Good facts make good law. And in Glynn in the Fosamax MDL, Merck had some pretty good facts. At first glance, the case appeared to be no different than every other pharmaceutical products liability case. You know how it goes – Plaintiff sustains an injury (or at least claims she did). Plaintiff claims the injury was caused by her use of Defendant’s drug (irrespective of any scientific evidence linking said injury to the use of said drug). Plaintiff claims Defendant failed to warn of the risk of the alleged injury with use of Defendant’s drug. Defendant claims Plaintiff’s suit is preempted. A trial ensues. It’s a textbook pharma case.
But here’s where the Glynn case deviated from the script. In Glynn, there couldn’t be much of a fight about whether or not Merck should have or could have changed the Fosamax label prior to Plaintiff’s alleged injury, because the clear factual evidence showed the FDA expressly rejected Merck’s efforts to do just that. It doesn’t get much better than that – Plaintiff’s claims preempted and summary judgment granted in favor of Merck.
Here’s the story. Fosamax is approved for the treatment and prevention of osteoporosis. Plaintiff Bernadette Glynn claimed that her use of Fosamax caused her to sustain an atypical femur fracture (“AFF”) in April 2009. A year earlier, on June 13, 2008, the FDA asked Merck and other bisphosphonate manufacturers for any information they had regarding the occurrence of AFF with bisphosphonate use. At the time, the FDA expressed concern about this “developing safety signal.” On July 18, 2008, Merck responded with its clinical and post-marketing data. The FDA, in turn, reviewed that data and determined that the data did not show an increase in AFF with bisphosphonate use.
Yet, having been down this road before (VIOXX anyone?), on September 15, 2008 Merck wisely submitted to the FDA a Prior Approval Supplement, proposing to add language to the Precautions and Adverse Reactions/Post Marketing Experience sections of the Fosamax label describing the temporal association between Fosamax use and AFF that had surfaced in the post-marketing data. On April 15, 2009, the FDA advised Merck that it would approve the proposed addition to the Adverse Reactions/Post-Marketing Experience section of the label, but significantly, it would not approve the proposed addition to the Precautions section of the label. On May 22, 2009, the FDA formally warned Merck that Fosamax would be considered to be misbranded if Merck made any changes to its label that were not approved by the FDA – clear evidence, indeed.
Unfortunately for Merck, it had to endure a jury trial (which it won) before the District Court of New Jersey granted Merck’s Motion for Summary Judgment based on Federal Preemption. Following the trial, Judge Pisano found that the record contained clear evidence that the FDA would not have approved a stronger warning to the Precautions section of the Fosamax label prior to Plaintiff’s alleged injury. Unfortunately for other pharmaceutical manufacturers, the factual record establishing the FDA’s rejection of a label change is not usually as strong as it was here.