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
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.Continue Reading No Shock Here: D. Mass. Holds Complaint Regarding Class III Medical Device Preempted
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
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. Continue Reading Mixed Bag Rule 702 Ruling from D. Mass.
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
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.Continue Reading The Problem with Pietrantoni – Unraveling Undertaking Liability
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.Continue Reading Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim
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. Continue Reading Adverse Event Reports Not Newly Acquired Information for CBE Label Change
Recently, in describing a decision granting summary judgment in an IVC filter case, we identified some additional analyses we would have liked to have seen:
[W]hile interrelated, we think the concepts of a “compensable injury” and causation are separate. For instance, an exposure might cause a risk of future injury, but state law may hold that such a risk without present injury is not compensable. Or a subclinical injury like pleural thickening may not be compensable, in part because of the inconsistency with the principles of accrual of claims for statute of limitations purposes. Is a medical procedure not required by specific symptoms—regardless of what caused them—itself a compensable injury? We think not. A surgery may be part of the damages allegedly related to an injury allegedly caused by the drug/device/exposure, but is not an injury in and of itself. Gomez did not delve into this either.
That same day—but well after we had set our prescient post to publish—the court in Fuss v. Boston Sci. Corp., No. 2019-02348, 2022 Mass. Super. LEXIS 251 (Mass. Super. Ct. Oct. 20, 2022), did those same analyses in another IVC filter case. Rather than fall prey to the post hoc ergo propter hoc fallacy that plagues plaintiffs’ causation theories in so many drug and device product liability cases, we will admit this is mere coincidence. After all, compensable injury seems like an obvious threshold issue in an IVC filter case where perforation of the inferior vena cava (IVC) is the only claimed injury.
Given the facts of Fuss, we will go a step further and say that it would be better if there were a way to get rid of cases without compensable injuries without the time and expense of going through fact and expert discovery and briefing an all-issues summary judgment motion with accompanying Daubert motion. After a pulmonary embolism, plaintiff had his IVC filter implanted by an experienced vascular surgeon in 2007. It has remained in place, without embolism or any symptoms tied a complication, for the fifteen years since. Then plaintiff saw a lawyer advertisement, was sent by lawyers to get a CT scan ordered by a doctor he did not know and never met, and brought a lawsuit over an alleged perforation. After suing, plaintiff conferred with his implanting surgeon, who, with the benefit of an x-ray, concluded the filter was doing its job and required no treatment or intervention. In deposition, plaintiff admitted that he had been asymptomatic. After the parties completed discovery and teed up motions for both summary judgment and exclusion Massachusetts’s version of a Daubert motion on plaintiff’s catchall expert, plaintiff still had never received any treatment or intervention.Continue Reading No Muss, No Fuss In Disposing Of Litigation-Driven “Injury”
Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown