Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues. Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon. Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility. Id. at *1.
The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). It wasn’t. Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.” Id. at *2. Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).
Continue Reading FDCA-Based Negligence Per Se & Informed Consent Don’t Mix