McWilliams et al v. Novartis AG et al
ORDER GRANTING IN PART AND DENYING IN PART PLAINTIFFS 100 MOTION FOR PARTIALRECONSIDERATION OF THE COURTS ORDER ON SUMMARY JUDGMENT. Signed by Judge Robin L. Rosenberg on 7/31/2018. See attached document for full details. (kpe)
UNITED STATES DISTRICT COURT
THE SOUTHERN DISTRICT OF FLORIDA
CASE NO. 2:17-CV-14302-ROSENBERG/MAYNARD
NOVARTIS AG, a global healthcare company,
NOVARTIS PHARMACEUTICALS CORPORATION,
a Delaware corporation,
ORDER GRANTING IN PART AND DENYING
IN PART PLAINTIFF’S MOTION FOR PARTIAL
RECONSIDERATION OF THE COURT’S ORDER ON SUMMARY JUDGMENT
This Cause is before the Court on Plaintiffs’ Motion for Partial Reconsideration of the
Court’s Order on Summary Judgment. DE 100. Defendant Novartis Pharmaceuticals Corporation
responded, DE 105, and Plaintiffs replied, DE 107. The Court has considered all of the filings.
For the reasons set forth below, the Motion is granted in part and denied in part. It is granted in
that the Court considers Plaintiffs’ argument that the New Jersey exception on the prohibition of
punitive damages is applicable in this case, an argument the Court did not consider in its Order
granting in part and denying in part Defendant’s Motion for Summary Judgment, DE 92. But it is
denied in that the Court concludes that the New Jersey exception is preempted. Accordingly,
Plaintiffs cannot seek punitive damages.
“[R]econsideration of a previous order is an extraordinary remedy to be employed
sparingly.” Burger King Corp. v. Ashland Equities, Inc., 181 F. Supp. 2d 1366, 1370 (S.D. Fla.
2002) (citing Mannings v. Sch. Bd. of Hillsborough Cnty., 149 F.R.D. 235, 235 (M.D. Fla.
1993)). “The ‘purpose of a motion for reconsideration is to correct manifest errors of law or fact
or to present newly discovered evidence.’” Id. at 1369 (quoting Z.K. Marine Inc. v. M/V
Archigetis, 808 F. Supp. 1561, 1563 (S.D. Fla. 1992)). Only three major grounds generally
justify reconsideration: “(1) an intervening change in the controlling law; (2) the availability of
new evidence; and (3) the need to correct clear error or prevent manifest injustice.” Id. (citing
Offices Togolais Des Phosphates v. Mulberry Phosphates, Inc., 62 F. Supp. 2d 1316, 1331 (M.D.
Fla. 1999)). On the other hand, “[a] ‘motion for reconsideration should not be used as a vehicle
to . . . reiterate arguments previously made.’” Id. (citing Z.K. Marine Inc., 808 F. Supp. at 1563).
This case arises from a stroke that Plaintiff Denis McWilliams suffered while he was
taking Defendant’s drug, Tasigna, for his chronic myeloid leukemia. Mr. McWilliams alleges
that his stroke was caused by Defendant’s drug and that Defendant did not properly warn about
the risks associated with its drug. Mr. McWilliams and his wife, Plaintiff Lori McWilliams,
brought a three-count Amended Complaint alleging: (1) strict product liability under a failure to
warn theory; (2) negligence under a failure to warn theory; and (3) loss of consortium for Mrs.
McWilliams. DE 19. Defendant filed a Motion for Summary Judgment, DE 61, which the Court
granted in part and denied in part, DE 92.
At issue in the instant Motion for Reconsideration is part of the Court’s ruling on
summary judgment with respect to punitive damages. In its Order on Defendant’s Motion for
Summary Judgment, the Court concluded that New Jersey, not Florida, law applied to the issue
of whether Plaintiffs are entitled to punitive damages. DE 92 at 15–18. The Court noted that
generally New Jersey law “prohibits an award of punitive damages in products liability actions
where the drug that caused the harm was subject to preapproval by the FDA.” Id. at 15. The
Court stated that “[t]here is one statutory exception to this prohibition on punitive damages
‘where the product manufacturer knowingly withheld or misrepresented information required to
be submitted under the agency's regulations, which information was material and relevant to the
harm in question.’ N.J. Stat. Ann. § 2A:58C-5. Courts, however, have found this exception to be
preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001). See
McDarby v. Merck & Co., Inc., 949 A.2d 223, 276 (N.J. Super. Ct. App. Div. 2008). Plaintiffs do
not argue that this exception applies. Thus, the Court does not need to analyze whether the
exception is preempted under Buckman.” Id. at n.3.
In their Motion for Reconsideration, Plaintiffs state that they “did argue that the
exception to New Jersey’s prohibition on punitive damages applies and that such damages are
not preempted.” DE 100 at 1 (emphasis in original). Plaintiffs point to a footnote in their
opposition to Novartis’s Motion for Summary Judgment in which they state:
For reasons already briefed (Doc. No. 28), even if New Jersey law applies,
Plaintiffs have still created a triable issue of fact on punitive damages. Under New
Jersey law, punitive damages are available “where the product manufacturer
knowingly withheld or misrepresented [material and relevant] information
required to be submitted under the agency’s regulation.” N.J.S.A. § 2A:58C-5c.
Here, Plaintiffs have shown that Novartis both withheld material information
related to atherosclerosis-related conditions associated with Tasigna, and further
made material misrepresentations to the FDA about such information,
intentionally misrepresenting to the FDA, among other things, the state of the
medical literature on the association and Novartis’s own internal analyses
regarding the association. This is sufficient to create a triable issue of fact.
Further, punitive damages under New Jersey law are not preempted. Forman v.
Novartis Pharms. Corp., 793 F. Supp. 2d 598, 607 (E.D.N.Y. 2011); Chiles v.
Novartis Pharms. Corp., No. 3:06-cv-96-J-25 JBT (M.D. Fla. Feb. 25, 2013)
(Order, Doc. No. 214).
The Court recognizes that it did not consider Plaintiff’s argument that the exception to New
Jersey’s prohibition on punitive damages applies and is not preempted. Accordingly, it grants
Plaintiff’s motion for partial reconsideration in that it will consider now whether the exception
N.J. Stat. Ann. § 2A:58C-5c prohibits an award of punitive damages in products liability
actions where the drug that caused the harm was subject to preapproval by the FDA except
“where the product manufacturer knowingly withheld or misrepresented information required to
be submitted under the agency's regulations, which information was material and relevant to the
harm in question.” There is a split of authority about whether the exception to the prohibition on
punitive damages is preempted by the Supreme Court’s decision in Buckman Co. v. Plaintiffs’
Legal Comm., 531 U.S. 341 (2001). Plaintiffs argue that the exception is not preempted under
Buckman and that there is a triable issue of fact as to whether Defendant knowingly withheld or
misrepresented material information required to be submitted to the FDA. Defendant argues that
the exception is preempted under Buckman.
In Buckman, the plaintiffs brought claims against the manufacturer of orthopedic bone
screws alleging that the manufacturer had “made fraudulent representations to the [FDA] in the
course of obtaining approval to market the screws.” 531 U.S. at 344. Plaintiffs claimed that these
misrepresentations were the “but for” cause of their injuries. Id. The Supreme Court found that
plaintiffs’ “fraud-on-the-FDA” claims were impliedly preempted by the federal Food, Drug, and
Cosmetic Act. Id. In reaching this conclusion, the Court found that “in contrast to situations
implicating federalism concerns and the historic primacy of state regulation of matters of health
and safety,  no presumption against pre-emption obtains” in fraud-on-the-FDA claims. Id. at
348 (citations omitted). The Court noted the inherently federal nature between a federal agency
and the entity it regulates and “that the federal statutory scheme amply empowers the FDA to
punish and deter fraud against the Administration, and that this authority is used by the
Administration to achieve a somewhat delicate balance of statutory objectives.” Id. The Court
further explained that:
State-law fraud-on-the-FDA claims inevitably conflict with the FDA's
responsibility to police fraud consistently with the Administration's judgment and
objectives. As a practical matter, complying with the FDA's detailed regulatory
regime in the shadow of 50 States’ tort regimes will dramatically increase the
burdens facing potential applicants-burdens not contemplated by Congress in
enacting the FDCA and the MDA.
Id. at 350.
A few courts to have considered the issue have found that the exception is not preempted.
See Order, Chiles v. Novartis Pharm. Corp., No. 3:06-cv-00096-HLA-JBT, (M.D. Fla. Feb. 25,
2013), ECF No. 214; Forman v. Novartis Pharm. Corp., 793 F. Supp. 2d 598 (E.D.N.Y. 2011).
For example, in Forman, the Court, relying on the binding Second Circuit precedent of Desiano
v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2008) found that the New Jersey exception was
not preempted. In Desiano, the Second Circuit interpreted a Michigan statute under Buckman.
The statute immunized manufacturers of drugs that were approved by the FDA from all products
liability actions unless the manufacturer withheld from or misrepresented material information
from the FDA. Id. at 87–88. The Court held that Buckman did not preempt the statute stating
Because of its important role in state regulation of matters of health and safety,
common law liability cannot be easily displaced in our federal system. Buckman
underscored this fact, finding implied preemption of a newly-fashioned state
cause of action only where (1) no presumption against federal preemption
obtained, and (2) the cause of action, by assigning liability solely on the basis of
fraud against the FDA, imposed significant and distinctive burdens on the FDA
and the entities it regulates.
Id. at 98 (emphasis in original). Desiano was summarily affirmed by an equally divided Supreme
Court. Warner-Lambert Co., LLC v. Kent, 552 U.S. 440 (2008). Relying on Desiano, the Forman
Court found that the New Jersey exception was not preempted because “(1) it is properly
classified under Desiano as a permitted state common-law tort claim premised on the obligations
between a manufacturer and a consumer that require a prerequisite showing of fraud-on-the-FDA
and (2) the presumption against preemption is equally applicable to claims for compensatory
damages and punitive damages claims premised on state common-law torts.” 793 F. Supp. 2d at
606. The Court noted that “to the extent the Plaintiff is seeking punitive damages based solely on
NPC's alleged misrepresentations to the FDA, this is not permissible. However, the Plaintiff in
the instant case is also seeking punitive damages that stem from NPC's misrepresentations to
decedent Napolitano and the medical community.” Id.
On the other hand, the majority of courts to have considered the issue have found that
Buckman preempts the exception found in N.J. Stat. Ann. § 2A:58C-5c. See, e.g., Guenther v.
Novartis Pharm. Corp., 8:06-cv-1787-24-TBM, 2014 WL 2722483, at *3–4 (M.D. Fla. June 16,
2014); Dopson-Troutt v. Novartis Pharm. Corp., No. 8:06-cv-1708-T-24-EAJ, 2013 WL
3808205, at *4–5 (M.D. Fla. July 22, 2013).; Zimmerman v. Novartis Pharm. Corp., 889 F.
Supp. 2d 757 (D. Md. 2012); McDarby v. Merck & Co., Inc., 949 A.2d 223 (N.J. Super. App.
Div. 2008). In Zimmerman, for example, the District Court found that the New Jersey exception
was preempted because the “FDCA empowers the federal government, through the FDA, to
regulate the safety and efficacy of pharmaceutical drugs via an extensive drug approval process”
and that the New Jersey exception did “not enjoy a presumption of validity” “[b]ecause New
Jersey’s statutory immunity provision attempts to legislate in an area of significant federal
concern.” Zimmerman, 889 F. Supp. 2d at 768–71. The Zimmerman Court also noted that
“[a]lthough the form of Plaintiff’s claims differs from that of her counterparts in Buckman, both
claims are identical in substance because they present the same conflict with the FDCA
regulatory scheme and the FDA’s enforcement prerogatives.” Id. at 773–77. Accordingly, the
Zimmerman Court found the New Jersey exception to be preempted.
The Court agrees with these cases that have held that the New Jersey exception is
preempted by Buckman. The Court in Zimmerman put it succinctly:
Plaintiff’s claim for punitive damages requires a state fact finder to determine
what was required to be submitted to the FDA, whether it was submitted to the
FDA and, whether the FDA would have made a different approval decision had it
been provided with the correct or missing information. Plaintiff's claim thus
requires a fact finder to make these types of determinations as a matter of state
law even though federal law makes such determinations the exclusive province of
the FDA. Accordingly, Plaintiff's claim for punitive damages poses an obstacle to
the objectives and purpose of the FDCA, and is therefore preempted by the
889 F. Supp. 2d at 776. Like the Court in Zimmerman, this Court finds the claims at issue here
and those at issue in Buckman to be substantively the same. See id. Accordingly, the New Jersey
exception is preempted under Buckman and Plaintiffs cannot seek punitive damages.
For the foregoing reasons, it is hereby ORDERED AND ADJUDGED that that
Plaintiffs’ Motion for Partial Reconsideration of the Court’s Order on Summary Judgment [DE
100] is GRANTED IN PART AND DENIED IN PART. Plaintiffs’ cannot seek punitive
DONE AND ORDERED in Chambers in West Palm Beach, Florida this 31st day of July,
ROBIN L. ROSENBERG
UNITED STATES DISTRICT JUDGE
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