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    Our team is proud to be appointed co-lead counsel for the Gardasil MDL- Multidistrict litigation.

Gardasil Vaccine Lawsuit

Gardasil Lawsuit Update - September 2023

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. The most prominent among these side effects is postural orthostatic tachycardia syndrome (POTS).

To better assist those who are uncertain about their legal rights after suffering from serious health issues after receiving the HPV vaccine, our firm created the Gardasil Injury Compensation Guide. If you believe Gardasil may have caused autoimmune disorders or other injuries, this guide can help answer some of your questions. We have also included some helpful resources for seeking care and support groups.

Gardasil achieved FDA approval in just six months. Even one of the principal investigators of the Gardasil clinical trials (the human testing that precedes FDA approval) said the process “went too fast.”

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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 Lawsuit FAQS

  • 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 vaccine lawsuit against Merck & Co. in civil court.
  • 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:

    • Auto-immune disorders
    • Chronic fatigue syndromes
    • Chronic pain syndromes, including Chronic regional pain syndrome (CRPS)
    • Death
    • Dysautonomia
    • Fibromyalgia
    • Idiopathic Thrombocytopenic Purpura (ITP)
    • Lupus
    • Movement disorders
    • Neurological disorders
    • Postural orthostatic tachycardia syndrome (POTS)
    • Reproductive disorders, including premature ovarian failure (POF)
    • Small fiber neuropathy

    If you or someone in your family suffered from any of the adverse events listed above, we recommend that you consult with a Gardasil side effects lawyer about your case.

  • 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.

  • Can Vaccine Manufacturers Be Sued in Civil Court or Do They Have Immunity?

    The National Childhood Vaccine Injury Act provides that an individual may bring a civil lawsuit under certain circumstances, and if such a lawsuit is in accordance with the provisions of the Act, including:

    1. File a petition with The United States Court of Federal Claims (Vaccine Court);
    2. Either wait the required 240 days for the petition to be resolved in Vaccine Court or await receipt of a Judgment from the Vaccine Court; and,
    3. Elect to opt-out from the Vaccine Court after the passage of 240 days, or reject the Judgment from the Vaccine Court and file a lawsuit in civil court directly against the vaccine manufacturer.

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Gardasil Injury Attorney Team with Proven Track Record Against Major Pharmaceutical Companies

Wisner Baum represents individuals who were harmed by HPV vaccine side effects. If you or a member of your family suffered an adverse reaction after a Gardasil injection, we recommend that you speak with an experienced attorney to discuss the possibility of pursuing a Gardasil shot lawsuit. Even if you suffered from Gardasil side effects years after injection, you may have a claim.

Learn more about the Gardasil HPV Vaccine Multidistrict Litigation (MDL) in this interview with Gardasil injury lawyer and Wisner Baum senior shareholder Bijan Esfandiari. The Gardasil MDL, which was approved after this interview was conducted in August of 2022, allows HPV vaccine injury cases to move into coordinated discovery and pretrial proceedings. People who allege in  lawsuits that they sustained debilitating Gardasil side effects will now be able to have their day in court.

Wisner Baum is evaluating lawsuit claims based on the following HPV vaccine side effects after the Gardasil shot (or shots):

  • Auto-immune disorders
  • Chronic fatigue syndromes
  • Chronic pain syndromes, including Chronic regional pain syndrome (CRPS)
  • Death
  • Dysautonomia
  • Fibromyalgia
  • Idiopathic Thrombocytopenic Purpura (ITP)
  • Lupus
  • Movement disorders
  • Neurological disorders
  • Postural orthostatic tachycardia syndrome (POTS)
  • Reproductive disorders, including premature ovarian failure (POF)
  • Small fiber neuropathy

If you or someone in your family suffered side effects related to the HPV vaccine, 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.

Gardasil Vaccine Lawsuit Update

September 12, 2023: As of today, there are 94 Gardasil claims pending in the MDL with more cases expected to make their way into civil court over the next few months. Our firm has 135 cases that will soon be filed in the MDL as they have completed their obligation in the United States Court of Federal Claims, Vaccine Injury Compensation Program (VICP). We have an additional 66 Gardasil claims pending in the VICP and 52 cases soon to be filed in the VICP.

September 1, 2023: The federal Judge overseeing the Gardasil MDL has indicated that the litigation will be bifurcated into two phases. The first phase will address the issue of general causation (whether the HPV vaccine is capable of causing the alleged side effects). The second phase will address all remaining liability and damage issues. 

Thirteen of the 16 plaintiffs selected as bellwether candidates have filed amended complaints, per the latest case management conference on August 29. Additionally, one of the cases Merck chose as a bellwether candidate was dismissed with prejudice. The company will soon select a replacement. 

With nearly 100 cases in the MDL, there are currently hundreds of additional claims making their way through Vaccine Court. We believe many of these cases will enter the MDL in the coming months. 

August 23, 2023: As of today, there are 92 Gardasil lawsuits pending in the MDL. In September, our firm and colleagues with cases in the MDL will start conducting depositions. A deposition is an important part of the discovery process where attorneys question experts, company representatives, and other parties under oath. In these depositions, we plan to gather testimony and facts about what Merck knew about Gardasil and its potential to cause injuries, and more. 

Other upcoming events in the Gardasil MDL: Plaintiff Expert reports are due in March of 2024, and we anticipate an order on summary judgment in the fall of 2024. This order will determine the next phase of the litigation. If Judge Conrad denies Merck’s motion for summary judgment, the litigation will move toward trial. 

July 26, 2023: Gardasil lawyers at Wisner Baum and colleagues in the federal MDL recently submitted a joint report to the judge overseeing the litigation. The report detailed progress as attorneys prepare the initial group of bellwether cases. Bellwether trials are essentially test cases that indicate potential results for the pool of similar lawsuits. 

A total of 16 claims were selected as bellwether cases; the plaintiffs selected five cases, Merck selected five cases, four were selected at random, and U.S. District Judge Robert J. Conrad selected the remaining two. The first Gardasil trial in the federal MDL will likely occur in late 2024 or early 2025. 

Although the outcomes of the bellwether trials will not be binding on other claims, they will be closely monitored to assess how juries respond to the evidence and expert testimony. The average payouts in these cases may influence settlement offers from Merck to avoid individual cases going before juries.

As of this writing, there are at least 89 cases in the Gardasil MDL, though we expect this number to increase significantly in the coming months as hundreds of claims are pending in Vaccine Court. Those who allege HPV vaccine side effects must first bring their claims to Vaccine Court before they can file a lawsuit against Merck in civil court. 

June 14, 2023: The judge overseeing Gardasil lawsuits consolidated in the federal MDL has ruled that bellwether trials will involve plaintiffs who allege the HPV vaccine caused POTS (postural orthostatic tachycardia syndrome) or primary ovarian failure (POF) / primary ovarian insufficiency (POI).

May 22, 2023: Gardasil lawsuits are progressing in the federal MDL. As of this date, there are 86 cases in the Gardasil MDL, many of which were filed on behalf of our clients. We have 88 other Gardasil cases that have gone through Vaccine Court and are being worked up for filing in civil court. Over 100 cases are pending in Vaccine Court with 32 others that are being prepared to file.

While the Gardasil MDL is where federal cases are consolidated, there are Gardasil cases filed in California state court as well. As of this date, seven are pending in California.

April 6, 2023: We are pleased to report that the judge overseeing the federal Gardasil MDL in North Carolina recently ordered Merck to produce its entire database of Gardasil adverse events to attorneys representing women and men suing the company over Gardasil-induced autoimmune conditions. With the order, plaintiffs’ attorneys and their experts will have access to Merck’s adverse event database under a protective order.

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Gardasil Lawsuit Seeks Punitive Damages Against Merck for Fraud, Deceit and Negligence

Wisner Baum 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 vaccine lawsuit also seeks punitive damages due to Merck’s alleged deceit and fraud.

Talk to a Gardasil Lawyer About Your Claim

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We believe our track record speaks for itself. But you don’t have to take our word for it. See what our clients have to say about working with us.

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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.

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.”

The Gardasil attorneys at Wisner Baum have filed numerous lawsuits on behalf of young adults who suffered Gardasil shot reactions. Many of our clients allege they developed POTS from Gardasil. Others say the HPV vaccine caused other autoimmune diseases and debilitating injuries.

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%).