Congressional Proposal Would Expand Generic Drug Manufacturers’ Duty to Warn

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For Immediate Release: April 18, 2012

Contact: Katie Gommel
American Association for Justice
202-965-3500 x8369
AAJ Press Room

Congressional Proposal Would Expand Generic Drug Manufacturers’ Duty to Warn   

Legislation would eliminate discrepancy created by Pliva v. Mensing Ruling

Washington, DC—Today Senator Patrick Leahy (D-VT) and six co-sponsors introduced the “Patient Safety and Generic Labeling Improvement Act of 2012” (S. 2295), amending U.S. Food and Drug Administration (FDA) regulations to allow manufacturers of generic drugs to initiate labeling updates. A companion bill, “Patient Safety and Drug Labeling Act,” (H.R. 4384) was introduced in the U.S. House of Representatives by Reps. Bruce Braley (D-IA) and Chris Van Hollen (D-MD).

This bill would allow generic manufacturers to initiate changes to their labels to reflect current health and safety information under the same circumstances that apply to manufacturers of branded drugs; ensuring brand and generic manufacturers have the same responsibility to adequately warn the public of their drugs’ risks.

The American Association for Justice (AAJ) has called for expanding generic drug manufacturers’ responsibility to warn since last June’s U.S. Supreme Court decision in Pliva v. Mensing.

“With the expanding generic drug market, it is essential all manufacturers—brand and generic—are held accountable for the safety of their drugs,” said AAJ president Gary M. Paul.

As a result of Mensinghundreds of patients have had their cases dismissed because the court ruled that state law-based failure to warn claims conflicted with FDA labeling requirements.

As Gabriel N. Drapos wrote last week in his university’s newspaper, The Harvard Crimson, the Mensing decision has prevented him from having the facts of his case heard in court because he took the generic form of Accutane and not the brand name drug. He developed Ulcerative Colitis his freshmen year at Harvard University after taking a generic form of Accutane in high school.  After months of pain, tests and surgeries doctors were forced to remove Gabriel's entire large intestine greatly impacting his day-to-day actives. 

“This legislation would restore the civil justice system for hundreds of Americans injured by defective generic drugs,” said Mr. Paul.  

Over 75 percent of prescriptions are filled with generic drugs. Once a drug goes generic most brand name manufacturers leave the market resulting in inaccurate and old warning labels. Accountability is the only incentive generic drug companies have to monitor and adequately warn patients about the safety of their drugs. 

For more information and a list of cases that have been dismissed as a result of the Mensing decision please visit

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