Merck to Face California Jury as ‘Historic’ Gardasil HPV Vaccine Trial Gets Under Way

Jennifer Robi, confined to a wheelchair since age 16 after receiving three doses of the Gardasil HPV vaccine, will face off against Merck in Los Angeles.

Jan 25, 2025

Jury selection began this week in a Superior Court of California case filed against Merck accusing the vaccine maker of fraud, negligence and concealing the likelihood and severity of adverse effects associated with its Gardasil HPV vaccine.

The case involves a lawsuit, filed in Los Angeles County in July 2016, by Jennifer Robi. Robi has been confined to a wheelchair since age 16, after receiving three doses of the Gardasil human papillomavirus, or HPV, vaccine.

The outcome of the trial could affect hundreds of other lawsuits involving Merck’s Gardasil vaccine.

Robi’s lawsuit also accused Kaiser Foundation Hospitals of medical malpractice for administering the vaccine and failure to diagnose her immunological condition and its link to the vaccine.

However, late Wednesday, Kaiser settled with Robi, avoiding a trial. Terms of the settlement are confidential. Robi also won key pretrial motions when Superior Court Judge Elaine Lu ruled against Merck’s motion for summary judgment and several motions to exclude key expert witnesses for the plaintiff.

The trial is “historic,” according to Michael Baum, an attorney with Wisner Baum, because it’s the first vaccine injury case to go through the required process of applying for compensation through the federal vaccine injury compensation program and then on to a civil trial.

Children’s Health Defense (CHD) General Counsel Kim Mack Rosenberg, who has been actively involved in the litigation from the beginning, said the start of the trial is a “real milestone” in litigation against Gardasil.

“Because of the extraordinary liability shield protecting the pharmaceutical industry under the 1986 Act, it is the rare case for a vaccine recommended on the childhood vaccine schedule to see the inside of a state or federal courthouse,” Mack Rosenberg said.

CHD is supporting Robi’s case.

Several other Gardasil cases are pending against Merck in state courts, and as of December 2024, there were 212 cases pending in federal court.

Opening statements in Robi’s case are expected early next week. The trial is slated to last six weeks.

‘Gardasil vaccine has destroyed my daughter’s life’

Robi, a former high school athlete and honor student, was forced to drop out of school and 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, and 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 concealed risks, exaggerated effectiveness of Gardasil

Merck’s Gardasil won fast-track approval from the 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.

Plaintiff scores major wins in pretrial motions

After years of discovery and hearings on pretrial motions, jury selection in the case began Wednesday — after Judge Lu ruled on a series of pretrial motions, largely in favor of the plaintiffs.

In July 2024, Merck filed a motion for summary judgment — a request for a ruling in their favor without a trial. The company argued that Robi hadn’t filed her initial claim with the federal vaccine injury compensation program in a timely manner, that federal and California law shields the company from liability, and that Robi couldn’t prove the vaccines caused her injuries.

Merck also proposed that if the court were to deny a summary judgment, it should instead grant a summary adjudication, which would limit the amount of damages the court could award to Robi.

Lu, who heard arguments on the motion last October, denied Merck’s motions for summary judgment or adjudication in their entirety. In a 60-page decision issued Dec. 20, 2024, she provided a point-by-point rebuttal to Merck’s arguments.

Merck also filed motions to exclude evidence related to Gardasil’s profitability, some symptoms the plaintiff alleged are linked to Gardasil and conflicts of interest. The company also attempted to limit or exclude the testimony of many of the plaintiff’s expert witnesses including Martin Kulldorff, Ph.D., Dr. Mitchell Miglis and many others.

Kaiser filed similar motions to exclude evidence or testimony.

Lu denied or deemed moot or irrelevant all of Kaiser’s pretrial motions and denied most of Merck’s, allowing almost most evidence and testimony. Most of the plaintiff’s pretrial motions were deemed moot because the parties resolved the motion in advance of the ruling.

How did Robi’s case against Merck get to a civil courtroom?

Mack Rosenberg said that Jennifer Robi and her family have “suffered tremendously” and “fought valiantly.” As a result, “Her case has survived defendants’ attempts to avoid trial in order to arrive at this momentous day.”

She said that as the first civil case against Merck related to the Gardasil vaccine, Robi’s trial is “critically important in the fight for justice for Gardasil victims.”

“This is the first case to go to trial, and while there may be issues specific to Ms. Robi, there also are general issues concerning vaccine injury causation that may be instructive in future litigation.”

Vaccine injury lawsuits are uncommon because vaccine makers are largely protected from liability for injuries caused by a fully licensed vaccine if that vaccine is listed on the Centers for Disease Control and Prevention’s childhood vaccination schedule.

However, that doesn’t mean drugmakers can never be sued for vaccine injuries from protected vaccines — as long as the injured follow a prescribed process. The first step requires them to seek compensation through the National Vaccine Injury Compensation Program (VICP), also known as the “vaccine court.”

The VICP is a special no-fault tribunal alternative to the traditional legal system set up to resolve vaccine injury claims for 16 federally recommended vaccines. Since it began accepting claims in 1988, the VICP — despite its shortcomings — has awarded $5.3 billion to more than 8,000 families for vaccine injuries.

Payouts, including attorneys’ fees, are funded by a 75-cent tax per vaccine. There is a $250,000 cap on pain and suffering and death benefits.

But many people are unaware that claimants who are dissatisfied with the outcome of the VICP process can move on to step two: suing the pharmaceutical company directly in civil court, as long as that claimant completed the VICP process.

Once an injured person files a case with the VICP, the VICP has 240 days to respond to complete the process. Injured people who choose not to accept the vaccine court’s judgment can opt out of the program, and elect to file a lawsuit in civil court.

Baum told The Defender in an earlier interview the vaccine court has paid out more than $70 million to people making claims against Gardasil. However, over the last few years, without explanation, the court stopped making payments for autoimmune conditions caused by the vaccine.

Robi filed a case with the VICP on Sept. 20, 2013, and received a judgment on May 29, 2015. Unsatisfied with the judgment, she filed a legal action.

Baum said Robi’s case is significant because it is the first vaccine injury case that has gone through the VICP and then on to a civil case. “This has never happened before,” he said.

The other 200-plus lawsuits pending in federal court have been consolidated into multidistrict litigation (MDL) in a single court. The order allows Gardasil lawsuits filed throughout the country to move into coordinated discovery and pretrial proceedings.

Merck opposed the consolidation, alleging that publicity surrounding the consolidation would “spread misinformation about vaccines,” “increase vaccine hesitancy” and could cause a flood of “meritless” vaccine injury claims. However, the court disagreed.

Sixteen cases were selected as exemplar cases from a larger pool of lawsuits. They will serve as a series of “bellwether trials,” the outcome of which will shape the process for the growing number of claims brought against Merck for Gardasil-related injuries.

As those cases move forward, the judge is ruling on many of the same summary judgment motions and motions to exclude the same expert witnesses and evidence.

“The wins in this case on the summary judgment and motions to exclude expert witnesses show the judge in the MDL that a judge in California has deemed our experts to be credible and reliable,” Baum said. “Of course, the judge in the MDL has the right and power to decide differently.”

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