Supreme Court Generic Drug Ruling Complicating Lawsuits

Last year’s Supreme Court ruling which barred the public from suing makers of generic prescription drugs over side effects caused by the medication is starting to result in some legal disappointment.

In a report from The New York Times, the cases of two women who were forced to endure limb amputations because of gangrene caused by an anti-nausea drug, promethazine, are detailed. One woman is blocked from pursuing legal justice against the makers of the drug because of the high court’s ruling that generic drug makers are unable to modify the safety labels of the drugs they’re mimicking and therefore exempt from legal actions against them.

In the other case, the woman was injected with Phenergan, the name-brand version of promethazine and she was recently awarded $6.8 million in her court case.

Most prescriptions filled in the U.S. are for the generic version of a prescription drug. They are similar drugs but usually vary greatly in cost, making generics the preferred choice 80 percent of the time. In some cases, insurance companies require a generic drug replace a prescription for the name-brand version.

Supreme Court justices ruled that because the makers of the name-brand prescription drug also write the safety information included with the drug, they are legally responsible for the damages it may cause or the side effects that may result. Generic drug makers are forced to adopt the safety information as written by the previous company and include it with their version of the drug.

This decision could eventually leave millions of Americans without legal options if they were to suffer any side effects, ranging in severity, caused by generic drugs. And those who bought the name brand would be the only ones with a legal avenue to explore.

New York Times reports that since the Supreme Court ruling last year, at least 40 judges across the country have rejected lawsuits filed against the makers of generic prescription drugs. Some judges have reportedly dismissed “dozens” of cases filed before him or her that were consolidated in their court.

The Food and Drug Administration has heard from advocates Public Citizen and their demanding the agency write new rules which would allow the public to hold the makers of generic drugs accountable.

Makers of generic drugs are exempt from pursuing the same pre-market safety testing of their version of name-brand drugs because of a 1984 law which also mandated if a generic maker pursued this path to the market, they would also have to adopt the safety information as distributed by the makers of the name-brand alternative. To qualify for these exemptions, generics makers must prove their version of a drug is identical to the name brand.

The FDA has yet to respond to Public Citizen’s call for action but that could change as more and more Americans realize their legal rights have been taken away by last year’s Supreme Court ruling.

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