Public policy favors scientific and medical research. So do we. While the theories of various claims asserted against sponsors of medical research—and the reasons for rejecting them—vary greatly, the underlying incentive to promote good research certainly plays a role in protecting those that sponsor and conduct medical research from virtually unlimited liability for alleged
This is from the Holland & Knight side of the Blog only.
If you have followed the Blog, then you will know that we have long touted the importance of Erie deference by federal courts sitting in diversity. We have also questioned the expansion of tort law to allow governmental entities to use public nuisance to shift the costs of governmental services to private entities without calling it a tax. We have even discussed the issue of abrogation of common law claims, which can be seen as a lingering source of unchecked liability, when a state enacts a product liability act. For various reasons, however, we have largely declined to comment on the use of public nuisance as the primary theory for governmental entities as plaintiffs in opioid litigation. Today’s post is an exception, and it deals with a pretty significant decision, which we think is overdue.Continue Reading Ohio Does Not Recognize Public Nuisance Claims For Products
This is from the non-Dechert part of the Blog.
Over the years, the Blog has had many, many posts related to the issue of whether Pennsylvania recognized any form of strict liability in product liability actions against prescription medical products. In addition to the fact that several of the principal authors of the Blog have
Adding to the growing favorable precedent concerning state human tissue shield statutes is Heitman v. Aziyo Biologics, Inc., 2024 WL 4019318 (N.D. Fla. Jul. 22, 2024).
The plaintiff alleged that he was infected with tuberculosis from an unfortunately contaminated human tissue allograft that was implanted in his spine during surgery. The plaintiff alleged
In Clemens v. DaimlerChrysler Corp., 534 F.3d 1017 (9th Cir. 2008), the court, applying California law, correctly “decline[d plaintiff’s] invitation to create a new exception” to that state’s privity requirement “that would permit [plaintiff’s] action to proceed.” Id. at 1023-24. “[A] federal court sitting in diversity is not free to create new exceptions” to state law limiting liability. Id. at 1024 (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)). D&Z held, as we’ve discussed many times:
A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.
423 U.S. at 4. And the Supreme Court has kept on saying this. Erie principles prohibit “federal judges” from “displac[ing] the state law that would ordinarily govern with their own rules.” Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988). “[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.” Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).
But when updating the learned intermediary section of his treatise, Bexis came across a peculiar MDL holding, that because a defendant supposedly “cite[d] no cases” for the proposition “that the learned intermediary doctrine should apply to Plaintiffs’ . . . consumer protection claims” under the laws of California, Maryland, Illinois, and Florida, then “the learned intermediary doctrine should not apply” to claims brought by plaintiffs in any of these states. In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023). The decision did not cite any precedent from any of these states (not even a trial court decision) affirmatively creating any exception to the learned intermediary rule for consumer fraud claims. Id.Continue Reading Debunking Another Stunningly Wrong MDL Expansion of Liability
For design defect claims, a key issue is whether the relevant jurisdiction requires evidence that a suitable alternative design existed that would have allowed the plaintiff to dodge the alleged injury. This blog has posted at length about alternative design requirements and their nuances. These posts address everything from the existential question of “What
Abuse of substantive law as a weapon to force settlement occurs so frequently in multidistrict litigation (“MDL”), that we’ve given it a name – “the MDL treatment.” The linchpin of the MDL treatment is that plaintiffs are allowed to take way more liberties with state law than the Erie doctrine allows. Readers can recall from our prior posts that both the Supreme Court and Third Circuit (to take the relevant example), view expansive federal court “predictions” of state law – and state tort law in particular – usurp the prerogatives of the states and are an abuse of power. Continue Reading CPAP MDL Overinflates Plaintiffs’ Claims
For much of the sixteen and a half years of this Blog, we have been tracking the acceptance and rejection of the learned intermediary doctrine. The first year that we compiled a worst decisions of the year list it was topped by a case that still holds the title for worst, most thinly veiled legislation
Two weeks ago, we decried the pattern that some courts follow in allowing shifting slates of boilerplate allegations to cases to discovery. The decision in Corrigan v. Covidien LP, No. 22-cv-10220, 2022 U.S. Dist. LEXIS 210296 (D. Mass. Nov. 21, 2022), reminded us of another of our post-TwIqbal pet peeves: when courts treat sweeping legal conclusions as if they were plausible factual assertions. The basic allegations in Corrigan were that the plaintiff’s surgeon used defendant’s surgical stapler to perform an anastomosis—reattachment of two parts of the digestive tract—in connection with removing part of his sigmoid colon (for unspecified reasons, but often diverticulitis or cancer) and the anastomosis later leaked, leading to further surgical intervention. As we said two weeks ago, medical device manufacturers are not insurers. That makes sense because surgery on humans, even done by the best surgeons, in the best hospitals, and with the best devices and equipment, has less than a 100% success rate. Anastomoses leak, infections develop, hernias recur, patients report post-operative pain, and all manner of complications and less than optimal outcomes occur. A common refrain when scientists are presented with a surgical study reporting no complications or failures is that the study was too small, too short, and/or insufficiently rigorous. Thus, a common procedure with a very high success rate will still generate large numbers of reported failures, like anastomoses that leak. This is part of why rates, and particularly comparative rates, provide more useful information about devices and surgeries than do gross numbers.
Even more authoritative sources than this Blog agree with us. FDA, for instance, makes clear that data from its Manufacturer and User Facility Device Experience (“MAUDE”) database “is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.” The reasons for this are not a secret: “The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.” Directly stated, “[t]he submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event.” FDA’s description of the MAUDE database also makes clear in a number of places that the data may be outdated or incomplete for various benign reasons.Continue Reading Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim
When we say “bananas,” today’s case is actually about bananas, that herb people tend to call a fruit. It is also quite unusual and complicated. Because it also involves some tragic underlying events, our quips are done. A bit of etymology is warranted, though. We used the term “judge-made law” in the title and that