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
No Mulligans in Delaware – Exclusion of Plaintiffs’ General Causation Experts Results in Dismissal of 80,000 Zantac Cases
This post is not from the Reed Smith or Dechert sides of the blog.
We previously posted about the Delaware Supreme Court’s ruling that proper application of Delaware Rule 702 required the exclusion of plaintiffs’ general causation experts in the Zantac litigation. Since then, we’ve been waiting for the other shoe to drop. Last week, it dropped with a resounding boom. Today’s decision applied the Delaware Supreme Court’s ruling and dismissed over 80,000 cases. In re Zantac (Ranitidine) Litig., No. N22C-090101, 2026 WL 1009008 (Del. Super. Apr. 14, 2026).
The decision focuses on the question of which plaintiffs are bound by the exclusion of the plaintiffs’ general causation experts. The court denied plaintiffs leave to supplement their expert reports on December 1, 2025, and the defense argued that all plaintiffs with cases filed before December 1, 2025, are bound by the ruling. Recognizing that the litigation was about to be eviscerated, plaintiffs made a number of desperate arguments.
Continue Reading No Mulligans in Delaware – Exclusion of Plaintiffs’ General Causation Experts Results in Dismissal of 80,000 Zantac CasesAdverse Event Reports May Not Be Used to Establish Causation
It’s hard to think of any recent litigation where plaintiffs didn’t seek overblown discovery about adverse event reports and then have their experts rely on those reports in an effort to establish causation. But as we’ve blogged about repeatedly, reports from the FDA’s Adverse Event Reporting System (“FAERS”) do not establish causation (and, for good measure, they don’t constitute newly acquired information). Today’s decision, Taylor v. Dixon, 2026 WL 865183 (M.D. Fla. Mar. 30, 2026), is a little different since it involves a federal habeas petition. But we couldn’t resist blogging about it given the court’s comprehensive take-down of the attempted use of an adverse event report to show causation.
Continue Reading Adverse Event Reports May Not Be Used to Establish CausationInjunction Granted against Revised Childhood Vaccination Schedule and Wholesale Reconstitution of Vaccine Advisory Committee
We’re not bashful about our affinity for real science. It underpins our clients’ ability to develop life-saving drugs and devices, supports Rule 702’s role in keeping junk science out of courtrooms, and reflects the skeptical habits of mind that should matter to everyone. Shortly before his death in 1996, Carl Sagan discussed with Charlie Rose the dangers of a society where fundamental understandings of science and technology continue to diminish:
There [are] two kinds of dangers. One is . . . [t]hat we’ve arranged a society based on science and technology in which nobody understands anything about science and technology, and this combustible mixture of ignorance and power, sooner or later, is going to blow up in our faces. I mean, who is running the science and technology in a democracy if the people don’t know anything about it? And the second reason that I’m worried about this is that science is more than a body of knowledge. It’s a way of thinking. A way of skeptically interrogating the universe with a fine understanding of human fallibility. If we are not able to ask skeptical questions, to interrogate those who tell us that something is true, to be skeptical of those in authority, then we’re up for grabs for the next charlatan political or religious who comes ambling along. It’s a thing that Jefferson laid great stress on. It wasn’t enough, he said, to enshrine some rights in a Constitution or a Bill of Rights. The people had to be educated, and they had to practice their skepticism and their education.
Carl Sagan’s Last Interview. Fast forward, and today we’re discussing a case where the court quotes Carl Sagan and notes that, in the context of vaccines, science is “the best we have.” Am. Acad. of Pediatrics v. Kennedy, __ F. Supp. 3d __, 2026 WL 733828 (D. Mass. Mar. 16, 2026). Through a combination of good science and government oversight, the United States’ vaccination program has been a beacon for public health:
Congress and the Executive have built—over decades—an apparatus that marries the rigors of science with the execution and force of the United States government. One extraordinary product of that apparatus has been the eradication and reduction of certain communicable diseases through the development and use of vaccines. In the words of the Centers for Disease Control and Prevention (CDC), vaccines are one of the greatest achievements of biomedical science and public health.
Id. at *1 (cleaned up). That success in the eradication of certain diseases is based on a rigorous method by which decisions about vaccine policy are made—“a method scientific in nature and codified into law through procedural requirements.” Id. In this case, that rigorous and well-established method (both scientific and legal) was ignored.
Continue Reading Injunction Granted against Revised Childhood Vaccination Schedule and Wholesale Reconstitution of Vaccine Advisory CommitteeUntimely Piggybacking
We almost never post on securities decisions, but we’re making an exception today. Our readers know that the initiation of MDLs and state court coordinated proceedings—often loaded with unvetted and bogus claims—can drive down defendants’ stock prices. When that happens the plaintiffs’ class action bar swoops in and files securities class actions, essentially trying to make the same defendant pay twice for the same claims. Call it the “unholy alliance.” Today’s decision (another one arising out of the Zantac litigation) is notable because it strikes directly at the linkage between mass torts and the securities class actions that try to play piggyback. In Roofers Loc. No. 149 Pension Fund v. GSK PLC, 2026 U.S. Dist. LEXIS 44087 (E.D. Pa. March 4, 2026), the information contained in mass tort filings and accompanying discovery were enough to bar the securities class action based on the statute of limitations.
Continue Reading Untimely PiggybackingA Drug Dealer? Seriously?
We’ve blogged about aspects of the Model Drug Dealer Liability Act before. Over 20 states have enacted versions of the model act in an effort to shift liability for harm caused by illegal drugs to the drug dealers and traffickers who sell and promote illegal drug use. Those are not normally the types of claims of interest to our readers. But, given that we’ve been blogging this week about fraudulent and harmful medical procedures and junk science in mass torts, maybe it’s no surprise that today’s decision deals with an attempt to use a version of the model act as a vehicle for finding liability against a major distributor of legitimate, FDA-approved drugs. McKesson Corp. v. Bolton, 2026 WL 394505 (Ga. App. Feb. 12, 2026).
Continue Reading A Drug Dealer? Seriously?The Zantac Defense Has the Hammer in Delaware
This post is not from the Reed Smith or Dechert sides of the blog.
We hope we’re not the only ones distracted by the Winter Olympics. We’re breathless from Breezy Johnson taking gold in the downhill, Jordan Stoltz emerging as the U.S. speed-skating phenom, Jessie Diggins battling bruised ribs to take bronze in the 10K cross country freestyle, and Ilia Malinin throwing in a back-flip in his skating routine just for kicks—despite it not earning him any points. Not to mention short-track skating, biathlon, luge, moguls, snowboard-cross, bobsledding, the Olympic debut of ski mountaineering, and all kinds of other ski and snowboarding events where the contestants either fly down mountains at cataclysm-embracing speeds or hurl themselves into the stratosphere while contorting themselves in twists and turns that make us dizzy. Combine that competition and athleticism with the Olympic themes of unity and sportsmanship, and you can see why we’ve got Olympic fever.
We were particularly enthralled with the U.S. mixed-double’s curling team. This is from humble bloggers who, other than every four years, have no idea what curling is. But when the Winter Olympics roll around, we’re watching to see who’s dominating the house and who has the hammer. The U.S. mixed doubles team had never taken home a curling medal. This year’s team, Cory Thiesse and Korey Dropkin, absolutely dominated the round robin and earned a spot in the medal round. After a magnificent shot in the last end (like a game winning home run in the bottom of the ninth), the U.S. defeated defending gold-medalist Italy for a chance to play for the gold medal. While “Corey and Korey” ending up taking home silver, it was the first ever medal for the U.S. in mixed curling and the first ever Olympic medal in curling for an American woman. What a run.
One of the curling commentators noted that Korey Dropkin was one of the best sweepers in the game. While it may be a stretch to connect curling to the legal side of these posts, we think it is fair to note that mass torts defendants often engage in years of clean up after securing victories in mass torts. Call it sweeping the house if you will. Case in point is the Zantac litigation. The defendants secured litigation-ending rulings excluding plaintiffs’ general causation experts in the federal MDL (which we posted about here and here). Plaintiffs then fled to Delaware (of all places to see mass torts plaintiffs flocking, we continue to be surprised and disappointed at this trend). The Delaware trial court refused to follow the well-reasoned decisions from the MDL and appeared to give new life to the Zantac litigation (see this post), but the Delaware Supreme Court reversed and remanded with instructions for the trial court to apply Delaware’s Rule 702 consistently with the federal rule (see here).
Continue Reading The Zantac Defense Has the Hammer in DelawarePMA Preemption in the Northern District of Illinois
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 IllinoisLearned Intermediary Success at the 12(b) Stage in Alabama (plus a Double Whammy)
We write a lot about the learned intermediary rule. It’s a fundamental aspect of the defense of drug and device cases, it’s grounded in the realities of the physician-patient relationship, and it tends to produce a lot of cases worth blogging about. We also refer to it as a rule (e.g., here, here, here, and here), rather than a doctrine, because that’s what it is. We particularly like it when courts dismiss warnings claims based on the learned intermediary rule at the pleadings stage. Today’s case is one of those. Plaintiff filed a shoddy complaint, was able to amend in response to an initial motion to dismiss, and then saw his warnings claims dismissed with prejudice under Alabama’s learned intermediary rule.
In McCrackin v. Rex Medical L.P., 2026 WL 66797 (N.D. Ala. Jan. 8, 2026), the plaintiff alleged he received an Option retrievable IVC filter in 2012. Twelve years later, he allegedly suffered complications when a “leg” from the filter fractured and penetrated a vein, with the further allegation that his spine grew around the fractured leg. He sued based on allegations that the device was marketed as permanent when it should have been temporary, and that there were not adequate warnings about the risk of “tilt, fracture, migration and/or perforation.” Id. at *1. Plaintiff previously obtained leave to file an amended complaint in response to an initial motion to dismiss, so this was his second bite at the apple. The defendant who marketed and distributed the device moved to dismiss.
New Year, Same Old Standing Problems
Happy new year, and welcome to 2026. While we may still be pondering the meaning of auld lang syne or waxing philosophical about the new year, we’ll quickly move on and get to work defending our clients. That’s what we do as defense hacks, and kudos to all of you for doing it so well.
We’ve written many times about plaintiffs who try (and fail) to plead injury by alleging hypothetical risks, speculative future harm, or buyer’s remorse untethered to actual loss. Today’s dismissal of a putative class action from the Northern District of California is a new year’s reminder that Article III and statutory standing remain stubbornly real requirements. Druzgalski v. CVS Health Corp., 2025 U.S. Dist. LEXIS 265766 (C.D. Cal. Dec. 23, 2025).
Continue Reading New Year, Same Old Standing Problems