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In re Fosamax Products Liability Litigation

January 3, 2008


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




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 allegation 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 evidentiary record.*fn1 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.*fn2 Osteoporosis afflicts more than 10 million Americans over the age of fifty, eighty percent of whom are women. (DX. 22.)*fn3 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 resorbed (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 overactive and/or the cells responsible for bone formation (osteoblasts) are underactive, 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 bisphosphonates: 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 bisphosphonates 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 myeloma and breast cancer.*fn4

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.)*fn5 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. Plaintiff's expert, Dr. Marx, states that ONJ may be caused by each of the following: osteoradionecrosis (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 ¶ 32; Glickman ¶ 10). Dr. Marx asserts that, since 2003, more than five thousand cases of ONJ have been reported in people using bisphosphonates. (Marx Aff. ¶ 24.) Invasive oral surgical procedures initiated ONJ in most of these cases, but the condition has also presented spontaneously in a small number of cases. The parties' experts agree that ONJ is much more rarely associated with oral bisphosphonates such as Fosamax than with the more potent intravenous bisphosphonates. (Bilezikian ¶ 33; Goss ¶¶ 38-39; Marx et al., Oral Bishposphonate-Induced Osteonecrosis, J. Oral Maxillofacial Surgery 65: 2397-2410 (2007)).

In an August 2004 Post-Marketing Safety Review, the FDA found that, as of May of that year, physicians had reported 139 cases of ONJ associated with intravenous bisphosphonates and 12 associated with oral bisphosphonates to the FDA's Adverse Event Reporting System. The review concluded that the incidence of ONJ may be an event associated with all bisphosphonates, rather than limited to intravenous bisphosphonates, and recommended that the product labels of oral bisphosphonates include language reflecting this association. In January 2005, the FDA asked Merck to update Fosamax's label to include class-labeling for ONJ. After obtaining FDA approval of the language of a revised label, Merck made the new label publicly available in July 2005. On Page 13 of the revised label, under the heading "Precautions," it states in pertinent part:

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. Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), poor oral hygiene, and co-morbid disorders (e.g., pre-existing dental disease, anemia, coagulopathy, infection).

Patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonate therapy should receive care by an oral surgeon. Dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk for ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual risk/assessment.

(DX 23). Six pages later, under the heading of "Adverse Reactions," the label states that "Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported rarely." (Id.)

ONJ's association with oral bisphosphonates has been documented by many experts and leading oral and maxillofacial, dental, and medical associations. (PX BB, CC, EE). Estimates of the incidence of oral bisphosphonate-associated ONJ vary widely. On the high end, plaintiff's expert Dr. Goss estimates that the frequency of ONJ for patients taking oral bisphosphonates for osteoporosis is 1 in 2,260 to 8,470 (0.01 to 0.04%) (Goss Aff. ¶¶ 20, 23). He found the frequency to be substantially higher for the relatively small percentage of patients taking oral bisphosphonates to treat Paget's disease and for those patients who had dental extractions (Goss ¶¶ 20, 22, 24). On the low end, Merck's experts estimate the frequency at about 0.7-1.0 in 100,000 patient years of exposure (0.0007 to 0.001%), noting that this is only slightly higher than the risk of death by lightning strike.*fn6 (Bilezikian ¶ 36.)

Not surprisingly, the parties dispute whether a causal relationship exists between oral bisphosphonates such as Fosamax and ONJ. This merits question need not be addressed in order to decide the class certification motions.

There seems to be some consensus that oral bisphosphonate-associated ONJ may depend on several factors. For example, Dr. Goss states that the frequency of the disease depends on the dosage taken, the duration of use and whether the drug was prescribed to treat osteoporosis or Paget's disease. (Goss Aff. ¶¶ 9, 36, 39). Dr. Marx also states that the degree of bone turnover suppression, which he asserts is the mechanism by which Fosamax causes ONJ, depends upon the length of time that a patient uses the drug and whether and for how long the patient discontinues its use. (Marx Aff. ¶ 39). He reports that, according to his research, the risk of ONJ is "small" and "insignificant" until a patient uses Fosamax continuously for three years. (Marx Dep. Tr. at 80.) It also appears from the expert affidavits submitted that a Fosamax user's medical history, i.e. the absence or presence of the risk factors for ONJ listed above, affects his or her risk of developing the condition.

D. The Proposed Classes

1. The Class Representatives

The present motions seek certification of three statewide classes under Federal Rule of Civil Procedure 23(b)(3). The three putative class representatives are Dr. Trent Nichols, Jr., a resident of Pennsylvania, Ms. Greta V. Murphy, a resident of Florida, and Ms. Aline Trahan, a resident of Louisiana. These individuals would represent all persons in their respective home states "who are taking or have ...

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