Legal Advocacy
AARP Asks U.S. Supreme Court to Allow Rx Consumers Access to Court
AARP Foundation Litigation attorneys filed AARP’s brief urging the U.S. Supreme Court not to disrupt the current balance in the law that provides both regulatory review and courtroom redress for people harmed by pharmaceuticals.
The dispute
When Diana Levine went to the hospital suffering from migraines, doctors intravenously administered Phenergan, a drug manufactured by Wyeth. The drug’s contact with her arteries led to gangrene and eventual amputation of her arm. Levine alleged that Wyeth had evidence that if the drug reached arteries, it could cause gangrene but despite this it did not warn of this danger. A jury agreed that the company had failed to warn of risks and awarded her $6.7 million in damages.
At trial and in its appeal, Wyeth argued among other things that it was exempted from state tort law because the federal Food and Drug Administration (FDA) had approved the drug without requiring the warning sought and this preempted state tort law. The Vermont Supreme Court disagreed, ruling that the FDA approval process did not preempt state law. Wyeth has appealed to the U.S. Supreme Court, which is considering the preemption issue. Its decision could have significant ramifications for consumers.
Background
The FDA is tasked with providing regulatory approval for pharmaceutical products before they come on the market and for approving any necessary warnings. The FDA has the authority to require pre-approval tests of products but, chronically underfunded and often criticized for its reliant relationship with industry, the agency also suffers from a limited authority over drugs after they come on the market.
Fortunately, there has been another safety net built into the legal system – the traditional tort lawsuit. By imposing the possibility of significant monetary penalties directly on wrongdoers, tort lawsuits incentivize those who develop, make, and distribute pharmaceuticals to do so with the utmost consideration for human health. The tort system plays a critical complementary role with FDA’s regulatory process to help ensure that drugs placed into the marketplace are not only effective, but safe and that any necessary warnings are adequately written and targeted.
AARP’s brief
AARP Foundation Litigation attorneys filed AARP’s brief in Wyeth v. Diana Levine, joined by the National Women’s Health Network and Prescription Access Litigation (PAL). The brief emphasizes the importance of the two-part (tort and regulatory) system and details the FDA’s long history of under-funding, under-staffing, and lack of sufficient legal authority to protect health on a stand-alone basis.
AARP’s brief points out that the federal Government Accountability Office (GAO), Institute of Medicine, and the FDA’s own Science Board have emphasized the agency’s inability to monitor the safety of drugs once on the market and have concluded that the FDA’s ineffectiveness already places American lives at risk, particularly after a drug has been approved and is on the market – but not only then. A 2006 report by a Subcommittee of the FDA’s Science Board raised concerns about the agency’s ability to handle the new burdens of advanced scientific discoveries, complexity of new products, globalization of industries under its oversight, the emergence of new safety challenges, and the challenges of dealing with an antiquated agency information technology system.
Also spotlighted in AARP’s brief are the criticisms that have been levied of a too-close relationship with the pharmaceutical industry, on whose data, funding, and expertise FDA tests often rely. Moreover, statutory limitations require FDA to negotiate with manufacturers when levying post-approval powers, circumscribing its powers even if it had the will to act. As for its willingness to be proactive, AARP’s brief notes that the FDA has only forcibly withdrawn a drug once in its entire history and most applicable to this lawsuit, the brief emphasizes that the agency has never filed a misbranding claim against a manufacturer on grounds of inadequate warning.
Finally, AARP’s brief notes the serious regulatory limitations on the agency that hamper its ability to effectively monitor safety. Pre-approval clinical studies rely on carefully controlled study conditions of a limited number of subjects, which can be incapable of detecting unforeseen or long-term side effects. A major concern is the fact that a drug’s full range of risks may not be evident until the drug has actually been on the market for many years.
Because of the limitations of resources, regulatory authority, and because of significant industry links, AARP’s brief argues, the FDA is unable to assume sole responsibility for protecting the American public from inadequately labeled drugs. As the brief notes, if the FDA is left as the sole protector of the American consumer, then people will be in a precarious situation indeed.
Contact persons:
Stacy Canan
scanan@aarp.org
Bruce Vignery
bvignery@aarp.org
(202) 434-2060