A federal court recently denied certification of state-law medical monitoring claims, finding that individual questions of fact doomed class-treatment. In Re: Fosamax Products Liability Litigation, MDL No. 1789, 2008 U.S. Dist. LEXIS 199 (S.D.N.Y. Jan. 3, 2008). In this MDL litigation, plaintiffs sought certification of classes of current and former users of Fosamax® (a prescription nitrogen-containing bisphosphonate drug used for treatment of osteoporosis and other bone disorders) who have not been diagnosed with osteonecrosis of the jaw (“ONJ”). ONJ is a rare but painful and disfiguring and debilitating condition characterized by an area of exposed bone in the oral cavity that does not heal or heals poorly. Proposed class members were limited to residents of Pennsylvania, Florida and Louisiana, jurisdictions that have recognized some form of a tort for medical monitoring. Plaintiffs sought to have the manufacturer, Merck, set up and fund a program for a regimen of dental and medical procedures (e.g. twice yearly dental examinations, radiographs, CTX tests for bone resorption, dental cleaning, etc.) intended to monitor patients for ONJ.
Although the putative state-wide classes purportedly would have asserted claims under states that have recognized a substantive cause of action for medical monitoring, the Court held that the elements of medical monitoring claims involved inherently individualized questions that presented an insurmountable obstacle to class action prerequisites of typicality and predominance. Moreover, the predominance of individual questions also proved fatal to the class action prerequisites of superiority and manageability.
The opinion struck a familiar theme: that plaintiffs’ attempt to find liability in the face of FDA approval of a prescription drug and its labeling is suspect. Specifically, the Court stated:
Plaintiffs have cited no authority for the proposition that a pharmaceutical drug that currently enjoys FDA-approval can be proven to be inherently hazardous to all persons who have taken it. The only plausible claim would seem to be that Fosamax is hazardous under certain circumstance, which of course would vary from class member to class member [defeating typicality].
Id. at pp. 9-10 (citations omitted).
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The proposed class actions call for an extraordinary intrusion into the FDA’s regulatory mandate, even while many in the scientific community believe that more research is needed. In this regard, the Court concurs with the sentiments of the district court in In re Propulsid Products Liab. Litig.
[T]he issues of the timeliness of the requested remedy presents a significant obstacle for the plaintiff. Neither the FDA, nor any medical organization or institution, nor anyone else for that matter, except the plaintiff’s expert, has recommended or suggested that a program of medical monitoring or a group study of all former Propulsid users be undertaken. This raises the issue of the role of the courts in such an instance. Stated succinctly, the question is whether the courts should lead the scientific community in an area of medical science.
208 F.R.D. 133, 147 (E.D La. 2002). Assuming that it would be appropriate for a court to determine whether someone who takes an FDA-approved drug is entitled to medical monitoring for any user of the drug, a more cautious, case-by-case approach focusing on the particular factual circumstances of individual plaintiffs would be more prudent.
Id. at pp 11-12.
This denial of class certification is the most recent in a long line of authority rejecting class certification of personal injury claims presented as “mass torts,” especially in cases against pharmaceutical companies. Plaintiffs have generally been unable to satisfy the “typicality” requirement of Fed. R. Civ. P. 23(a), or to show that individual issues predominate over common ones, as required under Rule 23(b)(3), among other problems. The rationale based on inherent individual questions for rejecting class certification is further strengthened by deference to FDA’s judgment concerning approval of and recommended uses and best practices for the prescription drug.