Constitutional Law

Injured Consumers, Prescription Drugs, and Getting Your Day In Court

Attorneys for drug makers say they are "on the verge of success" in creating what The New York Times deems a legal shield against patients injured by pharmaceutical company products even when the companies "play down" the risks of their medicines and fail to publicly disclose clinical trials, The New York Times reported. Under an expanded view of the legal doctrine of "pre-emption," medical device manufacturers successfully argued this past year before the U.S. Supreme Court that when the Food and Drug Administration gives its approval to their products, anyone harmed by their use cannot sue in state courts under traditional tort theories. The Supreme Court agreed to hear a case next year that would expand this doctrine to drugs approved by the FDA, putting an end to liability in state courts for harm caused by drug manufacturers.

ACS hosted a panel discussion in November on the medical device pre-emption case, Riegel v. Medtronic, as well as released an ACS Issue Brief entitled "The Emerging Threat of Regulatory Pre-emption," by Georgetown University Law Professor David Vladeck. In late March, ACS co-hosted a day long symposium on "Justice and the Role of Class Actions" (video forthcoming), which explored the use of lawsuits to protect consumer safety, among other issues. Lawsuits provide compensation and an incentive to product manufacturers beyond regulation to ensure that goods are safe, reliable, and accurately marketed.

As a case study, the Times reported on the drug Ortho Evra, a birth control patch manufactured by Johnson & Johnson that delivered a higher dose of estrogen than standard birth control pills, potentially increasing the risks of blog clots and strokes, while its label inaccurately reported the amount of estrogen released. The drug company was aware of the higher dosage. Nearly 3,000 women and their families are suing Johnson & Johnson, which, after it changed its label six years later to reflect the actual dosage, saw prescriptions falls 80%.

According to the Times, the FDA relies upon drug makers to report the results of their own tests, and does not itself test experimental medicines. Professor Vladeck explained "these are scientists, not cops." A former FDA scientist testified that the agency does not always ask for strong warnings even when it believes a drug is risky because companies typically oppose such warnings, and the agency must either compromise or face years of delays.

The heart of the pre-emption argument is that Johnson & Johnson should not be liable in state courts for its manufacture of Ortho Evra and its failure to accurately disclose the amount of estrogen released by the patch because the FDA approved of the patch and its label. The case involving Johnson & Johnson is currently proceeding in Ohio. A similar case, Wyeth v. Levine, involving another drug manufacturer is before the Supreme Court this upcoming term.

Full post as published by ACS Blog on April 08, 2008 (boomark / email).