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Generic Drug Decision Disastrous to Patient Safety

SCOTUS Decision in Pliva v. Mensing Affects 70 Percent of All Drug Prescriptions

American Association for JusticeWashington, D.C. – Yesterday’s U.S. Supreme Court decision in Pliva v. Mensing is a disastrous outcome for patient safety, giving generic drug companies legal immunity when they ignore harmful side-effects of the drugs they manufacture and profit from.  This decision eliminates any incentive for generic manufacturers to ensure their drug is safe and adequately warn consumers of their drugs’ potential dangers.

This decision also means that brand-name manufacturers will be held to a different yet safer standard.  The Supreme Court decided in Wyeth v. Levine, brand-name manufacturers are responsible for their warning labels and required to update them at all times.

“Patients will now be taking generic drugs at their own risk,” said American Association for Justice President Gibson Vance. “It is absurd that doctors and patients will have to make medical decisions knowing that only brand-name drug manufacturers – not generics – can be held accountable for their drugs’ dangerous side-effects.”

Today, 70 percent of all prescription drugs are filled with generic versions, accounting for about 2.6 billion prescriptions every year.  Additionally, the generic drug industry continues to expand – nine of the industry’s 10 biggest blockbuster drugs are going off-patent within in the next few years. 

“Congress and the Food and Drug Administration need to quickly address the huge legal disparity between brand-name and generic drugs,” said Vance.  “Today’s decision sends a dangerous and expensive message to patients: you are safer taking brand-name drugs.”

Louis Bograd, Senior Litigation Counsel at the Center for Constitutional Litigation, argued this case on behalf of Mensing, and AAJ also filed an amicus brief.  For more information, visit www.justice.org/courts.  To speak with counsel or parties in Pliva v. Mensing, contact Jennifer.Fuson@justice.org, 202-944-2896.

Drugs Expected to Come off Patent in the United States by Year:
2011 2012 2014
Actos Plavix Lexapro Celebrex
Cozaar Seroquel Singulair Cymbalta
Concerta Valtrex Viagra Nexium
Effexor ZyPrexa   Risperdal
Flomax     Symbicort

About the American Association for Justice

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 .


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