In re Fosamax Products Liability Litigation

248 F.R.D. 389, 2008 WL 58890
CourtDistrict Court, S.D. New York
DecidedJanuary 3, 2008
DocketNo. 1:06-md-1789 (JFK)
StatusPublished
Cited by33 cases

This text of 248 F.R.D. 389 (In re Fosamax Products Liability Litigation) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Fosamax Products Liability Litigation, 248 F.R.D. 389, 2008 WL 58890 (S.D.N.Y. 2008).

Opinion

[390]*390 MEMORANDUM OPINION & ORDER

JOHN F. KEENAN, District Judge.

Introduction

In this multidistrict litigation (“MDL”), more than three hundred and sixty products liability actions have been filed by individuals who claim to have taken Fosamax, a prescription drug approved for the treatment of osteoporosis and other bone disorders, against Merck & Co., Inc., the drug’s manufacturer. Common to all actions is the alie-[391]*391gation that ingesting Fosamax caused plaintiffs to either develop a medical condition known as osteonecrosis of the jaw (“ONJ”) or to suffer a significantly increased risk of developing the condition in the future. These cases have been transferred to this Court for coordinated pretrial proceedings pursuant to 28 U.S.C. § 1407.

Currently before the Court are motions filed by putative class representatives to certify three state-wide classes. The proposed classes are defined to include all current and former users of Fosamax in the states of Pennsylvania, Florida and Louisiana who have not been diagnosed with ONJ. Each class would bring a claim for medical monitoring under the respective laws of those three states. They would seek to have Merck set up and fund a program that would administer to all class members a regimen of dental procedures intended to monitor for ONJ.

In connection with the present motions, the parties have established an extensive evi-dentiary record.1 The Court heard oral argument on the motions on November 30, 2007.

This decision on class certification is not about whether Fosamax causes or significantly increases the risk of ONJ, or whether Merck was or was not negligent in labeling Fosamax, or whether the proposed dental monitoring program is an effective way to prevent the onset of ONJ. These questions will be resolved at future stages of these proceedings. The narrow question before the Court is whether, under Federal Rule of Civil Procedure 23, a class action is a proper vehicle for litigating the state-law medical monitoring claims brought by the named plaintiffs. For the reasons discussed below, the Court finds that class-treatment of these claims is inappropriate because they present too many individual questions of fact particular to each class member’s claim. Accordingly, the motions for class certification are DENIED.

I. Background

A. Fosamax

Fosamax is an oral prescription drug approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of osteoporosis and other bone disorders.2 Osteoporosis afflicts more than 10 million Americans over the age of fifty, eighty percent of whom are women. (DX. 22.)3 The disorder is characterized by reduced bone density and quality that diminishes bone strength and increases susceptibility to fractures. Throughout a person’s life, his or her bones continuously undergo a remodeling cycle whereby older bone is re-sorbed (broken down) and new bone is formed to replace it. Osteoporosis results from an imbalance in this bone turnover cycle that is associated with, among other things, aging and the drop in estrogen levels in post-menopausal women. The cells responsible for resorption (osteoclasts) are [392]*392overactive and/or the cells responsible for bone formation (osteoblasts) are underac-tive, resulting in net bone loss. A person is diagnosed with osteoporosis when his or her bone density falls a certain level below normal.

Approved by the FDA in September 1995, Fosamax seeks to restore this balance and decrease bone loss by inhibiting resorption and reducing the rate of bone turnover. The active ingredient in Fosamax is alendronate, a compound consisting of a bisphosphonate and a nitrogen-containing amino group. The parties dispute several issues with respect to the effects of nitrogen-containing bisphospho-nates: whether they merely inhibit the function of osteoclasts or kill them; whether bone turnover is reduced to rates within a normal range or completely inhibited; whether or not bisphosphonate remains active over its 10-12 year half life when it is taken up into the bone, producing a cumulative effect on bone turnover; and whether or not it accumulates preferentially in the jaws, which have a relatively high turnover rate. These issues need not be addressed at this stage of the proceedings.

Fosamax is one of several oral bisphospho-nates currently on the market to treat osteoporosis and other bone disorders. Since their market introduction, doctors have prescribed oral bisphosphonates over 191 million times; 77% of these prescriptions have been for alendronate (Nieves Aff. ¶ 20). The FDA has also approved intravenously-administered bisphosphonates, which are much more potent and are prescribed to treat metastatic bone disease resulting principally from mye-loma and breast cancer.4

B. Osteonecrosis of the Jaws

Osteonecrosis of the jaws (“ONJ”) is a condition characterized by an area of exposed bone in the oral cavity that does not heal or heals poorly within a normal healing time. The area often becomes infected, causing pain, swelling and purulent secretion. (PX R.)5 In a small percentage of cases where antibiotics and regular irrigations are not effective in preventing or treating infection, regions of necrotic bone must be surgically removed. (PX G, K.).

The cause or causes of this rare but painful, disfiguring and debilitating condition are not fully understood or agreed upon. Plaintiffs expert, Dr. Marx, states that ONJ may be caused by each of the following: osteora-dionecrosis (radiation therapy to the head and neck), osteomyelitis (infection in the jaw), osteopetrosis (a genetic defect in the osteoclast cell) and trauma to the jaw. (Marx Aff. ¶ 17.) He also states that some practitioners believe that long-term steroid use and various forms of chemotherapy can cause ONJ, although he does not believe so. (Id.) Defendant’s experts add to the list of risk factors for ONJ the following: cancer, HIV disease, immunosuppressed hosts, herpes infection, periodontal disease, poor oral hygiene, invasive dental procedure, anemia and coagulapathy (a defect in the blood-clotting process). (Bilezikian ¶ 31; Glickman ¶ 9; Nieves Aff. ¶ 17.)

There is no definitive treatment for ONJ. Studies have found that the treatment outcomes of surgery, antibiotics and hyperbaric oxygen therapy are poor and that, for most ONJ patients, the area of exposed bone will remain permanently. (PX R; Robert E. Marx, Oral & Intravenous Bisphosphonate-Induced Osteonecrosis of the Jaws 63 (2007)). Therefore, those at risk for the condition should seek to prevent its development by obtaining proper dental care and avoiding invasive dental procedures.

C. Bisphosphonate-associated ONJ

The first cases of ONJ associated with intravenous bisphosphonate use were reported by Dr. Marx in the medical and dental literature in the fall of 2003. ONJ associated with the use of oral bisphosphonates was first reported in the literature by another doctor in the spring of 2004. (Bilezikian [393]*393¶ 32; Glickman ¶ 10). Dr.

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Bluebook (online)
248 F.R.D. 389, 2008 WL 58890, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-fosamax-products-liability-litigation-nysd-2008.