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.”

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.

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.

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 pain syndromes, including Chronic regional pain syndrome (CRPS)

Chronic fatigue syndromes

Chronic inflammatory demyelinating polyneuropathy (CIDP) 

Interconnective tissue disorder

Lupus

Gardasil arthritis

Fibromyalgia

Postural orthostatic tachycardia syndrome (POTS)

Gardasil auto-immune disorders

Heart problems, including severe arrhythmia and heart attacks

Pulmonary embolism

Guillain-Barre syndrome

Multiple sclerosis

Paralysis

Miscarriage

Gardasil epilepsy (seizure disorder)

Reproductive disorders, including premature ovarian failure

Rheumatological disorders 

Birth defects

Small fiber neuropathy  

Cervical intraepithelial neoplasia – CIN 2/3

Coma

Stroke

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.

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

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 FAQ

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:

How Do I File a Gardasil Lawsuit?

  1. 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.
  1. 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.

Who Can File a Gardasil Lawsuit?

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

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

And, the side-effect:

  • Lasted for more than six months after the vaccination; or
  • Resulted in inpatient hospitalization and surgical intervention; or
  • Resulted in death.

If you or someone in your family suffered from any of the adverse events listed above, it is in your best interest to consult with an attorney about your case.

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 lawsuit against Merck & Co. in civil court.

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.

The Gardasil Lawyers

If you or a loved one has suffered serious adverse reactions after a Gardasil 4 or Gardasil 9 injection, it is in your best interest to speak with an experienced pharmaceutical defect attorney about your case. 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 800-827-0087 or contact us for a free and confidential Gardasil case evaluation.

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