Monday, November 08, 2010

November 2010 Georgia Reglan News




The U.S. Solicitor General has asked the U.S. Supreme Court to reject an appeal by pharmaceutical companies in a generic Reglan lawsuit, in a case known as the Mensing decison.

The manufacturers of the generic Reglan, metoclopramide, are seeking a reversal of an appellate court decision that holds them liable for failing to warn patients about the risk of tardive dyskinesia, a rare movement disorder linked to the drug. The Supreme Court asked the U.S. Solicitor General for an opinion on the accountability of generic Reglan manufacturers.

The Solicitor General supported the appellate court ruling in an amicus brief that had been filed a week ago.  “The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted,” the brief said. “A generic manufacturer can (and indeed, must) inform the FDA of new information about the risks that may require a change in the labeling of its drug.”