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Labels affecting drug lawsuits

Last Updated 30 March 2012, 17:04 IST

Debbie Schork, a deli worker at a supermarket in Indiana, 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.

That result stands in sharp contrast to the highly publicised 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 drugmaker, Wyeth, and won $6.8 million.

The financial outcomes were radically different for one reason: Schork had received the generic version of the drug, known as promethazine, while Levine had been given the brand name, Phenergan. “Explain the difference between the generic and the real one – it’s just a different company making the same thing,” Schork said.

Across the country, dozens of 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 therefore could not be sued for failing to alert patients about the risks of taking their drugs.

Deciding factor

Now, what once seemed like a trivial detail – whether to take a generic or brand-name drug – has become the deciding factor in whether a patient can seek legal recourse from a drug company. The cases range from that of Schork, who wasn’t told which type of drug she had been given when she visited the hospital, to people like Camille Baruch, who developed a gastrointestinal disease after taking a generic form of the drug Accutane, as required by her health care plan.

The Supreme Court ruling affects potentially millions of people: Nearly 80 per cent of prescriptions in the US 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 issued its ruling last June, including some who dismissed dozens of cases that had been consolidated under one judge.

Public Citizen, a consumer advocacy group, has petitioned the Food and Drug Administration to give generic companies greater control over their labels, a rule change that could allow users of generic drugs to sue, but the agency said earlier this month that it needed more time to decide. “Congress can make this problem go away, and the FDA could, too,” said Allison Zieve, the director of Public Citizen Litigation Group.

“But we haven’t seen signs that either of them is paying much attention.”  The Supreme Court’s ruling, which was split 5-4 on ideological lines, has its roots in the Hatch-Waxman Act, the 1984 law that opened the floodgates to generic drugs. That law allowed companies to skip the lengthy process required to approve new drugs if they could prove that the generic drug was equivalent to its brand-name counterpart. With few exceptions, it also required generic manufacturers to use the same labels – the lengthy list of a drug’s uses, dosages and risks – used by the brand names.

If a problem develops, the brand-name companies are responsible for changing the label, and the generic companies must follow their lead. As a result, the court’s majority ruled, generic companies cannot be held responsible for failing to alert patients to problems with their drug.

The dissent, which was written by Justice Sonia Sotomayor, argued that generic companies nevertheless have a responsibility to report problems to the FDA and should be held liable for failing to warn patients. The ruling came just two years after the Supreme Court established – in Levine’s case – that, by contrast, brand-name companies can be sued for failing to adequately warn patients.

Levine was given an injection of Phenergan in 2000 during a visit to a clinic to treat a migraine headache. Her hand and forearm turned black and eventually had to be amputated.

Reports had shown that the drug can cause gangrene if it enters an artery, especially if it is placed directly into the vein rather than injected into the muscle or through a diluted intravenous drip. Although the label warned that gangrene could occur if the drug cameinto contact with arterial blood, Levine argued that the warning did not go far enough.

She sued Wyeth and a Vermont jury awarded her $6.8 million. Wyeth appealed and the Supreme Court sided with Levine, agreeing that the company could be held liable for failing to adequately warn about the risks of a drug.

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(Published 30 March 2012, 17:04 IST)

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