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TODAY: Press Call on SCOTUS Bartlett Generic Drug Safety Decision

WASHINGTON, June 24, 2013 /PRNewswire-USNewswire/ -- The following is being released by the American Association for Justice:

Today the U.S. Supreme Court issued another handout to the generic drug industry, shielding it from lawsuits for the design of their drugs at the cost of consumer safety.  In a 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett the Court, once again, let a generic drug manufacturer off the hook for the safety of the drugs they produce.  

Despite lower court rulings in favor of Karen Bartlett that the drug she took is an unreasonably unsafe drug, SCOTUS sided with Mutual and decided that they cannot be held responsible for the design of their drugs.

WHAT:    Press call on SCOTUS decision in Mutual Pharmaceutical Co. v. Bartlett

WHEN:    TODAY, Monday, June 24, 2013, at 2:30 p.m. EDT

Lou Bograd with the Center for Constitutional Litigation
Allison Zieve with Public Citizen
Sue Steinman with the American Association for Justice
David Fredrick argued this case for Bartlett in front of SCOTUS

CALL-IN #: 1-800-434-1335; Conference Code: 971187#

The Facts

  • Generic drug corporations are off the hook from legal accountability due to the U.S. Supreme Court case Pliva v. Mensing.  [U.S. Supreme Court]
  • Nearly 80 percent of all prescriptions in the U.S. are filled with the generic version of a drug.  [U.S. Food and Drug Administration]
  • Half of all black box warnings on drugs introduced after 1975 were added after the drug had received FDA approval and been on the market for seven years.  [The Journal of American Medical Association]

Mutual Pharmaceutical Co. v. Bartlett (argued March 19, 2013)

  • Karen Bartlett, of Plaistow, N.H, was prescribed a drug for shoulder pain that was filled with generic sulindac. 
  • Soon after, two-thirds of her skin began shedding off and she spent months in a burn unit in a medically induced coma. 
  • She endured 13 eye surgeries and numerous cornea implants. 
  • She now has trouble walking, is legally blind and will need care for the rest of her life due to Stevens-Johnson syndrome which she developed as a result of taking the generic drug.
  • Lower courts concurred sulindac was unreasonably dangerous compared to similar drugs, awarding Karen $21 million in damages for her injuries. 
  • Mutual argued it is only making a copy of the brand drug, and therefore it has no legal responsibility for its design or safety.

AAJ filed comments in support of Public Citizen's citizen petition asking the FDA to address the Mensing decision.  Public Citizen also issued a new report today highlighting how many potential hazards are not discovered until years after drugs have been on the market and the risk this poses to patients.

For more information on generic drugs, please visit

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

SOURCE American Association for Justice
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