Human papilloma viruses (HPVs) are small non-enveloped DNA viruses that belong to the papilloma virus family, and infect cutaneous and mucosal epithelia in humans (1). HPVs are extremely common worldwide, and consist of >170 types (2).
A persistent infection with certain mucosa-tropic types of HPV is recognized as the major factor in the etiology of cervical cancer (3–6). According to the World Health Organization (WHO), cervical cancer is the second most common type of cancer in women, with ~530,000 newly diagnosed cases every year (7).
The incidence of cervical cancer in Germany is one of the highest among Western countries, and it is currently the second cause of mortality among women >50 years of age (8).
HPV is usually acquired via sexual transmission, and may induce the development of cervical cancer within several years following a persistent infection (9). The progress of cervical cancer is slow, commencing from cervical intraepithelial neoplasia (CIN) (3) and ending with invasive cancer. Precancerous lesions may be effectively detected by cervical screening using the Papanicolaou test (Pap smear).
HPVs have been classified into high-risk types (HR-HPVs), which are oncogenic or have oncogenic potential, and low-risk types (LR-HPVs), which do not exhibit a causal association with cancer (9). A recent study provided biological evidence of carcinogenicity for HPV types 26, 53, 66, 67, 68, 70, 73 and 82, which were previously classified as possibly carcinogenic (HPV26, 53, 66, 68, 73 and 82) and non-carcinogenic (HPV67 and 70) (10).
Whereas LR-HPV types account for non-fatal conditions, including warts and condylomas, numerous studies have demonstrated the causal association between HR-HPV and malignant lesions (4,6,11). In a retrospective cross-sectional worldwide study concerning the association between HPV genotype and cervical cancer using data from >10,000 patients, HPV DNA was identified in 85% of patients with cervical cancer (12). The highest carcinogenic risk is attributed to the following HR-HPV types: 16, 18, 31, 33, 35, 52 and 58 (13). HPV16 and 18 are associated with >2/3 of all cervical cancer cases worldwide (14–16), which has led to the development of prophylactic vaccines against these two HPV types (17).
Currently, there are two approved HPV vaccines in Germany (18). These are the quadrivalent vaccine Gardasil® (Merck & Co., Inc., Whitehouse Station, NJ, USA), which targets HPV6, 11, 16 and 18, and the bivalent vaccine Cervarix® (GlaxoSmithKline, Brentford, UK), which targets HPV16 and 18.
Since 2006, numerous countries have implemented vaccination programs using these two vaccines (18). In Germany, HPV vaccination is usually performed during a routine adolescent health check-up termed J1, which is available for 12–14 year-old girls, and the recommendation of the Standing Committee on Vaccination at the Robert Koch Institute is to vaccinate between the ages of 9 and 14 years (19).
The results from clinical trials indicate that vaccinated girls and women have an increased protection against the development of CIN (20–23). In addition to the proven efficacy against HPV16 and 18 (10,15), the above bivalent and quadrivalent HPV vaccines are known to confer cross-protection against certain non-vaccine HPV types. The quadrivalent vaccine has been described to cross-protect mainly against HPV31 (24), while the bivalent vaccine has been demonstrated to exhibit a protective effect against HPV31, 33, 45 (25) and 51 (26).
With the increasing impact of vaccination against certain HPV types in young women (27), it is important to monitor shifts in the prevalence of HPV types.
reference link : https://www.spandidos-publications.com/10.3892/ol.2016.4668
The case…
The Gardasil vaccine, manufactured by Merck & Co., was approved by the U.S. Food and Drug Administration (FDA) in 2006 for use in preventing infection from only a few of the hundreds of types of human papillomavirus (HPV).
Since hitting the market, however, thousands of adolescents and adults have reported serious and disabling Gardasil side effects after receiving the HPV vaccine. The most prominent among these side effects is postural orthostatic tachycardia syndrome (POTS).
Gardasil achieved FDA approval in just six months. Even one of the principal investigators of the Gardasil clinical trials (the human testing that precedes FDA approval) said the process “went too fast.”
Researcher Peter C. Gøtzsche in his book Vaccines: Truth, Lies, and Controversy noted some of the research inadequacies in the HPV vaccine clinical trials:
“It is a requirement for registration of drugs that randomized trials have been carried out where one group received the drug and the control group received placebo or nothing. This allows assessment of both the benefits and harms of drugs. I have done research on non-vaccine drugs for decades and was shocked when I learned through my work with vaccines against human papilloma virus (HPV) that the regulatory requirements are much less for vaccines. Almost all the HPV vaccine trials have a control group receiving a hepatitis vaccine or a strongly immunogenic adjuvant, which makes it impossible to find out what the harms of the HPV vaccines are.”
Apr 25, 2023 3:30 PM ET
Legal Newswire POWERED BY LAW.COM
Human papillomavirus (HPV) vaccine injury lawyers from Wisner Baum (formerly Baum Hedlund Aristei & Goldman) filed a lawsuit in federal court on behalf of a young Utah woman who alleges Merck’s Gardasil HPV vaccine caused her to develop cervical cancer and other injuries. This is the first lawsuit to allege Gardasil can cause cervical cancer, the very cancer Merck asserts Gardasil prevents.
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.
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.
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.
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.
Name: Robin McCall
Email: [email protected]
Job Title: Director of Public Relations
reference link
https://www.wisnerbaum.com/prescription-drugs/gardasil-lawsuit/
