Karen Bartlett began taking a mild anti-inflammatory drug, sulindac, in 2004 after her doctor prescribed it to relieve pain in her shoulder. Within weeks, her skin developed a severe reaction to the drug. The condition put her in a burn unit for nearly two months, and she spent several more months in a medically induced coma. Her lungs and esophagus were permanently damaged, and the reaction left legally blind.
In 2010, Bartlett sued Mutual Pharmaceutical Company, the generic drug manufacturer, alleging the drug was defective and dangerous. The jury sided with her, and awarded her $21 million. An appeals court upheld the verdict.
The New York Times reports that now the Supreme Court will hear arguments on whether the manufacturer may be held responsible for Bartlett’s injuries. In 2010, SCOTUS took a stance in Pliva v. Mensing that critically limited consumers’ ability to bring lawsuits against generic drug manufacturers. They ruled that generic companies didn’t have control over what warning labels said – since they are created by the brand name companies – and therefore could not be sued for patients not being alerted to risks when taking their drugs.
But Bartlett didn’t argue that the label was misleading or inadequate, only that the drug was defective. The company, however, contends that that it’s the same and, just like the label, they have no control over the drug’s design.
“Under federal law,” the article says, “generic companies are not allowed to deviate from the brand-name drug they are copying. Sulindac is the scientific name for Clinoril, a drug similar to ibuprofen that was approved by the Food and Drug Administration in 1978 and is sold by Merck. Like ibuprofen, sulindac is in a class of drugs known as nonsteroidal anti-inflammatory drugs or Nsaids, which are in widespread use.”
Any decision could have a major affect on the public, because generic drugs account for 80% of prescriptions in the U.S.