Like the tobacco companies, for decades the drug companies have been trying to excuse themselves from any liability when their products harm or kill people.
Take for example the much discussed Riegel v. Medtronic decision where the U.S. Supreme Court decided that if the FDA has approved a medical device, then the manufacturer can't be sued. Or, more recently, the Third U.S. Circuit Court of Appeals ruled that the makers of selective serotonin re-uptake inhibitors (a type of antidepressant) cannot be sued for failing to warn consumers of the risk of suicide - because the FDA had previously refused to place a warning on those drugs.
The muckety-mucks in the drug industry must have been dancing in the streets (or at least dancing in their gold-plated, money filled offices) at these recent rulings because it lets them avoid responsibility when things go wrong with their products.
Yet, I don't think the FDA should be the end-all-be-all when it comes to deciding what is safe with no recourse for consumers (just look at Michigan’s tragic drug industry immunity law). It is becoming common knowledge that the agency has been politically co-opted by the very industry it is supposed to regulate, part of which is due to the fact that it receives at least a third of its budget for approving new drugs – directly from the pharmaceutical companies.
But don't just take my word for it, check out this recent editorial in the New York Times
April 14, 2008
The Dangers in Pre-emption (excerpt)
The pharmaceutical industry and its good friends in the Bush administration are working hard to prevent consumers from filing damage suits for injuries caused by federally approved drug products. They may soon get a helping hand from the Supreme Court, which has already barred many suits over faulty medical devices.
If this perverse legal doctrine, known as federal pre-emption, continues to spread, the public will be deprived of a vital tool for policing companies and unearthing documents that reveal their machinations.
[I]t would be a mistake to rely solely on the F.D.A.’s judgment. The agency is short of skilled scientists. If a company buries important information deep in the bowels of a report, the agency may not detect it or appreciate its significance. Injured patients should not lose the right to sue if they are harmed by duplicitous manufacturers.