U.S. Supreme Court Says Rules Generic Drug Makers are Protected from Lawsuits

U.S. Supreme Court Says Rules Generic Drug Makers are Protected from Lawsuits

7/2/2011

 

The highest court in the nation has ruled that generic-drug companies cannot be sued for its failure in warning patients about the danger of hazardous side effects. Their brand name rivals, on the other hand, can face serious legal consequences if it fails to inform patients about possible side effects.

With 5 voting in favor, the decision effectively prohibited two women from filing a lawsuit against Mylan Inc and Teva Phamaceutical Industries Ltd (TEVA) over the drug called metoclopramide which is used for the stomach. They say that taking the drug caused them to contract a serious neurological disorder.

The U.S. Supreme Court decision limited the reach of a ruling made by the SC, requiring brand-name drug manufacturers to defend against failure-to-warn lawsuits under the state product liability law.

Generic-drug makers were successful in their argument that they should not be held to the same principle since federal law requires them to duplicate the packaging inserts that are used by brand-name manufacturers.

In the decision he wrote for the Court, Justice Clarence Thomas, said, “If the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law.”

The ruling split the court along familiar lines, with the Chief Justice, John Roberts, along with Justices Anthony Kennedy, Samuel Alito and Antonin Scalia going along with Justice Thomas in the majority.

WRITTEN BY:

blakeh@wellsdrew.com