Herbert Fussman v. Novartis Pharmaceuticals Corporation

UNPUBLISHED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Affirmed by unpublished per curiam opinion.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Unpublished opinions are not binding precedent in this circuit.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
19
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.
21
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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