Class III Medical Devices

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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.

Continue Reading More LifeVest PMA Preemption
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About a year ago we blogged about a strong preemption decision from the Eastern District of New York, Gallego v. Tandem Diabetes Care, Inc., 2025 WL 948282 (E.D.N.Y. March 28, 2025). Gallego involved a Class III insulin injection pump that sent a warning alarm to its user that insulin was no longer being delivered. The diabetic using the pump then spoke with a representative of the manufacturer who confirmed that the pump was not delivering insulin and that the user should replace the insulin cartridge. The user of the pump died later the same day, and his estate filed a lawsuit. As discussed in our prior post, the court dismissed with prejudice most of the estate’s claims, but it granted plaintiff leave to file a second amended complaint (SAC) that included a claim for negligent defective design and wrongful death. Today’s decision, Gallego v. Tandem Diabetes Care, Inc., 2026 WL 1130316 (E.D.N.Y. Apr. 27, 2026), applies another robust preemption analysis and dismisses the plaintiff’s remaining claims with prejudice.

Continue Reading Preemption Round Two in the Eastern District of New York
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We previously posted about plaintiffs’ shenanigans in attempting to defeat diversity in a medical device case removed to the Northern District of Illinois. Plaintiffs’ antics were unsuccessful, and the federal court denied plaintiff’s motion remand.  Today’s decision addresses the defendants’ motion to dismiss plaintiffs’ third amended complaint in the same case, and it is very favorable from a preemption standpoint. Miller v. Rush University Medical Center, 2026 WL 147413 (N.D. Ill. Jan. 20, 2026).

Miller involves a cervical disc replacement device (the “Mobi-C”). The device includes an accompanying inserter with a “depth stop” mechanism used to prevent the Mobi-C from going too far into the spinal cord during insertion. Plaintiff and his spouse sued the device manufacturer, the distributor, two sales representatives, the hospital, and the treating physician based on claims that he suffered spinal cord contusions during surgery. The defendants moved to dismiss, with the manufacturer and distributor arguing that all claims against them were preempted. The court agreed.  

Continue Reading PMA Preemption in the Northern District of Illinois
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Rieger v. Medtronic Minimed, Inc., 2025 Cal. Super. Lexis 14 (Cal. Super. L.A. Cnty. Jan. 28, 2025), is an excellent PMA preemption decision from, of all places, Los Angeles County Superior Court, in California – home of the notorious “the Bank” courthouse.  We have no idea whether Rieger was adjudicated in LA’s Central Civil West Courthouse, but that is the first thing we defense hacks think of when we see a “Cal. Super. L.A. Cnty.” citation.

But a few more like Rieger, and maybe we won’t any longer.

Continue Reading Taking Preemption to the Bank
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Happy Valentine’s Day. To celebrate, we will discuss a court decision that we love.

Preemption and the Ohio Product Liability Act (OPLA) are two of the best friends a drug/device defense lawyer has.  Both show up in Groeschen v. Alcon Laboratories, Inc., 2024 Ohio Misc. LEXIS 2 (Ohio Ct. Comm. Pleas Feb. 2, 2024). As…

Photo of Rachel B. Weil

When last we spoke, we were about to deliver our beautiful standard poodle puppy, Luca (registered name Tivin Dreamcatcher), to his show handler, who would trim him and train him and launch his dog show career.  The transfer was accomplished without incident, if you don’t count mommy’s predicable reaction to the separation.  It also included…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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