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"A seizure like this is by nature an encephalopathy," Menkes responds. "Something was going on in this child's brain that was bad."
Robert J. Baumann, director of pediatric neurology at the University of Kentucky's Chandler Medical Center, testifies for the government the next day. He disagrees.
An EEG showed no abnormality after Andrew's first seizure, Baumann says -- ergo no encephalopathy, ergo DPT isn't to blame. The debate over "encephalopathy" isn't a semantic one. In Dorland's Medical Dictionary, encephalopathy is defined as "any brain disease." But in the 1995 regulations, encephalopathy is defined as, among other things, "a significantly decreased level of consciousness lasting for at least 24 hours." Andrew Clements may have seemed groggy to his parents following his first seizure, but the medical record doesn't show a decreased level of consciousness, Baumann says. As for Andrew's 1995 catastrophe, he says, it was clearly brought on by an infection, not Andrew's epilepsy.
The Clementses' lawyer, Victor Harding, is sitting alone at the petitioner's table, Michelle Clements having since flown home to Milwaukee to tend to her son. Harding has been in the personal injury business for more than two decades and has won million-dollar judgments or settlements in nearly a dozen DPT cases. In 1987, he won a $15 million DPT award on behalf of a brain-damaged Wisconsin girl.
One thing Harding did during that trial was subpoena documents indicating that drug companies were working on pertussis vaccines in the 1960s that appeared to be less toxic and just as effective as the whole-cell vaccine. The documents suggest the companies dropped them because they were not profitable enough to produce. "The jury hated the drug companies so bad when we got through with them that they would have awarded money no matter what," Harding says.
He is convinced that the Clementses have a good case, and if they lose before Millman, or she offers them inadequate compensation, he says, he will help them sue the vaccine manufacturer in a regular court. But for now, he is pressing their claim here.
Harding has a thick Milwaukee accent, and a penetrating, Columbo-esque air that probably goes over better in front of a jury than it does in front of Millman. On the second day of the Clements hearing, he seems to be trying her patience. She wants to get answers to a series of particular questions about whether Andrew Clements qualifies for compensation. Harding seems more intent on rattling the government's witness: "Tell me, Dr. Baumann, is it possible, in your view, to prove that DPT causes encephalopathy?"
Baumann says that if it were not for the findings of the British study, he wouldn't believe DPT could cause brain damage. "There is no biological proof this occurs."
Harding has his own, somewhat mystifying, theory to present: Think of the fuzzy pertussis bacteria as a peach, he says. And the vaccine production procedure as killing a bunch of peaches. The more peaches you have, the more poison juice, and the more juice, the more reactions. And the American vaccine has more killed bugs than the vaccine used in Britain, Harding says.
The government attorney, Claudia Gangi, objects: "Petitioner's counsel is acting as his own witness."
"Mr. Harding, where are we going?" Millman asks. "Killing a peach doesn't do anything for me."
But Harding presses on. "Isn't it logical," he asks Baumann, "to assume that if the U.S. vaccine has more bugs in it, it's going to have more toxins and hurt more kids?"
"Science isn't based on logic," Baumann snaps. "It's based on experimental data."
Michelle and Scott Clements, on the other hand, have experimental data of their own from caring for an utterly disabled child.
To give Millman an idea of what they believe DPT has done to Andrew, they have videotaped their son's daily routine, so she can view it in her office.
Michelle approaches Andrew's hospital-type twin bed and gently shakes him awake. "Wake up, Drew bear. C'mon, sunshine." The Clementses live in a drab, three-bedroom, subsidized housing unit in northwest Milwaukee. The walls of Andrew's room are covered with "101 Dalmatians" decals, and the dresser and chairs are full of stuffed animals in high-contrast red and black and white, the colors to which newborns respond.
Andrew gradually comes awake, a subtle transformation in a semi-comatose child. His eyes flit back and forth, his nostrils flare and his mouth twitches into a smile. Although his motions are the tiny spasms of an infant, there is something rapt in Andrew's body language in proximity to his mother's voice. He unmistakably knows she's there, and it clearly comforts him.
Talking all the while to her immobile child, Michelle grinds up his pills -- antacids, muscle relaxants, stool softener, sodium fluoride for his teeth, potassium chloride for his blood pressure. She mixes them into a solution, takes a giant syringe and allows the liquid to drain through a plastic tube into Andrew's stomach. Then she lowers the metal bed guard, scoops him up and carries him to the bath. Andrew is four feet tall and weighs 50 pounds. After the bath, Michelle carries him into her bedroom to put on his diaper and dress him for the day. Then comes breakfast -- a can of PediaSure liquid formula syringed through the plastic tube. After breakfast, 20 minutes of nasal mist to break up congestion in Andrew's lungs, since he can't cough; tooth-brushing and drool-suctioning, since he can't swallow. All the while she talks to him. "There's a lot of letting him know you're there. Andrew puts the biggest smiles on when you talk to him," she says later.
"Sometimes he tries to talk back," adds Scott Clements, 36. "He's telling you how he feels, but you don't understand him."
Government disability payments of about $400 a month provide Andrew Clements with his most basic needs, but they don't begin to cover the real costs of caring for a severely disabled child. If they prevail in vaccine court and the money comes through, the Clementses hope to move into a house with tracking for a special wheelchair to move him around. A van with a ramp would be nice, too. It's hard to think of what other things they may need, considering that doctors say Andrew could live to be 40. The Clementses are determined to keep him forever. "No one else can care for him the way we do," Michelle says in an interview. "No one can love him the way we do." The idea of putting him in a home, she says, is "sickening and disgusting."
Nervous-system damage has left Andrew's muscles taut. In January he had surgery to repair both hips. He returns to Children's Hospital in Milwaukee some months later for a follow-up procedure. Michelle spends most of that week living in the hospital, sleeping on a small cot in Andrew's room. Driving to the hospital one day, she talks about an anti-vaccine chat room on the Internet that she regularly checks in on, to communicate with other mothers whose children suffered problems after they were vaccinated. "We're against the shots," she says. "I'll never let anyone I know immunize another person if I can help it."
Sometimes, when she sees a pregnant woman, Michelle will go right up and urge her to get educated about the risks of vaccination. "Nobody told me my child could have seizures. If I had known, the heck I would have immunized him." She has even started a support group for parents of vaccine-damaged children in Milwaukee. The women made little pins; imitation pearls and tiny angel's wings glued to a white ribbon, like the red AIDS-awareness ribbons. "Pearl is for mothers, the angel's wings are our children, and the white is for the purity of our kids before they got shots," she says. She pulls into the Children's parking lot, hangs a "Handicapped" sign on the windshield, and heads in.
In his third-floor room, Andrew looks as well as can be expected in his circumstances. He's in a body cast that extends from his feet to above his hips. His face is puffy, but the swelling has gone down some from the day before. Andrew whimpers mournfully as she tilts him to change his diapers -- one inside the cast, the other outside. Michelle knows this wing of the hospital well. When she's there, the nurses seem awed. They ask her permission before they do things. "Can we give him some ibuprofen now?" Liquid food goes into the tube. Then ibuprofen and morphine and Valium. Andrew cries a little, but his eyes are getting heavy. She pulls up his blanket. "You wonder what he's thinking," she says. "Maybe he's feeling lonely." Andrew is nestling into the pillow, drowsy and ready to sleep.
The Vaccine Injury Compensation Program is sometimes cited as a model for other no-fault courts -- offering a way, in theory at least, to resolve problems quickly, inexpensively and without confrontation. A bill moving through Congress now would create a $750 million fund to provide "compassionate payments" to hemophiliacs who got AIDS from contaminated blood supplies between 1982 and 1987. But many of those involved in the vaccine program say Congress should take a look at some of its problems: the backlog, the controversy over what constitutes an injury, the requirement that petitioners show at least $1,000 in medical costs, creating a Catch-22 for poor children, whose care -- however inadequate -- is covered by Medicaid or government disability payments.
The compensation fund has swelled to $1.2 billion. That being the case, some litigators wonder why it's so hard to win a case for families whose misery is uncontestable, even if their cases are not scientifically airtight. "The fund is so huge," says attorney Brian O'Connell of Boston, who has unsuccessfully represented a Massachusetts girl with a history of post-DPT seizures. "We had a pretty good case, the kid is very needy -- so why couldn't they give us some of the money?"
Public health officials have an answer for that: They don't want payments made for injuries that were not certainly caused by the vaccine. There's a larger issue, too. They want parents to immunize their children, and for that they want the record to show that vaccines are safe. "I'm not going to say that awarding too many people will undermine vaccine safety, but I look on the Internet, and I see that our statistics are taken out of context," says Evans, the medical director of the compensation program. "And so it's important that the table reflect what we think is really caused by the vaccines."
Soon, whole-cell pertussis vaccine will be history, in the United States at least. The vaccine is disappearing from pediatricians' offices, though not as quickly as some would like, and being replaced by safer, "acellular" vaccines. The new vaccines contain one or more elements of the pertussis bacteria, rather than the whole killed bug. Licensed for infants in 1996, the acellular shots are currently administered about two-thirds of the time.
The acellular vaccines have been in use in Japan since 1981, after the Japanese had their own troubling experience with the whole-cell variety. Authorities there withdrew most of the whole-cell vaccine after two infants died following shots in the early 1970s; in response, coverage plunged from 80 percent of infants in 1974 to 10 percent in 1976. Then in 1979, Japan suffered a whooping cough epidemic that left 41 people dead. It was an incentive to speed up introduction of the new vaccine, which has proved to be just as effective and to have far milder side effects.
U.S. vaccine manufacturers and public health officials point to the Japanese epidemic and argue that it would have been a mistake to drop the whole-cell pertussis vaccine until the FDA had appropriately tested and approved the acellular variety. Pertussis continues to be a problem in the United States. In 1996, more than 7,500 cases of whooping cough were reported here, the most in three decades. Why that's so is unclear. It may be that doctors are noticing more adult cases. And it just may be that some parents aren't vaccinating their kids against pertussis because of the controversy.
Industry and public health officials counter that it is not as simple as that. It takes years and millions of dollars to bring a new product to market. "To get a new vaccine through the FDA, you have to prove that it's safer than or as safe as the old vaccine," says Pasteur Merieux Connaught's Ruben, "and you have to prove the efficacy of the new vaccine in strict scientific terms. If something works, and is doing a pretty good job, you're not going to spend all your time worrying about why it does what it does when you've got other things to worry about and you have to allocate your resources."
Still, all sides now agree that the sooner the whole-cell vaccine disappears, the better. As Evans puts it, there may be limited scientific evidence to support the idea that the DPT shot can cause brain damage, "but when it happens to your child, there is an extremely strong feeling of association, and intuitively you'll always feel it was caused by DPT. That's a parent's intuition, and there's nothing that science can do about it."
Millman is uneasy about the Clements case. Under the old Vaccine Injury Table, it would have been easy to classify Andrew as having something called "residual seizure disorder" and automatically order compensation. In fact, the government offered the Clementses a $350,000 settlement in early 1995 -- after Andrew's epilepsy was diagnosed but before his crash -- based on this classification. But the Clementses rejected the offer after Andrew took his turn for the worse and refiled their claim in the summer of 1995.
By then, the new regulations and the new injury table were in force. Now, the table no longer included such a category as residual seizure disorder, and not being on the table meant the Clementses would have to prove that DPT caused Andrew's seizures. The question in the case now before Millman is, where is the proof?
The fact that his seizures started 15 hours after the shot isn't enough. Michelle Clements's gut feeling isn't enough. To award, Millman will have to accept Menkes' theory about the blood-brain barrier -- an unproven theory, albeit one that's been around for decades. Even if she accepts that DPT caused the first seizure, in order to give the Clementses the kind of monetary award that would make a difference, she'd have to accept that Andrew's full-blown collapse was caused by DPT-induced seizures, and not, as the government argues, by a grave infection of the blood. It's a tricky case, Millman says in the course of the hearing, and she lets Harding know it.
"There's a pretty good case for an appellate court to consider whether HHS has essentially gutted a statute that Congress passed," she says. Basically, she's encouraging him to challenge the constitutionality of the regulations under which she operates. She asks Harding to submit a formal brief on the issue -- is there a separation-of-powers issue here? Has Congress essentially delegated away to HHS a legislative function?
Harding, though, isn't terribly interested. "I'm saying the whole system is screwed up," he says in an interview at his Milwaukee office. And if Millman won't compensate the Clementses, Harding will take the case to a more familiar stomping ground.
As for Michelle Clements, she has put her trust in Harding -- and God. Andrew's misfortune has awakened her political activism, but she keeps her indignation separate from her main work -- to take care of the boy and hasten his return to some sort of life. It won't be like on TV, she knows. Andrew isn't going to suddenly sit up and walk. But she stays with him, talking to him, massaging his body every day, trying her best to keep alive a current that could turn him on again. "The doctors said he'd never smile, but he smiles," she says. "They say he's blind -- but no one can see through his eyes. Some days he catches you as you walk through the doorway." And someday he may talk again, she says. "We don't know. All we can do is pray on it."
On July 30, Millman finishes her deliberations: She dismisses the Clementses' case, finding that under the new regulations, they failed to prove that DPT caused Andrew's epilepsy. "The undersigned sympathizes with the Clements family for their situation and was very favorably impressed with Mrs. Clements as a witness and a mother," she writes in her decision. "However, petitioners may prevail solely on the evidence they present, not on the sympathy they engender."
For the Clements family, the decision comes as a frustration, but not a shock. "Part of me wanted to cry," Michelle says. "but it didn't surprise me." She and Scott are planning to continue their struggle in the legal system.
Arthur Allen is a frequent contributor to the Magazine.
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