Family Of A Autistic Child Suing The Vaccine Maker. Timothy Wells begins this day as he does every other eyes to the sky, shouting, “Sun come up! Sun come up!”
The 9-year-old Baton Rouge boy’s world is filled with requisite ritual. Words and phrases are repeated over and over again. Unfamiliar aisles at Wal-Mart are traumatic. Unexpected noises elicit screaming. And the sun absolutely must come up on time.
It’s the way of life that comes with being autistic, and Timothy was diagnosed with the disorder at the age of 3.
Over the years, Richard and Lisa Wells have worked three jobs between them, mortgaged their Bramble Drive home twice and sold possessions to help their son.
Now they’re trying another approach: taking the nation’s largest pharmaceutical companies to court.
The Wells are among seven Baton Rouge area families and dozens more throughout south Louisiana with autistic children who are suing companies that manufactured and marketed childhood vaccines containing the mercury-based preservative thimerosal.
The cases, filed about a year ago, could very well be the first of their kind in the nation to make it to trial in federal court.
It won’t be the first time Eli Lilly and Co., Wyeth Inc., Aventis Pasteur, Merck & Co. and SmithKline Beechum have been to court because of childhood vaccines.
In 1988, Congress established a National Vaccine Injury Compensation Program and a Vaccine Court in which all such claims first must be tried. Claims are subject to a three-year statute of limitations and a $250,000 cap for noneconomic damages.
The Wells and other families are trying the equivalent of a legal end-run around the special court. Rather than the child suing for an alleged injury, the parents are claiming “loss of consortium” the normal relationship they’ll never have with the injured child. They also are taking the approach that thimerosal was an additive, not an actual vaccine, and therefore not covered by the Vaccine Court.
Timothy Wells works on math problems during a class at Westminster Elementary School.
Even so, the parents will have to prove a connection between thimerosal and autism exists a theory the U.S. Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration and several independent medical organizations say has never been proven.
U.S. District Judge James Brady in Baton Rouge twice has refused to throw out the cases, writing that they are “importantly different” from previous litigation.
Attorneys for both sides already have ruled out settlement conferences and alternative dispute resolution. No trial date has been set.
“Bus coming! Bus coming! Bus coming!”
There are still 30 minutes until the yellow-and-black vehicle pulls up in front of his house to take him on the hour-long ride to Westminster Elementary School, but Timothy is certain something is amiss.
He has already run through his roster of rituals. He’s already gotten dressed. Eaten his instant grits. Pleaded with the sun to rise. Taken his medicine. Endured his mother brushing his teeth. Walked a bicycle up and down the street. Reminded his father to empty the trash compactor. And watched the Rev. Larry Stockstill’s morning message on TV.
“Bus coming!” he says, nearly in tears. He grabs his father’s hand and leads him outside to the curb.
“Tim,” Richard says, stroking the boy’s ginger hair. “You still have another 30 minutes. Seven o’clock.”
“Seven o’clock! Seven o’clock!” Timothy says, looking frantically down the street. “Bus coming!”
Even on mornings like these, Lisa hasn’t forgotten how badly she and Richard both Baton Rouge natives wanted their first child. It took them 51/2 years to have Timothy.
He was born healthy, his parents said, weighing in at 10 pounds, 12 ounces. He seemed to develop normally, eventually calling the couple “momma” and “daddy,” smiling, giggling and playing.
But when Timothy was 18 months old, Lisa and Richard said, they began to notice he no longer made eye contact. He had fits of screaming and crying. He became a picky eater and refused utensils. He stopped talking and started humming.
“It was like he just entered his own little world,” Lisa said. “We had no idea what happened.”
Although Richard’s mother told the couple she thought Timothy might have autism, the Wells had him tested for everything from deafness to allergies. At the age of 3, their son was diagnosed as moderately autistic.
The next four years were, according to Lisa, “a blur.” The couple would wake up in the middle of the night to comfort him during screaming fits one so violent that Timothy put his head through a sheetrock wall. They got rid of the television set because the noise bothered him. And they began to realize their marriage was strained.
But when Timothy became aggressive at times toward his two younger sisters Hannah, now 7, and Sarah, 6 Richard and Lisa made a decision.
They sent him to St. Mary’s Residential Training Facility, a live-in school for the developmentally disabled in Alexandria. Every weekend, the family traveled to Alexandria and slept in a camper at Indian Creek Recreational Area while visiting Timothy.
It took 10 days, but the school potty-trained their son. Through therapy and education, Timothy learned to care for himself like putting on his own clothes and eating with utensils again.
“It was like walking away from him,” Richard said. “We’d go in there and look at his empty bed and we’d cry. We just missed him. But it saved our marriage, our family and our nervous system. Lisa and I got to be husband and wife instead of caretakers for 24 hours a day.”
After two years, the Wells were ready to bring Timothy home, where he’s been ever since.
“The affection we missed out on with this baby it’s like a big hole in our hearts,” Lisa said. “It’s like somebody came into our house and stole our child’s personality overnight. That’s what autism is. That’s what it feels like. It’s like, where did he go?”
The bus arrives, and Timothy ambles up the steps and takes his seat always the same one, three rows back next to the window. The sun has come up. But if Timothy has noticed, he says nothing.
No one knows how many children have autism.
Various government entities and other organizations conservatively estimate the incidence to be anywhere between one in 250 to one in 1,000 children in the United States. The Louisiana Department of Health and Hospitals does not statistically track autism cases, spokeswoman Kristen Meyer said.
Autism refers not to a specific ailment but to a collection of neurological disorders. Those with the condition generally experience impaired social interaction and communication skills, and show a tendency toward repetitive behaviors or interests. Some are able to live independently; others require constant care.
Boys are three to four times more likely to have autism than girls, the CDC contends, but the condition occurs in all racial, ethnic and social groups.
Although autism cannot be cured, the federal agency notes, its symptoms can be treated with medication and therapy.
Its cause, however, has proven elusive. The NIH is exploring a variety of theories, including the possibility that it may be caused by a viral infection, environmental triggers, genetic predisposition or a combination of factors.
One theory is that childhood vaccines are to blame.
Estimated autism rates have tripled during the past two decades, according to the Autism Society of America. During that same period, the suggested childhood immunizations did, too. That, those who point to vaccines as the culprit contend, may have increased the amount of mercury to which children were exposed.
Until a few years ago, vaccines against such diseases as influenza, hepatitis, tetanus and diphtheria often contained thimerosal a mercury-based preservative. At one point, infants as young as six months were being injected with up to 187.5 micrograms of mercury, according to the U.S. Centers for Disease Control. Today, the approved level is less than 3 micrograms. There are one million micrograms in a gram.
Thimerosal was developed by University of Maryland researcher Morris Kharasch in 1927. Eli Lilly purchased the patent. In 1930, Dr. K.C. Smithburn conducted a study at Lilly Laboratories for Clinical Research in which he injected people dying of meningitis with Merthiolate, the trade name for thimerosal.
Those who are suing the company contend the study did not disclose that some of the test subjects began dying of a severe neurological disease and that at least one had a severe toxic reaction to the thimerosal.
Lilly no longer produces or distributes thimerosal, though the reasons are not clear.
In 1999, the American Academy of Pediatrics and the U.S. Public Health Service issued a joint statement alerting clinicians and the public of “concern” about thimerosal. Other pharmaceutical companies agreed to stop manufacturing vaccines containing the preservative in March 2001.
Lilly denies any link between the preservative and autism, as do Wyeth Inc. and SmithKline Beechum, which used Lilly’s thimerosal in their vaccines.
The drug makers deny the plaintiffs’ claims that thimerosal is “extremely hazardous to human health” or that the companies “intentionally failed to reveal knowledge of risks associated with the vaccines,” said, a attorney representing SmithKline Beechum. The companies also deny the contention that they “consciously and actively concealed and suppressed any information or knowledge or consciously disregarded the safety of children.”
Studies on the link between thimerosal and autism have been mixed. Besides the CDC, NIH and other medical organizations, the Autism Society of America the nation’s largest autism group hasn’t publicly supported the new batch of lawsuits because “the evidence is still out,” says its president, Lee Grossman.
A new approach
Since 1988, the federal Vaccine Act has mandated that injury claims against a vaccine manufacturer first go through the National Vaccine Injury Compensation Program.
A Vaccine Court then awards money to pay for the medical care of people injured by a vaccine. The awards are not paid by the pharmaceutical companies, but rather through a surcharge on inoculations.
Last year, more than 1,200 thimerosal cases were pending before the Vaccine Court. But even there, the link between thimerosal and autism remains undecided.
Chief Special Master Gary J. Golkiewicz has scheduled an evidentiary hearing March 22 to evaluate evidence from both sides on whether vaccines can cause autism symptoms. The decision will be issued July 3, and his conclusions will be applied to the thimerosal cases in the Vaccine Court.
Said Golkiewicz at the time he announced his plan: “So far the issue of thimerosal being a cause hasn’t been litigated specifically.”
His decision is expected to have significant bearing in the Louisiana cases as well.
“Causation is really going to be the battleground in this case,” said , the attorney representing the Wells and other families. “The ultimate question becomes, ‘Did the mercury in thimerosal that was shot into these children’s bodies create the injury of mercury poisoning?'”
The three pharmaceutical companies have argued in court that the Louisiana autism cases should be dismissed and pursued in Vaccine Court.
“The goal of the Vaccine Act is to protect the nation’s vaccine supply,” argues Eli Lilly attorney Heather Valliant of New Orleans. “If runaway tort liability forces the manufacturers of ingredients in vaccines out of the market, the attempt to preserve the vaccine supply would be in vain.”
But the court’s guidelines set a three-year statute of limitations and other restrictions on claims, leaving families like the Wells who would have had to file a complaint by the time Timothy was 6 with no prospects for relief.
Hundreds of lawsuits have been filed in federal and state courts seeking to lay blame on pharmaceutical companies for creating a market for thimerosal, failing to adequately research the dangers or purposely covering them up. Bickford is part of a group of lawyers representing the Louisiana families and others across the nation.
Their strategy is to claim the mercury poisoning has resulted in a loss of consortium essentially, the normal relationship the families otherwise would have enjoyed with their child.
They also claim that Lilly either was negligent or purposely withheld information when it marketed thimerosal as a vaccine additive. The point is key: The plaintiffs maintain the case should be decided outside Vaccine Court because Lilly is not being sued as a manufacturer of a vaccine, but of an additive.
In his ruling against dismissing the cases, Brady cited that very issue.
“Lilly’s arguments to the effect that it is entitled to protection under the Vaccine Act as a vaccine manufacturer are irrelevant to these consolidated cases,” Brady wrote. “This is so because Lilly is not sued as a manufacturer.”
An uncertain future
“Macaroni! Macaroni! Macaroni!”
It’s dinnertime, and Timothy is hungry.
“OK,” Richard says. “Get a pot.”
There are three clean pots in the cabinet, but none of them is The Macaroni Pot. That one is in the sink, and Richard must wash it immediately.
With his father’s help, Tim puts the water in the pot on the stove, and waits for it to heat up all the while crunching on the raw macaroni. Foods with casein and gluten give those with autism a morphine-like high.
“Tim, stop. Stop! Stop!” Richard says. “He eats it raw; I hope that’s not hurting him.”
“They recommend that he eat gluten and casein free foods, but it’s expensive to stock a pantry with that stuff,” Lisa says. “One thing that contributes to his behavior is that his biochemistry is so screwed up. He craves the stuff.”
“Messed up,” Richard says quickly.
“Screwed up!” Timothy says. “Screwed up!”
Though their son is only 9, they are already thinking ahead to his future. While he might be able to dress himself, ride a bus to school and cook a pot of macaroni, they know he’ll never be able to care for himself.
And that’s what worries them the most.
Richard and Lisa don’t want him to be a burden on other family members, but also don’t want him living in a state-run home. Their wish is for him to stay in their Bramble Drive home with round-the-clock care.
“The bottom line is, his care is all about money,” Richard said. The more money you have, the better care he’s going to get.”