Take a look at the case of Diana Levine – Her case is on the docket for the US Supreme Court to decide whether she will be protected under Vermont tort law – despite FDA approval of a migraine drug’s label.
Washington, D.C. (JusticeNewsFlash.com – News Report) – The case begins with Diana Levine who thought her severe migraine and nausea could be taken care of easily. She usually receives Demerol or morphine for her pain, which also causes her to experience nausea. The difference in this visit to the hospital was not the Phenergan that physicians used, rather they way in which they used it. The results were not what she expected. When she arrived at the hospital, physicians gave her Phenergan, a drug manufactured by Wyeth, by injecting it into her muscles. When her nausea did not subside, they administered the drug using the “IV push” method, which injects the drug directly into her vein. . The drug made contact with her arteries, lead to gangrene and forced the doctors to amputate her arm. Clearly unexpected results from common symptoms like nausea and a migraine.
In 1955, the FDA approved the label on the Phenergan drug and was later re-evaluated. The Wyeth Company knew full well what would happen if their drug reached the arteries, yet it merely wrote a small-print caution label that if given by IV drip method, extreme care should be taken to avoid arterial exposure. Nowhere on the label were even the words ‘IV push method of injection.’ In response to Levine’s case, a Vermont jury awarded her $6.7 million, concluding that Wyeth had failed to warn of the risks associated with IV push administration of Phenergan. In the appeal, the Vermont Supreme Court ruled, “that the state tort claim was not pre-empted by the FDA approval of the Phenergan label.” The court also stated that “it would have been possible for Wyeth to provide the FDA-approved label and additional warnings cautioning against IV push administration. It further found that requiring Wyeth to do so would not obstruct any goals of the federal Food, Drug and Cosmetic Act.”
The drug company responded by arguing that “state court are often asked to hold drug manufacturers to different standards than those set by the FDA, creating a situation of national urgency, and the FDA’s labeling requirement did not merely set a minimum standard for release of drug information, but took into account all the risks and benefits associated with Phenergan and opted for a label that reflected the best level of information to achieve optimal use of the drug.” But Levine would not give up. She brilliantly argued that “Vermont should not be prevented from applying its tort law where the FDA never considered whether to include a prohibition on the IV push method on its label.”
Levine sums it up extremely well in a recent interview with Pharmalot: “They should’ve taken responsibility for changing the label…It’s not a bad drug. It’s a good drug, for what it is. But I’d much rather throw up than lose my arm. I think they should’ve come out and said that, under no circumstances should the drug be administered under push IV. They didn’t protect me and ensure my safety…they have strong economic incentives and, sometimes, those things take precedent…They say the FDA is their first line of defense, but if a drug company recognizes there’s something that could hurt the public, they have an obligation to do something.” According to the Dow Jones Newswires, the appeal is the latest in a series of cases the court has agreed to hear on suits brought under state laws concerning FDA-regulated products, such as drugs and medical devices. Two other cases –one involving Medtronic and the other involving Pfizer – are pending in the court’s current term.
(Source: Oyez, On the Docket – Supreme Court News)