Bowdrie et al v. Sun Pharmaceutical Industries, Ltd. et al
Filing
46
DECISION AND ORDER: Each New York state law claim Plaintiffs plead in this action depend on their allegations that Defendant failed to adequately warn of the risk of SCAR events, and failed to test for and maintain bioequivalence with the Dilantin. P laintiffs' failure to warn claims are preempted by federal law. Plaintiffs have both abandoned their bioequivalence claims, and, also failed to state a cause of action premised upon their bioequivalence claims. Therefore, the Amended Complaint is dismissed in its entirety. Ordered by Judge William F. Kuntz, II on 11/9/2012. (Fwd'd for judgment) (Brucella, Michelle)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
---------------------------------------------------------J(
ANGELA BOWDRIE, et aI.,
DECISION AND ORDER
Plaintiffs,
12-CV-853(WFK)(MDG)
-againstSUN PHARMACEUTICAL INDUSTRIES
LTD., et aI.,
Defendants.
---------------------------------------------------------J(
Plaintiffs Angela Bowdrie, Sharon Brow, John L. Brown, Leonard Brown, Bonnie
Brubaker, Gail Cambell, Ada Cobbs, Michelle Couser, Eva Douglass, Josephine Dyer, Carol
Groomes, Latoya Hill, Danielle Hyden, Lonita Jackson, Loretta Johnson, Reginald Kennard,
Dorothy Kind, Susie Lekich, Jan Loput, Annie Morrison, Timothy Nelson, Patricia Parsons,
Svetlana Polovets, Patricia Rocha, Ashley Smith, Yelonda Swearengin, Monte Tyson, and
Dorothy Young (collectively "Plaintiffs") filed this action in New York State Supreme Court,
Kings County on or about October 12, 2011 against Defendants Sun Pharmaceutical Industries,
Ltd. ("Sun Ltd."), Caraco Pharmaceutical Laboratories, Ltd. ("Caraco"), Sun Pharmaceutical
Industries, Inc. ("Sun Inc."), Sun Pharma Global, Inc. ("Sun Global"), Taro Pharmaceutical
Industries, Ltd. ("Taro Ltd."), and Taro Pharmaceuticals, U.S.A., Inc. ("Taro Inc."). Plaintiffs
filed an Amended Complaint on January 20, 2012. On February 21, 2012, Sun Inc. and Caraco
removed this action to the Eastern District of New York. See Docket Entry 1 (the "Notice of
Removal"). Neither Sun Global nor Taro Ltd. has appeared in this action.
The remaining
Defendants (collectively "Defendants") now move to dismiss the Amended Complaint pursuant
to Rules 8(a) and 12(b) of the Federal Rules of Civil Procedure. Plaintiffs oppose and move to
remand this action to New York State Supreme Court.
This Court denies the motion to remand by Plaintiffs, and grants the motion to dismiss by
Defendants in its entirety.
BACKGROUND
Pursuant to the Federal Food, Drug, and Cosmetics Act, 21 U.S.C. § 301 et seq. (the
"FDCA"), to secure the approval of the Food and Drug Administration ("FDA"), a manufacturer
of a new drug must file an application demonstrating the drug is safe, effective, and adequately
labeled. 21 U.S.C. § 355(b), (d); 21 C.F.R. § 314.1 et seq. The Drug Price Competition and
Patent Term Restoration Act, 98 Stat. 1585, (the "Hatch-Waxman Amendments") amended the
FDCA to permit generic drug manufacturers to bypass the approval practice by submitting an
"abbreviated new drug application" ("ANDA")-an application showing the proposed generic
drug to be the same as a reference listed drug ("RLD") that has already gained FDA approval.
21 U.S.C. § 3550)(2); 21 C.F.R. § 314.94. The generic must be bioequivalent to and have the
same labeling as the RLD. 21 U.S.C. § 355(j)(2)(iv), (v); 21 C.F.R. § 314.94(a)(7), (8).
,
Plaintiffs are all individuals or their decedents who allege they were injured after
ingesting generic Phenytoin ~odium ("Phenytoin"), an anti epileptic manufactured by
Defendants. Am. Compl., ~~ 9-38. Plaintiffs allege the Phenytoin they ingested differed from
the RLD-Dilantin-in terms of labeling and bioequivalence. Id. at ~~ 4,5,8,91-106,126-50,
159, 177-226. Plaintiffs allege it is recognized widely in the medical community that the side
effects of Phenytoin include what are collectively referred to as "severe cutaneous adverse
reactions," or SCAR events, which may result in "painful and debilitating tissue injury and loss,
2
epidermal blistering, necrosis, and sloughing." Id. at
~
18. Plaintiffs allege the makers of
Dilantin enhanced the warnings regarding SCAR events on their labeling and in a medication
guide in July 2009. Id. at
~
128. Plaintiffs allege Defendants failed to update their labeling to
mirror Dilantin's July 2009 revision and failed to implement the Dilantin medication guide. Id.
at
~~
130-49.
Plaintiffs allege the makers of Dilantin implemented changes in the
manufacturing process for that drug in 2007, after the FDA had granted Defendants' ANDAs for
Phenytoin. Id. at ~~ 91,95, 100-05. Plaintiffs allege Defendants failed to assure bioequivalence
to Dilantin following the changes in Dilantin's manufacturing process. Id. Plaintiffs allege they
experienced SCAR events as a result of the differences between the Phenytoin they consumed
and Dilantin, and plead the following causes of action under New York state law: (1) strict
product liability; (2) negligence; (3) fraud; (4) breach of implied warranties; (5) negligence per
se; and (6) wrongful death.
ANALYSIS
I. Wyeth v. Levine and PUva, Inc. v. Mensing
Two decisions of the United States Supreme Court, Wyeth v. Levine, 555 U.S. 555 (2009)
and Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) are at the forefront of all recent products
liability actions alleging inadequate warnings by drug manufacturers, including this one.
The plaintiff in Levine was injured when the intravenous form of Phenergan, an
antihistamine used to treat nausea, caused gangrene that ultimately required the amputation of
her right forearm. The plaintiff filed a products liability action in Vermont state court, alleging
the drug's labeling was defective because, although it warned of the danger of gangrene
following intra-arterial injection, it failed to instruct physicians to use the safer of two methods
of intra-arterial injection.
The trial judge instructed the jury that evidence of Wyeth's
3
compliance with FDA requirements did not establish the adequacy of the existing warnings, and
the jury found Wyeth liable for negligence and Phenergan defective as a result of inadequate
warnings. The Vermont Appellate and Supreme Courts affirmed.
The United States Supreme Court granted Wyeth's petition for certiorari to address, inter
alia, the issue of impossibility preemption. Wyeth argued it would have been impossible to
comply with its state law duty to warn without violating the FDCA and FDA regulations. The
Supreme Court rejected Wyeth's argument, finding Wyeth could have could have unilaterally
strengthened its warnings without prior FDA approval through the "changes being effected"
("CBE") process, 21 C.F.R. § 314.70(c)(6)(iii), which enables certain labeling changes to be
implemented simultaneous to submitting the changes to the FDA for review.
Two years later in Mensing, the Supreme Court decided two consolidated cases alleging
injuries based on manufacturers'
failure to provide adequate labeling for generic
metoclopramide, used to treat digestive tract problems. The RLD for generic metoclopramide is
Reglan, first approved for use by the FDA in 1980. Evidence shows that a percentage of longterm users of metoclopramide develop tardive dyskinesia, a neurological disorder. The plaintiffs
in the consolidated cases developed tardive dyskinesia after taking generic metoclopramide as
prescribed for several years beginning in 2001 and 2002, respectively. The manufacturer of
Reglan implemented FDA-approved labeling containing enhanced warnings for tardive
dyskinesia in 2004 and 2009. The plaintiffs alleged the generic manufacturers were liable under
state law for inadequate warnings. The Court of Appeals for the Fifth and Eight Circuits each
found the plaintiffs' state law claims were not preempted because means of enhancing warnings
were available to the generic manufacturers. Demahy v. Wyeth Inc., 593 F.3d 428 (5th Cir.
2010); Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009).
4
The Supreme Court reversed. The Supreme Court deferred to the FDA's interpretation of
its regulations that, under the Hatch-Waxman Amendments, the labeling of a generic drug must
be the same as the labeling of the RLD. Mensing, 131 S. Ct. at 2574-76; see 21 U.S.C. §
355G)(2)(A); 21 C.F.R. § 314.150(b)(10). That "ongoing federal duty of 'sameness'" precluded
manufacturers of generic drugs from unilaterally strengthening their labeling. Mensing, 131 S.
Ct. at 2575-82. Therefore, because the manufacturers could not simultaneously comply with
federal and state law, the Supreme Court held plaintiffs' state law claims were preempted.
II. Motion to Remand
Defendants contend Plaintiffs' allegations of: (1) violations by Defendants of federal law;
(2) violations by Defendants of the "federal duty of sameness;" and (3) Defendants' failure to
assure bioequivalence with the RLD subject this action to "arising under" jurisdiction. Notice of
Removal,
~~
3-22. Plaintiffs now move to remand this action to New York State Supreme
Court, Kings County. Because this Court possesses jurisdiction, the motion to remand is denied.
28 U.S.c. § 1331 vests the District Court with "original jurisdiction of all civil actions
arising under the Constitution, laws, or treaties of the United States." The question of whether a
claim or cause of action arises under federal law looks to the face of a well-pleaded complaint.
Franchise Tax Bd v. Constr. Laborers Vacation Trust, 463 U.S. 1, 9-10 (1983). In a state law
cause of action, federal question jurisdiction is proper only where "it appears that some
substantial, disputed question of federal law is a necessary element of one of the well-pleaded
state law claims." Id at 13; Grable & Sons Metal Prods., Inc. v. Darue Eng'g & Mfg., 545 U.S.
308, 312-14 (2005).
Plaintiffs argue their claims arise under New York state law, and resolving their claims
does not require the resolution of a substantial question of federal law. Pis.' Mem. of Law in
5
Supp. of Mot. to Remand, 2, 5-9. Plaintiffs submit the Amended Complaint implicates federal
law primarily in that it anticipates Defendants' affirmative defense of preemption. Id at 3-4;
Pis.' Reply Mem. in Supp. of Mot. to Remand, 1-2, 8-10. Citing Merrell Dow Pharmaceuticals
Inc. v. Thomson, 478 U.S. 804 (1986), Plaintiffs contend their use of the "federal duty of
sameness" as a standard in their state law causes of action is not sufficiently substantial to confer
federal question jurisdiction.
Defendants argue Plaintiffs' repeated invocation of the "ongoing federal duty of
sameness" implicates substantial federal issues irrespective of the fact the duty is pleaded in
conjunction with state law causes of action. Defs.' Mem. in Opp'n to Mot. to Remand, 1-2,811. Defendants argue federal jurisdiction is appropriate because resolving Plaintiffs' claims
necessarily implicates substantial and disputed federal issues. Id at 11-14.
A question of federal law is a necessary element of Plaintiffs' state law causes of action.
Plaintiffs allege Defendants failed to meet their ongoing duty of sameness by failing to utilize the
CBE process to update their FDA-approved labeling to mirror updated Dilantin labeling.
Therefore, Plaintiffs' claims fall in the small gap between Levine and Mensing. Indeed, the
boundaries of Plaintiffs' claims sounding in the ongoing federal duty of sameness are established
by the FDCA and the Hatch-Waxman Amendments.
Therefore, while Plaintiffs' causes of
action arise under state law, resolving them necessarily raises a federal question. Grable, 545
U.S. at 315; See W. 14th St. Commercial Corp. v. 5 W 14th Owners Corp., 815 F.2d 188, 19596 (2d Cir. 1987) (holding where the provisions of the Co-op Abuse Relief Act, 15 U.S.C. §
3607, give rise to a cloud on title, "the statute must necessarily be pleaded in a well-pleaded
action to remove that cloud").
6
The federal question in this case is substantial. In Merrell Dow, the issue presented to the
Court was solely "whether incorporation of a federal standard in a state-law private action, when
Congress has intended that there not be a federal private action for violations of that federal
standard, makes the action one 'arising under the Constitution, laws or treaties of the United
States.'" 478 U.S. at 805 (citing 28 U.S.C. § 1331). The Court found because Congress did not
intend to create a private cause of action under the FDCA, importing a standard from that statute
is not, by itself, sufficiently substantial to confer federal question jurisdiction. Merrell Dow, 478
U.S. at 813-14 (quoting Franchise Tax Ed., 463 U.S. at 20-21). However, the Court did not
foreclose the possibility that a state law cause of action utilizing a federal standard could raise a
substantial issue of federal law. Rather, the Court recognized the need for "principled, pragmatic
distinctions" and "careful judgments about the exercise of federal judicial power in an area of
uncertain jurisdiction." 478 U.S. at 814 (citing Franchise Tax Ed., 463 U.S. at 20-21); see also
W 14th St. Commercial Corp., 815 F.2d at 96 ("[A]ssuming that plaintiffs have no private right
of action under [the Co-op Abuse Relief Act], we conclude that the federal elements in plaintiffs'
state cause of action would still be sufficiently substantial to confer arising under jurisdiction.");
Virgin Islands Hous. Auth. v. Coastal Gen. Constr. Servo Corp., 27 F.3d 911, 917 (3d Cir. 1994)
("The nature of the federal interest at stake is determinative of whether it is sufficiently
substantial to displace state law."). In this case, the federal issue involved goes far beyond
simply incorporating a federal standard into a state law cause of action. To the extent they
invoke the "federal duty of sameness," Plaintiffs' causes of action implicate the labeling
requirements for generic drug manufacturers nationwide. The federal question present in this
case involves a responsibility that is in the first instance, and primarily, federal: regulation of the
manufacture, marketing, and distribution of drugs.
7
The federal question at issue here is a sufficiently substantial and necessary element of
Plaintiffs' state-law claims to confer original jurisdiction upon this Court pursuant to 28 U.S.C. §
1331. Having so found, we now turn to the merits.
III. Motion to Dismiss
Defendants move to dismiss the Amended Complaint.
Defendants argue Plaintiffs'
claims are preempted by the FDCA. Defendants further argue Plaintiffs have failed to plausibly
state a claim pursuant to Federal Rules of Civil Procedure 8(a) and 12(b)(6). This Court holds
Plaintiffs' failure to warn claims are preempted by federal law.
Furthermore, accepting all
factual allegations as true, this Court holds Plaintiffs have not stated a claim with respect to their
allegation that Defendants' Phenytoin was not bioequivalent to Dilantin.
a. Impossibility Preemption
The Supremacy Clause of the United States Constitution establishes federal law as the
"supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding." U.S. Const., Art. VI, cl. 2. State law is preempted "to the extent of
any conflict with a federal statute" irrespective of whether such conflict is express or implied.
Crosby v. Nat '[ Foreign Trade Council, 360 U.S. 363, 372 (2000). Impossibility preemption
occurs where it is "impossible for a private party to comply with both state and federal
requirements." Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1997).
Impossibility preemption, at issue here, formed the basis of the holding of the United
States Supreme Court in Mensing. The Supreme Court held the plaintiffs' state law failure to
warn claims were preempted because, under the FDCA and FDA regulations, generic drug
manufacturers could not unilaterally strengthen their warnings through the CBE process or
otherwise.
Mensing, 131 S. Ct. at 2575-82.
8
However, the Supreme Court left open the
possibility generic manufacturers may be able to use the CBE process in certain situations.
Specifically, it deferred to the FDA's interpretation that the CBE regulation, 21 C.F.R. §
314.70(c)(6)(iii), allows "changes to generic drug labels only when a generic drug manufacturer
changes its label to match an updated brand-name label or to follow the FDA's instruction."
Mensing, 131 S. Ct. at 2575.
Plaintiffs allege the manufacturer of Dilantin altered its labeling and issued a medication
guide to enhance warnings concerning SCAR events in July 2009 using the CBE process. Am.
Compl., ~~ 125-29; PIs.' Mem. in Opp'n to Mot. to Dismiss, at 7-8. Plaintiffs argue at that point
it became possible for Defendants to also utilize the CBE process to update their own labeling to
mirror Dilantin's labeling. PIs.' Mem. in Opp'n to Mot. to Dismiss, at 8, 13-18. Plaintiffs
contend "generic drug makers are permitted to conform their product labels to the labeling of
their Reference Listed Drug as soon as the RLD modifies its label using any permissible route of
revision." Id. at 8. Plaintiffs therefore argue their failure to warn claims are not preempted. Id.
at 13-18.
Plaintiffs attempt to circumvent the broad holding of Mensing by arguing Defendants'
obligation to update their labeling accrued before the FDA approved the Dilantin labeling that
drug's manufacturer unilaterally updated through the CBE process. However, their argument is
contrary to Mensing itself.
The Supreme Court found "[b]efore the [generic manufacturers]
could satisfy state law, the FDA-a federal agency-had to undertake special effort permitting
them to do so." Mensing, 131 S. Ct. 2580; see also id at 2580-81 ("To decide these cases, it is
enough to hold that when a party cannot satisfy its state duties without the Federal Government's
special permission and assistance ... that party cannot independently satisfy those state duties
for pre-emption purposes."). This Court will not construe "special effort" by the FDA to include
9
unilateral action by the manufacturer of Dilantin. That either FDA approval of RLD labeling, or
a specific FDA directive, is a necessary predicate to generic drug manufacturers' ability to
update labeling, including any medication guide, is consistent with the process by which FDA
approval of an ANDA is secured in the first instance. See 21 U.S.C. § 355(j)(2)(A)(v), (j)(4)(G);
21 C.F.R. §§ 314.94(a)(8), 314.127(a)(7); Mensing, 131 S. Ct. at 2575. Indeed, in deferring to
the FDA's interpretation of its regulations, the Supreme Court cited 21 U.S.C. § 355(j)(4)(G) and
21 C.F.R. § 314.94(a)(8), sections which specifically address initial approval of generic labeling
and require generics to conform to FDA-approved RLD labeling. Mensing, 131 S. Ct. at 2575.
In short, the preemption exception Plaintiffs seek to create is not supported by the law.
Several district courts have rendered decisions consistent with this Court's conclusion.
The courts in Fisher v. Pelstring, 817 F. Supp. 2d 791 (D.S.C. 2011) (Wooten, J.) and Cooper v.
Wyeth, Inc., No. 09-cv-929, 2012 WL 733846 (M.D. La. Mar. 6, 2012) (Brady, J.) each
addressed, inter alia, claims that the defendants, manufacturers of generic metoclopramide, did
not incorporate FDA-approved warnings used by the RLD, Reglan, into labeling for the drugs
plaintiffs alleged caused their injuries. 817 F. Supp. 2d at 804-05; 2012 WL 733846, at *3--4.
In each case, the Court found Mensing's conflict preemption analysis did not apply to any period
during which defendants failed to mirror FDA-approved Reglan labeling. 817 F. Supp. 2d at
805, 818-23; 2012 WL 733846, at *4. In Coney v. Mylan Pharms., Inc., the court held finding
the defendant, a manufacturer of generic Phenytoin, liable for "replicating, as required, the FDAapproved warnings used by Pfizer for Dilantin simply because a third party or the Federal
Government might bring about conditions that would enable Mylan to comply with both state
and federal law would eviscerate the supremacy clause." No. 6:11-cv-35, 2011 WL 170143, at
*5 (S.D. Ga. Jan. 19, 2012) (Edenfield, J.). See also Lyman v. Pfizer, Inc., No. 2:09-cv-262,
10
2012 WL 368675, at *5 (D.Vt Feb. 3, 2012) (Sessions, J.) (stating defendant was not only
permitted, but required to update generic drugs labeling to reflect changes to the RLD labeling
that were approved by the FDA).
To the extent Plaintiffs allege liability on the basis of a failure to warn, whether through a
medication guide or labeling, Plaintiffs' causes of action are preempted by federal law.
b. Bioeguivalence
Defendants' argument is twofold: (1) Plaintiffs allege Defendants failed to test for
bioequivalence, but they do not allege the generic Phenytoin was not actually bioequivalent; and
(2) Plaintiffs do not articulate how the alleged failure to test for bioequivalence contributed to
their injuries.
Defs.' Mem. in Supp. of Mot. to Dismiss, at 20-22.
Defendants contend
Plaintiffs' bioequivalence claims fail to state a plausible claim under Federal Rules of Civil
Procedure 8(a)(2) and 12(b)(6).
Plaintiff offers no argument in response. Rather, Plaintiff asserts "the vitality of the
bioequivalence ... [argument is] dependent on evidence that has not been finally secured by the
[Plaintiffs]. Thus, in the context of the present proceeding, [Plaintiffs] agree with [Defendants']
assertion that the gravamen of the [Amended Complaint] is the [Defendants'] alleged failure to
warn about certain risks associated with [Phenytoin]." PIs.' Mem. in Opp'n to Mot. to Dismiss,
at 6-7. Plaintiffs state they "do not raise the divergence on bioavailability as a case-specific
source of injury." Id., at 6 n.18. Because Plaintiffs raise no claim concerning bioavailability,
this Court assumes they intended to refer to bioequivalence. Nonetheless, Plaintiffs have not
opposed Defendants' arguments and have indicated they do not allege injuries resulting from the
claimed lack ofbioequivalence. The Court therefore has the discretion to deem Plaintiffs' claims
abandoned to the extent they relate to bioequivalence.
11
Metlife Investors USA Ins. Co. v.
Zeidman, 734 F. Supp. 2d 304, 313-14 (E.D.N.Y. 2010) (Spatt, J.); Lipton v. Cnty. a/Orange,
NY, 315 F. Supp. 2d 434,446 (S.D.N.Y. 2004) (Connor, J.).
Furthermore, Plaintiffs' bioequivalence claims do not meet the pleading standard of Rule
8(a). A complaint "attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual
allegations, [but] a plaintiffs obligation to provide the 'grounds' of his 'entitlement to relief
requires more than labels and conclusions, and a formulaic recitation of the elements of a cause
of action will not do." Bell Atl. Corp. v. Twombly, 550 U.S. 544,555 (2007) (citations omitted).
A plaintiff must state a claim that is not merely conceivable, but plausible on its face. Id. at 570.
"A claim has facial plausibility when the plaintiff pleads factual content that allows the court to
draw the reasonable inference that the defendant is liable for the misconduct alleged. Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009). Facial plausibility is not a probability standard, but "asks for
more than a sheer possibility that the defendant" has acted in the manner alleged. /d.
Plaintiffs fail to plead sufficient facts to state a claim concerning bioequivalence that is
plausible on its face. The basis upon which Plaintiffs' bioequivalence claims rest is an alleged
change in the process used to manufacture Dilantin undertaken by its manufacturer after
Defendants' Phenytoin had been approved by the FDA. However, bioequivalence is not an
inquiry into manufacturing processes. Rather, bioequivalence means the
(i) the rate and extent of absorption of the drug do not show a
significant difference from the rate and extent of absorption of the
listed drug when administered at the same molar dose of the
therapeutic ingredient under similar experimental conditions in
either a single dose or multiple doses; or
(ii) the extent of absorption of the drug does not show a significant
difference from the extent of absorption of the listed drug when
administered at the same molar dose of the therapeutic ingredient
under similar experimental conditions in either a single dose or
multiple doses and the difference from the listed drug in the rate of
absorption of the drug is intentional, is reflected in its proposed
labeling, is not essential to the attainment of effective body drug
12
concentrations on chronic use, and is considered medically
insignificant for the drug.
21 U.S.C. § 355 G)(S)(i) & (ii); see also 21 C.F.R. § 320.1 (Bioequivalence means the "absence
of a significant difference in the rate and extent to which the active ingredient or active moiety in
pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug
action when administered at the same molar dose under similar conditions in an appropriately
designed study."); c.f 21 C.F.R. § 314.94 (a)(9). Plaintiffs do not plead facts that would permit
this Court to infer the alleged change to Dilantin's manufacturing process either led to a
significant difference between the rate and extent of absorption of Dilantin and generic
Phenytoin, or that such difference caused Plaintiffs' injuries. Plaintiffs' conclusory claim that
Defendants failed to test for bioequivalence is no different, particularly in light of their curious
comment that bioequivalence is raised only "as a factor that disqualifies [Defendants] from
claiming they are entitled to rely on" impossibility preemption. PIs.' Mem. in Opp'n to Mot. to
Dismiss, 6 n.S.
Indeed, that Plaintiffs concede they do not possess facts to support their
bioequivalence claim furthers the conclusion that their claim is merely speculative, and nothing
in the prolix and circuitous Amended Complaint leads this Court to believe discovery will lead to
relevant evidence. Twombly, 550 U.S. at 556. Rule S is exceptionally permissive, but Plaintiffs
cannot simply throw unfounded allegations at Defendants and hope that some will stick. The
sheer possibility that a change in the process used to manufacture Dilantin caused a failure in the
bioequivalence of Defendants' Phenytoin is insufficient to state a claim. Iqbal, 556 U.S. at 67S.
Therefore, Plaintiffs' claims are dismissed to the extent they concern bioequivalence.
c. The Court must dismiss the Amended Complaint in its entirety
13
Plaintiffs plead seven New York state law claims on the dual theories that Defendants
failed to adequately warn of the risks of SCAR events, and failed to maintain bioequivalence
between the generic drugs they produced and Dilantin. Plaintiffs' claims are preempted to the
extent they allege a failure to warn. Plaintiffs have abandoned their claims to the extent they
concern bioequivalence. Even if they had not, Plaintiffs fail to state a plausible claim concerning
bioequivalence.
i. Strict Product Liability
Plaintiffs' first claim alleges strict product liability. Am. CompI., ,-r,-r 176-93. The strict
liability claim is broken into two parts. The first part alleges "the [Phenytoin] product label was
inadequate in that it was not revised in a timely manner to reflect additional, new safety
information that was contained in the product label for Dilantin" and because "it was not revised
in a timely manner to include a 'Medication Guide' ... even though a 'Medication Guide' was
distributed with the brand product, Dilantin." Id. at ,-r,-r 180-81. Plaintiffs allege Dilantin's 2009
labeling updates were implemented under the CBE process and therefore not approved at the
time of their implementation. Id. at,-r,-r 128-35; PIs.' Mem. in Opp'n to Mot. to Dismiss, at 8,
13-18. To comply with its state law duty to warn, Defendants would have to violate federal law.
Therefore, the first part of Plaintiffs' strict liability claim is therefore dismissed as preempted.
The second part of Plaintiffs' strict liability claim alleges the Phenytoin manufactured by
Defendants was defective because it was not "shown to be bioequivalent to, and therefore
identical to," Dilantin. Am. CompI., ,-r 189. Plaintiffs have not stated a plausible cause of action
concerning bioequivalence. See § III.b, supra. Plaintiffs plead no facts that would enable this
Court to reasonably infer Defendants are liable.
14
Rather, Plaintiffs' claim
IS,
m essence, a
"formulaic recitation of the elements of [the] cause of action." Twombly, 550 U.S. at 555.
Plaintiffs' strict liability claim is dismissed in its entirety.
ii. Negligence
Plaintiffs' second claim alleges Defendants were negligent for failing to update their
Phenytoin labeling, failing to distribute a medication guide, and failing to ensure bioequivalence.
Am. Compl., ,-r,-r 194-201. Plaintiffs again plead no facts to support their allegations concerning
bioequivalence. Accordingly, Plaintiffs' negligence claim is dismissed as preempted and for
failing to state a plausible claim.
iii. Fraud
Plaintiffs' third claim alleges common law fraud. Id. at ,-r,-r 202-09. Plaintiffs allege
"Defendants' fraudulent misrepresentations intentionally concealed [their failure] to conduct the
necessary and appropriate tests to assure the ongoing bioequivalence of their phenytoin
products" after the manufacturer of Dilantin allegedly underwent a manufacturing change in
2007. Id. at,-r 206(a). As an initial matter, Plaintiffs have alleged no specific misrepresentation
or omission and their claims are therefore subject to dismissal under the heightened pleading
standards of Rule 9(b). More importantly, for the reasons stated above, simply because Plaintiffs
have alleged a manufacturing change for Dilantin does not render their bioequivalence claims
viable. Nor does the sheer possibility that Plaintiffs failed to test for bioequivalence or that the
Phenytoin Plaintiffs' consumed was not, in fact, bioequivalent satisfy the pleading requirements
of Rule 8(a).
Plaintiffs also allege "Defendants' fraudulent misrepresentations intentionally concealed
[their failure] to revise their product labels to reflect the labeling changes and to include the
Medication Guide" implemented by the manufacturer of Dilantin in July 2009. Id. at,-r 206(b).
15
Plaintiffs again fail to point to a single misrepresentation or omission. Regardless, Plaintiffs'
claims concerning labeling are preempted under Mensing. Plaintiffs' fraud claim is dismissed as
preempted and for failing to state a plausible claim.
iv. Breach of Implied Warranties
Plaintiffs' fourth claim alleges the Phenytoin they consumed was not safe, fit for its
intended use, or of a merchantable quality, "as warranted by [Defendants], in that [the
Phenytoin] failed to include the revised 2009 warning that had been implemented by the RLD[.]
Further, the products in question failed to include the Medication Guide, thereby rendering them
unmerchantable." Am. Compl.,
~
213. However, federal law forbids Defendants from adopting
Dilantin labeling that had not received FDA approval. Therefore, Plaintiffs' breach of implied
warranties claim, in essence a failure to warn claim, is preempted under Mensing.
Plaintiffs also allege the Phenytoin was not safe or fit for its intended use because
Defendants failed to comply with their federal duty of sameness with respect to bioequivalence.
Id. at
~
214.
Plaintiffs allege "when the manufacturing process for [Dilantin] was revised,
[Defendants] were no longer capable of warranting that their generic phenytoin products were of
merchantable quality and safe and fit for the use for which [Phenytoin] was intended." Id.
Plaintiffs plead no factual support for their allegations, and neither allege any basis upon which
this Court could infer a connection between an alleged manufacturing change and
.bioequivalence, nor allege that any such deficiency caused their injuries. Plaintiffs' allegations
raise no more than a "sheer possibility" that Defendants' Phenytoin was unsafe, unfit for its
ordinary use, or merchantable. Iqbal, 556 U.S. at 678. Plaintiffs' claim for breach of implied
warranties is dismissed as preempted and for failing to state a plausible claim.
16
v. Negligence Per Se
Plaintiffs' fifth claim alleges negligence per se. Am. CompI.,
~~
215-18. Plaintiffs base
their claim on alleged violations by the Defendants of federal and state food and drug laws. Id.
at
~
217. Plaintiffs allege Defendants violated the law by failing to update their labeling for
Phenytoin, and by failing to monitor and test for bioequivalence with the RLD. Id. Plaintiffs'
bioequivalence allegations again contain no factual support, much less the bare minimum
required by Rule 8(a). Plaintiffs' negligence per se claim is therefore dismissed as preempted
and for failing to state a plausible claim.
vi. Punitive Damages and Wrongful Death
Plaintiffs' punitive damages and wrongful death claims must be dismissed. Neither claim
supplies an independent basis of recovery. Am. CompI.,
~~
219-33. Furthermore, the claims
upon which each depends are preempted under Mensing. Plaintiffs' claim for punitive damages
simply rehashes their failure to warn theory. Id. at
~~
219-27. Plaintiffs' wrongful death claim
conclusorily states certain Plaintiffs died as a result of exposure to Phenytoin, and Defendants
therefore are liable to the decedents' estates. Id. at ~~ 229-33. However, the New York Court of
Appeals has clearly stated a wrongful death claim belongs to the decedent's distributes, not the
estate of the decedent. Cragg v. Allstate Indem. Corp., 17 N.y'3d 118, 121 (2011). Moreover, a
wrongful death action is intended to compensate the decedent's distributes for their pecuniary
losses arising from a defendant's wrongful act. Id. Here, the only wrongful acts Plaintiffs allege
that could provide a basis of liability against the Defendants are dismissed as preempted or for a
failure to state a plausible claim.
17
CONCLUSION
Each New York state law claim Plaintiffs plead in this action depend on their allegations
that Defendant failed to adequately warn of the risk of SCAR events, and failed to test for and
maintain bioequivalence with the Dilantin. Plaintiffs' failure to warn claims are preempted by
federal law. Plaintiffs have both abandoned their bioequivalence claims, and, also failed to state
a cause of action premised upon their bioequivalence claims.
Therefore, the Amended
Complaint is dismissed in its entirety.
SO ORDERED
Dated: Brooklyn, New York
November 9,2012
s/WFK
HON. WILLIA
18
,II
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