Pre-Emption and Big Pharma

Drug makers may finally get what they want, a legal shield that will protect them from lawsuits when it comes to light that their drugs pose bigger risks to the public than previously thought. However, while the industry may look longingly at the prospect of a legal shield, it may just happen that they get what they want, and in the end, it will be their undoing.

A case that is currently in the Supreme Court may result in the legal shield that the drug industry wants. Pre-emption basically says that since the FDA approved the drug in the first place, the drug maker should be shielded from liability if things go bad. In the current case, Johnson & Johnson, the maker of the birth control patch, Ortho Evra, is being sued because the plaintiff's claim that the drug released more estrogen than the label claimed, injuring the plaintiffs.

"But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released."

The article goes on to tell the story of how the FDA knew of the problems with the patch in 1999 and 2003, but did not release the information to the public until November 2005. As a result, the drug maker, supported by the Bush Administration, argues that drug companies should have a legal shield to protect them since the FDA knew of the risks and approved the drugs.

"The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts."

While drug companies may welcome the idea of a wall protecting them from litigation, what they should be afraid of is losing billions of dollars in sales because the likely effect of such a legal shield is far more scrutiny from the FDA from any drug sent for approval. The FDA will now have an interest not to approve drugs that may be deemed too risky to the public. This could result in a more drawn out approval process, or even more rejections because the FDA no longer can pass the risk to the drug companies.

This will invariably have a negative impact on consumers who will have to wait longer for drugs that may help them, and will probably increase the price of drugs.