A lot of life comes down to timing. Maybe you submitted your job application just as positions were opening. Maybe a slow taxi driver caused you to miss a disaster. Maybe you met the love of your life because an elevator door slammed shut on you.
We’re here to talk about law, not love. Still, there is a lot to love in the SCOTUS Albrecht decision, which breathed new life into conflict preemption of drug failure to warn claims. Initially, we thought the most significant aspect of Albrecht was its insistence that judges, not juries, must decide whether there was “clear evidence” that the FDA would have rejected the warning urged by plaintiffs. But Albrecht has produced progeny and a parade of happy dismissals (well, happy if you are a flint-hearted defense hack), and it is now clear that the real force of Albrecht is the rigorous application of the “new evidence” component of the “Changes Being Effected” (CBE) provision. Was there actual “evidence” warranting a label change (not just a tentative article, not just some adverse event reports) and was it really “new”?
Zamfirova v. AMAG Pharmaceuticals, Inc., 2021 WL 2103287 (D.N.J. May 25, 2021), turned on whether the alleged evidence was “new.” It was about timing. Moreover, the issue of timing was exquisite and the court’s application was rigorous. Zamfirova is a decision that a drug and device defense lawyer should love, though that love will be a little less ardent given that Zamfirova is an unpublished decision.
Zamfirova was a putative class action brought under consumer protection and deceptive practices laws in California, New York, New Jersey, Kansas, Missouri, and Wisconsin. (Good luck coming up with some principle that explains that peculiar collection of states.) The plaintiffs alleged that a medicine marketed to prevent premature births was ineffective. Essentially, the plaintiffs wanted a warning that would say something like, Do not use this drug; it is ineffective. That strikes us as a tiny bit crazy. Here is a very bad fact for the plaintiffs: in 2011 the FDA approved the drug, which means it concluded that the drug was safe and – ta da! – effective.
Did someone say preemption?
Yes, the defendant did, as part of its motion to dismiss the complaint. There was no denying that the plaintiffs were attacking the content of the FDA approved label. In fact, the plaintiffs said that the label itself was “a thicket of misleading half-disclosures and omissions” that was “unquestionably misleading.” So what?
And now we must get to a very good fact for the plaintiffs: a study came out in March 2019 showing no statistically significant difference between the drug and placebo in preventing premature births, and that study prompted an FDA Advisory Committee to recommend that the drug be withdrawn from the market. Insurers then signaled that they would stop paying for the drug. Nevertheless, the manufacturer did not pull the drug from the market.
As we said at the outset, timing is important. The defendant argued that it could not have availed itself of the CBE exception until April 2019 at the earliest, meaning that the plaintiffs’ claims arising before then were preempted. The plaintiff responded that the defendant knew before finalization of the study that incoming data showed ineffectiveness. But that response was mere say-so premised on information and belief. The plaintiffs failed “to allege any specific facts” to support their assertion that the defendant somehow ascertained in advance the results of a double-blinded, placebo-controlled clinical trial. Thus, any claims arising before the final date (March 2019) of the damning study were preempted.
Does that mean that later claims are saved? No, because the plaintiffs failed to allege the specific date on which they were prescribed or they purchased or they took the drug. The plaintiffs simply referenced the “class period,” which would extend from January 2014 to the present. The complaint was vague and overbroad as to time. Because the plaintiffs failed to provide sufficient facts for the court “to determine whether or not their claims are preempted, the Court dismissed all of Plaintiffs’ consumer-fraud based claims….” We’ll get to that ellipsis soon.
The Zamfirova court also dismissed the unjust enrichment claims under New Jersey law because the plaintiffs did not allege that they purchased the medicine directly from the defendant.
About that ellipsis…. The dismissals in Zamfirova were without prejudice. That means the plaintiffs can amend their complaint. Better luck next time. (We say that without a smidgen of sincerity.)