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
Today’s case — In re Tepezza Mkt’g, Sales Pracs., & Prod. Liab. Litig., MDL No. 3079, 2025 WL 81338 (N.D. Ill. Nov. Jan. 10, 2025) – doesn’t really break new ground on the substantive law, in fact it is a split decision. But it comes from an unusual procedural posture worth pointing out.
The
[This post is from the non-Reed Smith side of the blog.]
Today we report on Dickson v. Dexcom, Inc, 2024 WL 4291511 (W.D. La. 2024), an important medical-device preemption case that started with a doctrinal bang but ended on a factual whimper.
Committed to nationally uniform standards based on good science, we believe that
We do not mean the German Renaissance painter and thinker Albrecht Dürer. His work, while a poor cousin to that of some famous contemporaries to the south, remains as is. We mean the Supreme Court’s decision in Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), which has been touted for the
A little over two years ago, we wrote a post called What’s In a Name? discussing an attempt by two plaintiffs to hold Pfizer liable for fraud and misrepresentation based on an allegation that it was misleading to call the drug Chantix by its name if it was contaminated. That case, as we noted in
Is what the court finally had to tell plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2023 U.S. Dist. LEXIS 166742 (C.D. Cal. Sep. 19, 2023) in dismissing his second amended complaint as both preempted and inadequately pleaded. We posted about the dismissals of the original and first amended complaints on the same grounds here
If we have said it once, we have said it a hundred times: medical product manufacturers are not insurers of their products. Almost as frequently uttered would be that strict liability is not the same thing as absolute liability. In the show position might be that the temporal relationship between a new medical condition and
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
The decision we report on today, Frye v. Novartis Pharms. Corp., 2022 WL 4305656 (E.D. Ark. 2022), leaves us shaking our heads. The court denied the defendant’s motion to dismiss, which was based on preemption and other grounds. In the course of denying the motion, the court misconstrued the law at least once and
They say the smartest people are the ones who are always learning something new. Those who are open to new ideas and concepts. People who are eager to acquire new information. That’s a great way to live. Long live enlightenment. However, when it comes to federal preemption of a failure to warn claim involving a