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Gardasil Lawsuit

Gardasil HPV Vaccine Lawsuit Update - July 2024

Research has linked the Gardasil HPV vaccine to serious side effects, including postural orthostatic tachycardia syndrome (POTS) and premature ovarian failure (POF), the latter of which can result in infertility. 

The Gardasil attorneys at Wisner Baum are in active litigation against Merck, the manufacturer of the HPV vaccine.  Our lawsuits allege Merck conducted fraudulent clinical trials for the Gardasil vaccine and failed to warn about severe side effects, which can remain serious for years after the Gardasil shot. We have filed multiple cases for plaintiffs alleging Gardasil caused dysautonomia, cervical cancer (which the vaccine is supposed to protect against), and wrongful death. 

Senior partner Bijan Esfandiari serves as co-lead trial counsel in the federal Gardasil MDL (multidistrict litigation), where approximately 200 cases are pending. The MDL should not be confused with a Gardasil class action; it is a group of individual HPV vaccine lawsuits filed in different districts that make similar allegations against a common defendant (Merck). There is no Gardasil class action.

If you would like more information on how to join the Gardasil lawsuit, please contact us or call (855) 948-5098 today for a free case evaluation. HPV vaccine side effect lawsuits need to be filed within a specific time frame called the statute of limitations. To ensure that your legal rights are protected, we highly recommend you contact a lawyer as soon as possible to see if you qualify for a Gardasil vaccine lawsuit.

WISNER BAUM GARDASIL LAWYERS | YOUR LEGAL RIGHTS EXPLAINED

Gardasil Lawsuit Update 2024

July 3, 2024: The updated case total for the HPV vaccine MDL against Merck is now 197. 

June 20, 2024: Wisner Baum Gardasil lawyers filed a lawsuit last week on behalf of a woman who alleges the Gardasil vaccine causes POTS, lupus, and other severe autoimmune conditions. The plaintiff alleges she suffers from the following side effects after Gardasil: 

  • Fibromyalgia
  • Idiopathic thrombocytopenic purpura (ITP)
  • Lupus
  • Nerve damage
  • Postural orthostatic tachycardia syndrome (POTS) 
  • Premature menopause
  • Premature ovarian failure (POF) 
  • Tourette’s syndrome

The lawsuit was filed in the federal Gardasil MDL, joining nearly 200 other claims. 

June 4, 2024: As of today we have 194 cases in the Gardasil MDL and expect a steady increase this summer as more claims go through Vaccine Court. 

May 1, 2024: Wisner Baum recently filed an HPV vaccine death case in the federal Gardasil MDL. The complaint was filed on behalf of Erin Ferguson, whose daughter Haley died at age 22 after years of battling cervical cancer. The lawsuit (Case No. 3:24-cv-00220) joins 180 claims filed in the Gardasil MDL before U.S. District Judge Kenneth D. Bell in North Carolina. You can read more about this case in our blog.  

April 2, 2024: There are now 168 HPV vaccine claims in the federal Gardasil MDL.

March 1, 2024: We have an updated case count in the Gardasil MDL. As of today, 143 claims are pending in the Gardasil Products Liability Litigation before Judge Kenneth D. Bell in North Carolina. Our vaccine attorneys have several cases making their way through Vaccine Court, so we anticipate this number to increase steadily in the next few months. 

Last month, our attorneys filed two new Gardasil death cases on behalf of two mothers who allege the HPV vaccine caused severe autoimmune and neurological dysfunction, ultimately resulting in the deaths of their daughters. You can learn more about these cases here

February 6, 2024: As of today, the Gardasil MDL has 140 cases pending, per the latest MDL Statistics report. We expect this number to continue rising in the coming weeks as we have numerous HPV vaccine claims making their way through Vaccine Court. Most of our cases in the MDL allege Gardasil causes infertility, POTS, or other autoimmune conditions. 

January 8, 2024: January is cervical cancer awareness month, which means HPV vaccination will be broadcast as a “primary prevention” mechanism against cervical cancer.As attorneys litigating cases for those harmed by the Gardasil vaccine, we wanted to take a moment to provide some important information on the HPV vaccine and cervical cancer. 

Merck has previously marketed Gardasil as a “cervical cancer vaccine” and asserted that Gardasil provides lifetime immunity to cervical, anal, and other HPV-associated cancers. Our lawsuits allege Merck does not have any scientifically reliable basis to make these claims. The question of whether the HPV vaccine prevents cancer is unproven, and evidence exists that Gardasil may actually increase the risk of cervical cancer in those previously exposed to HPV rather than prevent it.

We filed a case last year on behalf of a young woman who alleges Gardasil caused her cervical cancer. “Because most of her treatment was directed at her cervix,” the complaint states, “her ovaries were also affected, putting her into menopause in her 20s…She will never be able to have children of her own because her eggs are no longer viable due to the cancer treatment.”

Our complaint accuses Merck of falsely advertising and overstating Gardasil’s safety and effectiveness, which not only failed to prevent our client’s cervical cancer, it potentially caused her to develop cancer.

Raising awareness about cervical cancer is important. But the public deserves to be fully informed about the potential for harm that comes with HPV vaccination. 

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gardasil Lawsuit FAQS

  • Why Is There A Lawsuit Against Gardasil?

    HPV vaccine lawsuits against Gardasil allege Merck failed to properly warn people about the risk of serious side effects, including POTS, dysautonomia, premature ovarian failure, and more. Our Gardasil vaccine lawsuits further accuse Merck of fraudulently misrepresenting that Gardasil prevents cervical cancer when the company has never actually studied whether or not this claim is true. Our clients say they never would have consented to receive the Gardasil shot had they known about the potential for harmful side effects, which many continue to experience years later.

  • 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, 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
  • Who Can File a Gardasil Vaccine Lawsuit?

    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.

  • 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.

  • Is My Gardasil Lawsuit Against Merck?

    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.
    1. 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.
    1. The report is presented to a court-appointed special master who decides whether the petitioner should be compensated. This decision may be appealed.
    1. 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.
  • 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:

    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.
  • 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.

  • Was There A Gardasil Recall?

    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.

  • Do People Experience Gardasil Side Effects 10 Years Later?

    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
  • Can I File A Gardasil Lawsuit For Infertility?

    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.”

  • Can I Get HPV After Gardasil?

    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.

  • Who Makes Gardasil?

    Merck & Co. is the Gardasil manufacturer.

  • When Was Gardasil Approved?

    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.

  • Does HPV Cause Cancer?

    More than 90% of new HPV infections, including those caused by high-risk HPV types, go away naturally in 1 to 2 years. Clearance of the infection usually occurs within 6 months. Even when HPV does not resolve and causes abnormal changes in cervical cells, those “lesions,” as they are called, rarely progress to cancer.

  • How Do Vaccines Work?

    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.

  • Is Gardasil Effective?

    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.

  • Can Gardasil Cause Cancer?

    The Gardasil insert states, “Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity.”

    Researchers have suggested that the elimination or suppression of certain high-risk HPV viruses may in fact open an ecological niche for even more dangerous HPV strains. In other words, it could open pathways to cancer that did not exist prior to vaccination.

  • 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.

  • How Does Vaccine Court Work?

    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.
  • 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.

  • 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.

Contact Us Today We’re Ready to Help

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Bijan Esfandiari

Learn more about the Gardasil HPV Vaccine Multidistrict Litigation (MDL) in this interview with Gardasil injury lawyer and Wisner Baum senior shareholder Bijan Esfandiari. The Gardasil MDL, which was approved after this interview was conducted in August of 2022, allows HPV vaccine injury cases to move into coordinated discovery and pretrial proceedings. People who allege in  lawsuits that they sustained debilitating Gardasil side effects will now be able to have their day in court.

See if you qualify for a Gardasil HPV vaccine lawsuit by filling out our contact form.

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.

Underlying the entire Gardasil controversy are clinical trials (human testing) that victims allege were fraudulently conducted and reported. Preliminary evidence compiled by a team of Gardasil attorneys and investigators suggests that the clinical trials Merck conducted for the Gardasil HPV vaccine were flagrantly deceptive and unscientific.

According to Mary Holland and 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, some clinical trial subjects received aluminum-containing adjuvants, chemical mixtures, and other vaccines, which masked adverse events and made Gardasil seem safer than it would have otherwise.

According to Holland, Mack Rosenberg, and Iorio, “HPV vaccines have never been proven to prevent against cervical or other cancer.”

WHAT IS THE GARDASIL LAWSUIT ABOUT?

Gardasil shot lawsuits against Merck include allegations of fraud, deceit, and negligence for:

  • Failing to disclose important information regarding Gardasil’s safety and effectiveness.
  • Failing to perform essential “scientific and medical investigations and studies relating to the safety, effectiveness and need for the Gardasil vaccine” as required by FDA regulations.
  • Manipulating consumers by preying on their fear of cancer and 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.

HPV vaccine lawsuits further allege that Merck failed to properly warn consumers of the risk of serious adverse reactions tied to the administration of the Gardasil HPV vaccine and failed to inform them of material facts related to the vaccine, including:

  • The Gardasil shot was only known to be effective for five years.
  • Other methods were known to be effective in avoiding the HPV virus.
  • The risk that an HPV infection would lead to precancerous lesions was minimal.
  • Existing methods for diagnosing and treating HPV precancerous lesions or cancer were effective.

The Gardasil vaccine lawsuits seek punitive damages due to Merck’s alleged deceit and fraud.

HOW CAN A GARDASIL LAWYER HELP?

If you or a family member suffered severe side effects after a Gardasil injection, we encourage you to speak with an experienced Gardasil attorney. Our firm has been a leader in harmful drug and medical device litigation for more than 25 years. We know what it takes to go toe-to-toe against the largest drug companies in the world.

Our verdicts and settlements include:

Our firm has the resources and experience to get the justice and compensation you deserve. Call us today at (855) 948-5098 or contact us for a free and confidential Gardasil case evaluation.

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Is Gardasil Dangerous?

Gardasil ingredients include virus like particles (VLPs) which are genetically engineered from a protein of HPV types 6, 11, 16, 18 (and Gardasil 9 includes additional types: 31, 33, 45, 52, and 58); amorphous aluminum hydroxyphosphate sulfate (aka, AAHS); yeast protein; sodium chloride; L-histidine; polysorbate 80; sodium borate; and water for injection. As you can see, each Gardasil shot contains ingredients in addition to the genetically modified virus like particles. These ingredients are capable of causing adverse reactions in their own right.

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.”

The Gardasil attorneys at Wisner Baum have filed numerous lawsuits on behalf of young adults who suffered Gardasil shot reactions. Many of our clients allege they developed POTS from Gardasil. Others say the HPV vaccine caused other autoimmune diseases and debilitating injuries.

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).

As of Jan. 14, 2020, 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%).