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In re Fosamax Products Liability Litigation

March 29, 2010

IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION
THIS DOCUMENT RELATES TO:
SHIRLEY BOLES
v.
MERCK & CO., INC.



The opinion of the court was delivered by: John F. Keenan, United States District Judge

OPINION & ORDER

This action was the first taken to trial in this multi-district products liability litigation concerning Defendant Merck Sharp & Dohme Corporation's ("Merck or "Defendant") prescription osteoporosis drug Fosamax. Following a lengthy trial, the jury could not reach a verdict and the Court declared a mistrial. Before the Court is Merck's post-trial motion for judgment as a matter of law under Rule 50(b) of the Federal Rules of Civil Procedure. For the reasons that follow, the motion is granted in part.

I. BACKGROUND

Fosamax is an oral bisphosphonate manufactured by Merck for the treatment and prevention of osteoporosis.*fn1

Plaintiff Shirley Boles ("Boles" or "Plaintiff") is a Florida resident who alleges that she developed osteonecrosis of the jaw ("ONJ") as a result of taking Fosamax for nearly eight years. She first was prescribed the drug in July 1997 by Dr. James Mills ("Dr. Mills"), a board-certified obstetrician and gynecologist. At that time, the T-score - a measure of bone mineral density - of Ms. Boles's hip was -2.1, meaning that the density of her hip bone was 2.1 standard deviations below that of an average female adult. There appears to have been several definitions of osteoporosis promulgated over time by different medical organizations, the precise boundaries of which are not relevant to the instant motion. At the time Dr. Mills prescribed Fosamax to Boles, the drug was indicated for use by patients with a T-score of -2.0 or worse.

According to Plaintiff's medical records, she began having jaw complications following a tooth extraction in August 2002. Standard treatment methods were ineffective, and Plaintiff's condition persisted and gradually worsened. In late 2005, Plaintiff's medical records show that her condition deteriorated to the point where she had exposed necrotic bone in her jaw. Based on these records, Plaintiff's expert on causation, Dr. John Hellstein ("Dr. Hellstein"), testified that he believes that Plaintiff's use of Fosamax caused her to develop stage zero ONJ in August 2002, which eventually developed over time to become stage three ONJ.

Plaintiff began the trial with claims of strict product liability and negligence rooted in theories of failure to warn and design defect, and fraudulent misrepresentation and concealment.*fn2 Florida law governs these claims. Plaintiff's evidence at trial followed a few common themes. Plaintiff sought to prove that the benefits of Fosamax were overstated, in that certain reports and studies purportedly show that FosamaX (1) is ineffective in the first 18 months of use and again after 36 months of use, and (2) provides no benefit to patients, like Plaintiff, with a T-score better than -2.5. Plaintiff also attempted to prove that Merck had long known, but failed to warn, of studies and reports linking bisphosphonate use with the development of ONJ.

Merck twice moved for judgment as a matter of law during trial pursuant to Rule 50(a): on August 21, 2009, at the close of Plaintiff's case, and on August 31, 2009, after both sides rested. The Court dismissed the fraudulent misrepresentation and concealment claims after the close of evidence, finding that a reasonable jury could not find that Merck intentionally misrepresented or concealed the risk of ONJ before the date of Plaintiff's injury. (Trial Tr. at 2359-60.) Merck's motion for judgment as a matter of law was denied with respect to Plaintiff's other claims. The jury informed the Court after several days of deliberation that it was deadlocked and could not reach a verdict on any of Plaintiff's remaining claims. As a result, the Court declared a mistrial on September 11, 2009.

II. DISCUSSION

Merck timely filed the instant motion on September 25, 2009. It contends that it is entitled to judgment as a matter of law because Plaintiff failed to introduce evidence on critical elements of her strict liability and negligence claims. Specifically, Merck argues that (1) all of Plaintiff's claims fail because she has not submitted evidence to show she developed ONJ prior to October 1, 2003; (2) it is entitled to judgment as a matter of law on Plaintiff's failure to warn claims because, among other things, there was no evidence introduced at trial to support proximate causation; and (3) no reasonable jury could have found for Plaintiff on her design defect claims because there was no evidence at trial that Fosamax is unreasonably dangerous or that Merck breached any duty of care as to render it liable under Plaintiff's negligent design claim.

A. Rule 50

"Under Rule 50(a), a party may move for judgment as a matter of law during trial at any time prior to the submission of the case to the jury." Galdieri-Ambrosini v. Nat'l Realty & Dev. Corp., 136 F.3d 276, 286 (2d Cir. 1998); see Fed. R. Civ. P. 50(a). Under Rule 50(b), if the Court does not grant the Rule 50(a) motion at the close of evidence, the moving party may renew its motion for judgment as a matter of law under Rule 50(b) within 10 days*fn3 of an unfavorable judgment - or, as here, the order of a mistrial - but it "is limited to those grounds that were specifically raised in the prior [Rule 50(a) motion]." Galdieri-Ambrosini, 136 F.3d at 286; see Fed. R. Civ. P. 50(b).

The movant faces a "high bar," Lavin-McEleney v. Marist Coll., 239 F.3d 476, 479 (2d Cir. 2001); motions for judgment as a matter of law "should be granted cautiously and sparingly." Meloff v. N.Y. Life Ins. Co., 240 F.3d 138, 145 (2d Cir. 2001). In deciding the motion, the Court "must view the evidence in a light most favorable to the non-movant and grant that party every reasonable inference that the jury might have drawn in its favor." Merrill Lynch Interfunding, Inc. v. Argenti, 155 F.3d 113, 120-21 (2d Cir. 1998) (quoting Samuels v. Air Transport Local 504, 992 F.2d 12, 14 (2d Cir. 1993)). The Court "may not itself weigh the credibility of witnesses or consider the weight of the evidence." Galdieri-Ambrosini, 136 F.3d at 286. The Court may properly grant such a motion only where it "finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for" the non-movant. Fed. R. Civ. P. 50(a); see Arlio v. Lively, 474 F.3d 46, ...


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