Defective Generic Pharmaceutical Medication

Too often, a prescription medication is made into a generic version without updating information about adverse reactions. We represented a teenager who had a severe, life-threatening adverse reaction to a generic broad-spectrum antibiotic, minocycline, which had been prescribed for her acne. The manufacturer of the generic drug knew of problems with the medication that were not listed on the drug’s brand-name label. The generic manufacturer contended that FDA rules required only that it match the brand-name label, even when it was aware of problems greater or other than those mentioned in the brand-name label. We worked with experts in warnings, pharmaceutical marketing, FDA regulatory compliance, and medicine on the case. After extensive discovery, the generic manufacturer moved for summary judgment based on the federal preemption doctrine, arguing that given the FDA rules the young woman was not entitled to present her case at trial. The judge hearing the motion disagreed, and shortly afterwards the case settled for $635,000.00.