Trial Alleging Merck Hid Dangers of HPV Vaccine Delayed Again

After years of false starts, the trial got underway in January and was slated to run for six weeks. However, on Feb. 14, attorneys for Merck and the plaintiff agreed to reconvene the trial in...

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

by Brenda Baletti, Ph.D., The Defender

A landmark court case alleging Merck’s Gardasil human papillomavirus (HPV) vaccine seriously injured a 16-year-old girl was temporarily suspended late last week by mutual agreement of both parties, according to the plaintiff’s lawyer.

The lawsuit, filed in 2016, accuses Merck of fraud, negligence and concealing the likelihood and severity of adverse effects associated with its Gardasil HPV vaccine.

After years of false starts, the trial got underway in January and was slated to run for six weeks.

However, on Feb. 14, attorneys for Merck and the plaintiff agreed to reconvene the trial in September. The trial will start over from scratch — a new jury will be selected and the experts will testify again.

“Both sides believe that more information can better inform the trial,” lead plaintiff attorney Mark Lanier told The Defender. “The adjournment was initially our idea. We have some more developments in the near future, plus it was really tough having the trial while the confirmation hearings were ongoing.”

Lanier was referring to the confirmation hearings for Robert F. Kennedy Jr., who had participated in an early hearing in the case.

“We think that between those items, it was best to put the case back on the docket for September and release the jury from this trial.”

More information, including peer-reviewed studies, expected to come out in the next six months could help determine the case’s outcome, Lanier said.

“There’s more data that will help both sides assess not just the case, but the evidence in the case. I believe wholeheartedly in the jury system, and I look forward to all of the data being properly assessed before a finished trial,” he said.

Children’s Health Defense (CHD) is supporting plaintiff Jennifer Robi’s case.

CHD CEO Mary Holland said the pause will provide the opportunity for much more information about the side effects of the Gardasil vaccine to be made public.

Holland said:

“This pause in the long-planned case against Merck regarding its Gardasil case comes as a surprise. However, I look forward to the recommencement of this litigation and to getting to the truth and justice for Jennifer Robi who was profoundly injured by her Gardasil shots.”

Merck did not respond to The Defender’s request for comment, however, the vaccine maker told Reuters it was confident it would win.

“Merck remains confident that it will prevail in the Robi litigation based not only on the scientific evidence and defenses that it had presented during plaintiff’s own case, but also the additional evidence Merck would have presented in its defense, which had not even begun when plaintiff’s counsel proposed the adjournment.”

Several other Gardasil cases are also pending against Merck in state courts. And as of Feb. 4, 225 cases were pending in federal court.

In 2022, a judicial panel ordered the consolidation of the federal lawsuits against Merck into multidistrict litigation in a single court. The consolidation order allows Gardasil lawsuits filed throughout the country to move into coordinated discovery and pretrial proceedings.

Sixteen of those cases were selected to serve as “bellwether trials.” Their outcomes will shape the process for the growing number of claims brought against Merck for Gardasil-related injuries.

Preliminary hearings in those cases are set to begin in the coming months in North Carolina, likely before the Robi trial resumes.

Robi’s lawsuit — and the lawsuits that make up the multidistrict litigation — are historic because the liability shield protecting the pharmaceutical industry under the 1986 National Childhood Vaccine Injury Act has made it extremely difficult to sue vaccine makers.

The pharmaceutical companies can be sued only if a person first seeks compensation through the National Vaccine Injury Compensation Program (VICP), also known as the “vaccine court.”

Claimants dissatisfied with the outcome move on to step two: suing the pharmaceutical company directly in civil court. However, this process is costly, time-consuming and most people are not aware it is even possible.

Robi’s case, and the other cases against Merck, are the first to go through this process.

Merck concealed risks and exaggerated effectiveness of Gardasil

Robi, a former high school athlete and honor student, was forced to drop out of school and was confined to a wheelchair after receiving the Gardasil vaccine in 2010 and 2011 at age 16.

After each shot, Robi experienced serious and worsening immunological side effects including severe pain, headaches, nausea, fatigue, blurred vision, weakness and other symptoms.

Doctors didn’t diagnose her with postural orthostatic tachycardia syndrome (POTS) until August 2015. They later confirmed underlying small fiber neuropathy throughout her body, according to the complaint.

Today, Robi suffers continual uncontrolled neuromuscular contractions (jerking), POTS and many other symptoms of systemic autoimmune dysregulation. She has been disabled for more than a decade.

“The Gardasil vaccine has destroyed my daughter’s life and devastated our family,” her mother Katherine Robi testified to the California State Assembly Health Committee in 2023.

Robi seeks damages for loss of income, medical and legal expenses, and other relief the court deems appropriate.

Merck’s Gardasil won fast-track approval from the U.S. Food and Drug Administration (FDA) in 2006. The lawsuit alleges that during the brief, six-month approval process, Merck and its employees failed to disclose key safety and effectiveness data — including known adverse reactions to the drug — to the FDA.

After approval, the lawsuit alleges, the company aggressively marketed the drug to increase sales and “intentionally, wrongfully and deceitfully withheld, failed to provide and concealed” information about the vaccine’s safety and effectiveness from consumers.

According to the complaint, Merck specifically failed to disclose what the company knew about Gardasil’s effectiveness, including its limited duration of protection, the limited strains of HPV it protects against and the specific population it protects.

Robi also alleges Merck failed to disclose the minimal risk posed by HPV, existing effective treatments, and the likelihood and seriousness of possible side effects, among other things.

The Centers for Disease Control and Prevention recommends Gardasil as a routine immunization for 11- and 12-year-olds.

This article was originally published by The Defender — to the original piece from The Defender website.

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