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In re Fosamax Products Liability Litigation

October 4, 2010


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


This case was selected by the Plaintiffs' Steering Committee as a bellwether case in this multidistrict products liability litigation concerning Defendant Merck Sharpe & Dohme Corp.'s ("Merck" or "Defendant") prescription drug Fosamax. The case went to trial in August 2009 and ended in a mistrial after the jury could not reach a unanimous verdict. The contentious re-trial in June 2010 culminated with an $8 million verdict for Plaintiff Shirley Boles ("Plaintiff" or "Boles"). Before the Court are Merck's motions for judgment as a matter of law and for a new trial under Rules 50 and 59 of the Federal Rules of Civil Procedure. For the reasons that follow, the motions are denied. Although the Court does not believe that a new trial is warranted, it finds that the $8 million damage award is excessive and thus orders a remittitur sua sponte.


Merck manufactures and distributes Fosamax (alendronate), a drug widely prescribed for the treatment and prevention of osteoporosis. Fosamax belongs to a class of drugs called bisphosphonates, which have become standard treatment for various metabolic and oncologic diseases related to abnormalities in the bone remodeling cycle. The primary effect of Fosamax is the inhibition of bone resorption, which in turn decreases bone formation and remodeling.

The Food & Drug Administration ("FDA") approved Fosamax in 1995 for the treatment of osteoporosis and in 1997 for the prevention of osteoporosis. Osteoporosis is a disease characterized by bone loss and increased risk of bone fracture. There appears to have been several definitions of osteoporosis promulgated over time by different medical organizations, but an individual traditionally is thought to have osteoporosis when his or her bone mineral density ("BMD") is more than 2.5 standard deviations below the mean for young adults of the same sex. This is referred to as a T-score of - 2.5. According to Dr. John Bilezikian, the chair of the Department of Endocrinology at Columbia University and Merck's retained expert witness at trial, osteoporosis afflicts ten to twelve million Americans and leads to roughly two million bone fractures every year. Another roughly thirty million Americans have low bone mass and are considered at risk of developing osteoporosis, a state which is referred to as osteopenia. Those with a T-score from - 1.5 to - 2.5 are thought to have osteopenia.

Since 2003, there have been various published reports of bisphosphonate users developing a rare condition called osteonecrosis of the jaw ("ONJ"). ONJ is characterized by an area of dead jaw bone that becomes exposed in the oral cavity. Symptoms can include pain, swelling, and purulent secretion.*fn1

Plaintiff is a 72-year-old Florida resident who alleges that she developed ONJ as a result of taking Fosamax for nearly eight years. She filed a complaint against Merck on September 1, 2006 through her counsel, Timothy M. O'Brien, Esq., in the Northern District of Florida. The Judicial Panel on Multidistrict Litigation transferred the action to this Court on October 17, 2006, and it eventually became the first to go to trial of the roughly 800 actions that currently comprise this multidistrict litigation.

The first trial commenced on August 11, 2009, with Plaintiff asserting claims of strict liability and negligence rooted in theories of failure to warn and design defect, and fraudulent misrepresentation and concealment.*fn2 On September 1, 2009, after the close of evidence, the Court granted Merck's motion for judgment as a matter of law under Rule 50(a) on Plaintiff's fraudulent misrepresentation and concealment claims, 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. Merck's motion for judgment as a matter of law was denied with respect to Plaintiff's other claims. After several days of deliberation, the jury informed the Court that it was deadlocked and could not reach a verdict on any of Plaintiff's claims. As a result, the Court declared a mistrial on September 11, 2009.

Following the mistrial, Merck again moved for judgment as a matter of law under Rule 50(b). On March 26, 2010, the Court granted the motion in part, finding that Plaintiff had failed to establish proximate causation in that she did not introduce evidence from which a reasonable jury could conclude that Plaintiff's treating physician would not have prescribed her Fosamax even if he had been warned of the risk of ONJ. See In re Fosamax Prods. Liab. Litig., No. 06 Civ. 9455, 2010 WL 1257299, at *4-5 (S.D.N.Y. Mar. 26, 2010). The Court found, however, that Plaintiff had introduced sufficient evidence at trial to support her negligent design and strict liability design defect claims and thus denied Merck's motion with respect to those claims. See id. at *6-7.

The roughly three-week re-trial of Plaintiff's design defect claims began on June 7, 2010. Plaintiff was represented at trial by Mr. O'Brien and Gary Douglas, Esq. Mr. Douglas' involvement in the initial trial in August 2009 was limited to assisting Mr. O'Brien and his colleagues during jury selection. He had a more pronounced role in the re-trial, though, essentially splitting the questioning of witnesses with Mr. O'Brien and delivering an aggressive and impassioned closing argument.

The evidence introduced at the second trial was largely comparable to that in the first.

Plaintiff was prescribed Fosamax for the first time in July 1997 by Dr. James Mills, a board-certified obstetrician and gynecologist. At that time, Boles' hip T-score was - 2.1, meaning that she was osteopenic under current standards.*fn3

According to Plaintiff's medical records, she began having jaw complications resembling an infection in August 2002 following a tooth extraction. Standard treatment methods including curettage and debridement 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. She eventually developed three skin fistulas under her chin, which are small openings from which pus and other purulent liquids intermittently drain. Her condition has not subsided to date. Boles' long-time treating physician, Dr. James Elwell, told the jury that her pain has been at its worst for the past one and one-half to two years. He explained that the bone death extended into the area of her inferior alveolar nerve, which causes her increased pain and discomfort in the area of her lower lip, requiring treatment with narcotic pain medication.

Because of her worsening condition, Dr. Elwell told the jury that he now recommends that Boles have resection surgery, a procedure during which the area of dead bone is surgically removed from the jaw and replaced with a metal plate.

Boles testified at trial that the pain she endures from her jaw condition is "hard to explain" and "sometimes [is] worse than others," but is like "sticking something sharp.... into [her] jaw" and it "radiates up the whole side of [her] face." (Trial Tr. at 1017.) She explained that she has a strong appetite, but her jaw condition has made it difficult for her to eat. She can still eat soft foods, but has lost about forty pounds since the onset of her condition. She also stated that if Dr. Elwell were to recommend that she have the resection surgery, she would comply. No date has been set for surgery.

Boles initially was diagnosed with a bone infection known as osteomyelitis. Dr. Elwell testified that based on her symptoms and unresponsiveness to traditional therapy, he since has been able to rule out all other possible causes and concluded that Plaintiff's use of Fosamax caused her to develop ONJ beginning in August 2002. He testified that he and Plaintiff's other treating physicians failed to diagnose Boles with ONJ in the early stages of her condition because at the time the medical community was unaware of the association between Fosamax and ONJ. Another of Plaintiff's treating physicians, Dr. Patrick Anastasio, an infectious disease specialist, also opined that her condition is ONJ caused by her long-time Fosamax use.

Merck disputed Plaintiff's claim that she has ONJ, arguing that her jaw condition is osteomyelitis caused by severe periodontal disease and unrelated to her use of Fosamax. Merck argued that her condition has persisted because it had not been properly treated. Dr. Elwell acknowledged that Plaintiff has a bone infection, but believes she developed the infection and could not properly fight it off because of the pre-existing dead bone in her jaw caused by Fosamax. In essence, Merck argued that she has dead bone caused by an infection, whereas Plaintiff argued that she has an infection because of the dead bone in her jaw caused by Fosamax.

Along with the evidence that her jaw condition was caused by Fosamax, Plaintiff also sought to prove that the drug's benefits are minimal. According to Plaintiff's expert, Dr. Curt Furberg, the statistical studies of Fosamax conducted by Merck and reviewed by the FDA show that the drug has a definite fracture reduction efficacy, but only for a limited group of patients and for a limited period of time.

Dr. Furberg testified that, after reviewing the studies of Fosamax, he could find no evidence that Fosamax provides fracture reduction efficacy for users, like Plaintiff, who would be considered osteopenic under most standards, that is individuals with no prevalent vertebral fracture and a T-score better than - 2.5. He focused on two reports which analyzed Merck's pivotal clinical trial referred to as the "Fracture Intervention Trial" or "FIT": an article published in the Journal of the American Medical Association ("JAMA"), and a report written by Dr. Anthony Mucci (the "Mucci Report"), a biostatistician for the FDA.

In the FIT trial, within the group of patients with a T-score of - 2.0 or worse, there were 22 percent less fractures in the group of patients receiving Fosamax than in the group receiving placebo. As such, as Merck often noted, the authors of the JAMA article provide that they "observed a 22% lower risk of clinical fracture in those whose T-scores were more than 2.0 [standard deviations] below the normal mean." (Pl. Ex. 2.0018.)

Dr. Furberg criticized the authors' conclusion, testifying that they needed to deconstruct the data further to arrive at an accurate conclusion. Looking at the data tables of the JAMA article, Dr. Furberg showed the jury that the group of patients in the study with a T-score worse than - 2.5 had a thirty-six percent fracture reduction benefit versus placebo. However, for the group of study patients with a T-score of - 2.5 to - 2.0, the data did not show a statistically significant benefit for Fosamax use compared to placebo: in fact, there were more fractures in the group receiving Fosamax (92) than in the placebo group (87). Dr. Furberg believed that such "data pooling" was incomplete and misleading. He testified:

This is a misleading way of presenting the findings. The benefit is, as we've seen in the [JAMA] analysis only in those who have a score of minus 2.5 or worse, and there's no benefit in the group between minus 2 and minus 2.5. So by combining them, it's misleading, you're combining a group with benefit with a group with no benefit, and scientifically, that doesn't make any sense. You don't do that. You don't combine groups with benefit with other groups where there's no benefit, and try to draw an overall conclusion. It's misleading. And I call it deceptive. (Trial Tr. at 843.) Dr. Furberg read to the jury portions of the Mucci Report which showed that Dr. Mucci came to the same conclusion. In the report, Dr. Mucci concluded that "the nonosteoporotic cohort reveals no efficacy of Fosamax versus placebo for any category of fracture.... Thus, Fosamax can be said to be effective in osteoporotic patients with no prevalent vertebral fracture only if osteoporosis is defined in the more stringent fashion wherein the previous inclusionary criterion with BMD set as a negative 2 T-score is replaced by a new inclusionary criterion which sets BMD at a negative 2.5 T-score." (Id. at 757-58.) Even Merck's expert, Dr. Bilezikian, acknowledged the lack of solid evidence showing whether Fosamax provides fracture reduction benefit to that specific group of patients. See id. at 1496-97 ("Q. And in fact, your opinion is that there is no evidence [of fracture benefit for the women who have a T-score of - 2.0 to - 2.5 with no prior vertebral fractures], but that doesn't mean it doesn't work. That's your opinion, right? A. Well, I think - - that's right. You need to do the study with the proper power before you can reach any conclusions.").

Dr. Furberg also analyzed for the jury the "life table graph" contained in the JAMA article, a line graph which compared the number of fractures sustained by Fosamax and placebo users during the four-year FIT trial. According to Dr. Furberg, the graph shows that the FIT study's Fosamax group sustained roughly the same number of fractures as the placebo group for the first eighteen months of the study. After eighteen months, the lines of the two groups diverge indicating that patients in the Fosamax group sustained fewer fractures, but then after thirty-six months of use, the instances of fracture within the two groups began to converge. These results indicate to Dr. Furberg that Fosamax is not efficacious for the first eighteen months of use and confers no added benefit after thirty-six months of use. Merck did not cross-examine Dr. Furberg on this timing issue and did not introduce any other studies to directly refute his conclusion.

Based on the foregoing evidence, Plaintiff argued to the jury that the risk of ONJ vastly outweighed the complete lack of benefit to patients like Boles, who had a T-score better than - 2.5 and without a previous vertebral fracture. On June 25, 2010, after the thirteen-day trial, the jury found for Plaintiff on both her strict liability design defect and negligent design claims, awarding her $8 million in compensatory damages.


A. Motion for Judgment as a Matter of Law

Merck essentially raises two grounds for judgment as a matter of law. First, Merck argues that Plaintiff's negligent design and strict liability design defect claims fail because she provided no evidence from which the jury could have found for her on certain shared elements of those claims. Merck also argues these state law tort claims are preempted by federal law because the FDA effectively declared Fosamax safe and effective by approving it for sale for its indicated uses.

1. Rule 50 Standard

"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). 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 28 days of an unfavorable judgment, 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 289. 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, 51 (2d Cir. 2007) (holding that judgment as a matter of law should be granted when "the evidence, viewed in the light most favorable to the nonmoving party, is insufficient to permit a reasonable juror to find in [the non-moving party's] favor").

2. Plaintiff Introduced Sufficient Evidence to Prevail at Trial

"Under Florida law, a strict product liability action based upon design defect requires the plaintiff to prove that (1) a product (2) produced by a manufacturer (3) was defective or created an unreasonably dangerous condition (4) that proximately caused (5) injury." Pinchinat v. Graco Children's Prods., Inc., 390 F. Supp. 2d 1141, 1148 (M.D. Fla. 2005). "[I]t is unnecessary in a strict liability action to show that the manufacturer has been negligent in any way. In fact [it] can be found ...

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