James C H et al v. Mylan Inc et al
DECISION AND ORDER Granting Partial Motion to Dismiss 6 signed by Judge Charles N Clevert, Jr on 11/13/12. (cc: all counsel) ((cef), C. N. Clevert, Jr.)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF WISCONSIN
JAMES C H, a minor,
DIAMOND A H, a minor,
ESTATE OF JAMES HAYDEN,
by Karen Marie Hayden-Jefferson
as Administrator for the Estate,
Case No. 12-C-0772
MYLAN PHARMACEUTICALS INC.,
DECISION AND ORDER GRANTING PARTIAL MOTION TO DISMISS (DOC. 6)
On August 3, 2012, defendants filed a partial motion to dismiss pursuant to Federal
Rule of Civil Procedure 12(b)(6). Plaintiffs allege that James Hayden died as a result of
using a defective 100 mcg fentanyl patch for chronic pain. On the other hand, defendants
assert that plaintiffs’ strict liability/marketing defect (count one), negligent marketing (count
two), negligent misrepresentation (count three), fraud (count four), and failure to warn
(count five) claims are preempted by the United States Supreme Court’s ruling in PLIVA
v. Mensing, 131 S. Ct. 2567 (2011). In addition, any claim that the defendants failed to
inform the FDA, withheld information from the FDA, or otherwise committed fraud on the
FDA, are impliedly preempted by federal law as set forth in Buckman Co. v. Plaintiff’s Legal
Committee, 531 U.S. 341 348 (2001). In lieu of a response, plaintiff filed a proposed
stipulation of the failure to warn claims and the state law fraud on the FDA claims. For the
reasons set forth below, defendants’ partial motion to dismiss will be granted.
The Supremacy Clause provides that “the Laws of the United States ... shall be the
supreme Law of the Land....” U.S. Const. art. VI, cl. 2. Preemption is the application of the
Supremacy Clause, resulting in the rule that “any state law that conflicts with federal law
is without effect.” Cippolone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992) (internal
citations omitted). Express preemption occurs when Congress preempts state law by so
stating in express terms. Hillsborough County v. Automated Med. Labs., Inc., 471 U.S.
707, 712 (1985). Implied preemption occurs upon an inference that the state law is
preempted. Id. A court will find implied preemption “where it is impossible for a private
party to comply with both state and federal law, and where under the circumstances of a
particular case, the challenged state law stands as an obstacle to the accomplishment and
execution of the full purposes and objections of Congress.” Crosby v. Nat. Foreign Trade
Council, 530 U.S. 363, 372–73 (2000).
In PLIVA, the Supreme Court found that the FDCA preempts failure-to-warn claims
against generic drug manufacturers. Generic drug manufacturers, unlike brand-name
manufacturers, cannot unilaterally change their labels, 21 C.F.R. § 314.94(a)(8)(iv) (2011),
and thus cannot comply with federal labeling standards and state law requirements
deviating from those standards. PLIVA, 131 S. Ct. at 2578.
Although not alleged in the complaint, plaintiffs do not dispute that the Mylan Fetanyl
Transdermal System is a generic product approved by the FDA as the bioequivalent to
Duragesic pursuant to the Abbreviate New Drug Application. Based on the clear language
of Pliva, the plaintiffs concede that the failure to warn claims are subject to dismissal. In
addition, any state law fraud-on-the-FDA claims conflict with the medical device
amendments to the Federal Food Drug and Cosmetic Act. Buckman Co., 531 U.S. at 350352. Consequently,
IT IS ORDERED that counts defendants’ partial motion to dismiss is granted.
IT IS FURTHER ORDERED that the marketing defect claim asserted in count one
(paragraph 28) is dismissed.
IT IS FURTHER ORDERED that the negligent failure to warn claims asserted in
count two (paragraphs 33(a), (n), and (q)) are dismissed.
IT IS FURTHER ORDERED that the negligent misrepresentation claim asserted in
count three is dismissed.
IT IS FURTHER ORDERED that the fraud claim asserted in count four is dismissed.
IT IS FURTHER ORDERED that the failure to warn claim asserted in count five is
IT IS FURTHER ORDERED that the punitive damages claim asserted in count six
is dismissed to the extent it is predicated on a fraud and/or failure to warn theory.
Dated at Milwaukee, Wisconsin, this 13th day of November, 2012.
BY THE COURT
/s/ C. N. Clevert, Jr.
C. N. CLEVERT, JR.
U. S. DISTRICT JUDGE