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Published: May 1, 2023 | Print Friendly and PDF


Plaintiff Caroline Cantera, 25, alleges New Jersey-based Merck & Co., Inc. and subsidiary Merck Sharp & Dohme oversold Gardasil as a “cervical cancer vaccine” and downplayed known health risks to enhance sales.

Cantera’s attorneys, Bijan Esfandiari, Michael L. Baum, and Monique Alarcon filed the complaint (Case No. 3:23-cv-00161) in U.S. District Court for the Western District of North Carolina as part of the Gardasil multidistrict litigation (MDL No. 3036). Dozens of federal Gardasil injury cases filed throughout the country have been consolidated in North Carolina.

According to the complaint, Merck has never studied whether Gardasil prevents cervical cancer. Instead, Gardasil was tested to determine if it could prevent development of certain lesions, some of which are considered related to cancer, however, a majority of such lesions, even the most serious, regress on their own.  Not every HPV infection places one at risk for cervical cancer.  Only persistent HPV infections (not short-term or transient infections) in a limited number of cases may cause the development of precancerous lesions.

Public health officials have long recommended the Pap test as the most effective frontline public health response to preventing cervical cancer. Long before Gardasil was introduced to the market in 2006, cervical cancer rates had been plummeting by up to 80% with implementation of routine Pap testing. For those who are diagnosed with precancerous lesions or worse, cervical cancer is largely treatable if caught early.

Nonetheless, Merck sought fast-tracked FDA approval of Gardasil to fill a purported unmet need in preventing cervical cancer, with its expensive HPV vaccine.  Once approved, Merck engaged in a relentless marketing campaign falsely proclaiming that Gardasil was a “cervical cancer vaccine” and that any young girl vaccinated with Gardasil would become “one less” woman with cervical cancer, the lawsuit claims.

Cantera alleges Gardasil can actually increase the risk of cervical cancer.

The Gardasil vaccine label specifically states, “Gardasil has not been evaluated for potential to cause carcinogenicity or genotoxicity.” Studies from the U.S. Centers for Disease Control and Prevention (CDC) suggest the suppression of the HPV strains targeted by Gardasil (there are over 200 HPV strains and Gardasil targets between four and nine strains) may actually open an ecological niche for replacement by more virulent strains, thus increasing the risk of cervical cancer.

Merck’s own studies show that, for those previously exposed to HPV (a huge percentage of the population) when vaccinated, there is an up to 44.6% increased risk of developing advanced abnormal pre-cancer cells or worse.  The Cantera Complaint concludes, “Merck’s studies suggest that its HPV vaccines may cause cancer in women who have previously been exposed to HPV, particularly if they also have a current infection.”  Because this is a little-known fact, no screening is done prior to vaccination, thus increasing the risk.

The Complaint also cites rapidly climbing cervical cancer rates among young women in countries where Gardasil has seen a high uptake.  Studies have also shown that young women who have received the Gardasil vaccine are foregoing routine Pap screening due to a false sense of security that the HPV vaccine will protect them from cervical cancer.

“Merck has heavily promoted Gardasil as a cancer prevention vaccine even though the studies weren’t designed to answer that question, and its marketing has effectively resulted in young women foregoing Pap screening, the most reliable and proven method of preventing cervical cancer. Merck also hasn’t studied whether Gardasil can cause cancer, but we now have evidence it can increase the risk of cancer” says HPV vaccine injury attorney Bijan Esfandiari, who serves as co-lead counsel for plaintiffs in the Gardasil MDL. “Given Merck makes over six billion dollars a year on Gardasil, it has little incentive to stop the deception. Through our litigation, we hope to expose the truth and hold Merck accountable for the harm it has done to Caroline and others.”

Caroline Cantera was 19 years old when she received her first of three Gardasil shots. She agreed to receive Gardasil after being convinced by Merck’s prolific marketing that the vaccine is very safe and prevents cervical cancer.

Before receiving the HPV vaccine, Caroline was very healthy and never had to go to the doctor for anything other than regular checkups and physical exams for sports. She received routine Pap testing, all of which were negative prior to Gardasil. In high school, she played tennis, regularly went backpacking, and loved spending time outdoors. She lived a happy, carefree life filled with friends and activities.

After her Gardasil injections, Caroline experienced unexpected fatigue, intense stomach aches, and overall weakness throughout her body. The fatigue and occasional abdominal pain continued until she noticed that her period had lasted over four weeks. After what she thought was an initial visit to a gynecologist, her life suddenly took a drastic and unexpected turn.

Caroline was diagnosed with stage four cervical cancer. She received multiple biopsies, CT scans and MRIs, had six rounds of chemotherapy, 30 radiation treatments, three brachytherapy treatments, and countless doctor visits. She was unable to go back to university for her final semester and struggled to finish the classwork necessary to receive her undergraduate degree.

Because most of her treatment was directed at her cervix, her ovaries were also affected, putting her into menopause in her 20s. She will never be able to have children of her own because her eggs are no longer viable due to the cancer treatment.

“Every day since my diagnosis has been a battle,” says Caroline. “My body is still recovering from the toll of such intense treatments to fight cancer, and I live in constant fear that my cancer could come back at any time. On top of all that, I also had to face the painful fact that I will never be able to have children of my own. If Merck knew this vaccine can cause so much harm, why didn’t they warn people?”

Gardasil Vaccine Lawsuit Allegations Against Merck

Lawsuits against Merck include the following causes of action and claims:

1) Negligence

2) Strict Liability (Failure to Warn)

3) Strict Liability (Manufacturing Defect)

4) Breach of Warranty

5) Common Law Fraud

Merck has a long history of bringing controversial products to market, including Fosamax (a purported bone density drug that caused bone fractures) and Nuvaring (a birth control device associated with life-threatening blood clots and death).

Merck’s most infamous drug is Vioxx, a pain medication the company had to pull from the market due to cardiovascular risks. Tens of thousands of patients filed lawsuits against Merck alleging they suffered heart attacks and other cardiovascular injuries as a result of ingesting the medication.

The litigation revealed that Merck knew early on that Vioxx was linked to fatal cardiovascular adverse events but intentionally chose to conceal the risks from the public and medical community. Lawsuits accused Merck of orchestrating a scheme to downplay the severity of the risks, misrepresenting the results of its clinical trials, failing to undertake the clinical trials that would reveal risks, and blacklisting medical professionals who dared to publicly criticize the safety of Vioxx.

Merck paid nearly $5 billion to settle the tens of thousands of Vioxx personal injury actions and an additional $1 billion to settle a securities class action. The company was also forced to pay $950 million in civil and criminal fines to the Department of Justice and other governmental entities as a result of various criminal activities Merck had engaged in with respect to Vioxx.

Plaintiffs in the Gardasil litigation allege Merck has engaged in similar corporate malfeasance with its HPV vaccine.

According to the lawsuit allegations, Gardasil, which Merck markets as an anti-cancer product, may itself cause cancer or mutagenetic changes that can lead to cancer.

Peer-reviewed studies, including CDC’s own studies, have suggested that the suppression of the HPV strains targeted by the Gardasil vaccine may actually open an ecological niche for replacement by more virulent strains.  See Fangjian Guo et al., Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20–26 years), 11 HUMAN VACCINES & IMMUNOTHERAPEUTICS 2337 (October 2015); Sonja Fischer et al., Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccinations, 12 ONCOLOGY LETTERS 601 (2016); Martcheva M. et al. Vaccine-induced pathogen strain replacement: What are the mechanisms?, J.R. SOC. INTERFACE 4:3-13 (2008); J. Lyons-Weiler, Biased Cochrane Report Ignores Flaws in HPV Vaccine Studies, and Studies of HPV Type Replacement, (May 18, 2018).

Furthermore, cervical cancer rates are climbing rapidly in countries where Gardasil has a high uptake.

In Norway, with an 80% uptake, there has been a 24% increased rate of cervical cancer in women 25 to 29 years old since introduction of Gardasil.

In Sweden, with a 70% uptake, there has been a 16% increased rate of cervical cancer in women 25 to 29 years old since introduction of Gardasil.

In Scotland, with an 80% uptake, there has been a 15% increased rate of cervical cancer in women 25 to 29 years old since introduction of Gardasil.

In the United States, with a 70% uptake on the first dosage of Gardasil, and 50% uptake on the second, there are increases in cervical cancer in women under 50, and a decrease in women over 50 (who would not have received the Gardasil vaccine).

Since the introduction of HPV vaccine in England, cervical cancer rates among young women aged 20 to 24 have risen 65%.

In Australia, government data reveals there has been a sharp increase in cervical cancer rates in young women following the implementation of the Gardasil vaccine. The most recent data reveal that, 13 years after Gardasil was released and pushed upon teenagers and young adults, there has been a 34% increase in women 30 to 34 years old developing cervical cancer, corroborating the clinical trial data that Gardasil increases the risk of cervical cancer, particularly in patients who had previous HPV infections.  Meanwhile, rates are decreasing for older women (who have not been vaccinated).

Importantly, considering Merck’s marketing for Gardasil as a “cervical cancer vaccine,” young women who have received Gardasil are foregoing regular screening and Pap tests in the mistaken belief that HPV vaccines have eliminated all their risks.

Until 2021, Gardasil had more reported adverse events than any other vaccine. The U.S. Food and Drug Administration’s (FDA) Vaccine Adverse Event Reporting System (VAERS) had received more than 64,000 HPV vaccine adverse event reports by December 2019. The Vaccine Injury Compensation Program (VICP) has paid out millions of dollars in damages for injuries and deaths.

“As a result of Merck’s fraud, Gardasil is wreaking havoc on a substantial swath of an entire generation of children and young adults on a worldwide scale,” the Gardasil lawsuits allege.

About Wisner Baum

The award-winning law firm of Wisner Baum (formerly Baum Hedlund Aristei & Goldman) has successfully litigated cases against many of the largest pharmaceutical companies in the world. The firm has earned a reputation for breaking new legal ground, holding corporations accountable, influencing public policy, and raising public awareness on important safety issues. Using its longstanding tradition of success in the courtroom, the firm always strives to shine a spotlight on unsafe products or harmful practices to protect consumers from dangerous products. Across all areas of practice, the firm has won more than $4 billion in settlements and verdicts.

The Gardasil attorneys at Wisner Baum wish to stress that our law firm is not against vaccines. The firm is, however, against intentional efforts to mislead consumers about the safety and effectiveness of a drug or vaccine. Wisner Baum has 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.



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