Teen Suffers From Autoimmune Disease After Taking HPV Vaccine, Lawsuit Filed Against Merck

A sign at a Merck plant in Rahway, N.J., on Nov. 29, 2005. Marko Georgiev/Getty Images

A lawsuit has been filed against Merck by an individual who allegedly suffered multiple medical complications after being injected with the company’s HPV vaccine, Gardasil, as a teenager.

As a result of taking Merck’s HPV vaccine, plaintiff Katherine E. Miller suffered “chronic and severe post-Gardasil symptoms,” the lawsuit (pdf) claims. “Plaintiff has been diagnosed with various medical conditions, including but not limited to, autoimmune hypothyroidism, polycystic ovarian syndrome (PCOS), brain cavernoma, and irritable bowel syndrome (IBS).”

The lawsuit was filed Sept. 1 in the Western District of North Carolina. The suit joins around 100 similar claims being pursued against Merck, alleging the pharma giant withheld critical safety information from the medical community.

Ms. Miller was 17 years old when she received her first dosage of Gardasil in 2017. The second and third doses were given in 2018. She and her mother decided for the vaccination “after being convinced by Merck’s marketing that Gardasil is very safe and Gardasil prevents cancer.”

“Following her third Gardasil vaccine, Plaintiff began experiencing abdominal symptoms, including indigestion and constipation, trouble focusing, brain fog, extreme fatigue, dizziness, imbalance issues, missed menstrual cycles, cold hands and feet, and headaches.”

As months passed, the symptoms also progressed and Ms. Miller saw multiple physicians and specialists to deal with the issue. Due to post-Gardasil symptoms, Ms. Miller was unable to engage in activities that “a normal young person would enjoy.”

“Her academic performance and social and extracurricular activities have been adversely affected by her post-Gardasil symptoms.”

The lawsuit alleges that prior to providing consent to being injected with the Gardasil vaccine, Ms. Miller and her parents were not informed of the following:

• Gardasil is linked to a host of “serious debilitating and chronic adverse events including, autoimmune injuries, increased risk of cancer, and death.”
• Merck did not conduct the proper testing necessary to demonstrate the safety and efficacy of the vaccine.
• Merck “manipulated” clinical studies in a bid to “mask and conceal” the adverse effects of Gardasil.
• Clinical trials for Gardasil never established the vaccine can “prevent cervical or anal cancer,” even though the company stated in its promotional material that Gardasil was a “cervical cancer vaccine.”

“Merck’s representations were false, because in truth, Gardasil has not been proven to prevent cervical or anal cancer and is associated with a myriad of dangerous and undisclosed risks,” the lawsuit stated.

Ms. Miller contended that Gardasil injections resulted in her developing serious medical issues and is seeking compensatory damages and other relief.

The suit charges Merck with five counts—negligence, failure to warn, manufacturing defect, breach of express warranty, and common law fraud. Ms. Miller has demanded a jury trial.

Allegations Against Merck, CDC Stance

The lawsuit points out that “the median age of death from cervical cancer is 58, and death from anal cancer is 66, and teenagers (who are the target population of Gardasil) essentially have zero risk of dying from cervical or anal cancer.”

Clinical trials conducted for the vaccine by Merck “did not even examine Gardasil’s potential to prevent cancer.”

“Rather, the trials only analyzed whether Gardasil could prevent potential precursor conditions, i.e., HPV infections and cervical interepithelial neoplasia (“CIN”) lesions … the vast majority of which resolve on their own without intervention.”

In this handout from Merck, a box of Gardasil, a new cervical cancer vaccine, is seen is this undated photo. Photo by Russell Kirk/Merck & Co. via Getty Images

The lawsuit alleges that Merck “purchased” a fast-track review for Gardasil. To obtain approval from the U.S. Food and Drug Administration, Merck conducted a series of “fraudulent Gardasil studies.”

The company then “influenced” the votes of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory Committee on Immunization Practices (ACIP) to secure an FDA license, a CDC/ACIP approval, and recommendation that all girls between the ages of 11 and 12 years be vaccinated with Gardasil, the lawsuit alleged.

“That ACIP ‘recommendation’ was, effectively, a mandate to doctors to sell Merck’s very expensive vaccine, thereby compelling parents of American children as young as nine years old to buy this expensive product.”

According to the lawsuit, the then-director of CDC, Julie Gerberding, “obligingly ushered” Merck’s Gardasil vaccine through the agency’s regulatory process while “ignoring clear evidence” that its efficacy was “unproven” and that it was “potentially dangerous.”

“Merck, shortly thereafter, rewarded Gerberding by naming her President of Merck Vaccines in 2010.”

A year before obtaining licensing for Gardasil, Merck engaged in a “disease branding” campaign to “create a market for its vaccine out of thin air,” the lawsuit said.

“Merck also engaged in a relentless propaganda campaign aimed at frightening and guilting parents who failed to inoculate their children with Gardasil.” The company “intended its campaign to create fear and panic and a public consensus that ‘good mothers vaccinate’ their children with Gardasil.”

The U.S. Centers for Disease Control and Prevention (CDC) states that HPV vaccines can result in some minor side effects like fever, headache, and swelling in the site where the shot was injected. There is also a “very remote chance” of an HPV vaccine causing a severe allergic reaction, serious injury, or death.

A spokesperson from the CDC told life science news outlet BioSpace that “more than 160 studies have been conducted in multiple countries to look at whether specific adverse events can be linked to HPV vaccine. These studies have shown HPV vaccines have a reassuring safety profile.”

The spokesperson also insisted that Gardasil effectively prevents HPV infections that are linked to several cancers in both men and women.

In a statement to AP in March, Merck defended the Gardasil vaccine.

“The overwhelming body of scientific evidence—which includes more than 20 years of research and development—continues to support the safety and efficacy profile of our HPV vaccines,” said a spokesperson. “We will vigorously defend against these cases.”

The Epoch Times has reached out to Merck for comment.

Multidistrict Litigation

Ms. Miller’s lawsuit will be consolidated with the roughly 100 other lawsuits on Gardasil vaccines, centralized as part of the Gardasil multidistrict litigation (MDL).

U.S. District Judge Robert J. Conrad is presiding over the discovery and pretrial proceedings stage of the litigation, which is expected to see a series of bellwether trials. In legal parlance, a bellwether trial involves a small group of lawsuits consolidated from a larger group of similar cases.

These bellwether trials are aimed at gauging how juries might potentially respond to some of the testimony and the evidence brought forward during the course of the litigation.

According to law firm Miller & Zois, which is reviewing Gardasil vaccine lawsuits in 50 U.S. states, 16 bellwether cases have been selected jointly by plaintiffs and defendants for the preliminary trials.

During an Aug. 29 pretrial conference held by Judge Conrad, it was revealed that 13 of these 16 cases had amended their complaints.

Though the outcome of preliminary trials will not impact other claims, they will play a key role in determining future settlements on the issue.