From: Randice <>
To: Undisclosed-Recipient:;
Sent: Tue, 20 Dec 2005 05:56:41 -0500
Subject: IMMUNITY FOR THE DRUG INDUSTRY - Democratic Health, Education Labor, and Pension Staff, by Senator Frist, in a must pass DoD appropriations bill:

Written by the Democratic Health, Education, Labor, and Pensions Staff, addressing scandelous language added in once again by Senator Frist, in a must pass DoD appropriations bill:


In the middle of the night, Republican leaders attached sweeping, never-before-seen immunity for drug companies into the Department of Defense Appropriations Conference Report. The language constitutes an unprecedented pharmaceutical industry wish-list of liability protections that go way beyond avian flu preparedness and that will allow the industry to injure or kill Americans with contaminated drugs and vaccines and never be held accountable. This language is broader than any House or Senate bill and has never been considered by any committee or passed by either body. The language in fact, even expressly immunizes pharmaceutical company recklessness.

The language:

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.

Allows the Secretary to declare an emergency under ANY circumstance. The immunity for drug companies is triggered upon a declaration by the Secretary of Health and Human Services (HHS). The language is so broad that it allows the Secretary to make a declaration at any time, for almost any reason, and for any period of time he or she so chooses. The Secretary may make a declaration pursuant to this section if a disease or health condition is a public health emergency or "there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency." [emphasis added.] There will always be a future risk of a health condition becoming an emergency, but that future risk alone should not be enough to justify total immunity for the pharmaceutical industry. This declaration is not subject to appeal, or to any independent judicial review.

Provides for total preemption of state law during the declaration. The language also preempts all state laws, requirements, or state tort law that is different from or in conflict with the federal rule.

Immunizes drug companies for reckless and grossly negligent conduct. The only exception to the grant of wholesale immunity is in the case of "willful misconduct." However, willful misconduct is defined as evidence that the drug company had actual knowledge that their product would injure or kill someone. This requirement means that only conduct that would also constitute assault, battery or murder would be sufficient to find "willful misconduct." The language explicitly protects recklessness by stating, "a standard for liability that is more stringent that a standard of negligence in any form or recklessness." That is language never before seen in any proposed bill.

Immunizes criminal conduct when the Secretary or the Attorney General fails to act. Even if a drug company has acted with "willful misconduct" as defined by this language, the drug company is still immune from accountability unless the Secretary or the Attorney General initiates an enforcement action against the drug company and that action is pending at the time a claim is filed or the action resulted in some form of punishment. So even if a drug company knowingly kills thousands of people, if no official enforcement action is taken, that company is still immune.

Erects insurmountable barriers such that Americans will never be able to hold a drug company accountable. Under the language, a person who has been injured by a dangerous drug or vaccine must prove "by clear and convincing evidence willful misconduct" on the part of each and every defendant drug company. This standard of proof is so high, and rarely used in civil proceedings, that the injured individual will never be able to hold a drug company accountable.

Includes severe restrictions even if a claim is allowed. In the unlikely event that a claim is allowed to go forward because a court has found sufficient evidence that 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.

Establishes a "compensation" fund under the sole direction of the Secretary. The language establishes a fund similar to the smallpox compensation fund. However, the fund is operated under regulations established by the Secretary alone, includes caps on compensation, and is inoperable until Congress appropriates a sufficient amount of money for the fund to operate.