The New England Journal of Medicinehas published a perspectivebyLeonard H. Glantz and George J. Annas "The FDA, Preemption and the Supreme Court" that has provocative ideas about the subject. They acknowledge the obvious fact that:"Everyone would like to be immune from lawsuits" but, note that providing immunity deprives injured people of their day in court. Immunity, they point out, undermines the tort system’s goal of deterring unreasonably dangerous actions or omission.
In 1992, the U.S. Supreme Court in Riegel v. Medtronic determined that the Medical Device Amendments of 1976 preempted the area of device regulation. In an 8 to 1 decision the court said in cases where people were injured by defectively designed medical devices that the FDA had determined were safe and effective after full review were barred by preemption. The Medical Device Amendments to the Food, Drug and Cosmetics Act contain language prohibiting the states from establishing "any requirement" that is "different from or in addition to" requirements in federal statute relating to health and safety
Next Fall, the court will a case involving FDA approved drugs. The pharmaceutical industry with the support of the Bush Administration is arguing that once the FDA approves a drug preemption prohibits lawsuits by people injured from the drug.
This is a frightening situation because there is no remedy provided for the injured person once immunity is given. There is no means of accountability for the industry involved because the FDA is understaffed, overworked and administered by Bush appointee’s in the hip pocket of the pharmaceutical industry. The result is no remedy for the wrong done and no sanction to change behavior.