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Today’s opinion, Digan v. Luxco, Inc., 2026 U.S. Dist. LEXIS 209391 (D. Mass. Sept. 16, 2026), arises from the bad combination of an open flame, a fraternity party, and Everclear alcohol. For those who’ve never encountered Everclear, it’s a 95% ethanol, 190-proof alcoholic beverage. Stiff and obviously flammable stuff. A frat-member poured a bottle of Everclear on a backyard fire during a party, creating a fireball that badly burned the plaintiff. Plaintiff sued the manufacturer of Everclear alleging a variety of claims, most of which would not make the opinion blog-worthy for us. But one aspect of the opinion caught our eye—the court’s rejection of “negligent undertaking” liability. 

We’ve blogged about some troubling aspects of negligent undertaking liability before, and we don’t want to see it creep into our practice area. Here the court held that marketing a product does not create a special duty to ensure the protection of its consumers, and that’s worth a post.

Continue Reading Dismissal of Negligent Undertaking Claim in Massachusetts

About four years ago we posted about a decision in which the Wisconsin Court of Appeals reversed a trial court’s injunction requiring the administration of a certain medication to treat a patient suffering from COVID-19. In that decision, the party seeking the injunction relied on an unsworn declaration from a physician who stated that he was “generally considered the foremost authority” on the proposed treatment. Gahl v. Aurora Health Care, Inc., 403 Wis. 2d 539, 554-55 (Wis. Ct. App. 2022). That decision rejected the assertions in the declaration and noted that the declaration was “conspicuously devoid of any discussion of the patient in [the] case.” Id.  Today’s decision, Kory v. Waters, 2026 WL 2507087 (2d. Cir. Aug. 26, 2026), comes full circle—the physician who offered the declaration in Gahl supporting what might be considered unorthodox treatment was named as a defendant in a medical malpractice claim related to his treatment of a patient with COVID-19.  The dismissal of the malpractice claims underscores the broad scope of immunity under the Public Readiness and Emergency Preparedness Act (the PREP Act), 42 U.S.C. § 247d-6d.  Even if the treatment might be considered “counter-culture,” if the Act’s requirements are satisfied, it is subject to immunity from suit.

Continue Reading PREP Act Comes Full Circle for “Counter-Culture” Expert in COVID-19 Treatment

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

Today’s post is from the Zimmer hip prothesis MDL, which appears to be winding down and which we’ve blogged about here. It’s a Rule 702 decision that excluded a treating surgeon who offered unsupported expert opinions about an alleged product defect. In re: Zimmer M/L Taper Hip Prosthesis Prods. Liab. Litig., 2026 WL…

We’ve wondered if the widespread use of generative AI was going to produce an increase in the filing of pro se complaints and a marked change in their content. While the results are preliminary, at least one study shows a significant increase in pro se filings following the general availability of AI tools. And our own anecdotal experience suggests that, with the benefit of AI, pro se filings are moving from handwritten one-pagers to lengthy and more sophisticated complaints.

If AI is helping pro se plaintiffs prepare more sophisticated pleadings, we would hope that courts would become less deferential. After all, if generative AI helps pro se litigants bring their claims on a more level playing field, and if they’re bombarding courts with complaints, shouldn’t we see an end to the type of judicial indulgence in favor of pro se plaintiffs that leads to bizarrely pro plaintiff results? While we will continue to hold out hope, today’s case is an example of a court giving a pro se plaintiff the benefit of the doubt and, unfortunately, potentially expanding Texas product liability law into enterprise software.

Continue Reading Pro Se Blues in Texas

Today’s post is not from the Reed Smith side of the blog.

We remember a time years ago when the phrase “Lone Pine order” was not widely understood. That has long since changed, and now it’s tough to imagine anyone who practices in mass torts not being familiar with it. Indeed, we’ve posted repeatedly about courts entering Lone Pine orders in certain litigation.  We also have a cheat sheet of favorable Lone Pine orders. But as we posted a year ago, the term “Lone Pine” carries a lot of baggage, and we suggested it might be time to stop using the name of a 1986 New Jersey case to refer to a case management procedure for requiring plaintiffs to establish the factual bases for their claims. Terms like “Threshold Evidence Orders” or “Case Vetting Orders” seem more appropriate, and dropping the Lone Pine description might generate less resistance from plaintiffs’ counsel and courts.   

Continue Reading Case Vetting Order in the Thalidomide Litigation

Sometimes we read a decision in favor of the defense that makes it seem like getting the good result was easy. The court summarily disposes of plaintiff’s arguments, adopts the defendant’s reasoning, and might throw in a comment or two about things the plaintiff could have done—but didn’t. But getting those good results is almost never easy. The result is usually a reflection of good lawyering, hard work, and attention to detail (and of course, even with all those things plus favorable law, the client still may not get the result it deserves). Today’s decision, Giddens v. Tift Reg’l Health Sys., 2026 WL 555070 (M.D. Ga. Feb. 27, 2026), reads like it was easy, but we suspect that was because of the work that went into it by defense counsel. So, as we roll into our observance of the Memorial Day holiday and perhaps look forward to some legitimate “easy living” over the weekend, we’ll tip our hats to our friends and colleagues who do the diligent work on behalf of their clients.  

Continue Reading Fraudulent Joinder and Some Easy Living in the Middle District of Georgia

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

Drug & Device Resources

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.
Learn more about this book