Senate Moves Towards Forced Vaccinations

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" Zeus " <info

Senate Moves Towards Forced Vaccinations

Tue, 10 Jan 2006 02:06:12 -0000

 

 

 

Zeus Note: This legislation was passed just before Christmas. Below

are a collection of related articles. Some of the links that no

longer work have been taken out.

 

 

Senate Moves Towards Forced Vaccinations, Vaccine Damage Immunity for

Drug Companies

Associated Press | December 2, 2005

By ANDREW BRIDGES

 

 

CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES

 

By creating a federal agency shielded from public scrutiny, some

lawmakers think they can speed the development and testing of new

drugs and vaccines needed to respond to a bioterrorist attack or

super-flu pandemic.

 

The proposed Biomedical Advanced Research and Development Agency, or

BARDA, would be exempt from long-standing open records and meetings

laws that apply to most government departments, according to

legislation approved Oct. 18 by the Senate health committee.

 

Those exemptions would streamline the development process, safeguard

national security and protect the proprietary interests of drug

companies, say Republican backers of the bill. The legislation also

proposes giving manufacturers immunity from liability in exchange for

their participation in the public-private effort.

 

" We must ensure the federal government acts as a partner with the

private sector, providing the incentives and protections necessary to

bring more and better drugs and vaccines to market faster, " Sen.

Richard Burr, R-N.C., said when the Committee on Health, Education,

Labor and Pensions approved the bill.

 

The agency would provide the funding for development of treatments and

vaccines to protect the United States from natural pandemics as well

as chemical, biological and radiological agents.

 

But it is the secrecy and immunity provisions of the legislation that

have alarmed patient rights and open government advocates. The agency

would be exempt from the Freedom of Information and Federal Advisory

Committee acts, both considered crucial for monitoring government

accountability.

 

" There is no other agency that I am aware of where the agency is

totally exempt either from FOIA or FACA, " said Pete Weitzel,

coordinator of the Coalition of Journalists for Open Government. The

coalition is an alliance of journalism groups, including the American

Society of Newspaper Editors and Associated Press Managing Editors,

that wrote to lawmakers seeking amendments to the bill. " That is a

cause for major concern and should raise major policy concerns, "

Weitzel said.

 

Burr spokesman Doug Heye said the provisions would keep competitors

from gaining proprietary information through FOIA. However,

confidential business information already is exempt from FOIA.

 

" There's no secrecy involved in BARDA, " Heye said. " That is absolutely

false. This is an agency that will be putting out information daily. "

 

Some Democrats question whether the public would accept drugs or

vaccines developed in conjunction with the agency, citing the abortive

2003 effort to vaccinate 500,000 front-line health care workers

against smallpox. Only about 40,000 workers ultimately received the

vaccine amid concerns about the vaccine's safety, which health

authorities initially downplayed.

 

" Republican leaders in Congress are now proposing a plan that would

make exactly the same mistake, " Sen. Chris Dodd, D-Conn., said in a

statement. " Their plan will protect companies that make ineffective or

harmful medicines, and because it does not include compensation for

those injured by a vaccine or drug, it will discourage first

responders and patients from taking medicines to counter a biological

attack or disease outbreak. "

 

The bill does provide for limited compensation. However, another

provision would grant drug companies immunity unless " willful

misconduct " can be shown.

 

The Pharmaceutical Research and Manufacturers of America said it was

reviewing the bill. Another industry group, the Biotechnology Industry

Organization, declined comment.

 

The National Vaccine Information Center, an advocacy group, called the

legislation " a drug company stockholder's dream and a consumer's worst

nightmare. "

 

The proposed law comes amid growing concern about pandemics and the

government's ability to meet such threats. For instance, the United

State needs another three to five years to develop the manufacturing

capacity to produce 300 million doses of flu vaccine, Health and Human

Services Secretary Mike Leavitt said Sunday on NBC's " Meet the Press. "

 

The agency would improve on Project BioShield, a barely two-year-old

program also meant to encourage production of vaccines and drugs, Heye

said.

 

" While some progress has been made, we still haven't seen the

participation from companies, universities and research institutions

in developing vaccines we might need to protect us from the next

threat, whatever that might be, " Heye said. " One of the reasons is

(they) don't want to put their very existence on the line. "

 

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,

said the agency as proposed would represent a setback to decades of

progress in opening up to the public the process of testing the safety

and efficacy of drugs.

 

" These provisions are extremely dangerous, " Wolfe said. " The fact that

they are being proposed, really exploiting people's fears about

pandemics and epidemics, is outrageous and goes backward on the

progress on the use of the Freedom of Information Act and Federal

Advisory Committee Act to increase public scrutiny and increase the

correctness of decisions that are made. "

 

Republican and Democratic lawmakers alike agree the drug industry

needs some protections to encourage it to produce emergency stocks of

vaccines and drugs, but Democrats have balked at providing blanket

immunity without first establishing a compensation fund for patients.

 

Republicans are pushing for liability protections for vaccine

manufacturers on other fronts as well. Senate Majority Leader Bill

Frist, R-Tenn., is seeking to add such protections to a defense

appropriations bill.

 

Frist spokeswoman Amy Call said drug company concerns about liability

are real.

 

" There's really no financial incentive for them to get into the

market, sell to the government at a reduced rate and then open

themselves up to losses that could potentially bankrupt them, " Call said.

 

The push for liability exemptions may force the Burr bill to the

sidelines until the next session of Congress, Republican and

Democratic aides said. But Call said Frist intends to pursue the

legislation.

 

__

 

 

 

 

Thanks to Sheri Nakken, R.N., MA, Classical Homeopath, for sending the

articles below:-

http://www.nccn.net

 

 

 

IMMUNITY FOR THE DRUG INDUSTRY 22/12/05 - Written by the Democratic

Health, Education, Labor, and Pensions Staff, addressing scandalous

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:

 

* The complaint must be accompanied by physician's affidavit by a

doctor who did not treat the person that the person is suffering from

an effect of the covered countermeasure;

 

* The injured individual must provide their medical records that show

that the injury was caused by that countermeasure;

 

* An exclusive federal cause of action, barring individuals from

filing a claim in their own state court under state law;

 

* The elimination of the collateral source rule such that any damage

award received by the injured person would be reduced by any other

payment received by the individual, such as health insurance or

disability benefits;

 

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.

 

_______

 

" Vaccines are proving they can be blockbusters. Prevnar, Wyeth's

children's pneumococcal vaccine, revenues total over $1 billion.

Analysts say vaccines against human papilloma virus, a sexually

transmitted disease that is a major cause of cervical cancer, could be

big sellers for Merck & Co. and Glaxo who are each developing one. "

 

http://www.thnt.com/apps/pbcs.dll/article?AID=/20051211/BUSINESS/512110337/1003

 

Drug makers seek protection

 

Home News Tribune Online 12/11/05

 

THERESA AGOVINO

THE ASSOCIATED PRESS

 

NEW YORK - Large pharmaceutical companies are approaching development

of vaccines and drugs for potential pandemics with trepidation, even

as fears abound of a bird flu outbreak and doctors lament a shortage

of treatment options.

 

Drug makers are especially afraid of lawsuits stemming from vaccines

which, unlike drugs, are given to healthy people, making any harm they

cause an even bigger legal risk.

 

Proposals in Congress would exempt companies that manufacture vaccines

and drugs for pandemics from lawsuits. Senator Bill Frist, R-Tenn., is

trying to put a rider on a spending bill that would immunize drug

makers and another freestanding bill introduced by Senator Richard

Burr, R-N.C., seeks to accomplish the same goal.

 

That's a necessary safeguard to promote interest in developing those

medicines, drug makers say.

 

" We won't do it without indemnification, " said Len Lavenda, a

spokesman for Sanofi Pasteur, the vaccine arm of Sanofi-Aventis SA.

 

But some insist immunizing drug companies won't be enough to spark

interest in a field fraught with an uncertain pricing structure.

Unlike drugs for conditions such as cholesterol and high blood

pressure, which have guaranteed markets, medicines for pandemics will

only be used sporadically, if at all.

 

The government adds to the pricing pressure. The Centers for Disease

Control and Prevention buys 55 percent of the recommended childhood

vaccines and pays substantially less than the private sector, so some

experts suspect payments for pandemic treatments will be less than

generous.

 

When anthrax fears surfaced after the Sept. 11 attacks, the U.S.

government threatened to break the patent covering Cipro, an

antibiotic made by Bayer AG. And Roche Holding Ltd. has already been

under tremendous pressure to lower the cost of its Tamiflu, which is

believed to be effective against bird flu, and give others permission

to make it.

 

" Companies are worried about low prices, " said Frank Sloan, professor

of health policy, law and management at Duke University.

 

" They are worried they won't recoup their research and development

costs, " he said. " That is the real problem. "

 

In a statement, Senator Edward Kennedy, D-Mass., called the attempts to

indemnify companies " a sweetheart deal for the drug industry. "

 

A spokesman for Burr said his bill contains provisions to compensate

people hurt from treatments through government funds and that

companies will only be indemnified when the product is used in a

pandemic, not for a general medical problem.

 

The drug industry insists such moves are crucial. In a pandemic, a

vaccine may be approved without the same level of testing that would

be normally required and given to virtually all Americans.

 

" This is 300 million plaintiffs you are talking about, " said John

Clerici, a lawyer who represents Sanofi and other companies. " If they

get anything, they'll blame it on the vaccine. "

 

Sheltering drug companies from lawsuits isn't without precedent. Acambis

PLC was protected to make an Anthrax vaccine and the manufacturers of

swine

flu vaccines were given the same treatment back in the 1970s.

 

Individuals seriously harmed by vaccines the U.S. government

recommends for

children are paid through a federal pool funded by a tax on inoculations.

But Lavenda said lawyers are seeking ways to collect damages from

companies

instead of the government fund.

 

Chris Viehbacher, president of GlaxoSmithKline PLC's U.S. pharmaceuticals

business, estimates the industry has spent $200 million preparing itself

for lawsuits over a vaccine preservative in children' s vaccines.

 

Lavenda said the issue of immunity from lawsuits must be cleared before

other negotiations can begin on issues such as price.

 

Lobbyists and pharmaceutical executives said the main force pushing for

indemnity is not the drug industry, but the Biotechnology Industry

Organization, a trade group. BIO declined comment, but lobbyists and

analysts suggested its members are far more interested in pandemic

medicines than drug companies.

 

" Biotech companies are more amenable to working in new areas. They are

startups, " said Christopher Milne, assistant director at the Tufts Center

for the Study of Drug Development. " Big pharmaceutical companies are

resistant to getting heavily involved where the government is paying. They

remember the Cipro incident. "

 

Generex Biotechnology Corp. recently hired a lobbying firm to help it get

government contracts to develop its bird flu vaccine.

 

Anna Gluskin, Generex's chairwoman, CEO and president, said she isn't

worried about lawsuits because the company's vaccine is made from

synthetic

proteins, which she maintains is a safer manufacturing process.

 

Some pharmaceutical companies have chosen to develop a vaccine for bird

flu. Sanofi Pasteur has a government contract to produce 8,000 doses of an

experimental vaccine, but it has received indemnity from lawsuits. Glaxo

said it will start a small trial in Europe during the first quarter of

next

year, and discussions with regulators haven't progressed enough to have

included the indemnity issue.

 

Viehbacher said any company which successfully creates a vaccine would

have

leverage over the government. Vaccine production is complicated, so

breaking a patent wouldn't guarantee supply, he said.

 

Vaccines are proving they can be blockbusters. Prevnar, Wyeth's children's

pneumococcal vaccine, revenues total over $1 billion. Analysts say

vaccines

against human papilloma virus, a sexually transmitted disease that is a

major cause of cervical cancer, could be big sellers for Merck & Co. and

Glaxo who are each developing one.

 

_____

U.S. Senators with up to $13.4 million in pharmaceutical holdings

increased the value of their stock portfolios last night when they

approved an amendment to the defense appropriations bill that

immunizes drug makers from accountability to the public when they sell

dangerous drugs and other products, according to the Foundation for

Taxpayer and Consumer Rights (FTCR).

 

_________

 

 

http://www.whitehouse.gov/news/releases/2005/12/20051222-10.html

 

President Applauds Congress for Passing Defense Appropriations Bill

I applaud the Congress for passing legislation to fund our troops who are

fighting the war on terror in Iraq, Afghanistan, and elsewhere. This

funding will help us continue to hunt down the terrorists, pursue our

strategy for victory in Iraq, and make America more secure. I look forward

to signing the bill into law.

 

What the president does not mention in the 'making of America more

secure' - is that in the bill, Senator Frist slipped language into the

bill indemnifying manufacturers from their products (drugs/vaccines,

et. al) that can harm, disable and/or kill the American people. The

arctic drilling was widely focussed on, and that amendment was pulled

from the bill. The environment in Alaska is now safe - Americans in

the US however, are now not. What the president also fails to mention

is that he was the #1 recipient of contribution funds for the 2004

election, bringing in over $1,000,000.00 from PHARMA.

http://www.secretwebsites.com/say_no_to_drugs.htm - For those that

believe I'm slamming Republicans, I am not - it just so happens those

mainly responsible are Republicans - but, there are a few democrats as

well.

 

Again, here are the 38 senators that voted this bill in, with a

conflict of interest with ties to the pharmaceuticals (stock holdings):

 

Allen (R-Va.), Bayh (D-Ind.), Bingaman (D-N.M.), Bond (R-Mo.), Boxer

(D-Calif.), Brownback (R-Kan.), Burns (R-Mont.), Carper (D-Del.), Coburn

(R-Okla.), Cochran (R-Miss.), Conrad (D-N.D.), Crapo (R-Idaho), Dayton

(D-Minn.), DeWine (R-Ohio), Dole (R-N.C.), Ensign (R-Nev.), Feinstein

(D-Calif.), Frist (R-Tenn.), Hatch (R-Utah), Hutchison (R-Texas), Inhofe

(R-Okla.), Isakson (R-Ga.), Kerry (D-Mass.), Kyl (R-Ariz.), Landrieu

(D-La.), Lautenberg (D-N.J.), Levin (D-Mich.), Lieberman (D-Conn.), Lott

(R-Miss.), Reed (D-R.I.), Reid (D-Nev.), Roberts (R-Kan.), Stevens

(R-Alaska), Sununu (R-N.H.), Talent (R-Mo.), Vitter (R-La.), Voinovich

(R-Ohio) and Warner (R-Va.).

 

If you notice that your state/senator is listed above, congratulations -

you just noticed that your Senator just screwed you over (don't expect

a dinner - and remember this on election day). If you think that

PHARMA does not run this country, think again. PHARMA has just proven

that they can buy and even own Congress and the President. With all

the hype on " protecing america against the war on terrorism " - today,

America has just been taken hostage by its own government.

 

Read the below statemement from Dem. David Obey (WI) - it is long,

but, it is very much worth the read. There are few exceptions to those

in power who I believe are trying to do the right thing for their

constituents and America - this gentleman below is one of them.

 

House Committee On Appropriations, Democratic Staff

David R. Obey (WI-07), Ranking Member

For Immediate Release

Contact: Kirstin Brost

December 22, 2005

202-593-1310

 

Obey Statement on Defense Appropriations Correction Bill

 

A Shameful End to a Shameful Congress

 

WASHINGON -Dave Obey (D-WI), Ranking Member of the House

Appropriations Committee, made the following statement this afternoon

on the bill stripping the provision to allow drilling in the Arctic

National Wildlife Refuge (ANWR) from the Defense Appropriations

Conference report:

 

" Mr. Speaker, reserving the right to object:

" More than a year ago, when Mr. Lewis was elected Chairman of the

Appropriations Committee, he came to me and asked if we could have an

understanding that we would express our substantive differences but

still cooperate in moving bills forward in an orderly way once those

differences had been expressed. We did that.

 

" Time and time again, the Minority was denied the opportunity to offer

different sets of priorities, priorities that did not offer huge tax

cuts for those who have the most in society, paid for with cuts in

education, health care, and worker protection for those who have the

least. Despite the fact that the rules of the House were used to

block our efforts to obtain on-the-record votes on a number of our

alternatives, Democrats continued to cooperate procedurally, even as

we made clear our differences on policy.

 

" The Republican Majority wanted to finish all of these bills by the

end of the fiscal year, and we did not procedurally obstruct them

because while we differed strongly with the values that lie behind

their budget priorities, we respected the fact that they are in the

Majority and we respect and revere this institution. But because of

internal divisions between the Majority party - divisions within the

House GOP caucus and divisions between House and Senate Republicans -

the fiscal year ended with the Labor-HHS bill and the Defense

appropriations bill that represent 67 percent of the discretionary

spending in our budget bill still being hung up in the legislative

process.

 

" Now in the closing days of this Congress, the Republican Leadership

has decided to use the must-pass Defense appropriations bill to force

down the throats of the American people a number of wholly unrelated

gifts to special interests. They decided to hold funds for our troops

hostage in order to force Congress into removing protections against

oil drilling in ANWR. To make room for their tax giveaways, they even

imposed a second round of cuts to education, health, worker

protection, and even imposing a $4 billion cut in military spending.

 

" Senate action yesterday has corrected one provision inserted in the

bill by abuse of power - the strong-arm attempt at drilling in ANWR -

and for that I mildly applaud the Senate. I led the opposition to

ANWR's inclusion in the Conference and I am happy that the Congress

was not blackmailed into accepting it.

 

" But frankly Mr. Speaker, continuing under my reservation, ANWR was

not the biggest problem with the Conference report. The biggest

problem is that it shortchanges our economic future by refusing to

make adequate investments in education and it cruelly neglects to

strengthen support for programs that help provide critical health care

services to people who desperately need them. But we have lost that

fight. This Congress has made the decision to cut critical health,

education, worker protection, and social service funding by $3 billion

below last year's level. What I find to be so gutless about Congress'

performance on this bill is that those cuts could not pass the Senate

on a roll call vote, so the Majority party had to arrange for their

Senators to duck this vote and hide from accountability by arranging

for the bill to be passed without a roll call vote.

 

That means the Majority party has denied critical help to families

most in need of help, but has not had the courage to forthrightly

defend their votes to the people affected in the public arena. This

bill makes that problem $1.4 billion worse for those programs and

because of the across-the-board cut, it makes other ill-advised cuts

in critical funding for the FBI, local law enforcement, and it even

cuts an additional $4 billion out of the defense bill. If I could do

anything to change that, I would. But it is clear that the die is cast.

 

" Continuing under my reservation Mr. Speaker, there is a second

outrageous problem with this bill. The Majority has turned the

proposal to prepare for a flu pandemic into a giveaway to the

pharmaceutical industry.

 

" When the President requested $7 billion to begin a much belated crash

program to develop a new generation of vaccines and antiviral drugs to

combat a potential flu pandemic, the Republican Majority responded by

cutting it in half. When I asked Senator Stevens in Conference why we

shouldn't fund the rest of the Administration's request so that it was

clear that the government had a long-term commitment to the

development of needed vaccines and antivirals, he responded that

because liability protection language for manufacturers was not being

adopted, long-range funding should be withheld.

 

 

The Conference Committee ended its work with an understanding, both

verbal and in writing, that there would be no -- I repeat no --

legislative liability protection language inserted in this bill. And

because the Majority told us it did not want any compensation

program for victims to come out of the discretionary portion of the

budget, no funding was provided for that either. But after the

Conference was finished at 6pm, Senator Frist marched over to the

House side of the Capitol about four hours later and insisted that 40

pages of legislation - which I have in my hand - 40 pages of

legislation that had never been seen by Conferees be attached to the

bill. The Speaker joined him in that insistence so that, without a

vote of the Conferees, that legislation was unilaterally and

arrogantly inserted into the bill after the Conference was over in a

blatantly abusive power play by two of the most powerful men in

Congress. We then discovered that this language provided all sorts of

insulation for pharmaceutical companies and that this insulation

applied not just to drugs developed to deal with the flu, but in fact

applied to a far broader range of products.

 

" In essence, the provisions allow the Secretary of HHS to issue a

declaration that has the effect of almost completely prohibiting

lawsuits in state or federal courts by persons whose health was

injured against manufacturers and various others for compensation for

injuries caused by the use of " covered countermeasures. " That

determination would bar lawsuits against a wide range of " covered

persons " involved with the countermeasures-including manufacturers and

their suppliers, distributors, state and local governments and their

employees involved with use of the countermeasures, medical personnel

prescribing and administering the countermeasures, and so forth. This

is very broad power indeed to ban lawsuits.

 

Unlike the language requested by the Administration, the Division E

language is not limited to products to combat a flu pandemic.

Rather, it applies to any drug, vaccine, medical device or other

products useful in dealing with anything the Secretary considers to

constitute a public health emergency or that could constitute an

emergency in the future.

 

" Although a rationale often offered for lawsuit protection is that it

is needed to encourage manufacturers to develop and produce new

treatments, the protections of Division E are not limited to new or

experimental products. Rather, nothing in the language would prevent

the Secretary from providing protection against lawsuits to drugs that

have been on the market for decades.

 

" Further, the language explicitly prohibits any judicial review, in

either federal or state court, of the Secretary's decisions to grant

immunity from lawsuits. If anyone believes that the power is being

exercised too broadly, or even in violation of the law, they

apparently would have no remedy other than asking the Secretary to

change his mind or asking Congress to amend the law.

 

" Although proponents point to provisions of this language that make an

exception and allow lawsuits in cases of willful misconduct, that

exception is so narrowly drawn as to be almost meaningless. First,

the provision defines " willful misconduct " as acts taken

" intentionally to achieve a wrongful purpose " , knowing there is no

legal or factual justification, and in disregard of known or obvious

great risk. Basically, Mr. Speaker, the only conduct that would permit

a lawsuit under this definition is probably conduct so egregious as to

be criminal in nature.

 

" However, even this highly restrictive definition of " willful

misconduct " doesn't seem to have been enough restriction on lawsuits

to satisfy the authors of Division E. They added yet another

provision that allows the Secretary of HHS to promulgate regulations

further narrowing the scope of actions that could give rise to a right

to sue. Then, there's yet another provision that says if the conduct

in question is regulated under the Food and Drug Act or Public Health

Service Act, a lawsuit for willful misconduct can be brought only if

the federal government has taken enforcement action against that

conduct. Finally, the language makes various changes to the

normal rules of civil procedure to add further obstacles and

difficulties in front of a potential plaintiff. In short, as a

practical matter there is virtually no right for anyone to sue about

anything covered by a Secretarial determination under this language.

 

" In summary, the Administration asked for some very broad liability

protections for manufacturers and others involved with countermeasures

against pandemic flu - and the Administration's proposal was widely

criticized as going too far. With Division E of the Defense

appropriations Conference report, Congress would be providing even

broader protection, potentially covering a wide range of drugs,

vaccines and devices far beyond what is needed to deal with the flu.

 

" Further, this denial of the right to sue is more sweeping than

provided in the case of childhood vaccines, or in the case of smallpox

vaccine. In the smallpox case, manufacturers are protected by

basically substituting the federal government as defendant-with the

scope of potential lawsuits against the federal government narrowed

but not eliminated.

 

" Now Mr. Speaker, I recognize that some sort of liability protection

or indemnification that would be necessary and appropriate to

encourage development and manufacture of some measures to deal with

pandemic flu and I would support such reasonable language, language

that has been reviewed by a Committee that knows what it is doing in a

process that allows for public comments. But there are real doubts as

to whether it needs to be this broad. Its worth noting that Sanofi

Pasteur, our only domestic flu vaccine manufacturer, has already

signed contracts with the federal government to make avian flu vaccine

and has already delivered some lots, rather than refusing to proceed

until legislation like this is enacted.

Similarly, Roche has been supplying Tamiflu for the national stockpile

and actively seeking contracts to supply more.

 

" The result of this legislative action was a provision in the pending

bill that prevents anyone who is a victim of a faulty vaccine from

being able to obtain compensation in the courts. It says that if you

become seriously ill because of mistakes in the manufacturing, that

you lose your right to sue for compensation, but you can seek

compensation from the government.

 

But guess what -- the problem is that no money was provided for that fund.

So anyone who gets sick would have to lobby Congress to put money in

the money in the fund before they can collect. Thus, people injured

lose their right to sue, but are not guaranteed any alternative means

of covering their medical bills, lost earnings and other costs.

 

" Mr. Speaker, the Committee system was created years ago to ensure

that to protect the public interest, legislation would be carefully

reviewed before it was placed before the body for consideration. But

that protection was arbitrarily by-passed by the Leadership in both

Houses.

 

" This is the second time that this Congress has supinely done the

bidding of the pharmaceutical industry in the dead of night. The

first time, a vote was held open for three hours while the Republican

Majority twisted arms to create the complex and ridiculously confusing

prescription drug bill that our seniors are now so desperately trying

to understand - a bill that was ushered through this institution by

over 600 lobbyists and that protected companies by preventing the

government from even attempting to negotiate lower drug prices.

 

" If I thought that denying unanimous consent on this bill would force

the Majority to eliminate that language I would object. But, Mr.

Speaker, it has also been made quite clear to me that the Majority

will not relent on the language that insulates drug companies. So Mr.

Speaker, I want it to be clear that the action to insert this special

interest language in the bill is in my view a corruption of the

legislative practices of the House.

 

When Congress returns in January, I intend to raise a question about

the privileges of the House that are highlighted by this action

because it has brought discredit to the House and should disturb every

Member who serves here. No Member of Congress, no matter how

powerful, should be able to unilaterally insist that provisions that

were never discussed and never debated in the Conference should be

slipped in to that Conference report without a vote of that same

Conference.

 

" This is what happens when there are no checks and balances, when one

party controls the White House, the Senate, and the House and respects

no limits on its own use of power. We have been placed in the this

position because the House Republican Leadership has sent Members home

for the Christmas holidays with the message to the Senate that we

would not be here even if the Senate changed the legislation the House

sent. That was irresponsible and the country will pay the price.

This institution will pay a price as well, in terms of diminished

respect from the people we were elected to represent. Members on both

sides know it and it is time to have a modicum of respect for the way

we do the people's business.

 

" This is a shameful and shabby way to the end the worst session of

Congress I've experienced in 36 years in Congress. I most reluctantly

withdraw my reservation because lodging an objection at this point

would simply delay the shameful inevitable. "

 

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