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In re Fosamax Products Liability Litigation

United States District Court, Second Circuit

December 18, 2013

IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION
v.
Merck, Sharpe & Dohme Corp., et al., No. 12 Civ. 7167 (JFK). This document relates to: Sylvia Clarke and Kenny Clarke Theresa Marcone
v.
Merck, Sharpe & Dohme Corp., et al., No. 11 Civ. 5174 (JFK). Victoria Miller
v.
Merck, Sharpe & Dohme Corp., et al., No. 11 Civ. 5393 (JFK). Essie Small
v.
Merck, Sharpe & Dohme Corp., et al., No. 11 Civ. 5152 (JFK). Raymond Smith
v.
Merck, Sharpe & Dohme Corp., et al., No. 11 Civ. 5178 (JFK)

Brandon Bogle, LEVIN, PAPANTONIO, THOMAS, MITCHELL, RAFFERTY & PROCTOR, P.A., FOR PLAINTIFFS.

Carla Rose Karp, GOODWIN PROCTER, LLP, FOR TEVA PHARMACEUTICALS USA, INC.

OPINION & ORDER

JOHN F. KEENAN, District Judge.

Defendant Teva Pharmaceuticals USA, Inc. has moved in the above-captioned cases for a more definite statement pursuant to Rule 12(e) of the Federal Rules of Civil Procedure. For the reasons that follow, the motion is granted in part and denied in part.

I. Background

This MDL involves claims that the drug Fosamax or its generic equivalent, alendronate sodium, caused users to suffer from a condition known as osteonecrosis of the jaw ("ONJ"). Plaintiffs have asserted claims against Merck, the maker of Fosamax, and against various manufacturers of the generic alendronate sodium (the "Generic Defendants").

Generic Defendants have previously moved for judgment on the pleadings under Federal Rule of Civil Procedure 12(c), asserting that federal law preempted Plaintiffs' state law tort claims in light of the Supreme Court's decisions in PLIVA, Inc. v. Mensing , 131 S.Ct. 2567 (2011) and Mutual Pharmaceutical Co. v. Bartlett , 133 S.Ct. 2466 (2013). The Generic Defendants alternatively argued that the claims were inadequately pleaded. The parties briefed the motion last fall, and then submitted supplemental briefing this past summer to address the Supreme Court's Bartlett decision.

In an August 14, 2013 Opinion, this Court concluded that Plaintiffs' design defect and failure to warn claims are preempted by federal law, with the exception of the theory that the Generic Defendants failed to timely update their alendronate sodium labels after Merck updated its Fosamax label in March 2010. In re Fosamax Prods. Liab. Litig., ___ F.Supp.2d ____, 2013 WL 4306434, at *3-7 (S.D.N.Y. 2013). As to that theory, the Court ruled that "plaintiffs have adequately pleaded that some Generic Defendants' delay in updating their labels was unreasonable." Id. at *3.

The Generic Defendants then sought to move for a more definite statement under Rule 12(e). To resolve a dispute among the parties about the timing and propriety of the contemplated motion, this Court issued a one-page Order on August 29, 2013, which stated in pertinent part:

The PSC correctly points out that Federal Rule of Civil Procedure 12(g)(2) precludes the Generic Defendants from making a Rule 12 motion that was available to them at the time they made their motion under Rule 12(c). Generic Defendants have represented, however, that the motion was not available to them at the time of their Rule 12(c) motion. Without resolving the issue of whether a motion for a more definite statement of fact is barred under Rule 12(g)(2), and noting that it may in fact have merit, the Court will give Generic Defendants the benefit of the doubt and would entertain a timely Rule 12(e) motion.

(ECF No. 1464.)

Teva Pharmaceuticals has now filed the instant Rule 12(e) motion. Teva states that the complaints in the five cases at issue do not assert any allegations against it for failure to update its alendronate sodium label following the FDA's approval of the Fosamax label change. Teva argues that it therefore cannot answer the complaint without prejudicing itself, and that it should not be forced to answer the preempted (and therefore invalid) claims. Teva also purports to reserve its right to bring a Rule 12(b)(6) motion. (Teva Br. at 2-3 n.2.)

Plaintiffs oppose the motion on two grounds. First, they assert that Teva has waived its opportunity to file a Rule 12(e) motion by not making the motion sooner. Second, Plaintiffs argue that even if the motion is properly before the Court, it should fail as a substantive matter because the ...


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