Gardasil Vaccine Lawsuits

Americans have filed dozens of lawsuits against Merck and its Gardasil vaccine. Across the country, thousands of people claim to have been seriously injured by this vaccine. Their injuries range from autoimmune disorders to death. Learn more about the Gardasil vaccine, your legal rights, and as leaders in the litigation, how The Lanier Law Firm can help. 

Gardasil Lawsuits: A Timeline

Multiple Gardasil vaccine lawsuits are currently ongoing across the United States. Dozens of Gardasil lawsuits have been filed against Merck in federal court.

  • In August 2022, the U.S. Judicial Panel on Multidistrict Litigation took steps to
    consolidate these individual claims.
  • In September 2022, lawyers representing those plaintiffs filed a position statement detailing their claims against Merck & Co., the Gardasil manufacturer. Included in these claims were Merck’s failure to warn of potential neurological and autoimmune injuries, Merck’s masking and downplaying of these risks, Merck’s negligence in its clinical trials and pharmacovigilance, and Merck’s misrepresentation of Gardasil’s efficacy.
  • On October 11, 2022, the judge held a status conference where he confirmed the appointments of the plaintiff’s leadership, including The Lanier Law Firm’s Rachel Lanier. It is estimated that Gardasil survivors and their families will soon file hundreds of claims in multidistrict litigation (MDL).
  • In 2023, the first Gardasil lawsuits are expected to go to trial.

Merck's Potential Misrepresentation of Gardasil's Efficacy

Merck received FDA approval in 2006 and marketed its Gardasil vaccine as a safe and effective way to prevent HPV infections. However, evidence has arisen that the Gardasil vaccine may cause serious and disabling side effects. Numerous lawsuits have been filed against Merck for issues like failure to warn of the Gardasil vaccine’s potential dangers. Plaintiffs claim the Gardasil vaccine’s manufacturer did not provide adequate warning of possible side effects associated with the product.

Potential Issues With the Vaccine Act

The Vaccine Act, or the National Childhood Vaccine Act of 1986, prohibits certain failures to warn and design defect claims against manufacturers. However, federal law does allow for negligence claims. The Vaccine Act created a no-fault compensation program for children injured by vaccines. It offers an alternative to the traditional U.S. tort system, where people harmed by certain vaccines can receive compensation.

You may file a petition under the Vaccine Act if the injury in question:

  • Lasted more than six months after vaccination; or
  • Resulted in inpatient hospitalization and surgery; or
  • Resulted in the patient’s death.

If the injury meets one of the above specifications, then you must file your petition within the following deadlines:

  • You must file injuries within three years of the first symptom or the significant aggravation of the injury.
  • Deaths must be filed within two years of the death and four years of the first symptom or the significant aggravation of the injury.

In some limited cases, the Court may extend a deadline.

Gardasil and HPV vaccines, in general, are covered under the Vaccine Act.

Potential Compensation Via the Vaccine Injury
Compensation Program

Congress created the National Vaccine Injury Compensation Program to allow petitioners to seek compensation for injuries and death following the administration of certain vaccines. The program is designed to provide relief to victims in a flexible, swift, and less adversarial environment than traditional U.S. tort litigation.

Since the Vaccine Court’s inception, it has awarded approximately $4.9 billion in vaccine injury compensation to 7,075 parties.

What Is the Gardasil Vaccine?

Healthcare providers use the Gardasil vaccine to vaccinate men and women against the human papillomavirus (HPV), the most common sexually transmitted infection in the U.S. More than 150 strains of the virus exist, and while most infections resolve on their own, more than 40 strains can cause cancer. The U.S. Food and Drug Administration (FDA) approved the first-generation Gardasil vaccine in 2006 and the newer Gardasil 9 vaccine, which aims to protect against more virus strains, in 2014. Gardasil helps prevent the spread of different strains of HPV and can help prevent cervical cancer if women receive the vaccination before being exposed to HPV. It can also help prevent vulvar and vaginal cancer. The U.S. Center for Disease Control (CDC) recommends that all 11 and 12-year-old Americans receive HPV vaccinations, along with anyone up to age 26 who has not yet received the Gardasil shot. The FDA has approved the vaccine for adults up to 45 years old.

Gardasil Vaccine Schedule 

The CDC recommends the following Gardasil vaccinations for protection against HPV:

  • Routine vaccine: for 11- to 26-year-olds, although children as young as nine may be vaccinated
  • Catch-up vaccine: for 13- to 26-year-olds
  • Shared clinical decision-making: for 27- to 45-year-olds

Gardasil Schedule for Children Under 15

A two-dose schedule is recommended for those who receive the vaccine before turning 15. In this situation, the second dose is administered 6 to 12 months after the first dose. The minimum interval between the first and second shots is five months. If the shot is administered less than five months after the first, then a third shot should be administered at least 12 weeks after the second. Although the second dose is recommended between 6 to 12 months after the first, there is no maximum interval, so interrupted vaccine schedules do not require re-administration.

Gardasil Schedule for Ages 15 and Older

Only one shot is necessary for those receiving their first vaccination at 15 or older. If you received the first shot before turning 15, a second shot is recommended to complete the schedule.

Gardasil Side Effects

Although the Gardasil vaccine is considered safe and effective at preventing HPV infections and related cancers, some people experience side effects ranging from mild to severe.

The most common side effects are mild irritations, like soreness at the injection site.

Common side effects of the Gardasil vaccine include:

  • Pain, swelling, or redness at the injection site
  • Muscle or joint pain
  • Nausea
  • Headache
  • Feeling tired
  • Fever

Serious side effects can be life-threatening. Severe allergic reactions to the Gardasil vaccine include:

  • Elevated heart rate
  • Difficulty breathing
  • Dizziness
  • Weakness
  • Hives
  • Swelling of the throat and face


These allergic reactions can be severe, and anyone experiencing them should call emergency services or visit the nearest hospital.

Long-Term Effects of the Gardasil Vaccine

The Gardasil vaccine is meant to offer beneficial long-term effects, like protecting the vaccinated from HPV infections and certain related cancers. However, some rare but serious long-term side effects can include:

  • Guillain-Barre Syndrome
  • Blood clots
  • Asthma
  • Intestinal and stomach lining inflammation


These long-term side effects of the Gardasil vaccine are rare but do occur. If you believe you have suffered from these side effects, contact our pharmaceutical attorneys today.

Potential Dangers of Merck's Gardasil Vaccine

Merck’s Gardasil vaccine is currently approved for use. It is known to reduce the risk of HPV infections and related cancers and is expected to prevent roughly 75% of cervical cancer. While the health benefits of the Gardasil vaccine may be substantial, understanding the potential dangers associated with Merck’s vaccine is essential.

Most Gardasil side effects are minor and temporary, like soreness or bruising at the injection site. However, certain rare and severe long-term side effects can have devastating results. For example, Guillain-Barre Syndrome is a rare, long-term side effect linked to the Gardasil 9 vaccine. Guillain-Barre Syndrome occurs when a person’s immune system attacks their nerves, and it can result in muscle weakness and even paralysis.

A peer-reviewed study in 2009, coauthored by the CDC and FDA, reviewed Gardasil’s safety data for certain adverse events reported between the vaccine’s licensure from June 2006 through December 2008. The report details 12,424 reported adverse events to the Gardasil vaccination. Of these reported events, 772 (6.2%) were classified as serious. The safety review assessed the following serious and non-serious adverse events:

  • Hypersensitivity reactions like hives, rashes, itchiness, and anaphylaxis
  • Injection site reactions
  • Dizziness
  • Nausea
  • Fainting
  • Guillain-Barre Syndrome
  • Pancreatitis
  • Transverse myelitis
  • Venous thromboembolic events
  • Motor neuron disease
  • Autoimmune disorders
  • Death

The article notes 56 cases of blood clot reports, of which 31 were confirmed. The article also notes 32 reports of death associated with the Gardasil vaccine by the end of 2008.

Why Should You Choose The Lanier Law Firm for Your Gardasil Lawsuit?

If you or a loved one suffered side effects from Merck’s Gardasil vaccine, a trusted legal team can help. The Lanier Law Firm wants to hear your story and help you pursue legal action. We know what it takes to stand up to big pharma companies like Merck and win. We won the first-ever verdict against Merck, leading to a $4.85 billion national settlement over Merck’s drug Vioxx.

At The Lanier Law Firm, we understand pharmaceutical liability, and we know Gardasil. Rachel Lanier of The Lanier Law Firm was recently appointed co-counsel on the Gardasil multidistrict litigation. She is one of four attorneys appointed to serve as litigation leadership for Gardasil survivors suffering severe side effects from Merck’s vaccine.

Frequently Asked Questions

Understanding key facts and context about the Gardasil vaccine, recalls, and other lawsuits will help you consider your options if you suspect the vaccine has caused you or your loved one to experience injury or adverse side effects.

Is there a lawsuit against Gardasil?

Multiple lawsuits against Merck for serious side effects associated with its Gardasil vaccine are pending. More than 30 lawsuits have been filed, with more than 50 pending. Many of these lawsuits will be consolidated under the MDL.

Why was Gardasil recalled?

In October 2020, Merck issued an urgent voluntary vaccine recall of Gardasil 9 belonging to Lot R030456. Merck recalled the Gardasil vaccine because some units were stored at inappropriate temperatures during shipment to a third-party delivery service.

What is the problem with the Gardasil vaccine?

Many have complained of negative side effects after receiving Merck’s Gardasil vaccine. Complaints range from dizziness and fainting to developing autoimmune disorders and even death.

Was Gardasil taken off the market?

The last doses of Gardasil-4 expired on May 1, 2017, and it is no longer on the market. Since late 2016, Gardasil 9 is the only HPV vaccine distributed in the U.S.

Schedule a Free Consultation With Our
Winning Gardasil Lawyers Today

If Merck’s Gardasil vaccine against HPV has harmed you or a loved one, you may have legal options even if you’re experiencing Gardasil side effects years later. The Lanier Law Firm is committed to holding pharmaceutical companies accountable. Schedule a free consultation with our experts to get answers to your questions and more information about your options.

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