We recently recapped the law relating to when experts are allowed to opine on what was in the head of another and how a pending Supreme Court criminal case might affect things.  In our area, this issue comes up most frequently in the context of plaintiff experts trying to offer their spin about how the purportedly nefarious machinations of drug and device manufacturers affected decisions on the design, labeling, testing, etc., of the product at issue in the case or some argued alternative feasible design.  Almost as often, where the prescribing physician is not deposed or where the p ..read more

Smith v. Angiodynamics, Inc., 2024 U.S. Dist. LEXIS 73561 (M.D. Alabama April 23, 2024), offers the veritable mixed bag of rulings. The plaintiff alleged that an implanted vascular device fractured, resulting in pieces of the device migrating to the plaintiff’s heart. The plaintiff underwent surgery to remove the fragments.  The plaintiff’s lawsuit included claims for (1) violation of the Alabama Extended Manufacturer’s Liability Doctrine (AEMLD); (2) negligence; (3) breach of warranties; and (4) wantonness. The defendant filed a motion to dismiss all of the claims.  The plaintiff co ..read more

Oh, so many years ago we started calling cases that prevent innovator liability and preempt generic liability the “one-two punch.”  But really any decision that strikes a substantive blow and follows it up with a preemption jab is OK in our books.  And that is just what happened in Harris v. Medtronic Inc., 2024 WL 1747385 (D. Minn. Apr. 3, 2024).  Plaintiff brought a putative class action on behalf of himself and others who received an implantable cardioverter defibrillator (ICD) manufactured after a certain date by the defendant.  The ICDs at issue were voluntarily recall ..read more

As we’ve discussed, such as here, Fed. R. Civ. P. 702 was amended in late 2023, because the Civil Rules Advisory Committee concluded that too many courts were erroneously admitting expert testimony that proponents had not established was reliable.  It does appear that at least some courts are cracking down.  Here’s one from an Eighth Circuit court, which is significant since the Eighth Circuit was one of the worst offenders under the prior version of Rule 702. “[M]any courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expe ..read more

We posted last year about plaintiffs who were dismissed from the Taxotere MDL for failure to serve defendants. To put it simply, the Federal Rules still apply in an MDL. 153 plaintiffs didn’t comply with the Rules, and their cases were dismissed. Not knowing when to walk away, as Kenny Rogers instructs, a number of these plaintiffs filed for reconsideration. The MDL Court rightly shut them down. Plaintiffs filed their motions under Fed. R. Civ. P. 59(e) and 60(b). Rule 59(e) relief is to “correct a manifest error of law or fact” or to address newly acquired evidence or a change in the law, whi ..read more

Local counsel in one of our cases made it clear that unless we wanted to broadcast that we were from out of state, we needed to pronounce Oregon as “Or-gun” not “Or-ah-gone”, and we have tried to remember that tip ever since.  But today’s District of Oregon case, Glover v. Avanos Med., Inc., No. 3:20-cv-01452-AR, 2024 U.S. Dist. LEXIS 66853, 2024 WL 1530685 (D. Or. Mar. 19, 2024), involves a Rule 702 expert exclusion and accompanying grant of summary judgment, so we will revert to our former mispronouncing ways because this case is gone (very bad sort-of pun regrettably intended). Or rath ..read more

This post is not from the Butler Snow part of the Blog. The plaintiff in Sheinfeld v. B. Braun Medical, Inc., 2024 WL 635483 (Mag. S.D.N.Y. Feb. 1, 2024), adopted 2024 WL 1075329 (S.D.N.Y. March 12, 2024), was representing himself (“pro se” in legal Latin).  Why was that? Well, let’s start with PMA preemption.  The medical device at issue, an “artificial disc replacement,” was pre-market approved by the FDA, which means that under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), most product liability claims are preempted.  Sheinfeld, 2024 WL 635483, at *2-3.  That is, excep ..read more

It has been some time since we have discussed False Claims Act (“FCA”) litigation over alleged promotion of a prescription drug for off-label uses.  And when we read United States ex rel. Hearrell v. Allergan, Inc., 2024 U.S. Dist. LEXIS 70888 (E.D. Tex. Apr. 18, 2024) we were reminded why.  Off-label promotion is not ipso facto false.  Plaintiff alleged that defendant promoted Botox for the off-label use of pediatric migraine therapy.  But an FCA claim has to begin with a “false statement or fraudulent course of conduct.”  Id. at *7.  Once upon a time, FDA took t ..read more

Bexis recently gave the keynote address at the Minnesota State Bar Association’s annual FDA Forum.  In preparing his speech, which concerned recent challenges to FDA regulatory authority, Bexis had occasion to study Apter v. Dep’t of HHS, 80 F.4th 579 (5th Cir. 2023), which the blog previously discussed here. Since Bexis was discussing a variety of existing or threatened disputes over the FDA’s power, he simultaneously took a fresh look at the FDA’s pending draft guidance, Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cl ..read more

We have been following – and commenting about − the unprecedented attacks on the FDA’s authority to approve drugs (and by extension all the products the agency regulates) in the Alliance for Hippocratic Medicine v. FDA litigation pretty much since the first bizarre district court rulings about a year ago in Alliance for Hippocratic Medicine v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023) (hereafter “AHM I” and AHM II”). We normally try to keep our political views to o ..read more