Credit: ivanko80/Adobe Stock Judge Clears Failure-to-Warn FDA Claims Against Korlym for Alleged Adverse Reproductive Health Issues
While the court granted the defendants' motion on the claims that alleged defective design and failure to warn premised on product labeling, Senior District Judge William G. Young ruled that the claims pertaining all failure to warn premised on reports to the FDA and all failure-to-monitor claims can proceed. Young reasoned that dismissal would be premature given unsettled Massachusetts law and that Pietrantoni plausibly alleged that the defendants breached their voluntarily assumed duty to monitor her health while taking the medication, the opinion said.
November 18, 2022 at 05:42 PM
5 minute read
As the Massachusetts Supreme Judicial Court is set to answer a certified question regarding a drug manufacturer's failure to report adverse events to the Food and Drug Administration, a woman's claims of failure to warn through reports to the regulator are allowed to proceed against the manufacturer and distributor of Korlym.
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