Ohio attorneys and patients are taking notice of a recent ruling by the Supreme Court stating that patients cannot sue generic drug makers for design defects, further limiting avenues of recovery for injured patients. Reversing an earlier state court’s decision awarding $21 million to a victim injured by a generic medication, the ruling states that generic drug manufacturers are not liable for design defects because federal law requires them to replicate the brand name drug.
The opinion recognizes the victim’s damages in the subject litigation, but says that sympathy for the victim does not relieve the Court’s responsibility to uphold the law. In 2011, the Court said that generic drug manufacturers are not responsible for the failure to warn of a drug’s dangers because generic manufacturers must use the same safety label as the brand name.
Based upon this decision, patients injured by generic drugs now have no legal recourse through either a defective design or failure to warn claim. The decision is a victory for generic drug makers, who say that the decisions of state courts should not usurp the authority of the FDA. One justice offered a dissenting opinion, stating that approval by the FDA should not absolve a drug maker from liability for selling an unsafe product. Advocacy groups suggested that the FDA and Congress increase accountability by allowing generic drug makers to change the warning labels on their products. The FDA is considering such action, but generic drug companies are resisting such a change.
Pharmaceutical litigation involves a complex and vast area of the law. Ohio pharmaceutical liability lawyers work diligently to protect the rights of patients who are injured by taking unsafe drugs. They do this by seeking legal recovery for the damages incurred as a result.
Source: New York Times, “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs“, Katie Thomas, June 24, 2013