Life Sciences

California appeals court rules FDA label doesn't protect manufacturer

Pharma Compliance Alert, October 8, 2008

The California Fifth District Court of Appeal in Fresno reinstated a Modesto woman's suit against generic drug maker Purepac Pharmaceutical Co. for allegedly downplaying side effects of one of its drugs.
Purepac argued that because the FDA approved its labeling for metoclopramide, the company cannot be found liable under state law for the woman’s injury. A Stanislaw County court agreed and dismissed the suit. However, the woman appealed and the appeals court ruled 3-0 that the drug’s FDA-approved label is not enough to preempt the case. The court said a company can still be held liable if a consumer can prove the company knew or should have know about a side effect and did not notify the FDA or take steps to add the warning to the label.
In February, the U.S. Supreme Court ruled 8-1 that medical device manufacturers are immune from liability for personal injuries if their devices passed the FDA’s most stringent pre-marketing review.
The Supreme Court is scheduled to hear Wyeth vs. Levine during its current term, which began October 6. At issue in the case is whether patients who have been harmed by a drug can sue under state law if the drug was produced and marketed under terms approved by the FDA.


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