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.
The decision we are discussing involved a plaintiff, Gaynor, who the defendant suggested in July 2013 be the plaintiff in the next bellwether trial. The plaintiffs bucked at that and countered with setting up a pool for a later bellwether trial of a post-labeling change case. After plaintiffs voluntarily dismissed two cases in the pool and the third was ruled out because she did not use the drug post-labeling change, Gaynor was the only one left, but plaintiffs still tried to delay the trial or any consideration of the merits of a warnings claim for the revised label. Along the way—the machinations bought them at least six months of delay—the plaintiffs contended that no consideration of the revised label was needed because “no Plaintiff alleges that the January 2011 label was proximate cause of his or her injury.” 2014 U.S. Dist. LEXIS, 82003, *17. Perhaps because the plaintiffs were not just dismissing all the post-labeling change cases anyway, the defendant moved for summary judgment in Gaynor and the court decided it despite claims that it was not ripe. Id. at *826-27.
After “tactfully re-characteriz[ing] their failure to warn claims through the procession of this MDL,” plaintiff (and plaintiffs) finally had to put up evidence to maintain a warnings claim under New York law, which is fairly standard in terms of learned intermediary, what makes a label (in)adequate, and proximate cause. Id. at 20-21. In general, when plaintiffs spend a bunch of effort building up how inadequate the old label was, it is difficult to prove that the revised label was still inadequate in ways that would matter to a prescriber’s decision making. Here, the concession on proximate cause should have been the end of things, but the court still walked through the analysis. Plaintiff, who was prescribed the drug by seven physicians over a 15 year period through her September 2011 AFF, started off with the old trick of trying to shift the burden to the defendant. Specifically, plaintiff contended defendant should have to prove that the use before the January 2011 labeling change did not proximately cause her injury. “This position is baffling, because if the Gaynor Plaintiffs are basing their failure to warn claim on [defendant’s] conduct between 1996 and 2010, or the fact that [defendant] should have updated its label by the mid 2000’s at the latest, then this Court has already held – twice – that such failure to warn claim fails as a matter of law on preemption grounds.” Id. at *24. That was the rock.
The hard place was that plaintiff’s own medical expert had already opined that plaintiff’s use through the labeling change had already caused her injury, because stopping then would not have avoided her injury. This negated proximate cause without even considering the impact on the prescribing decisions of any of the seven doctors (at least one of whom apparently continued prescribing post-revision). “Simply put, even assuming [defendant] breached a duty, if the alleged breach occurred in 2010 or earlier, the Gaynor Plaintiffs’ claims are preempted, and if the alleged breach occurred in 2011 or later, then no proximate cause exists linking such breach to Mrs. Gaynor’s injury as indicated by Plaintiffs’ own expert.” Id. at *26. While this ended the plaintiff’s warnings claim, it may not have been applicable to the other post-revision claims. However, the court’s decision that the revised label is adequate as a matter of law should be. With a limited challenge from the plaintiff, the label was easily seen as “accurate, clear, consistent and as a whole conveys a meaning that is unmistakable as it relates to AFFs.” Id. at *30. The defendant also made reasonable efforts to apprise physicians of the labeling change and the one prescribing physician whose testimony was discussed was clearly aware of the revision. Other plaintiffs should end up in the same place: summary judgment on warnings claims. If need be, defendant can probably pull out the six-headed preemption monster again for some post-revision claims because there would need to be some new risk evidence after January 2011 to support an argument that the revised label needed to change (through a CBE).
The court also knocked out plaintiff’s other claims, which, however captioned, were all predicated on a failure to warn under New York law. Because the court held that New York follows comment k for all prescription drugs, the finding of adequate warning as a matter of law also ended any design defect claim.
Lastly, the court brushed aside plaintiff’s request for more discovery as a reason not to grant summary judgment. The gamesmanship detailed above certainly did not help plaintiff’s credibility on her request. In addition, the strict application of Fed. R. Civ. P. 56(d) required an identification not just of the discovery plaintiff wanted but why it had not been obtained before and why it might create a genuine issue of material fact. Just claiming “I want more discovery” should not be enough, but it certainly should not function like a reset button when the plaintiff gets stuck.