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
Keeping Alert for (In)Valid Legislation
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
The Medical Device Labeling Exception for “Commonly Known” Hazards
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
Confident Learned Intermediaries Defeat Warning Causation
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.
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Unimpressed Learned Intermediaries Defeat Warning Causation
There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries. The law presumes that licensed doctors know what they are doing. That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. As part of that process, such physicians necessarily also evaluate what risks they should tell – and not tell − their patients.
One consequence of a physician’s presumed medical competence is that a learned intermediary is within his/her rights to disregard a manufacturer’s warning altogether, to decide that a particular risk was not severe enough to make a difference, or to conclude that such a risk did not exist or was not material in the context of a particular patient’s medical needs. In all of these situations, the prescriber’s independent evaluation of what risks to credit, which to ignore, and which to omit in counseling patients breaks the causal chain of , entitling a manufacturer defendant to judgment on a warning claim concerning such risks. This scenario was the “third hypothetical” in our “Learned Intermediary Rule 201” post back in 2008.
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PLAC Shameless Plug
Not too long ago we blogged about the value that the Product Liability Advisory Council (“PLAC”) brings to the table – particularly to drug and device manufacturers faced with relentless product liability claims. For the third time, we urged our corporate readers to support PLAC’s pro-defense advocacy by joining and becoming members.
Still not
Valuable Piece on Class Action Fairness Act (“CAFA”) Advanced Removal Strategies – Distributed with Permission
We’re not the font of all legal knowledge; we don’t claim to be. Every now and then we come across material published by our colleagues at other firms defending prescription medical product liability litigation that we think would be valuable to our readers, so we ask if we can republish. That’s how our 50-state survey
Ninth Circuit – First Amendment Prevails Over Prop 65
California’s Proposition 65, which has spawned litigation over scientifically questionable “known to the state [of California] to cause cancer” warnings on such everyday products as cola drinks, coffee, beer, and soy sauce, see Riva v. Pepsico, Inc., 82 F. Supp.3d 1045, 1062 (N.D. Cal. 2015), took one on the chin recently in the Ninth Circuit at the hands of free speech under the First Amendment.
We can’t say it was unexpected – indeed, Prop 65 was one of the targets of the First Amendment’s prohibition on governmentally compelled speech that we identified in our 2019 post on American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (“ABA”). And lo it has come to pass.
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Pennsylvania Also Rejects Educational Malpractice, and Thus Duty-To-Train Claims
We have posted twice before about decisions that reject duty-to-train claims under the rubric of “educational malpractice.” Now Pennsylvania has joined the party. Grady v. Aero-Tech Services, Inc., 2022 WL 683720 (Pa. Super. March 8, 2022), an unpublished, but citable, decision of Pennsylvania’s major intermediate appellate court, applied Pennsylvania’s prior precedents that reject educational
New Decision Directly Addresses the “Is Software a Product” Question
As regular readers know, we bloggers have been following the issue of whether software of various sorts – electronic bytes – is a “product” for product liability purposes. It’s a longstanding issue, since the current Restatements of Torts specifically defines a “product” as something “tangible,” which arrays of electrons are not. “A product is tangible