Gardasil® is a vaccine developed by Merck & Co. for the prevention of 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 serious adverse health consequences and hundreds have died as a result of 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 very common 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 the effectiveness (or lack thereof) and safety of Gardasil. Merck also failed to perform full 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.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.
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 who 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 a long-term side effects or autoimmune disorders Gardasil lawsuit, 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 vaccineGardasil 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.Gardasil Lawsuit
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 and this is important to understand to appreciate what a Gardasil lawsuit seeks. It is not that Gardasil is unreasonable for everyone. 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|
In March 2022, a federal judge in Nevada dismissed a Gardasil lawsuit on the grounds that 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 really a “poorly disguised” design defect claim and, therefore, barred by Vaccine Act. The court also found that 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. 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.
If you believe you developed an autoimmune disorder or other health condition from a Gardasil HPV vaccine, you should considering bringing a Gardasil lawsuit to get a verdict or fair settlement amount for the hard 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.