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In re Fosamax Products Liability Litigation

January 27, 2010


The opinion of the court was delivered by: John F. Keenan, United States District Judge*fn1


This case was selected by Merck Sharp & Dohme Corporation ("Merck" or "Defendant") as a bellwether case in this multi- district products liability litigation concerning the osteoporosis drug Fosamax. Before the Court is defendant Merck's motion for summary judgment seeking the dismissal of all claims filed by plaintiff Louise H. Maley ("Maley" or "Plaintiff"). For the following reasons, Merck's motion is denied.


A. Fosamax and ONJ*fn2

Fosamax is an oral bisphosphonate manufactured by Merck for the treatment of osteoporosis. Plaintiff and her experts contend that Merck has long known of studies and reports linking bisphosphonate use with the development of osteonecrosis of the jaw ("ONJ"), a condition characterized by exposed necrotic bone. Merck began warning consumers of a link between Fosamax and ONJ in July 2005, when it made the following FDA-approved addition to Fosamax's label:

Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates. Most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with intravenous bisphosphonates, but some have occurred in patients with postmenopausal osteoporosis.

(Def. Ex. 24.)

In 2006, the American Association of Oral and Maxillofacial Surgeons ("AAOMS") issued a position paper on bisphosphonate-related osteonecrosis of the jaw ("BRONJ") - the subset of ONJ injuries caused by bisphosphonate use. The position paper was developed by a task force of highly regarded clinicians, epidemiologists, and other researchers, who analyzed the existing literature and clinical observations of its members to provide perspectives on the risk of developing BRONJ and guidance to clinicians on diagnosing, treating, and preventing the condition. In the position paper, the AAOMS adopted a working definition of BRONJ, under which a patient is considered to have the condition if the following three characteristics are present: (1) current or previous use of a bisphosphonate; (2) exposed, necrotic bone in the maxillofacial region for more than eight weeks; and (3) no history of radiation therapy to the jaw. The AAOMS further classified the condition as stage one, two, or three, depending on the severity and type of the patient's symptoms. The experts on the issue of general causation in this multi-district litigation have used the same or similar definition. See, e.g., Marx Report, Def. Ex. 1, at 1 ("[B]isphosphonate-induced osteonecrosis of the jaws refers to a condition characterized by exposure of bone in the mandible or maxilla persisting for more than 8 weeks . . . ."); Goss Report, Def. Ex. 11, at 4 (including the presence of exposed bone that fails to heal within six weeks in his working definition of ONJ caused by bisphosphonate use).

In late 2008, the AAOMS task force reconvened to review the research on BRONJ conducted after the release of its 2006 position paper and to make any necessary updates. As a result, in January 2009, the AAOMS released an updated position paper. It maintained the same working definition of BRONJ, which includes a finding of exposed necrotic bone that persists for more than eight weeks. The staging system was amended, though, to include stage zero BRONJ, which includes patients who have been treated with a bisphosphonate with no clinical evidence of necrotic bone, but present with other non-specific symptoms or clinical and radiographic findings. (Mayer Decl. in Support of Daubert Motion, Ex. 42, at 10.)

B. Maley's Condition and the Initial Diagnosis

Maley was prescribed Fosamax by Dr. Dennis Lawton ("Dr. Lawton") beginning in January 1998. Dr. Lawton testified at deposition that he receives yearly updates to the Physician's Desk Reference ("PDR"), a published compilation of manufacturers' prescribing information, and generally keeps up to date on the medications he prescribes. Dr. Lawton first became aware of an alleged risk between Fosamax and ONJ in 2005. Dr. Lawton testified that despite this risk, he: (1) continues to prescribe Fosamax to patients; (2) does not inform these patients of the risk of developing ONJ; and (3) has never recommended that a patient take a "drug holiday" from Fosamax.

In March 2004, Ms. Maley began having severe aching pain in the upper-right side of her jaw. She had two dental extractions and was treated with Trileptal, an anti-convulsant. Her condition improved for several months following the dental extractions, but it again worsened in 2005, while she was still taking Trileptal. She described having "bad attacks" of "stabbing" pain in her jaw, extending through her forehead, which would last for hours at a time. (Def. Ex. 4.)

Maley's medical records indicate that she saw an array of doctors because of her jaw pain, including five different dentists, none of whom appear to have been able to diagnose her condition. In September 2005, Maley was referred to an endodontist, Dr. William Adams ("Dr. Adams"), to examine her jaw. Dr. Adams conducted exploratory surgery in Maley's jaw and performed a biopsy on a bone sample from her jaw. Dr. Adams found "chronically inflamed granulation," which he described for a layperson as inflammation in her jaw "which should not be there." (Adams Dep., Def. Ex. 9, at 145:15--19.) This led him to diagnose Maley with neuralgia-inducing cavitational osteonecrosis ("NICO"). According to Dr. Adams, NICO occurs when small areas of bone in the jaw develop cavitations and die, causing the patient to suffer pain.

Dr. Adams treated Maley's condition by surgically debriding the "broken down" area of her jaw, and then grafting the voided area with platelet-rich plasma and demineralized freeze-dried bone. (Id. at 135:4 -- 136:21.) Maley continued to experience pain in her jaw after the treatment.

In March 2006, Maley was directed to stop taking Fosamax by a different physician, Dr. Phillipsen, for a reason unrelated to her alleged jaw injury. Prior to receiving this advice, Maley regularly filled her Fosamax prescription but for a few occasions. She has not taken it since.

In June 2006, Maley also began feeling pain in the lower-right area of her jaw. She returned to Dr. Adams, who again diagnosed her with NICO and treated her in the same fashion as he did the prior year. Maley continued to have pain after the second surgery. She generally is pleased with the result of the treatments, though, testifying at her ...

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