Merck Sued Again for Gardasil Vaccine Adverse Events
- by Carolyn Hendler, JD
- Published
- Federal & State Courts
The number of lawsuits filed in North Carolina against Merck for its HPV (human papillomavirus) vaccine, Gardasil, continue to mount and allege the company did not prove the vaccine was safe and effective before marketing it as an anti-cancer vaccine. Since 2022, almost 200 lawsuits alleging serious injury after receiving Gardasil have been consolidated in the Western District of North Carolina, Charlotte Division. The injured Plaintiffs come from across the country stating that the vaccine caused serious injury and chronic poor health, including autoimmunity, encephalitis and neurological dysfunction, Postural Orthostatic Tachycardia Syndrome (POTS), development of diabetes, premature ovarian failure and infertility, and death.1
The lawsuits allege manufacture defect, failure to warn and negligence. They have been consolidated into one class action.2
North Carolina was the chosen forum for the cases which hail from across the country because Merck has a facility in the state. Plaintiffs allege that the drug company failed to “exercise ordinary care” in the research, development, distribution and marketing of Gardasil. They also point out that Merck did not use a saline placebo in pre-licensure trials and instead used a bioactive neurotoxic placebo, as well as failed to adequately test the vaccine in the targeted age group.3
Gardasil was fast tracked to licensure by the U.S. Food and Drug Administration (FDA) in 2006 and first recommended by the U.S. Centers for Disease Control and Prevention (CDC) to be given to all 11-12 year old girls. It was known at the time that Merck used an aluminum containing bioactive “placebo” in pre-licensure trials and only tested the vaccine in a small number of children under age 15.4
One injured Plaintiff received a diagnosis of endometriosis and fibromyalgia after experiencing, “excruciating pain post Gardasil shots.” Another Plaintiff was diagnosed with Type 3 diabetes along with mood disorders after her second Gardasil vaccine.5 A Plaintiff who has suffered from seizures and joint pain since receiving the Gardasil vaccines was diagnosed with Crohn’s and Celiac disease. While yet another Plaintiff has suffered from life-altering chronic body pain and memory problems since she had the Gardasil vaccines.6
Gardasil Allegedly “Obligingly Ushered” Through Approval Process
The lawsuit alleges that Julie Gerberding, MD, MPH, the director of the CDC in 2006 “obligingly ushered” the Gardasil vaccine through the regulatory process prior to leaving the CDC and being named president of Merck Vaccines.7 A June 2000 U.S. House of Representatives Committee on Government Reform hearing and August 2000 investigative report found that eight members of the Committee on Investigative Practices had a conflict of interest at the time that Gardasil was approved.8 9
The lawsuit states that the U.S. House Committee on Government Reform report found:
The chairman served on Merck’s Immunization Advisory Board and a number of the other members had received grants, salaries, or other forms of remuneration from Merck.10
The Court ordered Merck to release its entire adverse event database, Merck’s Adverse Event Reporting and Review System, to Plaintiffs after a Motion to Compel was filed. Judge Robert J. Conrad, Jr. Order issued on Mar. 20, 2023 stated:
[P]laintff’s and their experts should have the same opportunity as Merck to review and analyze the entirety of the data.11
New Lawsuits Allege Gardasil Caused the Death of Two Young Girls
Two additional lawsuits were filed recently by mothers who lost their daughters after receiving the Gardasil vaccine. The mothers assert that getting the vaccine led to serious autoimmune and neurological dysfunction, which ultimately led to the deaths of their daughters.
One of the mothers, Kristine Zuggi, said she decided to let her 10-year old daughter get Gardasil shots after seeing the marketing campaign claiming that the vaccine was safe and effective and prevents cancer. Her daughter, Isabella, developed lethargy, headaches, body aches, stomach pains, incontinence, insomnia, mood changes, and loss of balance, along with a fever, following the shots. She passed away within months of being vaccinated after being diagnosed with acute encephalitis caused by an autoimmune/autoinflammatory dysregulation process.12
The other mother to file a Gardasil injury lawsuit said that, after she relied on Merck’s claims that Gardasil was safe and effective, she let her 12-year-old daughter, Sydney, receive two Gardasil shots within a year. After the shots, her daughter suffered from fatigue, brain fog, headaches, ringing in her ears, leg pain, light sensitivity, involuntary body movements, inability to walk or swallow (which led to a feeding tube) and excruciating nerve pain, among other life-altering ailments.13
The young girl was soon in a wheelchair requiring 24-hour care and diagnosed with postural orthostatic tachycardia syndrome, functional neurological disorder and Tourette’s syndrome. Sydney ultimately died from a pulmonary embolism due to her immobility after receiving two Gardasil shots.
An attorney for the mothers said:
The senseless deaths of these two beautiful young girls brings home the seriousness of the allegations against Merck in these cases—that the company has exaggerated the benefits of Gardasil as cancer preventative and ignored the risks, including death—all for the sake of the company’s bottom line.14
Benefits of Gardasil Exaggerated, Adverse Events Not Disclosed
The Plaintiffs allege that Merck exaggerated the benefits of Gardasil and failed to properly disclose the adverse events. They claim that Merck knowingly failed to warn both doctors and the public about Gardasil’s true risk of injury and death. Plaintiffs state that Merck intentionally engaged in a “relentless propaganda campaign” with the intent to guilt and scare parents into giving their children the vaccine despite the lack of studies showing that Gardasil prevents cancer.15
The Complaint states:
Because it can take decades for a persistent HPV infection to proceed to development of cervical or anal cancer, and because cervical and anal cancers are so rare, a true efficacy study would require decades and likely hundreds of thousand—if not millions—of trial participants to demonstrate that eliminating certain HPV infections would actually prevent the development of cervical and anal cancer.
Merck never conducted these studies.
Merck countered the allegations arguing:
Nothing is more important to Merck than the safety of our products and the patients who take them. 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. We, along with regulatory authorities such as the FDA and other organizations around the world, continue to conduct post-marketing surveillance to monitor the safety of our HPV vaccines. We will vigorously defend against these cases.16
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