Massachusetts

Injunction Granted against Revised Childhood Vaccination Schedule and Wholesale Reconstitution of Vaccine Advisory Committee

By Eric Hudson on March 27, 2026

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.

Summers Round 2: Learned Intermediary Rule Applies to Claim Based on Device Recall

By Eric Hudson on August 15, 2025

Today’s post is our second installment about a case in the District of Massachusetts alleging injury from a Class III medical device. We blogged about it this spring when the court dismissed plaintiff’s claim that an implanted defibrillator and associated leads caused her numerous, unnecessary shocks. The court dismissed that complaint based on straightforward, premarket approval preemption. But the court granted plaintiff leave to amend, and she moved to file an amended complaint. Today’s decision, Summers v. Medtronic, Inc., 2025 WL 2201110 (D. Mass. Aug. 1, 2025), denied plaintiff’s motion for leave based on the learned intermediary rule in Massachusetts. It’s a helpful decision because it applies the learned intermediary rule at the 12(b)(6) stage in the context of a device recall.

Neither the Malfunction Theory Nor Res Ipsa Loquitur Excuses Failure to Offer Expert Evidence of a Manufacturing Defect

By Michelle Yeary on April 8, 2025

By their very nature, prescription only medical devices—particularly those that require surgical implantation—are complex products, the design and manufacture of which are not lay person knowledge. So, if you are going to claim such a device malfunctioned, you are going to have to prove it with expert evidence. This is a well-known legal concept. Yet…

No Shock Here: D. Mass. Holds Complaint Regarding Class III Medical Device Preempted

By Adaeze Ashiedu on March 28, 2025

Today’s case has shocking facts but not a shocking result. It should come as no surprise that a complaint attacking the safety of an FDA-approved Class III medical device is squarely preempted by the express preemption provision of the Medical Device Amendments, 21 U.S.C. § 360k(a). But somehow, 17 years post-Riegel, that still does not seem to deter plaintiffs from filing plainly preempted claims.

D. Mass Finds Pre and Post Approval Failure to Warn Claims Preempted

By Michelle Yeary on February 18, 2025

Prescription drug warnings require FDA approval which dictates what the manufacturer can say in the product’s labeling. An exception to the FDA-approval rule is the Changes Being Effected (CBE) regulation which allows a manufacturer to unilaterally change a drug’s warnings “to reflect newly acquired information” and where the revision would “add or strengthen a contraindication…

Mixed Bag Rule 702 Ruling from D. Mass.

By Eric Hudson on June 7, 2024

We like decisions applying Fed. R. Evid. 702 that recognize the recent amendment’s impact on judicial gatekeeping. A status update on post-amendment decisions is here, and there’s a lot to like. We don’t like post-amendment decisions that barely recognize the amendments to Rule 702 and instead parrot pre-amendment case law. As key proponents of the recent rule amendments continue to emphasize, “Don’t Say Daubert.” Hunt v. Covidien, 2024 WL 2724144 (D. Mass. May 28, 2024) says a lot about Daubert and pre-amendment case law, but very little about the recent rule amendments. Nonetheless, the decision excludes entirely the opinions of an expert regularly disclosed by plaintiffs on FDA regulatory issues—Dr. Laura Plunkett.

Preemption Ends Appeal Of Dyspeptic Supplement Case

By Eric Alexander on October 2, 2023

We have often characterized preemption as one of the most powerful tools in product liability defense lawyers’ toolboxes. It also gets utilized effectively by lawyers defending against a variety of consumer fraud cases about FDA-regulated products. We have, for instance, covered a number of decisions where plaintiffs complained about a range of food labeling issues…

The Problem with Pietrantoni – Unraveling Undertaking Liability

By Bexis on February 13, 2023

One aspect of Pietrantoni v. Corcept Therapeutics Inc., ___ F. Supp.3d ___, 2022 WL 16857262 (D. Mass. Nov. 10, 2022), has troubled us ever since we first noticed the opinion. But we recently noticed that Pietrantoni had been selected for publication, so we decided the issue was important enough to examine in depth.

Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim

By Eric Alexander on December 1, 2022

Two weeks ago, we decried the pattern that some courts follow in allowing shifting slates of boilerplate allegations to cases to discovery. The decision in Corrigan v. Covidien LP, No. 22-cv-10220, 2022 U.S. Dist. LEXIS 210296 (D. Mass. Nov. 21, 2022), reminded us of another of our post-TwIqbal pet peeves: when courts treat sweeping legal conclusions as if they were plausible factual assertions. The basic allegations in Corrigan were that the plaintiff’s surgeon used defendant’s surgical stapler to perform an anastomosis—reattachment of two parts of the digestive tract—in connection with removing part of his sigmoid colon (for unspecified reasons, but often diverticulitis or cancer) and the anastomosis later leaked, leading to further surgical intervention. As we said two weeks ago, medical device manufacturers are not insurers. That makes sense because surgery on humans, even done by the best surgeons, in the best hospitals, and with the best devices and equipment, has less than a 100% success rate. Anastomoses leak, infections develop, hernias recur, patients report post-operative pain, and all manner of complications and less than optimal outcomes occur. A common refrain when scientists are presented with a surgical study reporting no complications or failures is that the study was too small, too short, and/or insufficiently rigorous. Thus, a common procedure with a very high success rate will still generate large numbers of reported failures, like anastomoses that leak. This is part of why rates, and particularly comparative rates, provide more useful information about devices and surgeries than do gross numbers.

Even more authoritative sources than this Blog agree with us. FDA, for instance, makes clear that data from its Manufacturer and User Facility Device Experience (“MAUDE”) database “is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.” The reasons for this are not a secret: “The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.” Directly stated, “[t]he submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event.” FDA’s description of the MAUDE database also makes clear in a number of places that the data may be outdated or incomplete for various benign reasons.

Adverse Event Reports Not Newly Acquired Information for CBE Label Change

By Michelle Yeary on November 15, 2022

Today’s case is a favorable prescription drug preemption decision making a key holding on newly acquired information and adverse event reporting. It is a one-off case involving the prescription drug Korlym which is used to treat Cushing’s Disease. Pietrantoni v. Corcept Therapeutics Inc., 2022 WL 16857262 (D. Mass. Nov. 10, 2022). Plaintiff’s claims break down into three categories—design defect, failure to warn, and failure to monitor. Plaintiff dismissed her design defect claims and the failure to monitor claims are based on fairly unique facts. So, the case boils down to failure to warn which itself had two sub-categories—failure to warn based on product labeling and failure to warn based on failure to report adverse events. One is dismissed and the other is delayed.

Korlym was approved by the FDA in 2012. During the approval process, the FDA conducted a Medical Review of the drug which included information about endometrial thickening and the related complications experienced by users. Id. at *6. Therefore, the warnings that were approved to accompany the drug included the risks of vaginal bleeding and endometrial changes. Id. (full warnings set out in opinion at *7). The label was revised in 2016, but there was no change to these warnings. Plaintiff was prescribed the drug in 2018 and used it for approximately 10 months. She experienced complications that led to an emergency surgical procedure and further complications to future fertility. Id. at *8.

The opinion contains a nice recitation of the history of prescription drug preemption – Wyeth v. Levine, PLIVA, Inc. v. Mensing, Mutual Pharmaceutical Company v. Bartlett, and Merck Sharp & Dohme Corp. v. Albrecht. These four cases makeup the “analytical framework” for prescription drug preemption. Wyeth and Mensing establish that preemption hinges on the availability of the Changes Being Effected (“CBE”) procedure. If a manufacturer can unilaterally change the label without prior FDA approval via the CBE procedure, a warning deficiency claim is not preempted. Albrecht clarified, however, that even where the CBE procedure is available, if the manufacturer can demonstrate by clear evidence that the FDA would not have approved the change, the claim is preempted.

Drug & Device Law