The plaintiff in Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), lost the bulk of her case recently, on a motion to dismiss no less. In this case involving surgical staples, strict liability and negligence claims (which, in New York, are “functionally synonymous,” id. at *18) for design and
Boo, Hiss
As anyone who has read more than a paragraph of what we’ve written knows, this is a forthrightly pro-defense Blog. It is not our practice to criticize the strategy or tactics of defendants or their counsel. It’s not that what defendants do is always right, but to us its almost always understandable.
We were all
Courts Say “No” to Claimed Duties To Warn of Risks Created by Products Made by Others
In the last few months, we have discussed two decisions rejecting claims made by plaintiffs in prescription medical product liability litigation that medical device manufacturers somehow had a duty to warn about claimed risks that occurred when their products were used (by physicians, of course) in conjunction with some other product. In Silverstein v. Coolsculpting
“Radical” but Not “Transparent”
We were promised “radical transparency” by the incoming Secretary of HHS. We recently received something that, while meeting the description of “radical,” doesn’t exactly fit the definition of “transparent.” Since 1971, that is for over 50 years, HHS has had a policy called the “Richardson waiver” (after Elliot Richardson), whereby it expanded the “notice and comment” concept created by the Administrative Procedure Act, beyond the bare minimum required by the APA itself. For one thing, as we mentioned most recently here, the FDA takes notice and comment on guidance documents, such as those it issues that concern off-label speech. As we’ve pointed out many times, guidance documents are not regulations with force of law.Continue Reading “Radical” but Not “Transparent”
Taking Preemption to the Bank
Rieger v. Medtronic Minimed, Inc., 2025 Cal. Super. Lexis 14 (Cal. Super. L.A. Cnty. Jan. 28, 2025), is an excellent PMA preemption decision from, of all places, Los Angeles County Superior Court, in California – home of the notorious “the Bank” courthouse. We have no idea whether Rieger was adjudicated in LA’s Central Civil West Courthouse, but that is the first thing we defense hacks think of when we see a “Cal. Super. L.A. Cnty.” citation.
But a few more like Rieger, and maybe we won’t any longer.Continue Reading Taking Preemption to the Bank
Guest Post – Navigating the Israeli Pharma Class Actions Maze
Today’s guest post of from Ronnie Peleg, chair of the pharmaceutical practice at the Meitar Law Firm. Over the last two decades, Ronnie has been involved in most of the Israeli copycat filings of notable US drug and medical device cases. In this post he provides a useful thumbnail sketch of how Israeli
Learned Consumer Expectations
To say that we’re not big fans of the “consumer expectation” test in prescription medical product liability litigation is a gross understatement. That supposed “test” for design defect – the Third Restatement expressly ditched it as a separate test, Restatement (Third) of Torts, Products Liability §2, comment g (1998) – exists primarily to let plaintiffs claim they never expected that any product would ever injure them, no matter how badly they misused it. So again and again, we’ve decried the consumer expectation “test” on the Blog.
But at least in some states, the learned intermediary rule ameliorates the consumer expectation test in our sandbox – by considering the relevant “consumer” to be the physician to whom a drug or device warning is directed. Generally speaking, consumers of prescription medical products lack any expectations about the performance and safety of those products other than what their physicians tell them. Thus, quite a few courts have held that, in the context of prescription medical products, the physician is actually the “consumer” or the “intended user” of such products. Continue Reading Learned Consumer Expectations
Guest Post – More on Defense E-Discovery of Health-Related Data from Plaintiffs’ Devices
Today we have a guest post from Chris Campbell, Stephanie Peatman, and Sarah Carrier, all of DLA Piper, following up on a subject we wrote about not too long ago – ediscovery for defendants, but involving plaintiff’s devices that directly keep track of relevant health information, not social media. The more
Plaintiffs Reduce Loper Bright To Absurdity
We read a brief from the other side recently that claimed that Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), abolished implied preemption altogether. We kid you not. Under the heading, “Implied preemption is an unconstitutional intrusion into the dual sovereignty of the States,” plaintiffs made the following pitch:
The Supreme Court elucidated
Another Ohio Idea – How Far Does the Logic of the Opiate Decision Extend?
The Ohio Supreme Court’s decision in In re National Prescription Opiate Litigation, ___ N.E.3d ___, 2024 WL 5049302, 2024 Ohio Lexis 2785 (Ohio Dec. 10, 2024), which was our third best case of that year, was primarily a statutory interpretation case involving the Ohio Product Liability Act (“OPLA”), and specifically Ohio Rev. Code §2307.71(b)