One of the remand courts in the Aredia/Zometa litigation recently issued a decision on various motions in limine. See Brown v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 104985 (E.D. Ky. July 27, 2012). Here’s the rundown of the “good,” the “not-so-good,” and the “it depends.”
- Post-injury label changes: The court excluded evidence of the defendant’s changes to the label of Zometa in 2007 and Aredia in 2008. Id. at *38-40. Plaintiff’s injury was diagnosed in 2005, and the court held that these years-later label changes qualified as subsequent remedial measures. Of course they do. This has long been the view of the majority of circuit courts, and getting this type of ruling has become easier with amended FRE 407, which now reads in part: "When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove . . . . . a need for a warning or instruction."
- Emails by members of an Advisory Board to the defendant: The court excluded these as hearsay. Id. at *34-37. Defendant appears to have had an advisory board of outside doctors who gave the defendant advice on its draft of a white paper. Plaintiffs sought to admit emails from two of the advisors, arguing that the emails weren’t hearsay because the doctors were somehow agents of the defendant. But agreeing to participate in an advisory board is far different from being an agent. There was no evidence that the defendant controlled the two outside doctors or that the doctors acted on the defendant’s behalf. They just gave advice. Plaintiffs also argued that the emails were business records, but the court saw no evidence that serving on these advisory boards was regularly conducted business activity or that, even if it were, the emails were a regular part of that business activity.
- Adverse Event Reports (AEs): The court allowed plaintiffs to use AEs as evidence of causation and for notice. Id. at *25-30. We’ve blogged many times – because it’s right – that AEs should not be used as evidence of causation. They’re hearsay, anecdotal, incomplete, and unreliable. Unfortunately, this court will allow plaintiffs to do it here, so long as a plaintiffs’ expert testifies that he relied upon AEs to form a causation opinion. We don’t think that finding an expert to offer such an opinion changes the deficiencies of AEs. For those interested, we’ve compiled a cheat sheet of AE decisions that we believe got it right. Additionally, by the way, the court allowed plaintiffs to use AEs for notice to the defendant, a much less controversial ruling.
- Failure to warn non-prescribers. The court recognized that under Kentucky law a defendant is not liable in a failure to warn case if the defendant gave an adequate warning to the plaintiff’s prescriber. Id. at *33. That’s good. But plaintiffs also wanted to show evidence of a failure to warn non-prescribers. That seems wholly irrelevant. The prescribers were either warned or not. Now, while the court did not issue a final ruling, it did hold open the possibility of allowing non-prescriber failure-to-warn evidence if plaintiffs showed that the actual prescribers were not warned. Id. at *33-34. This seems like an invitation to mischief. Failure to warn does not occur in the air. It must involve the relevant learned intermediaries – the prescribers.
The "it depends":
- Choice-of-law on punitive damages. It depends because all lawyers approach this issue by first determining which state’s law they would prefer applied. Here, New Jersey law, the home of the manufacturer, allows no punitive damages because the FDA approved the drugs, while North Carolina law, where the plaintiff purchased, used and allegedly was injured by the drug, would allow punitive damages. The court applied Restatement (Second) of Conflict of Law and chose New Jersey. In short, the court held that, while North Carolina law properly applied to the underlying claim because it was aimed at protecting the plaintiff, New Jersey law should apply to the punitive claim because it was aimed at deterring any wrongful conduct of the defendant, a New Jersey company. Id. at *10-24. No matter how you look at this, though, it was a nice victory for the defendant.