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What Is the Gardasil® Claim? 

Gardasil® is an HPV vaccine developed by Merck and Co. FDA approved the vaccine in 2006 for HPV types 6, 11, 16, and 18 and prevention of cervical cancer. The vaccine started showing adverse effects in patients, which led to the filing of a Gardasil® class action lawsuit. 

Human papillomavirus (HPV) is a group of viruses that causes infection in adolescents and adults. It consists of hundreds of viruses that cause infection of the genitals (vagina, cervix, penis, etc.) and oral region (tonsils, lips, and base of the tongue). 

Studies show that vaccine programs for HPV (against HPV-16 and HPV-18) are effective in preventing the virus.

Gardasil is an HPV vaccine developed by Merck and Co. FDA approved the vaccine in 2006 for HPV types 6, 11, 16, and 18 and prevention of cervical cancer. The vaccine started showing adverse effects in patients, which led to the filing of a Gardasil class action lawsuit. 

So, what type of problems did the Gardasil vaccine cause? The list of side effects is a long one. This article discusses the details regarding the allegations against Gardasil, the Gardasil lawsuit settlement, and updates on the Gardasil lawsuit 2022.

Gardasil® Lawsuit Allegations

The Gardasil class action lawsuit claims that Merck and Co. are alleged to have run a fraudulent campaign and misguided the general public regarding the efficacy and safety of the vaccine. The lawsuits allege that the company has maliciously concealed the health risks associated with the vaccine. 

The HPV Gardasil vaccine lost its credibility due to dubious clinical trials (published in Clinical and Vaccine Immunology) to test the safety and efficacy of the vaccine. The group participants of the vaccine trial were supposed to receive a placebo or an inactive solution (as mentioned in the consent form). 

However, all the participants received amorphous aluminum hydroxyphosphate sulfate. The inclusion of this immune response-enhancing adjuvant blinded the safety and efficacy of the vaccine. 

A RIAT, i.e., Restoring invisible and abandoned trials initiative, concluded that the selection of a “control” lacked clinical relevance. This maneuver may have obscured the accurate analysis and assessment of the Gardasil vaccine safety.

POTS (Postural Orthostatic Tachycardia Syndrome) and other health problems are frequently reported in victims suffering from HPV Gardasil vaccine side effects. Some of the devastating side effects experienced by those who received the Gardasil vaccine include 

  • Auto-immune disorders 
  • POTS
  • Dysautonomia
  • Fibromyalgia
  • Neuropathy
  • Lupus

These adverse side effects led several victims to pursue a lawsuit against Gardasil, claiming that Merck conducted deceptive and unscientific clinical trials to falsely exhibit the effectiveness of the vaccine.

Young women are more prone to developing these severe and debilitating side effects with the vaccine. Merck did not inform of the extent of the side effects; instead falsely advertised the superior results of the Gardasil vaccine in preventing HPV and the health complications like cervical cancer.

Clinical trials have revealed a weak link between HPV vaccination and cervical cancer prevention. According to a critical appraisal of efficacy trials (of HPV vaccine), the vaccine did not target the causative agents of cervical cancer. 

Thus, the data is insufficient to claim that an HPV vaccine can be effective in the prevention of HPV and cervical cancer. 

By 2020, several individuals reported the potential nexus between the HPV vaccine and auto-immune diseases. The first few lawsuits against Gardasil for auto-immune disorders were filed in 2020 and gradually increased during 2021. 

As for the Gardasil lawsuit 2022 update, there were 34 pending Gardasil lawsuits in different federal districts (25) as of July 2022. The lawyers of the affectees filed a motion asking the JPML (Judicial Panel On Multidistrict Litigation) to create a new MDL (multidistrict litigation) Gardasil vaccine class action lawsuit. The MDL for the Gardasil vaccine was formed in August 2022.

Merck is trying to reach a Gardasil lawsuit settlement by arguing that MDL will conflict with the federal vaccine laws and lead to the promotion of vaccine hesitancy. However, the panel rightfully agreed to the MDL consolidation.

Another update on the Gardasil lawsuit 2022 is that the honorable judge will hold a conference (first of its kind) with the lawyers (for all parties) on 11th October 2022. The steering committee will take decisions on behalf of all the plaintiffs.

Why Was Gardasil® Recalled? 

On 16th December 2013, the manufacturers of Gardasil, i.e., Merck, informed the Centers for disease control and prevention (CDC) that they are voluntarily recalling one lot of Gardasil. Lot J007354 of Gardasil for HPV (6,11, 16, and 18 types) was planned to be redrawn. 

This step was taken because it was suspected that a small number of vials contained glass particles inside. The glass particles made their way into the vaccine vials due to breakage during manufacturing. 

The breakage and glass contamination only affected the vials that were distributed on 20th August 2013 and 9th October 2013. However, no other vaccines were affected. 

The only possible adverse reactions with glass contamination include mild reactions (redness, swelling) at the injection site.

Who Was Affected by Gardasil®?

The Gardasil class action lawsuit alleges Merck of launching a misleading market campaign for the HPV vaccine without proper research and clinical trials. Thousands of young men and women have come forward and reported adverse effects of Gardasil. 

Julia B, a 19-year-old Rhode Island resident, filed a lawsuit against Merck and Co. in August 2020. The young lady complained that Merck misled and overstated the vaccine's benefits without informing her of the side effects. 

The victim received the first and second doses of the HPV vaccine in August 2013 and October 2014, respectively, at the age of 13. The vaccine injections caused her to experience a range of side effects, including:

  • Flu-like symptoms 
  • Muscle pains and aches
  • Tinnitus (ringing sound in ears)
  • Headaches and migraines
  • Dizziness 
  • Fatigue 
  • Heart problems 

The vaccine continued to pose problems for the young lady for six years. The symptoms aggravated, and she was ultimately diagnosed with multiple auto-immune disorders, including:

  • Fibromyalgia 
  • Orthostatic Intolerance 
  • POTS 

The severe symptoms interfered with her daily activities, and she had to drop out of school. She filed a lawsuit in the U.S. District Court for the District of Rhode Island. 

The Gardasil vaccine continued to affect more individuals, and there was an increase in Gardasil lawsuits. In 2016, Victoria, an intelligent, athletic teenager, faced the negative consequences of the Gardasil vaccine. The ice-skating enthusiast, aged 13, received the first dose of the vaccine in December 2015, and by July 2016, she had received three shots of the vaccine. 

A couple of days after the shots, she reported severe shortness of breath and had to discontinue the game. She also reported symptoms similar to Julia, i.e., dizziness, headaches, and shortness of breath. Victoria also experienced the following symptoms:

  • Chest pain 
  • Blurred vision 
  • Insomnia 
  • Memory loss 
  • Nausea 
  • Appetite issues 
  • Abdominal distention and bloating 

For the next few months, she spent time in and out of clinics/healthcare setups for faulty vaccine-induced cognitive, psychological, and physical problems. Like Julia, Victoria was forced to drop out of school and abandon sports activities due to fatigue and debilitating symptoms. Doctors identified the following auto-immune disorders in Victoria:

  • POTS
  • Ulcerative colitis 
  • Mast cell activation syndrome (MCAS)
  • Hashimoto’s thyroiditis 
  • Fibromyalgia 

However, several studies have been carried out to check the efficacy and safety of HPV vaccines. In the majority of studies, the human papillomavirus vaccine (quadrivalent vaccine) did not trigger the auto-immune disorder in female subjects. 

According to the CDC, the HPV vaccine Gardasil-4 is no longer available in the United States. The last dose of the vaccine expired in May 2017. You can get Gardasil-9 VIS as an HPV vaccine.

What Can I Do if I Think I Was a Victim? 

If you or your loved one has received the Gardasil vaccine and are experiencing any of its adverse reactions, we recommend contacting an experienced vaccine injury lawyer. You can file a claim and might be eligible for compensation and punitive damages under the Gardasil lawsuit settlement.

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