Today’s decision comes from In re: Proton Pump Inhibitor Products Liability Litigation—an MDL pending in New Jersey.  But the decision is all about the 197 Michigan plaintiffs in the MDL.  The plaintiffs who either live in Michigan, got their prescription in Michigan, were diagnosed with their injury in Michigan, and/or received treatment for their injury in Michigan.  2022 WL 5265300, *1 (D.N.J. Sep. 20, 2022).  Because Michigan law applies to these plaintiffs, it was not disputed that they had no strict liability claims (not recognized in Michigan); no consumer protection claims (statute exempts claims based on marketing regulated by the FDA); and no punitive damages claims (requires express statutory permission).  Id. at *2.  As for the rest of their products liability claims, the Michiganders had to overcome a broad grant of immunity given to drug manufacturers.  They could not.

Michigan law does not allow products liability claims against drug manufacturers “if the drug was approved for safety and efficacy by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval.”  Id.  (citing MCL §600.2946(5)).  The immunity, however, is not absolute.  There are exceptions—on which plaintiff bears the burden of proof.  The immunity statute is “an extra hurdle that Plaintiff must overcome in order to reach their substantive claims.”  Id. at *3.     

In this case, the exception plaintiffs tried to demonstrate was that defendants intentionally withheld information from or made a misrepresentation to the FDA and that the drug would not have been approved or approval would have been withdrawn if the accurate information had been provided.  Id.  If Buckman preemption is flashing through your mind, we would say you are on the right track.  And so would the Sixth Circuit.  It concluded that the Michigan fraud exception would require a state court to rule on the question of whether there had been fraud-on-the-FDA without a finding by the FDA itself.  That is a Buckman no-no.  The Second Circuit has reached the opposite conclusion; however, the majority of district court decisions fall into the Sixth Circuit’s camp.  Id. at *4-5.  With a split in the circuits, no Third Circuit decision, and a split in the New Jersey district court decisions, the MDL court decided to steer clear of the preemption question and decide the case on whether plaintiffs had met their burden of proof on the fraud exception. 

As noted above, the fraud exception has two necessary elements – a withholding or misrepresentation of information to the FDA and if the FDA had received accurate information, it would have not approved or withdrawn approval of the drug.  The court focused on plaintiff’s lack of evidence on the second element.  Plaintiffs argued that defendants failed to submit adverse event reports, case reports, and at least one publication.  Id. at *6.  But the evidence showed that over the years, all of that information was shared with the FDA and the FDA has never withdrawn the drug from the market.  It has at most required label changes which defendants complied with.  Therefore, the court concluded no reasonable jury could find that the FDA would have withdrawn its approval when it in fact has not done so.  Id.  Given the ongoing obligations of drug manufacturers to provide information to the FDA, where a drug is still on the market, it is difficult to see how plaintiffs could ever meet their burden on the fraud exception.