Generic pharmaceuticals: Take at your own risk

Recent rulings by the U.S. Supreme Court created a product liability law disparity based on the type of pharmaceutical manufacturer, generic or brand-name. After Pliva v. Mensing, a patient harmed by ingesting a generic prescription drug is barred from pursuing a state failure-to-warn claim against the generic manufacturer. That same patient could seek similar legal redress if they were fortunate enough to ingest a brand-name prescription drug, under Wyeth v. Levine. This presentation examines the regulatory framework relied upon in Wyeth and Pliva, the disparity in product liability law created by these cases, and the impact of these decisions on the public health of the American population. As health care plans and the Affordable Care Act continue to promote generics over brand-name drugs, the reach of Pliva's ruling increases. And, with an increasing population covered by public health plans such as Medicare and Medicaid, many patients taking generics will also be those least able to absorb the risk of an adverse drug reaction. They will have no access to failure-to-warn tort remedies and will internalize the costs of injury. Finally, this presentation discusses and analyzes the most likely legal and policy solutions available following Pliva that may promote public health by removing or reducing this new barrier to legal remedies based on the type of pharmaceutical manufacturer.