The Fifth Circuit gave the plaintiff in Bruno v. Biomet, Inc., 2023 U.S. Dist. LEXIS 213826 (E.D. La. Dec. 1, 2023) a second chance, but it was short lived. This case had been dismissed on statute of limitations grounds. On appeal, the Fifth Circuit reversed that holding and remanded the case for the district
We are in New Orleans for the annual DRI Drug & Medical Device Seminar, so we would be remiss if we passed up the opportunity to write on a Louisiana case. The case will sound familiar. We reported six months ago on the dismissal of a case brought by the same plaintiff alleging that benzene
Today we ponder “do-overs,” a timely topic as the House of Representatives struggles, over and over, to elect a speaker. As we write, the seventh unsuccessful vote has just concluded. We have learned that the record stands at 22 votes before the beleaguered candidate finally prevailed. This was in 1820, as John W. Taylor, an
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 breast cancer as a result of using an antiperspirant that she asserts contained benzene.
The assertion that benzene was in the antiperspirant rested on testing by Valisure, an analytical pharmacy. Some of you have heard of a Valisure before, as its testing, and results allegedly showing contamination, have been relied upon by plaintiffs in other mass torts. Valisure calls itself “the pharmacy that checks.” Perhaps we are cynical, but we think of a different sort of checks when we see a purported independent outfit that seems to cooperate closely with plaintiff lawyers. Here, Valisure ran tests on batches of the antiperspirant and came up with concentrations of benzene significantly higher than levels recommended by OSHA. Valisure filed a Citizen’s Petition with the FDA seeking a recall of antiperspirant batches containing too much benzene. (Sound familiar?) The FDA had not responded to the Citizen’s Petition. The defendant voluntarily implemented a recall of certain batches of the antiperspirant.
Before the court was the defendant’s motion to dismiss the plaintiffs’ second amended complaint. The plaintiffs alleged that the defendant violated the Louisiana Products Liability Act by selling antiperspirants without issuing adequate warnings. The plaintiffs also alleged that the defendant was liable under theories of negligence, gross negligence, strict liability, and “fault,” and that the defendant violated the FDCA. Some of those claims seem weird (some of what’s missing also seems weird, but it’s not our job to help plaintiffs author complaints – our criticisms are strictly destructive), but remember, we’re in Louisiana. Not that we’re complaining. The people are fun, the food is great, and did we mention that the Judge in this case dismissed the second amended complaint? Continue Reading E.D. Louisiana Dismisses Antiperspirant/Benzene Claims
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