When doctors diagnosed Nancy Hokkanen’s son Andrew at age 4 with autism, the Bloomington mother suspected his neurological disorder was due to immunizations.
Today, six years later, Hokkanen is among several Minnesota families joining 4,800 petitioners across the nation in a legal battle to prove their children’s autism was caused by vaccines that had a preservative called thimerosal, which contains about 50 percent ethyl-mercury by weight.
It’s a legal fight with other Minnesota connections: Minneapolis lawyer Sheila Bjorklund, a partner at Lommen Abdo Cole King & Stageberg, who represents 33 Midwestern families, is one of 10 attorneys on the petitioners’ executive steering committee helping to oversee the massive litigation against the U.S. Department of Health and Human Services. A tribunal of three special masters in the Court of Federal Claims in Washington, D.C., is conducting the no-fault proceeding where the petitioners need to prove causation by a preponderance of the evidence—but not scientific certainty—to win damages.
Hokkanen views the litigation before the so-called “Vaccine Court” as a kind of “court of last resort” for parents of autistic children. Should the petitioners prevail, they will be eligible for compensation for pain and suffering, past and future medical expenses and loss of earning capacity.
That potential recovery would help offset the estimated $5 to $10 million it costs to care for an autistic person over a lifetime, Hokkanen says. The high expenses occur largely because autistic children usually need intensive behavioral therapy to mitigate the effects of their disorder, expenses that many insurance carriers don’t cover, Bjorklund says.
Autism, a spectrum of brain disorders that impairs a person’s social development and speech skills, is characterized by repetitive behaviors or interests and leaves some children with barely any living skills while others can function close to normally in most settings, according to the Minnesota Department of Health. Usually, autism is diagnosed during the toddler or preschool years.
The controversy over thimerosal in vaccines erupted in 1999 when Food and Drug Administration researchers determined that, under the recommended childhood immunization schedule of that day, infants might be exposed to cumulative doses of ethyl-mercury from immunizations that exceeded one of three federal safety guidelines established for the ingestion of methyl-mercury, the more common form of organic mercury.
Since then, however, government agencies have disputed that autism is linked to thimerosal.
“The bottom line is that the scientific evidence argues that thimerosal is not related to autism,” says Dr. James Nordin, a St. Paul pediatric practitioner and a site principal investigator for the Vaccine Safety Datalink with the HealthPartners HMO system.
Still, many parents have questions about this when they bring their children in for immunizations, Nordin says. Today he can tell parents that during the past eight years vaccine makers have phased out thimerosal from many shots, except some influenza vaccines, at the recommendation of the Centers for Disease Control and the federal Food and Drug Administration. Nordin says the two agencies recommended that vaccine makers take that action as a precautionary measure to further minimize mercury exposure. The drawback, however, is that move also raised the question, in many people’s minds, that if “thimerosal is not bad, why take it out?”
Nordin believes that is why there has been a continuing focus on thimerosal, something he considers to be a “red herring.”
Kris Ehresmann, of the Minnesota Department of Health, agrees. “There have been so many resources and efforts devoted to refuting that thimerosal is linked or connected with autism,” says Ehresmann, the department section chief of immunizations, tuberculosis and international health. “What I feel bad about as a mother and a scientist is that all of these efforts could have been better directed to looking at what could be done to help and support parents with autistic children.”
Recent studies have shown the autism rate continuing to climb, even though thimerosal has been phased out of pediatric vaccines, she says. Meanwhile, “Denmark has had thimerosal removed longer … and scientific studies have been done of their population and found that the removal did not affect the incidence of autism.”
Mercury is toxic at high levels, she says. But trying to say what level of ethyl-mercury is harmful based on the safety standards for methyl-mercury (the kind found in fish), is like comparing “apples to oranges.”
In the Vaccine Court litigation, Bjorklund acknowledges that the defense is formidable, armed with capable attorneys, experts and recent studies by the CDC and National Institutes of Health proclaiming no link between the thimerosal in the vaccinations and autism in children.
But Bjorklund adds, “There are two sides to every story, and recent independent research is pointing to a causal connection between exposure to mercury and neuro-toxicity, which may lead to the development of autism in susceptible children.” One of those studies tested infant monkeys exposed to a vaccine containing thimerosal, she says.
Bjorklund believes her team has sufficient evidence to show causation between the vaccines and the children who have autism, as required by the Vaccine Act.
“Mercury in organic form as either ethyl-mercury—that is found in thimerosal—or methyl-mercury—that is found in fish—can be toxic to humans,” Bjorklund adds. “It is undisputable that organic mercury can affect the human brain, immune system and other body systems.”
In 1986, Congress established the National Vaccine Injury Compensation program to compensate people who have received vaccines that are presumed to have caused their injuries. Congress set up the program to free pharmaceutical companies from facing lawsuits after some of them threatened to cease production due to a plethora of big jury verdicts in the late 1980s, Bjorklund says.
Under the Injury Compensation program, for each vaccine dose sold, a fee is charged that goes into a trust fund, which is set up for all the vaccines that are a part of the program. The program is meant to compensate persons who have had adverse reactions to vaccines that are covered under the vaccine program, Bjorklund says.
In the autism cases, however, the petitioners need to prove causation “in fact” to get compensation because their claims fall outside of the injuries presumed to be “vaccine-caused” under the Act, she says.
During the 1990s, many childhood vaccines contained thimerosal. By FDA regulation, multiple-dose vials of vaccines needed to contain some kind of preservative. The preservative is intended to decrease possible contamination of the vial from multiple entries to withdraw doses of the vaccine.
During the same decade, the number of vaccines that children were receiving was increasing, Bjorklund notes. “By six months to 18 months of age, children were receiving many more vaccines than children in previous generations.” Along with those additional vaccines was greater exposure to mercury via the thimerosal.
“Many parent advocacy groups were convinced their children’s autism was related to the exposure to all forms of mercury and were particularly concerned that the exposure through vaccines pushed them over the edge [toward neurological problems],” Bjorklund says. “The children appeared to develop normally for the first 15 to 18 months of their life and then their development regressed.”
That is what Liz Setnes experienced with her son A.J. (Austin John), now 10. Setnes, of Shakopee, suspected A.J.’s autism was due to immunizations after he had received a second series of vaccines when he was 18 months old.
Before those shots, A.J. was a smiling, attentive baby at age 1 when he went in for a studio portrait, says Liz, who is among Bjorklund’s clients in the vaccine cases. “He was so cooperative, smiling and looking at the camera.”
But at 18 months, when A.J. received his second series of shots, the boy suddenly stopped maintaining eye contact with people and his language skills regressed, his mother says. The next time A.J. went in for a photo portrait, this time at age 2, he wouldn’t sit down to be photographed, Setnes recalled. “He was just screaming, running in circles and flapping his arms,” she says. Doctors diagnosed A.J. at age 3 with autism.
“Why are schools shut down when loose mercury is found if it is not harmful?” she asks. “Yet mercury shot into our children’s bloodstreams, they tell us, it is not harmful. I think the pharmaceutical industry is trying to bury this epidemic.”
Both Setnes and Hokkanen said the early years of their sons’ autism was overwhelming, with constant worries about things such as whether their children would run out in the street without looking for cars.
“When we started therapy for A.J., he couldn’t even take simple direction such as to sit down,” Setnes says. “He was dangerous to himself and others. He didn’t speak even two- or three-word sentences until he was 5 or 6 years old.”
Setnes, an insurance claims adjuster, adds, “In the early years, you can’t imagine how many times we left a stranded cart in the grocery store because A.J. would have a meltdown.”
With aggressive applied behavioral analysis therapy and hard work, A.J. within the last couple of years has been able to travel with his family, and Liz now feels she is close to having a normal family life. Bjorklund explains that ABA therapy is an intensive program of relearning for autistic kids.
“Children with autism have something that is missing in their cognitive development, like a door did not open when it was supposed to,” Bjorklund explains. “The therapist takes them back and retrains them in building blocks for speech, interaction and understanding.”
Despite A.J.’s improvements, Setnes is angry that parents of autistic children have had to take legal action. “The pharmaceutical industry had to have known that thimerosal was a dangerous element to put into vaccines,” she says.
For Hokkanen, having an autistic child initially felt like “living under house arrest. I haven’t dared work full-time since 1998. It would be difficult to hold down a full-time job because you don’t know when [Andrew] is going to get sick.”
Hokkanen adds, “There are treatments Andrew needs that we can’t afford. We can’t even afford to buy him a swing set.”
A registered nurse and former public health nurse for 18 years, Bjorklund gained attention in national legal circles for prevailing on a high-profile statute of limitations issue in a 2003 Minnesota case against the federal government, representing a boy who developed autism after getting his childhood vaccinations. In that case, she convinced the judge there was no single factor that heralds the first symptom of autism and thus the claim was timely filed.
In 2007, the Vaccine Court heard three test cases espousing one theory of why the vaccines caused autism in children. It is expected to hear arguments this year on the second theory, which contends that when ethyl-mercury from thimerosal was broken down in the body into its component parts, the organic mercury crossed the blood brain barrier and got into brain cells and disrupted the cells’ normal development, thereby causing autism, Bjorklund says.
“As a public health nurse, I gave hundreds of immunizations,” Bjorklund says. “I am not anti-vaccine. But we have to realize that vaccines aren’t perfect. There will be a certain percentage of persons who receive those vaccines who are going to have some kind of an adverse reaction that is very serious. And if [children] are injured and there is compensation available to them, then they are deserving of this compensation.”
Meanwhile, Bjorklund estimates it will be several months before the Vaccine Court makes any rulings on the initial test cases that it heard arguments on last summer. If the petitioners lose their cases, they could appeal to the judges of the Court of Federal Claims. L&P
Scott Carlson is a former St. Paul Pioneer Press business reporter.
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