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TODAY: Press Call on SCOTUS Bartlett Generic Drug Safety Decision
Date:6/24/2013

ic 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 disco
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    SOURCE American Association for Justice
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