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.
"Design defect" suit threatens FDA review process
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