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Wednesday, November 16, 2005

Bird Flu Over the Cuckoo’s Nest

In the middle of the night, without a hearing or debate, friends of big drug companies have plans to attach to an unspecified conference report a pandemic disease proposal that instead of protecting the public health and safety would award special interest protections to the pharmaceutical industry.

If their proposal is so essential to the public health, why are proponents attempting to add it stealthily, while the American public isn’t watching? The truth is their proposal has nothing to do with public health and safety and everything to do with unnecessary giveaways to drug companies. The proposal includes language not included in any House or Senate passed bill—language that provides the drug companies with sweeping legal protections, releasing them from virtually all accountability. The proposal is so broad that it applies to a wide range of commercial drugs and products that may have nothing to do with bioterrorism or a potential pandemic. It even applies to commercial drugs already on the market for which drug companies are making billions of dollars.

Under the proposed language, drug company immunity is triggered if the Secretary of Health and Human Services (HHS) 1) declares an actual or potential public health emergency and 2) declares a drug, vaccine, or device a “countermeasure” or qualifying “pandemic or epidemic product.” Once this occurs, drug companies are virtually immune from all liability. The proposal:

Applies to a wide range of drugs, vaccines, and other products. The proposal provides that any “drug, biological product or device that is used to mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such pandemic or epidemic might otherwise cause…” may be covered and given immunity. The proposal does not, in any way, limit its application only to new drugs or vaccines used in a pandemic context. The scope of the proposal is so broad that it could include drugs like Tylenol, Advil or Vioxx.

Immunizes drug companies by erecting insurmountable barriers to the court system. Citizens can’t go to court unless the Secretary of HHS gives them permission. The proposal bars injured individuals from filing a claim against a manufacturer of a covered product, even in cases of gross negligence. The only exception to the grant of wholesale immunity is in the case of “willful misconduct.” An injured person may ask the Secretary of HHS to find that the manufacturer acted with willful misconduct and allow a case against a drug company to go forward. The Secretary has the sole discretion to investigate or to simply decline the petition. Because the Secretary is bound by an entirely new definition of “willful misconduct” it is virtually impossible for the Secretary to ever allow a claim to go forward. The proposal mandates the Secretary of HHS, together with the Attorney General, promulgate regulations defining what is meant by “willful misconduct” and requires them to find that the drug company had actual knowledge that their product would harm the petitioning individual. This requirement means that only conduct that would also constitute assault, battery or murder would be sufficient for the Secretary to find “willful misconduct.”

Includes severe restrictions even if a claim is allowed. In the unlikely event the Secretary allows a claim to go forward because he has found sufficient evidence a drug company intentionally and willfully injured or killed a person, the following restrictions would still apply:

Includes provisions of the so-called “Lawsuit Abuse Reduction Act” (LARA). Proponents have even dumped into this proposal provisions of LARA, a bill which has twice passed the House but has never been considered in the Senate. Among other things, the proposal would amend the Federal Rules of Civil Procedure without following the normal rule-making processes.

Fails to specify any time limitation for application of immunity. Under the plan, immunity may be triggered at any time because the Secretary of HHS is given broad and unfettered discretion to declare a “public health emergency” when he or she decides there is an actual or potential threat of a pandemic occurring. This could occur tomorrow in light of new risks posed by such diseases as avian flu. Once this declaration occurs, anything deemed a “countermeasure” under the proposal receives wholesale liability protection. A drug or vaccine is shielded from liability whether or not it is actually given in response to a flu pandemic health emergency.

Fails to provide any alternative compensation remedy and is therefore wholly unconstitutional. This proposal sweeps away a host of rights under state and federal law for persons who may be injured by drugs and vaccines. Yet the proposal neither establishes nor provides access to an alternative compensation system. The Supreme Court of the United States has repeatedly made clear that constitutional rights, including specifically an injured person’s right to a jury trial, may not be simply eliminated. The legislature must offer a reasonably equivalent right to a remedy.

Without a safety or compensation component, the proposal asks the American public to trust the pharmaceutical industry to keep them safe. And if that trust is broken, Americans are left with no place to turn for a remedy—no access to the court system and no access to any compensation system when they or their loved ones are injured or killed by a covered countermeasure.

Posted by Becca

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