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Latest from Drug & Device Law
Does the State of Washington Recognize A ‘Direct-to-Consumer’ Exception to the Learned-Intermediary Doctrine?
A federal court has asked the supreme court of Washington to address the scope of that state’s learned-intermediary doctrine. In particular, it has asked whether Washington recognizes a “direct-to-consumer” exception to the doctrine.
Under the learned-intermediary doctrine, which has been adopted by every state other than West Virginia, a manufacturer of a prescription medical product satisfies its duty to warn of the risks associated with the product if it provides adequate warning to prescribing physicians.…
E.D. Pa. Rejects PREP Act Immunity in Nursing Home Case
A month ago we thought our country had turned the corner on Covid-19. Not so. The plague continues. Bad show, America. We’re sick of Covid, sick of reading about Covid, sick of the controversies, sick of the deprivations, and, most of all, sick of all the disease and death. We won’t say we’re sick of writing about COVID, because we’ve mostly left that to others. When the tongue of history tells the final tale of…
Massachusetts Sends Litigation Tourist Packing
What happens when a plaintiff from Kentucky sues a New York company in Massachusetts? The case gets tossed for lack of personal jurisdiction. That is exactly what happened in Kingston v. Angiodynamics, Inc., 2021 WL 3022320 (D. Mass. Jul. 16, 2021). It is what should have happened in Hammons v. Ethicon, Inc., 240 A.3d 537 (Pa. 2020), but instead that case was No. 1 on our list of worst decisions in 2020. Fortunately, Massachusetts…
Zantac Chronicles V – Medical Monitoring and the Wheels Coming Off
Still more Zantac MDL dismissal orders.
Today’s installment grants dismissal of the plaintiffs’ medical monitoring claims, and also sheds some light on the questionable factual basis of everything being asserted in this MDL. As we’ve pointed out in our prior posts (such as this one), plaintiffs allege that the active ingredient in this drug could break down into an alleged carcinogen, particularly in warm or moist environments. However, N-Nitrosodimethylamine (“NDMA”), the allegedly harmful breakdown…
Excellent “Generic Preemption” Amiodarone Decision out of the District of New Jersey
The Drug and Device Law Rock Climber celebrated her birthday this week by acquiring a companion for the Irascible Rescue Pomeranian (you can read about him here). The new family member is a four-month-old Australian Shepherd mix, pure white with blue eyes. We sense figurative ears perking up at this description, as dog- (and cat-) savvy readers are no doubt aware that this lack of pigmentation is genetically linked to deafness. And, indeed, the puppy…
FDA Reporting and Consumer Protection Issues Certified to Connecticut Supreme Court
As we discussed in our recent 50-state survey on failure-to-report claims, plaintiff-side allegations seeking to predicate “warning” liability on a defendant’s allegedly failing to comply with FDCA adverse event reporting claims are “relatively new.” That’s because, like so many other novel claims we’ve seen lately, it’s a transparent dodge to avoid preemption. We said there:
In the FDA context, the idea of a “reporting” cause of action for failure to warn is almost never…
Pain Doctor Challenge to Pharmacy Refusal to Fill Prescriptions is Subject to Board of Pharmacy Primary Jurisdiction
Today’s case, Bradley v. CVS Pharmacy, Inc., 2021 Cal. App. LEXIS 451, 2021 WL 2176797 (Cal. Ct. App. May 28, 2021), is not about drug or device product liability, but its discussion of deference to administrative agencies is interesting. There are several different but closely related doctrines that either require or permit judicial deference to administrative agencies. One such doctrine, typically described as the exhaustion doctrine, requires parties to exhaust their remedies in an administrative…
Defendant Wins Summary Judgment Battle in Louisiana
We’ve used the term one-two punch to refer to a couple different situations – Daubert wins followed by the grant of summary judgment; Mensing preemption for generic manufacturers and no innovator liability for brand manufacturers. And we’re going to dust it off again today to refer to Couturier v. Bard Peripheral Vascular, Inc., — F.Supp.3d –, 2021 WL 2885903 (E.D. La. Jul. 8, 2021). Not only did defendant win summary judgment on design defect, but…
Banned on the Run
With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”
That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the “F.4th”). The FDA made a back-door move to prohibit an off-label use it didn’t think was safe using what it claimed was its power…