The U.S. Supreme Court will hear argument today on one of the most important cases in recent history to be heard on the rights consumers. The case of Wyeth v. Levine will take up the issue of pre-emption of FDA approved prescription drugs. The pharmaceutical industry has been pushing this doctrine for years. The basic argument is that once the FDA has approved a drug, an injured plaintiff cannot sue the producer of the drug for any harm caused by that drug. When one considers the history of the FDA and its failure to adequately evaluate drugs before releasing them to the market, it is clear that the consequences of pre-emption for the general public are quite severe. The history of adverse side effects from prescription drugs is so long and so tragic, it is beyond the pale that the pre-emption doctrine is being considered. The reason consumer groups are so anxious about this case is the Supreme Court’s recent decision upholding pre-emption for medical devices approved by the FDA in Reigel v. Medtronic.
The Center for Justice and Democracy published a report describing how the FDA often fails to adequately protect women in assessing the safety of prescription drugs. An excerpt from the report states:
“Women have been hurt many times over the years by FDA-approved drugs, whether because drug companies withheld information and lied about health risks, or because the FDA has lacked the resources or political will to keep dangerous products off the market,” said Cynthia Pearson, Executive Director of the National Women’s Health Network. “This report from Center for Justice & Democracy documents the devastating consequences of these regulatory failures and shows how women who have been hurt by unsafe drugs have used lawsuits to bring critical information to light, protecting other women from suffering similar harm.”
If the pharmaceutical companies have their way, consumers will have no recourse to the civil justice system for defective drugs that can cause catastrophic injury.