Some of us DDL bloggers have admitted to occasionally choosing our subject case based on its length. In theory a shorter case is less complicated, has less to analyze, and takes less time to write up. In theory. In reality, if there is not enough “there” there, drafting a compelling post can require more creative
Learned Intermediary
No DTC Advertising Exception to Learned Intermediary Rule in Washington
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 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.
Continue Reading Confident Learned Intermediaries Defeat Warning CausationUnimpressed 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.
Continue Reading Unimpressed Learned Intermediaries Defeat Warning CausationChoice of Law Nixes Punitive Damages in Remanded Mesh Case
New Jersey ain’t Florida and vice versa. Obviously, it’s warmer in Florida for more of the year and it never gets cold enough to snow. That could be a pro or a con. Florida has the second longest coastline among U.S. States which gives it a greater opportunity to have more highly rated beaches. But…
D. Nevada Dismisses Gardasil Vaccine Lawsuit
Happy Star Wars Day. May the Fourth be with you.
If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.…
Not the Best Wisconsin Law Decision We’ve Ever Seen
A few years ago we did a couple of posts about the learned intermediary decision that arose from the Zimmer Nexgen Knee Implant MDL, and was subsequently affirmed by the Seventh Circuit Court of appeals. We designated the opinion In re Zimmer Nexgen Knee Implant Products Liability Litigation, 218 F. Supp. 3d 700 (N.D.…
Learned Intermediary – Not Just For Failure to Warn
Coming off Super Bowl weekend, we have commercials on the brain. The big game has given us some of the most iconic ads and mascots of all time. From Budweiser alone we have the Frogs, Wassup!, and the Clydesdales. This year’s ads were full of celebrities, but that’s nothing new. McDonald’s had the Showdown with…
Court Allows Fraud and Misrepresentation Claims to Proceed Despite the Learned Intermediary Doctrine
A federal court applying Florida law has refused to dismiss fraud and misrepresentation claims brought by a patient against a medical-device manufacturer, rejecting the manufacturer’s contention that such claims are categorically barred by the learned-intermediary doctrine.
It is perhaps telling that the decision, Pirlein v. Ethicon, Inc., Med. Devices Rep. ¶ 24,799 (S.D. Fla.…
Don’t Overlook “I Don’t Recall” Testimony
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…