No drug company wants to face the massive liability created when a Fen-phen or Vioxx is exposed as being dangerous. Thus, much has been made in the press of the new in vogue defense employed by big drug companies. They argue that because prescription drugs are federally regulated, companies that make dangerous drugs are not responsible for their side effects. At its basic level, the defense amounts to “Not my problem…” Rather than simply make their products safer or provide adequate warnings, drug companies have instead determined they are liability proof, provided the given drug and warnings are FDA approved. The matter has made it all the way to the Supreme Court. It appears now that the American public has a powerful new ally in the fight to hold drug companies accountable. No less than the country’s preeminent medical journal, The New England Journal of Medicine (the “NEJM”) has come out decidedly against the argument. In a “Friend of the Court” brief filed with the Supreme Court, the NEJM correctly notes that civil lawsuits deter irresponsible and dishonest behavior by drug companies.
The FDA is of course the federal body that oversees drug safety in this country. Prescription drugs do not hit the market until they win the FDA’s seal of approval. Unfortunately, the FDA lacks the resources to fully investigate every new drug that will hit the market. Moreover, drug companies do all they can to lobby and convince the FDA of approval. This is because they spend million after million on research and development and make no return unless the product makes it to market. The process often means the FDA may not get the whole picture and may not know all there is to know about a drug before it appears in pharmacies and hospitals. To think the FDA alone can fully protect the public is dangerously naïve.
As the FDA can only do so much, the NJEM correctly notes that civil lawsuits against drug companies are a crucial way of preventing the public from being put at greater risk. Without the threat of legal action, drug companies would have far less incentive to make safe drugs. Rather, their only goal would be to get a drug past the FDA as cheaply as possible. Everyday, we trust doctors with our lives. If the country’s leading medical journal says making big drug companies immune from liability is a bad idea, than I am inclined to agree with them. Hopefully, the Supreme Court will reach the same conclusion.