Sept. 16, 2020 – Orange County, California - - Attorneys from the national law firm of Baum Hedlund Aristei & Goldman filed a Gardasil lawsuit today against Merck on behalf of a young man who sustained life-altering injuries he alleges were caused by the HPV vaccine.
Attorneys Bijan Esfandiari, Nicole K. H. Maldonado, Michael L. Baum, and co-counsel Robert F. Kennedy, Jr. filed the latest Gardasil lawsuit in Superior Court for the State of California, County of Orange against Merck & Co. Inc. and subsidiary Merck Sharp & Dohm Corp., both of New Jersey.
The complaint (case no. 30-2020-01160496-CU-PL-CJC) seeks damages, including punitive damages, for the following causes of action:
- Strict Liability – Failure to Warn
- Strict Liability – Manufacturing Defect
- Breach of Warranty
- Common Law Fraud
- Violation of California’s Unfair Competition Law
Plaintiff Zachariah (Zach) Otto received his first Gardasil shot in Orange County, California when he was 16 years of age. He lived in Fountain Valley and Huntington Beach until two years ago. Now 24 and living in Denver, Colorado, Mr. Otto alleges multiple Gardasil injections caused him to develop life-altering injuries, including dysautonomia, postural orthostatic tachycardia syndrome (POTS), Orthostatic Intolerance (OI), small fiber neuropathy (SNF), chronic fatigue syndrome (CFS), mast cell activation syndrome, autoimmune disease, and fibromyalgia, as well as a constellation of other serious health issues.
According to the complaint, Mr. Otto’s Gardasil-induced injuries have caused him to become disabled and unable to work or to physically attend college as he had desired.
Background on the Gardasil Vaccine
The U.S. Food and Drug Administration approved Gardasil in 2006 after being “fast-tracked” over six short months. The FDA’s fast-track process allows for an expedited review process for drugs or vaccines that treat serious conditions and fill unmet medical needs.
According to the complaint filed today, in its bid to prove that Gardasil treats a serious condition and fills an unmet medical need, Merck allegedly presented misleading data to the FDA suggesting that human papillomavirus (HPV) infections and some abnormal cervical tissue—cervical interepithelial neoplasia (CIN) lesions—inexorably result in cancer. The FDA approved Gardasil based on Merck’s theory that HPV alone causes cervical cancer, and that Gardasil could eliminate cervical cancer and other HPV-associated cancers.
According to Mr. Otto’s attorneys, none of those contentions are true.
In 2009, the FDA approved Gardasil for use in boys between the ages of nine and 26 for the prevention of genital warts caused by two strains of HPV. In 2010, the FDA approved Gardasil for the purported prevention of anal cancer in males and females ages nine through 26.
According to attorneys for Mr. Otto, Merck has never proven that Gardasil prevents cervical cancer or any type of cancer. Studies have shown, however, that systemic administration of Gardasil leads to increased rates of cervical cancer and other serious health issues, including the severe side effects Mr. Otto now suffers.
Gardasil’s Hazardous Ingredients Linked to Severe Side Effects
The lawsuit alleges Gardasil contains a host of hazardous ingredients, including at least one ingredient that the vaccine manufacturer failed to disclose to regulators and consumers.
Gardasil contains potentially hazardous DNA fragments (HPV LI-DNA fragments) to make the vaccine more potent. According to the allegations, Merck lied to the FDA and the public about including this hidden DNA adjuvant in Gardasil; it is not approved by the FDA, and Merck does not list it among the ingredients as federal law requires.
The HPV vaccine also contains Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS), a potent neurotoxin that can cause very serious harm. Aluminum, including AAHS, has been linked to several serious side effects, including impairing cognitive and motor function, inducing autoimmune interactions, and increasing blood-brain barrier permeability, among other issues.
Other potentially dangerous ingredients include borax, polysorbate 80, and genetically-modified yeast, all of which are capable of causing adverse events, the lawsuit alleges. To this day, Merck has never tested any of these added ingredients for safety in vaccines.
Allegations of Fraud in Gardasil Clinical Trial
Clinical trials measure the safety of a drug or vaccine against an inactive placebo. Those who receive the active medication are compared with those who receive an inert placebo, such as a saline solution.
In the Gardasil clinical trials, Merck did not use a true placebo, the complaint alleges. Instead, the company “spiked” the placebo with AAHS and the vaccine’s other additives, which resulted in approximately equal numbers of subjects in the vaccine group and the placebo group suffering adverse reactions. According to the complaint, this gave the false impression that the Gardasil HPV vaccine was “as safe as a placebo” when, in fact, significant numbers of subjects in both treatment groups suffered many serious medical conditions, including symptoms of autoimmune disease.
Attorneys Discuss Lawsuit Filed on Behalf of Young Man Who Received His First HPV Vaccine as a Minor
“Most people think Gardasil is for girls, but since 2009, Merck has made billions in profit by marketing the HPV vaccine to the parents of boys and to young men,” says attorney Nicole K.H. Maldonado. “Through its advertising, Merck sold parents on the idea that Gardasil is a safe and effective tool to stop the spread of HPV and prevent cervical cancer. But Merck knew that Gardasil was neither safe nor effective at preventing cervical cancer, and worse, the company knew that Gardasil could cause a host of serious health issues.”
“Merck fast-tracked Gardasil by presenting misleading data to the FDA and fabricating a health crisis,” says Mr. Otto’s co-counsel Robert F. Kennedy Jr. “They claimed they were ‘filling an unmet medical’ need but in reality, the only thing Merck was interested in filling was the $6 billion financial hole created by the Vioxx scandal.”
Plaintiff Zach Otto Developed Several Vaccine Injuries After Receiving Gardasil Shots
Zach Otto was a 16-year-old minor when he received his first shot of Gardasil in 2012. His mother, Jennifer Otto, agreed to her son receiving his Gardasil injection after viewing various online, print, and television marketing materials stating that Gardasil is very safe, that Gardasil prevents cancer, and that good mothers must vaccinate their children with the Gardasil vaccine.
Mr. Otto’s mother relied upon Merck’s ubiquitous representations concerning the safety and efficacy of the Gardasil vaccine when she consented to her son’s first Gardasil vaccination.
In 2014, Mr. Otto received his second Gardasil injection and shortly thereafter experienced body pains, headaches, cold-like symptoms, unexplained rashes, joint pains, ear pain, and enhanced lymph nodes in his neck. Over the next few months, he was in and out of doctors’ offices to treat his symptoms.
In 2015, he received his third Gardasil shot. Two days after the vaccination, Mr. Otto’s knees gave out while he was at work. Unable to move, he was forced to call his mother to take him home. As months passed, Mr. Otto began to have a host of other serious and disabling complications. He sought treatment and relief from multiple physicians and specialists for a wide variety of injuries and ailments, including weakness, low-grade fever, chronic pain in joints, abnormal gait, burning sensation on various parts of his body, hives, extreme weight loss, chronic fatigue, unexplained sweating, rashes, gastrointestinal issues, severe headaches, visual disturbances upon standing, inability to sleep, dizziness upon standing, sensory complaints (intermittent numbness in arms, face, and lower extremity), memory and cognitive issues, brain fog, leg weakness, orthostatic intolerance, dysautonomia, leg tremors, feelings of fainting, vasovagal syncope, osteopenia, osteoporosis, disability, and inability to walk any significant distance without a cane.
In 2016, Mr. Otto tested positive for postural orthostatic tachycardia syndrome (POTS), an autoimmune disorder that can be incapacitating. POTS affects a branch of the nervous system that regulates functions we do not consciously control, including heart rate, perspiration, blood pressure, and body temperature. People with POTS often experience fainting, migraine headaches, anxiety, and a host of other life-changing health issues.
As a result of his injuries, Mr. Otto is unable to engage in the normal activities that a teenager and young adult would enjoy; he had to drop out of college for a time and can no longer work. He has recently attempted to start college for the third time, but finds it challenging as he has to take his two online classes while in bed, due to his condition. And studying just after his IVIg treatment is difficult. Currently, Mr. Otto is immobile without the aid of a cane for short distances and requires a power-assisted wheelchair for longer distances. He is now legally disabled and must live with his mother who acts as his primary caregiver.
Mr. Otto is visited by nurses at his home that administer his intravenous immunoglobulin (IVIg) therapy to help combat his Gardasil-induced autoimmune injuries. IVIg therapy is expensive and time-consuming with the recipient hooked up to an IV for hours on end.
He continues to experience many of the Gardasil-induced symptoms outlined previously, and is forced to be homebound, bedbound, and remains generally inactive as a result of his injuries. His serious and disabling physical injuries, pain, and mobility limitations have also had a devastating impact on Otto’s emotional wellbeing.
According to the complaint, if Mr. Otto knew of the risks associated with the vaccine, he never would have consented to receive it. Likewise, if Mrs. Otto had been informed about the known safety risks associated with the Gardasil vaccine, she never would have allowed her son to receive the first injection.
Gardasil Causes More Injuries Than Any Other Vaccine
According to the Vaccine Adverse Event Reporting System (VAERS), more than 64,000 case reports of adverse events have been reported among individuals who received the Gardasil HPV vaccine. The actual number of adverse events associated with Gardasil is likely far greater, as experts estimate that only one percent of vaccine adverse events are actually reported.
As the complaint filed today illustrates, Gardasil now has more reported injuries than any other vaccine on the market. The Vaccine Injury Compensation Program has paid out millions of dollars in damages for Gardasil-induced injuries and deaths.
Despite the reported injuries and deaths, Gardasil is also the most expensive vaccine currently on the market. Two doses of Gardasil 9 cost approximately $450 plus the cost of two doctor’s office visits. In 2018, Merck made $2.2 billion from Gardasil sales in the U.S. alone. In 2019, Merck made $3.7 billion in worldwide Gardasil revenue.
About Zach Otto
Zach Otto seeks to hold Merck accountable for causing his life-changing physical and emotional injuries. His lawsuit accuses Merck of knowingly and recklessly placing Gardasil’s profits ahead of patient safety. He is requesting that exemplary (punitive) damages be assessed to deter Merck and other would-be defendants from engaging in similar alleged reprehensible conduct.
"My life is a constant battle between attempting to improve my life and being held back by my own body's limitations,” says Mr. Otto. “Gardasil has turned my body into a prison, an anchor that won't afford me the ability to live an independent life and one that significantly restricts my ability to grow as a person. Life with vaccine injuries has been a battle, not just to survive, but to live. It's the myriad of doctor appointments and tests, the IVIg I receive every three weeks just to get some level of relief from the chronic pain and weakness that I suffer every day.
Mr. Otto credits his dog Jekyll with helping him through his life’s greatest challenges over the last several years. “I was fortunate enough to have found Jekyll in an animal shelter in Los Angeles,” he says. After walking past dozens of dogs, I felt an instinctual tug that seemed to tell me that he was meant to be my dog. We've since spent about eight years together, two of which were when I was still healthy and six of which weren't. There isn't a single day that passes where I don't find myself grateful to have him watching over me, where he manages to make me smile through his playfulness even on my toughest days.”
Zach’s health issues have also weighed heavily on his mother Jenn, who has dutifully assumed the role of his primary caregiver since the onset of Zach’s vaccine injuries. "We have 19-years-worth of photos capturing a life well-lived,” says Jenn Otto. “Seeing these photos now is a painful reminder of a quality of life that was robbed. We have spent almost six years fighting to get back even a fraction of the life my son had before Gardasil. Since the approval for males in 2009, Gardasil has been an attack on our youth, its target no longer gender-specific. My biggest regret: I entrusted my son's livelihood to Merck's toxic product."
About Baum Hedlund Aristei & Goldman
Baum Hedlund Aristei & Goldman is one of the nation’s leading law firms representing individuals who have sustained injuries after receiving the Gardasil vaccine. In practice for more than 40 years, our firm has won over $4 billion in settlements and verdicts on behalf of more than 20,000 clients across all areas of practice. The firm filed a similar Gardasil lawsuit on behalf of Julia Balasco, 19, last month. Julia alleges she sustained severe injuries after receiving her first Gardasil dose at the age of 13.
Attorney Robert F. Kennedy, Jr. is co-counsel to Baum Hedlund in the Gardasil litigation. As a staunch consumer advocate, Mr. Kennedy has been fighting for safer vaccines for years. His reputation as a resolute defender of the environment led TIME magazine to recognize him as one of the “Heroes for the Planet.” Mr. Kennedy is also the Founder and President of Waterkeeper Alliance and the Founder of Children’s Health Defense.
It is important to note that, while there is currently a great deal of controversy surrounding vaccines, the attorneys at Baum Hedlund Aristei & Goldman wish to stress that we and our clients are not against vaccines. Vaccines have the potential to eradicate disease and save millions of lives.
However, our firm is against intentional efforts to mislead consumers about the safety and effectiveness of a drug or vaccine. We have always fought—and will continue to fight—for the rights of consumers to be fully and honestly informed about risks associated with any drug, vaccine, chemical, or medical device. We will work tirelessly to ensure those rights are defended and victims of injustice are compensated for their injuries.
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