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.
The bulk of the court’s analysis in Pietrantoni was about whether plaintiff had alleged that defendant had newly acquired evidence that would have permitted it to revise its label to add or change the warning regarding endometrial risks. Again, the court starts at Wyeth but quickly acknowledges that in the years since, courts “have taken a notably more restrictive approach” in defining newly acquired information. Id. at *12. The trend among the circuits is that newly acquired information “must be information the FDA lacked when it approved the drug.” Id. (emphasis in original).
“New”, however, is not enough. The information must be “based on reasonable evidence of a causal association.” Id. Plaintiff relies solely on post-marketing adverse event reports as the newly acquired information. But, as the court explains, they are neither new information nor reasonable evidence of a causal association.
Adverse event reports “do not represent that the drug caused or contributed to an adverse event.” Id. at *13. Most adverse event reports are silent on causation. They merely report that an event occurred while the patient was also using the drug. For each AER, the “causal chain is incomplete” because the report does not answer the question whether any other pre-condition or medication was the cause of the adverse event. Therefore, even the FDA disclaims any causal association from adverse event reports and no court has ever allowed AERs alone to form the basis for a CBE label change.
Moreover, the adverse events are not actually “new” information. The events reported between when the drug was approved and when plaintiff stopped taking the drug “do not reveal risks of a different type or greater severity or frequency than previously known to the FDA.” Id. at *14. Certain of the reported events were of risks that were fully known and analyzed by the FDA prior to approving the drug. In fact, the condition plaintiff suffered was in the highlight section of the warning. The risk plaintiff suffered was discussed in the FDA’s medical review. Further AERs of these same risks were not “new” information. The AERs were also too infrequent (no more than 20 cases over seven years) to be considered occurring at a greater frequency than at the time of FDA approval. Id. at *15. Because plaintiff’s claim was unsupported by newly acquired information, her warning claims based on labeling were preempted.
Plaintiff also premised her failure to warn claims on a failure to report adverse events to the FDA. The court declined to dismiss the claims based on a mistaken belief that the question of whether Massachusetts would recognize a failure to report claim under state law was pending before the Massachusetts Supreme Judicial Court. The court appears to be unaware that the case that certified the question to the Supreme Judicial Court was settled and so the question was never reached. Once this information comes to light, we assume the court will need to tackle the question itself. Perhaps it once again gets to the First Circuit and re-certified to Massachusetts. We’ll continue to monitor the case on this issue.
That leaves the final claim of failure to monitor. Defendant argued these were “poorly disguised” failure to warn claims. However, they were not based on the drug’s labeling but rather on defendant having voluntarily assumed and thereafter breached a duty to monitor plaintiff. Defendant offers patients taking Korlym a support program and a “Patient Care Advocate.” Plaintiff spoke several times with her assigned patient care advocate and advised the advocate about her menstrual complications. Plaintiff alleges her advocate failed to advise her to seek medical care or to stop taking the drug. The court found plaintiff had sufficiently plead her negligence-based failure to monitor claims which were not preempted warning claims. Id. at *16-17. Not a claim we see that often and not one we are worried about on the preemption front.