Preemption Threatens Public Safety

Robert Binstock

Attorney
(866) 735-1102 Ext 345

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Preemption has been a big topic in the legal world over the past several months. Basically the issue is whether or not the FDA’s approval of a drug should preempt consumers from filing lawsuits for adverse effects experienced from the drugs. Preemption in fact shields pharmaceutical manufacturers from lawsuits brought forth by consumers who were injured from their highly profitable drugs. Since the induction of FDA, over 70 years ago, the drug approval process has been supplemented by the extra layer of protection provided by the right of private litigation. A case coming before the Supreme Court this fall could eliminate this long established president of protection.

As a cascade of recent examples demonstrates, FDA approval does not and cannot warrant a drug's safety over its lifetime. Vioxx, Celebrex, Halcion, Paxil, the weight loss pill ephedra -- the list goes on. In each of these cases, private litigation exposed risks the FDA did not foresee -- and, importantly, likely could not have foreseen -- at the time the drug was approved. Each of these cases also exposed ample evidence that the drug manufacturers did have knowledge of these risks, and did not disclose them.

To think that it is possible for the FDA to ensure accurate safety warnings of every drug they approve is unrealistic. Drugs that are seen to be very beneficial or are thought to have unique treatment aspects are often placed on the fast track for FDA approval. It often takes years on the market before true dangers of a drug are revealed. To take away the right of individual citizens to pursue private legal action gives big pharma free pass. We have seen in the past that even with the threat of multi-billion dollar class-action lawsuits these companies have deliberately concealed data that would be damaging to their products, with no concern for the lives of innocent Americans. What do you think they would be hiding if they knew that they couldn’t be sued for the harm caused by their products?