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In re Fosamax Prods. Liab. Litig.

United States District Court for the Southern District of New York

July 27, 2009, Decided; July 27, 2009, Filed

MASTER FILE 1:06-MD-1789 (JFK)

Opinion

 [*168]  OPINION & ORDER

JOHN F. KEENAN, United States District Judge:

Currently pending in this multi-district litigation ("MDL") are omnibus Daubert motions filed by the Plaintiffs Steering Committee ("PSC") and Defendant Merck  [*169]  & Co., Inc. ("Merck"). For the following reasons, the Court rules as follows.

I. Background

Merck makes  [**2] and distributes Fosamax (alendronate), an FDA-approved drug widely prescribed for the treatment or prevention of osteoporosis. Fosamax belongs to a class of drugs called bisphosphonates. Bisphosphonate drugs have become standard treatment for various metabolic and oncologic diseases related to abnormalities in the bone remodeling cycle.

Also referred to as bone turnover, the bone remodeling cycle is a continuous process of renewal in which old or damaged bone is broken down (resorbed) and then replaced with new bone. The process starts by activation of the osteoclast, which is the cell responsible for resorption. The osteoclast breaks down a small amount of bone, leaving an excavated pit that becomes the bone remodeling unit. A bone-building cell called an osteoblast then fills the bone remodeling unit with organic bone matrix that, once mineralized, becomes new bone. The living bone cell itself is called the osteocyte. The rate of bone remodeling varies depending on the skeletal site.

Osteoporosis is a disease that afflicts more than 10 million Americans over the age of 50, 80% of whom are women. In healthy young adults, bone resorption and formation are balanced. With aging, bone turnover  [**3] can become unbalanced due to relative decreases in osteoblast activity or increases in osteoclast activity. In addition, as women age, the decline in estrogen levels after menopause can stimulate osteoclast activity and resorption. The uneven remodeling cycle produces net bone loss. Over time, this leads to reduced bone density and quality and an increased risk of fracture. 2 An additional 34 million Americans have low bone mass and are considered at risk for osteoporosis, a state referred to as osteopenia. The high incidence of fracture in persons with osteoporosis is a major public health concern.

Several other diseases are related to abnormalities in bone turnover. Paget's disease of bone is characterized by accelerated turnover that results in the production of new bone that is structurally defective. In metastatic bone disease, tumors metastasize into the skeleton and stimulate osteoclast activity, causing hypercalcemia and bone pain. One form of  [**4] osteopetrosis, which is a group of disorders characterized by very dense bone, involves defective osteoclast function.

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645 F. Supp. 2d 164 *; 2009 U.S. Dist. LEXIS 64661 **; 80 Fed. R. Evid. Serv. (Callaghan) 143; CCH Prod. Liab. Rep. P18,286

IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION; This Document Relates To All Actions

Subsequent History: Motion granted by In re Fosamax Prods. Liab. Litig., 2009 U.S. Dist. LEXIS 70246 (S.D.N.Y., Aug. 4, 2009)

Prior History: In re Fosamax Prods. Liab. Litig., 2009 U.S. Dist. LEXIS 27209 (S.D.N.Y., Mar. 4, 2009)

CORE TERMS

bisphosphonates, bone, osteoporosis, studies, causation, patients, epidemiological, disease, scientific, fracture, jaw, cases, argues, clinical trial, efficacy, expert testimony, maxillofacial, reliable, methodology, clinical, expertise, challenges, factors, causal, opine, asserts, exposed, deposition, users, bisphosphonate-associated

Evidence, Admissibility, Expert Witnesses, Daubert Standard, Scientific Evidence, Standards for Admissibility, Relevance, Exclusion of Relevant Evidence, Confusion, Prejudice & Waste of Time, Torts, Causation, Proximate Cause, General Overview, Types of Evidence, Circumstantial Evidence, Testimony, Qualifications, Expert Witnesses, Civil Procedure, Discovery, Methods of Discovery, Expert Witness Discovery, Hearsay, Credibility of Declarants, Impeachment