Power to the…Pharmaceutical Companies?

If the U.S. Supreme Court rules in favor of barring lawsuits against Food and Drug Administration-approved medications, pharmaceutical companies will be quite pleased. Earlier this year the Supreme Court reinterpreted a 1976 amendment that had originally been intended to protect the public against dangerous medical devices by requiring the FDA to review and approve such devices before they could be sold to the masses. The reinterpretation led the Supreme Court to bar lawsuits against FDA-approved medical devices. Now the Supreme Court may extend this ruling to FDA-approved drugs. If this happens, some tens of thousands of lawsuits will be dismissed, and the public will have no recourse or protection when harmed by pharmaceuticals.

Pharmaceutical companies and their advocates argue that the FDA is filled with experts, and the decision as to whether a medication is safe or dangerous should be left to them. Juries, they argue, are made up of lay people, who most likely would not be able to make informed decisions about a prescription medication’s safety. Consumer rights groups, on the other hand, argue that the public deserves added protection and that lawsuits can bring to light new dangers or issues that the FDA was not aware of.

The case the Supreme Court will rule on on November 3, 2008, involves a Vermont woman who suffered from severe headaches. She went to a clinic with a headache and was given Demerol for pain relief and Phenergan for nausea. Phenergan’s warning label indicates that extreme caution must be exercised if the drug is given via injection. Hitting an artery can cause extreme damage. The patient was given Phenergan via injection, and an artery was struck. As a result, the patient lost part of her arm and her hand due to gangrene. She filed a lawsuit against Wyeth, the maker of Phenergan, arguing that the company should have warned against injecting Phenergan in any situation. The case went to trial in Montpelier, Vermont, and the jury found in favor of the plaintiff. Wyeth, however, appealed, and that is the appeal on which the Supreme Court will rule.

For more information, see this article in the Los Angeles Times.