In our 2017 post, “Medtronic v. Lohr Has Two Shadows,” we pointed out that the “presumption against preemption” that was the linchpin of that decision’s crabbed and atextual reading of the FDCA’s express preemption clause for medical devices, 21 U.S.C. §360k(a), was no more. Lohr had justified its specificity gloss on the broad
In a ruling that is contrary to Supreme Court precedent, the district court presiding over the Zostavax MDL recently held that federal law does not preempt a state-law design-defect claim based on the manufacturer’s failure to seek FDA approval of a different, purportedly safer vaccine.
Zostavax, a shingles vaccine, received FDA approval in 2006. The
The defense response to so many plaintiff allegations amounts to: so what? What difference did the complained of conduct make? Think of medical causation. Or think of warning causation in the context of a learned intermediary. In securities cases or, closer to our DDL hearts, False Claims Act cases, the ‘so what’ arrives dressed in
A little over a year ago, the Supreme Court heard argument in Ford Motor Co. v. Montana Eight Judicial District Court, 141 S.Ct. 1017 (2021) regarding an issue of personal jurisdiction. At that time, we tried our hand at reading the tea leaves and made this prediction about how the Ford Motor decision might adversely
We’ve commented extensively on COVID–19–related vaccination cases, because vaccines are prescription medical products. We haven’t commented on another aspect of litigation intended to sabotage public health efforts to combat the COVID-19 pandemic – attacks on masking requirements − mostly because masks don’t require prescriptions. The kind of masks involved in
Regular readers know that, after receiving a useful guest post on Iowa learned intermediary law, we asked our readers if they would like to prepare similar detailed arguments in favor of the LIR for other states in which there was no state-court appellate law. Here is one for Wisconsin. It’s authored by three attorneys from
Recently, when we have spoken of vaccine litigation, it has mostly been about challenges to public health policies requiring vaccination against COVID-19 for healthcare workers, students at public universities, etc. We have been pleased to report that these challenges have been failing without lingering too long at the trial court level, like here, here
It has been a while since we’ve written about a case delivering a one-two punch against a plaintiff suing both brand and generic drug manufacturers for alleged injuries from ingesting generic drugs. Punch One is rejection of the claims against the brand manufacturers because they did not make or sell the products at issue in
Today’s case is not new to us. A year and a half ago we were extolling the virtues of Blackburn v. Shire U.S., Inc., 2020 WL 2840089 (N.D. Al. June 1, 2020), for granting summary judgment where the testimony from plaintiff and his prescribing physician shot holes in proximate causation too large for a
We are headed to New York on Monday for the A.C.I. Drug and Medical Device Conference. We love this conference – we always see so many old friends and former colleagues – and we are delighted that it is back “in person” this year. We are speaking on a panel about the proposed amendments to