On December 21st the U.S. Senate, at the request of Senate Majority Leader Bill Frist, gave the powerful drug industry an early Christmas present. A 45-page rider tacked on to the Defense spending bill conference report by Senator Frist absolves drug makers of responsibility even for gross negligence or recklessness when making tainted, defective or deceptively labeled products. Worse still, legal immunity under the bill would extend to already available commercial drugs if they are used to prevent, treat or cure a designated epidemic or pandemic disease. Clearly, the measure will reduce the incentive for drug makers to make safe pandemic vaccines or drugs, and will deter people from being vaccinated. Congress has done a great disservice by bowing once again to corporate greed. The manner in which the drug industry has given virtual immunity for wrongdoing by the GOP leadership tells us how powerful the industry is.

Senator Frist’s strong-arm tactics, which defied his own written assurances to conferees that the report would not contain the liability provision, demonstrate the extreme lengths to which he is willing to go to pay back corporate cronies at the public’s expense. The powerful Senator’s latest maneuver came despite his acknowledgment that even high-quality drugs and vaccines, let alone those hurried through production to meet emergency deadlines, may harm patients. For example, after the 2001 Capitol Hill anthrax scare, Senator Frist told CNN that Senate staffers should not be inoculated with the anthrax vaccine because of its potentially serious side effects. Yet his cautiousness has not extended to concern for the general public. Another example is a controversial adjuvant, MF59, which has been cited as a possible cause of Gulf War syndrome. It is being used by Chiron in its experimental avian flu vaccine, for which the company recently signed a $62.5 million contract with the U.S. government. Under Frist’s drug company immunity provision, Chiron would have no responsibility if anyone is injured by the substance.

The bill grants unprecedented immunity to the drug industry and forces citizens and first responders to choose the lesser of two large-looming evils: (1) taking the recommended countermeasure with its potential for causing harm; or, (2) taking a chance on contracting the pandemic disease. Some of the bills more outrageous provisions include:

• Sweeping, unchecked power for the Secretary of Health and Human Services (HHS) to activate drug company immunity. The Secretary of HHS may declare that a disease, health condition or threat constitutes a public health emergency or that there is a credible risk that these “may in the future” constitute such an emergency. Not only is “public health emergency” undefined, but the terminology is so broad as to allow a declaration of emergency under virtually any circumstances whatsoever. The Secretary’s decisions can be made with utter impunity. Some say the decision can’t be reviewed or appealed to any court. Hopefully, that won’t be the case.
• Danger to the public is not considered a factor in declaring an emergency. The only factor that the Secretary must take into account when determining whether to declare an emergency is the desirability of promoting development, manufacturing and marketing of pandemic products. The focus is on commercial interests rather than creating meaningful guidelines for assessing the degree of danger represented by a particular disease threat.
• All state laws regarding the designated products are pre-empted. State consumer protection laws – for example, one that requires a package label to warn against administering a vaccine containing Thimerosal to pregnant women – will no longer be enforceable. Laws deliberated and passed by state legislatures to ensure protection of residents against dangerous drugs – including laws making drug companies liable for injuries – will immediately be suspended upon declaration of an emergency by the Secretary of HHS.
• Obstacles to liability are impossibly high; the sole exception to immunity is conduct tantamount to criminal assault or murder. A company would lose its immunity only if the victim of one of its products could prove by clear and convincing evidence that the defendant had actual knowledge that use would result in injury or death. In fact, the bill expressly protects drug companies from liability for reckless conduct or gross negligence.
• Imposes archaic, onerous and outmoded procedural requirements on victims who attempt to hold drug companies accountable. The bill ignores modern legal rules and procedures developed over the years by the courts, instead reverting to the legal Dark Ages by imposing a combination of extraordinary technical pleading rules and bizarre requirements unknown to any other form of litigation, such as affidavits from non-treating physicians and certified medical records. Moreover, even if the victims get this far, a defendant company is still protected from suit if the HHS Secretary or U.S. Attorney General has not taken some enforcement action against it for violating the federal Food, Drug and Cosmetics Act.

The federal government certainly has a responsibility to protect the nation from the risk of widespread disease. However, allowing the powerful drug industry to market dangerous products and then barring consumers from meaningful recourse when injured is not the answer. The only way Senator Frist could get this bill passed in the Senate was to attach it to the defense appropriations bill. He did it with the help of the Speaker of the House late on a Sunday night without alerting the full Senate. I am told this was done after the conference committee report had been signed by many of the conferees. To assure passage of the drug provisions, a great number of other measures were added, including the hurricane relief appropriations.

This is not the first time that Senator Frist has done this sort of thing. In 2002, the powerful Senator surreptitiously exploited a procedural loophole in the legislative process to tuck an inconspicuous provision into the Homeland Security bill that shielded major Republican donor Eli Lilly from accountability for injuries caused by its vaccine preservative, Thimerosal. Congress was forced to repeal the measure when it was revealed later. As to the current bill, there may well be a constitutional problem relating to the immunity provisions of the bill.

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