A plaintiff lawyer recently filed a case against our client in North Carolina. He has made a settlement demand that any rational observer would regard as ambitious to the point of outrageous. Despite that crazy number, we are on fairly friendly terms with the plaintiff lawyer. We jawbone at each other in a generally good
Montana became the first state to ban TikTok this month. You no doubt have seen the press and have read the spirited discussion condemning foreign spies on the one hand and championing First Amendment rights on the other. Litigation has already commenced. But, while all that was developing, you may have overlooked that Montana
Today’s case is Thelen v. Somatics, LLC, 2023 WL 3338221 (M.D. Fla. May 5, 2023). It is a straightforward products liability case involving a medical device used in electro-convulsive therapy. Plaintiff alleges the device caused a permanent neurological injury, memory loss, and brain damage and that the manufacturer is liable for failure to warn
If we have said it once, we have said it a hundred times: medical product manufacturers are not insurers of their products. Almost as frequently uttered would be that strict liability is not the same thing as absolute liability. In the show position might be that the temporal relationship between a new medical condition and
More than once have we taken note of the current plaintiff lawyer infatuation with enlisting “independent” (ha ha ha) laboratories that will manage to detect contaminants in any drug, cosmetic, or puddle of unicorn tears. For example, see our coverage of the Zantac MDL magnum opus ruling where the court was less than impressed by
Quick – when’s the last time that a federal court of appeals certified a pro-plaintiff ruling to the relevant state supreme court?
We don’t remember either.
Continue Reading Alternative Design Issue Certified to West Virginia High Court
When we see a court dismiss a pharma product liability case on preemption grounds, we simply have to write about it. Otherwise, we’d be required to turn in our bar card, our defense hack card, and our friendly neighborhood DDL blogger card.
In Polson v. AstraZeneca Ltd. Partnership, 2023 WL 2770687 (D.Conn. April 4, 2023)
Second chances, sure. Two bites at the apple, we see it all the time. Three strikes before you are out, fairly common. But a fourth amended complaint to cure basic pleading deficiencies? That seems overly generous by any standards. Well, almost any standards because that is what plaintiff got in Greenwood v. Arthrex, Inc.
In updating chapter three of his book, on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions. Quite a few states, as well as the Third Restatement of Torts, require plaintiffs alleging design defects to identify a “feasible” alternative design for the product as a prerequisite for asserting a design defect claim. Even where an alternative product design is not mandatory, plaintiffs frequently offer such evidence. In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.”
But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Thus, as a matter of logic and semantics, “feasibility” would seem to demand that any proposed “alternative” to the existing design of a product subject to FDA scrutiny must likewise have passed the same level of FDA scrutiny. For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims.
Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible for crafting (and sometimes outright inventing, see fraud on the FDA) defenses for that then-unusual medical device-related mass tort. One of the first post-MDL-remand Bone Screw cases involved a Louisiana statute, La. Stat. Rev. §9:2800.56, requiring that, for a product to be “unreasonably dangerous in design,” the plaintiff must establish that “[t]here existed an alternative design for the product that was capable of preventing the claimant’s damage” based on the statute’s risk/utility test.