Flu Vaccine Preparedness Press Kit | Drug Safety News

Proposed Legislation Protects Drug Company Profits Over Americans' Health and Safety

A special interest giveaway that could prove deadly for the public.

Legislation proposed in the U.S. House and Senate (S.1873 and H.R. 3970) protects drug companies without regard for the safety of the American public. The bills include sweeping immunity that releases drug companies from any and all accountability, even for gross negligence and intentional misconduct.

The immunity proposals are unnnecessarily broad in scope—so broad that they even apply to a wide-range of commercial drugs and products that have nothing to do with a bioterrorism or a potential pandemic. The immunity even applies to commercial drugs already on the market.

Without a safety or compensation component, S. 1873 and H.R. 3970 ask 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: the bills limit all access to the court system and fail to provide the American public with any compensation system when they or their loved ones are injured or killed by a covered countermeasure.

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

Disturbing Facts About the Special Protections for Drug Companies in Proposed Bioterror and Pandemic Preparedness Legislation

Legislation is unnecessarily broad and applies not only to new vaccines but also to existing drugs and devices. The bills do not limit their application only to new vaccines used in a bioterrorist or pandemic context. Instead, provisions in the legislation provide that any drug, device, or biological product used to "diagnose, mitigate, prevent, or treat" a potential pandemic may qualify for protection. The bills also apply to any existing drug, device, or biological product used to "diagnose, mitigate, prevent, or treat" a side-effect of another vaccine or drug. This means for example, that if Tamiflu qualifies for protection under the bills because it is a potential treatment for avian flu and an individual takes an ordinary pain reliever like Vioxx to treat side-effects caused by Tamiflu, both Tamilu and Vioxx could be protected under the bills' immunity provisions.

The immunity provisions insulate all drug companies from virtually all accountability. The proposals provide sweeping immunity for all manufacturers, distributors, administrators, and health care providers related to the sale, testing, labeling, distribution, design, or prescription of a covered product, no matter what the injury or how bad the drug company's conduct. This even applies to drug companies who are grossly negligent or intentionally harmful. Only one, effectively meaningless exception is offered: an injured person may petition the Secretary of HHS or the U.S. Attorney General to allow a case against a drug company to go forward. Those entities have the sole discretion to investigate or simply to decline the petition. If a petition is denied, there is no other option or remedy available to that injured individual; there is no appeals process through which to challenge the Secretary's or Attorney General's decision. In the unlikely event that an investigation occurs, the Secretary is bound by such unreasonably high standards of proof, that in order for the Secretary or Attorney General to make a finding that a claim against a drug company could go forward, he would have to make findings virtually impossible to prove.

There is no reasonable limit to the bills' application. 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 there is an actual or potential threat of a pandemic disease 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 bills would receive wholesale liability protection. The drug or vaccine is shielded from liability whether or not it is actually given in response to a pandemic health emergency.

Proposals allow drug companies access to the court system, but do not give that same right to injured Americans. These efforts to shield manufacturers cynically allow only the drug company to appeal to the federal court system, but not an injured individual. In the unlikely event that the Secretary or Attorney General rules that a claim may go forward against a drug company, the drug company is allowed to appeal that decision to the United States District Court. To add insult to injury, the injured individual is completely barred from participating in this appeals process. The bills go to great lengths to preserve a drug company's constitutional right to have access to a court system but do nothing to protect that same right for injured Americans.

Eliminating citizens' access to civil justice is not only unecessary and unsafe - it's also wholly unconstitutional. 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. The proposed bills, however, sweep away a host of rights under state and federal law for persons who may be injured by drugs and vaccines. Yet, they neither establish nor provide access to an alternative compensation system. Persons are not permitted even to petition a court for the right to seek compensation.

November 8, 2005