JURIST Supported by the University of Pittsburgh
PAPER CHASE NEWSBURSTDigest RSS feedFull RSS feed
Serious law. Primary sources. Global perspective.


Saturday, December 11, 2010

Supreme Court to hear 3 cases involving labeling of generic medicines
Brian Jackson at 10:06 AM ET

Photo source or description
[JURIST] The US Supreme Court [official website; JURIST news archive] on Friday granted certiorari [order, PDF] in three cases related to the duty of generic drug manufacturers to list possible side effects on the labels of medicines they produce. The three cases, PLIVA Inc. v. Mensing [docket; cert. petition, PDF], Actavis v. Mensing [docket; cert. petition, PDF] and Actavis v. Demahy [docket; cert. petition, PDF] were consolidated and will receive one hour of oral argument time. In each of the three cases, the drug manufacturers sought review after appellate courts ruled that the plaintiffs' cases could move forward and that federal law did not preempt their state law claims. Both plaintiffs suffered a neurologic side effect, tardive dyskinesia [NIH backgrounder], from their use of the generic drug metoclopramide to treat gastric reflux.

These consolidated cases will answer a question that the Supreme Court left open when it decided Wyeth v. Levine [JURIST report] in 2009—namely, is state law preempted in drug labeling cases when the drug is a generic, rather than name-brand medication. In the Wyeth decision, the court held that manufacturers of name-brand medicines bear primary responsibility for product labeling, and that the silence of the Food, Drug, and Cosmetic Act [text] on the issue of preemption was sufficient proof that Congress did not contemplate preemption in medication labeling. The court stated that manufacturers may themselves initiate strengthened warning labels to comply with state and federal requirements. The court's decision in Wyeth upheld a Vermont Supreme Court's affirmance of a $6.7 million jury award for the plaintiff.




Link |  | print | subscribe | RSS feeds | latest newscast | Facebook page

For more legal news check the Paper Chase Archive...


LATEST LEGAL NEWS

 Malaysia authorities seize newspapers, detain opposition activists
12:34 PM ET, May 23

 Member of feminist rock group Pussy Riot denied parole
11:56 AM ET, May 23

 Egypt court acquits police officers accused of killing protester
11:39 AM ET, May 23

 click for more...

Get JURIST legal news delivered daily to your e-mail!

LATEST FORUM

The War on Terror and the Need for Muslim Support
DOMESTIC
Faisal Kutty
Valparaiso University Law School

ABOUT

Paper Chase is JURIST's real-time legal news service, powered by a team of 30 law student reporters and editors led by law professor Bernard Hibbitts at the University of Pittsburgh School of Law. As an educational service, Paper Chase is dedicated to presenting important legal news and materials rapidly, objectively and intelligibly in an accessible, ad-free format.

CONTACT

Paper Chase welcomes comments, tips and URLs from readers. E-mail us at JURIST@jurist.org