The U.S. Supreme Court is scheduled to hear arguments soon on whether a generic drug maker can be held responsible for a patient’s injuries. The case is considered very important for pharmaceutical companies, federal regulators and patients who take generic drugs. Some experts estimate that generics make up 80 percent of all drugs taken by people in the United States.
The case before the high court will involve Mutual Pharmaceutical Co., which sold a drug called sulindac, an anti-inflammatory. This medication was given by a pharmacist to a patient named Karen Bartlett, who was suffering mild shoulder pain in 2004. Bartlett, who lives in New Hampshire, claims she began taking the drug and, only a few weeks later, suffered an intense reaction to it. Her skin began to peel off, she was forced to live in a burn unit in a nearby hospital and later was in a medically induced coma. She lost her vision and is now legally blind. Also, she alleges that the medication permanently damaged her lungs and esophagus.
Bartlett sued Mutual, saying the company should be liable for her injuries. She took her case to federal district court, where a jury awarded her $21 million. An appeals court upheld that verdict in 2010; now the case is headed for the high court.
Two years ago, the Supreme Court issued a ruling in Pliva v. Mensing that limited conditions under which consumers of generic drugs could sue manufacturers. In that ruling, the court said companies did not have control over what warning labels said and therefore could not be sued for failure to alert patients about the risks of taking certain drugs.
Bartlett’s case is different, however. Her attorneys did not argue that the drug’s warning label was inadequate. Instead, she claimed that the drug itself was defective. But Mutual has contended that it has no control over the drug’s design because sulindac is a copy of another drug — just like it has no control over warning labels.
The law states that generics may not deviate from a brand-name drug they are copying. Sulindac is the scientific name for Clinoril, a drug that is much like ibuprofen, which was approved by the U.S. Food and Drug Administration in 1978. Sulindac is in a class of drugs known as nonsteroidal anti-inflammatory drugs. They are widely used. Mutual is a subsidiary of Sun Pharmaceutical of India.
The Supreme Court’s ruling could have grave consequences for both sides.
If the court rules on the side of Mutual and says generics cannot be sued for defective products, many lawyers contend that patients will have little recourse if they are injured by a generic drug.
Meanwhile, makers of generics say if the court sides with Bartlett, the verdicts reached by juries would outweigh the power of federal agencies like the Food and Drug Administration. They say drug makers might even remove useful medicines from store shelves. The federal government has joined the generics in this case even though it opposed the industry in the Mensing case. In joining this case, the federal government pointed out that the F.D.A. had reviewed the drug, decided it was safe and determined it could remain on the market.
Attorneys for Bartlett say her suit could uncover new information about the safety of a new drug. They maintained that patients who took sulindac were more at risk of becoming ill like Bartlett, who developed toxic epidermal necrolysis, than those who took other drugs.
A story on the case appeared in the New York Times.
Kreisman Law Offices has been handling Illinois prescription error cases for individuals and families for more than 37 years in and around Chicago, Cook County, and surrounding areas, including Waukegan, Morton Grove, Des Plaines, Evergreen Park, Bellwood, Melrose Park, and Schiller Park.
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