The district court’s order applying Michigan law and dismissing one plaintiff’s complaint in the Tapezza MDL may be the last of a dying breed. The court faithfully enforced Michigan’s statute providing a presumption of non-defectiveness for FDA approved drugs and dismissed the plaintiffs’ case. But alas, Michigan repealed that law effective February 13, 2024, thus
A long time ago, in a mass tort far, far away, the plaintiffs’ lawyers were not content with collecting plaintiffs from within the US. They also brought a putative product liability class action in federal court in the U.S. on behalf of European plaintiffs. As a result, your bloggers learned a little bit (a very
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
As many of you no doubt already know, the federal judiciary’s Committee on Rules of Practice & Procedure gave its final approval to new Fed. R. Civ. P. 16.1, concerning MDL practice, on June 4. Here’s some commentary. We’ve also mentioned the proposed rule here on the Blog. Bexis went so far as to file an extensive comment on the proposed rule, primarily decrying the frequency with which MDL judges simply ignored the existing federal rules – most significantly (although hardly exclusively) those rules that act to weed out meritless claims in non-MDL situations.
Throughout the process that led to new Rule 16.1, the drafters consistently refused to impose any mandatory procedures at all for early vetting of the hordes of meritless to utterly frivolous claims that are routinely filed in mass tort MDLs. Thus, we bloggers were skeptical that all the effort to create a new, entirely voluntary list of potential MDL management tools was worth the candle. Indeed, new Rule 16.1 stands out like a sore thumb among the Federal Rules of Civil Procedure, precisely because it lacks any mandatory requirements. The new rule has lots of “shoulds” but practically no “shalls.” See Approved Committee Note and Text of Fed. R. Civ. P. 16.1.
Taking a closer look, we now believe that, if used according to its terms, new Rule 16.1 would actually be better than no rule at all, albeit not by a lot. MDL cases now comprise over 70% of the total federal caseload, so we still believe it is ludicrous that those cases are not subject to a single mandatory MDL-specific rule. But Rule 16.1 it is what it is.Continue Reading New Rule 16.1 – Better Than Nothing, But Not by a Lot
Today’s guest post is by Sherry Knutson and Brenda Sweet of Tucker Ellis, and concerns the recently passed legislative repeal of a Michigan statute that, for several decades had effectively immunized prescription drugs from ordinary product liability actions under Michigan law. For background, here’s a prior blogpost that focused on the now-repealed statute. As
Here’s a short one before the holiday (the one we have off, anyway). Most of our readers probably already know about the pending proposal for an MDL-specific rule of civil procedure, enumerated as Fed. R. Civ. P. 16.1. We’ve adverted to proposed Rule 16.1 a couple of times, but never done a deep dive.
Let us be clear at the outset. We were shocked and appalled by the 5-4 result in Mallory v. Norfolk Southern Railway Co., 143 S. Ct. 2028 (2023), holding that phony “consent” to general jurisdiction does not offend constitutional Due Process when a state statutorily declares something less than “at home” status − corporate
In addition to its expected slam of the judiciary’s Federal Rules Committee largely toothless proposal for an MDL-specific rule of civil procedure, the LCJ recently did something both innovative and unexpected (at least to us) – on September 19, it proposed amending multiple federal civil rules to address privacy issues. See LCJ, “FRCP
Montana became the first state to ban TikTok this month. You no doubt have seen the press and have read the spirited discussion condemning foreign spies on the one hand and championing First Amendment rights on the other. Litigation has already commenced. But, while all that was developing, you may have overlooked that Montana
About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. We probably should not have been surprised by the persistence of frivolous litigation. After all, our day job entails defending litigations that can last years longer than they