Lawsuit Information Center
Our lawyers are helping victims who want to bring a Gardasil HVP vaccine lawsuit throughout the United States. Our law firm is particularly focused on ovarian failure cases that lead to infertility in women who have taken Gardasil in the last few years.
Gardasil is a vaccine intended to prevent human papillomavirus (HPV), which can sometimes lead to cervical cancer in women. Gardasil was developed by the embattled pharmaceutical company Merck & Co.
Merck obtained FDA approval for Gardasil in 2006 based on deceptive research and clinical trials that misrepresented the vaccine’s efficacy while concealing its safety risks and side effects. Merck then launched an aggressive and highly misleading marketing campaign to include millions of parents vaccinating their pre-teen daughters with Gardasil.
Filing a Gardasil lawsuit is not an anti-vax statement. A Gardasil vaccine lawsuit is a statement that this specific vaccine that we all assumed was safe might not be.
- Gardasil settlement projections for different types of injuries
Gardasil Class Action Lawsuit Updates in 2024
September 12, 2024 – Appeals MDL Dismissal
Three women involved in the Gardasil multidistrict litigation have announced plans to appeal their cases to the Fourth Circuit U.S. Court of Appeals after their lawsuits were dismissed for failing to file timely petitions in the Vaccine Court.
These women argued for equitable tolling, claiming difficulties in linking their injuries to the Gardasil vaccine, an argument the MDL judge rejected. They will now appeal this decision.
September 3, 2024 – Only 3 New Cases in MDL Last 2 Months
The Gardasil class action MDL has only added 3 new cases over the last 2 months. The total number of pending cases in the MDL is now at 200.
August 4, 2024 – Four Cases Dismissed
The MDL judge has dismissed claims from four patients in litigation concerning injuries allegedly caused by Merck’s Gardasil HPV vaccine.
The dismissal was based on procedural grounds related to the National Childhood Vaccine Injury Act, which requires that any vaccine injury claim be first filed with the federal vaccine injury program, known as “Vaccine Court,” within three years of symptom onset. Three plaintiff, filed their petitions too late and failed to appeal the Vaccine Court’s dismissal of their time-barred claims before pursuing civil actions. (The fourth plaintiff did not file a petition at all and did not respond to the motion to dismiss.)
July 18, 2024 – First Gardasil Trial in Two Months
The Gardasil litigation in state court has outpaced in MDL. The first California state trial, Robi v. Merck, is set for October 7, 2024. The plaintiff in that case alleges severe side effects, including heart problems and nerve pain, from the vaccine.
July 1, 2024 – Case Count
This litigation is not exploding. The Gardasil Products Liability Litigation under Judge Kenneth D. Bell in North Carolina saw a minor increase in active cases from 194 in June to 197 in July 2024.
June 12, 2024 – Bellwether Trial Date To Be Set Soon
Lawyers for both sides in the Gardasil HPV vaccine MDL are very close to completing discovery in the initial group of test cases for bellwether trials. The date for the first Gardasil bellwether trial is expected to be set at the MDL status conference set for tomorrow. It seems likely, however, that the first Gardasil test trial will happen in California state court. The California case features a plaintiff who was allegedly left bed-ridden for life as a result of the Gardasil vaccine.
June 3, 2024 – MDL Approaches 200 Cases
There are now 184 total cases pending in the Gardasil class action MDL. Three months ago there were about 140, so this is not a high volume MDL, but it continues grow.
May 20, 2024 – Merck Seeks Dismissal
Last week, Merck moved to dismiss a group of 3 Gardasil cases from the MDL on the grounds that the plaintiffs in each case failed to exhaust their administrative remedies under the National Vaccine Injury Act. The Vaccine Act requires all plaintiffs in vaccine cases to first bring their claims in vaccine court before filing in civil court.
April 5, 2024 – New Case Study
A new case study has highlighted a significant association between Merck’s HPV vaccine, Gardasil, and the development of postural orthostatic tachycardia syndrome (POTS), an autoimmune condition characterized by chronic lightheadedness, fainting, and rapid heartbeat episodes.
Researchers in Utah documented a woman who developed POTS shortly after receiving the Gardasil vaccine in 2014. This case underscores the potential for the vaccine to initiate autoimmune or autonomic dysfunction, possibly as a result of the immune system’s response to a viral component.
This is one more piece of the puzzle linking POTS and the HPV vaccine.
March 29, 2024 – Judge Rules that Gardasil MDL Can Move Forward
Last month, Merck’s defense team filed a motion asking the MDL Judge to dismiss all of the Gardasil lawsuits on the grounds that the failure to warn claims asserted by the plaintiffs are legally barred under the National Childhood Vaccine Injury Act. Last week, however, MDL Judge Kenneth Bell issued a memorandum opinion denying the motion as to failure to warn. Judge Bell found that the claims that Merck negligently failed to warn healthcare providers about the potential risks of Gardasil are not fully barred under the Vaccine Act, nor are claims that Merck fraudulently concealed these risks. This ruling is significant because it clears the way for the Gardasil litigation to move forward into the next phase, which could prompt Merck to seek a global settlement deal.’
March 1, 2024 – 39 Cases Added to MDL Since Start of Year
There are now 143 total cases pending in the Gardasil class action MDL. Since the start of this year, a total of 39 new cases have been added to the MDL.
January 9, 2024 – Status Conference in MDL
Today, Judge Conrad will meet with lawyers about the Gardasil lawsuit. The judge will check on how things are going and listen to both sides about any issues they’re having with gathering information for the case. Before the meeting, both sides agreed on some topics to talk about. They’ll discuss how they plan to share information, give an update from Merck and figure out how to work with similar cases happening in state court in California, and talk about where the Gardasil lawsuits are going in 2024.
They also shared a report saying they’ve finished questioning people about how Merck watched for Gardasil’s side effects and how they tested the drug. They plan to question more people from Merck in the next few months.
The people suing have asked for more documents from Merck, but Merck doesn’t want to give three of those. They’re still trying to work out this disagreement. Big companies do not like to produce documents for one of two reasons: (1) they have something to hide, or (2) they are reflexively oppositional.
Both sides have also asked to have more time to prepare these lawsuits, and this will be discussed at the meeting today.
Here are some of the key deadlines coming up:
| Event | Deadline |
|---|---|
| Written Discovery Completion | February 15 |
| General Causation Expert Discovery Completion | August 30 |
| Deadline for Motions on General Causation Expert Testimony Admissibility | October 11 |
| Hearings on General Causation (Daubert) | Late January 2025 |
| Jury Trials Scheduled | Following the Hearings |
If you are putting this on a calendar, circle the Daubert hearing. That is what will make or break this litigation.
January 1, 2024 – MDL Adds 28 New Cases
The class action MDL involving the Gardasil HPV vaccine only has 132 pending cases. That is an increase of 28 new cases over the last 30 days, which marks one of the highest monthly volumes since the start of the litigation.
Gardasil Class Action Lawsuit Updates in 2023
December 1, 2023 – Case Count in MDL 3036
There are now 104 filed lawsuits in the MDL class action.
October 2, 2023 – MDL Status Hearing
Last week, a status hearing was held in the Gardasil MDL to provide the MDL Judge with updates on various issues. The topics included efforts to resolve the ongoing dispute over Merck’s document production, limits on the scope of discovery, and updates on the bellwether cases.
September 28, 2023 – Gardasil Lawyer Meeting
There was a status conference on Tuesday in the Gardasil class action. The topics were discovery dispute and limit an update on the bellwether Gardasil lawsuits that are being prepared for trial.
September 15, 2023 – What Is a Lexecon Waiver?
The only Gardasil lawsuits that will be bellwether trial cases have a Lexecon waiver. What is a Lexecon waiver?
A Lexecon waiver is an agreement that waives the right to challenge the venue (location) for where the suit is tried. So cases that belong in other jurisdictions can be tried in North Carolina instead of their home states so the MDL judge can preside over the trial.
September 1, 2023 – Getting Cases Ready for Trial
In June, sixteen bellwether cases for the Gardasil class action lawsuit were chosen by both plaintiffs and defendants to undergo early test trials to help determine settlement amounts.
In a recent pretrial conference with Judge Conrad this week, Gardasil lawyers discussed the progress of the litigation. According to a new status report, 13 of the 16 plaintiffs have amended their complaints, and Merck has responded with case-specific answers.
Merck intends to subpoena the parents of plaintiffs for depositions, given that many plaintiffs received the vaccine at a young age. One case in the bellwether pool was dismissed and will be replaced to maintain equal numbers.
We are getting closer to having the first trial in these lawsuits.
August 28, 2023 – 92 Cases Pending in MDL
When the Gardasil class action MDL was first established in September 2022, it had just 20 pending cases. A few months later, in January 2023, the MDL had tripled in size with 60 pending cases. Since then, however, the growth trajectory has flattened. There are currently only 92 pending Gardasil cases in the MDL, as only 32 new cases have been added since the start of the year.
August 2, 2023 – Joint Status Report in MDL
A recent joint status report submitted to the MDL Judge in the Gardasil HPV vaccine class action offers a glimpse of the most recent developments in this ongoing litigation. This week, the plaintiffs are deposing corporate representatives for Merck under FRCP Rule 30(b)(6). These depositions will be a key part of the case against Merck. 16 cases have been selected for a bellwether discovery pool, and those cases are going through discovery now. Finally, the plaintiffs are continuing to pry out of Merck the adverse event data that was the subject of an earlier motion to compel.
July 10, 2023 – Defendant Fact Sheets
Under a new order last month, Merck must fill out and submit something called a Defendant Fact Sheet (DFS) for each lawsuit that will provide key information about the case. This is required after each plaintiff gives their own Plaintiff Fact Sheet (PFS), which contains the basic facts of their claim.
The DFS must be submitted within 45 days of receiving the PFS, and the details given in the DFS will be treated as if they were provided in response to a formal request for documents. Any documents the defendants provide in response to the DFS are considered confidential, so they can’t be shared with others without permission.
June 27, 2023 – Preparing Bellwether Cases for Trial
The U.S. District Judge supervising the federal Gardasil vaccine class action lawsuit will work with lawyers this week to peel off some of the details of how the path to the first Gardasil trial will work. There are 16 potential cases that could the “the one” that is the first to go to trial. What happens in this first trial will be a big deal. If there is a large verdict, that will send like Gardasil settlement amount through the roof. If the case were dismissed, that would have a disastrous impact on projected compensation payouts.
June 1, 2023 – Bellwether Trial Plan
As long as mass tort litigation like the Gardasil class action lawsuit takes, there is a plan to get these lawsuits to trial. A bellwether trial program has been set up in the Gardasil class action MDL. In June, an initial pool of 16 cases will be selected as bellwether candidates. These cases will then go through a short fact-discovery phase to learn more about each case. After that is completed, the pool of 16 will be narrowed down to six cases which will be eligible for the opening round of bellwether trials next year. The plaintiffs will be patients who have one of the two main health complications associated with the HPV vaccine: Postural Orthostatic Tachycardia Syndrome (POTS) or Primary Ovarian Failure (POF), also referred to as Primary Ovarian Insufficiency (POI).
May 3, 2023 – Ruling on Experts
The court addressed last week the “Plaintiffs’ Motion to Withhold Expert Reports Filed in the Vaccine Program by Plaintiffs’ Consulting Experts.” Merck opposed the motion.
The court has granted the motion in part and denied it in part. It has allowed plaintiffs to withhold their expert reports filed in the Vaccine Court until they determine whether these experts will be retained as consulting or testifying experts in the MDL. This decision was made considering the fairness principles underlying Rule 26(b)(4)(D) of the Federal Rules of Civil Procedure. If plaintiffs decide not to retain any particular expert who filed a report in Vaccine Court, they must produce those experts’ reports to Merck within 10 days of such a decision.
However, the court has denied the plaintiffs’ request to withhold expert reports filed by the Department of Health and Human Services (DHHS) in Vaccine Court. The court found that the fairness considerations of Rule 26(b)(4)(D) do not apply to DHHS’s experts since they will not be retained by the plaintiffs. Therefore, the court has ordered the plaintiffs to produce DHHS’s expert reports from Vaccine Court to Merck within 10 days of the order.
April 14, 2023 – Document Discovery
In November 2022, the plaintiffs in the Gardasil class action MDL filed a motion to compel discovery, claiming that Merck had failed to produce documents and information about adverse event reports involving Gardasil. Merck strenuously opposed the motion, but the MDL Judge recently granted most of the plaintiffs’ requests. Merck has now been ordered to produce all information and documents relating to its adverse event reporting system and other vital documents.
March 1, 2023 – Delay in California Gardasil Lawsuits
Aside from the Gardasil vaccine lawsuits in the federal court MDL class action, there is a large group of Gardasil HPV vaccine lawsuits that have been consolidated in California state courts. The Gardasil cases in California state court are much farther along than their federal counterparts in the MDL.
In fact, a handful of those cases were scheduled to go to trial starting in September 2023. At the last MDL status conference, however, it was confirmed that these state court trial dates have been pushed back one year to September 2024. This was done to help coordinate the MDL with the California state court proceedings.
The postponement is a bit of a disappointment because it would have been very helpful to get a few test trials and verdicts to get a feel for what judges and jurors think of the science behind plaintiffs’ lawsuits.
February 9, 2023 – Motion to Dismiss Design Defect Claims
Earlier this week, Merck filed a Motion in the Gardasil MDL asking the Judge to dismiss all claims that are based on a design defect liability theory. Vaccine manufacturers are immune from design defect claims under the National Childhood Vaccine Injury Act, which requires those claims to be submitted to an administrative process called “vaccine court.”
Merck argues that the bulk of the claims asserted by the Gardasil plaintiffs are design defect claims, whether they expressly say so or not.
February 1, 2023 – Merck Sets Out Its Affirmative Defenses
Merck filed a general denial and list of affirmative defenses last week, which outlines its planned strategy for defending the Gardasil lawsuits. As expected, one of Merck’s primary defenses in the class action lawsuit will be that all Gardasil claims based on an alleged failure to warn are precluded under the National Childhood Vaccine Act of 1986 (42 U.S.C. § 300aa-22).
With respect to the claims based on defective design, Merck will assert that the vaccine design was not defective. Merck’s lawyers will also push a defense based on the learned intermediary doctrine, which essentially puts the obligation to warn about Gardasil risks on the doctors who recommended the vaccine.
I don’t think Merck has much chance of prevailing on these defenses in the MDL class action.
January 18, 2023 – Gardasil Litigation Status
The Gardasil class action MDL in the Western District of North Carolina now has 60 active Gardasil lawsuits. When the MDL was first created in September 2022, it had over 20 cases. Future Gardasil cases will probably be added in consecutive waves as previously filed claims clear the vaccine court process.
January 3, 2023 – Gardasil Lawsuit Continues to Advance
The Gardasil class action lawsuit is moving forward. Not at the pace many of us would like, but the ball is being advanced toward bellwether trials.
Lawyers for both sides in the Gardasil class action MDL in North Carolina recently submitted a proposed bellwether plan to MDL Judge Robert Conrad. Under the joint proposal, 16 bellwether candidate cases would be selected and go through fact discovery. The deadline for completing that discovery process would be February 2024.
By August 2024, six of the 16 cases would be selected for bellwether test trials. Judge Conrad will likely approve the joint plan at the next monthly status conference. So that gives you some idea of the time horizon we are looking at in this litigation.
Meanwhile, the cases keep moving forward. The plaintiffs in the Gardasil MDL filed a motion to compel back in November to force Merck to provide additional documents and better responses to certain interrogatories submitted in discovery. Merck has been stalling for time since then. After being granted an extension of their response deadline, Merck now has until January 5, 2023, to either respond to the motion to compel or provide supplemental discovery responses.
Gardasil Class Action Lawsuit – December 2022 Update
Last month, Judge Robert Conrad of the Western District of North Carolina will hold the first status conference in the new Gardasil class action MDL litigation. Judge Conrad will likely announce his selections for lawyers to serve on the plaintiffs’ leadership committee, the body of lawyers who collectively make decisions on behalf of all the other plaintiffs in the MDL.
Gardasil Class Action Lawsuit – October 2022 Update
The judge in the newly formed Gardasil class action lawsuit will hold his first initial conference with lawyers for all parties on October 11, 2022.
The primary focus of this initial conference will be the appointment of lawyers to serve on the plaintiffs’ leadership committee (also known as a “steering committee”).
The committee will make important decisions on behalf of all the plaintiffs in the MDL class action. Other topics that will be discussed at the conference will include a proposed discovery plan and the creation of master pleading forms.
Gardasil Lawsuit – August 2022 Update
We now have a Gardasil class action lawsuit. The panel that oversees federal multidistrict litigation agreed to form a new class action MDL for consolidated handling of all Gardasil HPV product liability lawsuits in federal courts.
The Western District of North Carolina was selected as the venue for the new MDL (In re: Gardasil Prod. Liab. Lit., MDL No. 3036). The panel agreed to the MDL consolidation despite strong objections by defendant Merck who argued that the MDL would conflict with federal vaccine laws and promote vaccine hesitancy.
The case has been assigned to Judge Robert Conrad Jr. Parenthetically, Judge Conrad played point guard for Clemson over 40 years ago.
Gardasil Lawsuit – July 2022 Update
Lawyers for a large group of plaintiffs filed a motion asking the JPML to create a new MDL Gardasil HPV vaccine class action lawsuit, seeking consolidation of all current and future HPV lawsuits alleging health complications from Merck’s Gardasil HPV vaccine.
A total of 34 pending Gardasil lawsuits in 25 different federal districts were identified in the motion. The volume of Gardasil product liability cases is expected to grow very rapidly over the next year. The plaintiffs are claiming that the Gardasil HPV vaccine caused them to develop auto-immune and/or neurologic disorders because Merck failed to properly research it before pushing it on the market.
New Gardasil HPV Research Leading to a Lawsuit
New research has shown that Gardasil can induce and increase the risk of auto-immune diseases, and a host of other serious health complications including Postural Orthostatic Tachycardia Syndrome, Neuropathy, and Fibromyalgia. Gardasil has also been linked to premature ovarian failure and infertility. (Our lawyers are getting a lot of Gardasil infertility lawsuit inquiries.) What is even more unsettling, however, is that there is also evidence to suggest that rather than preventing cervical cancer, the Gardasil HPV vaccine may increase the risk of cervical cancer.
Our firm is currently seeking new Gardasil HPV vaccine lawsuit cases. If you had the Gardasil HPV vaccine and subsequently developed serious side effects, call us today at 800-553-8082 or get a free consultation online.
Gardasil HPV Vaccine
HPV is a common virus that is easily passed through skin contact. HPV is the most common STD, and it is estimated that 2/3 of the adult population will have an HPV infection during their lifetime. Most HPV cases are harmless. But a very small percentage of HPV cases in women can potentially contribute to the development of cervical cancer. So a safe drug that can fight HPV and cervical cancer would be meaningful.
Merck fast-tracked approval for Gardasil from the FDA in 2006. Gardasil’s approval came right on the heels of Merck’s Vioxx disaster which cost the company billions in losses. Gardasil was viewed as Merck’s next big blockbuster drug that was going to pull the company out of its financial hole. Unfortunately, however, Merck learned very little from the Vioxx disaster because they repeated many of the same mistakes.
About Human Papillomavirus (HPV)
HPV stands for human papillomavirus. HPV is an exceedingly common type of virus that lives in the skin. Over 200 different strains of the HPV virus have been medically identified. About 2/3 of these strains of HPV are benign and have zero symptoms.
A handful of HPV strains are known to cause growth in the skin or mucous membrane. These growths are commonly called “warts.” HPV is highly transmissible via skin-to-skin contact, including sexual or other types of intimate contact such as kissing. Around 40 of the known HPV strains are transmitted primarily through sexual contact.
Genital HPV is so ubiquitous that experts estimate that over 75% of the sexually active adult population will have genital HPV at some point in their life. Most people with genital HPV never have any physical symptoms at all and the infection simply goes away on its own without the individual even realizing they were infected. 2 of the 40 genital HPV strains are known to cause genital warts.
Most HPV infections occur unnoticed and resolve on their own without any long-term consequences. However, there are a few strains of HPV that do not clear up on their own and can eventually lead to abnormal growths that could develop into cancer. These strains of HPV are called “high-risk” HPV. Out of the 40 types of genital HPV, only 12 strains are classified as high-risk and potentially can lead to cancer. Two of these 12 high-risk HPV types account for over 80% of all cancer cases.
High-risk HPV is primarily a concern for women because it can develop into cervical cancer. These types of HPV can gradually cause the formation of abnormal growths in the cervical tissue. If these growths are not promptly removed they will often develop into cervical cancer.
Pap smear examinations are intended to identify these abnormal growths and remove them before they lead to cervical cancer. Although cervical cancer is the most common, HPV can also lead to other types of cancer including anal and penis.
Merck Brings Gardasil to Market with Fraudulent Marketing Campaign
Leading up to and after the 2006 approval of Gardasil, Merck launched a massive marketing campaign to manufacture demand for its HPV vaccine. Before Gardasil, there was little or no demand for an HPV vaccine, and HPV was never viewed as a pressing public health emergency. To ensure the financial success of its new vaccine, Merk preceded the release of Gardasil with expensive HPV “disease awareness” marketing. This marketing campaign greatly exaggerated the health risks of HPV.
Merck launched a years-long disease awareness campaign to make people fear HPV and cervical cancer, despite the lack of a public health emergency in high-resource countries like the United States. Prior to FDA approval, Merck used its marketing campaign to create a market for its vaccine out of thin air, while simultaneously engaging in a cringe-worthy propaganda campaign aimed at frightening and guilting parents who failed to inoculate their children with Gardasil.
Merck aggressively marketed Gardasil as a miracle vaccine, falsely proclaiming it a “cervical cancer vaccine” that could protect against cervical cancer. Merck’s message was that cervical cancer is a real-life killer of young women, notwithstanding the fact that the average age for the development of cervical cancer is 50 years old, and the cancer is virtually nonexistent in women under 20.
Merck also attempted to make the Gardasil vaccine mandatory for all school children by using scare tactics and providing financial incentives to legislatures. Merck mobilized dozens of “pay to play” lobby groups, like the National Association of County and City Health Officials and Women in Government, to push for HPV vaccine mandates. Merck made large contributions to political campaigns and legislative organizations to push its agenda, and several states passed laws allowing preteen children as young as age 12 to “consent” to vaccination with an HPV vaccine without parental consent or knowledge.
Implications of Merck’s Obsession to Milk Gardasil Profits
It is no secret that the world we live in is driven by profit. Merck is the game to make money and that is to be expected, right? But there are varying degrees of profit-driven motives among pharmaceutical companies. Some prioritize profits over all else, including safety and patient well-being. Others place a greater emphasis on ethical considerations and the greater good, while still maintaining a healthy bottom line.
Merck has shown us time and again they are on the high end of the food chain (to put it charitably) in passion to obtain massive profits. When a company is so clearly profit-driven, it can be hard to trust its scientific credibility or feel comfortable that they are telling you everything you need to know. This is because the profit motive can sometimes cloud judgment and result in biased reporting of scientific data. Everyone agrees that pharmaceutical companies are sometimes prone to present only positive results from a clinical trial of their product, while downplaying or ignoring negative results.
Merck likely accuses plaintiffs’ lawyers of believing Gardasil causes every infirmity that has ever affected the human race. I get that. I’m about to put out a list of possible harm that Gardasil may cause. Many of these may be proven wrong (or at least never proven right). But the point is Merck holds most of the cards on the harms Gardasil could cause and it is reasonable not to trust them to conduct studies and interpret data as fairly as they would if it was not so driven by profit
Gardasil Can Induce or Increase the Risk of Auto-Immune Diseases
To get Gardasil approved by the FDA, Merck allegedly manipulated its clinical trials to conceal risks and falsely enhance the safety profile of the vaccine. Now we are begging to realize why Merck did this. In the years since Gardasil was released, medical research revealed that Gardasil could induce autoimmune disorders in a certain percentage of patients.
Various scientific studies have linked Gardasil to the following autoimmune diseases:
| Guillain–Barré syndrome | Orthostatic Intolerance
|
| Small Fiber Neuropathy | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
|
| Systemic Lupus Erythematosus | Multiple Sclerosis
|
| Autoimmune Pancreatitis | Autoimmune Hepatitis
|
Gardasil has also been connected to a host of other health conditions that are closely linked to autoimmune conditions. These include fibromyalgia, dysautonomia, chronic fatigue syndrome, chronic regional pain syndrome, encephalitis syndrome, autonomic dysfunction, and joint pain.
Gardasil Linked to Premature Ovarian Failure
Premature Ovarian Failure (POF), also known as premature ovarian insufficiency or early menopause, is one of the most serious autoimmune disorders that can be caused by the Gardasil HPV vaccine. Premature ovarian failure is also known as primary ovarian insufficiency. This condition occurs when an abnormal autoimmune response causes a woman’s immune system to target the egg-producing tissue in her ovaries. This causes the ovaries to stop releasing viable eggs.
With Premature Ovarian Failure, a woman’s ovaries stop functioning normally before the age of 40, which can lead to infertility. POF can occur due to a variety of reasons such as genetics, autoimmune disorders, chemotherapy, radiation therapy, and infections. However, some studies suggest a possible link between POF and certain vaccines, including the human papillomavirus (HPV) vaccine. Several studies have identified premature ovary failure as an autoimmune condition associated with adverse reactions to the HPV vaccine.
2014 Article
An article titled “Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination: A Case Series Seen in General Practice” in the Journal of Investigative Medicine High Impact Case Reports, describes three cases of premature ovarian insufficiency in young women aged 16 to 18 years who had received the quadrivalent human papillomavirus (HPV) vaccine. The authors note that the long-term effects of vaccination on ovarian function and durability have not been studied in preclinical, clinical, or post-licensure studies. Of course, this was just three girls and it could have been a coincidence. But for some, that was the first time people learned that this much-ballyhooed vaccine had never been tested for its impact on human fertility.
2020 and 2022 Studies
A study published in 2020 was the first to find an association between premature ovarian failure and the Gardasil vaccine based on a disproportionate number of adverse vaccine event reports. This finding was subsequently confirmed in another study published in March 2022 in Drugs Real World Outcomes.
What is the mechanism of injury that could lead to the HPV vaccine causing the premature ovarian failure? No one knows for sure. But it could cause of premature ovarian failure due to the aluminum content that can destroy the maturation process of the eggs in the ovaries.
Fertility Rates
The introduction of the Gardasil vaccine in 2006 coincided with a significant decrease in fertility among American women. This is particularly evident in teen pregnancy statistics which have reduced by more than 50% since 2007. The total fertility rate for the United States in 2017 has also dropped below what is required for the population to replace itself, according to a report by the National Center of Health Statistics. The rate for women between the ages of 15 and 44 has also declined by 2% between 2017 and 2018.
Could there be other causes? Sure.
Gardasil Lawsuit
The emerging scientific evidence establishing the connection between Gardasil HPV vaccines and autoimmune health conditions has led to a growing wave of Gardasil HPV lawsuits against Merck. The first few Gardasil lawsuits started getting filed in the second half of 2020.
The volume of Gardasil cases increased slowly but steadily throughout 2021. But more victims are filing a Gardasil vaccine lawsuit as awareness of the issues with Gardasil emerges from both victims and Gardasil HPV vaccine lawyers are starting to see the potential size of these claims.
The plaintiffs in the Gardasil lawsuits are women (and some men) who received Gardasil vaccinations and subsequently developed autoimmune diseases and other serious health conditions linked to Gardasil such as postural orthostatic tachycardia syndrome (“POTS”).
The HPV Gardasil vaccine side effects lawsuits allege that Merck fraudulently concealed evidence about the health risks of the vaccine while at the same time misrepresenting that Gardasil could prevent cervical cancer. The tort claims being asserted against Merck in the Gardasil lawsuits include traditional product liability tort claims such as failure to warn, manufacturing defect, and negligence. They also include fraud claims that are not commonly seen in product liability cases.
Gardasil Lawsuit and the National Vaccine Injury Compensation Program
A Gardasil lawsuit in the District of Nevada was recently dismissed – mostly without prejudice, which means it can be refiled. The judge found that the plaintiff’s claims were “partially” preempted under the National Vaccine Injury Compensation Program.
The Vaccine Act is a law that says vaccine manufacturers cannot be sued for certain types of claims, including design defect claims and some failure to warn claims. The purpose of the Act is to make it hard to sue vaccine manufacturers even when they screw up to keep vaccine prices stable and to encourage manufacturers to make vaccines. Negligence claims are allowed.
In Flores v. Merck & Co., a Nevada schoolteacher filed a Gardasil lawsuit alleging she has never been the same since taking the HPV vaccine at age 14. Specifically, she believes she developed postural orthostatic tachycardia syndrome (“POTS”), as a result of receiving Merck’s HPV vaccine. POTS is an injury that is a definite focus of this litigation.
Merck filed a motion to dismiss. The judge found that the plaintiff did not plead in her lawsuit a viable negligence claim. The court ruled her Gardasil lawsuit was just a design defect claim that was barred under the Vaccine Act. So the plaintiff’s failure to warn claim, as worded in her Gardasil vaccine lawsuit, was also held to be barred under the Vaccine Act.
Despite the dismissal of all the plaintiff’s claims, this Gardasil lawsuit is not over. The plaintiff’s primary claims were dismissed “without prejudice,” meaning that the plaintiff and her lawyers get a chance to “try again” by filing an amended complaint restating the claims.
The amended complaint will need to reshape the negligence claim to make it clear that it is not based on any alleged defect design of the Gardasil vaccine. The failure to warn claim also needs to be reshaped to clarify the allegations that Merck failed to warn the plaintiff’s medical providers about specific risks associated with the Gardasil vaccine.
The plaintiff’s Gardasil lawyer has already filed a new lawsuit. Merck has filed an 18-page motion to dismiss the claim. The motion argues, among other things, that the Vaccine Act “explicitly protects vaccine manufacturers from liability ‘for damages arising from a vaccine-related injury that is ‘associated with the administration of a vaccine due to the ‘drugmaker’s failure to provide direct warnings….'”
The point of all this is that Gardasil lawyers have some work to do to get these cases past the Vaccine Act. But with the new Gardasil vaccine side effects class action lawsuit becoming an MDL, these concerns have been alleviated to some degree. Still, it will take refinement of how these Gardasil lawsuits are pled to avoid preemption under the Vaccine Act. This case will be closely watched as the Gardasil side effects litigation progresses.