Products Liability
Our lawyers are reviewing Gardasil vaccine lawsuits in all 50 states for victims who have suffered side effects from the Gardasil HPV vaccine. Deaths and injuries have been linked to this vaccine. Our law firm is looking at various Gardasil lawsuits, focusing on premature ovarian failure and premature menopause claims.
This page is to help you better understand whether you want to bring a Gardasil lawsuit and whether you might have a viable claim for settlement compensation or a jury payout. This is new litigation, and our attorneys update this page regularly (last content update: June 1, 2023) to bring you the latest Gardasil HPV lawsuit news and updates.
Gardasil HPV Class Action Lawsuit Updates
June 2023 Update
- June 1, 2023: Last month, the judge in the Gardasil class action MDL ruled that the opening bellwether trials will involve plaintiffs who are claiming one of the two primary injuries allegedly connected to the HPV vaccine: postural orthostatic tachycardia syndrome (POTS) or primary ovarian failure (POF)/primary ovarian insufficiency (POI). We think the ovarian failure cases are stronger claims than the POTS claims. That does not mean the POTS lawsuits cannot be one. It means – our lawyers think, anyway – that they will be generally hard to win than cases of premature ovarian failure or premature menopause.
May 2023 Update
- May 3, 2023: The court has granted in part and denied in part last week a plaintiffs’ motion to withhold expert reports filed in the Vaccine Program by their consulting experts. Plaintiffs are allowed to withhold their expert reports filed in Vaccine Court until they determine whether those experts will be retained as consulting or testifying experts in the case. However, plaintiffs must produce the Department of Health and Human Services’ expert reports from Vaccine Court within ten days of the order, as well as any expert reports they decide not to retain within ten days of such a decision.
April 2023 Update
- April 13, 2023: The judge in the Gardasil class action lawsuit has granted a motion to compel filed by the plaintiffs and ordered Merck to produce all data and documents related to adverse event reports for Gardasil. The order also forces Merck to produce many other key documents, as well as a list of company executives who were involved in the Gardasil decision-making process. Merck’s attorneys had aggressively opposed the plaintiffs’ efforts to obtain this evidence, particularly the adverse event reporting data. These lawsuits may be won or lost on getting all of the relevant paper Merck has and what those documents say.
March 2023 Update
- March 21, 2023: The U.S. District Judge overseeing all federal lawsuits regarding Gardasil has instructed each plaintiff making a claim to fill out a Plaintiff Fact Sheet. What is a Plaintiff Fact Sheet? A Plaintiff Fact Sheet is a document used in an MDL class action lawsuit to collect information on the plaintiffs. It provides information about the plaintiff, the party making a claim against another party, such as a defendant, and the specific injuries alleged to be connected to the product. The purpose of the Plaintiff Fact Sheet is to gather information about the plaintiff’s background, the circumstances of the case, and the nature of the claim being made. This information is used by the court and the parties involved in the lawsuit to understand the case better and to make decisions about the best way to proceed. The information included in a Plaintiff Fact Sheet can vary depending on the specific case. Still, it may include the plaintiff’s name, address, contact information, date of birth, employment history, and details about the claim being made. This document will provide information about the injuries they experienced after receiving the vaccine and help select a few cases for trial.
- March 1, 2023: In addition to the Gardasil cases pending in the MDL in federal courts, many Gardasil vaccine lawsuits are pending in California state courts. Many of the state court Gardasil cases were filed first, and a group of them were scheduled to go to trial beginning in September of this year. Unfortunately, however, all those upcoming trial dates in the California state court cases have now been postponed to September 2024. This postponement was done to coordinate the progress in the California Gardasil litigation with the MDL schedule.
February 2023 Update
- February 9, 2023: On Tuesday, Merck filed a Motion asking the MDL Judge to dismiss all claims against it based on “design defect” tort theories. The National Childhood Vaccine Injury Act expressly precludes design-defect claims against vaccine manufacturers and forces claimants through an administrative claim process known as “vaccine court.” Merck’s Motion argues that most of the product liability claims asserted by the MDL plaintiffs are de facto design defect claims, even if they avoid using that phrase. If this Motion is granted, it would significantly narrow the scope of the Gardasil litigation.
- February 1, 2023: Last week, Merck filed a denial and list of affirmative defenses, which offers a detailed outline of its apparent strategy for defending the Gardasil lawsuits. Merck will argue that the Gardasil claims based on failure to warn are precluded under the National Childhood Vaccine Act of 1986 (42 U.S.C. § 300aa-22). Merck also intends to contest the allegations that Gardasil was “defective” in its design and assert the learned intermediary defense, which puts the obligation to warn about the risks of Gardasil on doctors. Gardasil lawyers are optimistic these defenses can be defeated.
January 2023 Update
- January 18, 2023: 60 active Gardasil lawsuits are now pending in the Gardasil class action MDL in the Western District of North Carolina. The MDL class action was established in September with just over 20 cases, which means it has already tripled. A large influx of new cases will probably be coming at some point shortly as previously filed Gardasil claims clear the vaccine court process.
- January 12, 2023: In November, the plaintiffs in the Gardasil class action MDL filed a motion to compel seeking to force the defendant, Merck & Co., to produce additional documents and supplement their interrogatory responses. After being granted an extension of time on its deadline to respond to this Motion, Merck and its lawyers now have until the end of this week (January 5, 2023) to file a response to the Motion (or provide supplemental discovery responses).
December 2022 Update
The road to the first Gardasil trial is a long one. But victims’ lawyers are inching closer as we approach 2023. Getting a trial date matters because a Gardasil settlement will be impossible without real pressure on the defendants. Trials put on the pressure that leads to settlements.
Gardasil lawyers submitted a joint bellwether program proposal last week for both sides in the Gardasil class action. The joint proposal calls for a pool of 16 bellwether candidate cases to be worked up for trial over the next year. Under the pre-trial plan, six of these cases would be picked for the initial bellwether trial, and those selections would be made in August 2024. MDL Judge Robert Conrad will likely approve and adopt the plan at the next monthly status conference.
October 2022 Update
The initial status conference in the newly formed Gardasil MDL is scheduled for October 11 before MDL Judge Robert Conrad in the Western District of North Carolina. One of the primary items on Judge Conrad’s agenda will be the selection of attorneys to serve on the plaintiffs’ leadership committee and appointing lead counsel. The leadership committee is the body of attorneys that will make strategic decisions for all plaintiffs in the litigation.
August 2022 Update
The MDL Panel will hear the arguments for whether the Gardasil vaccine lawsuits should be consolidated in an MDL class action lawsuit. The plaintiffs seek consolidation in either Arizona or Wisconsin federal court, and Merck opposes a class action lawsuit because it believes these cases should go to vaccine court. The MDL Panel hearing is set for July 28, 2022.
June 2022 Update
Last month the JPML granted a motion to consolidate all Gardasil HPV vaccine lawsuits into a new class action MDL. The new class action – designed as In re: Gardasil Prod. Liab. Lit., MDL No. 3036 – has been assigned to Judge Robert Conrad Jr. in the Western District of North Carolina.
In granting the Motion and forming the new MDL, the JPML rejected arguments by defendant Merck that MDL consolidation would conflict with the Vaccine Act and lead to vaccine hesitancy. There will be a conference before the judge in Charlotte, North Carolina in October 2022. The first initial conference in the new Gardasil class action MDL will focus on selecting attorneys to serve on the plaintiffs’ leadership or steering committee.
This committee is composed of lawyers representing plaintiffs in the Gardasil MDL. The plaintiffs’ lawyers initially showed little interest in the Gardasil lawsuit, but this class action certification will help bring some attorneys around to the viability of these lawsuits. So it will be interesting to see which attorneys apply to the steering committee.
The committee is tasked with making decisions for all the other Gardasil plaintiffs. The conference will also address other housekeeping issues, such as creating master pleading forms and a discovery plan – in other words, how to kickstart this litigation.
What Is HPV?
Human Papillomavirus (HPV) is a viral infection that can be passed between people through skin-to-skin contact, especially sexual contact. Over 200 strains of HPV, and of those, more than 40 can be transmitted sexually.
HPV is the most common sexually transmitted disease, and it’s estimated that most sexually active people will contract it at some point. However, over 90 percent of HPV infections cause no clinical symptoms and are removed naturally by the body’s immune system. Only a limited number of HPV strains, around 12 to 18, are linked to cervical cancer.
Persistent infections with these strains may cause precancerous lesions, which can be detected through Pap smears and removed. Smoking and other factors can also increase the risk of cervical cancer.
The Pap test is the most effective frontline public health response to the disease and has reduced cervical cancer rates in developed countries by up to 80 percent. Cervical cancer is largely treatable, with a five-year survival rate of over 90 percent when detected early. Merck sought to fast-track a vaccine onto the market to prevent infection from four types of HPV, but only two of these strains are associated with cancer.
Gardasil HPV Vaccine Lawsuits
Gardasil® is a vaccine developed by Merck & Co. to prevent HPV (human papillomavirus). Merck obtained approval for Gardasil in 2006 with deceptive research trials, which overstated the benefits and vastly understated the risks and side effects of the vaccine. Merck aggressively marketed Gardasil utilizing scare tactics, false advertising, and political lobbyists to induce millions of parents to vaccinate their adolescent girls with Gardasil.
Now thousands of girls who received the Gardasil vaccine are experiencing severe adverse health consequences, and hundreds have died due to vaccine complications. Our firm is currently seeking new Gardasil cases. If you received the Gardasil vaccine for HPV and subsequently experienced side effects, complications, or other adverse health events that may be connected to the vaccine, call us today at 800-553-8082 for a free consultation to discuss what a Gardasil lawsuit might do for you.
Approval of the Gardasil Vaccine
Gardasil is a vaccine that is supposed to protect against HPV (human papillomavirus). HPV is a widespread viral infection passed through skin-to-skin contact. HPV is the most common sexually transmitted disease, and the majority of people will get HPV at some point in their life. Most HPV cases are entirely benign, but if left untreated, a very small percentage of HPV cases in women can eventually develop into cervical cancer.
Merck obtained a fast-track FDA approval for Gardasil in June 2006. At that time, Merck was still reeling from the billion-dollar losses incurred after being forced to pull its drug Vioxx off the market. Within Merck, Gardasil was described as the “holy grail” that would help the company replace the revenues lost from Vioxx. Executives at Merk often said that “HPV” stood for “Help Pay for Vioxx.”
During the fast-track approval process, Merck concealed material facts about Gardasil’s effectiveness (or lack thereof) and safety. Merck failed to perform complete and appropriate medical investigations and studies during the preapproval or post-approval stages.
The clinical trials Merck undertook did not even examine Gardasil’s potential to prevent cancer, rather, the trials only analyzed whether Gardasil could prevent potential precursor conditions. Merck then submitted misleading data suggesting that these “precursor conditions” inexorably result in cancer.
Merk’s Deceptive Marketing Campaign to Push Gardasil
Both before and after the approval of Gardasil, Merck engaged in unscrupulous marketing tactics designed to overemphasize both the risks associated with HPV and the purported efficacy of Gardasil to scare the public into agreeing to mass vaccinations of the Gardasil vaccine.
Before Gardasil, there was no HPV public health emergency in the U.S. and few women had even heard of HPV so there was little or no demand for an HPV vaccine. To ensure the financial success of its new “holy grail,” Merk preceded its rollout of Gardasil with years of expensive HPV “disease awareness” marketing.
Once Gardasil was approved for pre-teen girls, Merck launched an aggressive propaganda campaign aimed at scaring and guilting parents who did not inoculate their daughters with Gardasil. Merk’s campaign implied that “good parents” vaccinate their children with Gardasil.
During these aggressive marketing efforts, Merck fraudulently concealed the known risks and dangers of the HPV vaccine while exaggerating its efficacy. Merck marketed Gardasil with the most aggressive campaign ever mounted to promote a vaccine, spending more on Gardasil advertising than any previous vaccine advertising campaign.
Real Life Implications of Merck’s Thirst for Profti
Merck’s Political Lobbying to Make Gardasil Mandatory
In addition to its aggressive advertising campaign, Merk also used political lobbyists and financial incentives to get state legislatures to make the Gardasil vaccine mandatory for all school children. Starting in 2004, Merck pumped millions into political lobbying organizations such as Women in Government and NACCHO. These organizations then started aggressively pushing legislators around the country to mandate Gardasil vaccines for all 6th-grade girls. It was a clinic on how to get hte governement to push your product.
Merck supplemented these paid lobbyists with contributions to political campaigns and millions in direct funding to state health departments. Between 2012 and 2018, Merck directly funneled $92 million to the Maryland Department of Health for the promotion of Gardasil vaccines in public schools. This funding essentially paid school officials to deceive students and parents into believing that Gardasil vaccination was mandatory.
Merck Misrepresented the Efficacy of Gardasil
To convince regulators and public health officials to accept Gardasil, Gardasil lawsuits allege Merck misrepresented the efficacy of the vaccine by falsely advertising that Gardasil prevents cervical cancer. No credible studies demonstrate that Gardasil prevents cervical cancer.
Merck did not want to invest the time or money necessary to perform testing that would prove its vaccine prevented cervical cancer. Instead, Merck persuaded regulators to allow it to use “surrogate endpoints” to support its theory that the HPV vaccines would be effective in preventing cervical cancer. The use of these surrogate endpoints allowed Merck to shorten the clinical trials to a few years and gain regulatory approvals for the vaccines without any evidence the vaccines would prevent cancer in the long run.
In January 2020, a study from the UK raised significant doubts about whether the Gardasil vaccine prevented cervical cancer as claimed by Merck. The study highlights the fact that Gardasil has never been proven to prevent cervical cancer (or any other type of cancer).
Gardasil May INCREASE the Risk of Cervical Cancer
Contrary to Merck’s representations, Gardasil may increase the risk of cervical and other cancers, not prevent them. Several studies (including one from the CDC which has still stood by the vaccine so far) have found that by suppressing certain HPV strains, Gardasil vaccines may promote mutagenetic changes in the virus that can lead to cancer.
Public health data seems to support the conclusion that Gardasil may be increasing the rate of cervical cancer. After the introduction of the HPV Vaccine in Britain, cervical cancer rates among young women aged 25 to 29 increased by 54%.
In Australia, 13 years after Gardasil was released and pushed upon teenagers, there has been a 16% increase in women 25-29 and a 30% increase for women 30-34. Meanwhile, rates are decreasing for older women (who have not been vaccinated).
In other words, Gardasil may increase the risk of cancer. This will be the crux of the claim for some victims who file a Gardasil vaccine lawsuit. But there is still some research to be done on this issue.
For most women bringing long-term side effects or autoimmune disorders Gardasil lawsuits, the focus will not be on whether Gardasil helps prevent cervical cancer. The focus will be on the other side effect that Gardasil may cause that people, mostly girls, did not expect when they took the HPV vaccine.
Gardasil HPV Side Effects Long-Term and Autoimmune Disorders
Recent scientific research has found that Gardasil induces and increases the risk of many long-term side effects related to autoimmune disorders. Specifically, Gardasil has been linked to the following autoimmune diseases:
- Guillain–Barré syndrome
- postural orthostatic tachycardia syndrome
- chronic inflammatory demyelinating polyneuropathy
- multiple sclerosis
Gardasil has also been linked to a myriad of long-term side effects associated with induced-autoimmune diseases, including such dangers as fibromyalgia, dysautonomia, premature ovarian failure, chronic fatigue syndrome, and chronic regional pain syndrome. migraines, severe headaches, persistent gastrointestinal discomfort, widespread pain of a neuropathic character, encephalitis syndrome, autonomic dysfunction, joint pain, and brain fog.
A variety of published medical journal articles have discussed the association between Gardasil and a myriad of serious injuries and have reported on patients developing POTS, OI, fibromyalgia, and other symptoms of autonomic impairment years later following Gardasil vaccination. Our firm is focused on premature ovarian failure claims.
Gardasil Linked to Premature Ovarian Failure
One of the most serious adverse side effects – one our lawyers are really drilling down on – is that can be caused by the Gardasil HPV vaccine is premature ovarian failure. Premature ovarian failure (also called primary ovarian insufficiency) occurs when the ovaries stop working and no longer produce eggs before age 40 and before menopause.
Premature ovarian failure is associated with abnormal production of the hormone estrogen in the ovaries. Premature ovarian failure is a serious condition because it can cause infertility. There are many factors that can result in premature ovarian failure such as autoimmune failure, X chromosomal abnormalities, idiopathic causes, toxins, and, of course, removal of the ovaries.
Several recent medical studies have found that premature ovarian failure can be triggered by an autoimmune reaction to the Gardasil HPV vaccine. This occurs when the body’s immune system generates antibodies that attack the tissue in the ovaries which hold the eggs.
The first significant study linking premature ovarian failure to the Gardasil vaccine was published in 2020 and identified a disproportionate number of adverse vaccine event reports involving premature ovarian failure and premature menopause. A follow-up study was published in March 2022 in Drugs Real World Outcomes. This study also concluded that there was a potential association between premature ovarian failure and the HPV vaccine.
- Case study on the link between premature ovarian failure and the HPV vaccine
Gardasil Lawsuits
The emergence of recent evidence linking Gardasil to various autoimmune disorders and other health conditions has prompted some Gardasil product liability lawsuits against Merck. These Gardasil lawsuits are being filed by women who developed an autoimmune disease and other serious health conditions such as postural orthostatic tachycardia syndrome (“POTS”).
The Gardasil lawsuits accuse Merck of fraudulently concealing evidence regarding the health risks of Gardasil while falsely promoting it as a vaccine that can prevent cervical cancer. The claims against Merck in a Gardasil lawsuit include traditional product liability tort claims such as failure to warn, manufacturing defect, and negligence.
The Gardasil class action lawsuit also includes fraud claims. These are less common in product liability lawsuits, underscoring how strong Gardasil lawyers feel about Merck’s conduct.
Few Gardasil attorneys are demanding a Gardasil recall. This is important to understand to appreciate what a Gardasil lawsuit seeks. It is not that Gardasil is unreasonable for everyone which is why there is no groundswell for a recall. It is that patients, doctors, and parents should have been given accurate information on the benefits and side effects of Gardasil.
Our firm is currently seeking new Gardasil cases from anyone who received the Gardasil vaccination and was subsequently diagnosed with autoimmune disorders such as autoimmune disease and other serious health conditions such as POTS or any of the following related conditions:
| Guillain–Barré syndrome | Orthostatic Intolerance |
| Small Fiber Neuropathy | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
| Systemic Lupus Erythematosus | Multiple Sclerosis |
| Autoimmune Pancreatitis | Autoimmune Hepatitis |
| Fibromyalgia | Premature Ovarian Failure |
| Chronic Regional Pain Syndrome |
The Gardasil Lawsuit and Vaccine Act
In March 2022, a federal judge in Nevada dismissed a Gardasil lawsuit because it was “partially” preempted under the Vaccine Act. The Vaccine Act is a federal law that prohibits design defect and some failure to warn claims against vaccine manufacturers but allows for negligence claims.
In Flores v. Merck & Co., Plaintiff’s Gardasil lawsuit alleged after getting the Gardasil HPV vaccine, her body broke down. She suffered dizziness, fatigue, and nausea and those symptoms came progressively worse over time.
Merck filed a motion to dismiss based on the National Childhood Vaccine Injury Act (NCVIA). What is the Vaccine Act? The Vaccine Act is a law passed in 1986 that created a no-fault compensation program for vaccine injuries in children.
The court agreed with Merck that the plaintiff’s negligence claim was a “poorly disguised” design defect claim and, therefore, barred by Vaccine Act. The court also found that the failure to warn claim, as stated in the plaintiff’s Gardasil lawsuit, appeared to be barred by the Vaccine Act and had to be dismissed.
Although the judge ultimately dismissed all of the plaintiff’s claims, most of the dismissals were “without prejudice,” which means that the plaintiff has the opportunity to “try again” by rewriting her claims and filing an amended complaint.
So this Gardasil lawsuit is not dead. But an amended complaint needs to clarify that the negligence claim is not a design defect claim. As for the failure to warn claim, the amended complaint simply needs to clarify the allegations that Merck failed to warn the plaintiff’s medical providers about specific risks associated with the Gardasil vaccine. An amended complaint has been filed. And, yes, Merck has filed yet another motion to dismiss.
But the Vaccine Act is a problem for those looking to bring a Gardasil lawsuit. Every Gardasil lawyer must find a path around the Act. Otherwise, the Gardasil lawsuit will be preempted, forcing the victim to seek settlement compensation through the National Vaccine Injury Compensation Program. You can win in Vaccine Court. But the compensation for those claims will be far less than what jurors would award in a civil lawsuit if they believed in the victim’s complaint.
Contact Us About a Gardasil HPV Vaccine Lawsuit
If you believe you developed an autoimmune disorder or other health condition from a Gardasil HPV vaccine, you should consider bringing a Gardasil lawsuit to get a verdict or fair settlement amount for the harm that has been done to you. Call a Gardasil lawyer today for a free consultation at 800-553-8082 or get a free online consultation.