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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 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.

  • 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 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.

  • 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.

  • 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.

Our Case Results

  • $2.0 Billion Verdict Personal Injury

    In May of 2019, the jury in the case of Pilliod et al. v, Monsanto Company ordered the agrochemical giant to pay $2.055 billion in damages to the plaintiffs, Alva and Alberta Pilliod, a Bay Area couple in their 70s.

  • $289.2 Million Verdict Personal Injury

    On Aug. 10, 2018, a San Francisco jury ordered Monsanto to pay $39.25 million in compensatory damages and $250 million in punitive damages to Mr. Johnson, a former groundskeeper who alleged exposure to Monsanto’s herbicides caused him to develop terminal non-Hodgkin lymphoma.

  • $265 Million Settlement Fatal Train Crash

    In 2016, Wisner Baum attorney Timothy A. Loranger and six other attorneys in the Plaintiffs’ Management Committee were able to secure a $265 million settlement for victims of the 2015 Amtrak 188 derailment in Philadelphia, one of the largest in the U.S. for 2016.

  • $105 Million Settlement Pharmaceutical Settlement

    Wisner Baum obtained $105 million on behalf of multiple clients involved in a pharmaceutical negligence case.

  • $80 Million Verdict Personal Injury

    Wisner Baum attorneys served on the trial team in the case of Hardeman v. Monsanto Company, which resulted in an $80 million jury verdict for the plaintiff, Edwin Hardeman.

  • $63 Million Settlement Paxil Pediatric Class Action

    $63 million pediatric class action re false promotion of Paxil. Judge approves final terms of improved national pediatric paxil class action settlement – consumers get a better deal.

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