Patients file lawsuits in Charlotte court alleging issues caused by Merck’s HPV vaccines

A vaccine manufactured in North Carolina — and the only one given to protect against human papillomavirus in the U.S. — is facing hundreds of lawsuits filed in Charlotte.

The FDA has long approved Merck & Co.’s Gardasil vaccine, which has prevented cancer and protected individuals against HPV— the most common sexually transmitted infection among women — since 2006.

But a series of at least 185 lawsuits — 20 of which involve minors — filed in Charlotte since 2022 question the CDC and allege the shots could come at a cost: autoimmune disorders, premature ovarian failure and the same cancer they claim to ward off.

“Nothing is more important to Merck than the safety of our products and the patients who take them, ” Julie Cunningham, a Merck spokesperson, wrote in an email to The Charlotte Observer. “...We will vigorously defend against these cases.”

Since 2016, Gardasil 9 has been the only HPV vaccine distributed to preteens and young adults in the country. It prevents diseases related to nine of the most common types of HPV, according to Merck. Its original version protected against four strands of the genital infection and was made available to those between the ages of 9 and 26.

The CDC and FDA say the vaccinations are safe, and more than 15 years of research and monitoring back up that claim.

“Since HPV vaccination was first recommended in 2006, infections with HPV types that cause most HPV cancers and genital warts have dropped 88% among teen girls and 81% among young adult women,” according to the CDC website.

Gardasil was studied in clinical trials with more than 29,000 females and males, and Gardasil 9 was studied in clinical trials with more than 15,000 females and males, according to the CDC.

More than 135 million doses have been distributed since 2006, and data continues to show the vaccines are safe and effective.

But in court documents filed in Charlotte’s U.S. District Court for the Western District of North Carolina, lawyers claim too much research was overlooked or never completed.

Gardasil’s approval

While Gardasil awaited the CDC’s regulatory process, then director Julie Gerberding, “obligingly ushered” it through following the drug’s 2006 approval from the FDA, the complaints allege. In 2010, they say, she was “rewarded” and named president of Merck Vaccines. She retired in 2022.

According to the CDC, clinical trials can take years, but an application to the FDA is either approved or denied within six months. A review from the CDC follows shortly after.

According to a 2000 U.S. House of Representatives investigation report, the majority of the CDC’s eight Committee on Immunization Practices members had conflicts of interest, the lawsuit says.

“The chairman served on Merck’s Immunization Advisory Board and a number of the other members had received grants, salaries, or other forms of remuneration from Merck.”

Lawyers say the quickness of Gardasil’s approval ultimately landed 185 plaintiffs in hospitals and, now, in court. They allege their medical issues — ranging from autoimmune disorders to cancer — arose after they were vaccinated.

The CDC refutes that the vaccines cause cancer, and no studies have found any association between the HPV vaccination and autoimmune conditions.

“The vaccine is made from one protein from the virus and is not infectious, meaning it cannot cause HPV infection or cancer,” the agency stated in a 2021 fact sheet on the inoculation.

It acknowledges minor side effects caused by the vaccine, like fainting, nausea and headache, and maintains that the vaccine does not cause fertility problems.

“CDC is aware of public concern about the safety of HPV vaccine,” it says on its website, but “...there is no current evidence that HPV vaccines cause reproductive problems in women.”

Between 2014 and 2017 the CDC received three reports of premature menopause following Gardasil 9 vaccinations. Each was determined to be a hearsay report based on secondhand information, meaning there was not enough information to confirm a diagnosis of primary ovarian insufficiency (POI).

The same happened between 2009 and 2015, when the CDC received 17 reports of early menopause. Only two were based on a physician’s diagnosis, but neither could be tied to the vaccine, the CDC says.

Premature menopause is defined by the Mayo Clinic as reaching menopause before the age of 40. It affects about 1% of women.

Merck’s Gardasil lawsuit

While the complaints against Merck were filed in North Carolina, the alleged issues are widespread. Many plaintiffs have never lived in the state, and the pharmaceutical company’s U.S. headquarters are in Rahway, New Jersey.

The company operates a 262-acre facility in north Durham, so Charlotte’s court is fair game, the complaints say.

In late February, a judge ruled the 185 cases filed since 2022 be consolidated under one case.

In the most recent lawsuit, filed Tuesday, plaintiff Shanie Roman of Illinois claims she began experiencing uncharacteristic, “excruciating pain” before and during her period only after she was vaccinated.

She’s since had her reproductive organs removed after being diagnosed with endometriosis, according to the complaint. She’s also been diagnosed with fibromyalgia — or long-lasting, pervasive pain throughout the body — and ovarian remnant syndrome. — which causes pelvic pain.

She got her first dose of the Gardasil vaccine at 25 and a second dose at 26. Her current age is not listed in the complaint.

In late February, the New Jersey parents of a minor identified as E.H. filed their complaint against Merck. Before receiving her second dose of Gardasil in 2020, their 13-year-old daughter was “self-possessed and fearless” despite the pandemic, they say.

After the dose, they allege, her moods “shifted erratically,” and she was soon diagnosed with phase 3 Type 1 diabetes.

“The second Gardasil vaccination provoked an intense & potent auto-immune response that stimulated E.H.’s immune system to wage war against the insulin producing ‘B’ cells in her pancreas,” the parents allege.

The rest of the cases are filled with similar stories of “serious autoimmune, autonomic, and neurological dysfunctions” developed only after Gardasil vaccinations. In every instance, they ask the pharmaceutical company to award compensation related to plaintiffs’ “economic and non-economic damages,” including medical and psychological expenses.

It also asked the court for preliminary injunction relief against Merck, which would prevent it from continuing its business.

Plaintiffs say Merck failed to “exercise ordinary care” in research, development, marketing and distribution of Gardasil when it used a “toxic placebo” and failed to sufficiently test the targeted patient population (pre-teens between the ages of 9 and 12).

According to the CDC, large studies have concluded that HPV vaccines do not cause autoimmune disorders, “including Guillain–Barré syndrome, multiple sclerosis, and diabetes.”

Gardasil and misinformation

Last year, a Facebook post circulated misinformation alleging Merck was already on trial for a cancer-causing HPV vaccine and saying the drug had been banned in other countries. The post was not true.

“Gardasil has not been banned anywhere and federal health officials say the vaccine cannot cause cancer,” spokespersons for Merck and a law firm representing various plaintiffs previously told the Associated Press.

More than 20 years of research and development supports both the safety and efficacy profile of Merck’s HPV vaccines, spokesperson Bob Josephson wrote in an email to the AP.

“We will vigorously defend against these cases,” the company reiterates.

Merck sues the US government

In 2023, Merck sued the U.S. government, trying to halt drug price negotiations under Medicare. With Americans paying more for prescription medicines than any other country, President Joe Biden’s reform looked to save $25 billion through negotiations for drugs paid for by Medicare.

Merck’s lawsuit, filed in the U.S. District Court for the District of Columbia, argues Biden’s plan violates part of the Fifth Amendment — which requires the government to pay just compensation for private property taken for public use.