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are another example, since all of those second-generation drugs were safer than the older forms of blood thinners they superseded.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?

Today we revisit the Lone Pine order for the Taxotere MDL.  We previously discussed the entry of the Lone Pine order and the court’s denial of plaintiffs’ motion to reconsider entry of the order.  Here, plaintiffs tried once again to take an axe to the Lone Pine, this time by arguing that it is unfair specifically with respect to deceased plaintiffs.  The court roundly rejected plaintiffs’ arguments. In re: Taxotere (Docetaxel) Prods. Liab. Litig., 2024 WL 4362982 (E.D. La. Oct. 1, 2024).

Continue Reading Taxotere Lone Pine Continues to Stand

We’ve reviewed litigation precedent concerning causation-related genetic testing orders on the Blog twice before, in 2020 and in 2015.  We even proposed a rule of federal procedure to govern the conditions under which such testing could occur, which predictably went nowhere, since there is no crisis – yet.  Here’s another update.

As we discussed

We’ve discussed our Drug and Device Law Blog elder care duties before and how it has educated us about health issues faced by the senior population.  Shingles is one health risk that increases as you get older.  It is often described as a painful rash, but “painful rash” doesn’t really capture how bad shingles can

The recent decision of the Hawai’i Supreme Court in State ex rel. Shikada v. Bristol-Myers Squibb Co., ___ P.3d ___, 2023 WL 2519857 (Haw. March 15, 2023), isn’t all bad by any means – but it’s bad enough, and it carries with it the prospect of liability based on a virtually limitless number of individualized genetic traits, so you can bet we’re not very happy after reading it.

You’d be right.

Continue Reading Trouble in Paradise

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 2022