Merck’s Gardasil Under Legal Scrutiny Despite Lack of Evidence to Support Suits

Pictured: Doctor injecting child with vaccine

Pictured: Doctor injecting child with vaccine/Courtesy of iStock, Prostock-Studio

National and international experts still recommend Gardasil HPV vaccination, despite critics’ claims it can cause serious side effects.

In April, a federal court ordered Merck to turn over data detailing adverse events from trials of the company’s human papillomavirus vaccine, Gardasil, which is designed to lower the risk of cervical and other cancers. The move comes after plaintiffs claiming to have suffered due to the vaccine were consolidated into a Multidistrict Litigation suit, with proceedings expected to begin in the next two years.

Though this most recent action conveys that the court considers the claimants’ allegations serious enough to merit compelling Merck to release data for discovery, legal experts say the history of the suits goes back several years, with divisive opinions on both sides.

“The big question is whether a jury is going to accept the plaintiffs’ theory despite the lack of scientific rigor to back up their claims,” Harry Nelson, founding partner of Nelson/Hardiman Healthcare Lawyers, a firm specializing in healthcare, told BioSpace. “If that happens and there is a big plaintiff win in one or two of the early cases, that will force a settlement.”

A History of Gardasil and Related Lawsuits

Beginning in 2020, Merck has faced approximately 80 lawsuits over its human papillomavirus (HPV) vaccine. Claimants allege that Gardasil causes side effects as severe as cancer and that Merck misrepresented its safety and efficacy.

Gardasil is designed to prevent infections with certain strains of HPV, which can cause cervical cancer, pre-cancerous cells and genital warts, according to the CDC. The FDA first approved Gardasil in 2006 for people ages 9 to 26, and in 2018 the agency expanded approval for people through age 45. Around 125 countries have since introduced the HPV vaccines, offering access to one in three girls aged 9-14 worldwide, according to UNICEF.  

However, some individuals and the firms that now represent them claim the vaccine has caused serious adverse reactions (autoimmune disorders, premature ovarian failure, chronic fatigue), leading to legal action against Merck. They have also accused Merck of downplaying the risks associated with Gardasil and putting profits ahead of public health. They argue that more research is needed to fully understand the potential long-term effects of the vaccine, especially in young people.

According to the lead attorneys’ websites, the plaintiffs claim the Gardasil vaccine’s manufacturer “did not provide adequate warning of possible side effects associated with the product and that Merck fraudulently concealed evidence about the health risks of the vaccine while at the same time misrepresenting that Gardasil could prevent cervical cancer.” Specifically, lawsuits have been filed against Merck for issues such as failure to warn, manufacturing defects and negligence. 

Merck has defended the safety and efficacy of Gardasil, stating that the vaccine has undergone rigorous testing and has been proven to prevent HPV-related illnesses. The company also argues that the reported adverse reactions are extremely rare and that the vaccine’s benefits outweigh potential risks. 

“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,” Bob Josephson, a spokesperson for Merck, wrote in an email to the AP in March 2023. “We will vigorously defend against these cases.”

A Multitude of Cases

By July 28, 2022, 48 cases were pending, with at least 100 more set to be filed in federal courts nationwide. Then in August, the U.S. Judicial Panel on Multidistrict Litigation (MDL) [JA9] consolidated many of the legal challenges against Merck under a single federal judge, U.S. District Judge Robert J. Conrad in the Western District of North Carolina, to streamline the discovery and pre-trial process.

Litigation is also playing out in some state courts, including seven cases in California. Omar Ochoa, an MDL expert and analyst in Texas, said that in similar suits, California has tended to have better results for plaintiffs than in more conservative states, as the laws of the typically Democratic state favor consumers over corporations. Though postponed to September 2024, these rulings are expected to move before the consolidated federal suits, and the outcomes may act as a harbinger for the MDL, Ochoa predicted.   

In the meantime, the MDL presses on. In April 2023, Judge Conrad ordered Merck to turn over its entire adverse event database to plaintiffs. 

Ochoa said this action was not unusual. 

“It’s typical for parties in a lawsuit to request documents from each other, especially documents the parties believe will prove their case,” Ochoa told BioSpace. “Here, the plaintiff asked for information about adverse event reports regarding the HPV vaccine. Merck refused to produce it, so the plaintiff filed a motion to compel, which is essentially asking for a court order to force Merck to produce the information.”

Nelson agreed that the recent decision doesn’t mean Merck is in a weak legal position. Quite the opposite, Nelson said; the science doesn’t support the claimants.

“If I was deciding this case, I think the plaintiffs should have a tough time given the absence of any credible studies to support their claims,” he said. “All the same, as a parent, I understand the hesitation to take the vaccines because there are alternatives. HPV is a cancer risk, but a relatively small one relative to other cancer risks. It’s also preventable. If people are not sexually active, they are not at risk.” 

Merck declined to comment to BioSpace for this story, as did attorneys representing the plaintiffs.

Agencies Line Up in Favor of Gardasil Vaccination

No national or international regulatory agencies or professional organizations recommend against using Gardasil. The American Academy of Pediatrics, the American Cancer Society, the American Academy of College of Obstetricians and Gynecologists and the World Health Organization all concur with the FDA’s guidelines that people between the ages of 9 and 45 should receive the vaccine as of 2023. 

In its fact sheet, the CDC acknowledges that HPV vaccines can cause minor side effects such as fainting, nausea and headache. But the vaccine does not cause fertility problems or other severe side effects, according to the agency.

“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.

The FDA declined to comment to BioSpace for this story, but a CDC spokesperson told BioSpace via email that the organization monitors all vaccines for safety concerns. Further, the agency asserted that more than 15 years of monitoring and analysis have demonstrated that HPV vaccines are safe.

“More than 160 studies have been conducted in multiple countries to look at whether specific adverse events can be linked to HPV vaccine,” the spokesperson said. “These studies have shown HPV vaccines have a reassuring safety profile.”

The spokesperson also emphasized that Gardasil effectively prevents HPV infections linked to several types of cancer in both males and females. According to the CDC fact sheet, infections that cause most HPV-related cancers (cervical, vaginal and anal) and genital warts also have dropped 88% among teen girls. In addition, the fact sheet states that fewer women are developing cervical pre-cancer since Gardasil was initially approved in 2006.

“HPV vaccination has the potential to prevent more than 90% of HPV-attributable cancers,” the CDC spokesperson said.

Lisa Munger is a senior editor at BioSpace. You can reach her at Follow her on LinkedIn.

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