When we (belatedly) learned of the Supreme Court’s abolition of the so-called “presumption against preemption” in express preemption cases, that knowledge just about made our year. Since then we’ve written several posts about that case, Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016), and its effect on preemption cases in our
An amendment to the FDCA, called the “Verifying Accurate Leading-edge IVCT Development Act” – or VALID Act (cute) for short – has been wending its way through Congress. It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on
Today’s case is Glover v. Bausch & Lomb, Inc., — A.3d –, 2022 WL 2035805 (Ct. S. Ct. Jun. 7, 2022). And all we can say is Boo! Not a Halloween, Casper-type Boo! But a real Queen of Putrescence-type Boo! Because unfortunately, the Connecticut Supreme Court, responding to a certified question from the
We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.
The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” 21 C.F.R. §801.109(c). That requirement comes
On this gorgeous late-spring Philadelphia day, we are excited about a couple of things. The Drug and Device Law Dowager Countess is home, after an improbable recovery from a horrific fall. We just learned that the Colorado Symphony is resurrecting an (also improbably) cool tribute to John Denver we saw a few years ago, featuring
Several weeks ago, we reported on Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), in which the Third Circuit affirmed dismissal of a failure-to-warn claim because the plaintiff had failed to allege facts sufficient to overcome New Jersey’s “compliance presumption,” a statutory presumption (adopted by numerous states) under which a medical
The late chef and travel raconteur Anthony Bourdain said that great chefs pride themselves on what they can do with offal. Anybody can make a fine steak. It takes real creativity and skill to turn glands and guts into something delectable. Think of sweetbreads, tripe, or liver. No, really. A couple of weeks ago on
It has been 23 years since New Jersey adopted a direct-to-consumer advertising exception to the learned intermediary rule. And, as of last week it remains the only state to have done so. Every state has adopted some version of the learned intermediary rule. So, it is saying something that in almost a quarter of a
Confident prescribing physicians and implanting surgeons are the best “learned” intermediaries. They’re experienced at what they do and aren’t intimidated by plaintiffs’ counsel and their threats of malpractice claims if they don’t testify the way plaintiffs want them to. Confident learned intermediaries stand by their medical decisions. Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases.
Continue Reading Confident Learned Intermediaries Defeat Warning Causation
A very helpful to-be-published opinion from the California Court of Appeal caught our eye this week because it comes out the correct way on an issue that has always bothered us: Does a defendant (not the plaintiff) in a product defect case have to offer evidence on medical causation to a reasonable degree of medical