WASHINGTON, D.C. -- (Mealey's) The U.S. Supreme Court on Dec. 10 agreed to decide whether the Hatch Waxman Act prevents manufacturers of generic drugs from adding new warnings to drug labels as new risks become known (Pliva, Inc. v. Gladys Mensing, No. 09-993, and Actavis Elizabeth, LLC v. Gladys Mensing, No. 09-1039, U.S. Sup.).
Gladys Mensing was prescribed metoclopramide, the generic version of Reglan, over several years to treat heartburn. She developed tardive dyskinesia, a permanent neurological disorder with symptoms similar to those of Parkinson's disease.
Mensing sued metoclopramide manufacturers Pliva Inc. and Actavis Elizabeth LLC in the U.S. District Court for the District of Minnesota. The trial court in 2008 ruled that because the Hatch Waxman Act requires that the labels of generic drugs be identical to brand-name predecessor drugs, the generic defendants had no duty to warn of the risks of tardive dyskinesia.
Mensing appealed, and in December 2009, the Eighth Circuit U.S. Court of Appeals ruled that Mensing's claims were not preempted by Hatch Waxman. The appeals panel extended the U.S. Supreme Court's 5-4 drug preemption ruling in Wyeth v. Diana Levine (No. 06-1249, U.S. Sup.; 2009 U.S. LEXIS 1774) to generic drugs, finding no intention by Congress in enacting Hatch Waxman to relieve generic drug makers of their duty to keep drug labels updated.
The Fifth Circuit has followed suit.
Pliva and Actavis Elizabeth petitioned the U.S. Supreme Court for a writ of certiorari. The court invited the U.S. solicitor general to brief the issue, and the office on Nov. 2 told the high court that Mensing's claims should not be preempted.
In granting the petitions on Dec. 10, the Supreme Court consolidated the cases and allotted one hour for argument.
Justice Elena Kagan might not participate in the case because she was U.S. solicitor general when that office was invited to submit a brief on the case.
[Editor's Note: Full coverage will be in the Dec. 16 issue of Mealey's Emerging Drugs & Devices. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
For more information, call editor Tom Moylan at 215-988-7739, or e-mail him at firstname.lastname@example.org.