Court Opinion

ID: 820021
Source: CourtListenerOpinion
Date Created: 2013-02-08 20:03:35.602218+00
Date Added: 2024-06-11T09:03:01.937642
License: Public Domain

UNPUBLISHED

                  UNITED STATES COURT OF APPEALS
                      FOR THE FOURTH CIRCUIT

                             No. 12-1030

HERBERT FUSSMAN, individually and as Administrator of the
Estate of Rita Fussman,

                Plaintiff - Appellee,

           v.

NOVARTIS PHARMACEUTICALS CORPORATION,

                Defendant - Appellant.

Appeal from the United States District Court for the Middle
District of North Carolina, at Greensboro. James A. Beaty, Jr.,
Chief District Judge. (1:06-cv-00149-JAB-PTS)

Argued:   December 7, 2012                 Decided:   February 8, 2013

Before NIEMEYER, KING, and FLOYD, Circuit Judges.

Affirmed by unpublished per curiam opinion.

ARGUED: Bruce Jeffrey Berger, HOLLINGSWORTH, LLP, Washington,
D.C., for Appellant.     John J. Vecchione, VALAD & VECCHIONE,
PLLC, Fairfax, Virginia, for Appellee.      ON BRIEF: Peter G.
Pappas, NEXSEN PRUET, PLLC, Greensboro, North Carolina; Joe G.
Hollingsworth,   Katharine  R.  Latimer,  Robert  E.  Johnston,
HOLLINGSWORTH, LLP, Washington, D.C., for Appellant.    Jodi D.
Hildebran, ALLMAN SPRY LEGGETT & CRUMPLER, P.A., Winston-Salem,
North Carolina, for Appellee.

Unpublished opinions are not binding precedent in this circuit.
PER CURIAM:

        In   June    2001,     upon   learning      that       breast     cancer      had

metastasized        to   her     bones,     Rita    Fussman         (Fussman)      began

receiving     monthly     infusions    of      Aredia,    a    pharmaceutical         drug

approved by the Food Drug Administration (FDA) and marketed by

New Jersey-based Novartis Pharmaceuticals Corporation.                           Aredia

is a bisphosphonate, a drug designed to prevent the loss of bone

mass.        Fussman     began    Aredia       infusions       at   the      behest    of

oncologist Dr. Heather Shaw and continued receiving the drug

until November 2001 when Dr. Shaw changed her monthly regimen to

infusions     of    Zometa,      another    Novartis-marketed,            FDA-approved

bisphosphonate.          With the exception of a one month reprieve,

Fussman remained on Zometa until June 2005.                         Fussman died in

2009.

        This diversity action, which Fussman initiated in February

2006,    involves    a    side   effect     of   Aredia       and   Zometa    known    as

“osteonecrosis of the jaw” (ONJ).                ONJ occurs when the gums fail

to cover part of the jaw bone and the bone starves and dies from

lack of blood.           Fussman developed ONJ in March 2003, shortly

after having two teeth extracted.                Herbert Fussman, individually

and as the administrator of the Estate of Rita Fussman, alleges

that Aredia and Zometa caused Fussman’s ONJ and that Novartis

failed to warn adequately either Fussman or Dr. Shaw of the ONJ

risk associated with the drugs.

                                           2
      After coordinated Multidistrict Litigation proceedings in

the     Middle    District        of     Tennessee,        the     Judicial      Panel     on

Multidistrict          Litigation       remanded         this    case    to    the    Middle

District of North Carolina for trial.                          Following a fifteen-day

trial,    a    jury     awarded       $287,000      in    compensatory        damages     and

$12,600,000        in        punitive     damages         to     Herbert       Fussman     as

administrator.               Additionally,         it    awarded    $1     for     loss    of

consortium to Herbert Fussman individually.                         Per North Carolina

General Statute § 1D-25, the district court reduced the punitive

damages       award     to    $861,000.            See    N.C.    Gen.     Stat.     § 1D-25

(“Punitive damages awarded against a defendant shall not exceed

three times the amount of compensatory damages or two hundred

fifty    thousand        dollars       ($250,000),        whichever      is    greater.”).

Thus,    the     total       award,    including         pre-judgment      interest,      was

$1,258,083.19.

      Novartis filed three post-judgment motions:                          a motion for a

new trial, a motion for judgment as a matter of law on all

claims, and a motion for judgment as a matter of law on punitive

damages.         The    district       court   denied       all    three      motions,    and

Novartis now appeals the denial of its motion for judgment as a

matter of law on punitive damages and the denial of its motion

for a new trial.             It does not appeal the court’s denial of its

motion for judgment as a matter of law on all claims.                                For the

reasons that follow, we affirm.

                                               3
                                       I.

      We first address Novartis’s contention that the district

court erred in denying its motion for a new trial.                 We review a

district court’s denial of a motion for a new trial for abuse of

discretion, United States v. Perry, 335 F.3d 316, 320 (4th Cir.

2003),       recognizing      that    “[u]nder     the     applicable    legal

principles, a trial court ‘should exercise its discretion to

award a new trial sparingly,’ and a jury verdict is not to be

overturned except in the rare circumstance when the evidence

‘weighs heavily’ against it,” United States v. Smith, 451 F.3d

209, 216–17 (4th Cir. 2006) (quoting United States v. Perry, 335

F.3d 316, 320 (4th Cir. 2003)).

                                       A.

      Novartis       challenges      four   of     the     district     court’s

evidentiary rulings, which we also review under the deferential

abuse of discretion standard, King v. McMillan, 594 F.3d 301,

310   (4th    Cir.   2010),    and   overturn    only    when   “arbitrary   and

irrational,” United States v. Blake, 571 F.3d 331, 346 (4th Cir.

2009), and violative of a “party’s substantial rights,” Fed. R.

Civ. P. 61 (“At every stage of the proceeding, the court must

disregard all errors and defects that do not affect any party’s

substantial rights.”).          Thus, if we conclude that an alleged

error would be harmless, we need not conduct additional analysis

                                        4
to determine whether the district court actually erred.                    United

States v. Banks, 482 F.3d 733, 741 (4th Cir. 2007).

     In    this     case,   our    review     of   the    evidentiary      rulings

Novartis cites indicates that none of them, even if erroneous,

affected     Novartis’s     “substantial      rights.”         Accordingly,    we

affirm the district court’s denial of Novartis’s motion for a

new trial on that basis.

     E-mails Between Novartis and Drs. Schubert and Ruggiero

     In 2004, Novartis published a “white paper” about ONJ.                    The

paper indicated that although “[a] causal relationship between

bisphosphonate therapy and osteonecrosis of the jaws ha[d] not

been established,” a panel of experts had convened “to discuss

identification of risk factors” for ONJ, to “develop clinical

guidelines    for    prevention,      early    diagnosis,      management,    and

multidisciplinary treatment” of ONJ in cancer patients, and to

“develop[]    recommendations       to   reduce”    ONJ   in   cancer   patients

receiving bisphosphonates.

     At trial, the district court admitted e-mail conversations

that occurred between Novartis and two experts—Dr. Mark Schubert

and Dr. Salvatore Ruggiero—during the preparation and editing of

the paper.        In May 2004, during the final revisions of the

paper, an e-mail exchange occurred between Dr. Schubert and Dr.

Yong-jiang    Hei,    Global      Medical    Director     of   Novartis.      Dr.

                                         5
Schubert had requested that the following language be included

in the paper’s “Potential Risk Factors” section:

              While   osteonecrosis   of   the  jaws   following
         bisphosphonate   therapy   has  been  associated   with
         infection and/or dental surgery, cases of spontaneous
         osteonecrosis lesions without other apparent risk
         factors   have   been   observed.     Some   cases   of
         osteonecrosis of the jaws have been observed after as
         few as [two] administrations of a bisphosphonate.

Via e-mail, Dr. Hei responded that this language was excluded

from the final draft for several reasons, one of which being

that the language “implie[d] a degree of understanding of risk

factors for osteonecrosis of the jaws that is not warranted in

light of the general uncertainties regarding the causality of

[the condition].”         In a reply e-mail, Dr. Schubert commented at

length regarding Novartis’s decision not to include his proposed

language, and relevant to Fussman’s claims stated, “I encourage

you to take a bold and honest approach to realistically warn

people[,] an[d] this will, in the long run, be the best thing.”

In   a    different    May    2004    e-mail    exchange     with    Novartis,     Dr.

Schubert      commented      on    Novartis’s   decision     to     include   in   the

paper     a   long    list    of    risk   factors   that    were     “possibly     or

possibly not related” to ONJ.              Schubert stated, “The [inclusion

of a] laundry list of factors leading to ‘exposed bone’ does

have the appearance of ‘blowing smoke.’”                    Similarly, in August

2004, Dr. Ruggiero referenced the paper via e-mail, stating that

                                           6
it was misrepresenting the truth and that “bisphosphonates are

the real culprits” behind ONJ.

     Novartis contends that the district court erred in allowing

Fussman     to     reference    these       e-mails      because          the    statements

therein     were      inadmissible      hearsay.             But    we     conclude       that

regardless of whether the district court erred in admitting the

e-mails,    such       admission      was   harmless         because       the     testimony

included in the e-mails was also offered by Dr. Robert Marx,

another member of the expert panel who testified at trial.

     Dr. Marx testified that when he attended a meeting of the

panel in 2004, he brought with him a “Notice of Importance” that

he   had    developed        and      distributed        to        oral    surgeons        and

oncologists       regarding     the    relationship          of    ONJ    to     Aredia    and

Zometa.         Dr.   Marx   also     testified       that    his    office       faxed    the

Notice     to    Dr.    Peter   Tarasoff,         a    Novartis          medical    affairs

employee.        In part, the Notice stated, “The exposed bone in the

jaws (either the maxilla or mandible) is directly related to

Aredia/Zometa, but may be further contributed to by the primary

disease itself, other chemotherapy agents, and steroids such as

[D]ecadron.”          Regarding the white paper, Dr. Marx explained his

problems with the paper, stating,

          It     was    denying    any    cause-and-effect
     relationship. . . . [I]t was actually attributing so
     many things to exposed bone, none of which really did
     that, that many of us, not just me, objected to the

                                            7
      written form several times that it was not addressing
      what we had inputted into the meeting.

He further testified that he communicated his objections to the

paper to the Novartis employee who was managing the project:

“My   recollection        is     I    told    him     the    paper   danced    around   the

issue;      and    that       things    such    as     smoking,      alcohol    drinking,

periodontal disease, and a whole host of other possibilities

don’t cause exposed bone; and to throw it into that framework

was misleading to the readership.”

      In sum, to the extent that the jury concluded that Novartis

knew of the ONJ risks associated with bisphosphonates and that

it failed         to   warn    of    those    risks     or    intentionally     concealed

those risks, the e-mails from Drs. Schubert and Ruggerio were

not   the    sole      cause.         Dr.    Marx’s    testimony     supported    such   a

conclusion as well.             Accordingly, the district court did not err

in denying Novartis a new trial based on its admission of the e-

mails.

                          Dr. Lynne McGrath’s Testimony

      Since October 2005, Dr. Lynne McGrath has been the Vice

President of Regulatory Affairs at Novartis.                         At trial, Novartis

elicited     testimony         from    Dr.    McGrath       regarding   the    regulatory

history of Aredia and Zometa.                  The court ruled that Dr. McGrath

could testify only to information about which she had personal

                                               8
knowledge,    effectively           limiting       her    testimony     to   post-October

2005 history.           In contending that the district court erred in

limiting Dr. McGrath’s testimony, Novartis maintains that her

position     as    Vice        President      “required      her   to    have     personal

knowledge of the full regulatory history of the drug.”

      Novartis avers that the district court’s ruling inhibited

the jury from learning “information critical to [its] defense.”

Specifically, it notes that Dr. McGrath would have testified

that (1) Novartis “worked closely with [the] FDA on all of the

various label changes and that attention was paid to every word

in   the   label,”           (2)   Novartis      “worked    aggressively        to    obtain

information       from       Dr.   Marx    and     even    hired   a    medical      records

company to assist in the process of collecting medical records,”

(3) Novartis’s Emergency Management team “worked diligently to

understand the new side effect, and, within a month of convening

[in July 2003], decided to revise the label to reflect the cases

of ONJ and began the process of revising the label,” (4) “the

risk factors listed in the September 2003 label were considered

by   [Novartis]         to    be   well   documented        in   the    general      medical

literature        for    osteonecrosis           generally,      the    only    available

literature at that time,” (5) the “FDA simultaneously, looking

at   the   same     information,          also      recognized     the       propriety    of

listing the same risk factors,” and (6) Novartis “considered

label changes very serious matters and worked hard to ensure

                                               9
that there was a strong basis for what it included in each label

change.”         Additionally,          Novartis     contends       that   without      the

court-imposed       limitation          Dr.     McGrath      could    have       countered

Fussman’s presentation of the chronology of events, Fussman’s

implication that Novartis “simply ‘chose’ not to put necessary

safety information into its label,” and Fussman’s disparagement

of the Novartis Emergency Management team.

     Once       again,    we    need     not    determine     whether      the    district

court erred in limiting Dr. McGrath’s testimony because any such

error was harmless.              Novartis’s regulatory expert, Dr. Janet

Arrowsmith, provided the testimony that Novartis maintains Dr.

McGrath could have provided.                   Dr. Arrowsmith indicated that she

reviewed “new drug applications for Aredia and Zometa,” “notes

of meetings between FDA and Novartis,” and “notes of advisory

boards    [and]    internal          communications        within    Novartis.”        She

testified,       among        other     things,     concerning       the     details    of

Novartis’s interaction with the FDA; the timing and extent of

Novartis’s       knowledge       that    bisphosphonates          cause    ONJ;    whether

Novartis would have modified the initial label on the drugs had

potential    cases       of    ONJ    revealed      during    clinical      trials     been

notated    as    such;    the     organization        of    the   Novartis       Emergency

Management team; the team’s decision to modify the drugs’ labels

in August 2003; and the actual modification of the labels in

September 2003.          Given the extent of Dr. Arrowsmith’s testimony,

                                               10
we cannot conclude that the district court’s limitation of Dr.

McGrath’s testimony harmed Novartis in a manner that affected

its “substantial rights.”

                             Dr. Ruggiero’s Testimony

     At     trial,        Fussman     repeatedly        referenced          Dr.    Salvatore

Ruggiero’s     research       regarding          occurrences     of    ONJ    in     patients

that receive bisphosphonates.                    It presented an e-mail showing

that in April 2002, Dr. Ruggiero queried Dr. Tarrassoff about

whether bisphosphonates cause osteonecrosis.                          It also presented

an   e-mail    indicating          that     in    May    2003,    when       Dr.     Ruggiero

attempted      to        publish     a      case       series     regarding          ONJ     in

bisphosphonate           patients,        Novartis      sought        to    prevent        such

publication.        Using this evidence, Fussman averred that Novartis

knew bisphosphonates present ONJ risks and chose not to act on

what it knew.

     To rebut the implications of Fussman’s evidence, Novartis

attempted to admit deposition testimony that Dr. Ruggiero had

provided      in     another        Aredia       and    Zometa        case.          Novartis

represented to the district court that in the prior case Dr.

Ruggiero had testified that (1) in April 2002, he did not report

a case of ONJ to Novartis, and (2) he had “no knowledge of

anyone    trying     to    stop     him    from    publishing”        his     case   series.

Ultimately,        the    district       court     denied   the       admission       of    the

                                             11
deposition,       and   Novartis    now        argues      that   such    denial   was

prejudicial because the “excluded testimony tended to negate key

allegations of wrongdoing that Fussman used to support liability

and punitive damages.”          But such is not the case.                The excluded

deposition    testimony     would    not       have     helped    Novartis    to   any

notable degree.

      First, Novartis avows that Fussman repeatedly claimed that

Dr. Ruggiero reported cases of ONJ to Novartis in April 2002.

But our review of the record reveals that Fussman in fact did

not make such a claim.        Rather, Fussman merely repeated what the

evidence demonstrated—that in April 2002, Dr. Ruggiero asked Dr.

Tarasoff if bisphosphonates cause osteoneocrosis.                        Fussman did

not present evidence that Dr. Ruggierio reported specific ONJ

cases.      Thus, although Novartis contends that Dr. Ruggerio’s

testimony from the prior case would have undermined Fussman’s

claims,     his    deposition      would       have     simply    contradicted     an

argument that Fussman never pressed—namely, that Dr. Ruggiero

reported cases of ONJ to Novartis in April 2002.

      Similarly, Dr. Ruggiero’s testimony—that he did not know

Novartis attempted to prevent publication of his case series—

would have failed to contradict effectively Fussman’s evidence

that Novartis had indeed engaged in such conduct.                        Simply put,

one would not expect that Novartis would notify Dr. Ruggiero of

its   own   suppression     attempts.           It    is   unsurprising     that   Dr.

                                          12
Ruggerio     was     unaware   of    Novartis’s      actions,   and   evidence

supporting this fact would not have advanced Novartis’s defense.

Hence, given the harmlessness of any district court error, we

again affirm the district court’s denial of Novartis’s motion

for a new trial.

                   Evidence of 2007 Zometa Label Revision

       In   pertinent     part,     Zometa’s     2003   label   included   the

following paragraph:

       Cases of osteonecrosis (primarily of the jaws) have
       been     reported     since    market    introduction.
       Osteonecrosis of the jaws has other well documented
       multiple risk factors.       It is not possible to
       determine if these events are related to Zometa or
       other bisphosphonates, to concomitant drugs or other
       therapies . . . , to patient’s underlying disease, or
       to other comorbid risk factors . . . .

In 2007, Novartis revised this portion of the label so that it

stated the following:

            Cases of osteonecrosis (primarily involving the
       jaws) have been reported predominantly in cancer
       patients   treated  with   intravenous  bisphosphonates
       including Zometa.    Many of these patients were also
       receiving chemotherapy and corticosteroids which may
       be a risk factor for ONJ.      Data suggests a greater
       frequency of reports of ONJ in certain cancers, such
       as advanced breast cancer and multiple myeloma.     The
       majority of the reported cases are in cancer patients
       following invasive dental procedures, such as tooth
       extraction. It is therefore prudent to avoid invasive
       dental procedures as recovery may be prolonged . . . .

       Prior to trial, Novartis moved to exclude evidence of the

2007    revision,     maintaining     that     the   revision   constituted   a

                                       13
subsequent      remedial       measure.           See     Fed.    R.     Evid.    407       (“When

measures are taken that would have made an earlier injury or

harm less likely to occur, evidence of the subsequent measures

is not admissible to prove: negligence[,] culpable conduct[,] a

defect in a product or its design[,] or a need for a warning or

instruction.”).          Although the district court granted Novartis’s

pre-trial       motion,       it    reversed       course        at    trial     and    allowed

Fussman    to     cross-examine        Dr.        Arrowsmith          regarding       the    label

changes.        Additionally,         it    allowed       Fussman        to    reference       the

revision during closing argument.

     To the extent that the district court erred in admitting

evidence     of    the     2007      label        revision,       such        error    did     not

prejudice Novartis.                Evidence of the revision was relevant to

Novartis’s awareness of the dangers of Zometa and to whether

Zometa    caused       Fussman’s       ONJ.        Given       that     Fussman        presented

extensive       evidence       apart       from     the    2007        label     change      that

supported       both     of    these       claims,        we     cannot        conclude       that

admission of the label change “substantially swayed” the jury’s

verdict.     Thus, once again, we conclude that the district court

did not err in denying Novartis a new trial on such a basis.

                                              B.

     Novartis also contends that the district court’s denial of

two of its requested punitive damages jury instructions merited

                                              14
a   new   trial.        We   review   jury       instructions     “holistically        and

through the prism of the abuse of discretion standard.”                         Noel v.

Artson, 641 F.3d 580, 586 (4th Cir. 2011).                            We must “simply

determine ‘whether the instructions construed as a whole, and in

light of the whole record, adequately informed the jury of the

controlling legal principles without misleading or confusing the

jury to the prejudice of the objecting party.’”                          Id. (quoting

Bailey    v.    Cnty.    of    Georgetown,        94    F.3d   152,    156    (4th    Cir.

1996)).     A party challenging a jury instruction “faces a heavy

burden, for ‘we accord the district court much discretion to

fashion the charge.’”            Id. (quoting Teague v. Bakker, 35 F.3d

978, 985 (4th Cir. 1994)).              Indeed, we will reverse a district

court for declining to give a requested instruction “only when

the   requested     instruction         ‘(1)       was    correct;      (2)    was     not

substantially covered by the court’s charge to the jury; and (3)

dealt with some point in the trial so important, that failure to

give the requested instruction seriously impaired’ that party’s

ability    to    make    its   case.”        Id.       (quoting   United      States    v.

Lighty, 616 F.3d 321, 366 (4th Cir. 2010)).

      Novartis      challenges        the        district      court’s       denial     of

Requested Jury Charge No. 37, which states:

           In making your determination of punitive damages
      in this case, you cannot consider any conduct
      occurring outside the state of North Carolina.

                                            15
             In   making   your  determinations   of   punitive
        damages, you may not consider any harm that may have
        been done to any other individual not in this case.
             Thus, in making your determinations of punitive
        damages in this case, you can only consider profits
        derived by [Novartis] from the state of North Carolina
        during the years of Mrs. Fussman’s use.

It also challenges the denial of Requested Jury Charge No. 43,

which states, “The law prohibits imposing punitive damages based

on any corporate misconduct that did not specifically harm Mrs.

Fussman.”

       Novartis avers that it requested these charges to guard

against the risk that the jury would award damages to Fussman

for     harm    that    other        individuals     suffered.       And     Novartis

maintains       that    such     a     risk    was   concrete    because      Fussman

presented evidence that other individuals developed ONJ after

they    had    been    treated       with   Aredia   and   Zometa;   questioned       a

Novartis expert about his diagnosis of a Tennessee woman who

allegedly developed ONJ after using Aredia; and discussed total

Zometa sales across the United States in 2005 and 2009.                           Citing

Philip Morris USA v. Williams, 549 U.S. 346 (2007), Novartis

urges    that    the    “Due     Process       Clause   precludes    a     jury    from

punishing for ‘the harm caused to others,’” and that therefore,

“when asked, the district court is required to provide a jury

instruction that protects against the risk that punishment will

be meted out for harm done to others.”                     We conclude, however,

                                              16
that    the    district     court     did        not   abuse      its    discretion   in

declining to give the charges Novartis requested.

       First, Requested Jury Charge No. 37 is incorrect.                       Although

Novartis accurately states that “the Constitution’s Due Process

Clause forbids a State to use a punitive damages award to punish

a defendant for injury that it inflicts upon nonparties or those

whom they directly represent, i.e., injury that it inflicts upon

those who are, essentially, strangers to the litigation,” id. at

353, Novartis fails to recognize that due process does allow

reference to and consideration of nonparty injuries as evidence

of reprehensibility, id. at 355 (“Evidence of actual harm to

nonparties can help to show that the conduct that harmed the

plaintiff also posed a substantial risk of harm to the general

public, and so was particularly reprehensible . . . .”).                           Thus,

Requested Jury Charge No. 37’s counsel not to consider any harm

inflicted on any nonparty or any conduct that occurred outside

of     North     Carolina    is     improper,          and     the      district   court

appropriately declined to instruct the jury in this manner.

       Second,    Requested    Jury    Charge          No.   43   was    “substantially

covered” by the district court’s actual charge.                          Instead of the

language that Novartis requested, the court gave the following

punitive damages instruction:

            In making [a] determination [as to punitive
       damages], you may consider only that evidence which
       relates to the following: the reprehensibility of the

                                            17
        Defendant’s motive and conduct, if you have so found;
        the likelihood at the relevant time of serious harm to
        Ms. Fussman; the degree of the Defendant’s awareness
        of the probable consequences of its conduct; the
        duration of the Defendant’s conduct; the actual
        damages suffered by Ms. Fussman; any concealment by
        the Defendant of the facts or consequence[s] of its
        conduct; the existence and frequency of any similar
        past conduct by the Defendant, if you so find; whether
        the Defendant profited by the conduct.

We believe that when the court admonished the jury to “consider

only”    evidence     connected   to   reprehensibility        and        evidence    of

“actual damages suffered by Ms. Fussman,” it sufficiently dealt

with    the    risk   that   Requested    Jury   Charge      No.     43    presumably

sought    to    guard   against—namely,       that     the    jury    would     award

damages for harm suffered by “strangers to the litigation.”                          Id.

at 353.       Thus, we also affirm the district court’s decision not

to give Novartis’s Requested Jury Charge No. 43.

       In sum, as to the evidentiary rulings Novartis contests, we

hold that any errors by the district court were harmless.                            And

as to Requested Jury Charges Nos. 37 and 43, we hold that the

district court did not abuse its discretion in declining to give

these    charges.       Accordingly,     we   affirm    the    district       court’s

denial of Novartis’s motion for a new trial.

                                       II.

       We next address the district court’s denial of Novartis’s

post-trial motion for judgment as a matter of law on punitive

                                         18
damages.      “We review de novo a district court’s denial of a Rule

50 motion for judgment as a matter of law.”                       Lack v. Wal-Mart

Stores, Inc., 240 F.3d 255, 259 (4th Cir. 2001).                        “If, viewing

the facts in the light most favorable to the non-moving party,

there is sufficient evidence for a reasonable jury to have found

in   [Fussman’s]     favor,    we    are   constrained      to    affirm         the    jury

verdict.”     Id.

                                           A.

      In its motion, Novartis argued (1) that the evidence of its

misconduct suggests negligence, not willful or wanton conduct as

required under North Carolina law to support a punitive damages

award   and    (2)   that     evidence     of    its    suppression         of    medical

information     regarding      ONJ    cannot     support    a     punitive        damages

award   because      Fussman    failed     to    demonstrate       a    causal         nexus

between Novartis’s acts and her harm.              We disagree.

      First, Fussman presented evidence showing that Novartis’s

high-ranking officials knew about the drugs’ side effects and

subverted medical inquiries into such effects.                         This evidence

provided a sufficient foundation for the jury to determine that

Novartis’s     actions   were       willful,     not    simply    negligent.             And

second,    Fussman     presented      evidence      sufficient         to   support        a

determination that Novartis’s acts proximately caused her ONJ.

Fussman’s     deposition       testimony,       taken    before    her      death        and

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presented     at    trial,    indicated      that    she    would    not     have   taken

Aredia and Zometa if she had known the drugs’ risks.                               Indeed,

evidence      presented      at    trial    indicated       that    Fussman        stopped

taking      the    drugs    once     she    knew    their    hazards.         Moreover,

although      Dr.    Shaw    testified      that     she    would    have     continued

Fussman’s     treatments      even     if    she    had    known    that     ONJ    was    a

possibility, the jury could have determined from other evidence

that Dr. Shaw would have modified various aspects of Fussman’s

treatment had she been adequately warned of the drugs’ perils.

       We have simply sampled the record here.                         But the trial

proceedings and the whole of the evidence that Fussman supplied

to   this    Court    bely    a    conclusion       that    insufficient       evidence

supported the jury’s punitive damages award.                        Thus, we affirm

the district court’s denial of Novartis’s motion for judgment as

a matter of law on this basis.

                                            B.

       We also affirm the district court’s denial of Novartis’s

motion for judgment as a matter of law on a preemption theory.

Novartis contends that the Federal Food, Drug, and Cosmetic Act

(FDCA),      21    U.S.C.    §§ 301-399,      preempts      the     jury’s    award       of

punitive damages because the Aredia and Zometa labels complied

with   FDA    regulations      and    the    FDA    has    exclusive    authority         to

                                            20
enforce the labeling requirements of the FDCA.                     Once again, we

disagree.

       In no uncertain terms, the Supreme Court has dictated that

the    FDCA   does    not   preempt      state   law   claims   against       a    drug

company whose drug label complies with FDA regulations.                           Wyeth

v. Levine, 555 U.S. 555, 581 (2009).                   In Wyeth v. Levine, the

Court examined the history of the FDCA and Congress’s intent in

enacting      the    statute.      The    Court    noted    that    in    spite     of

Congress’s “certain awareness of the prevalence of state tort

litigation,” it declined to expressly preempt state law failure-

to-warn claims for prescription drugs.                  Id. at 575 (“The case

for federal pre-emption 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.”) (alteration in original) (quoting Bonito Boats,

Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 166–67 (1989)

(internal quotation marks omitted)).               Congress’s silence on the

matter    was   notable,     the   Court       reasoned,   because       in   another

context—i.e., medical devices—it had amended the FDCA to include

an express preemption provision.               See Pub. L. No. 94-295, § 521,

90 Stat. 574 (1976) (codified at 21 U.S.C. § 360k); Wyeth, 555

U.S. at 567.

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      Here,    Novartis      seeks   to    carve    out    a   niche     in    existing

precedent by arguing that Wyeth is inapplicable because it does

not expressly reference punitive damages.                  But Novartis fails to

put   forth    any   logical    reason     why     the    basis   for    the   Court’s

decision in Wyeth should not equally apply to claims involving

punitive damages.         Novartis argues that the FDCA preempts the

recovery of punitive damages because (1) the purpose of punitive

damages is to punish and deter, something the FDA has “ample

power”    to     accomplish          through       enforcement          of     labeling

requirements     and   (2)     allowing     the    punishment     of     FDA-approved

conduct is improper.         Neither of these arguments is efficacious.

Had Congress intended to preempt punitive damages recovery, it

could have clearly indicated as much—just as it did when it

addressed medical devices.           Thus, we affirm the district court’s

denial of Novartis’s motion for judgment as a matter of law on

this basis as well.

                                          III.

      For the foregoing reasons, we affirm the judgment of the

district court.

                                                                               AFFIRMED

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