The flimsy decision in In re Acetaminophen − ASD-ADHD Products Liability Litigation, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022), leaves us scratching our heads. First, it claims to find “helpful guidance,” id. at *7, in Wyeth v. Levine, 555 U.S. 555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. Since Levine is probably the worst prescription medical product liability decision to occur during the now 15-year lifespan of this Blog, when a citation like that appears, the result is not likely to be any good. Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves.
Continue Reading A Painful Preemption Decision
Shameless Plug − CLE Webinar on the Best and Worst Drug/Medical Device Decisions of 2022
As 2022 has come to an end, our loyal readers have joined us in reviewing our worst decisions of the past year and our best decisions of the past year.
As we do each year, we’re pleased to announce that three of your bloggers – Bexis, Steven Boranian, and Rachel Weil – will be
Are You a Geography Nerd?
We don’t do many “frivolous” posts anymore on the DDL Blog, unlike our earlier days. We used to do music posts and the like, but as the pandemic got serious, so did we.
But here’s a post that has nothing to do with drug and device product liability litigation, and everything to do with Bexis being an inveterate geography nerd. Since the Internet can be all things to all people, there is a site for geography nerds called “Worldle.” Yes, a not-too-subtle play on the much more famous “Wordle” gamesite.
Continue Reading Are You a Geography Nerd?The Thrill of Victory – The Ten Best Prescription Drug/Medical Device Decisions of 2022
So, another year has passed. 2022 is in the books and the republic still stands, even if Roe v. Wade (and, soon, Twitter) do not. The COVID-19 pandemic – if not COVID-19 itself, which has instead become endemic – is largely over, except for some probably PREP Act preempted shouting.
For the Blog, the end of the year means that it’s time for our annual celebration of the Drug & Device Law Blog’s top ten decisions of the year. Some of these cases establish important legal principles, such as preemption, Rule 702 expert exclusion (don’t say Daubert), or the learned intermediary rule. Others are important because they affect large numbers of cases gathered in the increasingly dysfunctional federal multi-district litigation system. Some do both. In either event, these decisions make the legal world at least somewhat less dangerous for our clients and (not incidentally) more favorable for us defense lawyers.
Continue Reading The Thrill of Victory – The Ten Best Prescription Drug/Medical Device Decisions of 2022Zantac Chronicles – Concluding Chapters in the MDL
What follows is from the non-Dechert side of the Blog.
In the Zantac MDL, the plaintiffs’ causation problems were plainly visible on the horizon, as we mentioned in our post last year about the Zantac ruling on medical monitoring, In re Zantac (Ranitidine) Products Liability Litigation, 546 F. Supp.3d 1152 (S.D. Fla. 2021). The Zantac MDL plaintiffs’ claims regarding risk of injury and exposure levels to purported ranitidine-derived nitrosamines (“NDMA” for short) seemed not only trivial, but in many ways bizarre (use of extreme temperatures and other parameters). They even relied on a retracted study. That’s why we referred to the “wheels coming off” the plaintiffs’ scientific case in that post.
Now the plaintiffs’ wheels are fully off in Zantac MDL – as we mentioned before, all of their causation experts for the five types of cancer that plaintiffs themselves considered the most plausible have been excluded under F.R. Evid. 702, and summary judgment entered. In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 17480906 (S.D. Fla. Dec. 6, 2022). This is a lengthy opinion, 341 pages in slip form. To keep this post as short as possible, we’ll be summarizing (at best) large parts of it.
Continue Reading Zantac Chronicles – Concluding Chapters in the MDL
The Agony of Defeat -The Ten Worst Prescription Drug/Medical Device Decisions of 2022
It’s that time of year again – time to review drug and medical device product liability litigation during 2022 and select the year’s ten worst decisions. Frankly, it’s not that hard to do – they reek to high heaven, so they are pretty easy to find. What’s harder is finding the motivation to write about decisions that we find profoundly distasteful for one reason or another. It’s fun to write about wins, but not about losses, so watch for decisions we might not have addressed previously.
Continue Reading The Agony of Defeat -The Ten Worst Prescription Drug/Medical Device Decisions of 2022Blackburn – That’s Just Plain Wrong
We disagree with plenty of courts on plenty of things, but most of the time it’s at least arguably just a conflict with one of our pro-defense views. But occasionally, very occasionally, we run into a decision that’s just plain wrong on some factual or legal aspect. Blackburn v. Shire U.S., Inc., 2022 WL 16729466 (11th Cir. Nov. 7, 2022) (thankfully unpublished), is such a decision.
Continue Reading Blackburn – That’s Just Plain WrongShameless Plug – Anybody Need End of the Year CLE?
To anyone who needs a few more CLE hours before the end of the 2022, we wanted to let you know that sessions from Reed Smith’s recent Life Sciences CLE Week are now available on demand. Here are descriptions of the topics, and registration links.
The Ebb and Flow of the Law – A Year
Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections
Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. §§300aa-10, et seq. That litigation, involving DTP and certain other childhood vaccines, nearly destroyed this country’s ability to vaccinate its children against often deadly diseases – much to the delight of antivaxxers everywhere. After Congress acted in 1986, much to the delight of everyone else, the Act’s alternative compensation system, combined with its strong preemption provisions restricting post-compensation system litigation have largely restored the nation’s childhood vaccine supply to a sound footing. The Supreme Court did its part in Bruesewitz v. Wyeth LLC, 562 U.S. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.
Continue Reading Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its ProtectionsBreaking News – Plaintiffs’ Zantac MDL “Experts” Dismissed Under Rule 702; Summary Judgment Granted
In a 341-page opinion, In re Zantac (Ranitidine) Products Liability Litigation, 9:20-md-02924-RLR, slip op. (S.D. Fla. Dec. 6, 2022), the MDL court held that all of the Zantac plaintiffs’ general causation experts (concerning five cancer types) failed to meet the admissibility standards of Fed. R. Evid. 702. Consequently the court granted the defendants’ motions