We have discussed before (here and here) how the defendant manufacturer in Fosamax litigation took advantage of a fairly unique regulatory history to meet the Supreme Court’s unprecedentedly high “clear evidence” standard from Levine and preempt an entire MDL’s worth of warnings claims from before the drug’s label changed in 2011. For us, this was noteworthy and welcome. Prescription drug cases are fundamentally about warnings and many plaintiffs base their claims on the purported need for labeling that never would have been approved in the real world. Without devolving into a Bexisish rant on why Levine was wrong and many courts have been unduly frightened away from applying preemption because of facile readings of Levine—our own version of Charybdis—we can say that a clean preemption win in a prescription drug case was long overdue.

The Fosamax plaintiffs, not surprisingly, did not share our view and persisted in trying to keep their litigation going with post-labeling change cases. Well, they kind of persisted. Mostly, it seems that they desperately wanted to avoid a consideration of the merits of their remaining claims while keeping the litigation pending. This required a series of maneuvers that ultimately ended up with the plaintiff in In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 12-1492, 08-08, 2014 U.S. Dist. LEXIS 82003 (D.N.J. June 17, 2014), squarely between—you guessed it—a rock and a hard place when the defendant moved for summary judgment. We suspect many other plaintiffs in the litigation will end up in the same place.

A brief recap of the labeling and litigation history is in order. The drug had been on the marker for osteoporosis for more than a dozen years when FDA asked all manufacturers of the class of drugs to report back on the issue of atypical femur fractures (AFF) based on adverse events it had received. Even though defendant and FDA agreed there was no evidence that Fosamax increased the risk of such fractures, in September 2008, the defendant proposed to revise its label to add Precautions and Adverse Reactions information about reports of them. FDA allowed the Adverse Reactions change, but rejected the Precautions change in May 2009. By this point, it looks like the plaintiffs had already started bringing their AFF suits. In 2010, FDA issued three Drug Safety Communications on AFF with the class of defendant’s drug, shifting from a position of no established increased risk to requiring manufacturers to add Precautions on AFF and limit the duration of use in the Indications and Usage section based on a report from the American Society of Bone and Mineral Research stating there was an association between long term use of the drugs and AFF. Defendant responded in January 2011 by adding a detailed section in Warnings and Precautions—we assume PLR reformatting was due—in the physician label and language in the patient Medication Guide. Based on this, in a two-step process, all labeling claims for AFF before the 2011 labeling change were held to be preempted. Thereafter, the court wanted to bring to a head the issue of whether there could be a warnings claim for cases where the plaintiff took the drug with the revised label. And then the plaintiffs started dancing.Continue Reading Fosamax Plaintiffs Between A Rock And A Hard Place