Today’s guest post comes from our Reed Smith colleague Jamie Lanphear on a topic near and dear to the Blog’s heart: The new EU Product Liability Directive. As always, our guest posters deserve 100% of the credit, and any blame, for their posts. But, also as usual, our guest posters deliver the goods, so we
Today’s guest post is from Reed Smith’s Matt Jacobson. He addresses the latest and greatest result from litigation that has been generating favorable decisions nationwide applying various states’ so-called “blood shield” statutes (practically every state has one) that declare the use of human cells or tissue in medical treatment to be services rather than products, which has the effect of limiting liability to negligence. As always our guest posters deserve 100% of the credit (and any blame) for their work.
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Milovich v. Aziyo Biologics, Inc., No. 1:24-cv-01208-CL, 2025 U.S. Dist. LEXIS 50935 (D. Or. Feb. 24, 2025), involves Oregon’s human blood and tissue shield statute. The Drug & Device Law Blog has written about similar cases before, but this one might be the best. Blood shield laws have been around for over 60 years. They sound like something that Dracula should fear, along with a knife through the heart, the sun, holy objects, and garlic. But they are not something that should scare anyone who manufactures blood or tissue based products. While states have different statutory language, the gist of blood shield laws is that blood transfusions and transplants are a service and not a sale (Dracula would agree he is performing a service), thus barring claims for breach of warranty and strict liability.Continue Reading Guest Post – The Sun Is Not Setting on Oregon’s Blood Shield Statute
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 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
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
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
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
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
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.