We have no personal knowledge of the litigation concerning GLP-1 receptor agonist medications and the Blog has not posted on it yet, but we do know something about litigation over widely used prescription medications. Over the decades, there have been many drugs or classes of drugs that became “blockbusters” because they were widely prescribed to
Last week, FDA released for comment a draft guidance titled Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers. FDA guidances are nonbinding recommendations without force of law, and this is only a draft. Nonetheless, it addresses a frequent and important problem in our industry.Continue Reading FDA Releases Draft Guidance on Responding to Internet Hogwash
As we emerge from our fourth month-long trial in a little over two years, we are sure that we have missed some recent legal developments. As good as this Blog is as a source for what is going on in drug and device product liability litigation, you do actually need to read it to absorb
If we have said it once, we have said it a hundred times: medical product manufacturers are not insurers of their products. Almost as frequently uttered would be that strict liability is not the same thing as absolute liability. In the show position might be that the temporal relationship between a new medical condition and
We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. When we say long-held, we mean it, because we had a few of the first cases where this theory was put
In today’s case, Chapman v. AstraZeneca, a Delaware state court granted summary judgment to the defendant pharmaceutical manufacturer after excluding the plaintiff’s causation expert under Delaware Rule of Evidence 702 because the expert’s opinion was not “stated in terms of medical probability.”
The plaintiff claimed that the defendant’s proton pump inhibitor, a class of
Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. § 314.70(c)(6)(iii)(A). Because the
After eschewing our blogging duties during a very long trial—followed by short deliberations and a verdict for the good guys—we are back at it. Normally, a significant criterion in how we select a case for a post is the length of the decision—the shorter, the better for our normally busy work lives. After trial, there
This post is a little different. Several of my colleagues – Reed Smith attorneys Robert J. Hill, Joseph W. Metro, Kevin M. Madagan, Andrew Y. Lu, Sung W. Park, Janine R. Tougas – wrote a client alert on the four recent executive orders that concerned pharmaceutical pricing. We had
That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof. Twerski’s Wikipedia page is the fifth result when we just Googled that phrase). Prof. Twerski, one of the ALI’s reporters for the Restatement (Third) of Torts: Products Liability, has