Lawsuits Claim Gardasil Infertility Risk Information Was Withheld from Parents, Doctors

For years, Merck & Co. has aggressively marketed the Gardasil vaccine as a safe and effective treatment to help prevent children from developing the human papillomavirus infection, which can lead to cervical cancer and other adverse health conditions later in life. However, a growing number of Gardasil lawsuits now allege parents and the medical community were never adequately warned that the HPV vaccine may cause infertility, autoimmune diseases and other complications.

Nearly 100 lawsuits have already been filed against Merck in the federal court system, with a substantial number of additional claims are pending in the U.S. Vaccine Court, where families must initially bring a petition seeking compensation under the National Vaccine Injury Compensation Program, before they are able to bring a civil lawsuit if the claim is not resolved within eight months.

The complaints each raise similar allegations, indicating that Merck withheld information from families about the risk that the Gardasil human papilloma virus vaccine can trigger a negative reaction within the body, leading to a host of autoimmune diseases, such as Postural Orthostatic Tachycardia Syndrome (POTS), Lupus, Idiopathic Thrombocytopenic Purpura (ITP) and others.

Some lawsuits also claim that autoimmune disease caused by Gardasil resulted in hormonal disruptions and damage to reproductive organs, which can result in long-term infertility risks from conditions like:

• Polycystic ovary syndrome (PCOS)
• Premature ovarian failure (POF)
• Primary ovarian insufficiency (POI)
• Premature menopause

While the U.S. Centers for Disease Control and Prevention (CDC) and other health organizations continue to support the use of Gardasil, there are increasing questions about whether accurate information about the Gardasil HPV vaccine safety risks were adequately disclosed to families, doctors and regulators.

In this featured post, AboutLawsuits.com will delve deeper into the allegations raised in a growing number of Gardasil infertility lawsuits, outlining the science behind the link between infertility and HPV vaccines, and take a closer look at the status of the growing Gardasil litigation.

Can the Gardasil HPV Vaccination Cause Infertility?

While lawsuits do not indicate the Gardasil human papillomavirus vaccination causes infertility directly, the claims point to research suggesting the vaccine causes the onset of certain auto immune diseases that disrupt hormones, menstrual cycles and can cause chronic inflammation damage to ovaries, leading to infertility later in life.

How Can An Autoimmune Disease From Gardasil Cause Infertility?

The Gardasil HPV vaccination can trigger a strong immune response and produces antibodies to defend against certain strains of HPV. Lawsuits indicate this can lead to the immune system mistakenly attacking the body’s own proteins and organs.

These side effects may occur due to the significant similarity between HPV and human proteins. As a result, individuals claim that Gardasil causes autoimmune diseases to develop in various organs of the body through a phenomenon referred to as “molecular mimicry.”

Research has pointed to several methods in which autoimmune diseases can lead to infertility, including;

Which Auto Immune Diseases From Gardasil May Cause Infertility?

A number of filed lawsuits involve allegations that Gardasil caused POTS (Postural Orthostatic Tachycardia Syndrome) or Lupus, which resulted in hormone changes, organ dysfunction or chronic conditions that may lead to fertility problems later in life when they attempt to conceive.

As such, Gardasil lawsuits are claiming these autoimmune disease disruptions to the normal function of the female reproductive system have caused women to experience Polycystic Ovary Syndrome (PCOS) and Premature Ovarian Failure (POF).

Does Gardasil Cause Polycystic Ovary Syndrome (PCOS)?

Claims have pointed to emerging medical theories that suggest the use of aluminum hydroxy phosphate sulfate in the Gardasil human papillomavirus vaccine can stimulate an immune response that influences the production of hormones related to PCOS, such as insulin or androgens.

Polycystic ovary syndrome (PCOS) is a condition related to a hormonal imbalance that affects women of reproductive age. The hormonal imbalance associated with PCOS primarily involves an excess of androgens, which are male sex hormones usually present in women in small amounts. The excess production of these hormones in the ovaries can lead to symptoms such as irregular menstrual cycles, missed periods, and the formation of small follicle cysts, among other things.

The main cause of infertility in women with PCOS is the absence of ovulation due to high levels of androgens in the body, which interfere with the growth and release of eggs from the ovaries at regular monthly intervals

Diagnosing PCOS is not always straightforward because of the variety of symptoms and hormonal imbalances it can cause. These imbalances may prevent a regular menstrual cycle from occurring and can vary from one woman to the next. However, common diagnostic criteria often include irregular periods, high levels of androgens, and the presence of polycystic ovaries

PCOS Infertility Rates Among U.S. Women

Polycystic ovary syndrome (PCOS) has become one of the most common causes of female infertility. It affects up to 10% of women of reproductive age (between the ages of 15 and 44) globally, and it has been shown that up to around 70-80% of women with PCOS have fertility issues.

According to the Centers for Disease Control and Prevention (CDC), PCOS is responsible for up to 25-30% of infertility in couples seeking treatment. In the U.S, it’s estimated that between 5-10% of women of childbearing age have PCOS.

Symptoms of PCOS After Gardasil HPV Vaccination

PCOS is a hormonal disorder that can cause a variety of symptoms, which can vary significantly from one individual to another. Some of the symptoms might include:

• Irregular menstrual cycle: This is the most common symptom and frequently serves as one of the earliest signs of PCOS. Women with PCOS may experience less than nine menstrual cycles in a year, encounter menstruation cycles that occur every 21 days or less, or grapple with unpredictable and inconsistent cycles.
• Heavy bleeding: The menstruation cycles that do occur can be heavier than normal.
• Excess androgen: High levels of androgen, a male hormone, can result in physical signs such as excess facial and body hair (hirsutism), severe acne, and male-pattern baldness.
• Polycystic ovaries: The ovaries might be enlarged and contain follicles that surround the eggs. This can result in the ovaries failing to function regularly.
• Weight gain or difficulty losing weight: Many women with PCOS experience weight gain or have a hard time losing weight.
• Darkening of the skin: Some women with PCOS have dark patches of skin on the back of the neck, in the groin, and under the breasts.
• Skin tags: These are small pieces of skin that pop up in the armpits or neck.

Is Gardasil Linked to Premature Ovarian Failure (POF)?

Premature ovarian failure (POF) and adolescent premature ovarian insufficiency (POI) are considered serious autoimmune disorders that have been linked to the Gardasil HPV vaccine, according to lawsuits. These claims allege that Gardasil’s aluminum content can destroy the maturation process of the eggs in the ovaries, leading to premature ovarian failure or progressive insufficiency.

Premature ovarian failure and premature ovarian insufficiency are terms used to describe a condition where the ovaries stop functioning normally before the age of 40. While the two conditions share similarities POF is considered a complete and permanent loss of ovarian function, while POI is categorized as intermittent dysfunction. However, each condition can result in infertility.

Studies Linking Gardasil To Premature Ovarian Failure

In recent years there have been several studies that that suggest there is a link between premature ovarian failure and Gardasil, which have been used to support the claims being made in Gardasil infertility lawsuits.

In July 2020, a study published in Scientific Reports looked at human papillomavirus (HPV) vaccine data from FDA Vaccine Adverse Event Reporting System (VAERS), and found a concerning pattern of reports of premature ovarian insufficiency (POI) and related issues after receiving the human papillomavirus (HPV) vaccine. Researchers identified reports that included problems like amenorrhea (absence of menstruation), irregular menstruation, increased FSH levels, and premature menopause following the vaccine.

A second study published in March 2022, in the medical journal Drugs Real World Outcomes, also reviewed data on primary ovarian failure reports submitted to the FDA’s VAERS, and found a significant increase following the release of Gardasil.

Researchers indicated the number of reported POF events significantly increased after the first first vaccine for the HPV infection was launched in 2006, with 22.2 POF cases/year up from 1.4 POF cases/year before the launch. The researchers stated that the increased Gardasil adolescent vaccination rates coincides with the increase of POF cases.

Lawsuits Claim Gardasil Causes Infertility

As a result of the failure to warn about these infertility risks, Merck & Co. now faces lawsuits brought by parents of young teens, as well as adults who developed an autoimmune disease after the HPV vaccine, which has left them facing infertility issues later in life and other long-term health complications.

Given similar questions of fact and law raised in the complaints, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order of August 4, 2022, creating a Gardasil MDL (multidistrict litigation), which has centralized all claims brought in the federal court system before U.S. District Judge Robert J. Conrad in the Western District of North Carolina for coordinated pretrial proceedings.

To help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of claims brought by individuals nationwide, Judge Conrad ordered the parties to each select five cases for inclusion in a bellwether pool in March 2023. Two additional cases were added to the pool by the Court, which had already been filed in the Western District of North Carolina before the Gardasil vaccine lawsuits were consolidated, and another four were to be randomly selected by the Court.

In a joint status report filed on June 20, the parties described pretrial preparations in these 16 cases, which should be ready for the first Gardasil bellwether trials to begin in late 2024 and early 2025.

Depending on how juries respond to certain evidence and testimony presented in the first trials, the manufacturer may begin Gardasil lawsuit settlement talks in an attempt to resolve certain claims involving infertility or specific autoimmune conditions, or the Court may begin remanding claims back to different U.S. District Courts nationwide for separate trial dates.

Gardasil Polycystic Ovary Syndrome (PCOS) Lawsuit Selected For Early Bellwether Trial

Among one of the first 16 lawsuits selected to go before juries is a Gardasil Polycystic Ovary Syndrome (PCOS) lawsuit (PDF) that was filed by Maeson Derr in the U.S. District Court for the Middle District of North Carolina back in August 2022.

According to the lawsuit, Derr claims that after receiving her first and only Gardasil HPV vaccination on June 2, 2015, when she was 13 years old, she almost immediately began to suffer from a constellation of symptoms including migraines, anxiety, chronic pain, weight loss and irregular menstrual cycles irregularities.

In the years following her Gardasil vaccination, Derr states that she has continuously suffered from a wide range of side effects and has been diagnosed with multiple debilitating conditions including autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia.

Derr states that in recent years she has also been diagnosed with polycystic ovarian syndrome, and cysts on her breast requiring surgery and reconstruction, and Factor XII deficiency blood diseases, that she claims have all been caused by the Gardasil injection.

Who Qualifies For A Gardasil Infertility Lawsuit?

As the news about auto immune diseases and infertility risks linked to Gardasil continues to spread, Gardasil injury lawyers are actively investigating Gardasil lawsuits for individuals who experienced a variety of side effects or have been diagnosed with any of the following conditions after receiving the Gardasil HPV vaccine:

• Autoimmune Diseases
• POTS (Postural Orthostatic Tachycardia Syndrome)
• Premature Ovarian Failure
• Premature Menopause
• Polycystic Ovary Syndrome (PCOS)
• Idiopathic Thrombocytopenic Purpura (ITP)
• Irregular Heartbeat/Tachycardia
• Lupus
• Neurologic Disorder
• Brain Fog or Chronic Inability to Concentrate
• Chronic Fatigue
• Chronic Pain
• Severe Headaches
• Difficulty Sleeping
• Fibromyalgia
• Nerve Damage
• Menstrual Disorders/Problems
• Gastrointestinal Issues (food intolerances, nausea, vomiting)