Visit the Press Room for more breaking news

Contact: Chris Mather
202-965-3500 x369
202-725-5252 (Cell)

FDA Uses Back Door to Issue New Rule Protecting Negligent Drug Companies
Rule Could Affect Majority of Drug Safety Cases

(Wednesday, January 18, 2006) - Today the Food and Drug Administration (FDA) issued a new rule – developed behind the scenes in consultation with the drug companies – that is designed to eliminate state drug safety protections.

In the preamble to the rule, the FDA states its position that a drug company that puts a dangerous drug on the market – such as Vioxx, which an FDA scientist acknowledged killed as many as 55,000 Americans – should be immune from liability based on the drug company’s failure to warn doctors and patients of a drug’s dangers if the drug’s warning label met the new minimum federal standard.

“The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process,” said Ken Suggs, President of the Association of Trial Lawyers of America (ATLA).

“Americans are already in danger from drug company executives that put profits before safety and an FDA that is beholden to the drug companies it is supposed to regulate -- eliminating the rights of individuals to hold negligent drug companies accountable only puts patients at greater risk,” he continued.

The liability protections were not even in the original, publicly circulated draft of the proposed rule. Rather, as the FDA admitted at today’s press conference announcing the new rule, the liability provisions were added behind the scenes, after the agency consulted with the drug industry, and announced as part of the final rule without ever being made subject to public comment or any review process.

The new rule represents a fundamental rollback of drug safety. Under current law, a drug company that met a minimum federal standard but still acted negligently in failing to warn patients about a drug’s dangers and harmed someone could be held accountable under state law. The FDA's position in the new rule is that the negligent company would not be held accountable if it met the new federal standard.

As the National Conference of State Legislatures has stated, “The Food and Drug Administration is attempting a back-door approach to preempt state prescription drug product liability laws despite Congress and the courts' refusal to grant them such power.”

A federal judge in Minnesota recently rejected the argument that meeting minimum federal warning label standards grants a drug company immunity and wrote, "federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability. ... state-law protections reinforce and enhance" federal efforts to protect the public from negligent pharmaceutical companies and deadly drugs.

###

As the world's largest trial bar, ATLA promotes justice and fairness for injured persons, defends the constitutional right to trial by jury, and strengthens the civil justice system through education and disclosure of information critical to public health and safety. With 60,000 members worldwide, ATLA provides lawyers with the information and professional assistance they need to serve clients successfully and protect the democratic values of the civil justice system.