Gardasil Lawsuit

Lawsuits allege numerous serious side effects following Gardasil vaccination, including:

Primary Conditions

• Postural Orthostatic Tachycardia Syndrome (POTS)
• Premature Ovarian Failure (POF), potentially causing infertility
• Guillain-Barré Syndrome
• Fibromyalgia
• Chronic Fatigue Syndrome
• Orthostatic Intolerance
• Dysautonomia
• Seizures
• Death

Additional Conditions

Autoimmune and Neurological Conditions:

• Multiple Sclerosis
• Systemic Lupus Erythematosus
• Rheumatoid Arthritis
• Inflammatory Bowel Disease
• Complex Regional Pain Syndrome (CRPS)
• Myalgic Encephalomyelitis
• Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)
• Chronic Migraines
• Sinus Tachycardia

Endocrine Disorders:

• Diabetes
• Hyperthyroidism
• Hypothyroidism

Other Conditions:

• Arthralgia, Arthritis, Arthropathy
• Celiac Disease
• Nephritis
• Scleroderma
• Stevens-Johnson Syndrome
• Ankylosing Spondylitis (males)
• Autoimmune Thrombocytopenia (males)
• Myocarditis (males)

Many plaintiffs report that these conditions have dramatically impacted their lives, forcing some to drop out of school or preventing them from maintaining employment. The lawsuits claim that patients would not have consented to vaccination had they known about these potential risks.

Long-Term Side Effects

Long-term Gardasil side effects, in some cases many years after vaccination, are not uncommon among litigation plaintiffs. Premature ovarian failure (POF) is one of the most prevalent long-term Gardasil side effects among plaintiffs in litigation.

One study, entitled, "Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination," identified premature ovarian failure after HPV vaccination in an adolescent. POF among adolescents is exceedingly rare, and the authors noted the following:

"Since there may potentially be a group for whom this vaccine is contraindicated, and since the occurrence of this event may possibly represent broader health implications, it is also suggested that long-term follow-up of ovarian function in a cohort of vaccinated girls and women be undertaken."

Infertility Concerns

Scientific literature has repeatedly found links between the Gardasil vaccine and infertility. In a 2013 study, researchers found evidence of the potential for the HPV vaccine to trigger POF. Per the authors, "[t]he increasing number of similar reports of post-HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry."

Another 2014 study that analyzed VAERS adverse events data to determine if there was a connection between the HPV vaccine and infertility found a "potential safety signal," adding that "further investigations are warranted."

What is the Gardasil Lawsuit About?

Allegations Against Merck

Gardasil lawsuits against Merck include allegations of:

• Fraudulent Clinical Trials: Claims that Merck's clinical trials were poorly designed and conducted in a way that masked adverse events and made Gardasil appear safer than it actually is.
• Failure to Disclose: Allegations that Merck failed to disclose important information about Gardasil's safety and effectiveness.
• Inadequate Testing: Claims that Merck failed to perform required scientific and medical investigations relating to the vaccine's safety and effectiveness.
• Deceptive Marketing: Allegations that Merck manipulated consumers by exploiting fear of cancer and misrepresenting the necessity of the vaccine.
• Failure to Warn: Claims that Merck failed to properly warn of potential long-term side effects and material facts about the vaccine, including: 
  
  • The vaccine was only known to be effective for five years
  • Other methods were known to be effective in avoiding HPV
  • The risk of HPV infection leading to precancerous lesions was minimal
  • Existing methods for diagnosing and treating HPV precancerous lesions were effective

The deception surrounding Gardasil applies to both consumers and the medical community alike. Merck & Co. manipulated people by "repeatedly stating, representing, urging and implying" that it was necessary for girls and young women to take the Gardasil vaccine to prevent cervical cancer, according to allegations in lawsuits filed in civil court. Doctors were also allegedly manipulated by Merck's claims of safety and efficacy.

Understanding HPV and Cancer Risk

The HPV Virus

Viruses, unlike bacteria, which are single-celled organisms, have no cellular structure. They are incredibly small packets of deoxyribonucleic acid, or DNA—the genetic material that carries a life form's operating instructions. The DNA is enclosed in a protein shell. Viruses cannot reproduce by themselves. They reproduce by inserting themselves into a cell and taking over the reproductive machinery of the cell.

Scientists have identified over 200 different types of HPV and fully mapped the sequence of biomolecular "letters"—called bases or nucleotides—that make up the DNA of each type. Each type is numbered according to the order in which it was "discovered."

Approximately 60 HPV types are capable of infecting the mucous membranes that line the genital regions and the anus. From there, they spread through direct genital contact.

High-Risk and Low-Risk HPV Types

HPV viruses are divided into two categories:

• Low-risk types: These pose little or no risk of causing cervical cancer but may cause genital warts and minor changes in cervical cells. HPV types 6, 11, 40, 42, 43, 44, 54, 61, 70, 72, and 81 are considered low-risk. 90% of genital warts are associated with types 6 and 11.
• High-risk types: These have been linked to cervical cancer. HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, and 82 are high-risk. Three other types, 26, 53, and 66, have been classified as "probable" high-risk types. Two of these high-risk types, 16 and 18, are said to cause about 70% of cervical cases.

Collectively, HPV types 16, 18, 45, 31, and 33 are said to account for approximately 85% of invasive cervical cancer worldwide.

The first Gardasil HPV vaccine, known as the "quadrivalent" Gardasil 4 vaccine (no longer available in the U.S.), purportedly protected against infection from two low-risk types (6 & 11) and two high-risk types (16 & 18). The current Gardasil 9 HPV vaccine purportedly protects against those four types plus 5 other high-risk types – 31, 33, 45, 52, and 58.

At best, Gardasil protects against only four to nine strains of the human papillomavirus. There are over 200 strains of HPV, and of those, more than 40 strains can be passed through sexual contact.

How HPV Infection Relates to Cancer Development

The path that leads from HPV infection to cervical cancer is not straightforward. Most of the time, cancer does not develop at all. According to the Centers for Disease Control and Prevention, "More than 90% of new HPV infections, including those caused by high-risk HPV types, clear or become undetectable within two years, and clearance usually occurs in the first six months after infection."

The basic steps in the process that sometimes lead to cervical cancer are:

1. Infection with HPV
2. Persistent HPV infection of the mucous membranes
3. Appearance of lesions (abnormal cells considered "pre-cancerous")
4. Lesions progress in seriousness
5. Appearance of non-invasive cervical cancer
6. Invasive cervical cancer

Gardasil Effectiveness and Cancer Prevention

Evidence that Gardasil prevents cancer is remarkably weak. The target age for inoculation is between 11 to 12 years old, but the median age of death by cervical cancer is 58 in the US and the cervical cancer death rate is 2.3 per 100,000. It takes 15 to 30 years for infection with HPV to lead to cancer. With such a low death rate and the decades it takes for cancer to develop, it would take an impossibly large population of patients to reach any statistically significant result in a study to show whether Gardasil prevents cancer.

• Cervical cancer causes 1 death in 43,500 Americans
• Median age of cervical cancer diagnosis: 50

[National Cancer Institute data]

Merck tested Gardasil against the development of lesions known as CIN2 and CIN3. CIN stands for "cervical intraepithelial neoplasia," an abnormal growth of cells on the surface of the cervix. Only a small fraction of these lesions ever progress to cancer.

The authors of a 2008 study published in Lancet Oncology estimated that, for women who received adequate treatment, including treatment for recurrent disease, the 30-year risk of cervical cancer in women diagnosed with CIN3 was 0.7%. In other words, in 30 years, 7 out of 1,000 women with CIN3 would get cervical cancer.

Researchers at the National Institute for Public Health and the Environment in the Netherlands estimated that the median time from CIN2/3 to cervical cancer was 23.5 years, with only 1.6% of lesions progressing to cancer within the first 10 years. According to the Cleveland Clinic, treatment of CIN2 and CIN3 lesions is 90% successful and reduces the risk of cervical cancer by 95% for 8 years. In short, with proper screening, cervical cancer is almost entirely preventable.

What is the Gardasil Controversy?

Clinical Trial Issues

A central claim in the litigation involves how Merck conducted its clinical trials. Critics allege:

• Participants in the control did not receive true saline placebos but instead received aluminum-containing adjuvants, chemical mixtures, or other vaccines (Holland, Mary, Kim Mack Rosenberg, and Eileen Iorio. The HPV Vaccine On Trial: Seeking Justice for a Generation Betrayed. Skyhorse Publishing, 2018.)
• This approach potentially masked adverse events and made the vaccine appear safer
• Nearly half of study participants reported "new medical conditions," including high rates of neurological, musculoskeletal, and autoimmune conditions that were categorized as unrelated to the vaccine

Specific issues with the clinical trials include:

• In one trial, only 10% of participants received vaccination report cards (used to obtain follow-up information about adverse reactions)
• 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 effects

In 2013, numerous medical professionals published an article in the British Medical Journal 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."

Additionally, a 2018 critique published in BMJ Evidence-Based Medicine by researchers from the Nordic Cochrane Center and Oxford's Center for Evidence-Based Medicine found:

• One-third of the clinical studies were not published, raising questions of publishing bias
• None of the 26 HPV vaccine clinical trials used a true inactive placebo
• Many women with a history of immunological or nervous system disorders were excluded from the trials

Cervical Cancer and Gardasil

FDA approval for Gardasil was fast-tracked in 2006 based on Merck's theory that HPV alone causes cervical cancer. However, lawsuits claim:

• Gardasil has never been proven to prevent cervical cancer
• Cervical cancer is a multi-factorial disease influenced by many environmental and genetic factors beyond HPV
• The median age of death from cervical cancer is 58, with teenage girls having virtually zero risk
• Pap screening has already reduced cervical cancer rates by up to 80% in developed countries
• Incidence of cervical cancer in the U.S. affects approximately 0.6% of women in their lifetime, with a five-year survival rate of over 90% when caught early, it is largely treatable.

According to data from the National Cancer Institute’s (“NCI”) Surveillance, Epidemiology and End Results Program (“SEER”), the incidence of deaths from cervical cancer prior to Gardasil’s introduction in the U.S. had been steadily declining for years and, in 2006, was 2.4 per 100,000 women or approximately 1 in every 42,000 women. The currently available rate is essentially unchanged, 2.2 per 100,000 women, based on data through 2017.

The American Cancer Society states there are "ways to stop this disease from developing" without vaccination. They note that "the most important thing you can do to prevent cervical cancer is to be tested according to American Cancer Society guidelines," including Pap tests and HPV testing. Other preventive measures include stopping smoking, limiting sex partners, using condoms, maintaining a healthy weight, eating a diet rich in fruits and vegetables, and monitoring vitamin A and folate levels.

Potential Cancer Risk Concerns

Contrary to Merck's marketing, some studies suggest the vaccine may actually increase cancer risk:

• The original Gardasil label states: "Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity"
• Peer-reviewed studies suggest that suppression of targeted HPV strains may open an ecological niche for replacement by more virulent strains. These studies include:
  • Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20–26 years) – Fangjian Guo et al. (2015)
  • Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccinations – Sonja Fischer et al. (2016)
  • Biased Cochrane Report Ignores Flaws in HPV Vaccine Studies, and Studies of HPV Type Replacement – J. Lyons-Weiler (2018)
• Merck's research showed women previously exposed to HPV were 44.6% more likely to develop cancerous lesions after vaccination
• Some regions with high Gardasil uptake have reported increasing cervical cancer rates among young women

FDA Approval Process and Conflicts of Interest