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Thousands of parents with disabled children got an unpleasant surprise this holiday season. They had sued Eli Lilly & Co. for billions of dollars, claiming that a preservative called thimerosal in vaccines had caused their children to develop autism. The suits were swept away by two paragraphs added to the Homeland Security Act and forced parents into the National Vaccine Injury Compensation Program. The program is a no-fault federally funded system intended to provide swift compensation to people harmed by vaccines — a predictable occurrence for at least a few recipients. The program was created 16 years ago in response to suits against vaccine manufacturers. It has become controversial, with plaintiffs’ lawyers charging that it has become increasingly adversarial, drawn out and uncertain. But at first it was popular among all sides. “Although the parents were losing the overwhelming majority of these suits, every so often they would get a big win,” says Thomas Burke, a Wellesley College political scientist who wrote a book on litigation that included an analysis of the vaccine program. “Vaccine companies felt they could not predict what would happen in litigation,” he says. “They had trouble getting insurance, and vaccines are a low-profit business, so companies were getting out.” Parents were unhappy because most of them were not getting any compensation. Drug companies were unhappy because they were being driven out of the vaccine business. And many in the health care profession feared there would soon be a scarcity of needed vaccines. Things got so bad that in 1985 the federal Centers for Disease Control and Prevention (CDC) told doctors to delay giving children DPT booster shots (against diphtheria, pertussis and tetanus) to stretch the supply. THE BIG CHANGE The National Childhood Vaccine Injury Act of 1986 changed everything. The program began operating in October 1988, administered jointly by the U.S. Court of Federal Claims, the Department of Health and Human Services (HSS) and the Department of Justice (DOJ). The program covers all vaccines recommended by the CDC for routine administration to children — currently diphtheria, tetanus, pertussis (whooping cough), measles, mumps, rubella (German measles), polio, hepatitis B, haemophilus influenza Type B, varicella (chickenpox), rotavirus and pneumococcal conjugate. The Homeland Security Act amendment added any “adulterant or contaminant” intentionally added to vaccines, such as thimerosal. A claimant may recover for any harm from a vaccine. The behavior of the manufacturer is irrelevant. The only issue is causation, which is presumed for every condition listed on a table of injuries compiled by HHS. An ailment not on the table shifts the burden of proof to the claimant. Recoveries come from a federal fund financed by a fee of 75 cents a dose. Manufacturers have nothing to do with this process and don’t pay for claims. Claimants can recover health care expenses, lost earnings and attorney fees. A claim for pain, suffering and emotional distress is capped at $250,000. If a vaccination produces death, the estate can recover up to $250,000. No punitive damages can be awarded. The claimant first files a petition for compensation with the Court of Claims. It goes to a special master for vaccine claims. HHS decides whether the claim meets the criteria for compensation and makes a recommendation to the DOJ, which reports to the special master. That official conducts a hearing of usually one to two days and issues a ruling that’s the basis of a Court of Claims order, unless the DOJ or the claimant successfully alleges that the ruling is arbitrary, capricious or not in accordance with the law. Appeals of Court of Claims orders go to the U.S. Court of Appeals for the Federal Circuit. Burke says in his 2002 book, “Lawyers, Lawsuits and Legal Rights,” that the vaccine program helped foster an explosion in vaccine research by reducing drug companies’ exposure to litigation. Plaintiffs’ lawyers, however, say the program is fraught with bad news for families with vaccine-caused injuries. Problems start with the right to sue, these attorneys say. People injured before the program started could choose to participate or not. Those claiming injuries by vaccines administered after Oct. 1, 1988, however, can’t sue to recover damages exceeding $1,000 before they seek relief from the program and eventually reject the outcome. The law makes it harder for plaintiffs to recover from drug companies for vaccines administered after Oct. 1, 1988. It outlaws strict liability claims and claims for failure to warn of a vaccine’s dangers. Punitive damages can be awarded only if the company lied or withheld information about the drug’s safety. The biggest obstacle to civil suits is one that Congress never intended to create, according to Cliff Shoemaker of Vienna, Va.’s Shoemaker and Associates, who has 20 years’ experience in representing plaintiffs in vaccine cases. Any claim under the program must be brought within three years of the onset of symptoms. The limit applies even if symptoms develop gradually and are only fully apparent years later. Moreover, says Shoemaker, “if you don’t file a claim within three years of the onset of symptoms, you may be barred from filing a claim anywhere.” All 50 states have laws that toll their statutes of limitation until a child reaches the age of majority, according to Shoemaker. So a state tort action brought on behalf of a child injured by a vaccine could easily be started a decade or more after the onset of symptoms. But two courts have ruled that the 1986 act creates a preemptive three-year statute of limitations even for state law tort actions. Both ruled that the law allows suits on vaccines administered after Oct. 1, 1988, only if the claims were first decided under the program. The law made no exceptions, according to the courts. So if a claim cannot be heard under the vaccine program because the three-year statute of limitations has expired, a tort suit can never be brought. Strauss v. American Home Products Corp., 208 F. Supp. 2d 711 (S.D. Texas 2002) and McDonald v. Lederle Laboratories, 341 N.J. Super. 369 (N.J. Super. Ct. App. Div. 2001). The three-year limit has harmed “hundreds and thousands of children,” Shoemaker says. “We hear from at least four to five people a week whose cases are time-barred.” DOJ RESPONSE The government concedes the limit needs to be changed by Congress. “This administration and the last one have supported extending the statute of limitations to six years,” says John L. Euler, a deputy director in the DOJ’s Civil Division. “We think that would catch virtually all the valid and meritorious claims.” Plaintiffs’ lawyers also say that soon after the program began operating, bureaucrats at DOJ and HHS began making it harder for parents to recover. “In 1989, the program almost ran out of money,” says Michael Hugo, a partner in Boston’s Hugo & Pollack who once represented plaintiffs in 25 percent of the nation’s vaccine-compensation cases and who was involved in creating the program. “That put a scare into DOJ and HHS. These agencies feared that pay outs could bankrupt the system. So the awards became more conservative. Decisions on when kids could get money got more conservative.” For instance, in 1995, HHS revised the table of injuries to remove “residual seizure disorder,” which had been the source of 40 percent of vaccine-compensation claims. This shifted the burden of proof against those claiming this type of injury and made it much harder for them to obtain compensation. A study by the General Accounting Office (GAO) said that, through 1999, claimants with on-table injuries won 35 percent of the time; those with off-table injuries won only 13 percent of the time. The government responds that changes to the table were not only justified but were required by law. “When Congress passed the vaccine act, it required HHS to modify the table as science evolved,” Euler says. “That’s what HHS was doing when they revised the table back in the mid-’90s. It was controversial, but the motivation of HHS was to keep current with the science.” The GAO study found a significant increase in the number of DOJ attorneys assigned to the program. This allowed the DOJ to use more aggressive tactics in defending the program’s fund, according to the GAO. “What was supposed to be a nonadversarial process is now anything but,” says Shoemaker. Claimants are “fought tooth and nail,” says Hugo. Because of DOJ’s aggressive stance, vaccine proceedings often drag on for years, according to the GAO. It found that, as of 1999, only 14 percent of claims were decided within a year; 39 percent were decided in two to five years; and 18 percent required more than five years. Currently, more than 14 years after the program began operating, six pre-1988 claims are pending. The DOJ says it is only doing its duty. “If the secretary of HHS thinks that a particular condition is not caused by a vaccine, it is our job to defend that position,” says Euler. Although the 20 DOJ attorneys working on the program are more than when it started, he says, the figure has remained stable for 10 years. He denies that the DOJ is fighting any more vigorously than in the past. WILLING LAWYERS Another obstacle facing claimants, Shoemaker and Hugo say, is finding lawyers willing to represent them. “The lawyers that work in this program on a regular basis, you can probably count them on your hands,” says Hugo. “Attorneys who have participated once in the program won’t go back.” He stayed out for five or six years, he says. “The only reason I went back is that people have come to me and said they couldn’t find legal representation,” he says. “I went back into the program very reluctantly.” DOJ’s Euler says there’s no shortage of willing lawyers. Several years ago, he says, more than 100 attorneys who had taken vaccine cases said they were willing to do so again. The program pays attorney fees so long as the claim is brought in good faith and there is a reasonable basis for the claim. But hourly rates are relatively low, lawyers say. They’re based on fees for attorneys with similar legal experience in the geographic area. “You won’t get more than $250 per hour,” Hugo says. “Most lawyers get between $150 and $175 per hour. Moreover, federal law forbids attorneys from receiving payments from any other source for their work in the program. They say that the money takes a long time to arrive, since payment isn’t made until after the claim is adjudicated. “You file a fee petition, the government files a response, you go before the special master,” says Hugo, and years can elapse before a fee petition finally gets approved. Shoemaker says, “I have $2 million in fees that are outstanding in the program. Not too many people can afford to defer their fees that long.” The government says it is not unreasonable to have attorneys wait a few years to get paid. That’s not “too long,” Euler says. But he agrees there is a problem with the existing fee arrangements. “We have supported payment of interim costs so that attorneys don’t have to front the costs of expert witnesses,” he says.

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