Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year. This decision stated that generic companies did not have control, based on a 1984 law, what their labels said, and therefore could not be sued for failing to alert patients about the risks of taking their drugs.
The Supreme Court ruling affects potentially millions of people: nearly 80 percent of prescriptions in the United States are filled by a generic, and most states permit pharmacists to dispense a generic in place of a brand name. More than 40 judges have dismissed cases against generic manufacturers since the Supreme Court ruled last June, including some who dismissed dozens of cases consolidated under one judge.
According to an article in The New York Times, this is a severe reality for a woman named Debbie Schork, a deli worker at a supermarket in Indiana. Ms. Schork had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it. Her case was quietly thrown out of court last fall.
But, how does this seem fair when that result stands in sharp contrast to the highly publicized case of Diana Levine, a professional musician from Vermont. Her hand and forearm were amputated because of gangrene after a physician assistant at a health clinic injected her with the same drug. She sued the drug maker, Wyeth, and won $6.8 million.
The financial outcomes were dramatically different for one reason- a generic drug. Ms. Schork had received the generic version of the drug, known as Promethazine, while Ms. Levine had been given the brand name, Phenergan.
The Food and Drug Administration is now hearing from several in opposition to these laws. Recently, the advocates from Public Citizen are demanding the agency write new rules which would allow the public to hold the makers of generic drugs accountable.