"Anti-vaccine warrior" Kennedy "takes on" Merck & Co., Inc. (MRK.US) in a courtroom showdown over the billion-dollar business of the Gardasil vaccine.

For a long time, US Secretary of Health and Human Services Robert F. Kennedy Jr. and a group of personal injury lawyers have been accusing Merck & Co., Inc. (MRK.US) of engaging in "disease panic marketing" to promote sales of its Gardasil vaccine. However, for decades, the mainstream medical community has always considered this vaccine to be safe and effective. It is understood that the Gardasil vaccine is used to prevent human papillomavirus (HPV) infection. Kennedy and others have consistently opposed this vaccine, but their efforts over the years have had little effect. Since it was launched 20 years ago, this vaccine, which can prevent cervical cancer and other cancers caused by sexually transmitted viruses, has been approved in about 150 countries. Merck & Co., Inc. claims that the global distribution total has exceeded 9 billion doses. Currently, a group of plaintiffs' lawyers suing Merck & Co., Inc. are trying to convince the jury that the vaccine has safety hazards and design defects. Despite facing obstacles, if successful, Merck & Co., Inc. may have to pay substantial compensation to hundreds of young women. These women claim that after receiving this popular vaccine, they have experienced infertility problems or serious autoimmune diseases and heart damage. As the trial in Los Angeles approaches, Merck & Co., Inc. has stated that it is prepared to endorse the safety of Gardasil in court. According to informed sources, the company is also negotiating settlements, but since the negotiations are private, those involved are unwilling to be named. In its annual report released in February, Merck & Co., Inc. disclosed that it had reached a tentative agreement with the plaintiffs in October of last year, but further processes are still required for the agreement to take effect. Both Michael Baum, the plaintiffs' attorney, and representatives of Merck & Co., Inc. declined to comment on the progress of the negotiations. Dorit Reiss, a professor specializing in vaccine law at the University of California, San Francisco, said, "This lawsuit is significant for Merck & Co., Inc. If they lose in court, the company may face more similar lawsuits, so they will inevitably consider settlements; but reaching a settlement may also trigger more lawsuits." In its February announcement, Merck & Co., Inc. mentioned that the settlement agreement had unspecified participation thresholds: a minimum number of participants in the lawsuit and eligible Gardasil recipients had to be reached for the agreement to take effect. In large-scale personal injury lawsuits like Gardasil, companies can choose to settle with the affected claimant group without admitting that the product itself is harmful. Kennedy himself is a veteran plaintiffs' attorney and was involved in preparing the current trial before becoming the US Secretary of Health and Human Services last year. He also led the compilation of trial statement materials to support the argument that Gardasil poses safety risks. The lawyers leading this lawsuit have stated in court documents that they plan to present evidence showing that Gardasil significantly increases the risk of autoimmune diseases. One of their key witnesses is a former pathology professor at Yale University specializing in cervical cancer and DNA sequencing research. The plaintiffs will also argue that Merck & Co., Inc. rushed Gardasil to market without completing thorough safety tests in order to gain an edge in the competitive market. Stephen Amato, a regulatory affairs expert hired by the plaintiffs to testify, highlighted in a report that Merck & Co., Inc. was solely focused on making Gardasil a bestseller, using misleading promotional materials to boost sales for profit, without providing accurate information on the vaccine's true safety conditions. For years, Merck & Co., Inc. has denied any wrongdoing in the marketing and clinical testing of Gardasil. The company stated in a declaration, "Over thirty years of research and data accumulation, along with vast scientific evidence produced by Merck & Co., Inc. and independent research institutions, continue to support the safety and efficacy of our HPV vaccine." However, vaccine manufacturers are currently facing unprecedented scrutiny from regulators, a situation that has developed since Kennedy assumed office. In March of this year, a federal judge temporarily halted Kennedy's efforts to reduce the scope of childhood vaccine mandates, including a new regulation that would change HPV vaccination from three doses to a single dose. Kennedy and the anti-vaccine non-profit organization he previously led, Children's Health Defense, have both appealed this ruling. In terms of clinical efficacy, Gardasil's success is well known. A report from the Centers for Disease Control and Prevention last year showed an approximately 80% decrease in cervical precancer cases among women aged 20 to 24 who were eligible for vaccination from 2008 to 2022. Multiple observational studies cited by Merck & Co., Inc. also confirm that the vaccine can effectively prevent invasive cervical cancer and some head and neck cancers. Gardasil's commercial performance is also undisputed. Since its launch, it has always been a top-selling product for Merck & Co., Inc., with sales surging in the early 2020s to reach $8.9 billion in 2023. However, sales have been declining in recent years as several low-cost competitors have entered the market. Merck & Co., Inc.'s first-quarter financial report released on April 30 showed that this trend is continuing. In March 2025, a federal judge in North Carolina dismissed more than 200 collective lawsuits against Gardasil, ruling that the claims were subject to federal jurisdiction because the vaccine label had been approved by the Food and Drug Administration. The judge also noted that with only limited evidence provided by expert witnesses for the plaintiffs, no scientist could reasonably determine that the vaccine could cause the various symptoms claimed by the plaintiffs. This ruling is currently under appeal. The California trial, originally scheduled to begin on July 27, was initially set to start in February 2025 but was halted three weeks after it started. The reason was that the judge and lawyers on both sides believed that media reports on Kennedy's controversies over joining the Trump administration could interfere with the jury's judgment. This lawsuit was initiated by Jennifer Robi ten years ago. She claimed to have suffered from heart weakness and lifelong wheelchair use after receiving Gardasil as a teenager. Her claim for compensation was rejected by the National Vaccine Injury Compensation Program in 2015. Kennedy, who is no longer involved in the case, publicly commented on the matter in 2019. The case in the Los Angeles Superior Court has been prolonged, with the case docket containing nearly 1,500 chronological entries and involving at least nine judges. It was not until 2024 that it was assigned to Judge Elaine Lu. Unlike the judge in North Carolina, Lu has repeatedly denied Merck & Co., Inc.'s requests to exclude reports from expert witnesses for the plaintiffs, deeming the materials admissible for trial and allowing the case to proceed. Although most of the evidence collected by Robi's legal team has been questioned by experts hired by Merck & Co., Inc., it has not yet been reviewed by the jury. If the jury accepts the evidence, Robi could receive millions of dollars in compensation, and this could also pressure Merck & Co., Inc. to expedite the settlement process of other similar cases. Robi, now 31 years old, is represented by the Wisner Baum law firm in Los Angeles. Between 2020 and 2022, lawyers from this firm handled at least five Gardasil-related lawsuits in partnership with Kennedy. Kennedy's son, Conor, now works at the firm but is not involved in this case. According to sources, Kennedy, who could have received a 10% commission from successful Gardasil cases, has voluntarily waived this income. The sources requested anonymity as they were not authorized to speak publicly, and Kennedy himself has not responded to requests for comment. During the pre-trial evidence exchange phase, Merck & Co., Inc. publicly released thousands of internal documents. Upon review, it was found that the documents detailed the company's internal planning on how to gain approval for Gardasil from federal regulatory agencies and the public. The legal team representing Robi stated that they will use these internal communication records as key evidence, alleging that Merck & Co., Inc. deliberately exaggerated the necessity of vaccination and used the FDA's priority review pathway to expedite market approval. Amato, hired by Robi's team to produce a specialized report in 2024, stated that Merck & Co., Inc. spent $182 million on extensive marketing for Gardasil, with the primary goal being to capture the market ahead of British pharmaceutical company GlaxoSmithKline plc Sponsored ADR (GSK.US), whose HPV vaccine was officially launched in 2009. Amato previously worked for the medical device company Smith & Nephew (SNN.US) and now teaches at Northeastern University. The plaintiffs' legal team plans to use these internal documents to argue to the jury that the company's decision-making was primarily driven by commercial interests rather than the health rights of patients. Conventional vaccines work by injecting inactivated virus or virus fragments into the body to stimulate the immune system to produce antibodies to resist future infections. Gardasil, however, uses virus-like particles and only simulates the outer shell structure of the human papillomavirus, without containing the virus itself. Sin Hang Lee, a former professor at Yale University, is expected to testify and explain his professional opinion that Robi's symptoms were caused by the vaccine. Lee was invited by the anti-vaccine organization SaneVax, which had long questioned Gardasil, to conduct related research. In 2011, Lee claimed to have detected transgenic HPV gene fragments in 16 samples of Gardasil from the United States, France, Australia, Spain, Poland, and other countries. He argued that these fragments could trigger abnormal immune responses in some recipients of the vaccine, such as patients like Robi, where immune cells not only attack the virus but also damage healthy tissues such as the heart. According to court documents, Merck & Co., Inc.'s Chief Medical Officer Carlos Sattler responded to Lee's allegations in an email in 2011, stating that there was no evidence to confirm that the trace gene fragments posed a health risk. The company also had no plans to conduct specific tests for the fragments. In 2016, the World Health Organization's Vaccine Advisory Committee publicly refuted Lee's theory, stating that the gene fragments in Gardasil posed no health threats, and pointing out significant flaws in studies associating the fragments with patient deaths in terms of clinical and experimental methods. The California trial is expected to last three to four weeks.