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March 25, 2013

U.S. Supreme Court Considers Liability of Generic Drug Makers

A case before the U.S. Supreme Court may determine if makers of generic drugs approved by the Food and Drug Administration (FDA) can be held liable under state law for alleged design defects, Reuters reports. Mutual Pharmaceutical Co. is asking the court to overturn a $21 million jury award to a New Hampshire woman who took sulindac, a generic nonsteroidal anti-inflammatory drug. Karen Bartlett took the drug in 2004 for shoulder pain, but suffered a rare reaction that made her skin peel off, which left her with burn-like lesions over two-thirds of her body. The company argues that federal law trumps state law in such claims for FDA-approved drugs. Such concerns may influence whether generic drugs for diseases such as HIV/AIDS and others become more widespread in the United States.

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