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JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

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The last time we looked into Bueno v. Merck, it was anything but bueno.  Taking the position that, “if there is a cause of action, there must be jurisdiction,” a misguided decision had held that a branded drug manufacturer could be haled to court under an innovator liability claim, despite the defendant having never sold anything to the plaintiff in the state.  See Bueno v. Merck & Co., 626 F. Supp.3d 1154 (S.D. Cal. 2022).  That decision made our bottom ten list in in 2022.

Two years later – and who knows how many $$$ spent in the interim – the result on the merits was incomparably better.  All claims dismissed with prejudice for a variety of excellent reasons.  Bueno v. Merck & Co., ___ F. Supp.3d ___, 2024 WL 3974754 (S.D. Cal. Aug. 27, 2024).  Ditto for a companion case decided the same day.  See Parker v. Merck & Co., 2024 WL 3974764 (S.D. Cal. Aug. 27, 2024).

Here’s what happened.Continue Reading Bueno and More Bueno

In 2018, our blogpost on In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Liability Litigation, 903 F.3d 278 (3d Cir. 2018), was entitled “Money For Nothing?  No Standing This Time in the Third Circuit.”  There, it appeared that the Third Circuit had drawn an eminently reasonable bright line disallowing no-injury…

From our very first post back in early 2020 on preclusive power of the PREP Act, 42 U.S.C. §247d-6d, we were impressed by the scope of its combined preemption and immunity language.  There, we quoted the language from the HHS secretary’s emergency declaration:

[A] covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.

Quoting 85 Fed. Reg. 15198, 15199 (HHS March 17, 2020).Continue Reading Deconstructing the PREP Act

In our two prior posts, Loper Bright Likely Lays Lohr Low, and Could Loper Bright Finally Do in FDA’s Rickety Off-Label Speech Ban?, we focused on ways that Supreme Court’s holding in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), that courts were not to defer to administrative agency views in evaluating such agencies’ interpretations of their organic statutes, could be used by our clients in a positive fashion in the defense of prescription medical product liability.

Today we’re addressing the flip side.  How do we defend against the other side’s attempts to use Loper Bright for nefarious purposes?

Understanding the limitations of Loper Bright is a good start.Continue Reading Limits to Loper Bright

To anyone who needs a few more CLE hours before the end of the 2024, we wanted to let you know that videotaped sessions from last week’s Reed Smith Annual Life Sciences Litigation CLE Week are now available on demand. Here are descriptions of the topics and the registration link.

340B Program: Update on…

Lord knows, there are a lot of meritless MDLs.  Bexis’ and Michelle’s Bone Screw litigation, prompted by a televised CYA freak-out by then-FDA Commissioner David Kessler over an off-label use that had become the medical standard of care, was one, and it gave us Buckman.  Several MDLs against modern anticoagulants, such as Xarelto, are another example, since all of those second-generation drugs were safer than the older forms of blood thinners they superseded.  Currently, the Taxotere MDL – based on the dubious proposition that the plaintiffs cared more about hair loss than most effectively treating their breast cancer – and Zostavax – where not a single plaintiff can prove causation – come to mind.  Our colleagues defending other MDLS can also be excused for believing that their own litigation should be added to this list.

But for sheer factual baselessness, it would be hard to top the still-ongoing Avandia MDL, which somehow has managed to persist since 2007.  The Avandia litigation is infamously based on a purported increased risk that, over a decade ago, the FDA scientifically determined did not exist.  Briefly, a study erroneously found an increased risk of cardiovascular events with Avandia that led to both a boxed warning and additional studies.  The additional studies debunked that supposed increased risk and the FDA removed the boxed warning:Continue Reading Avandia Litigation – Is This Finally the End?

The Drug and Device Law Blog is deliberately apolitical.  Our purpose is to support the defense of prescription medical product liability litigation, and we recognize that the political views of our intended audience undoubtedly vary widely.

But one of the foundational grounds of our defense efforts is that the FDA, in its approval and subsequent regulation of prescription medical products, does so through skilled experts impartially evaluating well-conducted research and sufficiently supported facts.  The agency’s adherence to the scientific method and scientific principles is essential to our clients as they develop, and seek regulatory approval for, new prescription medical products, as well as changes to existing labeling, designs, and manufacturing processes.  In litigation, the FDA’s adherence to the scientific method and scientific principles is the underpinning of our clients’ two most powerful defenses – preemption and Rule 702/expert admissibility.  If the FDA (and other federal agencies such as the CDC, NIH, and ACIP) ever abandoned, or were perceived to have abandoned, the scientific method in its decision-making, both regulatory and litigation chaos quite likely would result.

That’s why we are disturbed by indications that anti-vaccine crusader and all-around science denier Robert Kennedy, Jr. might be given authority over the FDA – and allowed to “go wild” over “health care” and “medicines.”  Here is a video link to a recent Trump speech, and here is our transcript limited to the relevant statements:Continue Reading This Is Disturbing

Unfortunately, the Third Circuit now seems to have a fetish with the presumption against preemption.  Not long after the Supreme Court abolished that presumption in express preemption cases in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), the Third Circuit refused to go along.  See Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771 n.9 (3d Cir. 2018) (finding Puerto Rico v. Franklin not controlling because it was not a product liability case).  Since then, as we discussed here, every other circuit court to address the issue has recognized the demise of the presumption against preemption in express preemption cases – several of them doing so in product liability litigation.  The Third Circuit stuck out like a sore thumb.

Then along came Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019).  In our initial “breaking news” post when Albrecht was first decided, we pointed out an interesting fact.  Among other things, Albrecht spent several pages restating and reworking the Court’s poorly reasoned Wyeth v. Levine, 555 U.S. 555 (2009), decision.  See Albrecht, 587 U.S. at 310-13 (“describing” Levine for four pages).  Levine, of course, had been the high water mark of the presumption against preemption, which it called a “cornerstone” of “pre-emption jurisprudence” generally.  555 U.S. at 565.  But nowhere in Albrecht’s discussion of Levine – indeed, nowhere in the Albrecht decision anywhere – did the Court even mention any presumption against preemption.  (If you don’t believe us, search Albrecht for “presum!”)  As we said then, “conspicuously absent from that description is any express reference to any ‘presumption’ (as opposed to the older ‘assumption’) against preemption.”  So on that issue, be believe that the Court in Albrecht actually pulled back from that presumption.Continue Reading Challenging The Role of the Presumption Against Preemption in Fosamax

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…

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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