Many consumers believe that the FDA actually tests presecription drugs for safety and efficacy before such drugs are approved to go on the market. This is not so. In fact, for the most part, the FDA simply reviews information (e.g., animal studies and clinical trials) submitted by the drug manufacturer in the pre-approval process. History is replete with examples of dangerous drugs that passed through the FDA approval process, were widely marketed, and caused serious drug-related injuries to citizens throughout the country. From Thalidomide to Rezulin, Fen Phen, Baycol, and Vioxx, the manufacturers ignored clear signals in the pre-approval stage, hid those signals from the FDA, and marketed aggressively dangerous drugs to the American public.
In nearly every case, product liability lawsuits were the only means to effect either the withdrawal of these dangerous drugs or the strengthening of the warnings and/or precautions sections of the product labeling. These lawsuits are often the consumer’s sole remedy following injury from defective prescription drugs. In January 2006, the FDA showed that it is in bed with the drug industry. FDA published its final rule on prescription drug labeling, and included in the preamble a lengthy commentary concluding that all lawsuits against drug manufacturers that are based on a theory of negligently failing to or inadequately warning of a drug’s dangers are preempted by the Supremecy Clause of Article VI of the Constitution. This opinion by FDA wanders far outside the agency’s authority (Congress did not give FDA the authority to determine the Constitutional effect of its own rules). The FDA position is contrary to two recent U.S. Supreme Court decisions and should not be entitled to any deference by the courts. However, in the past several years, the Bush Administration’s Department of Justice has filed an amicus brief in favor of manufacturers and against consumers arguing that claims should be preempted (i.e., not allowed to go forward). In at least one decision in Pennsylvania this year, the court ruled that the FDA’s opinion on the matter was binding.
The next time that you are tempted to believe the tort reform propaganda, remember that the federal regulatory agencies that you think are ensuring the safety of the products you use, are doing no such thing. The FDA has made news in recent years by ingoring warnings from its own medical reviewers in order to appease a manufacturer “client” seeking fast-track approval of a new, block buster drug. The reviewers’ concerns were confirmed when these drugs were later found to cause heart valve damage, liver damage, strokes, heart attacks, or suicide. In 1994, Newt Gingrich actually advocated doing away with the FDA and letting the industry regulate itself. The Seventh Amendment to the Constitution guaranties the right to trial by jury for a very good reason. Lawsuits are often the last line of defense-especially when the fox is guarding the chickens.