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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

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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

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Recently, largely related to the dubious pleasure of home ownership, we have had multiple occasions on which we were forced to shrug our shoulders and proclaim, “Nothing’s perfect.”  To wit, we recently noticed a small wet spot on our bedroom ceiling.  The roofing company discovered that the corresponding section of the roof was too shallow

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Well, at least that’s true when we are blogging about defense wins.  And this week, we have another good gadolinium case.  This time from New York.

Just a quick reminder – gadolinium is a contrast agent that is injected into a patient before undergoing an MRI.  The gadolinium is intended to pass through the body,

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The last baseball player to reach a .400 batting average for a season was Ted Williams in 1941.  In a sport that probably keeps more stats than any other, baseball sees records broken and milestones reached all the time.  Some marks, however, appear to be set in stone.  One of these is Ted Williams’s 1941

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This post is from the non-Reed Smith side of the blog.

When we say Nebraska, what comes to mind? Cornhusker football? Warren Buffet, the Wizard of Omaha? Buffalo Bill’s Wild West Show? Mutual of Omaha’s Wild Kingdom? An amazingly haunting album by Bruce Springsteen? As the Jersey Girl blogger on this site, it should be

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And it’s the start of another season of too much eating, drinking, shopping, and socializing. Sometimes it feels like a year’s worth cramped into a little over a month. And, for some of us (OK, me), we’re entering this week still a little groggy and foggy. So, we’ll admit to looking for something fairly straightforward

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Can you recall what you were doing back in March of this year? To be more precise the day before St. Patty’s Day and the day after the Ides. No? Well, apparently the defendants in the Risperdal and Invega Products Liability Cases pending in California state court were celebrating but they forgot to invite us

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We’ve got a copy of the Reply Brief filed by defendant Wyeth in the Wyeth v. Levine case. Here are the highlights as we see them (we’re trying to stay away from the Phenergan or Wyeth specific stuff):

  • Conflict preemption operates by the direct force of the constitution. Express congressional intent to preempt thus is