All You Need to Know about the Gardasil Lawsuit

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Researcher: Ariana Arce​

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Journalist: Aaron Vivanco

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Editor: Daniela Polo

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All You Need to Know about the Gardasil Lawsuit

Several lawsuits have been filed regarding the Gardasil vaccine, alleging that Merck & Co. concealed the risks of autoimmune diseases and other long-term side effects while promoting the vaccine as a safe and effective treatment for preventing cervical cancer.

HPV Vaccine on a tray.

The plaintiff’s state that Gardasil, a human papillomavirus vaccine, has caused serious illnesses, with the postural orthostatic tachycardia syndrome (POTS) being the most prominent.

In the next article, the Gardasil controversy will be discussed in depth, why it is important for people to know about its side effects and what to do if you were harmed by this product will be understood.

One of our main goals at Legal Help Advisor is giving out important information about harmful medications and corporate negligence, as it has happened with the case you are going to read.

Gardasil HPV Vaccine

Gardasil is a vaccine created by the pharmaceutical company Merck & Co. It is designed to prevent human papillomavirus (HPV) infection, which can potentially result in cervical cancer in women.

Gardasil was approved by the Food and Drug Administration (FDA) in 2006 after Merck fast-tracked its approval. This came after Merck’s significant financial losses from the Vioxx disaster. Gardasil was considered as Merck’s potential savior in terms of revenue. However, Merck failed to learn from their mistakes with Vioxx and repeated many of them.

What Is the Discussion Around Gardasil?

At the heart of these vaccine lawsuits is the controversy that although Gardasil can prevent HPV, it can supposedly cause other serious diseases.

Furthermore, there are claims alleging that the company Merck & Co, the manufacturer of Gardasil, conducted clinical trials in a potentially misleading and hazardous manner.

Moreover, doubts regarding the actual effectiveness of the medication arise as the claims make their way into the US justice system.

Approval of the Gardasil Vaccine

The US FDA ensures the safety and effectiveness of vaccines in the USA. Consumers rely on the FDA for its expert approval process.

In 2006, as the entity in charge, the FDA endorsed Gardasil as a preventive medication associated with four types of HPV. Merck was awarded with an expedited approval from this public institution.

However, Merck is accused of misrepresenting the results and efficacy of its new vaccine. An important part of the claims state that the company did not conduct quality medical investigations and studies before or after approval.

Nevertheless, in 2014, Gardasil-9, produced by Merk, was approved by the FDA. As of today, this medication is the sole HPV vaccine in the USA.

Merck Misrepresented the Efficacy of Gardasil

Vaccines work by imitating bacteria or viruses. They trigger the body’s immune system to develop defenses without inducing the disease itself.

The testing process involves the existence of a placebo control group. This group is composed by people who, as its name indicates, were given a placebo to compare results with the group who were inoculated with Gardasil. However, according to Mary Holland, Kim Mack Rosenberg, and Eileen Iorio, the coauthors of the book The HPV Vaccine on Trial: Seeking Justice For a Generation Betrayed, this did not happen.

They reported that the control group was given a dose of chemicals similar to those in Gardasil, which masked the vaccine’s possible health risks.

Gardasil Lawsuits: Substandard and Misleading Clinical Tests

Plaintiffs argue that Merck got its fast-track FDA approval for Gardasil with substantially deceptive research trial results. The evidence gathered so far by plaintiff-side attorneys, revealed that Merck’s clinical trials for the Gardasil HPV vaccine were not done correctly.

Subsequently, the British Medical Journal reported that Merck used inaccurate methods and suggested that these findings should undergo public scrutiny. The declaration points to the fact that patients in the control group were injected with aluminum hydroxy phosphate (AAHS), an element used in Gardasil to boost the immune response.

Furthermore, it has been alleged that Merck failed to report numerous patient side effects and inaccurately classified some as “new medical conditions” unrelated to the vaccine.

Merck’s Deceptive Marketing Campaign to Push Gardasil

Prior to the release of Gardasil, Merck got hit with the Vioxx scandal, which meant billions spent in settlement agreements for people affected by this defective drug. This is why they saw Gardasil as an opportunity to get back in the profitable way: it was a vaccine for a virus that supposedly affected everyone.

Merck employed its enormous marketing machine to establish the perception of an “HPV public health emergency” as a key component of their market strategy.

Furthermore, Merck offered financial assistance for lobbying endeavors to promote the mandatory administration of the Gardasil vaccine to increase the public awareness. The company invested heavily in marketing Gardasil, resulting in a significant success in multiple regions.

Gardasil Claims and the National Vaccine Injury Compensation Program

A Gardasil lawsuit in Nevada was dismissed after the judge argued that the claim was preempted under the national vaccine injury compensation program (VICP). This means that a higher authority of law will displace one of a lower authority when the two come into conflict.

The VICP went into effect in October 1986. It is a system created by the Federal Government designed to compensate families who experienced adverse effects from covered childhood vaccines.

It was established as a result of the National Childhood Vaccine Injury Act and covers all the vaccines, whether applied by private or public healthcare providers.

Individuals with certain case circumstances can opt to file a petition in the VICP, meaning it would go through a figure called a “vaccine court” or pursue a personal injury lawsuit.

Long-term Gardasil HPV Side Effects and Autoimmune Disorders

The Gardasil HPV vaccine has both mild and innocuous side effects; however, there are also serious adverse reactions and long-term health risks associated with its use, according to the manufacturer.

The Vaccine Adverse Event Reporting System reported a total of 53,337 adverse events for Gardasil and Gardasil-9 in the USA. Out of these, at least 9,600 events were classified as serious, including 547 deaths.

Postural Orthostatic Tachycardia Syndrome (POTS)

POTS is a medical condition characterized by an irregular heartbeat upon transitioning from a seated or lying down position. A growing body of evidence suggests that POTS may be an autoimmune disease.

A research suggests a potential link between the vaccine Gardasil and this condition. The condition generally affects female individuals within the age range of 15 to 50 years.

Premature Ovarian Failure (POF)

Premature ovarian failure, also referred to as primary ovarian insufficiency, is a medical condition characterized by the cessation of ovarian function and the inability to produce eggs before the age of 40 years and before menopause.

A 2020 study found a connection between the Gardasil and premature ovarian failure and premature menopause, with a higher number of adverse vaccine event reports.

Other Possible Autoimmune Disorders and Side Effects

Scientific research on Gardasil discovered that the vaccine induces and increases the risk of many long-term side effects associated with the following autoimmune disorders and reproductive disorders:

  • Reproductive disorders
  • Guillain–Barré syndrome
  • Fibromyalgia
  • Dysautonomia
  • Orthostatic intolerance
  • Myalgia encephalomyelitis/chronic fatigue syndrome
  • Chronic pain syndrome
  • Migraines/severe headaches
  • Persistent gastrointestinal discomfort
  • Widespread pain of a neuropathic character
  • Encephalitis syndrome
  • Autonomic dysfunction
  • Joint pain
  • Brain fog

Gardasil Lawsuit FAQs

Is There a Gardasil Lawsuit?

There are ongoing legal cases against Merck & Co., the manufacturer of Gardasil. These cases involve allegations of failure to warn about the potential risks, misrepresentations, negligence claims, and defective design. Multiple lawsuits have been consolidated into a Multidistrict Litigation (Gardasil MDL) in the Western District of North Carolina.

What to Do If You Are Experiencing Gardasil Vaccine Complications?

If you find any Gardasil vaccine side effects or health complications, the best course of action is to look for your closest medical providers.

Can I File a Gardasil Vaccine Lawsuit?

After seeking proper medical advice, you should be able to make take legal action with an experienced Gardasil attorney. Fill out our form for a free case evaluation today, and you may be eligible for compensation through a civil lawsuit.

What Could I Receive for My Gardasil HPV Vaccine Injury?

 To date, there has been no settlement reached, and no jury has awarded payouts in Gardasil lawsuits due to their consolidation in a federal MDL.

However, as the payouts for Gardasil victims can significantly vary based on specific side effects they experience after receiving the vaccine, the estimated payouts range from $250,000 to $1,000,000. The only way to know exactly how much a claim is worthed is by contacting a legal expert.

Has Gardasil Been Recalled?

Despite all the evidence from vaccine complications, Gardasil is still the only HPV vaccine available in the US Market. The FDA has not issued a recall order.