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A lawsuit filed Tuesday in federal court alleges Merck’s Gardasil human papillomavirus (HPV) vaccine caused a young Utah woman to develop cervical cancer and other injuries.

The lawsuit, filed on behalf of Caroline Cantera, 25, by Wisner Baum (formerly Baum Hedlund Aristei & Goldman), is the first lawsuit to allege Gardasil can cause cervical cancer — the very cancer Merck asserts Gardasil prevents.

Cantera 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 filed the complaint in the U.S. District Court for the Western District of North Carolina as part of the Gardasil multidistrict litigation (MDL). Dozens of federal Gardasil injury cases filed throughout the country have been consolidated in North Carolina.

According to the complaint, Merck never studied whether Gardasil prevents cervical cancer. Instead, the drugmaker tested Gardasil to determine if it could prevent the development of certain lesions, some of which are considered related to cancer — even though a majority of such lesions, even the most serious, regress on their own.

Public health officials have long recommended the Pap test as the most effective frontline public health response to prevent cervical cancer. Long before Gardasil was introduced to the market in 2006, cervical cancer rates had been plummeting by up to 80% with the 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 Track” U.S. Food and Drug Administration approval of Gardasil. 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 Centers for Disease Control and Prevention (CDC) suggest the suppression of the HPV strains targeted by Gardasil (there are more than 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 complaint also cites rapidly climbing cervical cancer rates among young women in countries where Gardasil has seen a high uptake. Studies also show young women who 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.

Bijan Esfandiari, co-lead counsel for plaintiffs in the Gardasil MDL, said:

“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. Given Merck makes over $6 billion 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.”

Cantera ‘had to face the painful fact that I will never be able to have children of my own’

Cantera was 19 years old when she received her first of three Gardasil shots. She said 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, Cantera was healthy and never had to go to the doctor for anything other than regular checkups and physical exams for sports. She received routine Pap tests, 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, Cantera 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.

Cantera 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 saw countless doctors.

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.

Cantera said:

“Every day since my diagnosis has been a battle. 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?”

In September 2022, Wisner Baum and Robert F. Kennedy Jr., chairman on leave from Children’s Health Defense, filed their first wrongful death suit against Merck, alleging the drugmaker’s Gardasil HPV vaccine caused the death of 13-year-old Noah Tate Foley.

Wisner Baum and Kennedy have filed numerous lawsuits against Merck alleging the company knowingly conceals the adverse events associated with its Gardasil vaccine. These include:

While each case is unique, all of the plaintiffs agree that if Merck had told the truth about the known dangers associated with Gardasil, they never would have consented to the HPV vaccine.

If you or your child suffered harm after receiving the Gardasil HPV vaccine, you may have a legal claim. Visit Wisner Baum for a free case evaluation or call 855-948-5098.