On Wednesday, the US Supreme Court ruled in favor of Diana Levine in her lawsuit against Wyeth Pharmaceuticals. The victory means that Ms. Levine, a professional guitarist whose lower arm had to be amputated after a Wyeth drug was improperly administered is now entitled to receive the $6.7 million dollars that was awarded to her by a Vermont court.
Ms. Levine has also secured a victory for the rest of us. In attempting to void the multimillion dollar award in this case, Wyeth claimed that once a product, any product, passes Federal guidelines, the maker cannot be sued, regardless of the injuries that the product might cause, a doctrine known as “preemption.”
The case behind this complex legal issue is simple and tragic. Diana Levine, a professional guitarist, lost part of her arm when she received the right drug, in the wrong way. Ms. Levine received Phenergan by IV push (injected directly into the bloodstream to act fast) to counteract the nausea of severe migraines. Instead of injecting the drug into a vein, it was mistakenly injected into an artery, leading to gangrene and subsequent amputation of Ms. Levine’s lower arm.
There is no dispute about the central facts of the case. Ms. Levine did mistakenly received Phenergan into an artery; the health care provider made the mistake; it is well known that Phenergan (like all medications) should never be injected into an artery; Wyeth had labeled Phenergan with warnings, but no specific warning about the consequences of injecting Phenergan into an artery instead of a vein. Ms. Levine has already won a multimillion-dollar judgment in state court against the clinic where she was treated. Then she attempted to sue Wyeth in state court, claiming that the drug label should have warned specifically about the outcome of injecting Phenergan into the wrong place.
Wyeth argued that it could not be sued in state court for an error in labeling because the Federal government, through the FDA, had approved the label. Therefore, any claims in state court are preempted by Federal regulation. If the Supreme Court had accepted this argument, the effect would have been to shut down injury lawsuits, not just those against drugs, but also lawsuits against cars, household products, agricultural products and chemicals.
Doctors strongly supported Ms. Levine’s right to sue Wyeth. The Role of Litigation in Defining Drug Risks, a paper in the January 17, 2007 issue of the Journal of the American Medical Associate (JAMA). championed the value of lawsuits in supplementing the regulatory process.
Most physicians and patients learn about prescription drugs from publications of clinical trials or case reports, promotional materials or alert letters provided by pharmaceutical manufacturers, and formal documents such as the FDA approved label. These sources, however, sometimes provide a limited perspective on a drug’s benefits and risks…
In both the premarketing and postmarketing stages, lawsuits have helped uncover important and previously unavailable data about major adverse events…
Litigation has also helped the medical community reassess drugs by bringing to light new information about adverse effects…
The paper ended with a rousing, and surprising, endorsement of litigation:
… [L]imiting legal involvement in the prescription drug arena is likely to increase the nation’s problem of poorly defined or inadequately presented drug risk information… [C]linical trials and routine regulatory oversight as currently practiced often fail to uncover important adverse effects for widely marketed products. In each instance, the litigation process revealed new data on the incidence of adverse events, enabled reassessments of drug risks through better evaluation of data, and influenced corporate and regulatory behavior. In performing these tasks, lawyers and their clients often find themselves serving as drug safety researchers of last resort.
This case was about a lot more than one woman’s right to sue a drug company because of a drug induced injury. Ms. Levine won a victory for herself, but in a very real way, we won, too. The Supreme Court has ruled that receiving Federal approval does not absolve drug companies of responsibility for injuries and deaths caused by their products. We still have a right to sue drug companies (or the manufacturers of any product), to review their internal documents, and to determine if they introduced a product to market that they knew could harm consumers.
