A teen who developed vaccine-induced narcolepsy after taking the Gardasil human papillomavirus (HPV) vaccine won a major victory this month when the federal “Vaccine Court” ruled he is entitled to compensation under the National Childhood Vaccine Injury Act of 1986.
Trey Cobb received a third dose of Merck’s Gardasil vaccine in August 2015, when he was 14 years old. Soon after, he began experiencing autoimmune symptoms, including severe fatigue and difficulty carrying on normal activities.
Now 22, Cobb still experiences a multitude of symptoms that likely will never go away.
Expert testimony showed Cobb developed autoimmune narcolepsy induced by processes called “molecular mimicry” and “cross-reactivity.”
Infectious virus-like particles from the Gardasil vaccine mimicked the body’s natural amino acid sequences and confused the immune system into attacking the body’s own cell receptor sites, affecting wakefulness and sleep.
Cobb petitioned the National Vaccine Injury Compensation Program (VICP), also known as the “Vaccine Court,” for compensation. VICP is a “no-fault” alternative to the traditional legal system for resolving injury claims for vaccines whose makers have no liability under federal law. Cases are adjudicated by a court-appointed “special master” rather than a judge.
VICP has been criticized for its long, opaque and often adversarial process and its failure to recognize autism as a potential vaccine injury.
In this case, Special Master Katherine E. Oler ruled on Aug. 21 that Cobb successfully demonstrated his condition was caused by the Gardasil vaccine and that he is entitled to compensation.
The decision was made public today, but the amount of compensation has not yet been determined.
Mary Holland, president of Children’s Health Defense and author of “The HPV Vaccine On Trial: Seeking Justice For A Generation Betrayed,” told The Defender:
“While I applaud the decision, this young man’s condition is tragic. His life has been forever scarred by a vaccine he didn’t need.
“Deplorable also is the time it took to reach this compensation decision — eight years after the initial injury, and he still has no compensation, only a ruling to compensate, which may yet be overruled.”
Narcolepsy with cataplexy following third Gardasil shot
Cobb was a healthy 14-year-old boy when he received his third dose of Gardasil during a routine visit to his primary care physician in August 2014. Within a few weeks, he began experiencing headaches and pain in his lower back and neck. At first, he attributed the pain to playing football, according to the ruling.
Soon other symptoms appeared. His doctor noted that on his next visit, after receiving the third shot, Cobb had a sore throat, was “really low energy since school started, feels tired all the time,” and had “mildly swollen, tender liver and spleen.” He diagnosed Cobb with mononucleosis.
By November 2014, Cobb was unable to complete a full day of school and was sleeping for two to three hours during the day after sleeping for 10-and-a-half hours at night. He also was rapidly gaining weight.
By February 2015, he was exhibiting neurological symptoms. At times, he struggled to find words, would feel like fainting when he laughed, and had eye twitches and would lose control of his facial muscles.
In April of that year, doctors at a sleep clinic diagnosed Cobb with narcolepsy with cataplexy (type 1 narcolepsy), a disabling sleep condition that affects 0.02% of adults. They prescribed him several medications and strategic napping, which helped stabilize his condition.
But he continued to suffer “extreme fatigue, inconsistent sleeping patterns, irritability and fear of collapse after excitement, restlessness and muscle weakness.”
Strong emotions would trigger his cataplexy and he would begin to laugh, fall over and lose control over his body.
By the time Cobb finally testified in front of the special master at a VICP hearing in 2021, he was a 20-year-old junior at the University of Iowa.
In addition to his physical symptoms, Cobb told the special master that the cataplexy affected his social life. Because he would fall asleep at events, he eventually stopped going to them and his peers stopped inviting him to socialize.
When he meets new people, he said, they think he is “unfriendly or unenergetic or using drugs” because he appears so tired.
Cobb, whose life today is structured around his sleep and medications, said he tries to limit the medications he takes because he doesn’t like the side effects. His daily medications include Xyrem, Ritalin and “a decent amount of caffeine.”
Molecular mimicry caused Cobb’s immune system to attack brain cells
The special master found that Cobb’s case met the criteria to show that his injury was caused by the Gardasil vaccine, even though his injury is not one recognized and listed on the Vaccine Injury Table — which lists injuries that are recognized to be caused by certain vaccines.
That means his attorney demonstrated a medical theory causally connecting the vaccine and the injury, a logical sequence of cause and effect, and a proximate temporal relationship between vaccination and injury.
Stanford neurologist Dr. Lawrence Steinman provided the expert reports and testimony that persuaded the special master, despite dissenting opinions offered by University of Pennsylvania emeritus professor of neurology and pediatrics Dr. Lawrence Brown and University of Utah neurologist Robert Fujinami, Ph.D.
Holland explained the scientific reason behind the special master’s decision:
“The medical theory his attorney advanced is that narcolepsy is caused by a substantial decrease in neurons that produce orexin, a neuropeptide that regulates appetite and wakefulness. Type 1 narcolepsy is considered to be an autoimmune condition related to orexin.”
Cobb’s attorney, Mark Sadaka, broke it down even further. “All proteins in our body — skin, eye, heart, cardiac cells — every single protein in our body is made of building blocks called amino acids. Those amino acids gather into a chain that creates a three-dimensional structure called a protein,” he told The Defender.
Molecular mimicry is when something from outside the body looks like one of those amino acid sequences in the body, he said. And it isn’t uncommon for such mimicry to happen.
In this case, Gardasil has a string of amino acids, called L1 capsid protein, which Steinman theorized are molecular mimics of hypocretin, also called orexin, which is a neuropeptide — a string of amino acids — that regulates arousal, wakefulness and appetite.
Steinman explained that “the mechanism of molecular mimicry caused Petitioner’s immune system to attack the cells in his brain that produce hypocretin and that the resulting hypocretin deficiency caused him to develop narcolepsy,” according to the special master.
This happens through a phenomenon called “cross-reactivity.” Gardasil introduces the L1 capsid protein antigen — a foreign substance that creates an immune response — as a way to prime the body to attack the HPV virus, should it ever present itself.
But when cross-reactivity happens, rather than attacking only the HPV virus, through molecular mimicry the immune system attacks the part of the body that the L1 capsid protein antigen is mimicking — in this case, the cells that produce hypocretin.
Autoimmunity at a low level is common, Sadaka said, but in some cases like Cobb’s, the body cannot tolerate it and it develops into an autoimmune disorder.
Holland said, “Cobb’s medical expert successfully argued that there is homology between orexin and parts of the Gardasil vaccine, resulting in cross-reactions, causing the destruction of orexin-producing neurons” and causing Cobb’s autoimmune narcolepsy with cataplexy.
Ruling sets precedent for lawsuits against Merck
This is the third VICP ruling to find Gardasil can induce autoimmunity through the mechanisms of molecular mimicry and cross-reactivity.
In the first case, 22-year-old Bard College student Christina Tarsell died from her vaccine injuries. In the second, several petitioners suffered primary ovarian insufficiency, a condition where the ovaries stop functioning,
Sadaka said Cobb’s case was significant because “it is the third first-of-its-kind victory against Gardasil … and it demonstrates that Gardasil can cause autoimmunity in certain circumstances.”
This will be important, he said, in the upcoming litigation against Merck in federal court.
Vaccine makers are typically protected from liability for injuries caused by a fully licensed vaccine if that vaccine is listed on the Centers for Disease Control and Prevention’s childhood vaccination schedule.
Merck’s Gardasil is one of those vaccines.
People injured by vaccines listed on the childhood schedule must first seek compensation through VICP established in 1988 by the U.S. Department of Health and Human Services.
In the Cobb case, the special master found in favor of the petitioner, but it is often exceptionally difficult to obtain compensation within the VICP. The proceedings are often turned into drawn-out, contentious expert battles and the backlog of cases is substantial.
Because of this, a single case can drag on for years, as it has in this case.
But petitioners claiming injury from a covered vaccine who have exhausted the VICP process and are not satisfied with the outcome can, in fact, sue the drug maker.
Gardasil has been linked to numerous neurological and autoimmune disorders. Robert F. Kennedy Jr., CHD chairman on leave, said in a video that evidence shows that “Gardasil has distinguished itself as the most dangerous vaccine ever invented.”
There are currently about 80 cases pending in federal court against Merck for injuries associated with Gardasil, with hundreds more cases likely to be filed in federal court in the coming months.
In August 2022, a judicial panel ordered the consolidation of more than 30 lawsuits pending against Merck into multidistrict litigation in a single court. The panel said the individual lawsuits involve common questions of fact and that consolidation would “promote the just and efficient conduct of the litigation.”
The consolidation order allows Gardasil lawsuits filed throughout the country to move into coordinated discovery and pretrial proceedings.
A North Carolina federal district court early next year will hear the first 16 lawsuits against Merck alleging Gardasil vaccine caused injuries.
The lawsuits were selected as exemplar cases from a larger pool of lawsuits pending in the U.S. District Court for the Western District of North Carolina. They will serve as a series of “bellwether trials,” the outcome of which will shape the process for the growing number of claims brought against Merck for Gardasil-related injuries.
Cobb, Sadaka said, sets an important precedent for those lawsuits, because it “further highlights that the theories put forth in the multidistrict litigation, also premised on molecular mimicry, are sound and scientifically valid.”
Holland agreed. “The bright news here is that this is the same theory attorneys are advancing in multidistrict litigation in North Carolina against Merck for fraud related to Gardasil that will go to trial in 2024,” she said.
“The theory of homology or ‘molecular mimicry’ is the likely explanation for the explosion of autoimmune conditions arising after Gardasil injections,” she added.