MOLNAR et al v. MERCK & CO., INC.

Filing 469

MEMORANDUM OPINION filed. Signed by Judge Joel A. Pisano on 1/17/2012. (eaj)

NOT FOR PUBLICATION
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IN RE: FOSAMAX (ALENDRONATE SODIUM) :
PRODUCTS LIABILITY LITIGATION (NO. II)
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RELATES TO ALL ACTIONS
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MDL No. 2243
(JAP-LHG)
MEMORANDUM OPINION

PISANO, Judge
Presently before the Court is Defendants’ Watson Pharmaceuticals, Inc. and Watson
Laboratories, Inc. (collectively “Watson”) Motion for Judgment on the Pleadings seeking
dismissal from this MDL pursuant to the Supreme Court’s decision in PLIVA v. Mensing, 131 S.
Ct. 2567 (2011). (DE 250.) Plaintiffs opposed the motion. (DE 296.) On January 12, 2012, the
Court held oral argument on Watson’s motion. For the reasons that follow, the Court will grant
the motion and dismiss Watson from the case.
I.

BACKGROUND
The MDL is a series of products liability suits concerning Fosamax, a drug prescribed for

the treatment and prevention of osteoporosis and Paget’s disease. Plaintiffs in these cases
brought claims in various courts and venues against both the manufacturer of Fosamax, Merck &
Co., Inc. (“Merck”), and against manufacturers of generic Fosamax. Plaintiffs’ claims emanated
from a general theory of failure to warn, but also included claims based upon various state law
products liability theories, including, inter alia, defective design, negligence, fraud,
misrepresentation, breach of express and implied warranties, violation of consumer protection
statutes, restitution, and loss of consortium. On May 25, 2011, the United States Judicial Panel

on Multidistrict Litigation centralized all actions for coordinated and consolidated pretrial
proceedings in the District of New Jersey. (DE 30.)
Watson is named as a defendant in seven (7) cases currently pending in this MDL.1 In
one of those cases, Welch v. Merck, Sharp & Dohme Corp et al. (“Welch”), Plaintiffs named
Watson to the group of “Generic Defendants” who they allege manufactured, promoted, and sold
generic Fosamax (alendronate sodium). (Welch Compl. ¶¶ 15, 18.) In a later paragraph,
however, the Welch complaint states the following: “Defendant Watson was what is known as
the authorized distributor of branded Fosamax. Upon information and belief, under the
agreement between Merck and Watson, Merck manufactured and supplied alendronate and
Watson marketed and sold the drug under branded name Fosamax.” (Welch Compl. ¶ 109.)
None of the other six complaints naming Watson as a defendant make this allegation.
On October 3, 2011, Defendants Teva Pharmaceuticals USA, Inc., Barr Pharmaceuticals,
LLC, Barr Laboratories, Inc., Mylan, Inc., Mylan Pharmaceuticals, Inc., Apotex Corporation,
Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharmaceuticals Inc. on
behalf of and formally known as Cobalt Pharmaceuticals Company, and Sun Pharmaceuticals
(collectively, the “Generic Defendants”) filed a motion for judgment on the pleadings, arguing
that Plaintiffs’ claims were preempted based upon the Supreme Court’s recent decision in PLIVA
v. Mensing, 131 S. Ct. 2567 (2011). Plaintiffs opposed the motion.
On November 14, 2011, Chief Judge Garrett E. Brown denied Watson’s motion for
judgment on the pleadings. (See DE 344, 345.) That decision was based on the statement in the
Welch complaint that alleged that Watson was an authorized distributor of branded Fosamax.

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Eastwood v. Merck, Sharp & Dohme Corp., 3:11-cv-05188; Marks v. Merck & Co, Inc., 3:11-cv-05079; Hardy v.
Merck & Co, Inc., 3:11-cv-5077; Murphy v. Merck & Co. Inc., 3:11-cv-5082; Naccio v. Merck, Sharp & Dohme
Corp., 3:11-cv-4055; Brown v. Merck & Co. Inc., 3:11-cv-3867; and Welch v. Merck, Sharp & Dohme Corp., 3:11cv-03045.

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Chief Judge Brown found that he could not “rule as a matter of law that Watson is a generic”
manufacturer because he was required to take the Plaintiffs’ allegations as true for purposes of
the motion. (11/14/11 tr. 12: 25–13:2.)
On November 28, 2011, Watson moved for reconsideration and clarification of Chief
Judge Brown’s decision. On December 23, 2011, the Court granted in part Watson’s Motion for
Reconsideration and Clarification as it related to the denial of Watson’s motion for judgment on
the pleadings, and the Court vacated the Order entered on November 14, 2011 to the extent it
denied Watson’s motion for judgment on the pleadings. The Court reopened the record for oral
argument on January 12, 2012.
II.

STANDARD OF REVIEW
Rule 12(c) of the Federal Rules of Civil Procedure allows a party to move for judgment

on the pleadings “after the pleadings are closed but within such time as not to delay trial . . .”
Fed. R. Civ. P. 12(c). The applicable standard on a motion for judgment on the pleadings is
materially the same standard applied on a motion to dismiss pursuant to Rule 12(b)(6). Spruill v.
Gillis, 372 F.3d 218, 223 n.2 (3d Cir. 2004). In reviewing a motion made pursuant to Rule 12(c),
a court must take all allegations in the complaint as true, viewed in the light most favorable to
the plaintiff. Gomez v. Toledo, 446 U.S. 635, 636 n.3, (1980); Robb v. City of Philadelphia, 733
F.2d 286, 287 (3d Cir. 1984). Under Rule 12(c), “judgment will not be granted unless the
movant clearly establishes that no material issue of fact remains to be resolved and that he is
entitled to judgment as a matter of law.” Jablonski v. Pan American World Airways, Inc., 863
F.2d 289, 290 (3d Cir. 1988) (citation omitted).

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III.

DISCUSSION
Watson asserts that it is entitled to judgment on the pleadings because Plaintiffs’ state tort

claims are preempted by federal law. The Supremacy Clause states that federal law “shall be the
supreme Law of the Land . . . and any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. Implied preemption, the type of
preemption at issue in this motion, occurs when it is “impossible for a private party to comply
with both state and federal requirements.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287
(1995). In other words, when state law requires what federal law forbids, state law must give
way. See Wyeth v. Levine, 555 U.S. 555, 583 (2009).
In PLIVA v. Mensing, the Supreme Court ruled plaintiffs’ state failure-to-warn claims
against several generic manufacturers of the drug metoclopramide were preempted by the federal
Food, Drug and Cosmetic Act (FDCA). Mensing, 131 S. Ct. at 2573. The state tort laws
applicable in the case required manufacturers that are “or should be aware of [their] product’s
danger to label that product in a way that renders it reasonably safe.” Id. at 2573. But the Court
found that generic manufacturers have, under the FDCA, a federal duty of “sameness” to ensure
that the label for the generic drug is identical to the label adorning the corresponding branded or
reference-listed drug. Id. at 2575. Generic manufacturers have no means for unilaterally
changing the labeling of their generic products. Id. Changes of generic labeling required action
by either the reference-listed drug manufacturer and/or the FDA. Id. at 2576-78.
Accordingly, the Court held “that when a party cannot satisfy its state duties without the
Federal Government’s special permission and assistance, which is dependent on the judgment by
a federal agency, that party cannot independently satisfy those state duties for pre-emption
purposes.” Id. at 2581. As a result, the Mensing plaintiffs’ state failure-to-warn claims were

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preempted “because it was impossible for the Manufacturers to comply with both their state-law
duty to change the label and their federal law duty to keep the label the same.” Id. at 2587.
The Mensing decision, however, does not apply to brand manufacturers. In Wyeth v.
Levine, 555 U.S. 555 (2009), the Supreme Court held that a patient’s state law failure-to-warn
claim against a brand drug manufacturer is not preempted by federal law. Unlike a generic
manufacturer, a brand manufacturer may “unilaterally strengthen its warning.” Id. at 573.
Consequently, a brand manufacturer can simultaneously comply with both state and federal law.
Here, it is important to highlight the distinction created by the Supreme Court between
generic and brand manufacturers. Watson claims it is a generic manufacturer, requiring its
dismissal under Mensing. But Plaintiffs assert that Watson is not a generic manufacturer because
it contracted with Merck to distribute branded Fosamax. As a result, Plaintiffs allege that
Watson stands in the shoes of Merck and has the ability to change the Fosamax labeling. If this
is the case, Wyeth applies to prevent Watson’s dismissal from the MDL.
Plaintiffs’ argument fails as a matter of law for two reasons. First, the Plaintiffs in
Naccio, Brown, Hardy, Murphy, Marks, and Eastwood do not allege that there was an agreement
between Watson and Merck that allowed Watson to distribute branded Fosamax. In other words,
those Plaintiffs did not make the claim that formed the basis of the November 14, 2011 decision
to deny Watson’s motion to dismiss. Therefore, Watson is entitled to dismissal from those cases
because, as a generic manufacturer, the Plaintiffs’ state law claims against Watson are preempted
under Mensing.
Second, even if the Plaintiffs in the Naccio, Brown, Hardy, Murphy, Marks, and
Eastwood cases made the allegation found in Welch—that Watson was an authorized distributor
of Fosamax—Watson would still be entitled to judgment on the pleadings and dismissal from the

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MDL. As a distributor of Fosamax, Watson has no power to change Fosamax labeling. That
power lies with the applicant who filed the New Drug Application (NDA) seeking approval to
market Fosamax. See 21 U.S.C. 355(b); 21 C.F.R. 314.70 (describing the Changes Being
Effected or “CBE” regulation, which requires that “the applicant must notify FDA about each
change in each condition established in an approved application.”) (emphasis added). In this
case, Merck is the NDA applicant with the corresponding authority to change labeling.
Additionally, if FDA had “become aware of new safety information” in connection with
Fosamax use that “it believe[d] should be included in the labeling,” FDA must notify the holder
of the NDA to initiate the changes. 21 U.S.C. 355(o)(4)(A). Neither of these procedures
involves a distributor.
As a result of the scheme set forth by the FDCA, Watson has no authority to initiate a
labeling change of Fosamax. That authority lies with the FDA and/or with Merck. Even taking
the allegation in Welch as true, a contractual relationship between Watson and Merck cannot
change the fact that Watson is not the NDA holder. Consequently, Watson has no power to
unilaterally change Fosamax labeling. Because Watson could not “independently do under
federal law what state law requires of it,” the state law claims brought against it are preempted.
Mensing, 131 S. Ct. at 2579.
III.

CONCLUSION
For the reasons above, Watson’s motion for judgment on the pleadings is granted. An

appropriate Order will follow.

Date: January 17, 2012

/S/ JOEL A. PISANO
United States District Judge

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