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
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)
Guest Post – Twlqbal in the E.D. Cal.- No Screws Loose There
Today’s guest post comes from Reed Smith partner, Matt Jacobson. He discusses a new medical device case that puts the “Tw” in TwIqball – as in twisting a screw. The result is a total defense win, albeit with the “twist” that the plaintiff can try again, if he can. As always, our guest posters deserve 100% of the credit (and any blame) for what they write.
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Have you ever heard that old idiom “having a screw loose” and wondered where it came from? My guess is most of you have heard the saying, but never thought twice about its origin (well maybe Bexis has). But since I have your attention, here is a small history lesson. During the industrial revolution, if a screw from a machine came loose it meant that the machine was not behaving normally. Since these machines were built for mass production, having a screw come loose would cause the entire machine to shut down, halting the process. At least one person claims that Eli Whitney, famed for inventing the cotton gin, was the person to say this phrase first. But I cannot verify that fact no matter how many internet searches I ran, so that will remain a mystery. Continue Reading Guest Post – Twlqbal in the E.D. Cal.- No Screws Loose There
On the New York Consumer Protection “Consumer Orientation” Element
New York’s consumer protection statute (N.Y. Gen. Business Law §§349-50) has a “consumer orientation” element that has largely prevented that enactment from being abused by P-side purveyors of prescription medical product class actions. We’re looking at how that works today.
The New York Court of Appeals held that, “as a threshold matter, plaintiffs claiming the