A little over a year ago, we reported on a decision by Judge Rufe (E.D. Pa.) dismissing an Avandia heart attack case on the grounds of the learned intermediary rule (Utah law). All of the plaintiff's claims boiled down to an alleged failure to warn, and that was a problem for the plaintiff, as the plaintiff's proposed enhanced warning ended up being discredited by the science after the case was filed. Thus, even though the prescriber had stopped prescribing the product for a period of time after some adverse data came out, by the time of the prescriber's deposition he testified that he felt comfortable with his decision to prescribe the medicine to the plaintiff. That evidence prompted the district court to bid adieu to the claims. Our defense hack hearts were gladdened by this result.

Those defense hack hearts are even more gladdened by the Third Circuit's recent affirmance of the district court's decision. In re: Avandia Marketing, Sales Practices and Products Liability Litigation (Siddoway), 2018 WL 6828423 (3d Cir. Dec. 28, 2018). The Third Circuit did not see fit to publish the affirmance in the West Reporter, but we see fit to publicize it.

As the Third Circuit reminds us, the plaintiff's claims in Siddoway drew a causal link between prescriptions for Avandia prescribed in 2001 and 2002 and the plaintiff's two heart attacks in 2003. The case hinges on what the prescribing doctor would have done, with regard to prescribing Avandia, if he had seen the warning the plaintiff preferred. The prescriber testified that he stopped prescribing the drug after learning of a 2007 meta-analysis of 42 clinical trials by Dr. Steven Nissen – a familiar name to many of us — that associated Avandia with an increased risk of heart attack. The prescriber testified that he would have "thought twice" and would have been "much more thoughtful" about prescribing Avandia and would not have prescribed the drug to the plaintiff "in the middle of all these heart attacks" if he knew this information in early 2003.

That testimony is mildly interesting, but does not really mean much because (a) the undisputed record shows that the actual prescription occurred one year before the plaintiff's heart attacks, not "in the middle" of them, and (b) for the prescriber to say he would have been "much more thoughtful" and would have "thought twice" about prescribing Avandia if he knew in early 2003 the risk information that arose in 2007 does not cut it. The Third Circuit concluded that "the vague and highly speculative nature" of the prescriber's testimony "suggests no concrete action and it is tied to hypothetical knowledge in 2003." That is an important ruling, because it is exactly that sort of general, speculative, might've-thought-more stuff that plaintiff attorneys usually elicit from prescribers. The plaintiff lawyers then pack up their papers and smugly climb aboard their private jets, sure that they have staved off summary judgment. But they have not (or should not have) staved off summary judgment. Rather, they have walked right into it.

And then there is the inconvenient (for the plaintiff) fact that the prescriber in Siddoway also testified that if he had also known in 2001 and 2002 about the exculpatory information available in 2015, the time of his deposition, when the Food and Drug Administration removed the link between Avandia and an elevated risk of heart attack, he would have made the same choice to prescribe the drug to Siddoway. As we wrote a little more than a year ago, the result in Siddoway seemed "inevitable." The Third Circuit saw it the same way.

This article is presented for informational purposes only and is not intended to constitute legal advice.