Manufacturers have been granted exemption from liability for any resulting harm. Ruud Dobber, a member of AstraZeneca’s senior executive team, said: “This is a unique situation where we as a company simply cannot take the risk if in … four years the vaccine is showing side effects.” (The government has taken on the liability and has an insurance scheme in place.)
Dr. Hodkinson, here to discuss the dangers of the COVID-19 vaccines, the possibility of infertility, and the very real concerns about the vaccine-induced spike proteins and what new scientific research is clearly suggesting about their risks to your health.
Published 9 September 2009
WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.
Wikipedia snapshot from 9 March 2021:
|Year||Company||Settlement||Violation(s)||Product(s)||Laws allegedly violated |
|2012||GlaxoSmithKline||$3 billion ($1B criminal, $2B civil)||Criminal: Off-label promotion, failure to disclose safety data. |
Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program
|Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex||False Claims Act, FDCA|
|2009||Pfizer||$2.3 billion||Off-label promotion, kickbacks||Bextra, Geodon, Zyvox, Lyrica||False Claims Act, FDCA|
|2013||Johnson & Johnson||$2.2 billion||Off-label promotion, kickbacks||Risperdal, Invega, Nesiritide||False Claims Act, FDCA|
|2012||Abbott Laboratories||$1.5 billion||Off-label promotion||Depakote||False Claims Act, FDCA|
|2009||Eli Lilly||$1.4 billion||Off-label promotion||Zyprexa||False Claims Act, FDCA|
|2001||TAP Pharmaceutical Products||$875 million||Medicare fraud, kickbacks||Lupron||False Claims Act, Prescription Drug Marketing Act|
|2012||Amgen||$762 million||Off-label promotion, kickbacks||Aranesp||False Claims Act, FDCA|
|2010||GlaxoSmithKline||$750 million||Poor manufacturing practices||Kytril, Bactroban, Paxil CR, Avandamet||False Claims Act, FDCA|
|2005||Serono||$704 million||Off-label promotion, kickbacks, monopolistic practices||Serostim||False Claims Act|
|2008||Merck||$650 million||Medicare fraud, kickbacks||Zocor, Vioxx, Pepsid||False Claims Act, Medicaid Rebate Statute|
|2007||Purdue Pharma||$601 million||Off-label promotion||Oxycontin||False Claims Act|
|2010||Allergan||$600 million||Off-label promotion||Botox||False Claims Act, FDCA|
|2010||AstraZeneca||$520 million||Off-label promotion, kickbacks||Seroquel||False Claims Act|
|2007||Bristol-Myers Squibb||$515 million||Off-label promotion, kickbacks, Medicare fraud||Abilify, Serzone||False Claims Act, FDCA|
|2002||Schering-Plough||$500 million||Poor manufacturing practices||Claritin||FDA Current Good Manufacturing Practices|
|2006||Mylan||$465 million||Misclassification under the Medicaid Drug Rebate Program||EpiPen (epinephrine)||False Claims Act|
|2006||Schering-Plough||$435 million||Off-label promotion, kickbacks, Medicare fraud||Temodar, Intron A, K-Dur, Claritin RediTabs||False Claims Act, FDCA|
|2004||Pfizer||$430 million||Off-label promotion||Neurontin||False Claims Act, FDCA|
|2008||Cephalon||$425 million||Off-label promotion||Actiq, Gabitril, Provigil||False Claims Act, FDCA|
|2010||Novartis||$423 million||Off-label promotion, kickbacks||Trileptal||False Claims Act, FDCA|
|2003||AstraZeneca||$355 million||Medicare fraud||Zoladex||Prescription Drug Marketing Act|
|2004||Schering-Plough||$345 million||Medicare fraud, kickbacks||Claritin||False Claims Act, Anti-Kickback Statute|
$3 billion GSK settlement. On 2 July 2012, GlaxoSmithKline pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud case in the U.S. and the largest payment by a drug company. The settlement is related to the company’s illegal promotion of prescription drugs, its failure to report safety data, bribing doctors, and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses. Those and the drugs Imitrex, Lotronex, Flovent, and Valtrex were involved in the kickback scheme. The government investigation of GSK was launched largely on the basis of information provided by four whistleblowers who filed two qui tam (whistleblower) lawsuits against the company under the False Claims Act. GSK settled the whistleblowers’ lawsuits for a total of $1.017 billion out of the $3 billion settlement, the largest civil False Claims Act settlement to date.
Pfizer $2.3 billion settlement: Pfizer settled multiple civil and criminal allegations for $2.3 billion in the largest case of pharmaceutical and health care fraud in US history. The drugs involved were Bextra (an anti-inflammatory drug), Geodon (an anti-psychotic drug), Lipitor (a cholesterol drug), Norvasc (anti-hypertensive drug), Viagra (erectile dysfunction), Zithromax (antibiotic), Zyrtec (antihistamine), Zyvox (an antibiotic), Lyrica (an anti-epileptic drug), Relpax (anti-migraine drug), Celebrex (anti-inflammatory drug), and Depo-provera (birth control).
Merck $650 million settlement: Merck settled a nominal pricing fraud case in which the company was accused of taking kickbacks and violating Medicaid best price regulations for various drugs.
United States et al., ex rel. Jim Conrad and Constance Conrad v. Forest Pharmaceuticals, Inc, et al. involved a drug manufacturer selling a drug, Levothroid, that had never been approved by the FDA. These allegations settled for $42.5 million due to multiple whistleblowers stepping forward to provide detailed information on the alleged fraud. The collective reward to the relators in this case was over $14.6 million.
Wikipedia snapshot from 28 January 2021:
- In July Health Secretary Matt Hancock claimed that conspiracy theorists are putting lives at risk
- The UK government’s Vaccine Damage Payment scheme is proof that vaccines can be unsafe
- Eligibility criteria Vaccine Damage Payment changed in 2015
- Update October 2020: AstraZeneca protected from vaccine liability
- Update November 2020: MHRA expects high volume of COVID-19 vaccine adverse drug reaction
- Update December 2020: Pfizer is given protection from legal action by the UK government
Discussion around vaccinations can be very contentious. There’s great nuance in this area and a short post will not do justice to the complex issues surrounding the usefulness and safety of vaccines. Nevertheless, while vaccines may have their role in protecting target populations from disease, not all have been proven safe to an acceptable level as shown in the resources below.
The UK government’s Vaccine Damage Payment scheme is probably the strongest proof that vaccines can be unsafe. Under the Vaccine Damage Payment scheme, people who have been severely disabled as a result of a vaccination against certain diseases can be eligible for a one-off tax-free payment of £120,000.
Conspiracy theorists are putting lives at risk?
It is an objective fact that a compensation scheme exists for those who have been damaged by vaccines. Nevertheless, Health Secretary Matt Hancock claimed that conspiracy theorists are putting lives at risk:
“Those who promulgate lies about dangers of vaccines that are safe and have been approved–they are threatening lives…”Source: The Independent, 20 July 2020
Clearly, concerns about the safely of vaccines cannot be lies if there is a vaccine damage compensation scheme in place.
Eligibility changed in 2015
Eligibility requirements for vaccines covering certain diseases are listed and change over time. Interestingly, sometime around 2015, damage from vaccines for influenza caused by pandemics are explicitly listed as not eligible.
We do not know how the government compiles is eligibility criteria or why this change was made. However, it would be worthwhile to keep an eye on this list to see if the status of the upcoming COVID-19 vaccines.
AstraZeneca protected from vaccine liability
Update 1 August 2020: On 30 July 2020, Reuters reported that AstraZeneca, the UK government’s partner for developing its COVID-19 vaccine, will be exempt from coronavirus vaccine liability claims in most countries. The countries have not been named but Ruud Dobber, a member of Astra’s senior executive team, commented:
“This is a unique situation where we as a company simply cannot take the risk if in … four years the vaccine is showing side effects.
In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest.”
MHRA expects high volume of COVID-19 vaccine adverse drug reaction
Update November 2020: It came to light in mid-November that the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) put out a contract award notice for an Artificial Intelligence (AI) software tool. It appears they expect a high volume of COVID-19 vaccine Adverse Drug Reaction (ADRs) from the upcoming vaccines:
…it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively.
Pfizer given legal indemnity
Update 2 December 2020: According to the Independent, Pfizer now has a legal indemnity from being sued by patients who develop any complications from its new mRNA vaccine that will be rolled out in the UK. NHS staff providing the vaccine will also be protected.
- UK Government Vaccine Damage Payment (gov.uk)
- Ministers lose fight to stop payouts over swine flu jab narcolepsy cases (The Guardian)
- Dengue vaccine fiasco leads to criminal charges for researcher in the Philippines (Science Magazine)
- Polio outbreaks in Africa caused by mutation of strain in vaccine (The Guardian)
- Pakistan accused of cover-up over fresh polio outbreak – (The Guardian)
- The Vaccination Debate (The Guardian)
- AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries (Reuters)
- Zostavax Lawsuit (ClassAction.com)
- Pfizer to pay £50m after deaths of Nigerian children in drug trial experiment (The Independent)
- MHRA urgently seeks software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (Tenders Electronic Daily)
- Pfizer given protection from legal action by UK government (The Independent)
View all articles related to COVID-19 and vaccination.