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of existing or threatened disputes over the FDA’s power, he simultaneously took a fresh look at the FDA’s pending draft guidance, Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cl ..read more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

We have seen a number of consumer fraud class action cases brought over a range of fairly ticky tacky issues about OTC drugs and consumer products.  California law and courts have been fairly favorable to these cases, which follow a pattern of a test plaintiff seeking to represent some large class because (s)he claims to have purchased some typically safe and effective OTC product due to a misimpression about some aspect of its labeling and packaging, with the alleged damages being measured as the cost of the product or some part of the cost paid that was purportedly excessive.  Thes ..read more

Few things in the law are as subject to abuse as the False Claims Act, 31 USC section 3729 et seq.  (the FCA). It was originally enacted to stop massive frauds perpetrated by large contractors during the Civil War. Now it is a litigation cottage industry.  In United States ex rel. Bennett v. Bayer Corp., 2024 U.S. Dist. LEXIS 63654 (D.N.J. April 4, 2024), the relator alleged that two defendant pharmaceutical companies violated the FCA by misleading the federal government to get approval to sell fluoroquinolone antibiotics (FQs), resulting in doctors prescribing the FQs and seeking fr ..read more

Remember the case we told you about last week where the court shutdown plaintiff’s attempt to use non-mutual offensive collateral estoppel?  Well, that wasn’t that plaintiff’s only loss that week.  In a companion decision, the court also rejected plaintiff’s attempt to use Federal Rule of Civil Procedure 43(a)’s remote trial testimony rule to skirt the jurisdictional limitations of Rule 45(c)(1).  Coblin v. Depuy Orthopaedics, Inc., 2024 WL 1357571 (E.D. Ken. Mar. 29, 2024).  As we explained in our prior post, this case was remanded from the hip implant MDL.  During wh ..read more

The result for the defendant (a “distributor of ophthalmologic supplies”) in the False Claims Act decision, United States ex rel. Fesenmaier v. Cameron-Ehlen Group, Inc., ___ F. Supp.3d ___, 2024 WL 489708 (D. Minn. Feb. 8, 2024), was so terrible that something good ended up happening. The total judgment was over $487 million “not including post-judgment interest, statutory attorneys’ fees or other taxable costs.”  Id. at *1.  Here are that judgment’s components: Of that amount, less than one tenth ($43,694,641.71) represented actual damages to the United States.  That actual-d ..read more

Released in 1965 by the Miracles, “The Tracks of My Tears” is ranked by Rolling Stone as the “Greatest Motown Song of All Time.” Smokey Robinson’s lead vocals are pure silk, the harmonies ooze soul, and  the guitar licks and strings tie it all together.  The song and the Miracles helped spread Motown around the globe.  Today’s decision about an artificial tears product won’t stack up against Smokey and the Miracles, but it hits a few chords worth sharing. Mosley v. EzriCare, 2024 WL 1342615 (E.D. Ky. Mar. 29, 2024) is a putative economic loss class action arising from the purcha ..read more

We write a lot of briefs involving federal preemption and Class III medical devices with premarket approval (or “PMA”).  Many of those briefs are in support of motions to dismiss lawsuits brought by attorneys who don’t regularly practice in the pharmaceutical and medical device product liability space.  The complaints filed by such attorneys often are written as if federal preemption doesn’t exist, so our motions to dismiss start by explaining the basics of express medical device preemption, 21 U.S.C. § 360k(a) as interpreted by Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), an ..read more

Coblin v. Depuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 62114 (E.D. Kentucky April 4, 2024) is the ultimate dodged bullet.  It is part of a multidistrict litigation.  That’s bad enough. Then it gets worse.  It’s not just any MDL, it’s the hip implant MDL. Then it gets even worse. This Coblin decision involves a plaintiff’s motion for partial summary judgment.  Yikes.  Then it gets even even worse.  The plaintiff in Coblin moved for summary judgment based on nonmutual offensive collateral estoppel.  What is so bad – or perhaps we should say offensive ..read more

We have previously analogized that when a case is dismissed for failure to state a claim under Rule 12, that is like the plaintiff not even getting to first base.  And that when a complaint is dismissed for lack of standing, a rarer form of dismissal, the plaintiff couldn’t even get up to bat, let alone get on base.  A dismissal for lack of standing recently occurred in Gibriano v. Esai, Inc., 2024 U.S. Dist. LEXIS 59535 (D.N.J. Mar. 31, 2024).  When that kind of dismissal occurs, you can bet the complaint is really bogus. And this wasn’t plaintiff’s first attempt.  She got ..read more