In re Fosamax Products Liab. Litigationthis Document Relates To:shirley Boles v. Merck & Co. Inc. Case No. 1:06–cv–09455–jfk

• Decision Date: 04 October 2010
• Docket Number: No. 06–MD–1789–JFK.,06–MD–1789–JFK.
• Citation: 742 F.Supp.2d 460
• Parties: In re: FOSAMAX PRODUCTS LIABILITY LITIGATIONThis Document Relates to:Shirley Boles v. Merck & Co., Inc. Case No. 1:06–cv–09455–JFK
• Court: U.S. District Court — Southern District of New York

742 F.Supp.2d 460

In re: FOSAMAX PRODUCTS LIABILITY LITIGATIONThis Document Relates to:Shirley Boles

v. Merck & Co., Inc. Case No. 1:06–cv–09455–JFK

No. 06–MD–1789–JFK.

United States District Court, S.D. New York.

Oct. 4, 2010.

Timothy M. O'Brien, Esq., Levin Papantonio Thomas Mitchell, Echsner Rafferty & Proctor, P.A., Gary J. Douglas, Esq., Douglas & London, P.C., for Plaintiff Shirley Boles.Norman C. Kleinberg, Esq., Theodore V.H. Mayer, Esq., William J. Beausoleil, Esq., Hughes Hubbard & Reed LLP, Paul F. Strain, Esq., David J. Heubeck, Esq., Stephen E. Marshall, Esq., Venable LLP, for Defendant Merck Sharp & Dohme Corp.

OPINION & ORDER

JOHN F. KEENAN, District Judge:

This case was selected by the Plaintiffs' Steering Commit tee 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.

I. BACKGROUND

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. ¹

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.² 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.³

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.

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