We are not the only ones who have pointed out that every new contraceptive for the last fifty years or so has been the subject of litigation and that it is not hard to see how the burden associated with such litigation, even if the manufacturer does well, discourages the development of new options. This
Preemption
Court Denies Motion to Dismiss Claims Targeting a Biologic

The decision we report on today, Frye v. Novartis Pharms. Corp., 2022 WL 4305656 (E.D. Ark. 2022), leaves us shaking our heads. The court denied the defendant’s motion to dismiss, which was based on preemption and other grounds. In the course of denying the motion, the court misconstrued the law at least once and…
Eastern District of Texas Tells Plaintiff to Try Again
Failure-to-Warn Claim Targeting Branded Drug Held Preempted: Litigation-Driven Expert Analysis Is Not “Newly Acquired Information” for Purposes of the “Changes Being Effected” Regulation

Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. § 314.70(c)(6)(iii)(A). Because the…
Who Needs a Lawyer in the Eleventh Circuit?

Jacob v. Mentor Worldwide, LLC, 40 F.4th 1329 (11th Cir. 2022), is a very peculiar case and will probably leave some plaintiffs wondering if, maybe, they would be better off without their lawyers.…
Continue Reading Who Needs a Lawyer in the Eleventh Circuit?
For Preemption, “Newly Acquired” Does Not Mean “By Plaintiff”

They say the smartest people are the ones who are always learning something new. Those who are open to new ideas and concepts. People who are eager to acquire new information. That’s a great way to live. Long live enlightenment. However, when it comes to federal preemption of a failure to warn claim involving a…
Childhood Vaccine Case Gets TwIqballed

Since the Supreme Court decided Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), product liability litigation over childhood vaccines is rare but not extinct. As demonstrated by today’s case — Garcia v. Sanofi Pasteur Inc., 2022 U.S. Dist. LEXIS 134330 (E.D. Cal. Jul. 28, 2022). And while the decision does discuss preemption, this…
Food Labeling Claims Get the Boot in Texas

They say everything is bigger in Texas and when it comes to cowboy boots – they are actually correct. Built by Bob “Daddy-O” Wade in 1979, the largest cowboy boots in the world measure 35 feet tall and 33 feet long and purportedly can hold 300,000 gallons of beer. They stand in front of a…
ND Alabama Finds Plaintiff’s Shotgun Pleadings a Mortal Sin (and Preempted) (and no Personal Jurisdiction)

While two-fer Tuesday has that nice alliterative ring to it – three-fer Tuesday gives you more bang for your buck. Pleadings, preemption, and personal jurisdiction. Maybe trifecta-Tuesday?
Plaintiff in Froman v. Coopersurgical, Inc., 2022 US Dist LEXIS 120725, *2-3 (N.D.AL Jul. 8, 2022) filed her complaint alleging that she suffered an injury when a…
Minnesota Court Holds that Dispute with Compounder is Preempted

We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., Inc. v. IntegraDose Compounding Servs., LLC, 2022 Minn. Dist. LEXIS 1734 (Minn. 4th Dist. May 24, 2022), is unusual. It is not a product liability case. Rather, a pharmaceutical company sued a compounder for fraudulently…