In a precedent-setting ruling, the US Supreme Court sided with the victim in a case of bodily injury caused by unlabeled side effects against the drug’s manufacturer.  The drug maker, Wyeth Pharmaceuticals, of Madison, New Jersey, claimed it could not be held liable in this case since the drug, and its warning label, had been approved by the US Food and Drug Administration (FDA).

Diana Levine, 63, a musician from rural Vermont, was awarded $6.7 million in her lawsuit against Wyeth although she says she’d happily give the money back if she could get her arm back instead.  A botched injection of the anti-nausea drug, Phenergan, caused gangrene and amputation of her right arm.

Levine’s ordeal started in 2000, when a migraine headache sent her to a local clinic.  She was given painkillers and an intramuscular injection of Phenergan, although her nausea continued.  A second injection, administered as an IV-push, punctured an artery.  This injury led to gangrene and amputation.

A musician for 30 years, Levine wrote songs and worked with children but she also played the guitar and piano and was a member of a rock band.  All these activities became impossible once her arm was amputated.  In addition to losing her only means of income, Levine required constant help from others to sustain her life in a 150-year-old farmhouse and to survive the ravages of harsh New England winters.  Relying too heavily on her remaining hand has led to overuse injuries that require physical therapy.

Historically, approval by the FDA shields a pharmaceutical company from liability when patients are injured by a drug but a 6-to-3 Supreme Court majority ruling holding Wyeth responsible for Levine’s amputation came in light of 20 additional cases in which patients developed gangrene and required amputations after getting injections of Phenergan.  The ruling highlights the need for pharmaceutical companies to strengthen warning labels when necessary, with or without prompting from the FDA to do so.

A statement issued by Wyeth implies the verdict is a mistake since the Supreme Court justices making it are not trained medical professionals and suggests the verdict will make patients and doctors uncertain about using prescription drugs safely and effectively.

Industry analysts say the ruling will put a dollar value to potential side effects of drugs under development as well as those already on the market, perhaps leading to improved scrutiny of safety issues associated with all medicines.