Gardasil 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, which can be autoimmune-mediated.

Other autoimmune diseases Gardasil lawyers are evaluating for potential lawsuits include:

• Chronic Fatigue Syndromes
• Chronic Regional Pain Syndrome (CRPS)
• Dysautonomia
• Fibromyalgia
• Guillain–Barré Syndrome
• Idiopathic Thrombocytopenic Purpura (ITP)
• Lupus
• Movement Disorders
• Orthostatic Intolerance (OI)
• Reproductive Disorders
• Small Fiber Neuropathy

You may have a claim if you (or a loved one) experienced any of the following Gardasil side effects:

• Auto-immune disorders
• Chronic fatigue syndromes
• Chronic pain syndromes, including Chronic regional pain syndrome (CRPS)
• Death
• Dysautonomia
• Fibromyalgia
• Idiopathic Thrombocytopenic Purpura (ITP)
• Lupus
• Movement disorders
• Neurological disorders
• Postural orthostatic tachycardia syndrome (POTS)
• Reproductive disorders, including premature ovarian failure (POF)
• Small fiber neuropathy

If you or someone in your family suffered from any of the adverse events listed above, we recommend that you consult with a Gardasil side effects lawyer about your case.

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.

Yes, Merck & Co. (manufacturer of Gardasil) is the defendant in all Gardasil lawsuits our law firm files. All Gardasil claims follow a specific protocol:

1. A person files a petition with the Court against the Department of Health and Human Services (HHS) under VICP. The Department of Justice (DOJ) and HHS receive notification of the petition from the Court.

2. HHS reviews the petition and determines if it meets the medical criteria for compensation. Based on the findings, HHS makes a preliminary recommendation to DOJ. HHS includes its position in a DOJ report, which is submitted to the Court.

3. The report is presented to a court-appointed special master who decides whether the petitioner should be compensated. This decision may be appealed.

4. If the special master does not allow for compensation, petitioners can reject the decision of the Court (or withdraw their claims after certain timelines are met) and file a Gardasil vaccine lawsuit against Merck & Co. in civil court.

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:

1. File a petition with The United States Court of Federal Claims (Vaccine Court);
2. 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,
3. 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.

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.

Yes, 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.

Long-term Gardasil side effects, in some cases many years after vaccination, are not uncommon among our clients. 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.”

Other long-term HPV vaccine side effects alleged in litigation against Merck:

• Autoimmune disorders
• Chronic Regional Pain Syndrome (CRPS)
• Dysautonomia
• Fibromyalgia
• Guillain-Barré syndrome
• Idiopathic Thrombocytopenic Purpura (ITP)
• Lupus
• Neurological disorders
• Postural orthostatic tachycardia syndrome (POTS)
• Small fiber neuropathy

We represent clients who allege Gardasil caused premature ovarian failure (POF) or premature ovarian insufficiency (POI). The scientific literature has repeatedly found links between the Gardasil vaccine and infertility.

In this 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.”

Yes. 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.

Merck & Co. is the Gardasil manufacturer.

The FDA approved the quadrivalent Gardasil 4 in 2006 after being fast-tracked for approval (the process only took six months). Gardasil 9 was approved in 2014.

When a virus attacks the body, the body’s immune system responds by creating antibodies – proteins that attach to the virus and mark it for destruction. Antibodies remain in the body even after the virus is destroyed. This means that, after the viral attack, the body has a “standing army” of antibodies ready to respond to the next attack.

Vaccines work by simulating a viral attack without actually causing one. This causes the body to create an army of antibodies even though there is no virus. Then, when the real virus appears, the body is prepared to eliminate the infection.

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.

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.

1. 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.
2. 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.
3. The report is presented to a court-appointed special master who decides whether the petitioner should be compensated. The petitioner may appeal the decision.
4. 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.

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.

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.