In preparation for our OTC panel next week at ACI-NY, we have kept our eyes open for any OTC cases that raise interesting issues. Today’s case, Rooney v. Procter & Gamble Co., 2022 U.S. Dist. LEXIS 210218 (E.D. La. Nov. 21, 2022), involves a claim by the plaintiffs that a woman developed triple negative
We have a case going on where the plaintiff wants to preclude the use of a term found in his medical records to describe something that happened to him in the past that is highly relevant to the claims and injuries in the case. Instead of using the actual term, which was also used in
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v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues.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
This post is from the non-Winston & Strawn side of the blog.
As we write today, we are nine days from an event, two years in the planning, that we have mentioned in these pages before. We are taking the Drug and Device Law Dowager Countess (nearly 88) and her slightly younger sister to see
Every once in a while, we encounter a decision that is so obviously wrong that we have to pause and go back to the basics to make sure we did not miss something in our initial read. This dynamic is something like reading the troubleshooting instructions that you might get when you buy a new
Today’s post is not about something cutting edge or controversial. It’s a don’t lose sight of the basics kind of post. Plaintiff bears the burden of proof on causation. In a prescription drug failure to warn case, that means plaintiff must demonstrate that a different warning would have changed whether the drug would have been
In Hayes v. University Health Shreveport, LLC, 2022 WL 71607 (La. Jan. 7, 2022), the Louisiana Supreme Court ruled that a hospital – or any other private employer – may impose an absolute vaccination requirement and fire any employee who fails to comply. The case involved medical centers that notified all employees that they
We’ve used the term one-two punch to refer to a couple different situations – Daubert wins followed by the grant of summary judgment; Mensing preemption for generic manufacturers and no innovator liability for brand manufacturers. And we’re going to dust it off again today to refer to Couturier v. Bard Peripheral Vascular, Inc., —
The Xarelto personal injury claims settled in 2019 after six bellwether trials all ended with defense verdicts. What remained, until now, were several third-party payor (health insurers, “TPPs”) actions that have been dormant for almost six years. Despite the passage of time, the motions before the court in 2021 were to dismiss under Rules 12(b)(6)
We don’t know much, but there are a few things we know for sure. One is that when a topic is complex and not within the knowledge of an ordinary lay person, you generally need an expert. A second is that determining the medical cause of a disease is almost always complex and not within