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Stevens Johnson Syndrome Case Highlights Need for Change

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Washington, DCKaren Bartlett had no idea what hit her when a Stevens Johnson Syndrome rash turned into a nightmarish health scare that left her disfigured and nearly blind from SJS. The latter is a rare, but nonetheless debilitating reaction to medication akin to suffering serious burns.

Bartlett had been given a prescription painkiller for shoulder pain. The Stevens Johnson Syndrome that resulted left the New Hampshire woman in a burn unit with entire sheets of her upper dermis - her skin - sloughing away from her body. Stevens Johnson Syndrome symptoms are so serious, they can be fatal, and have proven to be for some victims.

Bartlett survived, but sued the manufacturer of the painkiller prescribed to her - and she won a $21 million verdict. However, according to a report by The Times of Trenton (New Jersey, 2/18/14), that verdict was vacated on appeal, due to the fact that Bartlett had been prescribed a generic version of Clinoril.

Under current rules, plaintiffs have recourse to sue manufacturers of brand-name drugs for serious adverse reactions such as Stevens Johnson Syndrome skin disease. But they are barred from pursuing litigation if the drug they take is a generic.

Same drug. Same risks. But the prescribing labels inherent with brand-name drugs do not apply to generic drugs under current rules. According to The Times of Trenton report, there was no mention about the possibility for Stevens Johnson Syndrome rash and the potential for full-blown SJS on the prescribing label that came attached to sulindac, the chemical name for Clinoril by which most generics are identified.

But that’s about to change. The US Food and Drug Administration (FDA) in November floated a proposal to allow manufacturers of generic drugs to change and update their product labels, as manufactures of brand-name drugs now do. In so doing, generic drug manufacturers would no longer be shielded from lawsuits.

According to the report, manufacturers of generic drugs are not happy and oppose the change. Generic drug industry insiders say that its members “cannot support a proposed rule that undermines public health merely to facilitate litigation against generic drug companies by the plaintiff’s bar.”

But Rep. Henry A. Waxman (D-Calif.), the co-founder of the Hatch-Waxman Act of 1984 that fostered the introduction of generic drugs in the first place, thinks the change makes perfect sense.

“Patients should have the same rights to seek compensation if they are injured by a drug, regardless of whether it is a brand-name or a generic,” Waxman said in an interview with The Times of Trenton. “It doesn’t make sense,” he said, to have patients’ rights depend on which version of a drug they took.

Leveling the playing field in this way would have helped Karen Bartlett, who was denied compensation for her Stevens Johnson Syndrome battle just because she was prescribed the generic sulindac, rather than the brand-name Clinoril.

Public Citizen, the consumer advocacy group founded by Ralph Nader and an outspoken critic of the medical device and pharmaceutical industries, notes that the ongoing rise in availability of generic drugs makes such a change necessary.

“Many potential hazards are not discovered until years after drugs have been on the market,” said Dr. Michael Carome, director of the Health Research Group arm of Public Citizen, in comments published in The Times of Trenton. “The proposed rule would remedy this public health problem” by requiring generic makers to disclose new safety risks as they are known, he added.

It was reported that IMS Institute for Healthcare Informatics has found the introduction of generic drugs to have lowered health care costs by about $1.2 trillion over the last 10 years. The fear, say critics of the rule change, is that losing its current shield from litigation will drive up the cost of generics.

Advocates of the change, however, point to the fairness - or lack thereof - encountered by people like Karen Bartlett, who lost out on a $21 million Stevens Johnson Syndrome award just because of a name…

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