Katherine Watt
Mar 17, 2025
Orientation for new readers; American Domestic Bioterrorism Program; Tools for dismantling kill box anti-law
2005.12.21 Congressional Record PREP Act discussion S14233 to 14240
2005.12.21 Congressional Record PREP Act discussion S14241 to 14254 Chemerinsky
2005.12.21 PREP Act Senate Roll Call
2005.12.30 Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act – PL 109-148.
Senator Edward Kennedy:
…Over these last several months in the Senate we have addressed the issue of a potential epidemic, the pandemic flu. There have been two areas of leadership. One has been in our [Health, Education, Labor and Pensions] HELP Committee under the chairmanship of Senator Enzi and Senator Burr, where we have tried to work out a whole approach to deal with the area of epidemics and bioterrorist attacks, and another with the leadership of Senator Harkin, who had asked that we commit some $8 billion to be able to purchase vaccines and also antiviral drugs for influenza.
I attended the NIH announcement by the President of the United States when he actually requested $7.1 billion to prepare for a flu pandemic. Those funds were going to be used for public health, first of all, to be able to detect flu outbreaks overseas; secondly, to be able to detect them here at home; then to be able to build containment capacities, what we call ‘‘surge’’ capacity; and, also to have a generously funded vaccine program, and also an antiviral program.
That is really where we were before the Defense appropriations bill.
A number of us on the HELP Committee had a series of negotiations to try to make a bipartisan recommendation to the Senate. We did so on pensions, on higher education, on work-force, and on Head Start. We were able to do so in a number of different areas. And we were moving ahead toward making a recommendation in issues related to the purchase of vaccines and antivirals. There are two important issues to consider with the purchase of pandemic influenza vaccine and antivirals. One is the danger to an individual that is going to take those vaccines or antivirals; and the other is the risk those dangers raise for the companies that produce them. One is the compensation issue, and the other is the liability issue.
We have dealt with these issues on several occasions. We dealt with them with respect to the swine flu. We dealt with these issues with smallpox. We dealt with these issues for childhood vaccines.
One thing we know from experience is, if you do not have an adequate compensation program, no matter how much money you put in for the purchase of vaccines or of antivirals, the program is not going to work. There has to be an assurance that, if first responders and others are going to go out there and take their chance with these new vaccines or other drugs, that if they become grievously ill or sick or even die there will be some compensation for them and for their families for lost wages and medical costs and the like. And there has to be the assurance to the first responders and others that those vaccines are not going to be produced negligently. Otherwise, they will not take the risk of using the vaccines or drugs. That is the framework.
We have to ask ourselves, for the liability and compensation provisions that have been put in the Defense appropriations bill, how do they line up with what has been successful in the past, with bipartisan efforts? These provisions fail in every respect of the word.
First, there is a compensation program that is not funded. It is not funded. It will depend upon future appropriations. If you want to buy a pig in a poke, buy that particular provision. All you have to do is ask my friend from Utah, Senator Hatch, how we have funded the compensation program for the downwinders. Over a long period of time, we did not have the required payments for them, when we know, as a direct result of governmental action, we adversely affected tens, even hundreds, of thousands of downwinders in the State of Utah and in the West more broadly. We have not measured up to our responsibilities to them, and the compensation program before us now is no more adequate. And as a consequence, this compensation program is not going to work.
Not only that, what have we done with regard to the manufacturers? What kind of immunity have we given to them? It’s really extraordinarily broad, effectively complete. What they call the ‘‘bad actor’’ provision describes the circumstances in which the immunity from liability fails. And it’s really very narrow, because a company’s actions have to meet a very narrow definition of willful misconduct.
Page 12 of this 40-page liability section says in order to have any kind of liability, you have to have willful misconduct. This is an act or omission that is taken intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
As if that isn’t clear, and narrow, enough, on the same page, underneath this language, is a rule of construction. This rule says that this language establishes a standard for liability more stringent than a standard of negligence in any form or recklessness. So companies are not deterred from acting recklessly, or with gross negligence.
Now that is pretty narrow, but apparently it isn’t narrow enough. Right here on page 12, it says that the Secretary of Health and Human Services, in consultation with the Attorney General, must issue regulations that further restrict the scope of actions or omissions that may qualify as willful misconduct.
So ‘‘willful misconduct,’’ which should just mean intentional, isn’t good enough.
Well, at least we have solved that, right, to make it as narrow as possible? Wrong. Go down to the standard of evidence. The bill changes the standard of evidence in the various trials, to ‘‘clear and convincing evidence.’’ That is at the bottom of page 13.
The bill defines a very narrow standard of willful misconduct, and it sets a very high standard of evidence. Shouldn’t that be enough? Wrong. You don’t have a case against a company under these provisions unless the FDA begins an enforcement case against that company. So if FDA goes ahead and begins the case, you have a chance, right? Wrong again. FDA has to bring it and conclude it successfully before you have any right to proceed with your case.
A person might think, I am not very satisfied with how this liability provision has worked, maybe I will appeal to the courts of this country, right? Wrong. There is absolutely no, no, no, no judicial review when the Secretary of Health and Human Services grants a company immunity by issuing a declaration. No judicial review of that. And there is no judicial review of FDA’s decision not to bring an enforcement action. So it is whatever the administration says, whatever the Secretary says, whatever the head of the FDA says, with changed and gimmick rules. This is a sham. There is no possibility of liability here.
Now, we would say, OK, this is bad, but this liability protection is limited to just a few products, right, products that few of us will ever have to use? It actually applies to products—vaccines, drugs, diagnostic tests—for epidemics. We rarely have to worry about epidemics, right? Well, who defines ‘‘epidemics’’? It is rather interesting who defines epidemics. Senator Domenici says diabetes is an epidemic. Senator Frist himself says meth abuse is an epidemic. Bill Frist himself said obesity is an epidemic. Senator Bond says arthritis is an epidemic.
This week in Newsweek Magazine, the Secretary of Health and Human Services, who is going to enforce this provision, says this: “We’re seeing an epidemic of chronic diseases. Obesity is just one example.”
So how many diseases are going to be considered epidemics? A lot, perhaps, but at least we say that is all right, because it is just going to apply to drugs for that particular epidemic disease, right? Wrong again. This provides the same kind of liability protections for any of the drugs or anything else that deals with the side effects of the products for that epidemic disease.
My goodness. Generally around here we measure who the winners are and who the losers are. And we have seen over the last year and a half how the drug companies come out on top, time and time and time and time again. But never, never, never, ever, ever like they have with this sweetheart deal that was stuck into this conference report after the assurances had been given to the conferees that there were no provisions in it with regard to liability.
The Medicare drug law made it illegal for the Government to negotiate prescription drug discounts for seniors. They do it in the VA system, and drug prices for the VA are lower. But we weren’t able to permit the government to negotiate drug prices for seniors. The Republican Congress blocked legislation to allow importation of safe and less expensive drugs.
And now we find in this biodefense and pandemic flu provision liability shields for companies that make dangerous drugs, with no compensation for injured patients.
That is a scandal. It has no business being in this bill. The Judiciary Committee requested an opportunity to examine it. It was rejected. We have had no hearings on this particular provision. It is the wrong thing to include in this legislation.
Let me share what one of our colleagues has said about childhood obesity:
The responsibility for this growing epidemic rests with us—the American consumer. We need to get serious about fighting fat.
Let me cite you the language of the provision, the broad definition on page 31 of what gets liability protections under this bill. It says: ‘‘Qualified pandemic or epidemic product’’ means any drug, biological product, any device to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit harm from the pandemic or epidemic. And the term includes not only those products, but any other product, any other product that is produced to deal with the side effects of those products.
This is a scandal. It is a giveaway. It is outrageous. It is rare, if ever, that we give this kind of privileged status to any industry in the country, and give this kind of authority and power solely to one branch of the Government. There is no second guessing. There is no judicial review. There is no further involvement of the Congress. That is basically and fundamentally wrong and we are asking and committing $3.7 billion to go down this road. It is outrageous and it is wrong.
I am sure that as soon as the Secretary of Health and Human Services issues what is called a declaration for a pandemic or epidemic to give immunity from liability to vaccines or other products, there is going to be a charge to the courts. The constitutionality of this provision is going to go into the Federal district courts and the circuit courts of appeal.
Included in the [Congressional] Record is legal authority that I believe shows that this provision, the way it is drafted, is absolutely unconstitutional because of the indefiniteness of the criteria under which the executive branch makes decisions and because there is the real possibility and likelihood of serious in- jury to individuals without any right to go to court or for judicial review of declarations.
This provision is going to be challenged along the way. We want to tell those in the bio industry—and they are healthy in my State and I have worked with them—if you want to work with us to get an effective compensation program, as we did in the past with smallpox or childhood vaccines, if you want to get an effective provision to deal with liability, one that is responsible and that responsible drug manufacturers will welcome, then we are more than willing to welcome you and to work with you.
But I think we can be certain that this provision will not be effective, and it is misleading the American people to say we are making a downpayment in the development of vaccines for the reasons I have mentioned this evening.
Slipping a provision into a major spending bill late at night at the end of Congressional session is a trick to shield from public debate a provision that is so wrongheaded that it would never stand public scrutiny.
The Republican congressional leadership has snuck yet another special favor to drug companies into the defense appropriations bill.
It is an outrageous provision that has nothing to do with protecting our troops, and it should be dropped from the bill.
This provision allows drug companies to flagrantly disregard basic safety measures in making a broad range of drugs or vaccines, while giving patients who are injured by shoddy products only an empty promise of compensation.
It is cynical to claim that this is what is needed to deal with avian flu.
Drug industry advocates will say that this debate is about trial lawyers, and we have heard phrases like ‘‘jack- pot justice’’ and ‘‘runaway juries,’’ and tales of endless lawsuits against the firms that make the vaccines. But that couldn’t be further from the truth: Senator Dodd and I offered a plan that included important legal protections for drug companies that make experimental flu vaccines and other drugs needed to respond to a pandemic or a bioterrorism attack as well as a compensation program modeled after the Vaccine Injury Compensation Program that already works well for childhood vaccines.
Our proposal follows the successful examples of the past. For swine flu, for the smallpox vaccine and for childhood vaccines, the Government has set up a way to compensate the injured. Whenever Congress has provided an alternative to liability in the past, there has always been an assured means for patients to receive compensation.
The current proposal violates that past practice.
It twists and turns the law to stack the deck against patients, and abrogates basic principles of judicial review. It is no wonder the provision’s authors hid it from public debate and didn’t let the Senate Judiciary Committee even look at the proposal before it was jammed into the massive conference report.
If they had allowed our Judiciary Committee to examine this proposal, we would have quickly seen its constitutional flaws. I received a detailed analysis of this provision from Professor Erwin Chemerinsky, who is the Alston and Bird Professor of Law and Political Science at the Duke University School of Law.
According to his analysis, the provision gives the Secretary of HHS ‘‘unfettered discretion . . . to grant complete immunity from liability’’ while also ‘‘depriving all courts of jurisdiction to review those decisions…’’
Senator Joseph Biden:
Mr. BIDEN. …I rise to express my surprise and deep-seated opposition to the so-called Public Readiness and Emergency Preparedness Act, which is included in the Defense Department Appropriations bill.
This provision would give the Secretary of Health and Human Services authority to provide almost total immunity from liability to the makers of almost any drug, and to those who administer it.
While the measure’s proponents portray it as a simple tool to make sure we have sufficient vaccine available in the case of an avian flu pandemic, the actual language of the provision is far broader than that, and it therefore poses a danger to all Americans.
The actual provision permits immunity for the makers of virtually any drug or medical treatment. All the secretary need do is declare that it is a ‘‘countermeasure’’ used to fight an epidemic. One solitary person gets to decide what is a countermeasure and what is an epidemic. There is nothing to prevent the declaration of immunity for, say, Tylenol. There is nothing to prevent a declaration that, say, arthritis is an epidemic.
What’s more, this is no typical grant of immunity. No, the breadth of this provision is staggering. A drug maker can be grossly negligent in making or distributing a drug, and still escape liability. It can even make that drug with wanton recklessness and escape scott-free after harming thousands of people.
In fact, under this provision, the only way a victim could still recover compensation from a drug maker for a dangerous drug or vaccine would be to prove ‘‘willful misconduct,’’ and then only by ‘‘clear and convincing evidence.’’ What this means is that, for a victim to be able to be compensated by the company that harmed him, he must prove that they committed a crime…
Is this the sort of justice system that Americans desire?
The answer to this question seems clear from the way this provision was inserted in the larger bill. No hearings were held on this language; no Committee vote was taken; no bill passed the House or the Senate. Not even the House and Senate conferees had a chance to give input on this provision. Indeed, I’m told it was inserted in the dead of night, after conferees had al- ready signed the conference report!
Perhaps the folks who secretly inserted this provision in the dead of night knew that it was overly broad, as I’ve discussed; perhaps they knew that it was constitutionally suspect, as has been noted by at least one prominent law professor; or perhaps they just knew that, if this provision ever saw the light of day, the American people would not stand for such secrecy and injustice.
This should not be how we conduct the business of the American people, and we will all suffer if this provision is permitted to go forward.
Senator Hillary Clinton:
I would like to take this opportunity to object to insertion of a provision in the Department of Defense appropriations bill that would provide sweeping immunity protections to pharmaceutical manufacturers. I know that this provision is being billed as a simple liability protection to help those who would manufacture avian flu vaccine, but it is nothing of the sort. I support limited liability protections for manufacturers to help cover their risks in developing products that our Nation will need in case of emergency. However, this provision would grant immunity to all claims of loss, including death and disability, for a broad range of products, including any drug that the Secretary designated as one that would limit the harm caused by a pandemic—a definition so broad as to encompass nearly any drug.
This immunity is not subject to judicial review. It preempts any State laws that provide different liability protections or that may provide stronger consumer safety protections for pharmaceutical products. In fact, the only exception to this immunity is for actions of ‘‘willful misconduct,’’ which is so narrowly defined that it would only apply to cases where a company intentionally set out ‘‘to achieve a wrongful purpose . . . in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.’’
The provision requires the Secretary and the Attorney General to narrow the scope of willful misconduct even further and states that for any FDA-approved product, willful misconduct will not apply unless the Government is already taking action against the manufacturer for such misconduct.
If the Government is providing complete immunity to manufacturers, how are those who may be injured to seek compensation in case of injury? This provision sets up a ‘‘Covered Countermeasure Process Fund,’’ but fails to provide any money for this fund. We all recognize that in a public health emergency, we may need to seek whatever protections we can find to prevent widespread death and disease—but those who are asked to take these products are told that if they are injured, their only recourse is to seek compensation from a fund which currently has no money to award.
I am also gravely concerned by the fact that this provision was included in the appropriations bill without following the process for passing legislation used by this Chamber. This authorizing — authorizing, not appropriating — language was never considered, let alone agreed to by the Senate. It was never agreed to by the HELP or Judiciary Committees, which have jurisdiction over this matter. It is a mockery of the legislative process. I believe that the American people are ill-served by Congress when controversial and potentially harmful provisions can simply be inserted without undergoing the open deliberations and debate that are fundamental to the democratic process and are designed to protect our citizens from special interests and back-room dealings. This provision should be stripped from the bill.
Senator Robert Byrd:
…I continue to have serious concerns about the avian flu-related liability provisions that were slipped into the conference report without debate. These liability provisions did not appear in either the House- or the Senate-passed bill. These provisions were not in the materials presented to the conference committee during its deliberations. It was not until the dead of night on this past Sunday, after signatures had already been collected on the conference re- port, that the Republican majority slipped these provisions into the bill before the Senate today. What an insult to the legislative process.
It makes sense for Congress to take steps to encourage companies to develop and manufacture lifesaving flu vaccines. Manufacturers and health professionals acting in good faith to protect the public health, by developing and distributing critical vaccines, should not be unfairly penalized for their efforts to protect the American people from the horrors of a pandemic disease.
However, our country has a moral obligation to look out for those who may become seriously ill as a result of these vaccines. We are talking about the lives of real American people. There ought to be compensation available to those persons who may suffer adverse effects from these kinds of vaccines.
But the liability amendment slipped into the bill does not contain any meaningful provisions establishing a fair compensation system to protect vaccine recipients. Americans who pull up their sleeves to receive an emergency flu vaccine must be provided with some assurance that they would not face economic catastrophe should they be harmed.
Top 10 US federal laws Congress should repeal to end worldwide vaccination, mutilation and killing programs.
Katherine Watt
·
May 23, 2024
Top 10 US federal laws Congress should repeal to end worldwide vaccination, mutilation and killing programs.
Orientation for new readers – American Domestic Bioterrorism Program – Tools for dismantling kill box anti-law
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