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
Strict Liability
Another Blood and Tissue Statute Win

This has been a big year for blood and tissue statute decisions. Given their subject matter, we’ve previously lamented that the decisions didn’t fall closer to Halloween. While not quite coinciding with our doorbells ringing and handing out candy to the little ones, today’s decision is close enough for a little seasonal digression.Continue Reading Another Blood and Tissue Statute Win
Don’t Let Pennsylvania Plaintiffs Succeed with Phony Comment K Argument

Recently we discussed the latest opinion in the ongoing “controversy” over the application of Pennsylvania’s comment k across-the-board rule to cases involving medical devices. Douglas v. Atrium Medical Corp., 2024 WL 4364950 (M.D. Pa. Sept. 20, 2024). We use “controversy” advisedly, because as Douglas held, there is “no substantial ground for difference of opinion…
No Debating Pennsylvania’s Rejection of Strict Liability for Implantable Medical Devices

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…
Erie Doctrine Requires Narrow Interpretation of Florida Human Tissue Shield Statute

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…
Cal. Human Tissue Shield Statute Bars Claims for Strict Liability and Breach of Warranty

Lokkart v. Aziyo Biologics, Inc., 2024 U.S. Dist. LEXIS 111265 (C.D. Cal. May 29, 2024), is yet another case arising from the unfortunate contamination of a batch of tissue allograft with a disease. We have written about similar cases before. These cases have consistently produced favorable precedent concerning state human tissue shield statutes (in…
Post-Gilead Heartburn in the California Ranitidine Litigation

This post is from the non-Reed Smith, non-Dechert , and non-Holland & Knight side of the blog. Everyone else is involved.
The Good, the Bad, and the Ugly is a classic Clint Eastwood spaghetti Western where even the Good may not be all good. In California state court, a demurrer sustained is a defense win, right? Although there are some bright spots, In re Ranitidine Cases is one of the ugliest defense wins we have seen in a while, providing leave to amend and a roadmap for further expansion of the Gilead duty-to-innovate.Continue Reading Post-Gilead Heartburn in the California Ranitidine Litigation
Is Human Tissue A Product?

We don’t see many cases involving human tissue, but medical products derived from human tissue are actually quite common. Skin replacement products, tissue-engineered cartilage, compounds for treating bone fractures and tumors. Those kinds of things. Just yesterday in our annual Ten Best/Ten Worst Cases webinar we discussed a case involving transplanted human eye tissue. …
Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability. That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their…
Creazzo, False “Pro Se” Claims, and Candor Towards Tribunals

Beginning – at least − with the awful decision in Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448, 465 (W.D. Pa. 2019) (discussed here), plaintiffs seeking to overturn the longstanding Pennsylvania (since the 1940s) prohibition against strict liability in prescription medical product liability litigation have been systematically attacking the precedential weight…