Two years ago, in Pliva v. Mensing the U.S. Supreme Court determined that patients injured or killed by dangerous generic drugs have no legal recourse when the manufacturer failed to warn consumers about dangerous side effects. This is called federal preemption. Last month, in Mutual Pharmaceutical Co. v. Bartlett, the Court expanded immunity for generic drugs to include lawsuits claiming that, if the drug company would not change the warning, they should just stop selling the dangerous drug. This is in stark contrast to consumers injured or killed by name brand drugs, who continue to have the right to seek compensation in the courts based upon the Court’s 2009 ruling in Wyeth v. Levine. These three rulings created two classes of consumers: those with rights, and those without. Making matters worse, three out of four prescriptions are filled with generics. Those are bad odds for consumers’ rights, here in Jacksonville and across the nation. Compare this with the rights of those injured in car accidents; their rights to compensation are the same regardless of whether the auto accident is caused by a car, a truck or a bus.
Last week, the United States Food and Drug Administration (FDA) signaled its intention to address this arbitrary inequality with a proposed rule that would see to it that generic drug makers make necessary changes to their safety labels or be subject to liability. This would reestablish the rights of consumers when generic drug makers fail to warn about dangerous side effects. In a summary posted on the Office of Management and Budget website last Wednesday, the FDA indicated that it intends to “publish a proposed rule by September, when the public would be asked to comment.”
The Wall Street Journal quoted Sen. Patrick Leahy (D-VT): “I welcome this first step by the Food and Drug Administration to address this troubling inconsistency in the law.” However, industry groups such as the Generic Pharmaceutical Association declined to comment.
Although the exact wording of the proposed rule is still not known, the rule change would be a major step toward giving consumers equal legal rights both when dangerous drugs are name brand, and when they are generic. Terrell • Hogan personal injury and wrongful death law firm will continue to alert the public as more information emerges.
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Generic Drug Makers Will Soon Face The Regulatory Music