Gardasil is a vaccine manufactured by Merck. It is intended to prevent some strains of the human papillomavirus (HPV) that may lead to cervical cancer. However, growing research and hundreds of lawsuits allege Merck obtained approval for Gardasil based on deceptive clinical trials and marketed the HPV vaccine as safe and effective while concealing the risk of harm to young girls and boys.
Legal Status and Representation
Gardasil vaccine lawsuits are filed in both federal and state courts. Federal lawsuits have been consolidated in a Gardasil multidistrict litigation (MDL), with Wisner Baum senior partner Bijan Esfandiari serving on the plaintiffs' leadership as co-lead trial counsel.
Important Note: This MDL is not a class action lawsuit. An MDL groups individual lawsuits with similar allegations against a common defendant to improve efficiency, while a class action consolidates plaintiffs into a single lawsuit. Each case in the Gardasil MDL remains an individual lawsuit.
Gardasil Lawsuit FAQS
How Do I File a Gardasil Lawsuit?
Choose an experienced attorney to represent you. The first thing you will need to do is choose an experienced Gardasil attorney to handle your case. Vaccine claims are complex, so hiring a law firm with a proven track record of success in litigating defective pharmaceutical product cases is a must. We have extensive experience in this field.
We will help you file your claim with the Vaccine Court. Individuals who were harmed after receiving the Gardasil 4 or Gardasil 9 HPV vaccine must file a claim against the Secretary of the Department of Health and Human Services (HHS) in the U.S. Court of Federal Claims under the National Vaccine Injury Compensation Program (VICP), also known as “Vaccine Court.” The VICP provides compensation to individuals who file a claim and are found to have been injured by a VICP-covered vaccine (Gardasil is a covered vaccine). After filing a claim in vaccine court, however, it is possible to file a lawsuit in civil court against the manufacturer.
If you do not get approved for a settlement or choose not to accept the settlement, we are prepared to file a lawsuit on your behalf in civil court. In the event the VICP court decides that, in its opinion, a petitioner has not been harmed by the VICP-covered vaccine and a settlement is not reached, the petitioner may file a Gardasil lawsuit in civil court to seek compensation for their injuries from the manufacturer. Rest assured, we will guide you to help you understand your options and help you determine what is the right next step for you.
Can I Sue the Doctor Who Gave Me the Gardasil Shot?
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.
Is There a Gardasil Class Action?
No. Wisner Baum represents individuals who were harmed by HPV vaccine side effects in personal injury and wrongful death lawsuits. Some individual lawsuits against Merck have been consolidated in a Gardasil multidistrict litigation (MDL) in North Carolina federal court, but these cases are not part of a Gardasil class action.
Multidistrict litigation is a legal process that simplifies complex litigation involving numerous cases of individuals who have suffered harm from the same product or incident. Unlike class action lawsuits, which consolidate multiple plaintiffs into one case, an MDL involves grouping similar cases and hearing them in a single court. MDLs typically involve numerous personal injury cases related to physical injuries caused by a defective product, in this case, Gardasil.
The primary aim of an MDL is to centralize civil lawsuits filed across the country that have common liability claims against the same defendant(s). The MDL process avoids duplication of discovery, and other legal proceedings, reducing the burden of federal district courts and improving efficiency. The MDL court ensures multiple plaintiffs' cases are handled fairly and effectively while protecting each individual's rights and ensuring justice is served.
What Autoimmune Disease is Involved in Gardasil Vaccine Lawsuit?
The two main autoimmune side effects currently being prepared for trial in the Gardasil MDL are postural orthostatic tachycardia syndrome (POTS) and premature ovarian failure (POF), also known as primary ovarian insufficiency. See the detailed list of alleged side effects.
Is Gardasil Dangerous?
In a 2020 peer-reviewed study, Dr. Jørgensen and other researchers analyzed the available clinical trial data for all HPV vaccines, including Gardasil. The researchers found that the HPV vaccines were associated with a nearly two-fold increased risk of POTS. The study authors further reported that "HPV vaccines increased serious nervous disorders."
One lawsuit alleged Gardasil contains "dangerous and undisclosed ingredients”. Gardasil contains various ingredients including amorphous aluminum hydroxyphosphate sulfate (AAHS), polysorbate 80, and other components that are capable of causing adverse reactions. See detailed information about Gardasil ingredients and their potential effects.
How Effective is Gardasil?
Evidence that Gardasil prevents cancer is remarkably weak. Cervical cancer causes 1 death in 43,500 Americans, with a median age of cervical cancer diagnosis at 50. Merck tested Gardasil against lesions (CIN2 and CIN3), not cancer itself. Only a small fraction of these lesions ever progress to cancer. See detailed effectiveness information and statistics.
Can I Skip Vaccine Court and File a Gardasil Lawsuit Against Merck?
No. Individuals may only file a Gardasil lawsuit against Merck if their VICP petition does not result in acceptable compensation. Because Gardasil is a covered vaccine, all claims must first go through petition under VICP (Vaccine Court). If your case is rejected, you may file a Gardasil lawsuit against Merck & Co. in civil court.
Can Vaccine Manufacturers Be Sued in Civil Court or Do They Have Immunity?
The National Childhood Vaccine Injury Act provides that an individual may bring a civil lawsuit under certain circumstances, and if such a lawsuit is in accordance with the provisions of the Act, including:
- File a petition with The United States Court of Federal Claims (Vaccine Court);
- Either wait the required 240 days for the petition to be resolved in Vaccine Court or await receipt of a Judgment from the Vaccine Court; and,
- Elect to opt-out from the Vaccine Court after the passage of 240 days, or reject the Judgment from the Vaccine Court and file a lawsuit in civil court directly against the vaccine manufacturer.
How Does Vaccine Court Work?
- An individual files a petition with the Court against HHS under the VICP. The Court sends both the Department of Justice (DOJ) and HHS notification of the petition.
- HHS reviews the petition and determines if the petitioner's claims meet its medical criteria for compensation. HHS then makes a preliminary recommendation to DOJ. HHS includes its position in a DOJ report, which is submitted to the Court.
- The report is presented to a court-appointed special master who decides whether the petitioner should be compensated. The petitioner may appeal the decision.
- If the special master does not allow for compensation, the petitioner may reject the decision of the Court (or withdraw their claims after certain timelines are met) and file a lawsuit against Merck & Co. in civil court. Wisner Baum will file this lawsuit on your behalf.
What is Vaccine Court?
The U.S. Department of Health and Human Services created the VICP to compensate individuals and families of individuals who were injured by covered vaccines. Gardasil is one of many covered vaccines.
Instead of filing a lawsuit against a vaccine maker in civil court, individuals who allege they were harmed by a covered vaccine file a petition for compensation against the U.S. Department of Health and Human Services. Those who are eligible may recover compensation for vaccine injury-related medical and rehabilitative expenses, for pain and suffering, and lost earnings.
Is Your Firm Anti-Vax?
Absolutely not. We believe that vaccines have the potential to eradicate disease and save millions of lives. We are, however, against intentional efforts to mislead consumers about the safety and effectiveness of a drug or vaccine. Our firm has always fought—and will continue to fight—for the rights of consumers to be fully and honestly informed about risks associated with any drug, vaccine, medical device, or consumer product. We will work tirelessly to ensure those rights are defended and victims of injustice are compensated for their injuries.
Common Alleged Side Effects
Lawsuits allege numerous serious side effects following Gardasil vaccination, including:
Primary Conditions
Additional Conditions
Autoimmune and Neurological Conditions:
Endocrine Disorders:
Other Conditions:
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:
- Infection with HPV
- Persistent HPV infection of the mucous membranes
- Appearance of lesions (abnormal cells considered "pre-cancerous")
- Lesions progress in seriousness
- Appearance of non-invasive cervical cancer
- 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:
- 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
The FDA's Vaccine and Related Biological Products Advisory Committee (VRBPAC) evaluates the safety and effectiveness of vaccines. A 2000 investigation by the U.S. House of Representatives Reform Committee found that "the overwhelming majority of members, both voting members and consultants, have substantial ties to the pharmaceutical industry" and "in many cases, significant conflicts of interest are not deemed to be conflicts at all."
Once the FDA licenses a new vaccine, the CDC's Advisory Committee on Immunization Practices (ACIP) adds it to a "recommended" schedule. The same House committee investigation found ACIP was similarly compromised, with members allowed to vote even if they have financial ties to drug companies making similar vaccines. The investigation found ACIP committee members serving on Merck's Immunization Advisory Board, accepting Merck grants, receiving salaries from Merck, and participating in Merck studies.
A 2009 report from the U.S. Department of Health and Human Services Office of Inspector General stated that the "CDC had a systematic lack of oversight of the ethics program" and that 97% of CDC committee members' conflict disclosures had omissions.
Further complicating matters, scientists from the National Institute of Health (NIH), which is a division of the Department of Health and Human Services (HHS), discovered the method of producing "virus-like-particles" (VLPs) that made creation of the Gardasil vaccine possible. The NIH scientists' method was patented by the Office of Technology Transfer (OTT), part of the NIH, and the licensing rights were sold to Merck. This means that HHS and NIH receive royalties from sales of Gardasil, and the scientists whose names appear on the vaccine patents can receive up to $150,000 per year in perpetuity.
The Vioxx Parallel
Plaintiffs draw parallels between Merck's handling of Gardasil and its previous drug Vioxx, which was withdrawn from the market in 2004 after being linked to cardiovascular side effects:
- Internal documents from the Vioxx litigation revealed Merck scientists acknowledged risks early but did not conduct necessary safety studies
- Medical journals expressed concern that Merck obscured safety data for Vioxx
- Similar allegations of data manipulation and selective reporting are made regarding Gardasil
- The New England Journal of Medicine (NEJM) published an "Expression of Concern" regarding Merck's omission of adverse event data in Vioxx studies
Gardasil Ingredients and Adjuvants
Gardasil ingredients include hidden adjuvants capable of creating biochemical disturbances that cause numerous health problems.
What is an Adjuvant?
In immunology, an adjuvant is an agent added to a vaccine to enhance the immune response to the vaccine’s antigen. An adjuvant is included in the vaccine and injected along with the antigen to produce antibodies against the antigen. The Centers for Disease Control and Prevention (CDC) says that adjuvants “help vaccines work better” by producing an immune response that protects someone from the disease he or she is being vaccinated against.
But adjuvants, including the aluminum and other ingredients in Gardasil, have been shown to cause serious side effects.
Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS)
- Added to produce a stronger immune response
- Known to be neurotoxic if accumulated in the brain
- No human safety testing data exists on AAHS
- Merck claims AAHS is proprietary and has refused to provide samples for independent testing
The many toxic effects of aluminum include:
- Impairing cognitive and motor function
- Altering of DNA, chromatin RNA structure
- Inducing autoimmune interactions and macrophagic myofasciitis, a rare muscle disease
- Blocking neuronal signaling
- Binding to protein and affecting protein function
- Inhibiting antioxidant enzyme action
- Interfering with synaptic transmission and disrupting mitochondria and organelles in cells
Polysorbate 80
- Used as an emulsifier to keep ingredients mixed
- Weakens the blood-brain barrier and binds to aluminum
- Associated with anaphylactic shock and hypersensitivity reactions
- Linked to reproductive effects in animals
Sodium Borate (Borax)
- Banned in food in the U.S.
- Potential harm to male reproductive system and developing fetuses
- Can cause acute toxic reactions when eaten or inhaled
L-Histidine
- Used by the body to make histamine
- Histamines increase blood vessel permeability
- May increase blood clotting when combined with surfactants
Additional Components
- Genetically modified yeast (Saccharomyces cerevisiae) potentially linked to autoimmune responses
- Undisclosed HPV DNA fragments found in samples by independent researchers
Gardasil Vaccine Recalls
Merck has issued voluntary Gardasil recalls. In 2020, the company issued an urgent voluntary vaccine recall of Gardasil 9 (Lot R030456) because the vaccine vials were stored at inappropriate temperatures.
In 2013, Merck told the U.S. FDA that it would voluntarily recall one lot of its Gardasil HPV vaccine. The reason behind the Gardasil recall was the potential for a small number of vials to contain glass particles due to breakage during the manufacturing process.
Gardasil Vaccine Deaths and Injuries
The Vaccine Adverse Events Reporting System (VAERS) was established in 1990 as a means of detecting problems in vaccines. The system is managed by the FDA and the Centers for Disease Control and Prevention (CDC).
The VAERS database contains over 64,000 case reports of adverse reactions tied to HPV vaccines worldwide (over 50,000 in the U.S.). More than 9,600 cases reported serious adverse events, including 547 deaths.
Serious adverse events are defined as adverse reactions that result in death, are life-threatening, require hospitalization or lengthen a hospital stay, or result in persistent or significant disability. However, it is estimated that only 1% of serious adverse events are actually reported to VAERS.
The vast majority of HPV vaccine cases, serious cases, and deaths reported in VAERS are tied to Merck’s HPV Gardasil vaccine. For example, of the death cases found in VAERS, Merck is named in 399 (73%).
Important Statement on Vaccines
Our firm wishes to emphasize that we are not against vaccines. They have the potential to eradicate disease and save millions of lives. We are, however, against intentional efforts to mislead consumers about the safety and effectiveness of any medical product. We fight for consumers' rights to be fully informed about risks associated with drugs, vaccines, and medical devices.
Informed consent is a basic principle of medical practice. It means that patients should be fully informed about the purpose, risks, and rewards of the treatment they are receiving. Medical decisions involving cancer are very personal and often involve a complex trade-off between risks and rewards. The balance of risk and reward is equally important, perhaps even more so, when it is not a disease that is being treated, but the potential of acquiring a disease, often decades later, as is the case with the HPV vaccine Gardasil.
