The Supreme Court voted on Monday to protect generic drug manufacturers for design defects if federal officials had previously approved the brand-name version of the drug. This controversial decision means victims of adverse drug effects, including New Hampshire woman Karen L. Bartlett cannot sue the drug maker for compensation.
Bartlett had received $21 million in compensation from generic manufacturer Mutual Pharmaceutical Co, Inc. after Sulindac caused her outer skin layer to burn off. The jury agreed initially that the pain pill was "unreasonably dangerous" and granted her the compensation.
Mutual Pharmaceutical Co. is owned by Sun Pharmaceutical Industries Ltd. Sulindac, known as a nonsteroidal anti-inflammatory drug, is used to reduce the pain, swelling, and joint stiffness that accompanies arthritis.Bartlett had taken Sulindac in pill form to relieve shoulder pain.
The drug caused Bartlett's skin to deteriorate, leaving at least 60 percent of her body as an open wound. The side effects were so severe that Bartlett is now legally blind.
After taking Sulindac at the direction of her doctor, Bartlett spent over two months in the burn unit of a Boston hospital. Her rare and severe reaction is known as toxic epidermal necrolysis.
The Supreme Court voted 5-4 in favor of the generic drug manufacturer. The court majority said the Food and Drug Administration had approved Clinoril, the brand name of the drug. Moreover, federal approval over the sale of drugs overpowers any state's consumer-protection laws.
Following Bartlett's initial win in the court, Mutual Pharmaceutical Co. appealed and argued the verdict was inconsistent with federal law.
Bartlett's "situation is tragic and evokes deep sympathy, but a straightforward application of preemption law requires that the judgment [in her favor] be reversed," Justice Samuel A. Alito Jr. wrote for the court majority. Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Anthony M. Kennedyand Clarence Thomas agreed.
Dissenting, Justice Sonia Sotomayor said that "the court has left a seriously injured consumer without any remedy despite Congress' explicit efforts to preserve state common-law liability."
The controversy of the court's ruling stems from the fact that approximately 80% of prescriptions written in the U.S. are for generic drugs. This means that consumers hurt by a brand name drug can sue the drug maker for adverse effects, but those suffering the same damage from a virtually identical but generic drug cannot.
Many view the court's decision as a blow to patient safety. Public Citizen, a consumer watchdog group, claimed the court's decision undermines patient safety and creates adverse incentives for generic drug makers.
"Today's court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients," Michael Carome, director of Public Citizen's Health Research Group, said in an interview.
If you or a loved one has been injured as a result of a defective drug there is still hope. Sheff Law Offices has successfully represented victims in these situations for many years. Please call our offices at (617) 227-7000 or toll free at (888) 423-4477 to schedule a free consultation.