Court Opinion

ID: 2651416
Source: CourtListenerOpinion
Date Created: 2014-01-28 19:52:30.825466+00
Date Added: 2024-06-11T12:33:39.899312
License: Public Domain

PUBLISHED

                   UNITED STATES COURT OF APPEALS
                       FOR THE FOURTH CIRCUIT

                               No. 12-1259

ARTHUR L. DRAGER, as personal representative for the Estate
of Shirley Gross,

                 Plaintiff – Appellant,

           v.

PLIVA USA, Inc.,

                 Defendant – Appellee,

           and

PFIZER, Inc.; WYETH, Inc.; WYETH PHARMACEUTICALS,             Inc.;
SCHWARZ PHARMA, Inc.; TEVA PHARMACEUTICALS USA, Inc.,

                 Defendants.

Appeal from the United States District Court for the District of
Maryland, at Greenbelt.      Alexander Williams, Jr., District
Judge. (8:10-cv-00110-AW)

Argued:   December 12, 2013                  Decided:   January 28, 2014

Before SHEDD, DUNCAN, and DAVIS, Circuit Judges.

Affirmed by published opinion. Judge Duncan wrote the opinion,
in which Judge Shedd and Judge Davis joined.

ARGUED:   Louis  Martin   Bograd,  CENTER   FOR  CONSTITUTIONAL
LITIGATION, PC, Washington, D.C., for Appellant.  Michael David
Shumsky, KIRKLAND & ELLIS LLP, Washington, D.C., for Appellee.
ON BRIEF: Terrence J. Donahue, Jr., MCGLYNN GLISSON & MOUTON,
Baton Rouge, Louisiana, for Appellant. Joseph P. Thomas, Linda
E. Maichl, Jeffrey Peck, ULMER & BERNE, LLP, Cincinnati, Ohio;
Jay P. Lefkowitz, John K. Crisham, KIRKLAND & ELLIS LLP,
Washington, D.C., for Appellee.

                              2
DUNCAN, Circuit Judge:

        Appellant Arthur Drager, as personal representative of the

estate of Shirley Gross, seeks reversal of the district court’s

denial       of     Gross’s     request         to       amend    her     complaint            and    its

dismissal of her state common law tort claims against appellee

PLIVA USA, Inc. for injuries sustained as a result of her use of

a drug it manufactured.                    Drager contends on appeal that the

proposed amendments were not futile and that Gross’s state tort

claims       are    not    preempted       by    the       requirements         of       the    Federal

Food,    Drug,       and      Cosmetics     Act,          21     U.S.C.    §§    301       et        seq.,

(“FDCA”).          For the reasons that follow, we affirm.

                                                 I.

       In     2006,        Gross     was        prescribed            Reglan,        a     brand       of

metoclopramide,           a   drug   used       to       treat    gastroesophageal               reflux

disease and other ailments.                     Gross followed a ten-month course

of    generic       metoclopramide,         produced             by    appellee          PLIVA,      from

March 2006 to January 2007.                      As a result of Gross’s long-term

use     of        metoclopramide,          she           developed       permanent             injuries

including          the     movement        disorders             tardive        dyskinesia            and

akathisia.

       On January 15, 2010, Gross filed suit against PLIVA and

brand-name         Reglan     producers,         including            Pfizer,    Inc.,         alleging

state law claims of negligence, breach of warranty, fraud and

                                                     3
misrepresentation,        strict     liability,          and     failure       to   warn.

Pursuant to Gross’s stipulation that she ingested only PLIVA’s

generic metoclopramide, the district court dismissed her claims

against the brand name manufacturers on November 9, 2010.                               The

district   court    stayed       further   proceedings           against      PLIVA,    the

only remaining defendant, on April 7, 2011, pending the Supreme

Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567

(2011).

     After      Mensing    was    decided,       holding       that    FDCA     labeling

requirements preempted state failure-to-warn laws, see id. at

2577-78,   the    stay    was     lifted       and    PLIVA    filed     a    motion    for

judgment   on    the     pleadings.        It        contended    that       pursuant    to

Mensing, Gross’s claims were preempted by the FDCA because of

the impossibility of PLIVA’s compliance with both that statute

and the alleged state law duties.                     In her response to PLIVA’s

motion, Gross requested that the district court allow her to

amend her complaint to include allegations that PLIVA violated a

state law duty by failing to update its warnings to include

changes made by brand name manufacturers in 2004.                            On November

22, 2011, the district court granted PLIVA’s motion, holding

under the reasoning of Mensing that all of Gross’s state law

claims were preempted by FDCA requirements applicable to generic

drug manufacturers.          The district court also denied leave to

amend on the ground that the proposed amendments would be futile

                                           4
under Maryland law.        Gross filed a motion to alter or amend the

judgment, which the district court denied on January 27, 2012.

During the pendency of this action, Gross passed away and Drager

continued     the   case   on   behalf    of   her   estate.     The   district

court’s November 22 and January 27 orders form the basis of

Drager’s appeal.

                                       II.

      We review de novo a district court’s ruling on a motion for

judgment on the pleadings under Federal Rule of Civil Procedure

12(c).    Butler v. United States, 702 F.3d 749, 751 (4th Cir.

2012).    The standard of review for Rule 12(c) motions is the

same as that under Rule 12(b)(6).              Id. at 751-52.    Therefore, a

motion for judgment on the pleadings “should only be granted if,

after accepting all well-pleaded allegations in the plaintiff’s

complaint as true and drawing all reasonable factual inferences

from those facts in the plaintiff’s favor, it appears certain

that the plaintiff cannot prove any set of facts in support of

his   claim    entitling    him   to     relief.”      Edwards   v.    City   of

Goldsboro, 178 F.3d 231, 244 (4th Cir. 1999).                    A Rule 12(c)

motion tests only the sufficiency of the complaint and does not

resolve the merits of the plaintiff’s claims or any disputes of

fact.    Butler, 702 F.3d at 752.

                                         5
     Under Federal Rule of Civil Procedure 15(a)(2), the “‘grant

or denial of an opportunity to amend is within the discretion of

the district court.’”     Scott v. Family Dollar Stores, Inc., 733

F.3d 105, 121 (4th Cir. 2013) (quoting        Foman v. Davis, 371 U.S.

178, 182 (1962)).    Consequently, we review the district court’s

denial of a motion to amend for abuse of discretion.            Nourison

Rug Corp. v. Parvizian, 535 F.3d 295, 298 (4th Cir. 2008).               A

district court’s denial of leave to amend is appropriate when

“(1) ‘the amendment would be prejudicial to the opposing party;’

(2) ‘there has been bad faith on the part of the moving party;’

or (3) ‘the amendment would have been futile.’”          Scott, 733 F.3d

at 121 (quoting Laber v. Harvey, 438 F.3d 404, 426-27 (4th Cir.

2006)).

     We   may   affirm   on   any   ground   supported   by   the   record

regardless of the ground on which the district court relied.

United States v. Moore, 709 F.3d 287, 293 (4th Cir. 2013).

                                    III.

                                     A.

     Drager contends on appeal that the district court’s denial

of leave to amend was an abuse of discretion because Gross’s

proposed allegations would have stated a cause of action under

Maryland law.    However, Drager concedes that Gross never filed a

motion to amend her complaint or a proposed amended complaint

                                     6
with   the    district    court.         Regardless     of   the    merits      of   the

desired      amendment,    a    district        court    does      not    abuse      its

discretion     “by   declining      to    grant   a     motion     that   was     never

properly made.”        Cozzarelli v. Inspire Pharms., Inc., 549 F.3d

618, 630-631 (4th Cir. 2008) (finding no abuse of discretion

where plaintiffs requested leave to amend in a response but did

not file a motion to amend or a proposed amended complaint).

       Consequently,      we   affirm     the   district     court’s      denial      of

leave to amend and hold that none of Drager’s claims regarding

PLIVA’s alleged failure to update its warnings are before us on

appeal.      Similarly, we find that the complaint did not allege

any violation of the federal misbranding laws or parallel state

duties.      To the extent Drager makes those claims on appeal they

are waived.      United States v. Evans, 404 F.3d 227, 236 n.5 (4th

Cir. 2005).

                                          B.

       Drager also argues that the district court erred by finding

Gross’s state tort claims to be preempted by the FDCA because of

the impossibility of PLIVA’s simultaneous compliance with FDCA

requirements     and     relevant    Maryland         law.       Although    one      of

Drager’s objections to the district court’s reasoning gives us

pause, all of Gross’s causes of action are indeed preempted by

the FDCA.     We therefore affirm the district court on all counts.

                                           7
                                               1.

     In Mensing, the Supreme Court reaffirmed the principle that

“[p]re-emption analysis requires [courts] to compare federal and

state law.”         131 S. Ct. at 2573.                   To make this comparison,

courts      first        “identify[]          the        state     tort       duties      and

federal...requirements applicable” to the parties.                             Id.    If the

applicable federal statute does not include a statement that

either     expressly       preempts       or        expressly     preserves         otherwise

applicable state law duties, the court must determine if there

is preemption by conflict.               Id. at 2577 n.5.

     “[S]tate law is naturally preempted to the extent of any

conflict with a federal statute,” Crosby v. Nat’l Foreign Trade

Council,     530    U.S.        363,     372        (2000),      because      the     federal

Constitution provides that every federal enactment is superior

to any state law or constitutional article, U.S. Const. art. VI,

cl. 2.     As a result, under the Supremacy Clause, “[w]here state

and federal law directly conflict, state law must give way.”

Mensing,    131     S.    Ct.    at    2577        (internal     quotation      marks     and

citation omitted).          The Supreme Court has held that state and

federal law conflict when it is impossible for a private party

to   simultaneously             comply     with          both     state       and     federal

requirements.        Id.        In such circumstances, the state law is

preempted    and    without       effect.           By   definition       a   party    cannot

state a claim for which relief may be granted pursuant to a law

                                               8
that       has    been     “effectively      repeal[ed]”          as   it    applies          to    a

particular set of circumstances.                     Id. at 2579.

       Mensing       and       another    recent       Supreme      Court        case,       Mutual

Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2471 (2013),

address the preemptive effect of the FDCA on state tort laws as

they apply to generic drug manufacturers.                              For a variety of

policy reasons, under the Hatch-Waxman amendments, codified at

21 U.S.C. § 355(j), the FDCA imposes substantially different

requirements on producers of name brand drugs and producers of

non-branded, or generic, counterparts.                            In greatly simplified

terms, manufacturers of generic medications gain authorization

to market their products by demonstrating that those products

are equivalent to the previously authorized name brand versions

in     a    number        of   ways,     including       formulation         and        labeling.

Generics           must        maintain     this        equivalence              to      maintain

authorization.            See generally 21 U.S.C. § 355(j).

       In        Mensing,      the     Supreme       Court   made      clear          that    under

§ 355(j)          generic       drug     manufacturers        are      not       entitled          to

unilaterally change their labeling and therefore any state law

tort premised on the failure of a generic to alter its labeling

is preempted.              Id. at 2578.          In Bartlett, the Supreme Court

emphasized that generics are also not permitted to change the

formulation         of     their     products.         133   S.    Ct.      at    2471,       2475.

Further, the Court rejected the argument that a generic drug

                                                 9
manufacturer is required to leave the marketplace in order to

avoid state law liability resulting from its inability to change

either its labeling or formulation.          Id. at 2477.           In other

words, courts may not avoid preempting a state law by imposing

liability on a generic manufacturer for choosing to continue

selling its product.

     Together,   these   cases   establish    that   under    the    FDCA   a

generic may not unilaterally change its labeling or change its

design or formulation, and cannot be required to exit the market

or accept state tort liability.        Therefore, if a generic drug

manufacturer cannot satisfy a state law duty except by taking

one of these four actions, that law is preempted and of no

effect.

                                  2.

     Drager   first   argues   that   we   must   reverse    the    district

court’s order as a whole because it failed to conduct a full

preemption analysis.     The district court did not undertake to

identify and compare all of the relevant duties imposed on PLIVA

by Maryland common law and the FDCA.              Instead, it held that

because of the structure of Maryland products liability law, all

of Gross’s causes of action, however characterized, must in fact

be failure to warn claims, and that they were all therefore

preempted under Mensing.

                                  10
      Although we agree that Mensing contemplates a more complete

analysis and that such an analysis would have been helpful for

our review, the method applied by the district court does not

constitute reversible error.            Because our review is de novo, we

do not defer to the district court and may affirm the dismissal

of Gross’s complaint on any ground.

                                         3.

      Drager also argues that the district court erred by finding

each of Gross’s individual causes of action to be preempted by

the   FDCA.      Because    each      alleged      cause   of    action      logically

requires PLIVA to either change its labeling, change its design

or formulation, exit the market, or accept tort liability, the

underlying Maryland laws as applicable here are preempted.

                                         a.

      Gross’s       complaint    alleges      that     PLIVA’s        metoclopramide

marketing     was    negligent   because      it    failed      to    reasonably   and

accurately      inform   the     medical      community,        and    by    extension

patients, of the dangers of the drug.                 Although Drager concedes

on appeal that all failure to warn claims are preempted by the

FDCA’s labeling requirements under Mensing, he argues that the

complaint’s     allegations      of   negligent      testing,        inspection,   and

post-market      surveillance      survive      because      they      are    actually

premised on independent Maryland duties unrelated to labeling.

                                         11
      In Maryland, to state a cause of action for negligence in

the products liability context, the plaintiff “must allege and

prove (1) that the defendant was under a duty to protect the

plaintiff    from   injury,        (2)   that      the   defendant   breached      that

duty, (3) that the plaintiff suffered actual injury or loss, and

(4)   that   the    loss      or   injury    proximately      resulted      from       the

defendant's breach of the duty.”                   Ga. Pac., LLC v. Farrar, 69

A.3d 1028, 1031-32 (Md. 2013).               Contrary to Drager’s assertions,

it is not clear that Maryland law recognizes specific causes of

action for negligent testing, inspection, and surveillance. 1

      More importantly, it is apparent from the nature of Gross’s

claim that any alleged failure by PLIVA to conduct adequate pre-

market    testing   or       post-market     observation     of   its     drug    is    in

actuality    merely      a    particular     act    or   omission    in   an     overall

negligent sale.       Divorced from the context of an eventual sale

to the consumer, PLIVA could not owe any duty to that consumer

to perform any testing or inspection on its product, and there

could therefore be no cause of action for negligence.                             If we

      1
        Drager cites no support for his argument that it does.
His citation to Worm v. Am. Cyanamide Co. actually undermines
his contention; in that case we interpreted the plaintiff’s
negligent testing claim to allege a failure to warn cause of
action.     970 F.2d 1301, 1304 (4th Cir. 1992).       Drager’s
citations to Restatement (Second) of Torts § 324A and Lucarelli
v. Renal Advantage, Inc., No. AW-08-2219, 2009 U.S. Dist. LEXIS
75506 (D. Md. Aug. 25, 2009), concern the Good Samaritan Rule
and are simply inapposite.

                                            12
assume     that      under   Maryland       law   there    is   a    general    duty       to

protect consumers from injury based on the negligent marketing

and     sale    of    a   product,     it    is    clear     that    a   generic         drug

manufacturer         whose   product    is    unreasonably         dangerous    as       sold

could    not     satisfy     that    duty     without      changing      its   warnings,

changing its formulation, exiting the market, or accepting tort

liability.        Therefore, Gross’s negligence claims are preempted

by impossibility.

                                             b.

      Gross’s complaint alleges that PLIVA’s metoclopramide was

defective in design as marketed due to an unreasonably dangerous

formulation,         inadequate     warnings       and     instructions,       or    both.

Drager maintains on appeal that PLIVA is strictly liable for

introducing       its     product    into    the    stream      of   commerce       in    its

defective condition and that this claim is not preempted by the

requirements of the FDCA.

      In       Maryland,     to     state     a    claim     for     strict     products

liability, a plaintiff must allege that:

      (1) the product was in defective condition at the time
       that it left the possession or control of the seller,
       (2) that it was unreasonably dangerous to the user or
       consumer, (3) that the defect was a cause of the
       injuries, and (4) that the product was expected to and
       did reach the consumer without substantial change in
       its condition.

Gourdine v. Crews, 955 A.2d 769, 780 (Md. 2008) (quoting Phipps

v. Gen. Motors Corp., 363 A.2d 955, 958 (Md. 1976)).                                Gross’s

                                             13
complaint alleges all of these facts and we must accept them as

true for purposes of this analysis.

      However, Drager also concedes that PLIVA was authorized to

market     metoclopramide               with        the      labeling     and       formulation

specified by the FDA, that it was not permitted to change the

labeling,      and     that       it        was     not      permitted       to    change         the

formulation.         It is clear then, from Drager’s arguments, that he

is attempting to rely on a “stop selling” rationale.                                 In effect,

he contends that although PLIVA was prohibited from altering its

metoclopramide        to    make       it    safer,       it   was    only     permitted,         not

obligated,      to    sell        the       drug,      and     is    therefore      liable        for

voluntarily introducing a defective product into the stream of

commerce.      In other words, if PLIVA wanted to avoid liability,

it should have exercised its option to not sell unreasonably

dangerous metoclopramide.                   As discussed above, the stop selling

rationale is an impermissible means of avoiding preemption under

Bartlett.

      Drager contends that Bartlett is not controlling because

Maryland      assesses       the       unreasonableness             of   the      danger     of    a

product using a consumer-expectations test while New Hampshire,

the   state    whose       tort    laws        Bartlett        interprets,        uses   a   risk-

utility approach.           To the extent that there is a difference in

                                                  14
approach between the two states, it is immaterial. 2                        The Court in

Bartlett    did    not   determine           that    the    New    Hampshire      law    was

preempted    because          it     applied        the     risk-utility         approach.

Instead,    it     concluded        that     there     was    no    action       that    the

defendant could take under that approach to increase the safety

of its product without violating the restrictions of the FDCA.

We have no trouble concluding that the same is true under either

the   risk-utility       or        the   consumer-expectations             approach       in

Maryland.    PLIVA cannot be required to stop selling its product,

but at the same time it is prohibited from making any changes to

the product itself or the accompanying warnings.                           Regardless of

the way in which Maryland assesses the unreasonableness of a

product’s    risks,      if        PLIVA’s     metoclopramide        is     unreasonably

unsafe,    there    is   no    apparent       action       that    PLIVA   can    take    in

compliance with FDCA restrictions to avoid strict liability. 3

      2
       It is not clear that there is any difference.   Maryland
uses both approaches in different situations, and applies risk-
utility when a product has malfunctioned, which is arguably the
case here. Halliday v. Sturm, Ruger & Co., 792 A.2d 1145, 1153
(Md. 2002).
      3
       Drager argues that we should follow the Eighth Circuit and
remand the strict liability question to the district court
because of the alleged difference in approach between Maryland
and New Hampshire.    In Fullington v. Pfizer, Inc., the Eighth
Circuit speculated that Arkansas law, which applies the consumer
expectations test, might provide “an opportunity, consistent
with federal obligations, to somehow alter an otherwise
unreasonably dangerous drug.”    720 F.3d 739, 746-47 (8th Cir.
2013). There is no such opportunity for PLIVA to simultaneously
(Continued)
                                             15
                                             c.

       Gross’s     complaint     next        alleges    that    PLIVA         created      and

breached express and implied warranties regarding the safety of

its metoclopramide by marketing it without sufficient warnings

in an unreasonably unsafe condition.                     This argument similarly

lacks merit.

       First,    although      the   Maryland        Court     of    Appeals         has   not

explicitly ruled on this question, it appears that Maryland law

does   not     recognize      causes    of     action    for    breach         of    implied

warranties       of   merchantability          or    fitness        for   a     particular

purpose when the goods at issue are pharmaceuticals.                                See Rite

Aid    Corp.     v.   Levy-Gray,       894    A.2d     563,    570-71         (Md.    2006).

However, even if such claims are cognizable, they are preempted

in the case of generic drug manufacturers.

       When a seller is a merchant with respect to the kind of

good   being     sold,   an    implied        warranty    of    merchantability,            a

promise that a good is fit for its ordinary purpose, arises

automatically at the time of the sale.                    Id. at 570 n.5 (citing

Md. Code Ann., Com. Law § 2-314 (2002)).                            When a seller has

reason to know that a buyer is relying on his skill and judgment

comply with the restrictions of the FDCA and Maryland strict
products liability law. Because the existence of such an option
is a question of law, there is no reason to remand to make this
determination.

                                             16
to select a good suitable for a particular purpose, an implied

warranty of fitness for that purpose arises automatically at the

time of sale.        Id. at 570 n.4 (citing Md. Code Ann., Com. Law

§ 2-315   (2002)).            We   accept       as   true     for    purposes       of   this

analysis that PLIVA is a merchant of pharmaceuticals, that it

had reason to know of Gross’s particular purpose in purchasing

metoclopramide,         and    that     as   marketed        its    metoclopramide        was

unreasonably dangerous when used as intended.                           On these facts,

PLIVA unavoidably created and breached these implied warranties

by selling metoclopramide.               Because PLIVA was not permitted to

change its warnings or formulation, it could not have avoided

liability    for     breach        of   these     implied         warranties     except   by

exiting   the    market.           Therefore,        to     the    extent    that   implied

warranties      of   merchantability            or        fitness    for    a    particular

purpose can arise in this context under Maryland law, they are

preempted by the requirements of the FDCA.

     Drager argues that state law liability for breach of an

express warranty is not preempted by the requirements of the

FDCA because it is a violation of contract law and not tort.                               He

contends that manufacturers voluntarily elect to make certain

assertions      about    their      products         in    warnings    and      promotional

materials and that as a result the manufacturers themselves, not

the law, impose the obligation to conform to those assertions.

Whatever the merits of this argument might be in general, it is

                                             17
indisputable       that     the   content     of    generic         drug     manufacturers’

product descriptions and other assertions is mandated by federal

law.     Because PLIVA cannot change its written materials or the

formulation of its product to ensure that its metoclopramide

functions as expressly warranted, it cannot avoid liability for

breach    of      express     warranty       except      by        leaving      the     market.

Gross’s    cause     of   action      for    breach      of    express       warranties      is

therefore preempted by the FDCA.

                                             d.

       Finally,      Gross’s       complaint       alleges          that,       through     its

promotional        and      warning        materials,         PLIVA        made       negligent

misrepresentations and fraudulently concealed information about

the     safety     of     its      product        from    consumers             and    medical

professionals.           Drager’s contention that these claims survive

preemption is frivolous.              Both causes of action are premised on

the     content     of    statements        made    by        the    defendant         to   the

plaintiff.        See Lloyd v. Gen. Motors Corp., 916 A.2d 257, 273

(Md.     2007)     (reciting       the      elements          of    Maryland          negligent

misrepresentation);          id.      at    274     (reciting         the       elements     of

Maryland fraudulent concealment).                  Drager’s conclusory statement

that the duties imposed by these legal principles are unlike

state     law     obligations         concerning         warnings          is     unavailing.

Assuming that PLIVA’s representations are false or misleading

because its metoclopramide is unreasonably unsafe as marketed,

                                             18
it   has   no   authority   to   add   or    remove   information   from   its

materials or to change the formulation of the product to make

its representations complete or truthful.                Therefore, PLIVA’s

only remaining options are to leave the market or accept tort

liability.        As   a    result,     Gross’s       misrepresentation    and

fraudulent concealment claims are preempted by the FDCA.

                                       IV.

      For the foregoing reasons the district court’s denial of

Gross’s request to amend her complaint and its dismissal of her

state law tort causes of action are

                                                                    AFFIRMED.

                                       19