of

imposing a form of innovator liability on manufacturers for harm caused

by a competitor’s product. Where would such liability stop? If a car seat

manufacturer recognized as the industry leader designed a popular car

seat, could it be sued for injuries sustained by a consumer using a

competitor’s seat that copied the design? Why not, under Huck’s theory,

if it is foreseeable others will copy the design?

      In sum, we will not contort Iowa’s tort law in order to create

liability for brand manufacturers. The unfairness resulting from Mensing

is best addressed by Congress or the FDA. See Mensing, 564 U.S. at ___,

131 S. Ct. at 2582, 180 L. Ed. 2d at 597 (“As always, Congress and the

FDA retain the authority to change the law and regulations if they so

desire.”); Schwartz, 81 Fordham L. Rev. at 1875 (“Congress and the FDA

. . . are the appropriate arms of government for making [drug liability]

decisions in the context of fashioning the best health care policy for the

country.”); see generally Daniel Kazhdan, Wyeth and PLIVA: The Law of

Inadequate Drug Labeling, 27 Berkeley Tech. L.J. 893 (2012) (discussing

Levine and Mensing and “propos[ing] ways that drug companies, the

FDA, Congress, and the states could remedy the harmful effects of the

Court’s distinction between brand-name drugs and generic drugs”).

Indeed, the FDA’s proposed rule allows generic manufacturers to

unilaterally strengthen their labels. See generally Proposed Rule, 78 Fed.

Reg. 67985–02.       This rule would abrogate the Mensing holding,
                                   48

permitting consumers of generic drugs to bring a claim against generic

manufacturers consistent with the Levine analysis.

      We will continue to apply the same long-standing causation rule

applied in Mulcahy, which required Huck to prove the defendant

manufactured or supplied the product that caused her injury, and we

decline to extend the duty of product manufacturers to those injured by

use of a competitor’s product. We will not impose liability on the brand

defendants for injuries to those using only the competing generic

formulation. The district court correctly concluded the brand defendants

were entitled to summary judgment in their favor.

      IV. Disposition.

      For the foregoing reasons, we vacate the decision of the court of

appeals, reverse in part the district court’s summary judgment for PLIVA

and remand for further proceedings on Huck’s claims against PLIVA

based on its failure to adopt the 2004 warning language approved by the

FDA for Reglan.    We affirm the district court’s summary judgments

dismissing the other claims against PLIVA and dismissing Huck’s claims

against the brand defendants.

      DECISION OF COURT OF APPEALS VACATED; DISTRICT

COURT JUDGMENTS AFFIRMED IN PART, REVERSED IN PART, AND

REMANDED WITH INSTRUCTIONS.

      All justices concur except Cady, C.J., who concurs specially, and

Hecht, Wiggins, and Appel, JJ., who concur in part and dissent in part.
                                    49
                                            #12–0596, Huck v. Wyeth, Inc.

CADY, Chief Justice (concurring specially).
      I concur in the opinion of the majority on the claims by Huck

against PLIVA, but otherwise concur in the result only.       I agree with

much of the dissent on the claims against the brand defendant, but

decline at this time to conclude the public policy considerations that

ultimately drive the decision in this case, on balance, support the

imposition of a duty of care as suggested by Justice Hecht’s opinion.

      After the United States Supreme Court held in PLIVA, Inc. v.

Mensing, 564 U.S. ___, ___, 131 S. Ct. 2567, 2580–81, 180 L. Ed. 2d 580,

595 (2011), that warning claims against a generic drug manufacturer

were preempted, consumers of generic drugs harmed by its label had

little avenue of relief except to turn to the brand drug manufacturer. A

credible legal theory of recovery against the brand drug manufacturer

has now been pieced together with the aid of our prior cases, but these

efforts do not confront the existing congressional preemption into the

broad area of brand and generic drugs. The law can stitch together legal

theories into legal claims of action, but the underlying public policy

ultimately drives the creation of a duty of care. Normally, courts are able

to discern the public policy and apply it to reach an outcome; but in this

case, the policies exist within an area fully occupied by Congress and

which is still developing. The public policy considerations normally at

play to impose a duty of care on manufacturers to protect product

consumers are simply too general and attenuated to support the

imposition of market-wide liability on the brand manufacturer, especially

at a time when its market share is steadily being consumed by the

generic drug manufacturer protected from liability.
                                     50

      Courts normally seek to find remedies for wrongs, but the

complexity and sheer size of the particular area of inquiry and the role

that has been assumed by Congress in regulating and navigating

through the area should make courts more than cautious to step in to

create legal liability for brand-name manufacturers. The policies at play

are currently being developed and shaped by Congress and include

policies that militate against court intervention at this time.
                                          51

                                                    #12–0596, Huck v. Wyeth, Inc.

HECHT, Justice (concurring in part and dissenting in part).

       I join the majority’s analysis with respect to Huck’s claims against

PLIVA.     As I believe the majority’s 18 “product-identification causation

requirement,” however, has no application in a case where the product

and warning allegedly responsible for injury have been identified, and

because I believe our caselaw regarding duty and factual causation

support the possibility of the brand defendants’ liability here, I

respectfully dissent from the majority’s analysis and disposition of the

claims against the brand defendants.

       I. Iowa Products Liability Law and Mulcahy.

       We have previously explained the law of products liability in Iowa

“may involve causes of action stated in negligence, strict liability, or

breach of warranty,” among others.             Bingham v. Marshall & Huschart

Mach. Co., 485 N.W.2d 78, 79 (Iowa 1992). We have noted these three

theories are separate and distinct theories of recovery, and a single set of

facts may give rise to any combination of the three. Lovick v. Wil-Rich,

588 N.W.2d 688, 698 (Iowa 1999). Typically, the underlying theories will

involve claims of improper design, inadequate warnings, or defects in

manufacturing. Id.

       The imposition of liability for manufacturing defects has a long

history in Iowa caselaw. See, e.g., Hawkeye-Sec. Ins. Co. v. Ford Motor

Co., 174 N.W.2d 672, 684 (Iowa 1970).               In Hawkeye, we adopted the

special, narrow principle of strict liability found in section 402A of the

Restatement (Second) of Torts. Id. We explained that for various policy

       18I will continue to refer to the analysis in Part III.B of the opinion by Justice

Waterman as the “majority” for ease of reference only. As Chief Justice Cady’s special
concurrence makes clear, the analysis in Part III.B of Justice Waterman’s opinion has
the support of three justices, while Chief Justice Cady has concurred in the result only.
                                     52

reasons, a commercial seller of a defectively manufactured product may

be liable for harm caused by the defect regardless whether the plaintiff

might establish negligence or breach of warranty by the seller. Id.; see

also Restatement (Third) of Torts: Prods. Liab. § 1 cmt. a, at 7 (1998).

While the facts in Hawkeye gave rise only to a claim of manufacturing

defect, our explanation of strict liability principles suggested the strict

liability theory might be applicable in cases involving allegations of

design defect as well. Hawkeye, 174 N.W.2d at 684 (quoting authority

applying strict liability when “ ‘the defect arose out of the design or

manufacture’ ” of the product). We gave no indication whether the theory

might also apply in a case giving rise to a claim of failure to warn, and it

was not until many years later we concluded failure-to-warn claims

typically invoke a reasonableness standard incompatible with a strict

liability theory. See Olson v. Prosoco, Inc., 522 N.W.2d 284, 289–90 (Iowa

1994); see also Restatement (Third) of Torts: Prods. Liab. § 1 cmt. a, at

6–7.

       After setting forth the justifications for our adoption of the strict

liability theory given the claim of manufacturing defect before us in

Hawkeye, we took care to note analysis of any claim of negligence was “a

different matter.” Hawkeye, 174 N.W.2d at 685. We had no occasion to

decide in Hawkeye how theories of negligence or strict liability might

apply in cases not involving a manufacturer, because the special strict

liability rule at issue there and elucidated in section 402A had no

application to a party not engaged in the activity of making or selling a

product as part of its business.      See Restatement (Second) of Torts

§ 402A cmt. f, at 350–51 (1965). While it may often be deceptively simple

to regard an actor’s liability for injuries related to a product as “strict,”

we cautioned in Hawkeye, the Restatement (Second) did not preclude
                                      53

liability based on the alternative ground of negligence when negligence

could be proved—the special rule of section 402A often simply had no

application to those claims. Hawkeye, 174 N.W.2d at 684–85; see also

Wright v. Brooke Grp. Ltd., 652 N.W.2d 159, 164 (Iowa 2002).

      We more recently addressed the prospect of liability for injury

caused by a product in Wright, a case presenting a claim of design defect.

Wright, 652 N.W.2d at 169. We acknowledged our conclusion in Olson

that cases involving claims of failure to warn should be analyzed under

the rubric of negligence.     Wright, 652 N.W.2d at 166.       We noted the

Restatement (Third) of Torts: Products Liability had, in addressing claims

of design defect, abandoned the consumer-expectations test traditionally

employed in strict liability analyses in favor of a risk–utility test typically

found in negligence analyses. Id. at 169. We concluded we favored the

Restatement’s preference for avoiding doctrinal designation of design-

defect claims as claims involving negligence or strict liability. Id. Like

the drafters of the Restatement, we explained, we favored a functional

risk–utility analysis for these claims without application of a doctrinal

label. Id. We therefore adopted the framework for analyzing the liability

of sellers and distributors of products for manufacturing defects,

defective designs, and inadequate instructions and warnings found in

sections 1 and 2 of the Restatement (Third) of Torts: Products Liability.

Wright, 652 N.W.2d at 169; see also Restatement (Third) of Torts: Prods.

Liab. §§ 1–2 at 5, 14.      In so doing, we reiterated the Restatement’s

recognition that a traditional conception of strict liability may well be

appropriate in manufacturing defect cases, but that negligence principles

will often be more suitable in cases involving other types of claims.

Wright, 652 N.W.2d at 168.
                                    54

      In the course of our analysis in Wright, we identified two principles

further illuminating our examination of the brands’ obligations here.

First, we suggested that in certain instances, manufacturers and other

parties may be liable in tort for damages suffered as a result of product

defect, regardless whether the parties actually produce the specific object

causing the damages. See Wright, 652 N.W.2d at 173 (examining civil

conspiracy scenario where “manufacturers agree to suppress information

about their product for the lawful purpose of facilitating the sale of their

product, and in effectuating this plan subject themselves to liability for

failure to warn of the risks of using their product”). Second, and more

importantly for purposes of our analysis here, in examining a claim for

failure to warn, we explained “what is really important is that the

statements were made for the purpose of influencing the action of

another,” and these claims need not “involve[] a business transaction

between the parties . . . .” Id. at 175–76. In Wright then, as in Hawkeye,

we took care to establish that specific theories of products liability,

whether strict liability or otherwise, did not displace other claims of

negligence, and that each theory of liability must be analyzed in terms of

the relevant facts and legal principles.     Wright, 652 N.W.2d at 176;

Hawkeye, 174 N.W.2d at 685.

      Long before we made these analytical refinements to our law of

products liability in Wright, we confronted certified questions from a

federal case involving parents who had suffered damages as a result of

the mother’s ingestion of DES during pregnancy. See Mulcahy v. Eli Lilly

& Co., 386 N.W.2d 67, 69 (Iowa 1986).             Unable to identify the

manufacturer of the DES ingested by the mother, the parents brought

suit against twenty-five drug companies who had manufactured or

marketed DES during the period in which the mother had ingested it. Id.
                                           55

The     parents     brought       claims        of   strict   liability,   negligence,

misrepresentation, and breach of warranty, among others. Id. We made

no reference to whether specific claims of manufacturing defect, design

defect, failure to warn, or any others had been advanced, but we gave no

indication we had any occasion to consider the DES manufacturers’

liability for claims of design defect or failure to warn. 19 See id. at 69–70.

       Setting forth legal principles applicable for analyzing the parents’

tort claims, we noted a “plaintiff in a products liability action must

ordinarily prove that a manufacturer or supplier produced, provided or

was in some way responsible for the particular product that caused the

injury.”    Id. at 70.     As authority for that proposition, we cited the

Restatement (Second) of Torts section 402A—the strict liability provision

having no application to negligence claims—and our earlier case of

Osborn v. Massey-Ferguson, Inc., 290 N.W.2d 893, 901 (Iowa 1980).

Mulcahy, 386 N.W.2d at 70. In Osborn, we had similarly noted claims of

strict liability for manufacturing defects typically involve a requirement of

manufacture by the defendant, but we had distinguished the negligence

claims at issue and noted those claims were to be analyzed in accordance

with our standard negligence principles. See Osborn, 290 N.W.2d at 901;

see also Wright, 652 N.W.2d at 168 (explaining principles underlying

“strict liability [are] appropriate in manufacturing defect cases, but

negligence principles are more suitable for other defective product

cases”). We cited our earlier case of Schiltz v. Cullen-Schiltz & Associates,

Inc., 228 N.W.2d 10, 16–18 (Iowa 1975), as illustrative of the appropriate

negligence analysis. Osborn, 290 N.W.2d at 901.

        19Our failure to address the theories of design defect and failure to warn might

be attributable to the fact the DES manufacturers were manufacturers, and to the fact
we had not often distinguished those claims from claims for manufacturing defect at
that point. See Mulcahy, 386 N.W.2d at 69–70.
                                        56

        In Schiltz, we had encountered a claim alleging defective design of

a sewage treatment facility.      Schiltz, 228 N.W.2d at 17.            We explained

that to prevail on a claim of negligent design by the engineers, the

claimant must prove the work fell short of the “degree of skill, care and

learning    ordinarily    possessed    and      exercised”   in   the    engineering

profession and the substandard care resulted in the damage.                      Id.

Notably, our negligence analysis in Schiltz imposed no requirement that

the engineers had built or manufactured the defective sewage treatment

facility. See id. Indeed, they had not, as they had merely provided plans

and specifications for the facility’s construction to an independent

contractor, who had independent obligations to inspect the site and

circumstances attending the project and to diligently pursue, supervise,

and complete the construction. Id. at 12–13. Instead, for purposes of

the negligence analysis, we made clear the important questions in Schiltz

were whether the engineers had negligently designed the facility and

whether that negligence had caused the damages suffered. Id. at 17; see

also McCarthy v. J.P. Cullen & Son Corp., 199 N.W.2d 362, 367–68 (Iowa

1972)    (examining      architects’   duties    with   respect    to    plans   and

specifications and noting duty extended to protection of owners of

adjacent properties from harms “which reasonably could be expected to

flow from” the plans).

        We acknowledged and employed the principles of these cases in

Mulcahy neither to elide theories of strict liability and negligence, nor to

suggest all products liability claims were to be treated as claims of

manufacturing defect, but to ensure a “causal connection between the

defendant’s product and plaintiff’s injury.” Mulcahy, 386 N.W.2d at 70.

Our general negligence principles, we noted, require a claimant to prove

“the defendant caused the complained of harm or injury.” Id. at 72. In a
                                     57

case involving so many apparent manufacturers of DES, some of which

had not been named as defendants, we explained, the claimants could

not prove any of the named defendants “was in some way responsible

for,” or had actually “caused the injury to” the plaintiff. Id. at 70, 72. In

a case involving fewer manufacturers, we noted, the plaintiff might not

have run up against the same causation problem—if, for instance, the

“plaintiff established that only two manufacturers’ DES products were

sold at a certain pharmacy, and [she] bought her DES only at that

pharmacy but c[ould not] identify which brand she purchased.” Id. at

73.   Other theories of liability, such as enterprise liability, might also

have “avoid[ed] the legal causation problem that arises from an inability

to identify the manufacturer of the specific injury-causing product” in

cases involving so many possible responsible parties, but we found those

theories inapplicable given the facts before us. Id. at 72. Instead, given

the sheer number of possibly responsible parties, we declined to adopt

the special liability theories advanced by the plaintiffs and concluded we

would not impose “liability upon a manufacturer for harm it may not

have caused.” Id. at 76.

      Based on our products liability principles, and based on the

specific problem at issue in Mulcahy, I believe our Mulcahy analysis

provides useful but limited guidance for our resolution of the case before

us.    We are not faced here with a claim of strict liability for

manufacturing defect on behalf of the brands, and thus the strict liability

causation requirement that the manufacturer be responsible for the

manufacturing defect, set forth in cases like Hawkeye and Osborn and

imported in Mulcahy, is inapplicable here. See Mulcahy, 386 N.W.2d at

70; Osborn, 290 N.W.2d at 901; Hawkeye, 174 N.W.2d at 684; see also

Wright, 652 N.W.2d at 164.        More importantly for purposes of our
                                     58

analysis with respect to the claims of negligence here, we are not faced

with a case involving numerous possibly responsible defendants or

involving the possibility an unnamed party might actually be responsible

for the harm suffered in lieu of any named defendant. See Mulcahy, 386

N.W.2d at 71–72. Instead, by contrast, the parties here have stipulated

to the relevant facts: the brands designed and manufactured branded

Reglan; PLIVA manufactured the generic product actually ingested; and

federal laws and regulations establish various obligations for PLIVA and

the brand defendants. The causation problem we identified in Mulcahy

therefore does not present itself here, and although our exposition of

general negligence principles has application here, Mulcahy gives us no

specific guidance as to how to resolve the negligence claims in scenarios

like this one where all relevant actors have been identified. Instead, the

negligence principles we have set forth in numerous cases like Schiltz

must guide our resolution here, and those cases have never required an

actor who has breached an obligation of care be a manufacturer for

purposes of tort liability.   See Schiltz, 228 N.W.2d at 17–18; see also

Bredberg v. PepsiCo, Inc., 551 N.W.2d 321, 327 (Iowa 1996) (noting

product designers are also subject to strict liability claims).

      Moreover, the brands have not offered any explanation as to why

we must treat them as manufacturers for purposes of our negligence

analysis. In fact, all parties involved have stipulated the brands were not

manufacturers of generic metoclopramide at the time of Huck’s ingestion.

As noted, we have in numerous prior products liability cases held an

actor need not be a manufacturer for purposes of analyzing liability,

regardless whether the claim is one of negligence or strict liability. See

Weyerhaeuser v. Thermogas Co., 620 N.W.2d 819, 825 (Iowa 2000)

(noting several justifications for holding an assembler liable in both
                                     59

negligence and strict liability for the failure of a component it did not

manufacture); Bredberg, 551 N.W.2d at 327; Schiltz, 228 N.W.2d at 18;

cf. Wright, 652 N.W.2d at 169 (adopting sections 1 and 2 of the

Restatement (Third) of Torts: Products Liability); Clark v. McDaniel, 546

N.W.2d 590, 592–94 (Iowa 1996) (holding used-car dealer liable for

misrepresentation of car quality).    Our negligence cases have always

required a negligent act or omission on the part of an actor, causation,

and damages within the actor’s scope of liability. See, e.g., Thompson v.

Kaczinski, 774 N.W.2d 829, 834 (Iowa 2009); Stotts v. Eveleth, 688

N.W.2d 803, 807 (Iowa 2004); Van Essen v. McCormick Enters. Co., 599

N.W.2d 716, 718 (Iowa 1999). As we have taken great care to emphasize

in our products liability cases, no principle of products liability law

displaces that framework.    See Wright, 652 N.W.2d at 164; Hawkeye,

174 N.W.2d at 685.

      Courts   from   numerous     jurisdictions   have   recognized   these

principles and declined to dismiss claims against brand defendants given

similar factual circumstances.    See, e.g., Dolin v. SmithKline Beecham

Corp., No. C6403, 2014 WL 804458, at *6 (N.D. Ill. Feb. 28, 2014)

(“[T]hese parties stood in a relationship to one another that, while clearly

not ‘direct,’ was sufficient for the law to impose a duty of reasonable

conduct upon GSK for the benefit of Plaintiff.”); Chatman v. Pfizer, Inc.,

960 F. Supp. 2d 641, 654 (S.D. Miss. 2013) (“Chatman may pursue her

common-law claims under ‘old’ state law theories of liability, even though

she may have been injured by a product manufactured by another.”);

Kellogg v. Wyeth, 762 F. Supp. 2d 694, 704 (D. Vt. 2010) (“To date,

however, Vermont has not eliminated common law actions for negligence

or fraud merely because they involve products.”); Easter v. Aventis

Pasteur, Inc., No. 5:03-CV-141 (TJW), 2004 WL 3104610, at *9 (E.D. Tex.
                                       60

Feb. 11, 2004) (“Lilly, as a designer, has a duty to develop a safe design

for thimerosal.      Also, Lilly’s design of and intimate knowledge about

thimerosal also gives rise to a duty to inform users of hazards associated

with the use of thimerosal. Therefore, the Court finds that the plaintiffs

have adequately stated a design defect claim against Lilly.”); Wyeth, Inc.

v. Weeks, ___ So.3d ___, ___, 2013 WL 135753, at 19 (Ala. Jan. 11, 2013),

reargument granted (June 13, 2013) (“Under Alabama law, a brand-name

drug company may be held liable for fraud or misrepresentation (by

misstatement or omission), based on statements it made in connection

with the manufacture of a brand-name prescription drug, by a plaintiff

claiming physical injury caused by a generic drug manufactured by a

different company.”); Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 320–21

(Ct. App. 2008) (“We hold that Wyeth’s common-law duty to use due care

in formulating its product warnings extends to patients whose doctors

foreseeably   rely     on   its   product   information   when   prescribing

metoclopramide, whether the prescription is written for and/or filled with

Reglan or its generic equivalent.”); Lance v. Wyeth, 85 A.3d 434, 461 (Pa.

2014) (“There has been no supported presentation here which would

persuade us to immunize companies from the responsibility to respond

in damages for such a lack of due care resulting in personal injury or

death.”); Clark v. Pfizer, Inc., No. 1819, 2008 Phila. Ct. Com. Pl. LEXIS

74, *29 (Ct. Com. Pl. 2008) (“[T]he relationship between the purchasers of

generic Gabapentin and these defendant [brand] manufacturers herein is

that of purchaser of drugs which never would have been purchased but

for defendants’ [conduct].”). See generally Allen Rostron, Prescription for

Fairness: A New Approach to Tort Liability of Brand-Name and Generic

Drug Manufacturers, 60 Duke L.J. 1123, 1160 (2011) [hereinafter

Rostron] (noting courts have recognized “[n]egligence and strict products
                                    61

liability are separate and distinct bases for liability” and “do not

automatically collapse into each other merely because there are some

situations in which a plaintiff might be able to assert both types of

claims” (internal quotation marks omitted)).

      Several courts have recognized that given the obligations created

by the Hatch-Waxman Act, the causation problem we identified in

Mulcahy is inapplicable here, because “whether a consumer ingests the

name-brand or generic version of a given drug is immaterial as to the

likelihood that negligence in the design or warning label of that drug will

cause injury.” Dolin, 2014 WL 804458, at *5; see also, e.g., Schedin v.

Ortho-McNeil-Janssen Pharm., Inc., 808 F. Supp. 2d 1125, 1131 (D. Minn.

2011) (“[u]nder the pre-2007 statutory framework . . . a brand-name

manufacturer was the only entity in the trifecta of actors (the FDA, the

brand-name manufacturer, and the generic) that could strengthen an

inadequate label.”), aff’d in part, rev’d in part on other grounds, 700 F.3d

1161 (8th Cir. 2012); Kellogg, 762 F. Supp. 2d at 702 (“A reasonable jury

could conclude that inadequate, misleading and inaccurate information

provided by the [brand defendants] was a . . . cause of her injury.”);

Weeks, 2013 WL 135753, at *19 (“In short, the patient must show that,

but for the false representation made in the warning, the prescribing

physician would not have prescribed the medication to his patient.”);

Rostron, 60 Duke L.J. at 1164 (“Throughout the long line of precedent

that flowed out of Foster, courts have repeatedly made the same mistake,

dwelling on the irrelevant concept of liability being imposed on multiple

manufacturers because of uncertainty about who made a product and

conflating that concept with the separate and distinct issue of whether a

manufacturer can be liable for wrongdoing other than making and selling

the product the plaintiff received.”). Several courts have reasoned “case
                                       62

law, commonsense and fairness dictates” the brands cannot both avoid

claims of strict products liability on the ground they were not

manufacturers of the generic version of the drug, and avoid claims of

negligence on the ground they were manufacturers of some other drug.

Chatman, 960 F.Supp.2d at 653 (“[T]hey cannot have it both ways.”); see

also Dolin, 2014 WL 804458, at *4 (“GSK has not shown why Plaintiff

should   be   precluded     from   claiming    at   common   law that   GSK,

independent of its capacity as a manufacturer . . . was negligent in

connection with its [other responsibilities] . . . .”).

      Many courts have recognized proper resolution of negligence

claims turns not on a question of whether a product is somehow

involved, but on an analysis of traditional negligence principles.      See,

e.g., Dolin, 2014 WL 804458, at *4–5 (rejecting defense of manufacturer

immunity and applying Illinois negligence law to claims against brand

defendants); Easter, 2004 WL 3104610, at *9 (rejecting defense of

manufacturer immunity and applying Texas negligence law to claims

against brand defendants); Lance, 85 A.3d at 458–60 (rejecting defense of

manufacturer immunity and applying Pennsylvania negligence law to

claims against brand defendants); see also Kolarik v. Corey Int’l Corp.,

721 N.W.2d 159, 162–63, 166 (Iowa 2006) (noting olives were “products”

for purposes of products liability and nevertheless allowing plaintiff to

proceed on general negligence claim for failure to warn).

      Finally, several courts have persuasively argued a decision to

eviscerate an enormous segment of our negligence law and “immunize

companies from the responsibility to respond in damages for such a lack

of due care resulting in personal injury” is a “weighty and consequence-

laden policymaking” judgment best left to Congress and the state

legislatures—none of which have granted such immunity just yet. Lance,
                                     63

85 A.3d at 461–62; see also Chatman, 960 F.Supp.2d at 654–55 (noting

“the Mississippi legislature has abolished the requirement of privity ‘in all

causes of action for personal injury . . . brought on account of

negligence’ ” (quoting Miss. Code Ann. § 11-7-20 (West, Westlaw through

2014 Regular (end) and First Extraordinary (end) Sess.)); Kellogg, 762

F.Supp.2d at 704 (“Neither the Vermont courts nor the Vermont

legislature have collapsed negligence actions into strict liability actions

where products are involved.”).

      I believe each of these principles is applicable in the case before us,

and I believe both our law of products liability and our law of negligence

dictate the brand defendants may be subject to liability here.             As

numerous authorities have noted, the causation problem the majority

has identified in Mulcahy is irrelevant given the facts and claims before

us.   Instead, we must analyze the claims given our long-standing

principles of negligence—a task I turn to now.

      II. Duty.

      We have often noted that while summary adjudication is rarely

appropriate in negligence cases, the determination of whether a duty is

owed under particular circumstances is a matter of law for the court’s

determination.    See, e.g., Hoyt v. Gutterz Bowl & Lounge L.L.C., 829

N.W.2d 772, 775 (Iowa 2013); Thompson, 774 N.W.2d at 834.                  In

Thompson, we adopted the duty analysis of section 7 of the Restatement

(Third) of Torts: Liability for Physical and Emotional Harm, and we

concluded an actor generally has a duty to exercise reasonable care

when the actor’s conduct creates a risk of physical harm.        Thompson,

774 N.W.2d at 835; see also Feld v. Borkowski, 790 N.W.2d 72, 75 (Iowa

2010) (“As a general rule, our law recognizes that every person owes a

duty to exercise reasonable care to avoid causing injuries to others.”).
                                   64

      We explained that in most cases, a court need not concern itself

with the existence or content of the duty, and should instead proceed to

analysis of the remaining elements of negligence liability. Thompson, 774

N.W.2d at 835; see also Feld, 790 N.W.2d at 76. In exceptional cases, we

noted, an actor’s general duty to exercise reasonable care might be

displaced or modified based on countervailing policy considerations

justifying limited or no liability in certain classes of cases—but those

policy reasons were not to depend on the specific facts of any given case.

Thompson, 774 N.W.2d at 835. In detailing this analysis more recently,

we have noted we may look to the comments and principles of the

current   Restatement,    the   comments     and     principles   of   prior

Restatements, and our prior caselaw in determining whether policy

considerations dictate departure from our general recognition of a duty to

exercise reasonable care in particular broadly drawn classes of cases.

See McCormick v. Nikkel & Assocs., Inc., 819 N.W.2d 368, 371–74 (Iowa

2012).

      A. Applicable Duty Principles From Our Caselaw and the

Restatements of the Law. The drafters of the Restatement (Third) have

set forth several important duty principles to guide us in our analysis

here. The drafters explain an actor’s business operations may provide a

fertile source for natural risks or third-party misconduct that creates

risks that would not have occurred in the absence of the business.

Restatement (Third) of Torts: Liab. for Physical & Emotional Harm § 37

cmt. d, at 5 (2012).   Section 19, they note, specifically sets forth the

standard of care for scenarios where an actor’s conduct increases the

risk of third-party conduct causing harm.          Id.   We adopted that

reasoning in Hoyt, where we concluded the duty of care applies to all

risks arising from a given course of conduct, even if also created in part
                                      65

by a third party’s conduct, regardless “whether innocent, negligent, or

intentional.”    Hoyt, 829 N.W.2d at 779.       In cases where business

operations provide a source of risk, the drafters note, “the actor’s

conduct creates risks of its own and, therefore, is governed by the

ordinary duty of reasonable care in [section] 7.” Restatement (Third) of

Torts: Liab. for Physical & Emotional Harm § 37 cmt. d, at 5.

         The drafters also note section 315 of the Restatement (Second) of

Torts has often led to pronouncements that “absent a special relationship

an actor owes no duty to control third parties.”        Id.   Section 315,

however, addressed only affirmative duties to control third parties—it

had nothing to say about “the ordinary duty of reasonable care with

regard to conduct that might provide an occasion for a third party to

cause harm.”      Id.   The Restatement (Second) actually addressed that

latter scenario in section 302B, the drafters explain, in providing for a

duty of care when an actor’s conduct “ ‘has created or exposed the other

to a recognizable high degree of risk of harm through such [third-party]

misconduct.’ ”      Restatement (Third) of Torts: Liab. for Physical &

Emotional Harm § 37, cmt. d, at 5 (quoting Restatement (Second) of Torts

§ 302B cmt. e, at 90).      Thus, the drafters note, both the Restatement

(Second) and the Restatement (Third) provide for liability when actors

engage in conduct that increases the magnitude of natural or third-party

risks.    Id. § 37, cmt. d, at 4–5.   Even when the actor and victim are

complete strangers and have no relationship, the drafters explain, the

basis for the ordinary duty of reasonable care under section 7 is conduct

creating risk to another. Id. § 37 cmt. b, at 3; see also West v. Broderick

& Bascom Rope Co., 197 N.W.2d 202, 209 (Iowa 1972) (noting Iowa

courts have “extricat[ed] themselves from the erroneous imposition of the

privity requirement”). A relationship, in other words, does not typically
                                      66

define the line between duty and no duty—instead, the line is drawn by

conduct creating risk to another. Restatement (Third) of Torts: Liab. for

Physical & Emotional Harm § 37 cmt. b, at 3; see, e.g., Keller v. State,

475 N.W.2d 174, 179 (Iowa 1991) (“[L]inking the existence of legal duty to

a particular relationship between the parties is not an unwavering

requirement for all negligence torts.”); see also Chatman, 960 F. Supp. 2d

at 654 (“As a general rule, in the context of negligence claims a

relationship is not necessary for a duty to exist.”); Gipson v. Kasey, 150

P.3d 228, 232 (Ariz. 2007) (“A special or direct relationship, however, is

not essential in order for there to be a duty of care.”).

      Further, the Restatement (Third) devotes an entire section to

conduct creating an ongoing risk of physical harm, in providing “[w]hen

an actor’s prior conduct, even though not tortious, creates a continuing

risk of physical harm of a type characteristic of the conduct, the actor

has a duty to exercise reasonable care to prevent or minimize the harm.”

Restatement (Third) of Torts: Liab. for Physical & Emotional Harm § 39,

at 31.   As the drafters make clear, the initial conduct need not be

actionable or even tortious for a duty to arise under the section. Id. § 39

cmt. c, at 31. In addition, they explain that even in the rare case a court

declines to apply the general section 7 duty we have recognized in our

caselaw, an actor will nonetheless have an ongoing duty to use

reasonable care to warn or otherwise mitigate risk under section 39. Id.

§ 39 cmt. d at 33–34..      Even if the actor does not know his or her

conduct has created a risk of harm, the drafters point out, the duty

provided in section 39 exists.      Id. § 39 cmt. d, at 34.   In that case,

however, “[b]efore a breach of the duty occurs . . . an objectively

foreseeable risk of harm must exist,” and that question, the drafters

note, “is a question of fact for the jury.” Id. § 39 cmt. d, at 34–35. The
                                            67

section 39 duty, the drafters explain, is justified both by an actor’s

creation of a risk, even if nontortiously, and by “the absence of the

pragmatic and autonomy explanations” for the no-duty rule set forth in

section 37. 20 Id. § 39 cmt. c, at 32. We have recognized the principles

expressed in section 39 for many years. See, e.g., Lovick 588 N.W.2d at

696 (“Our decision today confirms the existence of a post-sale duty for

manufacturers to warn . . . .”); see also Mercer v. Pittway Corp., 616

N.W.2d 602, 623–24 (Iowa 2000) (“[T]he inquiry is whether a reasonable

manufacturer knew or should have known of the danger, in light of the

generally recognized and prevailing best scientific knowledge, yet failed to

provide adequate warning to users or customers.”).

       Section 552 of the Restatement (Second) of Torts provides

additional insight. This section, setting forth requirements for the tort of

negligent misrepresentation, provides that an actor supplying false

information for the guidance of others may be liable for losses caused by

justifiable reliance upon the information. See Restatement (Second) of

Torts § 552, at 126–27. We have a long history of applying the section

552 principles in Iowa, and we have noted our caselaw ensures those

liable are in a position to weigh potential uses of the information against

       20Section   37 of the Restatement (Third) provides the standard autonomy-based
no-duty rule: “An actor whose conduct has not created a risk of physical or emotional
harm to another has no duty of care to the other unless a court determines that one of
the affirmative duties provided in §§ 38–44 is applicable.” Restatement (Third) of Torts:
Liab. for Physical & Emotional Harm § 37, at 2. The most common justification for this
rule, the drafters note, “relies on the liberal tradition of individual freedom and
autonomy” and places limits on “requiring affirmative conduct.” Id. § 37 cmt. e, at 5.
Tensions between the section 37 justification and our common “values about
humanitarian conduct” is reflected in the numerous exceptions to the rule elsewhere in
the Restatement. Id. § 37 cmt. e, at 6. The section 37 rule also has other less common
pragmatic justifications, the drafters explain, such as the concern that an affirmative
duty to aid others in peril might be confused with a general duty of self-sacrifice. Id.
§ 37 cmt. e, at 5–6. As the drafters note, the rule has no application in any case where
“the entirety of the actor’s conduct . . . [has] created a risk of harm.” Id. § 37 cmt. c, at
3.
                                     68

the potential magnitude and probability of loss if the information is

inadequate or incorrect.       See Van Sickle Const. Co. v. Wachovia

Commercial Mortg., Inc., 783 N.W.2d 684, 691–92 (Iowa 2010).

      As the drafters of the Restatement (Second) recognized long ago,

“[w]hen there is a public duty to supply the information in question . . .

the maker of the negligent misrepresentation becomes subject to liability

to any of the class of persons for whose benefit the duty is created.”

Restatement (Second) of Torts § 552 cmt. k, at 138.           The rule, the

drafters explained, applies to both public officers and private individuals

or corporations required by law to file information for the benefit of the

public.   Id. § 552 cmt. k, at 139.       In cases where the group to be

protected by the filing requirement is a broad one, the drafters noted, a

corporation might be liable to “any one who may reasonably be expected

to rely on the information and suffer loss as a result.”         Id.   As an

illustration of the principle, the drafters offered the following example:

      A, a United States government food inspector, in the
      performance of his official duties, negligently stamps a
      quantity of B’s beef as “Grade A.” In fact the beef is of
      inferior quality. In reliance upon the stamps, C buys the
      beef from D, and suffers pecuniary loss as a result. A is
      subject to liability to C.

Restatement (Second) of Torts § 552 illus. 18, at 139; see also id. § 552

cmt. i, at 136 (“When a misrepresentation creates a risk of physical harm

to the person, land or chattels of others, the liability of the maker

extends, under the rules stated in §§ 310 and 311, to any person to

whom he should expect physical harm to result through action taken in

reliance upon it.”).

      We have applied reasoning presaging the drafters’ section 552

analysis for more than a century here in Iowa.         See, e.g., Warfield v.

Clark, 118 Iowa 69, 72–73, 91 N.W. 833, 835 (1902) (“If the defendant in
                                     69

fact falsely reported the financial condition of his company for the

purpose of deceiving the public in relation to its responsibility as an

insurer, it seems clear to us that we should not say as a matter of law

that he only intended to wrong that particular class, and that those

dealing in its stock were not his intended victims; for he knew that stock

in such companies was often bought and sold, and that reliance might be

placed upon his sworn statement by those dealing therein.”).           As a

general proposition, we have long recognized and continue to recognize

an actor may be liable to third parties who reasonably rely upon

information prepared by the actor where the actor has reason to believe

the information will be relied upon by the third party.           See, e.g.,

Van Sickle, 783 N.W.2d at 691; Ryan v. Kanne, 170 N.W.2d 395, 403

(Iowa 1969). The point of this discussion, of course, is not that a brand

defendant must owe a duty to a consumer under section 552; the point,

instead, is the tort of negligent misrepresentation is another illustration

of the principle that an actor may create a risk of harm and thus owe a

duty to another even in the absence of having sold or manufactured a

product. Accordingly, the majority misses the mark in concluding the

brand defendants owe no duty to Huck because they never sold her a

product.

      Similarly, just as we have applied the duty principles of the

Restatement (Second) for many years, we have also applied the duty

principles of the Restatement (Third) both before and after our adoption

of the section 7 general duty in Thompson. See, e.g., Bohan v. Hogan,

567 N.W.2d 234, 237 (Iowa 1997) (“An act or omission may be negligent

if the actor realizes or should realize that it involves an unreasonable risk

of harm to another through the negligent or reckless conduct of the other

or a third person.” (quoting Restatement (Second) of Torts § 302A, at
                                     70

86)); Fiala v. Rains, 519 N.W.2d 386, 389 (Iowa 1994) (same); see also

Mitchell v. Cedar Rapids Cmty. Sch. Dist., 832 N.W.2d 689, 702 (Iowa

2013) (“[W]e have adopted the duty principles of the Restatement (Third)

. . . .”); Hoyt, 829 N.W.2d at 775–76, 776 n.4 (examining duty principles

of Restatement (Third) sections 7, 19, 37, and 40).

      Our analysis in Bohan is particularly illustrative of this point. See

Bohan, 567 N.W.2d at 235–37. In Bohan, a group of investors brought

negligence claims for losses suffered as a result of a deception by a

securities broker. Id. at 235. The broker had secured funds from the

investors by delivering them fictitious certificates of deposit purporting to

have been issued by a Chicago bank. Id. At issue in the case were not

the claims of the investors against the broker, but the investors’ claims

against a small Iowa printer who had printed the certificates, without

knowledge of the deception, at the broker’s request.       Id.   Despite the

printer’s lack of knowing involvement in the broker’s scheme, and despite

the lack of any special relationship between the printer and the

investors, we reasoned the investors had stated a claim of the printer’s

“own active negligence in furnishing an instrumentality that caused

harm to these claimants.” Id. at 236. With the aid of the principles set

forth in Restatement (Second) section 302B, and later in Restatement

(Third) sections 7, 19, and 37, we concluded a duty to exercise

reasonable care exists when an actor’s conduct creates a risk of harm,

even if the risk involves the negligent or reckless conduct of another. See

id. at 236–37.    No special relationship, we explained, was required

between the parties to give rise to the duty. Id. at 237. We were thus

“unable to conclude that there could be no set of facts proved that would

support a claim of actionable negligence on the part of” the printer. Id.

at 236.
                                    71

        Our cases following Thompson have applied the same principles.

In Feld, we explained all actors owe a duty to exercise reasonable care to

avoid causing injury to others, and the actor may be liable if the injury

caused by the actor’s conduct resulted from the risks rendering the

actor’s conduct negligent.     Feld, 790 N.W.2d at 75–76; see also

Restatement (Second) of Torts § 284(a), at 19 (providing negligent

conduct includes acts “which the actor as a reasonable man should

recognize as involving an unreasonable risk of causing an invasion of an

interest of another”).    We noted our long-standing contact-sports

exception to the general duty to exercise reasonable care, and noted

various policy reasons supported our modification of the general duty in

the realm of slow-pitch high school softball. Feld, 790 N.W.2d at 76–78.

We retained the general duty for that class of cases, but modified it such

that actors in slow-pitch softball games now have a duty to avoid

reckless disregard for the safety of others. Id. Similarly, in McCormick,

we noted we had affirmed our law recognizing the general duty in

Thompson and explained an actor generally has a duty to exercise

reasonable care when the actor’s conduct creates a risk of physical

harm.      McCormick, 819 N.W.2d at 371, 374.             Concluding the

subcontractor there owed no duty to a property owner’s employee who

had been electrocuted by a switchgear, we explained the subcontractor

had not “create[d] a ‘risk of physical harm,’ ” and thus our general

negligence principles and the principles of the Restatement (Third) would

not support liability. Id. at 374–75 (quoting Restatement (Third) of Torts:

Liab. for Physical & Emotion Harm § 7(a), at 77). Finally, in Hoyt, we

reiterated our long-standing rule that an actor has a duty to exercise

reasonable care when his or her conduct creates a risk of harm, while

explaining no-duty rulings should be limited to exceptional classes of
                                       72

cases     invoking     specifically    articulated     countervailing   policy

considerations. Hoyt, 829 N.W.2d at 775.

        Notably, we never invoked the duty question at all in Bredberg or

Mulcahy. See Bredberg, 551 N.W.2d at 323–29; Mulcahy, 386 N.W.2d at

69–76. The majority appears to agree Mulcahy had nothing to say about

duty—the court there was concerned with the majority’s proposed

“product-identification causation requirement,” because the existence of

a duty was never in question.         The duty principle most prominently

applicable in both Mulcahy and Bredberg was surely the long-standing

strict products liability principle that “the seller, by marketing his

product for use and consumption, has undertaken and assumed a

special responsibility toward any member of the consuming public who

may be injured by it.” Restatement (Second) of Torts § 402A cmt. c, at

349; see also Bredberg, 551 N.W.2d at 326–27 (citing section 402A);

Mulcahy, 386 N.W.2d at 70 (same); see also Moore v. Vanderloo, 386

N.W.2d 108, 117 (Iowa 1986) (“A drug manufacturer may be held liable

for a defective product in a strict liability action.”).

        That strict liability principle, however, was not the only principle

resolving the duty question in those cases or any other products liability

cases, because as we have long noted, our long-standing general duty of

reasonable care is also applicable in these cases. See, e.g., Osborn, 290

N.W.2d at 901 (citing cases examining “defective design of a product or

project as negligence”); see also Lovick, 588 N.W.2d at 696 (confirming

duty to exercise reasonable care in post-sale warning); Cooley v. Quick

Supply Co., 221 N.W.2d 763, 771 (Iowa 1974) (explaining question of

whom should receive warning is “to be decided [by a jury] by standards

of reasonable care.”); Hawkeye, 174 N.W.2d at 685; Bengford v. Carlem

Corp., 156 N.W.2d 855, 864 (Iowa 1968) (“Applying these rules to the
                                      73

evidence in this case it seems clear a jury could find defendant, Ford

Motor Company, failed to follow these recognized standards of care and

that as a proximate cause thereof plaintiff was injured.”); Wagner v.

Larson, 257 Iowa 1202, 1222, 136 N.W.2d 312, 324 (1965) (“If a

manufacturer does everything necessary to make the machine function

properly . . . then the manufacturer has satisfied the law’s demands.”

(quoting Campo v. Scofield, 95 N.E.2d 802, 804 (N.Y. 1950))). As we have

more recently explained, affirmative duties created as a result of a special

relationship or undertaking, like the strict liability duty, may often

overlap with the general duty, but the existence of an affirmative duty

does not displace the general duty. See, e.g., Hoyt, 829 N.W.2d at 775–

76; see also Hawkeye, 174 N.W.2d at 685; Restatement (Third) of Torts:

Liab. for Physical & Emotional Harm § 6 cmt. e, at 68–69 (explaining

special rules of law, “such as various rules of strict liability,” may impose

liability even in the absence of the general duty, and noting Restatement

(Third) of Torts: Products Liability details those strict liability rules); id.

§ 40 cmt. c, at 40 (explaining relationship between general and

affirmative duties); id. § 40 cmt. h, at 42–43 (same).

      B. Application of Our Duty Principles.             Applying our duty

principles as we always have, the existence of a duty should not be

controversial here. The brand defendants created risks in designing and

manufacturing Reglan®, and created risks in developing its warning,

which, by virtue of federal law, generics were required to mimic. Those

risks gave rise to duties.      These are not novel propositions in our

caselaw.   See, e.g., Cooley, 221 N.W.2d at 771 (requiring “reasonable

assurance that the information will reach those whose safety depends

upon their having it” (internal quotation marks omitted)); West, 197

N.W.2d at 209 (noting we recognize a duty of reasonable care “as to any
                                     74

product which [an actor] can reasonably expect to be dangerous if he is

negligent in its manufacture or sale”); Tice v. Wilmington Chem. Corp.,

259 Iowa 27, 43, 141 N.W.2d 616, 626 (1966) (“When a manufacturer,

distributor, producer or retailer markets a product with representations

as to its condition there should most certainly be imposed a strict

accountability   where   the   ultimate   consumer     relies   upon   those

representations and suffers injury. . . .”); see also PLIVA, Inc. v. Mensing,

564 U.S. ___, ___, 131 S. Ct. 2567, 2585–86, 180 L. Ed. 2d 580, 600–01

(2011) (Sotomayor, J., dissenting) (noting FDA requires drug companies “

‘to seek to revise their labeling and provide FDA with supporting

information about risks’ ” and explaining it is “undisputed” that drug

companies “have a duty under federal law to monitor the safety of their

products”); Restatement (Third) of Torts: Prods. Liab. § 6(c), at 145

(establishing duty of care to balance risks and benefits of prescription

drugs with respect to design); id. § 6(d), at 145 (establishing duty of care

to balance risks and benefits of prescription drugs with respect to

instruction and warning); cf. Lamb v. Manitowoc Co., 570 N.W.2d 65, 68

(Iowa 1997) (“A duty to warn exists when a party reasonably foresee[s] a

danger of injury or damage to one less knowledgeable unless an

adequate warning is given.” (Internal quotation marks omitted.)). Neither

the majority nor the parties have suggested we depart from our long-

standing recognition of both general and special duties when an actor’s

conduct creates a risk of physical harm, and I believe our recognition of

those duties settles the question here. See Restatement (Third) of Torts:

Liab. for Physical & Emotional Harm § 7, at 77; see also Hoyt, 829

N.W.2d at 776–77; Feld, 790 N.W.2d at 75–76; Thompson, 774 N.W.2d at

835; Restatement (Second) of Torts § 327, at 146 (“One who knows or

has reason to know that a third person . . . is ready to give to another aid
                                      75

necessary to prevent physical harm to him, and negligently prevents or

disables the third person from giving such aid, is subject to liability for

physical harm caused to the other by the absence of the aid which he

has prevented the third person from giving.”).        Whether countervailing

policy considerations may modify those duties is a separate question,

and a question the parties do not address directly, but I will analyze it in

turn.

        Before tackling that question, however, I note even application of a

relation-based conception of duty would establish duties on behalf of the

brands, because federal law establishes the brands’ responsibility for

both the design of the drug and the warning in question here. See, e.g.,

Dolin, 2014 WL 804458, at *4 (explaining brand “was responsible for”

generic’s “design and warning label”); see also Mulcahy, 386 N.W.2d at

70 (explaining liability may attach when actor “was in some way

responsible for the particular product that caused the injury”); Lance, 85

A.3d at 453 n.24 (explaining “federal law also imposes post-marketing

duties on pharmaceutical companies, including the obligation to ‘ensur[e]

that [their] warnings remain adequate as long as the drug is on the

market’ ”).   With respect to design, federal law requires the generic

version’s chemical equivalence to the approved brand-name drug: it must

have the same “active ingredient” or “active ingredients,” “route of

administration,” “dosage form,” and “strength” as its brand-name

counterpart. 21 U.S.C. § 355(j)(2)(A)(ii)–(iii) (2012). The generic must also

be “bioequivalent” and have the same “rate and extent of absorption” as

the branded drug.       Id. § 355(j)(2)(A)(iv), (8)(B).   With respect to the

warning, as the majority explains, the FDA must approve the accuracy

and adequacy of the brands’ labeling, and generic drug manufacturers

are required, by law, to show “the labeling proposed for the new drug is
                                        76

the same as the labeling approved for the [approved brand-name] drug.”

Id. § 355(a), (b)(1), (d), (2)(A)(v).   And, after initial approval of the new

drug application, a brand manufacturer may update its label to “add or

strengthen a contraindication, warning, precaution, or adverse reaction”

or to “add or strengthen an instruction about dosage and administration

that is intended to increase the safe use of the drug product” by filing an

application with the FDA, but it need not wait for FDA approval, and the

generic manufacturers are subject to an ongoing obligation of sameness.

21 C.F.R. § 314.70(c)(6)(iii)(A), (C) (2008); id. §§ 314.94(a)(8), .127(a)(7);

Abbreviated New Drug Application Regulations, 57 Fed. Reg. 17950–01,

17961 (Apr. 28, 1992) (“[T]he [generic drug’s] labeling must be the same

as the listed drug product’s labeling because the listed drug product is

the basis for [generic drug] approval.”). Moreover, every state now has a

drug substitution law, which requires pharmacists filling prescriptions

under most circumstances to substitute generic alternatives for branded

drugs when available. Dolin, 2014 WL 804458, at *5 n.5; see also, e.g.,

Iowa Code § 155A.32 (2013).

      There can be no doubt, then, the brands understood other

manufacturers were producing generic versions of the drug, those

versions were required by law to use the brands’ design and warning

label, consumers were purchasing those versions, and the brands had

the ability both initially and upon later investigation to remedy any

defects in the drug’s design or warning. Dolin, 2014 WL 804458, at *5–6;

see also Henkel v. R & S Bottling Co., 323 N.W.2d 185, 192 (Iowa 1982)

(“A manufacturer must anticipate the nature of the environment in which

the product [will] be used and [design against] the foreseeable risk

attending the product’s use in that setting.”). A mountain of authority

from other jurisdictions supports recognition of a duty on the part of a
                                     77

brand manufacturer given these considerations.           See Dolin, 2014 WL

804458, at *6 (“[T]hese parties stood in a relationship to one another

that, while clearly not ‘direct,’ was sufficient for the law to impose a duty

of reasonable conduct upon GSK for the benefit of Plaintiff.”); Schedin,

808 F. Supp. 2d at 1136 (“[T]he jury had sufficient evidence from which

to conclude [the brand] breached its duty to warn and that this breach

caused [the generic consumer’s] injuries.”); see also Chatman, 960

F. Supp. 2d at 655 (“In an affirmative misrepresentation case, even

though a defendant does not have a relationship with the plaintiff, it is

still possible for the defendant to be liable for causing the plaintiff's

physical injury if the plaintiff reasonably relies on false information

provided by the defendant”); Kellogg, 762 F. Supp. 2d at 706 (“To

recognize that a brand name drug manufacturer owes a duty to use

reasonable care to avoid causing injury to consumers of the generic

bioequivalents of its drugs does not ‘recognize a new cause of action or

enlarge an existing one’ . . . .”); Easter, 2004 WL 3104610, at *9 (“Lilly’s

design of and intimate knowledge about thimerosal also gives rise to a

duty to inform users of hazards associated with the use of thimerosal.”);

Weeks, 2013 WL 135753, at *19 (“[I]t is not fundamentally unfair to hold

the brand-name manufacturer liable for warnings on a product it did not

produce    because    the   manufacturing      process     is    irrelevant   to

misrepresentation theories based, not on manufacturing defects in the

product itself, but on information and warning deficiencies, when those

alleged   misrepresentations     were     drafted   by     the    brand-name

manufacturer and merely repeated by the generic manufacturer.”); Conte,

85 Cal. Rptr. 3d at 315 (“We hold that Wyeth’s duty of care in

disseminating product information extends to those patients who are

injured by generic metoclopramide as a result of prescriptions written in
                                     78

reliance on Wyeth’s product information for Reglan.”); Lance, 85 A.3d at

457 (“Wyeth—as the proponent of a contraction of existing tort law—has

failed to persuade us that federal regulatory involvement warrants a

departure from Pennsylvania’s system of civil redress, where there is a

demonstrated lack of due care in the face of an existing duty.”); Clark,

2008 Phila. Ct. Com. Pl. LEXIS 74, at *28–32 (concluding brand

manufacturer owed duty to generic purchaser).

      Accordingly,   I   believe   both   relation-based   and   risk-based

conceptions of duty compel our recognition of a duty here.

      C. Countervailing Policy Considerations.         As noted, we have

recognized categorical principles or policy considerations may sometimes

provide a basis for modifying or eliminating our long-standing general

duty of care for certain broadly drawn classes of actors. See, e.g., Feld,

790 N.W.2d at 76. In the context of prescription drugs, the drafters of

the Restatement (Third) have explained the general trend has not been to

disembowel the long-standing duty to warn—instead, courts have

typically recognized the duty, and modified it slightly such that the duty

is generally to warn and provide instructions to the prescribing

physician.   See Restatement (Third) of Torts: Liab. for Physical &

Emotional Harm § 7 cmt. i, at 82. Of course, as the drafters recognize,

even that minor modification is subject to important exception, as courts

have generally recognized the duty to warn extends even to patients

when a drug company “knows or has reason to know that health-care

providers will not be in a position to reduce the risks of harm.”      See

Restatement (Third) of Torts: Prods. Liab. § 6(d)(2), at 145. Neither the

parties nor the majority has advanced a suggestion we discard duties to

warn generally in the pharmaceutical industry, and I do not believe any
                                    79

court from any jurisdiction or any policy principle would support that

approach.

      I do not discount the impact of litigation on the pharmaceutical

industry. I would note, however, we have been presented with very little

information for purposes of undertaking any reasoned comparison of

that impact with the substantial social impact of filleting our long-

standing law of fault-based liability in Iowa.   We do know the brands

have been granted significant advantages in exchange for the burdens of

responsibility they bear for drug design and labeling. They are entitled to

an initial period of government-protected monopoly privileges in the form

of patent protection.   See 35 U.S.C. § 154.     They are entitled to an

extension of those monopoly privileges when generic versions of their

drugs receive FDA approval. See id. § 156 (patent-term extension); Drug

Price Competition and Patent Term Restoration Act of 1984, Pub. L. No.

98-417, 98 Stat. 1585 (codified in relevant part at 21 U.S.C. § 355

(1988)) (pairing generic approval with patent-term extension). We know

they enjoy “the fiscal rewards of name-brand recognition and the

commensurate ability to charge a higher price . . . , even after [their]

exclusive marketing period expires.”     Conte, 85 Cal. Rptr. 3d at 317.

Moreover, we know our recognition of a duty does not subject the brands

to any new obligation here—as all parties involved concede, the brands

are already subject to these obligations with respect to the branded

versions, and the design and warning must remain the same for the

generic versions.

      Perhaps most importantly, we know Congress weighed each of

these considerations in enacting the Hatch-Waxman amendments to the

FDCA, and notably, made no reference to elimination of the brands’

fault-based legal obligations.   See Drug Price Competition and Patent
                                     80

Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984).

Indeed, I believe both courts and legislatures have typically regarded the

tort system as providing powerful incentives to engage in responsible,

reasonable behavior to promote safety in numerous industries, including

the pharmaceutical industry.     See generally Wyeth v. Levine, 555 U.S.

555, 578, 129 S. Ct. 1187, 1202, 173 L. Ed. 2d 51, 68–69. Our general

assembly codified that recognition shortly after the Hatch-Waxman

amendments, in noting our general tort duties are applicable even in

products liability actions, to actors well outside the direct stream of

product distribution in both negligence and strict liability. See, e.g., Iowa

Code § 668.12 (1987) (“Nothing [contained in subsection providing state-

of-the-art defense] shall diminish the duty of an assembler, designer,

supplier of specifications, distributor, manufacturer, or seller to warn

concerning subsequently acquired knowledge of a defect or dangerous

condition that would render the product unreasonably dangerous for its

foreseeable use or diminish the liability for failure to so warn.”); see also

Lovick, 588 N.W.2d at 693 (explaining “section 668.12 clearly established

our legislature’s understanding of the duty”).

      Furthermore, as I have noted, the Supreme Court has rejected the

notion that negligence claims against brand defendants for failure to

warn based on state tort law are preempted by federal law. See Levine,

555 U.S. at 581, 129 S. Ct. at 1204, 173 L. Ed. 2d at 70.           Yet, the

majority quotes at length from an article authored by Professor Epstein

asserting the Supreme Court got it wrong on preemption. Repurposing

Epstein’s rejected policy arguments favoring preemption, the majority

advances them in favor of a no-duty rule in this case. As they failed in

furtherance of preemption, they must come up short here as well.
                                   81

      Epstein would place great reliance on the expertise of the FDA in

assessing the risks posed by medications to consumers, allocating the

duty to warn, and regulating the content of warnings.       But there is

another side of the story. As the Supreme Court noted in Levine, the

resources of the FDA are limited while the volume of regulated

medications is vast. Levine, 555 U.S. at 578–79, 129 S. Ct. at 1202, 173

L. Ed. 2d at 68 (noting the FDA has limited resources with which to

regulate 11,000 medications). This reality has prompted a former FDA

commissioner, along with a noted administrative law authority, to

express reservations about the agency’s ability to effectively monitor the

safety of the consuming public, and to affirm the ameliorative purposes

served by state tort law:

             Our second concern is that the FDA’s pro-preemption
      arguments are based on what we see as an unrealistic
      assessment of the agency’s practical ability—once it has
      approved the marketing of a drug—to detect unforeseen
      adverse effects of the drug and to take prompt and effective
      remedial action. After all, there are 11,000 FDA-regulated
      drugs on the market (including both prescription and over-
      the-counter drugs), with nearly one hundred more approved
      each year. The reality is that the FDA does not have the
      resources to perform the Herculean task of monitoring
      comprehensively the performance of every drug on the
      market. Recent regulatory failures, such as the agency’s
      ineffectual response to Vioxx, have demonstrated the FDA’s
      shortcomings in this regard. Given the FDA’s inability to
      police drug safety effectively on its own, we question the
      wisdom of the FDA’s efforts to restrict or eliminate the
      complimentary discipline placed on the market by failure-to-
      warn litigation.

            ....

              The information-gathering tools lawyers have in
      litigation are, by any measure, more extensive than the
      FDA’s.

            ....

      Statutory gaps in the FDA’s authority to gather information,
      especially post-approval, hamstring its ability to ensure the
                                      82
      safety of drugs on the market. The FDA Amendments Act
      may help close those gaps somewhat, but they remain
      substantial. . . . . The benefits of this litigation should not
      be discarded lightly, and, as we have said, we see no benefit
      to the FDA or the public in finding failure-to-warn litigation
      pre-empted.

David A. Kessler & David C. Vladeck, A Critical Examination of the FDA’s

Efforts to Preempt Failure-to-Warn Claims, 96 Geo. L. J. 461, 465, 492,

495 (2008). If the reasons advanced by Kessler and Vladeck—and by the

Supreme Court in Levine—for rejecting preemption of failure-to-warn

claims are to be given any practical recognition, they must apply with

equal, if not greater, force to the majority’s contention the courthouse

doors should be closed to consumers like Huck by a court-made no-duty

rule. See Levine, 555 U.S. at 592, 129 S. Ct. at 1210, 173 L. Ed. 2d at

77 (Thomas, J., concurring) (“Initial approval of a label amounts to a

finding by the FDA that the label is safe for purposes of gaining federal

approval to market the drug.      It does not represent a finding that the

drug, as labeled, can never be deemed unsafe by later federal action, or

as in this case, the application of state law.”).

      It is instructive, in my view, that Congress has not chosen to

preempt failure-to-warn cases brought against brands. The policy choice

against preemption maintained by Congress during the more than seven

decades of the FDA’s existence evidences that the legislative branch

values the salutary effects of tort law in this area.        Congress clearly

knows how to prescribe preemption, as it did so in the medical device

field in 1976. See 21 U.S.C. § 360k(a) (2012); Levine, 555 U.S. at 574,

129 S. Ct. at 1200; 173 L. Ed. 2d at 66.            The choice by Congress in

eschewing preemption for brand pharmaceuticals reveals faith in the

beneficial impact of the civil justice system in augmenting the protections

afforded by the FDA. See Levine, 555 U.S. at 574, 129 S. Ct. at 1200,
                                   83

173 L. Ed. 2d at 66 (“If Congress thought state-law suits posed an

obstacle to its objectives, it surely would have enacted an express pre-

emption provision at some point during the FDCA’s 70-year history.”);

see also id. 555 U.S. at 574, 129 S. Ct. at 1199–1200, 173 L. Ed. 2d at

65–66 (“Congress did not provide a federal remedy for consumers harmed

by unsafe or ineffective drugs in the 1938 statute or in any subsequent

amendment. Evidently, it determined that widely available state rights of

action provided appropriate relief for injured consumers.    It may also

have recognized that state-law remedies further consumer protection by

motivating manufacturers to produce safe and effective drugs and to give

adequate warnings.” (Footnote omitted.)); Rostron, 60 Duke L.J. at 1191

(“The FDA’s regulatory oversight repeatedly has proven insufficient to

prevent unreasonably dangerous drugs from reaching consumers. Tort

law provides vital incentives for drug makers to act with appropriate

care. Courts should apply tort law in a manner that encourages drug

companies to continue producing innovative products but to act

reasonably to ensure that their products are safe and accompanied by

adequate warnings and accurate information. Striking the right balance

is a challenge, but it is one that courts must continue striving to meet.

These issues can quite literally be matters of life and death.” (Footnote

omitted.)); cf. Allison Stoddart, Missing after Mensing: A Remedy for

Generic Drug Consumers, 53 B.C. L. Rev. 1967, 1998 (2012) (“The tort

system incentivizes manufacturers to strengthen warnings by allowing

tort claims against manufacturers when the probability of harm from an

inadequate warning is greater than the burden of enhancing the

warning—that is, when the manufacturer is negligent.”).

      The majority’s claim that the pharmaceutical industry will be

substantially harmed by a rule imposing a duty on the brands, who
                                          84

controlled the content of the warning PLIVA was legally required to use,

is, in my view, speculative and overblown. See Steven Garber, Economic

Effects of Product Liability and Other Litigation Involving the Safety and

Effectiveness of Pharmaceuticals, Rand Institute for Civil Justice, at xv

(2013),    available     at   www.rand.org/pubs/monographs/mg1259.html

(suggesting policymakers should be “wary of broad claims about

economic effects of pharmaceutical liability, including generalizations

based on anecdotes or examples”). 21                The safety-based regulations

promulgated by the FDA can comfortably coexist with the brands’ duty to

exercise reasonable care in warning consumers of grave health risks

attending the use of pharmaceuticals. 22            See, e.g., Levine, 555 U.S. at

       21Although  interests advocating restriction of tort liability contend certain
products have been either withdrawn or withheld from the market because of the costs
associated with the civil justice system, there is scarce direct empirical evidence
supporting these contentions. Even if we were to credit the contentions, however, our
analysis would require examination of additional crucial questions: Were the products
bad or dangerous? Was their withdrawal from the market in the public interest? See,
e.g., Gary T. Schwartz, Reality in the Economic Analysis of Tort Law: Does Tort Law
Really Deter?, 42 UCLA L. Rev. 377, 410–13 (1994) [hereinafter Schwartz].
       22Principles of federalism and practicality bolster this understanding. Numerous
commentators and authorities have recognized states are independent sovereigns in the
federal system, and play a historic and important role in the local regulation of health
and safety.    See, e.g., Ernest A. Young, Federal Preemption and State Autonomy, in
Federal Preemption: States’ Powers, National Interests 249, 251–52 (Richard A. Epstein
& Michael S. Greve eds., 2007) (noting preemption problematically limits regulatory
diversity by constraining state autonomy). Similarly, numerous commentators have
noted tort claims operate as an important check even in federally regulated fields. See,
e.g., Catherine M. Sharkey, Preemption by Preamble: Federal Agencies and the
Federalization of Tort Law, 56 DePaul L. Rev. 227, 230–33 (2007) (criticizing the
Consumer Product Safety Commission’s inclusion of an express preemption clause in
its mattress flammability standards as “[r]emoving a significant incentive for industries
to improve outside of meeting the federal standard” (internal quotation marks omitted));
see also Thomas O. McGarity, The Preemption War: When Federal Bureaucracies Trump
Local Juries 236–38 (2008) (explaining common law reinforces incentives for compliance
with federal regulations, fills gaps for unanticipated consequences of regulations, and
provides protection while agencies take time to formulate responses to problems);
Schwartz, 42 UCLA L. Rev. at 385 (“Likewise, tort suits can (first) uncover and (then)
dramatize information in a way that can set in motion a regulatory response.”). See
generally Thomas H. Sosnowski, Narrowing the Field: The Case Against Implied Field
Preemption of State Product Liability Law, 88 N.Y.U. L. Rev. 2286, 2293–94 (2013).
                                     85

593, 129 S. Ct. at 1211, 173 L. Ed. 2d at 78 (Thomas, J., concurring)

(“The federal statute and regulations neither prohibited the stronger

warning label required by the state judgment, nor insulated Wyeth from

the risk of state-law liability.”). As Robert Rabin has explained,

            Tort duties do not “require” anything other than the
      payment of damages. If tort liability does lead a defendant to
      a private assessment in favor of greater future precautionary
      measures, then tort, of course, has had a regulatory effect.
      But tort itself dictates no particular change in a losing
      defendant’s conduct.

            ....

             [T]here is no inexorable principle that productivity
      gains from uniform national health and safety standards—a
      frequently invoked rationale for preemption—should be
      borne by injury victims in cases of residual harm. Moreover,
      once again, it is critical to underscore the dynamics of tort.
      Liability does not entail enforced departure from regulatory
      standards; it only compels payment of damage awards.

            ....

             If the tort claim rests on an assertion that substantial
      post-approval new evidence of risk has come to light, and
      has neither been incorporated into a revised warning, nor
      rejected by the agency as insubstantial, the foundational
      risk/benefit analysis on which agency certification was based
      is inapposite. Hence, the tort claim is not an effort to revisit
      and supersede the regulatory approval process.

            ....

             In proposing a framework for addressing these
      tensions, based on focused examination of whether the
      agency directive is grounded in the same evidence-based
      risk/benefit inquiry as the tort process would entail, I join
      those commentators who seek to forge a path that recognizes
      the distinct benefits that both regulation and tort have to
      offer.

Robert L. Rabin, Territorial Claims in the Domain of Accidental Harm:

Conflicting Conceptions of Tort Preemption, 74 Brook. L. Rev. 987, 991,

993, 1002, 1009 (2009) (emphasis added).
                                   86

      Given these considerations, and taking account of the vast range of

information that must be weighed when balancing the interests of the

pharmaceutical industry and those of consumers, I do not believe we are

adequately equipped to craft a bright-line no-duty rule here.     I would

leave that policymaking to our general assembly, which has continued to

recognize duties in this realm. I would therefore continue to hew to the

long-standing and widespread recognition of the brands’ general and

affirmative duties here.

      III. Factual Causation.

      In addition to establishing the existence of a duty or duties, we

have often explained in both products liability and traditional negligence

cases the plaintiff “must establish a causal relationship between the

alleged negligence and injury.”   Lovick, 588 N.W.2d at 700 (products

liability); accord Thompson, 774 N.W.2d 836–39 (negligence).       In the

context of failure to warn claims, we have noted factual causation is

established by demonstrating “a warning would have altered the

plaintiff’s conduct so as to avoid injury.”   Lovick, 588 N.W.2d at 700.

More generally, as the drafters of the Restatement (Third) have provided,

“[c]onduct is a factual cause of harm when the harm would not have

occurred absent the conduct.”     Restatement (Third) of Torts: Liab. for

Physical & Emotional Harm § 26, at 346; accord Thompson, 774 N.W.2d

at 837–39 (adopting Restatement (Third) factual causation and scope of

liability principles); see also Asher v. OB-Gyn Specialists, P.C., 846

N.W.2d 492, 500 (Iowa 2014). This is tort law’s familiar “but-for” test,

and both the First and Second Restatements of Torts endorsed this

standard in providing “the harm would not have occurred had the actor

not been negligent.” See, e.g., Restatement (Second) of Torts § 431 cmt.
                                      87

a, at 429; see also Restatement (Third) of Torts: Liab. for Physical &

Emotional Harm § 26 cmt. b, at 347.

      Here, as the majority explains, Dr. Gyano relies upon information

published by the brands—for purposes of covering both branded versions

of drugs and their generic counterparts—in the Physician’s Desk

Reference in making prescription decisions generally, and she relied on

this information in 2004 to prescribe branded Reglan for Huck.

Dr. Gyano has explained the risk–benefit analysis she uses in making

prescription decisions has changed as a result of her access to the

brands’ updated information and labeling.        She now supplements the

conversation she typically has with patients with this risk–benefit

information before making prescription decisions.           Further, she has

noted she would have modified her treatment conversations and

decisions in the same way had she received this information back in

2004, and the information would have had the same impact.            Finally,

Dr. Gyano and Huck have explained had this information been available

sooner, and had they discussed the implications back then, Huck would

never have taken metoclopramide, and would never have developed

tardive dyskinesia.     Applying our principles of factual causation in

straightforward fashion, we may safely conclude Huck has advanced

evidence sufficient to allow a jury to find her harm would not have

occurred had the brands not allegedly failed to satisfy their obligation of

reasonable care, and similarly, she has advanced evidence sufficient to

allow a jury to find a warning would have altered her conduct such that

she would have avoided injury.             See Lovick, 588 N.W.2d at 700

(“[C]aus[ation] can be established by showing a warning would have

altered the plaintiff’s conduct so as to avoid injury.”).
                                         88

      Although that analysis resolves the factual causation question

simply and completely, I think it prudent to point out several general

principles relevant to the factual causation analysis in both products

liability cases in general and in the case we actually confront here. Dolin,

2014 WL 804458, at *7 (noting courts have often “conflate[d] two facially

similar, but fundamentally distinct, tort liability problems”); Rostron, 60

Duke L.J. at 1164 (“[C]ourts have repeatedly made the same mistake,

dwelling on the irrelevant concept of liability being imposed on multiple

manufacturers because of uncertainty about who made a product and

conflating that concept with the separate and distinct issue of whether a

manufacturer can be liable for wrongdoing other than making and selling

the product the plaintiff received.”).

      As I have already noted, the factual scenario we confront here is

not the one we examined in Mulcahy, where we could not identify the

actor allegedly responsible for harm. Instead, we face here a scenario

where an injury occurred in connection with a given product and the

plaintiff can demonstrate tortious conduct by someone other than the

product’s manufacturer had a causal role in producing the injury. This

latter scenario is not a novel one in the field of products liability law. See

generally Madden & Owen on Products Liability § 19:4, at 370–78 (3d ed.

2000) (collecting cases); Melissa Evans Bush, Products Liability and

Intellectual Property Licensors, 22 Wm. Mitchell L. Rev. 299, 311–14

(2000) (collecting cases).

      The scenario arises in numerous ways, and in each, courts have

not hesitated in finding factual causation. Where an organization in the

business of testing products and affixing labels certifying the results of

its testing is negligent in its labeling, for example, courts have concluded

the tester’s negligence may be a factual cause of injuries when these
                                     89

products fail to perform in accordance with the labeling.          See, e.g.,

Hempstead v. Gen. Fire Extinguisher Corp., 269 F. Supp. 109, 118 (D.

Del. 1967) (“If plaintiff succeeds in proving his charge that Underwriters

was negligent in approving the design of a fire extinguisher which was

imminently dangerous, and that plaintiff’s injury was a result thereof,

Underwriters must respond in damages.”). When a publisher is in the

business of placing an endorsement or seal of approval on products, and

fails to exercise ordinary care in approving a particular product, courts

have concluded the publisher’s conduct may be a factual cause of

damages when the product fails to perform in accordance with the

publisher’s representation. See, e.g., Hanberry v. Hearst Corp., 81 Cal.

Rptr. 519, 522 (Ct. App. 1969) (“[I]ts seal and certification tend to induce

and encourage consumers to purchase products advertised in the

magazine and which bear that seal and certification.”). Likewise, courts

have concluded nonmanufacturing seed certifiers constitute a nontrivial

link “in the chain of distribution which [places] a [product] in the stream

of commerce,” and thus those certifiers may play a causal role in any

damage suffered by third parties relying on those certifications.

Rottinghaus v. Howell, 666 P.2d 899, 907 (Wash. Ct. App. 1983) (“MPIA’s

conduct in certifying the defective seed, issuing a blue tag stating such

and representing the quality of the seed in the 1977 directory created an

issue for the jury as to whether defendant was liable for negligence and

negligent misrepresentation.”).    Similarly, a trade association or other

organization setting insufficient safety standards for a product may

factually cause harms flowing from the plaintiff’s use of the product. See

Meneely v. S.R. Smith, Inc., 5 P.3d 49, 57 (Wash. Ct. App. 2000) (“We hold

the evidence and the reasonable inferences therefrom support the jury’s

findings that NSPI negligently caused Mr. Meneely’s injuries. . . .”).
                                      90

      Perhaps more to the point, we recognized in both Schiltz and
McCarthy designers and suppliers of specifications may have a causal
role in damages resulting from the failure of structures built according to
those designs or specifications. See Schiltz, 228 N.W.2d at 17; McCarthy,
199 N.W.2d at 367–68.          In Schiltz, we explained the plaintiff had
advanced substantial evidence an engineering firm had negligently
designed protective dikes for a sewage treatment facility and substantial
evidence the negligence was a factual and legal cause—using our old tort
terminology—of the plaintiff’s damage.         Schiltz, 228 N.W.2d at 18.
Similarly, in McCarthy, we recognized an architect’s negligence in
supplying plans and specifications for the construction of a school might
constitute the factual cause of “improper collection and discharge of
surface waters upon” a plaintiff’s adjacent property.          McCarthy, 199
N.W.2d at 367.
      In addition to those propositions, I note products liability cases
have never displaced our age-old torts principle that “an intervening act
will not relieve a negligent defendant of liability if that act or force was a
normal consequence of the defendant’s conduct or was reasonably
foreseeable by that defendant.” Iowa Elec. Light & Power Co. v. Gen. Elec.
Co., 352 N.W.2d 231, 235 (Iowa 1984); see also, e.g., Rossell v.
Volkswagen of Am., 709 P.2d 517, 526 (Ariz. 1985) (explaining “an
intervening force becomes a superseding cause only when its operation
was both unforeseeable and when with the benefit of ‘hindsight’ it may
be described as abnormal or extraordinary” and applying rule in case of
negligent placement of car battery); Larson Mach., Inc. v. Wallace, 600
S.W.2d 1, 9 (Ark. 1980) (explaining “[t]he mere fact that other causes
intervene between the original act of negligence and the injury for which
recovery is sought is not sufficient to relieve the original actor of liability,
if the injury is the natural and probable consequence of the original
                                      91

negligent act or omission and is such as might reasonably have been
foreseen” and applying rule in case of fertilizer spreader); Weyerhaeuser,
620 N.W.2d at 831 (“[T]he fire and resulting explosion were . . .
foreseeable intervening causes [of product’s defect] that did not
supersede [defendant]’s responsibility.”); Zacher v. Budd Co., 396 N.W.2d
122, 135 (S.D. 1986) (explaining “even if a plaintiff is assumed
contributorily negligent, whether that intervening force supersedes the
defendant’s negligence is for the jury to decide” and applying rule in case
of wheel explosion).
      In short, the universe of imaginable scenarios in which an actor
who has not manufactured or sold a product may nevertheless both
cause and be liable for damages caused is enormous.         The majority’s
proposed “product-identification causation requirement” does no work to
address the vast majority of these scenarios.        See Dolin, 2014 WL
804458, at *8 (“Taken out of context, language in product identification
cases . . . may well appear to support GSK’s argument. In truth, the
principles for which that line of cases stands are inapposite here.”). The
majority’s invocation of the requirement here improvidently forsakes our
clear and easily applied principles of factual causation. I would instead
apply our traditional principles of factual causation in this case and
conclude Huck has advanced evidence sufficient to allow a jury to find
the brands’ alleged negligence was a but-for cause of the harm she has
suffered here.      I would therefore reverse the district court’s entry of
summary judgment on Huck’s claims with respect to the brands and
remand for trial.
      Wiggins and Appel, JJ., join this concurrence in part and dissent
in part.