"Design defect" suit threatens FDA review process

03/17/2013 | Politico (Washington, D.C.)

The "design defect" theory behind a lawsuit against generic-drug maker Mutual Pharmaceutical could result in a wave of lawsuits second-guessing the approval of any drug, former FDA Deputy Commissioner Dr. Scott Gottlieb writes. "The theory would allow state juries to relitigate the risk-benefit analysis that is at the very core of the FDA's authority to approve prescription drugs," he writes.

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Politico (Washington, D.C.)