New undisclosed risks often emerge years after a drug has been on the market. Often this results in a new warning and sometimes, as with Darvocet and Bextra, being pulled off the market for being unreasonably dangerous.
"The Supreme Court has even asserted the importance of lawsuits in consumer safety, helping discover new or undisclosed risks," asserted McLarty.
The U.S. Supreme Court opinion in Wyeth v. Levine stated:
State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.AAJ filed comments in support of Public Citizen's citizen petition asking the FDA to address the Mensing decision. For more information on generic drugs, please visit www.TakeJusticeBack.com/GenericDrugs. As the world's largest trial bar, the American Association for Justice (formerly known as the Association of Trial Lawyers of America) works to make sure people have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others--even when it means taking on the most powerful corporations. Visit http://www.justice.org . SOURCE American Association for Justice