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Gardasil Lawsuit

Deaths and Serious Injuries Linked to HPV Vaccine

The Gardasil vaccine, manufactured by Merck & Co., was approved by the U.S. Food and Drug Administration (FDA) in 2006 for use in preventing infection from only a few of the hundreds of types of human papillomavirus (HPV). Since hitting the market, however, thousands of adolescents and adults have reported serious and disabling Gardasil side effects after receiving the HPV vaccine, including death.

Gardasil was fast-tracked to the market, achieving FDA approval in six months, which usually takes three years. Even one of the principal investigators of the Gardasil clinical trials (the human testing that precedes FDA approval) said the process “went too fast.”

Gardasil Lawsuit Claims HPV Vaccine Caused Teen Severe Injuries | READ MORE

The clinical trials for the Gardasil HPV vaccine reveal several disturbing side effects that were not disclosed on the package insert:

  • The miscarriage rate for subjects who were injected with Gardasil was 25%. The miscarriage rate for women under 30 in the U.S. is 12.5%.
  • In the Gardasil group, 5 babies were born with congenital abnormalities. There were none in the control group (the group that does not receive treatment).
  • 10.9% of women who took Gardasil reported reproductive and breast disorders within 7 months. In the Protocol 18 placebo group, that figure was 1.2% (through 12 months).
  • The rate of Gardasil deaths in the clinical trials was 8.5 per 10,000, nearly double the background U.S. death rate for young women ages 15 to 24.

There are more than 64,000 case reports of HPV vaccine adverse reactions in the Vaccine Adverse Events Reporting System database. It is estimated that only 1% of serious adverse events are actually reported to VAERS.

Researcher Peter C. Gøtzsche in his book Vaccines: Truth, Lies, and Controversy noted some of the research inadequacies in the HPV vaccine clinical trials:

“It is a requirement for registration of drugs that randomized trials have been carried out where one group received the drug and the control group received placebo or nothing. This allows assessment of both the benefits and harms of drugs. I have done research on non-vaccine drugs for decades and was shocked when I learned through my work with vaccines against human papilloma virus (HPV) that the regulatory requirements are much less for vaccines. Almost all the HPV vaccine trials have a control group receiving a hepatitis vaccine or a strongly immunogenic adjuvant, which makes it impossible to find out what the harms of the HPV vaccines are.”

Today, the Gardasil shot has left many young women and men suffering (FDA also approved Gardasil for boys), and it has been a living nightmare for parents whose children have experienced severe adverse reactions to the vaccine. They all trusted Gardasil, never suspecting the grave illnesses and disabilities that could follow.

Class Action Attorneys with Proven Track Record Against Major Pharmaceutical Companies

The Gardasil lawyers at Baum Hedlund Aristei & Goldman represent individuals who were harmed by the HPV vaccine. If you or a member of your family suffered an adverse reaction after a Gardasil injection, we can help. Even if you suffered from Gardasil side effects years later, you may have a claim.

We are evaluating potential cases with the following HPV vaccine side effects after the Gardasil shot (or shots):

  • Gardasil death
  • Inflammatory disorders
  • Neurological disorders
  • Acute disseminated encephalomyelitis
  • Movement disorders
  • Chronic fatigue syndromes
  • Chronic pain syndromes, including Chronic regional pain syndrome (CRPS)
  • Chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Interconnective tissue disorder
  • Lupus
  • Gardasil arthritis
  • Fibromyalgia
  • Postural orthostatic tachycardia syndrome (POTS)
  • Heart problems, including severe arrhythmia and heart attacks
  • Gardasil auto-immune disorders
  • Pulmonary embolism
  • Guillain-Barre syndrome
  • Multiple sclerosis
  • Paralysis
  • Miscarriage
  • Gardasil epilepsy (seizure disorder)
  • Rheumatological disorders
  • Birth defects
  • Small fiber neuropathy
  • Cervical intraepithelial neoplasia – CIN 2/3
  • Coma
  • Stroke
  • Reproductive disorders, including premature ovarian failure

If you or someone in your family sustained Gardasil injuries, we would like the opportunity to hear your story. You may be able to pursue legal action in a Gardasil lawsuit.

Our firm has successfully litigated against many of the largest pharmaceutical companies in the world, obtaining justice and maximum compensation on behalf of clients. Across all areas of practice, we have won more than $4 billion in settlements and verdicts.

If you have been harmed by the Gardasil vaccine, you might have a potential claim, please click here to fill out our contact form.

What is the Gardasil Controversy?

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.”

Gardasil Makes Good Vaccines Look Bad

There is currently a great deal of controversy surrounding vaccines. Our firm wishes to stress 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 a drug or vaccine. We have 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, or medical device. We will work tirelessly to ensure those rights are defended and victims of injustice are compensated for their injuries.

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.

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%).

Gardasil Lawsuit Seeks Punitive Damages Against Merck for Fraud, Deceit and Negligence

Baum Hedlund Aristei and Goldman is one of the leading law firms filing Merck Gardasil lawsuits. In 2019, we joined forces with other attorneys to bring our expertise in litigating against big pharma in a Gardasil civil lawsuit pending in the Superior Court of California, Los Angeles on behalf of a woman who suffered severe adverse immunological and other adverse reactions, including postural orthostatic tachycardia syndrome (POTS) after receiving three injections of the Gardasil vaccine. Symptoms of POTS relate to reduced blood volume when a person stands up after lying down, resulting in lightheadedness, fainting and rapid heartbeat. The condition can be incapacitating.

The Gardasil lawsuit allegations against Merck include 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.

The suit further alleges 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 lawsuit also seeks punitive damages due to Merck’s alleged deceit and fraud.

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.

Gardasil Lawsuit FAQ

Frequently Asked Questions

We receive many inquiries about the Gardasil litigation, specifically related to how the claims work and who can file. Below we answer some of the most common Gardasil vaccine lawsuit questions:

  • 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.

  • 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.

  • 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.

  • 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.
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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