Generic Drugs Prove Resistant to Lawsuits, Compared with Brand-names

As reported in the New York Times, two females in separate cases received the same drug for treatment of nausea, both of which ultimately required amputation following adverse reactions, but only one of them won their lawsuit. Choosing a generic over the brand can be a big mistake if something goes wrong.

Debbie Schork, a deli worker at a supermarket in Indiana, developed gangrene in her arm after an Emergency Room nurse injected her with an anti-nausea drug. Ms. Schork had her hand amputated from the gangrene. She sued the manufacturer (named in the hospital’s records) for failing to warn about the risks of injecting this medicine. Unfortunately, her case was thrown out of court.

The other case involved Diana Levine, a professional musician from Vermont. She was injected with the same drug by a physician’s assistant in a health clinic. Diana’s hand and forearm were amputated due to gangrene following the injection. Ms. Levine sued the drug maker, Wyeth, and won $6.8 million.

These two outcomes were different for one reason: Ms. Schork received the generic version of the drug, known as promethazine, while Ms. Levine received the brand name, Phenergan.

All around the country, many lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said, and thus could not be sued for failing to alert patients about the risks of taking their drugs.

What used to be an insignificant decision – whether to take the generic or the brand-name version of a drug – has become the deciding factor in whether a patient can seek legal compensation from a drug company.  There are many issues to consider. Ms. Schork was not told which type of drug the emergency room nurse injected into her arm, generic or brand.

Another case involves Camille Baruch, who developed ulcerative colitis, a chronic gastrointestinal disease, after taking a generic version of Accutane, as required by her health care plan.  Also, when you fill a prescription, the pharmacist does not mention the fact that if they fill it with a generic, you will be giving up all of your legal recourses. Since the Supreme Court decided this last year, perhaps, if this were posted at the pharmacies, it may make a difference to many patients. This Supreme Court ruling potentially affects millions of people; nearly 80 percent of prescriptions in the U.S. are filled with a generic, and most insurance companies require you to accept the generic, when available.

More than 40 judges have dismissed cases against generic manufacturers since the Supreme Court ruled last June.

Public Citizen, a consumer advocacy group, has petitioned the U.S. Food and Drug Administration to give generic companies greater control over their labels, a rule change that would allow generic drug users to sue, if necessary. However, the Agency said earlier this month that it needed more time to decide. It is thought that congress can make this problem go away, as well as the FDA.  Why aren’t the generic manufacturers required to have warnings on their labels if the brand-name manufacturers are? The FDA is supposed to protect Americans, not the pharmaceutical companies. Is this justice?

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