ARE PATIENT’S RIGHTS AGAINST DRUG COMPANIES IN JEOPARDY?

September 20, 2008, by Jeffrey J. Kroll

This fall, the United States Supreme Court will hear oral arguments in the case of Wyeth v. Levine, No. 06-1294 . Diana Levine was using a drug company’s anti-nausea drug (Phenergan) which resulted in serious complications and, ultimately, the amputation of her arm. A Vermont jury awarded her $6.7 million dollars, concluded that the drug manufacturer had failed to warn of the risks associated with the drug. Wyeth is contending that the drug met FDA labeling requirements and should face no liability under state law. The drug company is arguing that the Federal Drug Administration’s authority to approve drug labeling pre-empt’s state laws governing products liability.

First and foremost, allowing the preemption argument would eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up to date information. It would all but eliminate any type of failure to warn product liability litigation against the drug companies.

As one reporter noted "The FDA does not have the ability at this time to oversee in a comprehensive fashion everything it regulates.” If the FDA’s position is adopted by the Supreme Court, it would eliminate any incentive for the drug company to ensure that its drug labels reflect accurate and up to date information. Who gets hurt? The answer is: the consumers. Without such lawsuits, regulators and the public may never hear of evidence that the drug manufacturers knowingly marketed products that were unsafe or untested . . . until it is too late and another senseless death or catastrophic injury occurs.

If you or someone you know has suffered injuries due to medication errors, please contact the Law Offices of Jeffrey J. Kroll.