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In re Fosamax Products Liability Litigation

October 22, 2010

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



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

OPINION & ORDER

JOHN F. KEENAN, United States District Judge

This is one of the "bellwether" cases selected for trial as part of the In re Fosamax Products Liability Litigation multidistrict litigation ("Fosamax MDL"). This opinion addresses Defendant Merck & Co. Inc.'s ("Merck") motions to exclude testimony under Daubert v. Merrell Dow Pharms., 509 U.S. 579(1993), and for summary judgment against Plaintiff Judith Graves ("Graves"). For the reasons discussed below, Merck's motion for the exclusion of expert witness testimony on Daubert grounds is granted with respect to Drs. Richard Adams, John Akers, and Robert Marx, but denied with respect to Drs. Douglas Villaret and James Cherry. Furthermore, Merck's motion for summary judgment is denied.

I. Background

This case was selected as a bellwether trial after the Court granted summary judgment in another Fosamax MDL case, Flemings v. Merck & Co., Inc. See In re Fosamax Prods. Liab. Litig., No. 06-MD-1789, 2009 WL 4042769 (S.D.N.Y. Nov. 23, 2009). The following facts are taken from the parties' Local Rule 56.1 Statements, the affidavits submitted in connection with the instant motion, and the exhibits attached thereto. Unless otherwise noted, the facts are undisputed.*fn1

A. FosamaX

Defendant Merck is a New Jersey-based pharmaceutical company that makes and distributes the drug alendronate sodium under the brand name Fosamax. Fosamax is one of several drugs known as "bisphosphonates," and is taken orally. It was originally approved by the FDA for the treatment of post-menopausal osteoporosis and Paget's Disease in 1995, and the FDA has since approved additional uses. In June of 1999, FosamaX was approved for the treatment of glucocorticoid-induced osteoporosis ("GiOP") in men and women. Glucocorticoids are a class of drugs that includes prednisone and other steroids used to treat rheumatoid arthritis.

Graves contends that Merck has long known of reports linking bisphosphonate use with the development of osteonecrosis of the jaw ("ONJ"). Graves alleges that Merck was aware that Fosamax could cause ONJ before Graves suffered her injuries, but failed adequately to warn the public of this risk. Graves references an article published in 2002, reporting that rats given Fosamax experienced delayed removal of necrotic bone, and various adverse event reports ("AERs") allegedly suggesting ONJ-related complications in certain persons being treated with Fosamax. To support her contention that the rat studies are relevant to the use in humans, Graves offers the deposition of Dr. Donald Kimmel, a Merck employee holding a D.D.S. and a Ph.D. who testified in his deposition that he had used rats to study bone growth in the study and writing of his Ph.D. dissertation, and that they can be "a good model of how bone behaves in many other species." (Kimmel Dep. Tr. at 16:1--22.)

With FDA approval, Merck modified its label in July 2005, informing the public that: "Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates." (Def. Rule 56.1 Statement ¶ 10.) Merck argues that the risk of bisphosphonate-associated ONJ was not known or reasonably knowable before it collected the information that led to the label change in 2005, and that even Graves' expert Dr. Robert Marx testified that while "he had treated Fosamax patients with ONJ as early as 2001 . . . even in 2003 he would not have alerted the medical community that Fosamax presented a risk of ONJ based on a few cases." (Def. Rule 56.1 Statement ¶ 12.)

B. Graves

Judith Graves is a 66-year-old Caucasian woman and a citizen of Florida. She alleges that she has suffered from ONJ and that her ONJ was caused by Fosamax. Graves has a history of severe rheumatoid arthritis, and to treat this condition, she has been prescribed various medications, including prednisone. In October 2001, Graves' general practitioner, Dr. Richard Adams, began to prescribe Fosamax to Graves, out of concern that her rheumatoid arthritis medications could cause her to lose bone density.

Merck contends that drugs Dr. Adams prescribed to Graves for her rheumatoid arthritis suppress the body's immune system and inhibit the ability of bones to heal, and while Graves disputes this characterization, her own expert, Dr. Adams, testified in his deposition that he was "aware . . . that each of [these] medicines inhibited the body's ability to fight infection" and that "prednisone [has] an adverse effect on bone quality" when he prescribed Fosamax to Graves. (Adams Dep. Tr. at 56:16--57:20.)

In March of 2003, Graves had a tooth extracted, and subsequently suffered from exposed bone and infection in the extraction area that lasted for several months. This infection was diagnosed as osteomyelitis, but in November of 2004, Graves' oral surgeon Dr. John Akers, concerned that she may be suffering from ONJ relating to her Fosamax use, recommended that Graves cease taking Fosamax. Mrs. Graves had been taking Fosamax for at most three years and one month when Dr. Akers recommended the termination of her Fosamax treatment.

On August 4, 2005, while treating her, Dr. James Cherry, a maxillofacial and oral surgeon, formed a "working diagnosis" that Fosamax was contributing to Graves' condition.

Graves has also been treated by Dr. Douglas Villaret, a specialist in head and neck reconstructive surgery, who performed a radical resection of Graves' mandible in June of 2006 and a revision surgery in June of 2007. Dr. Villaret diagnosed Graves as having bisphosphonate-associated ONJ using a differential diagnosis. Dr. Villaret reasoned that the only three possible causes for Graves' injuries, as reflected in her medical records, were radiation therapy, severe trauma, and bisphosphonate use. Given that there was no record of Graves having suffered from severe trauma or radiation therapy, he concluded that bisphosphonate use was the cause of Graves' injuries.

On August 8, 2007, Dr. Robert Marx began to treat Plaintiff after the fracture of a titanium plate placed in her jaw during Dr. Villaret's second resection surgery. At the time that Dr. Marx treated Graves, she was no longer suffering from ONJ, but Plaintiff characterizes Dr. Marx as having treated her for the "sequelae," or resulting injuries, of ONJ. Dr. Marx has testified that he concluded that Graves had suffered from ONJ related to her Fosamax use and based this conclusion on his review of prior doctors' treatment records. (Pl. Rule 56.1 Statement ¶¶ 30--33.)

Unlike many Fosamax patients that were prescribed Fosamax because they suffered from osteoporosis,*fn2 or osteopenia,*fn3 Dr. Adams prescribed Fosamax in order to prevent Graves from developing GiOP. The only bone scan presented in the record was taken in October 2002; the parties disagree about whether the result of that scan was 1.1 standard deviations above or below the young-adult mean, but it is clear that this bone scan was not taken until after Graves had been prescribed Fosamax for one year. (Pl. Rule 56.1 Statement ¶ 15; Def. SJ Reply Memo. at 4 n.4.)

II. Merck's Daubert Motion

The admission of expert testimony is governed by Federal Rule of Evidence 702, the three reliability-based requirements of which codified Daubert and its progeny. See In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 172 (S.D.N.Y. 2009) ("2009 Omnibus Daubert Opinion") (citing Fed. R. Evid. 702 Advisory Committee Note). Under Rule 702, the "district courts . . . act as gatekeepers by ensuring that expert scientific testimony both rests on a reliable foundation and is relevant to the task at hand." Id. (quoting Daubert v. Merrell Dow Pharms., 509 U.S. 579, 597 (1993)). The Court will therefore admit expert testimony only where it: (1) assists the jury to "understand the evidence or to determine a fact in issue"; (2) is offered by a qualified expert; and (3) satisfies the requirements of reliability outlined in Daubert. Fed. R. Evid. 702. In order for expert testimony to be admissible, it must satisfy all three of the above requirements, and the Court analyzes the qualifications of each of the proposed experts independently.

On July 27, 2009, the Court issued a 105-page opinion & order on the omnibus Daubert motions filed by Merck and the Plaintiff's Steering Committee ("PSC"). In that opinion, the Court summarized the factual background of the Fosamax MDL, discussing bisphosphonate drugs and their function, the FDA approval process for Fosamax, early reports of ONJ by ...


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