We were saddened this week to hear about the passing of Dolly Parton. A prolific and wonderful songwriter, she was also a relentless force for good. A shining example of her goal of improving the world is her Imagination Library, which she started to make sure as many kids as possible had a chance to read. Since its founding in 1995, the library has donated over three hundred million books to children across the world. As Dolly put it:
When I was growing up in the hills of East Tennessee, I knew my dreams would come true. I know there are children in your community with their own dreams. They dream of becoming a doctor or an inventor or a minister. Who knows, maybe there is a little girl whose dream is to be a writer and a singer.
The seeds of these dreams are often found in books and the seeds you plant in your community can grow across the world.
Dolly planted a remarkable number of those seeds, and in many ways she represented the best of us. Things seem a little darker knowing that such a positive driver of goodness is gone. We will miss her voice, her smile, and her charity, but we trust that her example of doing good will live on. It’s hard to relate that to our blogging, but ultimately we all have to turn back to the nine to five (OK, OK, we couldn’t help it).
Today’s case is another “LifeVest” wearable defibrillator case (we’ve blogged about prior cases involving this device here and here). Pellegrin v. Zoll Medical Corp., 2026 WL 2409216 (E.D. La. Aug. 1, 2026). Plaintiff was prescribed a LifeVest for her cardiac care after suffering heart failure. She claimed that she experienced two unnecessary discharges from the device when she was not undergoing a cardiac event. She alleged chronic neck pain following the alleged shocks from the device—although the court noted she had a history of cervical spine problems. The defendant moved to dismiss based on preemption.
The LifeVest is a Class III medical device that received PMA clearance from the FDA, so under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), any claim based on alleged requirements “different from or in addition to” the federally imposed requirements on the device would be preempted. Plaintiff sought to avoid preemption by arguing that she sufficiently alleged parallel claims based on manufacturing defect, design defect, inadequate warning, and breach of warranty. The court provided a detailed analysis of each claim and concluded that none of plaintiff’s allegations were sufficient to state a parallel claim that could escape preemption.
The court started with manufacturing defect. Plaintiff claimed that a “properly manufactured” LifeVest would not have administered the alleged shocks. But relying on Funk v. Stryker Corp., 631 F.3d 777, 781-82 (5th Cir. 2011) (which got an honorable mention nod in our 2011 top ten list), the court held that “the mere fact” that the device caused harm is not sufficient to state a parallel claim for manufacturing defect. Plaintiff went no further than that insufficient reasoning:
Plaintiffs do not identify any FDA design or manufacturing requirements that impact the LifeVest, nor do they detail how [defendant’s] manufacturing process for LifeVest failed or deviated from any federal requirements. Threadbare recitals of the [Louisiana Product Liability Act] manufacturing defect elements and conclusory assertions are insufficient to state a claim. Iqbal, 556 U.S. at 678. Additionally, failing to plead any violation of a federal design or manufacturing requirement amounts to a failure to plead a parallel claim. Rodriguez v. American Medical Systems, Inc., 597 F. App’x 226, 230 (5th Cir. 2014) (per curiam).
Id. at *6 (emphasis in original).
Turning to design defect, plaintiff claimed that there were feasible alternative designs for the LifeVest that would not have administered the alleged, inappropriate discharges. Plaintiff did not identify any federal violation and corresponding state duty, so the court found the design defect claim “clearly preempted.” Id. at *7. Plaintiff’s claim was a direct challenge to the FDA approved design requirements for the LifeVest.
The inadequate warning claim fared no better. Plaintiff alleged warning deficiencies that included the “risk and frequency of inappropriate discharge,” “the severe physical trauma that can result from device malfunction,” and “the violent physical force of discharge and the need to be in a safe position when discharge occurs.” Id. at *8. But the complaint did not “reference any FDA-approved warnings,” and it did not include “any suggestion that the warnings [the defendant] provided to [plaintiff’s] physician deviated from any approved warnings or instructions.” Id. at *9. The warning claim thus risked imposing liability for the failure to give a warning that was not sanctioned by the FDA, so the court held it was preempted.
Plaintiffs’ last claim was breach of express warranty. Aside from failing to meet Louisiana’s pleading requirements for a breach of express warranty, plaintiff tried to argue that she needed discovery to identify the specific content of the materials that constituted the alleged express warranty. That made no sense. How could the defendant have made an express warranty that induced the plaintiff to use the product if plaintiff didn’t even know what the warranty was? The court had none of it and held (1) that the allegations failed to support a plausible breach of warranty claim, and (2) the claim would be preempted regardless.
Plaintiff already amended her complaint once. Although plaintiff made some new arguments in her opposition to the motion to dismiss that were not included in the amended complaint, she did not request leave to amend. The court therefore declined to construe any new arguments in the opposition to motion to dismiss as a request for leave, and it dismissed all of plaintiff’s claims with prejudice.
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