The plaintiff in Vesoulis v. Reshape Lifesciences, 2021 WL 1909725 (E.D. Louisiana May 12, 2021), was a dentist. So if he was complaining about pain and suffering, we’d step back and take notice. (Think of the Steve Martin song from the Little Shop of Horrors musical film.) The plaintiff certainly did have something to cry about after the court’s decision, which dismissed his claims with prejudice.
The plaintiff alleged that a weight-loss device (involving a balloon) perforated his esophagus when it was removed from his stomach. He sued the manufacturer of the device for product liability and failure to warn. He also sued the treating doctor for medical malpractice and lack of informed consent. The defendants moved for summary judgment. The doctor’s argument centered on Louisiana law, while the manufacturer of the device – which had gone through the rigorous premarket approval (PMA) process – pointed to express preemption under the Medical Device Amendments Act of 1976. The court granted those motions based on an analysis both of PMA preemption and Louisiana state law.
The key fact is that the plaintiff signed an informed consent form that identified all of the risks he claimed to have suffered from the allegedly defective medical device. (The form actually warned of “death and/or esophageal perforation.”) As you would expect, that fact clobbered the plaintiff’s informed consent claim against his surgeon. The plaintiff argued that in addition to the general warning re death and perforation, he should have been warned of particular fatal adverse events. (One would think that a dentist would be particularly pro-active in inquiring about risks. Remember how Laurence Olivier in Marathon Man kept asking, “Is it safe?”) But the surgeon did not know about those adverse events, so it wasn’t his fault. So much for the med-mal claim.
The informed consent form also clobbered the plaintiff’s warning claim. Because PMA express preemption was at issue, the plaintiff’s only hope was to satisfy the dreaded parallel claim exception, meaning that the manufacturer had violated a provision of Louisiana law that tracked a federal requirement. The problem for the plaintiff was that under the Louisiana product liability statute, a warning need only inform of risks beyond those contemplated by an “ordinary user” with the usual “community” knowledge. The weight-loss product’s warnings were addressed to surgeons who knew these risks, and the surgeon here put those risks in the informed consent forms he used. Thus the plaintiff’s attempt to state a failure to report claim failed because it was not a valid claim under Louisiana law, but was, rather, a preempted private attempt to enforce the FDCA. Or, to borrow the Vesoulis court’s borrowing of Buckman’s elegant formulation, because the plaintiff’s state law claims against the manufacturer “exist solely by virtue of [federal] requirements enacted as part of a comprehensive regulatory scheme by Congress, they are either preempted by federal law, meritless under Louisiana law, or both.” So much for the product liability claim.