The Food and Drug Administration, at the request of the Bush White House, is doing its best to give drug companies virtual immunity from lawsuits. On January 19th, in what has been labeled by some as a sneak attack, the FDA announced its final rule on new federal requirements for drug warning labels. If the courts follow this new rule, it could have disastrous effects on the rights of people injured by dangerous and unsafe drugs to recover damages under state statutory and common law. In the preamble of the final rule, the FDA states its position that these new federal requirements preempt all state tort liability claims based on inadequate drug warning labels. Such an attempt to preempt state tort liability, if adopted by the courts, would have significant implications in failure to warn cases. Interestingly, the FDA provided no notice of their intention to include this language in the final rule. In fact, in the notice of proposed rule-making, issued December 22, 2000, the FDA stated:

FDA has determined that this proposed rule does not contain policies that have federalism implications or that preempt State law.

The Bush administration had previously failed to persuade Congress and, with a few exceptions, the courts (where it has filed amicus briefs) to shield drug makers from liability. This new tactic of writing preemption language into federal regulation notices is an attempt to bypass Congress and override consumer protection liability laws. Joan Claybrook, President of Public Citizen, had this to say on what the FDA has done:

This is a sneak attack on consumer rights. President Bush is once again abusing his executive powers, this time in his attempt to protect the big pharmaceutical companies from the consequences of their actions. Thousands of people in this country have died or been seriously injured by drugs approved by the FDA, and this administration is saying it doesn’t think people should have any recourse.

In effect, the FDA has, without any statutory authority, declared that federally-approved medication labels preempt state law. The drug industry’s goal is to make sure that persons killed or seriously injured by unsafe drugs won’t be able to pursue legitimate claims in court against the drug companies. Most likely the effect of what has done is to give drug companies a tool to use in future court cases filed in the future. The companies would be able to claim that they weren’t required to warn consumers about any known safety risks because the FDA determined the safety issue didn’t warrant inclusion on a medicine’s label. The new policy – which addresses state liability laws – has now been written into a broadview drug-labeling rule.

If the proposed changes come about, drug-product safety in the United States could suffer a major setback. When you consider how many drugs were approved by the FDA and later had to be pulled from the market because of serious safety problems, it’s obvious this rule – if followed by the courts – will be very bad for people who have to take prescription drugs in this country. As you know, the conduct of pharmaceutical companies and the FDA has been called into serious question in recent months and with good reason. It has been quite obvious over the past several years that the FDA is little more than an extension of the powerful drug industry. Ordinary folks in this country have no clue what is going on at the FDA. If they actually knew how powerful the drug industry is and what influence the companies exercise over the FDA, it would likely cause a major consumer rebellion against the federal government and the politicians who take the drug industry money.

According to the Wall Street Journal, inclusion of the new FDA policy in the drug-labeling rule had caused a great deal of disagreement between FDA career officials and Bush Administration appointees. I really believe that there are dedicated employees at the FDA who badly want the authority to properly regulate the drug companies. Unfortunately, the Bush Administration – at the urging of drug company lobbyists – has pushed this anti-consumer measure through the FDA. I don’t believe people will stand for this sort of thing once they realize what is happening. Due to the total lack of notice regarding the FDA’s intention to preempt state tort law, there was no opportunity for people to react or comment prior to the issuance of the final rule. The FDA admitted at a press conference called to announce the new rule that the liability provisions were added behind the scenes, after the agency consulted with the drug industry. Inserting language in the final rule counter to the proposed language is highly unusual and deprives organizations such as Public Citizen and individuals their right to comment in the rule-making process.

We are facing a major healthcare crisis in this county caused by the number of unsafe drugs put on the market by drug companies – after FDA approval – and the latest FDA action could add to this crisis. As we all know, the current environment in Washington is very antagonistic to defenders of the civil justice system and the right to a jury trial. Powerful industries, such as the drug industry, that have been unable to win special protections from legislative bodies are now manipulating the federal rule-making process to attack the civil justice system. The drug industry could never get Congress to do what the FDA has now done concerning preemption. Fortunately, the courts have rejected the preemption argument time and again. The new rule will not take effect until June 30, 2006, which will give time for folks to find out how this new rule will affect them and what’s happening to their rights.

It must be emphasized that Congress has never given the FDA the statutory authority required to promulgate rules preempting state tort law in this area. In the opinion of most legal scholars, the FDA has clearly overstepped its authority. I am convinced that the FDA’s new rule is unconstitutional under the same analysis the U.S. Supreme Court offered in Medtronic v. Lohr, 518 U.S. 470 (1996), which upheld state tort law claims against a medical device manufacturer. The Wall Street Journal recently reported:

Last July, a federal judge in Minnesota turned down a Pfizer request to bar a suit over the antidepressant Zoloft, writing that ‘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.

However, the fact that the drug industry could get the FDA to rewrite the rules so that companies such as Merck and Co. and Pfizer could possibly 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 in Washington. The drug companies will stop at nothing to avoid being held accountable when they put unsafe drugs on the market that are harmful to people. What they couldn’t get done in Congress, they’re trying to accomplish through this back-door rule-making process. Eliminating the rights of individuals to hold drug companies accountable when they are at fault in putting unsafe drugs on the market will put patients at even greater risk. The FDA’s poor record of approving harmful drugs based on limited, and even fraudulent, clinical trials performed by the drug companies has created a most dangerous situation. Both the FDA and the big drug companies share the blame for the serious problems caused when dangerous and unsafe drugs are put on the market. I am confident that the courts will say no to the FDA’s opinion on preemption, which is not based on any authority given to the FDA by Congress, and will summarily reject it.

Sources: The Wall Street Journal, Associated Press and Public Citizen

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