On January 3, 2008, the Hon. John F. Keenan welcomed in the new year with a memorandum and order denying class certification of three putative medical monitoring classes in the Fosamax product liability multidistrict litigation, In re Fosamax Products Liability Litigation, MDL No. 1789, 1:06-md-1789-JFK, pending in the United States District Court for the Southern District of New York. Memorandum Opinion and Order, Docket No. 222. The decision falls in line with a series of cases over the last several years, in which courts have consistently rejected medical monitoring classes in pharmaceutical and medical device products-based litigation because of the need for individualized proof.

In 1995, the Food and Drug Administration approved Fosamax, a prescription medication manufactured by Merck & Co., Inc., for the treatment of osteoporosis, which afflicts more than 10 million Americans over the age of 50 (80 percent of whom are women). Osteoporosis is characterized by reduced bone density and quality, which results in diminished bone strength and increased susceptibility to fractures. The disorder is caused by an imbalance between the resorption of old bone cells and the generation of new bone cells. Fosamax addresses this imbalance by inhibiting the resorption of aging bone cells and reducing the rate of bone cell turnover.

The active ingredient of Fosamax is alendronate, a compound that consists of bisphosphonate and a nitrogen-containing amino group. The plaintiffs allege that bisphosphonate causes a painful, degenerative bone condition known as osteonecrosis of the jaw (ONJ), which is difficult to treat and can result in infection. Merck is currently defending more than 360 product liability actions in the MDL alone.

The plaintiffs sought the certification of three statewide medical monitoring classes under the laws of Pennsylvania, Florida, and Louisiana that were defined to include citizens of those states who had ingested Fosamax during the class period, but had not been diagnosed with ONJ. The plaintiffs sought the creation of a monitoring program funded by Merck, under which each putative class member would receive bi-annual dental examinations that included comprehensive testing and the creation of a consultation report to be provided to the individuals’ treating physicians. Noting the rejection of medical monitoring classes in the Vioxx, Prempro, Baycol, Paxil, Rezulin, and Propulsid cases,[1] among others, Judge Keenan reached the same result here.

At the outset, Judge Keenan concluded that class certification was not appropriate based on the over-breadth of the class definition alone. He noted, in particular, that the class definition embraced any individual who had ever ingested Fosamax, while the plaintiffs’ expert conceded that only those who were currently taking the medication were at a heightened risk for developing ONJ. Furthermore, the definition “did not set any dosage limitations on class membership,” did not “attempt to screen individuals with unique risk factors for ONJ,” and “fail[ed] to specify the duration of the proposed dental monitoring program.” Judge Keenan was also unmoved by the plaintiffs’ assurances that the class definition could be subsequently refined. He explained, “This wait-and-see approach is untenable because, until a class of persons alleged to be entitled to relief is defined, the Court cannot conduct the numerosity, commonality, typicality[,] and adequacy analyses that must precede certification.”

More importantly, Judge Keenan concluded that, even if the plaintiffs’ class definition had been more diligently tailored, certification was untenable because the plaintiffs could not demonstrate the elements’ typicality, adequacy, predominance, or superiority.

The court observed, as in other medical monitoring cases, that the elements of typicality and predominance could not be met because “almost every element of a medical monitoring claim will require highly individualized proof of each class member’s medical condition in the circumstances of their use of Fosamax.” Among other things, the plaintiffs could not “advance a single collective theory of negligence that applies to all class members” because what Merck knew or should have known about the risks associated with Fosamax varied over time. In addition, Judge Keenan found no support for the contention that “a pharmaceutical drug that currently enjoys FDA-approval can be proven to be inherently dangerous to all persons who have taken it.” To the contrary, the heightened risk of ONJ due to Fosamax use was highly dependent on dosage, duration of use, past medical history, and exposure to other ONJ risk factors. Therefore, proof of causation presented “an insurmountable obstacle.”

In addition, Judge Keenan found that the need for individualized proof also undercut the class representatives’ ability to represent the class because “the inherent differences” in their claims— for example, due to exposure to different risk factors for ONJ— make it “possible that class representatives would rely on arguments that are adverse to the interests of other class members.”

Finally, Judge Keenan was not persuaded that the class action device was the superior vehicle to pursue medical monitoring claims, because “there is an insufficient basis to believe that all class members would prefer the proposed monitoring program to one designed with their own particular circumstances in mind.” He was not swayed by the notion that medical monitoring claims provide insufficient incentives for plaintiffs to initiate individual actions, explaining:

Hundreds of other Fosamax users have already filed suit against Merck seeking similar relief under many legal theories, and more lawsuits are filed each week. If these cases yield positive results for plaintiffs, more Fosamax users can be expected to come forward and prosecute their individual claims.

Lastly, the Court noted that the efficiencies of consolidation had already been achieved by instituting an MDL:

Plaintiffs have not convinced the Court that the significant manageability difficulties posed by the class actions would be offset by any gain in efficiency. Most of the efficiency gains that class-treatment could bring in a case such as this have been captured already by the consolidation of all Fosamax cases in this Court for pre-trial proceedings.

Conclusion

At the heart of Judge Keenan’s decision lies the prescient observation that the Supreme Court articulated more than a decade ago: “The class action device is not very useful in mass tort cases which tend to present significant questions, not only of damages but of liability and defenses of liability affecting individuals in different ways.” In light of Judge Keenan’s holding, and the wealth of case law rejecting medical monitoring classes that preceded it, one wonders how many more attempts the plaintiffs’ bar will make at certifying such cases, particularly those involving pharmaceutical and medical device products that are pending in federal court. To the extent the plaintiffs persist, Judge Keenan’s decision provides yet another road map for defending against these claims.