Late last year, when we were putting together our massive post that collected and categorized every case that had ever judicially noticed an FDA document, we ran across the intriguing proposition that in deciding Rule 12 pleading-based motions, “allegations in
Drug & Device Law
The definitive source for intelligent commentary on the law that matters for drug and device product liability cases
Drug & Device Law is a blog published by the Drug & Device Law Blogging Team that focuses on legal issues surrounding prescription drugs and medical devices. It covers topics such as product liability litigation, regulatory compliance, FDA approval processes, preemption doctrines, class action lawsuits, and statutes of limitations relevant to drug and device manufacturers. The blog discusses court decisions involving manufacturing defects, failure to warn claims, fraudulent joinder and misjoinder, and pricing program litigation like the 340B drug pricing program. It also addresses procedural and jurisdictional issues in multidistrict litigation and state versus federal court matters related to drug and device law.
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Guest Post − Texas Supreme Court’s “One Step” Grants A Distributor Interlocutory Review Regarding Non-Manufacturing Seller Immunity Statute
Today’s guest post is by Kevin Hara, of Reed Smith, who is pinch-hitting for Steve Boranian. His post today discusses the Texas Supreme Court’s procedural reversal of a lower court’s refusal to hear an interlocutory appeal concerning application…
An Ultra Processed Complaint Fails
This post comes from the non-RS and non-Dechert side of the Blog.
The great post-modern existentialist philosopher John Madden once said, “If you have two quarterbacks, you actually have no quarterback.” This was not the result of a fanciful math…
Second Circuit Upholds New York Vaccine Mandate (Again)
Lately, weirdly, sadly, some people have suggested that the Enlightenment was a mistake. They contend that an overemphasis on rationality robbed humanity of feeling, faith, etc. What drivel. Every day of the week, we’ll take Voltaire over any pretend-King, data…
The Eye of the Beholder: The Taxotere Warning Was Fine, But Don’t Tell That to This Court
We have written before about the Taxotere eye injury MDL — and we wish we could say things were getting better. They are not.
Last December, we noted the fundamental absurdity at the heart of this litigation. Cancer patients —…
Non-Patent Implications of Supreme Court’s “Skinny Label” Hikma Decision
We don’t normally discuss patent/intellectual property issues on the Blog, even though they arise all the time in prescription medical product litigation. The reason is simple − our clients (and target audience) can be found on either side of the…
Making It Easier For Injured People To Prove Liability And Get Full Compensation: More On The New European Union Product Liability Directive
If you are a regular blog reader, you may have seen some of our prior posts about the new Product Liability Directive adopted by the European Union and going into force this December.
Two weeks ago, we had…
Preemption Is a Defense, Not a Basis for Jurisdiction
If preemption were an independent basis for federal subject matter jurisdiction, almost all of our drug, device, and vaccine product liability litigation would be in federal court. We’ve long been resigned that preemption is a defense, not grounds for jurisdiction. …
Half-Squeezed: S.D.N.Y Splits the Difference on Heavy Metal Toothpaste Claims
June 25, 2026 was a very good day for preemption. While one hand of the judiciary was busy with the Supreme Court handing down its 7-2 ruling in Monsanto Co. v. Durnell — establishing that FIFRA expressly preempts Roundup state-law…
New Jersey Requires “Rigorous Gatekeeping” for Expert Opinions Across the Board
New Jersey law requires that trial courts conduct a “rigorous gatekeeping” analysis when assessing the admissibility of expert opinions. That’s the Accutane standard, named for the New Jersey Supreme Court’s opinion in In re Accutane, 234 N.J. 340 (2018). To…