This post is from the non-Reed Smith side of the blog only.
The InFuse litigation has certainly given us quite a lot to talk about – and almost all of it positive. It has been a treasure trove for defendants on off-label marketing and promotion claims. We’ve collected this bounty of riches here. While each case has its own nuances, they are all really slight variations on a theme – the almost unanimous rejection of plaintiffs’ attempts to use off-label marketing to thread the preemption needle. While the reasoning varies from court to court, the over-arching message is the same – off-label marketing does not change the preemption analysis. The InFuse device, regardless of how it was used by a particular surgeon in a particular surgery, is a PMA-approved, Class III device and therefore covered by both Riegel express preemption and Buckman implied preemption. Very little slips through the small space between the two.
If you want a more complete history of the InFuse litigation, we point you to our collection referenced above. For even casual readers of our blog, we think you’ve probably seen some of our writings on the topic and so we aren’t going to wade back through the details. Today’s post is more of an update. Here are the latest four InFuse victories.
Truthful v. Untruthful Promotion
First up is Byrnes v. John Small, 2015 U.S. Dist. LEXIS 33555 (M.D. Fla. Mar. 18, 2015). This case is fairly typical for InFuse. Failure to warn and design defect claims are preempted, id. at *13-14, *17-19. We will point out that this is another court that understands that the FDA approves devices, not “specific uses” of devices. Id. at *18. More importantly, Byrnes is also another outright rejection of our least favorite InFuse case, Ramirez, and points out the poor logic of that ruling. Id. at *18-19.Continue Reading Let’s Talk InFuse