Democrats seek to repeal US vaccine liability law

[Guest guest]

49 minutes ago

 

WASHINGTON (Reuters) - Congressional Democrats on

Wednesday introduced legislation that would repeal a

law that gives vaccine, drug and medical device makers

broad protection against lawsuits in a public health

or bioterror emergency.

 

Democrats generally agree there should be some legal

protections for certain vaccines but say the

Republican version defined health emergency too

broadly and did not compensate people who were

injured.

 

The liability provision, strongly favored by Senate

Majority Leader Bill Frist of Tennessee, was added to

a defense bill enacted in December. Democrats would

have an uphill struggle trying to repeal it.

 

Massachusetts Democrat Sen. Edward Kennedy (news, bio,

voting record) and 20 other House and Senate Democrats

wrote a letter to Republican leaders saying, " The

provision included in the bill is not limited to

vaccines for pandemic flu or other major threats to

the nation's health, but could instead be used to

allow manufacturers of virtually any drug or vaccine

to escape responsibility for gross negligence or even

criminal acts. "

 

more...

 

http://news./s/nm/20060215/pl_nm/congress_vacc...

 

 

 

 

From Ted Kennedy's Senate site:

 

 

February 15, 2006

 

 

KENNEDY, COLLEAGUES CALL ON FRIST AND HASTERT TO

REPEAL 'DEAD OF NIGHT' VACCINE LIABILITY PROVISION AND

ENACT REAL PROTECTIONS

SLIPPING THE MEASURE IN BEHIND CLOSED DOORS WAS A

TRAVESTY THAT THE HONEST LEADERSHIP ACT WOULD PREVENT

 

**Letter and Fact Sheet Included** FOR IMMEDIATE

RELEASE CONTACT: Laura Capps/Melissa Wagoner (202)

224-2633

 

Washington, DC: Today Senator Kennedy and twenty of

his colleagues in the House and Senate sent a letter

to Speaker Hastert and Majority Leader Frist to

express their disapproval of the tactic that was used

to slip in a damaging provision on vaccine liability.

Senators Kennedy, Dodd, and Harkin introduced a bill

that would repeal the deeply flawed provision, and

enact in its place a measure to give pharmaceutical

companies and medical professionals appropriate

liability on a targeted set of vaccines and other

countermeasures -- while ensuring that injured

patients are properly compensated. Today's letter

urges the Republican leadership to repeal their

measure, for the sake of the health and well-being of

all Americans. To prevent this kind of stealth action,

Democrats have included a provision in the Honest

Leadership Act that would require that all conference

committee meetings be open to the public and that

members of the conference committee have a public

opportunity to vote on all amendments. It would also

make copies of conference reports available to

Members, and post them publicly on the Internet, 24

hours before consideration, unless waived by a

supermajority vote. Below is the text of the letter

and a fact sheet on the Kennedy-Dodd-Harkin bill. A

PDF of the letter with signatures and the bill is

available upon request. February 15, 2006

 

The Honorable Bill Frist, M.D. The Honorable J. Dennis

Hastert Majority Leader Speaker U.S. Senate U.S. House

of Representatives 509 Hart Senate Office Building 235

Cannon House Office Building Washington, DC 20510

Washington DC 20515

 

Dear Speaker Hastert and Majority Leader Frist,

 

All of us share the goal of seeing that the nation is

properly prepared for an influenza pandemic or a

biological attack. Effective planning and adequate

funding are both indispensable elements of

preparedness.

 

We must also see that concerns about possible

litigation do not deter responsible manufacturers from

supplying vaccines and other drugs to our national

stockpile, or dissuade medical practitioners from

administering them to patients. An essential element

of any program to limit the legal liability of

manufacturers and medical professionals must be an

effective and properly funded compensation program for

patients injured by these products.

 

Many of us worked closely with our colleagues in the

majority to develop a bipartisan proposal to meet this

national need. We are deeply concerned that a stealth

provision to shield manufacturers from responsibility

for making faulty drugs and vaccines was included in

the Defense Appropriations Act without Congressional

debate or public scrutiny.

 

Legislation of such significance should have been

debated in the open, not sneaked into a larger bill

behind closed doors as a favor to special interests.

Doing so without the approval of the members of a

House-Senate conference committee was, in the words of

Thomas Mann of the Brooking Institution " a travesty

of the legislative process. "

 

The provision included in the bill is not limited to

vaccines for pandemic flu or other major threats to

the nation's health, but could instead be used to

allow manufacturers of virtually any drug or vaccine

to escape responsibility for gross negligence or even

criminal acts. The provision fails the basic test of

fairness by including only an empty shell of a

compensation program for injured patients with none of

the funding needed to make compensation a reality.

 

To correct this serious violation of Congressional

procedures, we urge you to schedule immediate action

on legislation to repeal this deeply flawed provision,

and enact in its place a measure to give

pharmaceutical companies and medical professionals

appropriate liability protection while ensuring that

injured patients are properly compensated. Signed by:

Senator Edward M. Kennedy Senator Christopher J. Dodd

Senator Patrick J. Leahy Senator Carl Levin Senator

Jack Reed Senator Barbara A. Mikulski Senatory Patty

Murray Senator Hillary Rodham Clinton Senator Daniel

K. Akaka Senator Dianne Feinstein Senator Ron Wyden

Senator Mark Dayton Senator Barbara Boxer Senator Tom

Harkin Senator Russell D. Feingold Senator Debbie

Stabenow Representative John D. Dingell Representative

David R. Obey Representative Lois Capps Representative

Henry Waxman

 

The Responsible Public Readiness and Emergency

Preparedness Act of 2006

 

Background When faced with the threat of smallpox, the

nation's health experts recommended that health care

workers be vaccinated. Congress provided

indemnification for those who manufactured and

administered the vaccine, which had not undergone FDA

clearance using modern procedures. The limited

circumstances that made this policy advisable in the

case of smallpox may recur if, for example, a pandemic

strain of flu hits the United States and the only

available vaccine has not been cleared for use under

full FDA review procedures, yet HHS recommends that

people receive the vaccine. Under these circumstances,

it is advisable to provide a targeted indemnification

for those who make and administer the vaccine,

provided that patients who suffer injury are

compensated.

 

The Republican Approach: Blanket Immunity with a Fig

Leaf of Compensation

 

Instead, in the conference report on the Defense

Appropriations bill passed in December 2005,

Republicans inserted at the last minute the Public

Readiness and Emergency Preparedness Act. This Act

provides a broad immunity for pandemic flu vaccines,

other countermeasures, and a broad class of other

products, including products that have received full

FDA approvals and are used everyday by patients. The

compensation program provided is one in name only,

because the established fund has absolutely no money

appropriated into it. As a result, the Republican plan

will fail to protect the American people. It provides

protection to a manufacturer even if its product is

ineffective or unsafe, and offers no help to patients

injured by a countermeasure.

 

Broad immunity.—Republicans gave drug companies and

those who administer a countermeasure effectively

complete immunity from suit for injuries caused by the

countermeasure when it is named in a " declaration " by

the Secretary of Health and Human Services. A

countermeasure can include any medical product to

prevent, treat, mitigate, or diagnose an epidemic.

Diabetes, obesity, methamphetamine addiction, and

arthritis are considered " epidemics, " so products such

as Vioxx could get complete immunity protection under

the bill, and a court could not review the decision.

 

" Limit " on immunity ( " bad actors " ).—An injured person

can break the immunity only by providing clear and

convincing evidence that the drug company or the

person who administered the medical product (the " bad

actor " ) acted with " willful misconduct. " This standard

will be essentially impossible to meet.

 

Willful misconduct includes only acts or omissions

taken— • intentionally to achieve a wrongful purpose,

• knowingly without legal or factual justification,

and • in disregard of known or obvious risks that are

so great as to make it highly probable that the harm

will outweigh the benefit. Gross negligence and

recklessness are excluded. The Secretary of Health and

Human Services must amend the definition of willful

misconduct by regulation, but only to make it

narrower.

 

An administrator, such as doctor, can act with willful

misconduct and may still be immune if it reports the

injury within 7 days. A drug manufacturer can act with

willful misconduct and is still immune unless FDA

initiates and wins an enforcement action against it.

Injured persons must meet extraordinary hurdles to

bring a lawsuit, including bringing the suit in

Washington, DC, heightened pleading requirements, very

limited discovery, and special appeal rights for drug

companies.

 

Compensation.—The compensation program includes no

funding, and drug companies receive immunity even when

the drug is administered to the wrong person, but that

person is denied compensation. Past experience has

demonstrated that, in the absence of a compensation

program, first responders will refuse to be

vaccinated.

 

The Democratic Alternative: Real Compensation and

Targeted Indemnification

 

The Democratic alternative, the Responsible Public

Readiness and Emergency Preparedness Act of 2006,

repeals the Republican approach and replaces it with a

responsible alternative. It will protect the American

people by offering an incentive to manufacturers to

make safe and effective countermeasures, while

encouraging first responders, health care workers, and

ordinary citizens to take these medicines in the event

of a pandemic flu or infectious disease outbreak or a

bioterror attack.

 

The bill provides a limited liability protection for a

limited set of countermeasures, and a fully funded

compensation program modeled on the successful Vaccine

Injury Compensation Program.

 

Indemnification, not immunity.—Manufacturers of, and

those who administer, certain countermeasures,

including pandemic flu vaccine, are indemnified by the

Federal government. In other words, injured patients

may sue the Federal government in Federal court to

pursue claims of negligence, strict liability, failure

to warn, or malpractice. Patients will not be able to

sue companies or doctors who administer these

indemnified countermeasures.

 

A targeted set of products.—Indemnification is

available only where (1) the product has not undergone

full FDA testing and (2) the product is recommended

for use by the Secretary of Health and Human Services

in a declaration. Products for epidemics like

diabetes, obesity, and arthritis cannot be given the

liability protection.

 

Real compensation.—Any injured patient for an

indemnified countermeasure will also be able to seek

compensation through a program modeled after the

Vaccine Injury Compensation Program, whether or not

there is negligence involved. Claims against the

government under both the indemnification program and

the compensation program are paid for the same way

claims under the Federal Tort Claims Act are paid—no

additional appropriations are required.

 

Accountability.—The government can sue a manufacturer

or doctor who was grossly negligent or reckless to

recover payments made to injured patients under the

indemnification or compensation programs.