Will the Supreme Court Listen?
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In the case of Wyeth v Levine, the high court is going to potentially change the entire system that protects consumers from bad drugs and medica devices. They will decide a hot issue concerning preemption.
Essentially, the case would shield manufacturers from liability in the negligent production of drugs or medical devices if they have secured FDA approval for it. The Bush administration has been aggressively promoting the shielding of manufactirers-- big surprise! It is startling that, although FDA officials themselves have warned against preemption, the Bush administration continues to place corporate profits over consumer safety.
Here is the problem. The FDA directs whether drugs must go through extensive clinical testing or whether manufacturers can short cut the lengthy process and take their devices to the marketplace with little or no testing. To arrive at this decision and to determine approval of drugs or devices, the FDA relies almost entirely on the data and testing results given to them by the manufacturer. The FDA simply does not have the staff or the funds to conduct independent clical trials and testing on every product before it goes to the market.
Drug and device manufacturers are often driven by the need to get a new drug or medical device on the market as quickly as possible. Billions of dollars in revenue and profits typically hinge on the speed at which an product can obtain FDA approval. The marketing departments of some manufacturers are, sadly, the driving force and the ultimate influence over decision making. So, to satisfy the pressure exerted by the marketing departments, the scientists are sometimes forced to short cut, manipulate and spin the results of clinical trials. This may be accomplished by fabricating data, manipulating the subjects chosen for clinical trials or simply eliminating testing the scientist knows ahould be done.
The end result will be that many injured victims of bad drugs and medical devices will have no recourse. The courthouse doors will literally be barred to their seeking any justice from manufacturers. Drug companies are run by business minds; if a company can get a product on the market early enough, the billions in profit may be sufficient enough to "cover" the lawsuits they will face in 2, 3 or 5 years.