Gardasil Lawsuit Worth $8 Billion Set for Jury Trial

Merck & Co. is about to face a jury trial defending against a claim that Merck advertisements misrepresented that the Gardasil vaccine was safe and effective

by Carolyn Hendler, JD

Merck & Co. is about to face a jury trial defending against a claim that Merck advertisements misrepresented that the Gardasil vaccine was safe and effective. The jury will determine whether the drug giant hid the risks and side effects associated with its lucrative HPV (human papilloma virus) vaccine marketed to children and young adults.¹

Merck received more than $8 billion dollars in the last two years from sales of its Gardasil vaccine, which was marketed as a safe and effective prevention of HPV. Plaintiff’s lawyer Mark Lanier, who has previously won multiple million-dollar lawsuits against pharmaceutical companies, warned:

This case has monumental significance to public health and the ways we trust companies who produce vaccines.²

Merck denies the claim and argues:

At Merck, the safety of our medicines and vaccines and the wellbeing of the people who take them are our top priority. An overwhelming body of scientific evidence, including more than 30 years of research and development along with real world evidence generated by Merck and by independent investigators, continues to support the safety and efficacy profiles of our HPV vaccines. The plaintiff’s allegations have no merit, and we remain committed to vigorously defending against these claims in the upcoming trial.

Plaintiff Lost Normal Life After Getting Gardasil Shots

The plaintiff, Catherine Boss, who lives in Los Angeles, was given her first Gardasil shot she was just 16 years old. The once active teen soon developed postural orthostatic tachycardia syndrome (POTS) among other symptoms. POTS, is a form of dysautonomia that causes the autonomic nervous system to malfunction. The autonomic nervous system controls the majority of the body’s tissues and organs and POTS can cause serious life long health problems.

Boss also experienced fatigue, shortness of breath, hypotension, headache and abdominal pain right after receiving the Gardasil shot. Despite suffering from migraines, vomiting, dizziness, insomnia, severe menstrual cramps, vision loss and panic attacks, Catherine’s doctor gave her the second and third doses of the vaccine over the next year. Unfortunately, Catherine’s symptoms only got worse and she was no longer able to participate in the activities she once enjoyed. Since the Gardasil shots, Catherine has been diagnosed with endometriosis, syncope, dysautonomia, POTS, and a pain disorder.³

Kathleen Boss, plaintiff’s mother, claims that she would never have allowed her daughter to take the controversial HPV vaccine had she been aware of its potential to cause such serious adverse effects on her daughter’s health.⁴

Merck Knew About & Hid Gardasil’s Serious Adverse Effects

The Complaint alleges that the big pharmaceutical company knew of the Gardasil vaccine’s serious side effects, including death, and made a conscious decision to fail to warn medical providers and the public of these risks. The Complaint also sets forth that Merck was aware of the questionable efficacy of the shot and engaged in a pervasive marketing campaign designed to scare the public into believing the vaccine was necessary in an attempt to guilt and shame parents choosing not to give the shot to their children.

Merck faces claims of failure to warn consumers of the dangers of the Gardasil shot. The allegations also consist of negligence, breach of warranty, common law fraud, violation of California’s unfair competition law and the strict liability claims of failure to warn and manufacturing defect.⁵

Expert Witness to Testify About DNA Fragments in the Gardasil Vaccine

There have been long-standing allegations that Merck knew that the vaccine was contaminated with HPV DNA fragments. Sin Hang Lee, MD discovered these DNA fragments in 16 Gardasil vials in 2011. Normally, DNA fragments are removed during vaccine production. The DNA fragments were found to be tightly bound to aluminum in the Gardasil vaccine and, when injected, they are absorbed by immune cells triggering pro-inflammatory responses. Dr. Lee has stated that for people with certain genetic variations, Gardasil vaccine could cause autoimmune disorders such as POTS.⁶

Lee is scheduled to testify as an expert witness in this trial. Newly acquired documents show that Merck’s chief medical officer admitted in an internal email that the drug giant failed to look for contamination of HPVL1 plasmid DNA in the vaccine. Merck scientist, Annie Sturgess, confirmed this damning admission stating, “We have not directly measured HPV DNA.”⁷

The U.S. Food and Drug Administration (FDA) approved the vaccine without testing for contamination with HPV L1 DNA.⁸ Accordingly, a victory for the plaintiff could damage the dwindling reputation of the federal agency legally charged with ensuring vaccine safety and already facing concerns over the safety of COVID-19 shots.

Merck’s Pay-Out for Gardasil Harms Could Be Substantial

Because the drug giant’s actions caused a substantial risk to vaccine recipients, the plaintiff may be awarded punitive damages.⁹ When a plaintiff successfully demonstrates by clear and convincing evidence that a defendant acted with, “oppression, fraud or malice” they may be entitled to punitive damages.¹⁰ California does not limit the amount of punitive damages that can be awarded. This means that the jury has free reign to set the damages as high as they see fit.¹¹

Stephanie Sherman, another plaintiff attorney, pointed out:

Merck’s efforts to conceal the risk of serious adverse events associated with Gardasil continue to pay off handsomely. The company knows that disclosing the possibility of life-altering side effects would hurt the bottom line, so the company chose to bury its head in the sand, even as the lives of young men and women are turned upside down after Gardasil. It’s shameful, but it’s also not surprising. Remember, this is the same company that decided Vioxx sales were more important than people. The story is no different with the Gardasil vaccine, and we intend to hold Merck accountable for its disregard for human life.¹²

Until 2021, Gardasil had the most side effects reported to the FDA’s Vaccine Adverse Event Reporting System (VAERS) since 1990 compared with any other federally recommended vaccine.

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