RECOMMENDED FOR FULL-TEXT PUBLICATION

Pursuant to Sixth Circuit Rule 206

File Name: 10a0250p.06

UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT _________________

OLIVER WIMBUSH, Individually and as

Executor of the Estate of Mary Buchanan, 

Plaintiff-Appellant,

v.

WYETH; WYETH-AYERST LABS. CO.; WYETH

PHARM., INC.; WYETH PHARM.,

Defendants-Appellees.

X

-

-

-

-

>

,

-

-

-

-

N

No. 09-3380

Appeal from the United States District Court

for the Northern District of Ohio at Cleveland.

No. 03-02042—Solomon Oliver, Jr., Chief District Judge.

Argued: January 13, 2010

Decided and Filed: August 18, 2010 

Before: MARTIN, BOGGS, and WHITE, Circuit Judges.

_________________

COUNSEL

ARGUED: Paul W. Flowers, PAUL W. FLOWERS CO., L.P.A., for Appellant.

George E. McDavid, REED SMITH LLP, Princeton, New Jersey, for Appellees.

ON BRIEF: Paul W. Flowers, PAUL W. FLOWERS CO., L.P.A., Benjamin H.

Anderson, ANDERSON LAW OFFICE, L.L.C., Cleveland, Ohio, for Appellant. George

E. McDavid, Eric L. Alexander, REED SMITH LLP, Princeton, New Jersey, David R.

Cooper, COOPER & WALINSKI, Toledo, Ohio, M. Sean Laane, ARNOLD & PORTER

LLP, Washington, D.C., for Appellees.

MARTIN, J., delivered the opinion of the court, in which BOGGS, J., joined.

WHITE, J. (pp. 20-22), delivered a separate opinion concurring in part and dissenting

in part.

1
No. 09-3380 Wimbush v. Wyeth, et al. Page 2

1

Pulmonary hypertension is characterized by an abnormally high blood pressure in the arteries

of the lungs, which forces the right side of the heart to work harder than normal. There is no

known cure. See Pulmonary Hypertension, Medline Plus Medical Encyclopedia, a service of the

U.S. National Library of Medicine and the National Institutes of Health,

http://www.nlm.nih.gov/medlineplus/ency/article/000112.htm.

_________________

OPINION

_________________

BOYCE F. MARTIN, JR., Circuit Judge. Mary Buchanan sued Wyeth, a

publicly-held corporation, Wyeth Pharmaceuticals, an unincorporated division of Wyeth,

and Wyeth-Ayerst Laboratories Company and Wyeth Pharmaceuticals, Inc., whollyowned subsidiaries of Wyeth, regarding a diet pill, Redux, that the companies

manufactured and sold. Buchanan’s claims sound primarily in strict liability and

common law negligence. Buchanan appeals the district court’s entry of summary

judgment for Wyeth on all of her claims. Relatedly, Buchanan requests a finding that

the district court abused its discretion in denying her Motion to Alter and Amend

Judgment and that the final judgment be reversed. 

For the reasons set forth below, we REVERSE the judgment of the district court

finding that approval of Redux by the Food and Drug Administration (FDA) preempted

Buchanan’s negligence claims taking issue with Wyeth’s actions before FDA approval,

as well as the district court’s related dismissal of Buchanan’s request for punitive

damages, and REMAND those issues back to the district court. We AFFIRM the

judgment of the district court on all other claims.

I.

Buchanan alleged that she was prescribed and that she ingested Redux for several

months during 1996 and 1997 in order to control her weight. After her November 2001

diagnosis with primary pulmonary hypertension,1

 she filed a complaint against Wyeth

in the United States District Court for the Northern District of Ohio on October 2, 2003.

She died December 18, 2003, allegedly as a result of having taken Redux.
No. 09-3380 Wimbush v. Wyeth, et al. Page 3

2

This case was originally filed by Mary Buchanan, whose estate, upon her death, was represented

first by Romona Longs and then Oliver Wimbush. For consistency purposes, we refer to plaintiff as

“Buchanan.”

Wyeth marketed and sold Redux after its approval by the FDA in April 1996.

Redux became available in June 1996 and was taken off the market on September 15,

1997. While Wyeth sold Redux to the public, it provided several warnings regarding the

health risks associated with ingesting Redux. In April 1996, Wyeth sent health

professionals a letter stating that “a small risk of a serious, potentially life-threatening

cardiovascular condition, primary pulmonary hypertension (PPH)” was “associated with

the use of all types of prescription weight loss drugs. This risk is . . . about 18 cases per

1,000,000 users per year.” On the first Redux label, the warning about PPH was written

in all bold typeface and contained the information above. 

Wyeth provided a second warning letter to physicians in August 1996, which

explained that a final report of clinical studies indicated that the risk of PPH was greater

than previously stated and that “the risk of PPH [is] calculated to be about 23 times

higher for patients using anorexigens for three or more months compared to non-users.”

It further warned that “PPH is a serious disorder with an estimated 4-year mortality rate

of 45%” and warned doctors that patients experiencing symptoms should immediately

discontinue their use of Redux. 

New labels were sent to health-care professionals in December 1996 along with

a third letter reporting changes made to the label. The letter stated that “Redux . . .

increase[s] the risk of developing primary pulminory hypertension, an often fatal

disorder.” The new labels provided updated information regarding the increased risk

of PPH reflected by new studies in boldface capitalized letters.

Buchanan’s2

 amended complaint, filed on January 22, 2007, stated claims for:

(1) strict product liability encompassing both design defect pursuant to O.R.C. § 2307.75

and failure to warn pursuant to O.R.C. § 2307.76; (2) common-law negligence; and

(3) wrongful death pursuant to O.R.C. § 2125.01, et. seq. Buchanan also sought

economic, non-economic, and punitive damages pursuant to O.R.C. § 2307.80(C). She
No. 09-3380 Wimbush v. Wyeth, et al. Page 4

later withdrew her claims for failure to warn, pursuing only a strict product liability

design defect claim, negligence claims, and punitive damages. 

Wyeth filed three separate motions for partial summary judgment on

September 21, 2007: one based on federal preemption; one arguing lack of evidence of

proximate causation; and one related to punitive damages. Oral arguments were held on

January 17, 2008. 

On February 28, 2008, the district court granted summary judgment in favor of

Wyeth on all claims. Longs v. Wyeth (Longs I), 536 F. Supp. 2d 843 (N.D. Ohio 2008).

The court found that Buchanan’s strict liability and negligence claims relating to

Wyeth’s conduct prior to the FDA’s approval of Redux for placement on the market

were preempted by the FDA’s subsequent approval of the drug and that any post-FDAapproval claims, which were not preempted, failed on their merits. As relevant to this

appeal, the court further held that: (1) Buchanan’s strict liability design defect claim

failed because Buchanan failed to provide evidence refuting Wyeth’s showing that the

Redux warnings were adequate as a matter of law; (2) Buchanan’s negligence claims

failed because Buchanan did not provide evidence of proximate causation; and (3) the

request for punitive damages was moot because, as a result of the dismissal of all of the

substantive claims, Buchanan could not establish liability under any theory for which she

could be entitled to any damages, much less punitive damages. As a result of these

holdings, the district court dismissed the case. 

On March 10, 2008, Buchanan moved to vacate the order and judgment and to

alter the judgment. Buchanan argued that: (1) her pre-FDA-approval claims were not

preempted in light of the Supreme Court’s intervening decision in Wyeth v. Levine, __

U.S.__, 129 S. Ct. 1187 (2009); (2) Wyeth bore the burden of proving that its warnings

were adequate rather than Buchanan bearing the burden of proving the warnings

inadequate; (3) Wyeth did not properly raise the argument that Buchanan lacked

evidence showing the inadequacy of Wyeth’s warnings with regard to Buchanan’s

design defect claim; and (4) Wyeth did not properly raise the issue that Buchanan lacked

evidence of proximate causation in regard to her negligence claim. The court denied
No. 09-3380 Wimbush v. Wyeth, et al. Page 5

Buchanan’s motion on March 20, 2009. Longs v. Wyeth (Longs II), 621 F. Supp. 2d 504

(N.D. Ohio 2009). Buchanan timely appealed.

II.

Buchanan appeals the district court’s summary judgment order as well as the

order denying her motion to vacate and alter judgment.

A. Standard of Review

“The Sixth Circuit reviews de novo a district court’s grant of summary

judgment.” Hamilton v. Starcom Mediavest Group, Inc., 522 F.3d 623, 627 (6th Cir.

2008) (citing Hardesty v. Hamburg Twp., 461 F.3d 646, 650 (6th Cir. 2006)).

“Summary judgment is proper where no genuine issue of material fact exists and the

moving party is entitled to judgment as a matter of law.” Id. (citing Fed. R. Civ. P.

56(c)). “The moving party has the initial burden of proving that no genuine issue of

material fact exists,” Vaughn v. Lawrenceburg Power Sys., 269 F.3d 703, 710 (6th Cir.

2001) (citing Street v. J.C. Bradford & Co., 886 F.2d 1472, 1477 (6th Cir. 1989)), and

the court must draw all reasonable inferences in the light most favorable to the

nonmoving party. Id. (citing City Mgmt. Corp. v. U.S. Chemical Co., 43 F.3d 244, 250

(6th Cir. 1994)). When a motion for summary judgment is properly made and supported

and the nonmoving party fails to respond with a showing sufficient to establish an

essential element of its case, summary judgment is appropriate. See Celotex Corp. v.

Catrett, 477 U.S. 317, 322-23 (1986); see also Street, 886 F.2d at 1479-80.

In Ohio, three basic theories of liability exist “under which a claimant may assert

a product liability action: (1) under the Ohio Product Liability Act; (2) negligence; and

(3) breach of warranty.” Christopher M. Ernst, et al., Baldwin’s Ohio Practice, Ohio

Tort Law, § 6.1 (2009). We will address Buchanan’s design defect claim under the Ohio

Product Liability Act and her common law theories of negligence first, and then address

the district court’s preemption ruling.
No. 09-3380 Wimbush v. Wyeth, et al. Page 6

B. Strict Liability Claims

Strict liability for manufacturers and suppliers is codified by the Ohio Products

Liability Act, O.R.C. §§ 2307.71-2307.80, effective January 5, 1988. Recent

amendments to the Act provide that the legislature intended the Act to abrogate all

common law product liability causes of action. See O.R.C. § 2307.71(B), effective April

7, 2005. Buchanan initially brought strict liability claims for design defect and failure

to warn, though she subsequently dropped the failure-to-warn claim. But, dropping the

failure-to-warn claim did not render the warnings irrelevant.

According to Ohio law, so long as adequate warning has been provided for a

pharmaceutical product, then the manufacturer cannot be strictly liable for design defect

under Ohio law, regardless of whether there is a causal connection between the

plaintiff’s use of the drug and the plaintiff’s injury or whether the product was

unavoidably dangerous. Frey v. Novartis Pharm. Corp., 642 F. Supp. 2d 787, 794 (S.D.

Ohio 2009) (citing Seley v. G.D. Searle & Co., 432 N.E.2d 831 (1981)). This is because

the common law “learned intermediary doctrine” is codified in the Act: 

An ethical drug is not defective due to inadequate warning or instruction

if its manufacturer provides otherwise adequate warning and instruction

to the physician or other legally authorized person who prescribes or

dispenses that ethical drug for a claimant in question and if the federal

food and drug administration has not provided that warning or instruction

relative to that ethical drug is to be given directly to the ultimate user of

it.

O.R.C. § 2307.76(C); see also Meridia Prods. Liab. Litig. v. Abbott Labs., 447 F.3d 861,

867 (6th Cir. 2006) (explaining that, in a case involving a drug prescribed by a

physician, the learned intermediary doctrine provides that the adequacy of a product’s

warning is based on “whether the doctor, rather than the patient, would reasonably

understand the risks”).

The parties disagree as to which party carries the burden of proof regarding the

adequacy of warnings in a design defect claim under O.R.C. § 2307.75(D). Buchanan

contends that, as is the case under the common law, adequacy of warning is an
No. 09-3380 Wimbush v. Wyeth, et al. Page 7

3

Because it is neither necessary for us to decide who has the burden regarding adequacy of

warnings under O.R.C. § 2307.75(D), nor was it ultimately necessary for the district court to decide, and

because the question presents an important issue of the interpretation of the Ohio code, we believe it to be

a question best answered by the Ohio state courts without the weight of a federal decision unnecessarily

tilting the scales one way or the other. Accordingly, the portion of Longs I, 536 F. Supp. 2d at 851, that

holds that the plaintiff bears the burden of proving the inadequacy of a warning under section 2307.759(D)

is vacated as moot. 

affirmative defense on which the defendant carries the initial burden of proof and the

plaintiff carries only a burden to produce rebutting evidence. Wyeth, on the other hand,

claims that the text of section 2307.75(D) makes the inadequacy of warnings an element

of the prima facie claim for design defect, so the plaintiff carries the initial burden of

proof and the defendant carries only a burden to produce rebutting evidence. After

considering the authorities, the district court found that the plaintiff bears the burden of

proving inadequate warnings in a design defect claim under the Ohio Products Liability

Act. Longs I, 536 F. Supp. 2d at 851. We need not pass upon3

 this question as,

regardless of whether Buchanan or Wyeth carries an affirmative burden of proof or

merely a burden of producing rebutting evidence on the question of warning adequacy,

Wyeth has met its burden and Buchanan has not. 

Wyeth contended at summary judgment that Buchanan’s strict liability design

defect claim failed because Wyeth had provided adequate warnings to Buchanan’s

physician about the risks of Redux as information became available, thus qualifying for

protection under O.R.C. § 2307.75(D)’s codification of the learned intermediary

doctrine. Wyeth submitted voluminous evidence in support of this argument with its

motion for summary judgment. Wyeth presented substantial evidence that it had

distributed information regarding risks to doctors, including Buchanan’s physician, and

that those warnings were adequate to inform a physician of the known risks associated

with Redux. 

In response, Buchanan did not specifically point to any evidence in the record

that would contradict Wyeth’s evidence, such as expert reports opining that the warnings

were inadequate to inform a physician of the true risks of the drug. As the district court

summarized, and as is supported by the record, Buchanan did “not put forward any

evidence that Defendants did not take appropriate steps in providing adequate warnings
No. 09-3380 Wimbush v. Wyeth, et al. Page 8

4

The most that Buchanan may point to as far as rebutting evidence is a large packet of evidence

attached to her response to Wyeth’s partial summary judgment motion regarding punitive damages. This

evidence was not attached to her brief responding to Wyeth’s merits argument, nor was it cross-referenced

in that brief. Instead, Buchanan suggests that the fact that the evidence was in the record somewhere is

sufficient to create a question of fact and survive summary judgment. This is simply incorrect. Even if

the evidence to which Buchanan now refers was sufficient to rebut Wyeth’s evidence of adequate warning,

it was Buchanan’s job to point to the evidence with specificity and particularity in the relevant brief rather

than just dropping a pile of paper on the district judge’s desk and expecting him to sort it out. As we have

previously noted, it is not the district court’s duty “to search the entire record to establish that it is bereft

of a genuine issue of material fact.” Street, 886 F.2d at 1480-81. The non-moving party must present

affirmative evidence on critical issues sufficient to allow a jury to return a verdict in its favor. Id. at 1476-

77. Here, as Buchanan did not adequately present evidence demonstrating a genuine issue of material fact

as to the issue of adequacy of warning, the district court did not err in granting Wyeth’s motion for

summary judgment on this issue.

about Redux, that Defendants should have taken Redux off the market sooner, or that

Defendants’ alleged failure to take Redux off the market sooner proximately caused

Buchanan’s injury and/or death.” Id. at 856. Instead, Buchanan argued the law,

insisting that adequacy of warning was a jury question because Wyeth bore the burden

of proof on the issue. 

But this argument misses the point as, even if Buchanan is correct and adequacy

of warnings is an affirmative defense for which Wyeth bears the initial and ultimate

burden, summary judgment is available on affirmative defenses. E.g., Thornton v. Fed.

Express Corp., 530 F.3d 451, 457-58 (6th Cir. 2008). Thus, even under Buchanan’s

interpretation of section 2307.75(D), Wyeth met its burden at summary judgment of

providing evidence that its warnings were adequate, at which point it became

Buchanan’s burden to point to evidence creating a genuine issue of fact as to the

adequacy of the warnings. For whatever reason, Buchanan did not point to any such

evidence.4 When responding to a summary judgment motion with legal argument

instead of factual rebuttal, a litigant takes the ever-present risk that she is wrong on the

law, leaving her with no factual safety net. Because she failed to point to any evidence

creating a factual dispute as to the adequacy of warning, the strict liability design defect

claim under the Ohio Products Liability Act fails as a matter of law. Thus, it was proper

to grant Wyeth’s motion for summary judgment on this claim. 
No. 09-3380 Wimbush v. Wyeth, et al. Page 9

C. Negligence Claims

Because Buchanan dismissed her failure-to-warn claims and cannot show that

Wyeth is strictly liable for defective design under the Act, her only remaining claims are

for negligence and for punitive damages. 

1. State Law Abrogation

We first address whether Buchanan may bring her claims under common law

negligence theories at all or whether Ohio has abrogated by statute all common law

products liability claims. The Ohio Products Liability Act defines a statutory product

liability claim. O.R.C. § 2307.71(M). In addressing whether passage of the Act

abrogated common law negligence claims, the Ohio Supreme Court in Carrel v. Allied

Prod. Corp., 677 N.E.2d 795 (Ohio 1997), held that “in the absence of language clearly

showing the intention to supersede the common law, the existing common law is not

affected by the statute . . .” and that, therefore, the statute did not abolish “common-law

actions sounding in negligence.” Id. at 798-99. In an amendment to the Act effective

April 7, 2005, however, the Ohio General Assembly explicitly eliminated “all common

law product liability claims or causes of action.” O.R.C. § 2307.71(B). Buchanan’s

claims were brought prior to the passage of this amendment, so her common law

negligence claims would be abrogated only if the amendment applied retroactively. See

Miles v. Raymond Corp., 612 F. Supp. 2d 913, 920 (N.D. Ohio 2009). 

Since the amendment came into effect, at least three decisions of the Ohio Court

of Appeals have held that the amendment is not retroactive, meaning that Buchanan’s

claims would not be abrogated. See Doty v. Fellhauer Elec., Inc., 888 N.E.2d 1138,

1142 (Ohio Ct. App. 2008); Luthman v. Minster Supply Co., No. 2-06-43, 2008 WL

169999, at *3 (Ohio Ct. App. Jan. 22, 2008) (unpublished); Hertzfeld v. Hayward Pool

Prods., Inc., No. L-07-1168, 2007 WL 4563446, at *9 (Ohio. Ct. App. Dec. 31, 2007)

(unpublished) (all holding that the amendments applied only prospectively and did not

apply retroactively). The Doty court also noted that “statutory-construction rules dictate

that a statute is presumed to be prospective” and that, although the amendment “clearly
No. 09-3380 Wimbush v. Wyeth, et al. Page 10

5

This finding conflicts with a previous Sixth Circuit ruling on this issue. We previously “applied

OPLA to product liability negligence claims [arising before the 2005 amendment of OPLA] and [have]

therefore implicitly concluded that common law negligence claims have been preempted by OPLA.”

Tompkin v. Am. Brands, 219 F.3d 566, 575 (2000) (citing Amendola v. R.J. Reynolds Tobacco Co., No.

98-4506, 1999 WL 1111515 , at *2 (6th Cir. Nov. 24, 1999)) (holding that a plaintiff’s negligent

misrepresentation and negligent infliction of emotional distress claims are governed by the Ohio Products

Liability Act). 

Typically, “[w]ithout taking a case en banc, a panel cannot reconsider a prior published case that

interpreted state law, absent an indication by the state courts that they would have decided the prior case

differently.” Rutherford v. Columbia Gas, 575 F.3d 616, 619 (6th Cir. 2009) (internal citations, quotations,

brackets omitted). Plainly stated, we are “bound by a prior published case that interpreted Ohio law unless

Ohio law has measurably changed in the meantime.” Id. (brakets omitted). Although the district court’s

order in this case was issued prior to the Ohio Court of Apeals’s decision in Doty, and thus the court did

not have the benefit of the only published state appellate court case, we “must give an intervening state

decision its full force and effect, despite the fact that the decision was unavailable to the district court at

the time it rendered its decision.” Chandler v. Specialty Tires of Am. (Tenn.) Inc., 283 F.3d 818, 823 (6th

Cir. 2002) (quoting Siegler v. IBM H08 Mktg., Inc., 249 F.3d 509, 518 (6th Cir. 2001)). We therefore find

that, although the Ohio Supreme Court has not yet spoken on the issue, the Ohio appellate courts’ decisions

provide the best indication of how the Ohio Supreme Court would rule on this issue and thus present such

a measurable change in state law that reconsideration of our precedents is justified. Thus, Tompkin and

Amendola are overruled to the extent that they provide that Ohio common law negligence claims arising

prior to the 2005 amendment of the Ohio Products Liability Act are abrogated by the Act.

states the intent to abrogate all common-law product-liability claims, it does not provide

that causes of action accruing prior to the effective date would be subject to the

amendment.” Doty, 888 N.E.2d at 1142. The court therefore held that the amendment

did not apply retroactively. Id. 

Buchanan filed her original complaint in 2003, well after the Act was enacted but

before the 2005 amendment expressly abrogated all common law product liability

claims. Thus, her negligence claims survive the enactment of the Ohio Products

Liability Act and the 2005 amendment and are not abrogated.5

2. Merits of the Negligence Claim

The nature of Buchanan’s negligence claim is unclear. Her Amended Complaint

states that Wyeth had a duty 

to manufacture, promote, and sell only safe drugs, and the duty to

investigate and disclose material facts about risks associated with their

drugs. Defendants breached their duty by . . . putting Redux on the

market in 1996, when Defendants knew the active ingredient in th[is]

drug[], namely, dexfenfluramine, was unreasonably dangerous.

Defendants further breached their duty by . . . failing to update the

drug[’s] labels, failing to adequately monitor the effects of the drug[],

failing to make timely . . . warning to the medical profession, failing to

timely and accurately report to the FDA all adverse drug experience
No. 09-3380 Wimbush v. Wyeth, et al. Page 11

information obtained, and concealing and misrepresenting the results of

studies to physicians and to the public.

Longs I, 536 F. Supp. at 854 (reproducing Buchanan’s Amended Complaint verbatim).

The district court noted that at oral argument Buchanan characterized her negligence

claim as attacking (1) Wyeth’s alleged failure to investigate, prior to FDA approval, the

early warning signs that led to the drug being taken off the market and (2) Wyeth’s

failure to take the drug off the market sooner. Id. at 855. We take this to mean that

Buchanan’s negligence claims may be divided into two general categories: (1) claims

regarding Wyeth’s acts and omissions, prior to the FDA’s approval, in bringing the drug

to market and (2) claims regarding Wyeth’s acts and omissions subsequent to the FDA’s

approval of Redux. 

We will address the post-FDA-approval negligence claims first. As characterized

by Buchanan and the district court, the post-approval negligence claims are either a

general negligence claim or a design defect claim. Whatever the label, the claim focuses

on Wyeth’s actions after the drug went to market, primarily Wyeth’s failure to take the

drug off of the market sooner. Wyeth moved for summary judgment on the basis that

Buchanan could not show that Wyeth’s actions or omissions after FDA approval caused

any of her injuries. Specifically, Wyeth contended that it had updated its warnings about

the risks of Redux as information became available and that it removed Redux from the

market as soon as it became aware of the extent of the risk, and it submitted a substantial

amount of evidence in support of this position. 

But, just as she did with regard to Wyeth’s request for summary judgment on the

strict liability design defect claim, Buchanan did not highlight any evidence in the record

that would contradict the evidence submitted by Wyeth. Instead, Buchanan again argued

the law, insisting that the warnings were irrelevant because Wyeth should have known

that the drug was so dangerous that no warning could make the drug acceptable.

Critically, Buchanan did not point to any facts or evidence in the record that would

reveal why Wyeth should have known any of this. The district court found that

Buchanan failed to present evidence demonstrating proximate cause between Wyeth’s
No. 09-3380 Wimbush v. Wyeth, et al. Page 12

6

This discussion assumes the viability of such a claim under the Ohio common law. We do not

address whether such a claim actually exists; instead, we address only whether FDA approval would

preempt such a claim if it does exist. 

alleged negligence after the FDA approved Redux and Buchanan’s injury or death

sufficient to survive a motion for summary judgment. We agree, for principally the same

reasons as we agreed that summary judgment was proper on the strict liability design

defect claim. When Buchanan failed to point to any actual evidence in a particularized

manner, she failed to meet her burden under Rule 56. Accordingly, we affirm the entry

of summary judgment for Wyeth on the post-FDA-approval negligence claims. 

3. Federal Preemption

However, Buchanan’s failure to provide evidence of proximate causation for

negligence occurring after the distribution of Redux does not dispose of her claims that

Wyeth was negligent for bringing Redux to market at all. Doctor notification of

potential harms necessarily does not factor into a claim of negligence for bringing a drug

to market in the first place.6

 Buchanan argues: 

the theory of causation supporting the remaining negligent introduction

and failure to withdraw theories set forth in Count II was completely

different. Had Defendants heeded the persistent and near unanimous

consensus of authority and either refrained from seeking approval of the

diet medication or at least terminating production by the Fall of 1996, the

Decedent never would have been exposed to Redux at all.

(Appellant Br. at 59.) Thus, we must address the district court’s finding that the FDA’s

approval of Redux preempted all state law claims based on Wyeth’s actions before that

approval.

The district court found that Buchanan’s pre-approval negligence claims were

preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 391 et

seq., which is enforced by the FDA, 21 U.S.C. § 393(b). The district court concluded

that:

the FDA is responsible for regulating which drugs are on the market and

the warnings such drugs must provide. As such, Plaintiff’s strict liability
No. 09-3380 Wimbush v. Wyeth, et al. Page 13

and negligence claims that Redux was an “unreasonably dangerous” drug

for which no warning would have been adequate directly conflicts with

the FDA’s authority to determine which drugs are sufficiently safe and

effective to be marketed. Although Plaintiff asserts that she alleges only

that Defendants should not have marketed Redux, and that she does not

argue that the FDA did anything wrong, the court finds that her claim that

Redux should never have been placed on the market interferes with the

FDA’s objectives. Consequently, all claims relating to pre-FDA

approval are preempted by the FDA.

Longs I, 536 F. Supp. 2d at 847 (emphasis in original). 

As the district court framed it, the issue is whether a state-court finding that a

manufacturer was negligent in bringing the drug to market conflicts or is inconsistent

with the FDA’s subsequent approval of that drug for the market. Determining whether

this is so requires some degree of understanding of the FDA approval process. A recent

Fifth Circuit case summarized the FDA’s role in approving new drugs: 

All prescription drugs marketed in this country must first receive FDA

approval. Manufacturers of new drugs must submit a new drug

application (NDA) to the FDA that demonstrates the drug’s effectiveness

and safety for its intended use. The 1962 Food, Drug and Cosmetics Act

(FDCA) established this avenue for pioneer drugs, with the core

objective of ensuring that drugs are both safe and effective; the FDA has

codified the NDA regulations at 21 C.F.R. Part 314. New drug approval

requires, among other deliverables, the results of successful clinical trials

and labeling that accurately portrays the benefits and risks of the drug,

as indicated by those trials and other data.

Demahy v. Actavis, Inc., No. 08-31204, 2010 WL 46513, at *2 (5th Cir. Jan. 8, 2010)

(internal footnotes omitted). With this basic understanding of FDA drug approval in

mind, we turn to federal preemption. 

Federal preemption draws its force from the Supremacy Clause of the United

States Constitution. U.S. Const. art. 6, cl. 2. “Here, as in every preemption case, ‘[t]he

purpose of Congress is the ultimate touchstone.” Demahy, 2010 WL 46513, at *3

(quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (plurality)). “[I]n all

preemption cases, and particularly in those in which Congress has legislated in a field

which the States have traditionally occupied, we start with the assumption that the
No. 09-3380 Wimbush v. Wyeth, et al. Page 14

historic police powers of the States were not to be superseded by the Federal Act unless

that was the clear and manifest purpose of Congress.” Levine, 129 S. Ct. at 1194-95

(internal quotation marks and ellipses omitted). “Although there is a presumption under

the Supremacy Clause that Congress did not intend to preempt state law, ‘an assumption

of non-preemption is not triggered when the State regulates in an area where there has

been a history of significant federal presence.’” R.R. Ventures, Inc. v. Surface Transp.

Bd., 299 F.3d 523, 562 (6th Cir. 2002) (quoting United States v. Locke, 529 U.S. 89, 108

(2000)). The analysis of whether the presumption of non-preemption applies “accounts

for the historic presence of state law but does not rely on the absence of federal

regulation.” Levine, 129 S. Ct. at 1195 n.3. 

Here, Buchanan is entitled to the presumption that Congress did not intend to

preempt state law because hers are claims under “preexisting state products liability

law.” Desiano v. Warner-Lambert & Co., 467 F.3d 85, 94 (2d Cir. 2006) (stating that

“state-based tort liability falls squarely within [a state’s] prerogative to regulate matters

of health and safety, which is a sphere in which the presumption against preemption

applies, indeed, stands at its strongest.”) (internal quotation marks and brackets omitted)

(aff’d Warner-Lambert Co., LLC v. Kent, 522 U.S. 440 (2008) (per curiam) (4-4

decision)). Although “[i]t is not a valid argument against preemption to say that the state

seeks to impose greater obligations than Congress did,” Smith v. Provident Bank, 170

F.3d 609, 613 (6th Cir. 1999), “[w]here possible, a court should try to reconcile federal

law and state law.” Rollins v. Wilson County Gov’t, 154 F.3d 626, 629 (6th Cir. 1998).

Keeping in mind that we operate under a presumption against preemption in this

case, we turn to the substance of federal preemption. “In general, a federal law may

preempt a state law in any of the following three scenarios. First, a federal statute may

expressly preempt the state law. Second, a federal law may impliedly preempt a state

law. Third, preemption results from an actual conflict between a federal and a state

law.” Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965 (6th Cir. 2004) (citations

omitted). Wyeth argues, and the district court based its holding on, the third type of

preemption, conflict preemption. 
No. 09-3380 Wimbush v. Wyeth, et al. Page 15

Conflict preemption refers to circumstances “where compliance with both federal

and state regulations is a physical impossibility, or where state law stands as an obstacle

to the accomplishment and execution of the full purposes and objectives of Congress.”

State Farm Bank v. Reardon, 539 F.3d 336, 342 (6th Cir. 2008). Conflict preemption

analysis “should be narrow and precise, ‘to prevent the diminution of the role Congress

reserved to the States while at the same time preserving the federal role.’” Downhour

v. Somani, 85 F.3d 261, 266 (6th Cir. 1996) (quoting Nw. Cent. Pipeline Corp. v. State

Corp. Comm’n, 489 U.S. 493, 515 (1989)). The Supreme Court has described

impossibility preemption as a “demanding defense.” Levine, 129 S. Ct. at 1199. 

In this case, as a general proposition, we can discern no physical impossibility

between complying with a state law duty to exercise reasonable care in the process

leading up to placing a drug on the market and complying with the federal government’s

process for approving drugs. This is not to say that such a physical impossibility could

never exist, for instance if a state duty required that the manufacturer do something that

the FDA forbade or vice versa. But such a situation would, we think, be the exception

to the rule. Thus, we are not persuaded that it is always impossible to comply with both

state law duties and FDA regulations in the process leading up to FDA approval.

The only remaining rationale to support conflict preemption, therefore, is that

allowing state tort lawsuits would stand as an obstacle to the accomplishment of the

statute. The district court quoted the FDCA to find that the purpose of the FDA is to:

(1) promote the public health by promptly and efficiently reviewing

clinical research and taking appropriate action on the marketing of

regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring

that–

. . . .

(B) human . . . drugs are safe and effective; . . . .

Longs I, 536 F. Supp. 2d at 847 (quoting 21 U.S.C. § 393(b)). The district court then

determined that permitting common-law negligence claims regarding a drug

manufacturer’s pre-approval conduct would conflict with this function of the FDA. 
No. 09-3380 Wimbush v. Wyeth, et al. Page 16

However, we cannot agree with the district court’s conclusion as, not only is

there a presumption against preemption, but the case law supports the conclusion that

Congress did not intend to preempt state tort law claims when it passed the FDCA. Part

of the Desiano analysis is applicable here: 

Significantly, all of the claims advanced by Appellants in this case are

premised on traditional duties between a product manufacturer and . . .

consumers. None of them derives from, or is based on, a newlyconcocted duty between a manufacturer and a federal agency. As a

result, were we to conclude that Appellants’ claims were preempted, we

would be holding that Congress, without any explicit expression of

intent, should nonetheless be taken to have modified (and, in effect,

gutted) traditional state law duties between pharmaceutical companies

and their consumers. We see no reason, nor can we identify any

precedent, to justify such a result.

Desiano, 467 F.3d at 94-95. Simply because tort liability “parallel[s] federal safety

requirements” does not mean that liability is preempted. Id. at 95. Allowing a state tort

claim under the instant circumstances would not “interfere[] with the methods by which

the federal statute was designed to reach its goal.” Verizon North, Inc. v. Strand, 309

F.3d 935, 940 (6th Cir. 2002) (internal brackets omitted) (quoting Gade v. Nat’l Solid

Wastes Mgmt. Ass’n, 505 U.S. 88, 103 (1992)). Wyeth defends the district court’s

preemption finding by citing two Supreme Court cases for the principle that “[s]tate tort

law disrupts the federal scheme . . .”, but these cases are distinguishable. 

In Geier v. American Honda Motor Co., Inc., 529 U.S. 861 (2000), the Court

found that the plaintiffs’ tort suit that “would have required manufacturers of all similar

cars to install airbags rather than other passive restraint systems, such as automatic belts

or passive interiors” would have presented an obstacle “to the variety and mix of devices

that the federal regulation sought” and “to the gradual passive restraint phase-in that the

federal regulation deliberately imposed.” Id. at 881. Such conflicts do not exist here

because the state duty urged by Buchanan does not create an obstacle to following the

federal regulatory scheme. 

Wyeth also cites Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). That case

addressed the Medical Device Act, which expressly preempts state requirements
No. 09-3380 Wimbush v. Wyeth, et al. Page 17

“‘different from, or in addition to, any requirement applicable . . . to the device’ under

federal law.” Riegel, 552 U.S. at 321 (quoting 21 U.S.C. § 360k(a)(1)). There is no

similar express preemption provision for drugs under the FDCA. Indeed, in the 1962

amendments to the FDCA, Congress expressly limited the preemptive effect of the

statute by stating: 

Nothing in the amendments made by this Act to the Federal Food, Drug

and Cosmetic Act shall be construed as invalidating any provision of

State law which would be valid in the absence of such amendments

unless there is a direct and positive conflict between such amendments

and such provisions of State law.

Drug Amendments of 1962 (Harris-Kefauver Act), Pub. L. No. 87781, ¶ 202, 76 Stat.

780, 793 (1962); see also Levine, 129 S. Ct. at 1195-96 (“As it enlarged the FDA’s

powers to ‘protect the public health’ and ‘assure the safety, effectiveness, and reliability

of drugs,’ Congress took care to preserve state law.”) (internal citations omitted). 

The Supreme Court also observed that “[i]n keeping with Congress’ decision not

to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state

law as a complementary form of drug regulation.” Levine, 129 S. Ct. at 1202. The Court

further stated: 

If Congress thought state-law suits posed an obstacle to its objectives, it

surely would have enacted an express preemption provision at some

point during the FDCA’s 70-year history. But despite its 1976 enactment

of an express pre-emption provision for medical devices, see § 521, 90

Stat. 574 (codified at 21 U.S.C. § 360k(a)), Congress has not enacted

such a provision for prescription drugs. Its silence on the issue, coupled

with its certain awareness of the prevalence of state tort litigation, is

powerful evidence that Congress did not intend FDA oversight to be the

exclusive means of ensuring drug safety and effectiveness. As Justice

O’Connor explained in her opinion for a unanimous Court: “The case for

federal preemption is particularly weak where Congress has indicated its

awareness of the operation of state law in a field of federal interest, and

has nonetheless decided to stand by both concepts and to tolerate

whatever tension there [is] between them.”
No. 09-3380 Wimbush v. Wyeth, et al. Page 18

7

Both the district court, Longs II, 621 F. Supp. 2d at 508-09, and Wyeth seek to distinguish

Levine from the present case on the basis that Levine involved a state law inadequate warning claim

whereas the instant case involves a state law negligent-bringing-to-market claim. It is indeed true that the

question presented in Levine dealt solely with state tort inadequate warning claims versus FDA-approved

labels, Levine, 129 S. Ct. at 1193, whereas this case pits state tort negligent-bringing-to-market claims

against FDA approval to market. However, we find this to be a distinction without a difference, as the

rationale in Levine applies with equal force to this claim as it did to the inadequate warning claim. Just

as state tort law on adequacy of warnings can be seen as “complementary,” id. at 1201, to the FDA’s

labeling regulation, so too can state law duties regarding the decision to bring a product to market be seen

as complementary to the FDA’s function of approving a drug for market. This makes sense, as whether

the FDA approves a drug for market depends, in very large part, upon the results of the manufacturer’s

investigation and testing prior to seeking FDA approval. Demahy, 2010 WL 46513, at *2. If the

manufacturer is negligent in this investigation, then the entire FDA approval process is tainted from the

outset. And it is in this way that Buchanan’s pre-approval negligence theory varies from a fraud-on-theFDA claim. Finally, the overwhelming take-away from the Levine majority opinion is that state tort law

has historically played a substantial role in the regulation of drug manufacturers and that Congress has

never indicated an intent to change this role. Thus, while Levine did leave open the possibility that there

may be some state law claims that would conflict with the FDA’s regulatory authority and function, the

claim at issue in Levine was not one of them. We do not believe that Buchanan’s pre-approval negligence

claims are, either. 

Levine, 129 S. Ct. at 1200 (internal citation and footnote omitted).7 Moreover, even

before the Supreme Court’s clarification in Levine, we previously found that the FDCA

did not preempt pre-approval design defect claims. Tobin v. Astra Pharm. Prods., Inc.,

993 F.2d 528, 537-38 (6th Cir. 1993). Finally, we are aware of no federal appeals court

decision since Levine concluding that FDA regulation preempts any aspect of state tort

law, though we admit that, until today, there is also no post-Levine court of appeals

authority for the proposition that the Levine rationale extends beyond the realm of

failure-to-warn claims to apply to all pre-approval state law claims.

For these reasons, we hold that the district court erred in granting summary

judgment to Wyeth on preemption grounds on Buchanan’s pre-approval common law

negligence claims. In so holding, however, we do not pass upon whether there may be

alternative bases for adjudicating these claims short of trial. Neither the parties nor the

district court have asserted any such alternative, so the issue is not before us. We hold

merely that FDA approval does not automatically preempt state law tort claims for

negligence, and we remand for such further proceedings as may be appropriate under the

facts and circumstances. Moreover, because we remand for further proceedings on the
No. 09-3380 Wimbush v. Wyeth, et al. Page 19

8

Because we conclude that the district court erred in granting summary judgment on the pre-FDAapproval negligence claims but affirm summary judgment on all other claims, we do not address

Buchanan’s appeal of the court’s order denying the subsequent motion to vacate and amend judgment. 

common law pre-approval claims, the district court’s mootness ruling as to punitive

damages must also be reversed and remanded.8

III.

For the reasons set forth above, we REVERSE the judgment of the district court

as to the pre-FDA-approval negligence claims and punitive damages and REMAND

those issues to the district court for further proceedings; we AFFIRM the judgment of

the district court on all other claims. Moreover, we VACATE AS MOOT the portion

of Longs I, 536 F. Supp. 2d at 851, that holds that the plaintiff bears the burden of

proving the inadequacy of a warning under section 2307.759(D).
No. 09-3380 Wimbush v. Wyeth, et al. Page 20

____________________________________________________

CONCURRING IN PART AND DISSENTING IN PART

____________________________________________________

HELENE N. WHITE, Circuit Judge, concurring in part and dissenting in part.

I join the majority opinion except Part II(C)(2) and the related portion of Part III, from

which I respectfully dissent. I would reverse the summary dismissal of claims based on

Wyeth’s alleged negligence in failing to adequately investigate adverse reports regarding

Redux after FDA approval, and in failing to timely remove Redux from the market, and

remand such claims to the district court for further proceedings. Although I agree with

the majority that Buchanan failed to present evidence in support of these claims, my

review of the record convinces me that this is because Wyeth’s motions for summary

judgment did not attack the factual support for these claims. 

Buchanan’s Amended Complaint included claims that Wyeth was negligent in

“failing to adequately monitor the effects of the drug[] . . . failing to timely and

accurately report to the FDA all adverse drug experience information obtained, and

concealing and misrepresenting the results of studies to physicians and the public.”

Wyeth brought three motions for summary judgment. The only motion potentially

related to the post-FDA-approval negligence claims was Wyeth’s Motion for Summary

Judgment Based on Lack of Evidence of Proximate Causation. Wyeth included two

arguments in that motion. The majority of the brief was dedicated to Wyeth’s argument

that Buchanan’s “failure to warn” claim is barred by the “learned intermediary” doctrine.

Wyeth’s second argument was that Buchanan’s “design defect” claim under the OPLA

is barred because Wyeth had provided a statutorily sufficient “adequate warning” under

Ohio Rev. Code Ann. § 2307.75(D), and that even if the warnings were inadequate,

Buchanan had not “established that any such claimed inadequacy proximately caused

her physician to prescribe the drug to her.” These arguments were not addressed to

Buchanan’s allegations that Wyeth is responsible for “[n]egligence in failing to

investigate adverse reaction reports and in other conduct below the industry standard of
No. 09-3380 Wimbush v. Wyeth, et al. Page 21

1

As the district court noted, much confusion could have been avoided if Buchanan had been

clearer in identifying and distinguishing her claims.

care . . . leading to Wyeth’s failure to withdraw Redux from the market before December

1996.”1

In its order granting summary judgment, the district court identified two

negligence claims, general negligence and negligent design. In granting summary

judgment to Wyeth on all negligence claims, the district court cited Wyeth’s evidence

regarding the warnings it sent to physicians, and specifically to Dr. Erokwu, and faulted

Buchanan for not submitting evidence that Wyeth should have taken Redux off the

market sooner. Although that failure was justifiably regarded as fatal to the designdefect claims based on inadequate warnings (which were directly addressed by Wyeth’s

summary judgment motion), it should not have been regarded as fatal to the general

negligence claims alleging failure to adequately investigate and/or to take Redux off the

market sooner.

In effect, the district court granted summary judgment on these claims sua

sponte. Although this is permitted, it is disfavored. Saxe v. Dlusky, 162 F. App’x 430,

432 (6th Cir. 2006) (“Sua sponte grants of summary judgment are disfavored.”) (citing

Employers Ins. of Wausau v. Petroleum Specialties, Inc., 69 F.3d 98, 105 (6th Cir.

1995)); Chance v. Mahoning County, 105 F. App’x 644, 649 (6th Cir. 2004) (noting that

grants of summary judgment sua sponte are discouraged in the Sixth Circuit). If a

district court is to do so, the losing party must be “on notice that she ha[s] to come

forward with all of her evidence.” Celotex Corp. v. Catrett, 477 U.S. 317, 326 (1986).

“Notice and opportunity are determined from the totality of the proceedings

below, including whether any party filed a motion for summary judgment on the claim

and whether the losing party addressed the claim in its arguments.” Aubin Indus., Inc.

v. Smith, 321 F. App’x 422, 423 (6th Cir. 2008). In this instance, Buchanan did not have

notice that she had to present her evidence as to the post-FDA approval failure to

investigate/failure to remove from the market negligence claims because Wyeth’s motion

did not address these claims. See Black Shield Police Ass’n v. City of Cleveland, 838
No. 09-3380 Wimbush v. Wyeth, et al. Page 22

2

To be clear, I would not hold that summary judgment on this claim is inappropriate, only that

the issue should be squarely addressed by the parties before the district court rules on it. 

F.2d 470, at *3 (6th Cir. 1988) (unpublished table decision); see also Shelby County

Health Care Corp. v. S. Council Indus. Workers Health & Welfare Trust Fund, 203 F.3d

926, 931 (6th Cir. 2000) (“[W]e have held that Fed. R. Civ. P. 56(c) mandates that the

losing party must ‘be afforded notice and reasonable opportunity to respond to all the

issues to be considered by the court.’”). As a result, Buchanan had “no reason to believe

that [her] cause of action was in danger of being dismissed.” Moisenko v.

Volkswagenwerk Aktiengesellschaft, 198 F.3d 246, at *5 (6th Cir. 1999) (unpublished

table decision). 

Further, the dismissal of the post-FDA approval negligence claims prejudiced

Buchanan because it foreclosed a potential avenue of relief. See Yahon v. Gregory, 737

F.2d 547, 552 (6th Cir. 1984) (appellant of sua sponte entry of summary judgment must

show prejudice); see also Moisenko, 198 F.3d at *5 (“This Court has held that ‘not

having an opportunity to respond constitutes prejudice,’ as a plaintiff is entitled to be

informed of the deficiencies in his case ‘in order that he might respond to the district

court’s proposal to grant summary judgment with whatever arguments and evidence in

the record that he could muster.’” (quoting Yashon, 737 F.2d at 552)). Buchanan had

no notice that the district court was contemplating granting summary judgment on the

post-FDA-approval general negligence claims, and therefore should not be penalized for

failing to address that point.2