The Supreme Court and Generic Drugs

What You Might Not Know About Generic Drugs

NEW YORK – Across the country, dozens of lawsuits against manufacturers of generic drugs have been dismissed because of a decision by the Supreme Court a year ago that makes it all but impossible to sue the firms for failing to provide adequate warning of a drug’s dangers.

Attorney Gary Leppla represented the family of a young woman who had an adverse reaction to a drug and died. He says it is critical to know what your health insurance plan tells your pharmacist to do.

“You have the drug manufacturers and insurance companies really dictating medical practice. Doctors have the opportunity to be aware of the risks of various medications, and yet what is used to fill a prescription is not necessarily dictated by the doctor. It happens after it leaves the doctor’s desk.”

Insurance companies say generic drugs save money and have the same active ingredients as the brand-name medications. As the law stands now, generic manufacturers are not required to update their warning labels, even when they are aware of new safety issues associated with a drug’s brand-name equivalent. Name-brand drug manufacturers, however, are required by the FDA to update their labels.

Proposed federal legislation would force generic drug-makers to update their warning labels when a new safety issue arises. Leppla says you should ask your pharmacist if you’re getting a generic.

“Consumers should be aware of this proposed legislation, which hopefully would level the playing field. We need to realize that ‘big pharma’ and insurance companies drive this train and the consumer has very little to say, that consumers need to gain information and network.”

Nearly 80 percent of all prescriptions in the U.S. are filled with generic drugs, Leppla notes.

“So, it’s got a tremendous impact, and the threshold question is, ‘Why should I be treated different as a consumer because I was required to have my prescription filled with a generic, as opposed to the original manufactured drug?’”

The Supreme Court decision referred to is Pliva v. Mensing. The legislation is S 2295 and HR 4384.

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