NOT FOR PUBLICATION 

___________________________________________ 

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IN RE: FOSAMAX (ALENDRONATE SODIUM) : MDL No. 2243 

PRODUCTS LIABILITY LITIGATION (NO. II) : (JAP-LHG) 

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 : MEMORANDUM OPINION 

RELATES TO ALL ACTIONS : 

 : 

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 

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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. 

                                                           

1 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., 3:11-

cv-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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