YOU HAVE ALL THE RISK – Manufacturers Have No Liability


by Sherri Tenpenny, DO, AOBNMM, ABIHM

Until recently, the concept of mandatory and mass vaccination was thought to be a far off possibility. Vaccination laws are regulated at the state level, and the federal government seemed to keep a watchful distance away from the subject. That appears to be changing, but the push for mandates is not new. This has been coming for a long time.

The groundwork to force everyone to be vaccinated began shortly after 911. President George W. Bush introduced Project BioShield during his State of the Union Address in  January, 2003. Project BioShield created a comprehensive, joint effort between the Department of Homeland Security (DHS), the Department of Health and Human Services (HHS)  and the private pharmaceutical industry to develop drugs and vaccines to be released in the event of a biological and chemical weapon attack. Signed into law in July, 2004, the program was funded with $5.6 billion over ten years. 

Project BioShield put forth three major components:

  • Indefinite funding  “medical counter-measures” – vaccines, drugs, technologies – to be released as soon as “experts” agree they were “safe enough.” In other words, Project Bioshield allowed the Secretary HHS to purchase – and use – unapproved and unlicensed vaccines/drugs.
  • New authority to the NIH to speed research and development of drugs and vaccines for bioterrorism threats, and
  • Authorized fast-tracking of drugs and vaccines, a fancy way to use medicines barely researched or tested – in the event of an “emergency.”

Between July 2004 and end of 2006, which was also the close the 109th Congress, 11 bills were introduced. Each of these pieces of legislation would have given unprecedented advantages to the drug industry and would have removed all safeguards preventing dangerous vaccines, drugs, and medical devices from reaching consumers.

The reaction against the bills was strong and loud from all political parties, stopping all bills except S. 3678, the Pandemic and All-Hazards Preparedness Act

Project BioShield: Not Good Enough

buckets of moneyFrustrated and running out of time, Senate Majority Leader, Bill Fritz, a former medical doctor (R-TN), literally bullied a drug company protection bill into law. He used his power and senate rank to get the bill passed during the literal eleventh hour – at 11:20p on a Saturday night. This was long after the House Appropriation Committee members had reached a final agreement on a defense bill, had signed off and (most) had gone home.

Representative Dave Obey (D-WI), Ranking Member of the House Appropriations Committee, gave a first-hand accounting of how complete liability protection for manufacturers become law. Excerpts of his speech are included here: 

Senator Frist marched over to the House side of the Capitol, about four hours after the Committee had finished at 6pm and were headed home. He insisted 40 pages of legislation—legislation that had never been seen by Conferees –be attached to the bill Defense Appropriation Bill.

“Speaker [Dennis Hastert R-IL] joined Frist’s insistence, and without a vote, the legislation was unilaterally and arrogantly inserted into the bill. [This was] a blatantly abusive power play by two of the most powerful men in Congress.

“We then discovered that the language provided all sorts of insulation for pharmaceutical companies…not just to drugs developed to deal with the [avian] flu, but for a far broader range of products.

“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 [1000 pages long, costing $400Billion], ushered through this institution by over 600 lobbyists and that protected [drug] companies by preventing the government from even attempting to negotiate lower drug prices.

“If I thought [it would do any good] 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.”

[Reading his entire speech here is highly recommended. Or, search the page for FRIST; read to the end.]

Medical-FraudCalled “Division EPublic Readiness and Emergency Preparedness Act (PREPA)” Senator Frist (a medical doctor) handed the drug companies (a special interest group) more immunity than any bill that has ever been passed by Congress.

The legislation provides at least sweeping provisions:

  1. Immunity from all liability.  In the event of an outbreak of any kind, all drugs, vaccines or biological products are completely protected, even if it kills you. The definition is so broad it could include OTC pills such as Tylenol, Advil . . . and would have applied to Vioxx.
  2. The Secretary of HHS has complete authority to declare and emergency. The Secretary of HHS is an appointed, non-medical person who has not accountability to the general public. The president’s hand-picked teammate will have the power to mandate vaccines and other medications for the American people.
  3. Immunity from all accountability. Even if the Company’s dirty facility created a batch of contaminated vaccines that resulted in death or injury to thousands of people, the drug company will have immune from liability.
  4. Immunity from all law suits. A person who suffers any type of loss will be legally prohibited from suing the drug companies.

Through the PREPAct, drug companies have  immunity from almost everything, perhaps even murder. The bill’s language explicitly protects frivolous suits and sets a rigidly high standard for defining negligence. Even if a pharmaceutical company knowingly harms people, the company will be immune from legal prosecution unless the U.S. Attorney General initiates “enforcement action” against the drug company in the name of the claimant. This means the U.S. government would have to go to bat for the plaintiff against the drug company for the lawsuit to move forward.

According to the American Trial Lawyers Association, the bill contains language never before seen in any proposal. One member said,

“At a time when we see the egregious things that are being done by major drug companies, the last thing in the world the consumer needs is immunity for drug companies to act with impunity.”

In simple terms, a plaintiff can only go forward with a claim if s/he can prove that the drug company performed an act of “willful misconduct” that resulted in an injury or a death. In other words, the injured party would have to prove the vaccine maker intentionally caused them harm. Unbelievably, even then the drug company is still immune from accountability.

Business and medicine handshakeEven if a pharmaceutical company knowingly harms people, the company will be immune from legal prosecution unless the U.S. Attorney General initiates “enforcement action” against the drug company in the name of the claimant. This means the U.S. government would have to go to bat for the plaintiff against the drug company for the lawsuit to move forward.

The mainstream media has been pushing for mandatory vaccination of everyone, from children to adults. There have been calls for arresting parents who don’t vaccinate and harassment of doctors who speak out about vaccines and calls for revoking a doctor’s license for daring to question the safety and effectiveness of vaccines.

The question to be asked: Who Stands to Gain from this process? Who stands to gain from selling vaccines? If you are injured? If you lose recourse for your vaccine injury? By forcing you to give up your right to refuse? 

Use this script. Call your legislators. Inform your neighbors. If we lose this battle now, they will lose the right to refuse the next 200+ vaccines coming down the pipeline.

(parts of this article are excerpts from the book, Fowl: Bird Flu, it’s not what you think.)

Photo by GotCredit



  1. Thank you for writing this article! I am looking for a concise explanation that I can offer the unaware as to if, how and why vaccines are not in the same legal classification as pharmaceutical drugs and thus are not required to undergo the usual testing for safety. Can you point me in the right direction on this?

    • Vaccines are classified by the FDA as biologics, because they contain microbial material, serum and such. Therefore they do not come under the same safety regulations as pharmaceuticals. It’s important to watch for “biologics” or such wording when signing hospital admissions, surgical or other medical forms, as well as vaccines – if you consent to biologics, you’ve consented to vaccination.

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