July 21, 2021 - Charleston, South Carolina - - Baum Hedlund Aristei & Goldman lawyers filed a lawsuit today on behalf of a 22-year-old woman who developed postural orthostatic tachycardia syndrome (POTS) and other serious health problems after receiving the Gardasil human papillomavirus (HPV) vaccine.
Abigail “Abby” Stratton of Mount Pleasant, South Carolina was a healthy and active young woman before receiving a Gardasil injection in November of 2017. However, within weeks of the shot, she was hit with a constellation of serious and debilitating health issues. Abby was eventually diagnosed with POTS and autonomic dysfunction, serious conditions that her attorneys allege were caused by the Gardasil vaccine.
Gardasil lawyers Bijan Esfandiari, Nicole Maldonado, Michael L. Baum, Monique Alarcon, and co-counsel Robert F. Kennedy, Jr. filed the Gardasil lawsuit (Case No. 3:21-av-99999-CIV) in United States District Court, District of South Carolina against Merck & Co., Inc. and subsidiary Merck Sharp & Dohme Corp, both based in New Jersey.
“For many young men and women suffering from POTS, Gardasil is the common denominator,” says attorney Nicole Maldonado. “So many of our clients grew up healthy and active only to be broadsided by this life-changing condition after receiving the vaccine. Abby is no different. She went from cheerleading and running cross-country to nearly passing out when she climbs the steps to her apartment. I think it’s time for Merck to do the right thing and admit that this dangerous vaccine is capable of causing POTS and other serious health issues.”
What is Postural Orthostatic Tachycardia Syndrome (POTS)?
Postural orthostatic tachycardia syndrome (POTS) is a blood flow disorder characterized by a heart rate increase of at least 30 beats per minute in adults or at least 40 beats per minute in adolescents when a person moves from laying down horizontally to standing up.
POTS is a type of dysautonomia, an autonomic nervous system (ANS) disorder. The ANS regulates the body functions that we do not consciously control, including heart rate, body temperature, and blood pressure.
While symptoms may vary from person to person, sufferers may experience (among other things):
- Severe fatigue that can be long-lasting
- Dizziness that can lead to fainting
- Heart palpitations and chest pain
- Chronic headaches and migraines
- Excessive sweating
- Vision issues due to the loss of blood flow to the brain
- Inability to exercise
- Prolonged worsening of general symptoms after increased activity
Lawsuit Alleges Merck Designed Clinical Trials to Mask Adverse Events, Concealed Link Between Vaccine and POTS
Ms. Stratton’s lawsuit accuses Merck of designing its clinical trials for Gardasil to mask adverse events. The gold standard for testing interventions is a randomized, placebo-controlled clinical trial, meaning each person participating in the trial is randomly assigned to either a group receiving the experimental intervention (aka experimental group), or a group receiving a placebo (aka control group). A placebo is an inactive substance like a sugar pill that looks like the experimental intervention being tested.
According to the complaint, Merck tested the Gardasil vaccine against a toxic placebo spiked with Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS), a potent neurotoxin. By adding this toxic ingredient to the control group, Merck could claim its vaccine’s safety profile was “as safe as a placebo.”
Other problems with the Gardasil clinical trials (as alleged in the complaint):
- Merck falsely told participants in the control group that the placebo was a saline solution.
- Merck cut the dose of aluminum in half for the vaccinated group, which further masked adverse events.
- Merck did not allow people to participate in the Gardasil clinical trials if they appeared likely to suffer adverse reactions to Gardasil’s ingredients.
- Merck did not follow the protocol to report adverse events.
- Merck falsely told participants that Gardasil was already proven safe.
- Merck hid adverse events by dismissing them as unrelated to the vaccine.
The complaint also accuses Merck of concealing the fact that the Gardasil vaccine induces and increases the risk of autoimmune diseases, including POTS and dysautonomia. The medical literature is supportive of this claim as several published studies have linked the Gardasil vaccine to POTS.
In the 2020 study, Benefits and Harms of the Human Papillomavirus (HPV) Vaccines: Systematic Review with Meta-Analyses of Trial Data from Clinical Study Reports, the authors found that “HPV vaccines increased serious nervous disorders” and that HPV vaccines were associated with a nearly two-fold increased risk of POTS.
Other studies linking Gardasil to POTS include:
- Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus (2015)
Gardasil Adjuvants and POTS
Gardasil contains a mixture of adjuvants that includes Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS), a proprietary blend of aluminum and other unknown ingredients developed by Merck. Federal law requires that manufacturers cannot add adjuvants to vaccines that have not been proven safe. Lawsuits against Merck contend that AAHS has never been proven safe and that peer-reviewed studies show that aluminum in vaccines can trigger autoimmune and other serious conditions.
Medical experts believe Gardasil’s adjuvants are responsible for post-vaccination-induced autoimmune diseases in select patients. The risks have become so prolific that medical experts have coined a new umbrella syndrome – Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA) to refer to the immune-mediated diseases triggered by an adjuvant stimulus contained in vaccines.
The difference in reported adverse events in the clinical trials for Gardasil 4 (approved in 2006) and Gardasil 9 (approved in 2014) corroborates the allegation that the vaccine’s aluminum adjuvant is a culprit in causing adverse events like POTS. The original Gardasil 4 vaccine contains 225 micrograms of aluminum compared to the Gardasil 9 vaccine administered today, which contains 500 micrograms of aluminum. According to data from both clinical trials, Gardasil 9 induced more adverse events than Gardasil 4.
Plaintiff Abby Stratton Developed POTS and a Constellation of Other Health Issues After Gardasil Shot
Abby Stratton was 19 years old when her doctor recommended the Gardasil HPV vaccine in November of 2017. An athlete throughout her teens, Abby competed in gymnastics, ran track and cross-country, and was a cheerleader. She had no autoimmune diseases and no autonomic issues.
Her physician stated that Gardasil was a safe and effective vaccine for preventing cervical cancer. In light of the doctor’s recommendations and Merck’s marketing and advertising messages stating that Gardasil is safe and effective, Abby consented to receive the HPV vaccine.
Within a matter of weeks, Abby could tell that something was wrong. It started with rosacea and other minor adverse reactions. But those symptoms were nothing compared to the excruciating migraines she began to experience after about a month. The headaches were so bad that she often threw up and had to go to the hospital multiple times to relieve the pain.
As the months passed, she began to experience symptoms of POTS. At first, these were nebulous symptoms such as joint pain, fatigue, and headache. By the summer and beginning of the school year 2018, Abby was going to Planet Fitness to try to work out. On one occasion, she attempted to do her normal workout on the treadmill. By the end of it, she was woozy and had make it to the bathroom stall before “everything would go black.” So severe were her symptoms that she had to sit on the bathroom floor, desperately trying to avoid passing out.
After this horrible experience, Abby had to stop going to the gym. She also had to stop climbing stairs and participating in many of the activities she once enjoyed. For an active and athletic young woman, these health issues did not make any sense.
In the summer of 2019, Abby was taken to the hospital by ambulance because she could barely walk. She essentially lived at the hospital for weeks because her symptoms were unbearable. Attending physicians told her she had a high heart rate when she stood up because she was “dehydrated.”
Abby had many random other incidents like this where doctors labeled her symptoms as not serious and anxiety-related. On at least one occasion, her doctor laughed at her for “being ridiculous” about her health issues.
As her symptoms continued to get worse, so too did her studies. Abby found it difficult to focus in class with extreme fatigue and severe migraines. She consulted with her school, the College of Charleston, about accommodating her disabilities with extra services. The school was open to her request if her physician documented her diagnoses and agreed that she could use the services. Her doctor, however, refused to sign the forms indicating her medical issues were hindering her studies. Even though the physician had diagnosed Abby with POTS, he accused her of using the condition as an excuse for her drop in performance.
“One of the hardest things about life after Gardasil is having people not believe me when I tell them I’m suffering,” Abby says. “The pain is hard enough to deal with; when you also have to suffer the indignity of not being believed about that pain, it’s so much worse. I’m doing this because I want others who are dealing with POTS to know that they aren’t alone.”
Abby has altered her life to compensate for her debilitating post-Gardasil symptoms. She eats a clean diet, drinks Liquid IV daily, supplements organic sulfur, and avoids caffeine to help regulate her blood flow and reduce the severity of her symptoms. However, her health and her life are drastically different than before Gardasil.
According to the lawsuit, Abby would never have consented to receive the Gardasil vaccine if Merck had adequately informed her and others about the questionable efficacy and serious risks associated with Gardasil. Per the allegations, Merck’s conduct created a substantial risk of significant harm to patients injected with Gardasil, and therefore, warrants an award of punitive damages.
Baum Hedlund Aristei & Goldman | Gardasil Attorneys
Baum Hedlund Aristei & Goldman is one of the country’s leading law firms pursuing justice and compensation on behalf of vaccine-injured plaintiffs in Gardasil lawsuits against Merck. Our award-winning attorneys have decades of experience holding companies accountable for putting profit over consumer safety. Across all areas of practice, our team of lawyers has won more than $4 billion in verdicts and settlements for clients.
Over the last two years, Baum Hedlund Gardasil lawyers have filed complaints against Merck on behalf of several young adults across the United States who developed serious injuries and health conditions after Gardasil vaccination. Following, are some of the other Gardasil injury lawsuits we have filed: