Will Merck’s Bad Clinical Trial Conduct Be Revealed?
by Mark A. York
(Mass Tort News) The United States Judicial Panel on Multidistrict Litigation (JPML) on August 4, 2022 consolidated MDL 3036 related to Gardasil Vaccine claims, before U.S. District Court Judge Robert J. Conrad, Jr. of the Western District of North Carolina. The MDL is named “In re: Gardasil Products Liability Litigation MDL No. 3036.”
Once again, the MDL dance begins when Big Pharma defends catastrophic bad conduct in getting a drug approved and into mainstream US healthcare commerce, this time it’s Merck and their blockbuster vaccine Gardasil. The primary issue here, is that the drug was and is targeted toward young people who are not fully developed in physical as well as mental responsiveness to potentially bad chemicals introduced into their bodies. How a major pharma group like Merck can conduct business in this way is still one of the most needed explanations that’s often missing in pharmaceutical litigation outcomes. Billions of dollars and positive shareholder earnings statements can and will set that stage in corporate America.
Mass Tort News and LegalCast have been fortunate to have been in contact with the Baum Hedlund firm as the Gardasil docket was formed, initially by filing single event cases in venues across the country, resulting in the now successful Motion to Consolidate Gardasil MDL 3036, so for that kudos to Bijan Esfandiari, Michael Baum and Stephanie Sherman @ BH on a well-managed effort.
The assertions that Gardasil clinical trial data was not only manipulated by false statements submitted to various regulatory, legal and other official agencies and channels, is the fact that Merck is also aggressively pushing for the Gardasil Vaccine to be added as a mandatory vaccine in schools across the country. The vaccine is now mandatory in at least 5 states and the approval and offering medical guidance was not viable in any way in getting the Gardasil Vaccine approved in any way, it was legislatively mandated in back office statehouse deal making. This is not a medical need in any way, this is a contrived ploy using Big Pharma lobbyists and legislative manipulation to embed a for-profit dangerous drug into our “perceived mandatory youth focused preventative medicine regimen” in school vaccines and hat’s now becoming more and more suspect each year. Note: The primary claims asserted in MDL 3606 do not go to the allegations of the school vaccine programs above, those comments are inserted as a point of view of the article author.
In April of 2022, Baum Hedlund Aristei & Goldman filed a motion to consolidate over 30 Gardasil vaccine lawsuits pending in district courts throughout the country. By July 28, 2022, 48 cases were pending with at least 100 more to be filed in federal courts nationwide. In the motion for consolidation, attorneys wrote that central to all of the cases is the question of whether Gardasil can cause autoimmune disorders, whether Merck adequately warned of Gardasil’s risks and whether Gardasil caused plaintiffs’ injuries.
“We are very pleased the JPML decided to centralize the Gardasil litigation,” says Bijan Esfandiari, a Gardasil lawyer and senior shareholder at Baum Hedlund. “Efficient coordination of the multi-district litigation makes the most sense and gives the plaintiffs the best path for seeking and obtaining justice. Our clients are looking forward to getting their day in court.”
MDL 3036 Supporting Filings: SIRI & GLIMSTAD LLP Brief in Support of MDL 3036 Consolidation
MERCK GARDASIL CLINICAL TRIALS BAD CONDUCT
In vaccine clinical trials, test subjects taking the vaccine are compared to subjects in another group taking a placebo. According to federal regulations and World Health Organization (WHO) experts, especially for a new vaccine, the control against which the vaccine’s safety is measured should be an inactive (inert) placebo. It should not produce any reaction. Often, the placebo is an injection of a saline (salt water) solution.
“MDL claims assert that during the Merck Gardasil vaccine clinical trials, Merck “spiked” the placebo with amorphous aluminum hydroxyphosphate sulfate (AAHS), a neurotoxin.” The result was that approximately equal numbers of subjects in the vaccine group and the placebo group suffered adverse reactions. This allowed the adverse reactions in both groups to appear similar and give the impression that Gardasil HPV vaccine was “as safe as a placebo,” or as safe as salt water. In fact, significant numbers of subjects in both treatment groups suffered many serious medical conditions, including symptoms of autoimmune disease.
The medical community raised objections about the serious flaws in how Merck designed, analyzed and reported its Gardasil studies. In particular, in 2013, numerous medical professionals published an article in the British Medical Journal (Call to action: RIAT restoration of previously unpublished methodology in Gardasil vaccine trials, 346 BRIT.MEDICAL J. 2865 ) outlining the flaws and incomplete nature of the publications discussing Merck’s Gardasil clinical trials. The authors issued a “call to action” for independent researchers to reanalyze or “restore the reporting of multiple trials in Merck’s clinical development program for quadrivalent human papillomavirus (HPV) vaccine (Gardasil) vaccine.”
Merck & Co. Used “New Medical Conditions” to Describe Adverse Reactions in Gardasil Clinical Trial Results
Merck did not report a large number of adverse reactions as Gardasil side effects. Instead, Merck categorized these serious illnesses as “new medical conditions” unrelated to the Gardasil vaccine. Close to 50% of the study participants reported a “new medical condition.” These included high rates of neurological, musculoskeletal, and autoimmune-related conditions.
Failure to Record and Follow up on Adverse Reactions in the Gardasil Clinical Trials
Many adverse reactions experienced by Gardasil clinical trial participants were never recorded.
- In one trial, only 10% of participants received vaccination report cards (used by investigators to obtain follow-up information from study participant’s about certain adverse reactions, especially in the first few days).
- Reports of serious events were not followed up.
- Medical records were not reviewed.
- Trial participants were told the vaccine was proven safe and the placebo was a saline solution, making it less likely they would report adverse Gardasil side effects.
According to Mary Holland, Kim Mack Rosenberg, and Eileen Iorio, co-authors of the book, The HPV Vaccine On Trial: Seeking Justice For a Generation Betrayed, “none of the participants in the [Gardasil] clinical trials received a true saline placebo,” which means the clinical trials failed to measure the effects of Gardasil against a true control.
Instead of receiving a placebo, clinical trial subjects were given aluminum-containing adjuvants and other chemical mixtures which masked adverse events and made Gardasil seem safer than it would have otherwise.
Other findings raised in Mary Holland, Kim Mack Rosenberg, and Eileen Iorio’s book:
- “HPV vaccines have never been proven to prevent against cervical or other cancer.”
- “Even if they were 100 percent effective, which they are not, HPV vaccines do not prevent all types of cervical cancer.”
- “The manufacturers never tested HPV vaccines on human fertility.”
- “The manufacturers never tested HPV vaccines to discover if they might cause cancer.”
There are various adverse medical conditions that have arisen in the research and review of Gardadsil Vaccine long term latent as well as merging injuries in vaccine recipients.
Primary condition summary related to Gardasil: National Institute of Health.gov/diseases POTS-postural-orthostatic-tachycardia-syndrome
Adverse Medical Conditions Related to Gardasial Vaccinations
- Auto-immune disorders
- Chronic fatigue syndromes
- Chronic pain syndromes, including Chronic regional pain syndrome (CRPS)
- Idiopathic Thrombocytopenic Purpura (ITP)
- Movement disorders
- Neurological disorders
- Postural orthostatic tachycardia syndrome (POTS)
- Reproductive disorders, including premature ovarian failure (POF)
- Small fiber neuropathy
Related information on Vaccine Claims that are available to others who may have been injured by a vaccine that’s not related to the Gardasil Vaccine through the United State Vaccine Court
What is the National Vaccine Injury Compensation Program (NVICP)?
Congress created the National Vaccine Injury Compensation Program (NVICP), also known as “Vaccine Court,” to allow petitioners to seek monetary compensation for allegedly suffering injury or death after receiving certain vaccines. The program is intended to provide individuals with a “swift, flexible, and less adversarial alternative to the often costly and lengthy civil arena of traditional tort litigation.”
Since it began in 1988, the NVICP has paid out roughly $4 billion in compensation to more than 8,000 families who presented a “preponderance of evidence” demonstrating vaccines caused their injuries.
Comparatively, if a pharmaceutical drug harms a person, the person has the right to retain an attorney and file a lawsuit in civil court for damages against the drug’s manufacturer. This is not the case for Gardasil. Instead, individuals injured by Gardasil must first file a petition in the Vaccine Court, where the manufacturer is not even a party or involved in any way. After a statutory period of time passes, or judgment is rendered, the petitioner can then choose to opt out of Vaccine Court and elect to file a civil lawsuit against the manufacturer.
“No person may bring a civil action for damages … against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccine-related injury … associated with the administration of a vaccine … unless a petition has been filed … for compensation under the Program for such injury … and (I) the United States Court of Federal Claims has issued a judgment … on such petition and (II) such person elects … to file such an action.”
Read more on the US Vaccine Court.
United States Court of Federal Claims
Vaccine Claims/Office of Special Masters
The National Vaccine Injury Compensation Program (“Vaccine Program”) comprises Part 2 of the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”). See Pub. L. No. 99-660, 100 Stat. 3755 (1986) (codified as amended at 42 U.S.C. §§ 300aa-1 to -34). The Vaccine Act became effective October 1, 1988. It establishes the Vaccine Program as a no-fault compensation program whereby petitions for monetary compensation may be brought by or on behalf of persons allegedly suffering injury or death as a result of the administration of certain compulsory childhood vaccines. Congress intended that the Vaccine Program provide individuals a swift, flexible, and less adversarial alternative to the often costly and lengthy civil arena of traditional tort litigation. Read more . . .
Notice of Vaccine Practices
- Chief Special Master’s Statement on Special Processing Unit Claims
- Office of Special Masters Pre-Assignment Review (“PAR”)
- Public Release of Rulings and Decisions
- Exiting the Vaccine Program
- Settlements and Alternative Dispute Resolution
- Lost Wages and Federal Register Notices
- Electronic Service on Secretary of Health and Human Services
- OSM Attorneys’ Fees and Costs Information
The Office of Special Masters—an office within the United States Court of Federal Claims, see 42 U.S.C. § 300aa-12(c)—maintains a list of attorneys as a service to petitioners seeking compensation under the National Vaccine Program established by the Department of Health and Human Services. See 42 U.S.C. §§ 300aa-1, 12(a).
For further information on Gardasil MDL 3036 or to contact parties referenced in this article please contact: