Lost in the excitement about the impending election, an important alliance has been getting short shrift. Doctors have come to the aid of patients opposing big Pharma in a major Supreme Court case. Yesterday’s Supreme Court argument, Wyeth v. Levine, has the potential to dismantle existing consumer protections. Patients should be worried. Doctors are worried for their patients and themselves.
The legal issue is complex, but the case behind it 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.
It is Wyeth’s defense that has catapulted the case into the national spotlight. Wyeth argues that it cannot 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 accepts this argument, the effect will be to shut down injury lawsuits, not just those against drugs, but also lawsuits against cars, household products, agricultural products and chemicals.
Patients, indeed all Americans, have a lot to lose if Wyeth wins. Doctors’ organizations have lined up squarely behind patients’ rights organizations. The New England Journal of Medicine has filed amicus curiae (friend of the court) briefs in support of Ms. Levine.
The New England Journal of Medicine explained its position in an editorial in the July 3rd, 2008 edition:
…. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine), drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective…
Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA’s regulatory actions and enhance patient safety…
But in the past few years, the government’s views have shifted, and the FDA has reversed its position, now claiming that common-law tort actions are preempted. The FDA argues that tort liability stifles innovation in product development and delays the approval process, and that lay juries are incapable of making determinations about product safety…
… Although frivolous lawsuits should not be condoned, product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it… Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety.
The Journal of the American Medical Association (JAMA) has an editorial in the current edition supporting Ms. Levine and opposing preemption.
…the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications. … If the court rules in favor of Wyeth, endorsing preemption, patients will lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by FDA.
A paper in a previous edition of JAMA laid about the implications of this case for doctors:
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 ends with a rousing, and surprising, endorsement of lawyers and lawsuits:
… [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 is about a lot more than one woman’s right to sue a drug company because of a drug induced injury. If the Supreme Court accepts Wyeth’s arguments that FDA approval means that drug companies cannot be sued for adverse effects of their drugs, doctors will be deprived of important information, and patients will be left at the mercy of big Pharma and their friends at the FDA.
