Brevard County woman details delay in compensation for daughter Date: 9/19/02; Publication: Gannett News Service; Author: LARRY WHEELER

  <http://ask.elibrary.com/images/shim.gif>     Gannett News Service
<http://ask.elibrary.com/pubminis/Gannett_News_Service.gif> WASHINGTON

-- Janet Zuhlke is still struggling with legal whirlpools and bureaucratic roadblocks keeping her from getting help for her 16-year-old daughter, disabled because of childhood vaccines. Zuhlke, of Satellite Beach, appeared before a congressional panel Wednesday to update members on her troubled experience with the National Vaccine Injury Compensation Program.

"That past 10 months have been a continuation of the adversarial process I described last year," Zuhlke told members of the House Government Reform Committee.

Last fall, Zuhlke talked to the same panel and described the devastating reaction her daughter Rachel Anne had to a diphtheria, tetanus and pertussis booster shot administered in 1990 when she was 5 and the frustrating years spent trying to win financial assistance from the vaccine compensation program.

A Justice Department official would not talk about the specifics of Zuhlke's case.

Almost 1,800 families have received more than $1.3 billion in compensation from the program. Since 1988, almost 7,000 petitions for claims have been filed. Almost 3,800 were dismissed, and more than 1,300 cases still are in the pipeline, according to the program's Aug. 9 report.

The average time for a successful case to progress from filing a claim to the award of compensation is seven years, said Ron Homer, a lawyer who specializes in vaccine injury compensation. After nine years of legal wrangling, a special master ruled in July 2001 that Rachel Zuhlke is entitled to compensation. A final decision on the amount of compensation is expected by the end of this month, the 10th anniversary of Zuhlke's claim. She says a vaccine left her daughter mentally retarded, confined to a wheelchair and now suffering from optic nerve degeneration that has caused bouts of blindness.

The vaccine injury compensation program, created by Congress to assist disabled individuals quickly and avoid lengthy litigation, hasn't worked, Zuhlke said. "My experience is not at all consistent with that intention," she said. "As I saw the program, it is highly adversarial and, in my opinion, very unfair."

Zuhlke's complaints were received a sympathetic ear from Rep. Dan Burton, R-Ind., committee chairman, and Rep. Dave Weldon, R-Palm Bay. Burton helped write legislation that created the National Vaccine Injury Compensation Program and is sponsoring a new bill intended to improve the claim process and eliminate protracted challenges from the Justice Department and the Department of Health and Human Services. 

"(This program) was intended by Congress to provide compensation quickly and easily to people who have suffered very serious injuries," Burton said. "Unfortunately, that doesn't seem to be happening." Weldon sounded incredulous after listening to Zuhlke, including her heartfelt testimony that an expert witness the Justice Department hired had all but accused her of child abuse for submitting her daughter to an intravenous drug treatment that required a five-day hospital stay.

"That's abusive," Weldon said.

The Space Coast congressman, also a physician, spoke highly of the doctors and medical centers the Zuhlke family used and criticized the Justice Department for challenging their judgment on Rachel Zuhlke' s treatment.  Paul Harris, deputy associate attorney general, declined to discuss the specifics of Zuhlke's case but defended the agency's administration of the program. 

"We, too, are concerned that there are examples of cases that have taken too long to resolve, that there are individuals who are displeased with the manner in which their case has been processed, and that the program is sometimes perceived as too adversarial," Harris said. " These are the exceptions, not the rule." 

Victims increasingly view U.S. compensation program as adversarial and tightfisted.

By Myron Levin
Times Staff Writer

November 29, 2004

Like good moms everywhere, Janet Zuhlke made sure her kids got their shots.

This proved disastrous for her daughter, Rachel. She was a healthy 5-year-old until a brain injury triggered by a routine vaccination left her mentally retarded, physically handicapped and legally blind.

A single mother raising three daughters in Satellite Beach, Fla., Zuhlke needed help with the enormous costs of Rachel's lifetime care. So she brought a case in a federal tribunal set up to handle vaccine injury claims.

There, opposing lawyers hired expert witnesses to prove that Rachel's injuries weren't vaccine-related. When that failed, they balked at paying for costly medicines her doctors said she badly needed.

The Zuhlkes finally won — but it took more than 10 years.

"I thought it was very cruel," Zuhlke said. "People were very aware of the fact that my family was suffering."

The lawyers who opposed the Zuhlkes were not working for a vaccine company but the Justice Department. Government attorneys fought relentlessly to defeat a mother who thought she was doing the right thing by getting her daughter a government-mandated vaccine.

It wasn't supposed to happen that way in the Vaccine Injury Compensation Program, informally known as the vaccine court. Created by Congress and jointly run by the Department of Health and Human Services, the Justice Department and the U.S. Court of Federal Claims, it was designed to shield vaccine makers from damage awards that were threatening to drive them from the business.

It also was supposed to compensate victims in rare cases of injury under a flexible, no-fault system that would avoid the rancor and delay of traditional litigation. Claims were to be handled "quickly, easily and with certainty and generosity," said a House report accompanying the legislation in 1986.

Instead, say advocates for families with injury claims, federal officials often fight them with such zeal that many who deserve help are denied it, and even successful cases get bogged down for years.

The program "was supposed to be non-adversarial and it's become very adversarial," said Rep. Dan Burton (R-Ind.), whose House Subcommittee on Human Rights and Wellness has held hearings on the matter. Many have "had legitimate claims and they went on for eight, nine, 10 years."

Vaccine compensation officials refused to be interviewed, but in written statements they said the program had "an excellent record of promptly and appropriately compensating" valid claims.

Over the years, about $1.5 billion has been paid out in compensation and legal fees for more than 1,800 families, most of which would have had little chance of winning a civil trial, the officials said. They insisted that the vaccine court was less adversarial than civil courts, but said they were obliged to fight claims that weren't based on good science.

This was "never intended to serve as compensation source for … conditions that are not vaccine-related," said Joyce Somsak, the program's acting director.

But in trying to weed out undeserving claims, critics say, the government has insisted on a level of proof of injury that is almost impossible to meet.

And a Times analysis of claims data shows that the court has become more unyielding over time: Officials are much less likely than in earlier years to concede that a vaccine was responsible for an injury or death. The percentage of people getting awards also has declined.

Even when families do win compensation, officials have sometimes battled them over just a few dollars.

In one case, government representatives argued that $150 a year was too much to spend on wheelchair maintenance. They have haggled over how much to allow for replacement shoes and braces for people with polio. Another time, they recommended rubber sheets for the bed of an incontinent person because they were cheaper, although less comfortable, than disposables costing $135 a year.

"We never anticipated the extent [they] would go to deny these kids compensation," said Barbara Loe Fisher of the National Vaccine Information Center, who lobbied for the bill that created the program.

Viewed another way, by being tightfisted, officials have been good stewards of the vaccine injury trust fund, the self-insurance pool that pays awards to the injured. In fact, the fund — fed by a surcharge of 75 cents per vaccine dose — has ballooned to more than $2 billion, while earning about as much in annual interest as it pays in awards.

But the fund was not meant to be a moneymaker. The idea was that it was better to "err on the side of compensating the victim," said Rep. Henry Waxman (D-Los Angeles), sponsor of the legislation.

Roots of the Program

Along with clean water and sanitation, mass immunization ranks among the great milestones in public health. Among its glittering achievements: Measles cases in the U.S. dropped from about half a million in 1960 to 42 last year, according to the Centers for Disease Control and Prevention, or CDC.

But although millions benefit, even the safest vaccines aren't safe for everyone.

Because of genetic differences, some people are harmed by vaccines "that almost everybody else responds to just fine," said Dr. Robert W. Block, former chairman of a federal advisory panel on childhood vaccines.

And some have paid a terrible price. For example, until 2000, when the U.S. switched from the oral live polio vaccine to inactivated polio shots, the vaccine itself caused a few polio cases each year.

Gordon Pierson, a 12-year-old in Jackson, Tenn., contracted polio as an infant this way and is paralyzed and unable to speak.

"We were doing what we thought was best for our son, and the exact opposite happened," said his father, Randy Pierson. "We were just heartbroken, and we are every day."

Fear of legal fallout inspired the National Vaccine Injury Compensation Act. At the time, vaccine makers were facing a surge in claims, mainly from adverse reactions to the diphtheria-pertussis-tetanus, or DPT, vaccine. An exodus from the market and shortages seemed possible. In response, Congress decreed that instead of suing vaccine makers, people would first have to seek compensation from the new vaccine court.

Health and Human Services officials would administer the trust fund and screen petitions, deciding whether to concede or oppose each claim. Justice Department lawyers would appear in court on their behalf.

Petitioners could not seek awards for punitive damages or losses to family members as they could in civil court. But they were to benefit from greater speed and flexibility, and a lower burden of proof. Moreover, the program typically would pay petitioners' legal costs once the case was over, win or lose.

However, what was meant to be a win-win proposition instead has been mostly "a stupendous success in protecting the industry," said George Washington University law professor Peter H. Meyers, who directs a group of law students who represent petitioners. As for helping victims, he said, the record is "much more spotty."

Some see this as a natural result of federal health officials' fierce devotion to the immunization program — and their fear that if enough injuries were acknowledged, people would be afraid to get their shots.

Universal immunization is a fundamental mission of Health and Human Services. One of its branches, the Food and Drug Administration, licenses vaccines, and another, the CDC, promotes their use with such slogans as "Vaccination: An Act of Love."

From the start, agency officials worried that the program might create an exaggerated public impression of the risks of vaccines. At a congressional hearing before passage of the bill, Assistant Secretary for Health Edward N. Brandt Jr. warned that despite the program's laudable goal, it could "provide a significant disincentive to childhood vaccination programs."

Burden of Proof Shifts

In 1995, the government changed the rules of the vaccine court in a way that made cases more contentious, protracted and harder for petitioners to win.

Officials amended the vaccine injury table, a set of guidelines that had tilted many cases in petitioners' favor. According to the table, if certain symptoms appeared within a specified time after a shot, the vaccine was deemed the culprit unless the government could prove another cause. Many "table injuries" were simply conceded by the government, leaving only the amount of compensation to be determined.

A few amendments changed all that. In one major shift, "seizure disorder" was scratched from the table as a telltale sign of injury from a DPT shot. And a new, more restrictive definition of encephalopathy — or brain dysfunction — meant that many conditions that had been table injuries suddenly were not.

Somsak said the table was changed for one reason only: to better "conform with the scientific evidence."

But the upshot was that in many cases the burden shifted from the government to prove the shot didn't cause injury to the petitioner to show that it did. Because it's usually hard to prove with certainty that a vaccine caused harm, the effect of the change was profound.

The Times analyzed a vaccine court database of 10,741 claims filed over 16 years. The analysis showed that in the three years before the changes, the government conceded one-third of all claims. Of cases filed in that period, compensation was awarded in just over half.

But since the changes took effect March 10, 1995, the government has conceded just one claim in seven. About 35% of petitioners have received compensation.

And cases dragging beyond five years have become increasingly common.

Even the court's top judicial officer, Chief Special Master Gary J. Golkiewicz, has lamented the drift toward "full-blown litigation."

"Clearly," he said in one of his rulings, "that is not what Congress intended when it designed the program as an alternative to tort litigation."

Clifford J. Shoemaker, a lawyer for petitioners, said if the government softened its stance, the worst that would happen is that a "family that needs some money to deal with their profoundly injured child is going to get it."

"Is that such a terrible thing?" he asked.

Some observers have warned that the government's uncompromising attitude could backfire.

Although the law directs all claims to vaccine court, it allows those who disagree with a ruling — or have waited more than 240 days — to sue vaccine makers in civil court. So far, few have.

But by their tough stance, officials may be inviting more civil suits, Rep. Waxman said. "The whole idea of the compensation system is to be generous so they [petitioners] won't want to go to court."

Lost on a Technicality

Vaccine court officials were none too generous with Veronica Spohn.

Her parents claimed that a DPT shot caused their infant daughter to suffer brain damage. But they lost on a technicality: Their petition was filed a few hours late.

Although the vaccine compensation program was billed as more flexible, its three-year statute of limitations is draconian compared with rules of civil courts in all 50 states, which place no deadlines on the filing of injury claims for minors.

In the Spohn case, the doctor's records were a mess, alternately giving July 17 and July 19, 1992, as the date of the fateful shot. The family's lawyer filed the petition July 18, 1995, thinking he had made the deadline with a day to spare. In fact, he was a day late.

Seizing on the error, the Justice Department moved for dismissal. Special Master Elizabeth Wright concurred, citing the Spohns' "failure to use due diligence in pursuing the claim."

It was "very much an injustice," said Veronica's mother, Karen Spohn, a nurse in Butler, Pa. "I had a normal child, and all of a sudden in one day, within hours of the vaccine … she became a child with a disability" who is "going to need assistance for the rest of her life."

"They didn't rule that she didn't have damage. All they did was say, you filed 12 hours too late — too bad on you."

Spohn said she was too heartsick at that point to look into filing a civil lawsuit.

"Emotionally I couldn't deal with" continuing the fight, said Spohn, who preferred to "accept what you're dealt with and go through life."

Lengthy Legal Battle

In the case of Dustin Barton, the government fought so long that the Albuquerque boy did not live to see the resolution of his claim.

As an infant, he had suffered seizures and brain damage after a DPT shot. But Dustin had a congenital neurological condition, known as periventricular leukomalacia, that the government blamed for his injuries.

His mother, Lori Barton, filed the claim in November 1991. The case dragged on for years. Barton told friends and family that she suspected the government was waiting for Dustin to die — noting that it would be cheaper for the program to pay the death benefit of $250,000 than to buy an annuity to cover lifetime care.

Dustin eventually did die of a seizure, nearly six years into the case, but the government continued to fight. Finally in May 2000, 8 1/2 years after the petition was filed, the family won a ruling that Dustin's injuries were vaccine-related.

Not ready to give up, Justice Department lawyers considered an appeal. Then they offered a deal: They would drop the challenge if the Bartons agreed the decision would remain unpublished. This meant it would not be sent to legal databases, such as Westlaw, where attorneys for other petitioners could see it.

Lori Barton, who has since died, described her reaction at a congressional hearing in December 2001: "To me, it was extortion." But Barton, who then was seriously ill and had borrowed thousands of dollars to pay expert witnesses, took the deal.

In a statement to The Times, the Justice Department said it had made similar deals "on very rare occasions." It happens when the government "disagrees with a decision but believes that settlement is fair and in both parties' interests."

Family Finances Ruined

Rachel Zuhlke's claim was filed in September 1992. The government blamed her brain injuries on complications from a strep infection she had about the same time she got her DPT shot.

Janet Zuhlke said Rachel's illness contributed to the breakup of her marriage. She also lost her job as a dental assistant because of frequent absences to deal with Rachel's medical emergencies. Even with health insurance, the family's finances were wrecked.

"We had a lot of hot dogs," Zuhlke said. "We had two other children that went without many, many, many things … because I couldn't afford them."

Her case moved at a crawl, getting repeatedly reassigned to different special masters, and from one Justice Department lawyer to another, who repeatedly got extensions to complete filings in the case.

Nearly eight years into the case, Golkiewicz, the chief special master, brought in a mediator for settlement talks. Zuhlke recalled her despair — and the special master's shock — when the Justice Department refused to make a settlement offer. "You should have seen Golkiewicz's face fall on the table," she said.

Golkiewicz said recently that he was disappointed that the case didn't settle, but that didn't mean "that one side or the other was at fault."

Still, he said, the case took far too long, and the Zuhlkes "had every reason to feel frustrated."

As it turned out, the government lost its all-or-nothing gamble. In July 2001, Special Master George Hastings ruled that Rachel was entitled to compensation. Fifteen months later, he granted a multimillion-dollar award, including $925,000 for her pain and suffering, future lost earnings and past medical bills, and at least $90,000 a year for living and healthcare costs.

Although relieved that the case is finally over, Zuhlke still struggles with grief over what happened to her child, now a young woman. Rachel's life, she said, "is so different from what it should be at 20."

And she still finds it "unfathomable" that the government fought her claim for so long, Zuhlke said. "My little girl hadn't done anything wrong."
 

http://www.smmirror.com/MainPages/DisplayArchiveArticle.asp?eid=2423

Government Of, By and For The Pharmaceutical Industry
Dan Hamburg, Mirror contributing writer
Hidden in the folds of the thickly pork-laden Department of Defense Appropriations bill that slid through Congress just before Christmas and was signed into law a day before New Year’s was a big slab of holiday cheer for the pharmaceutical industry. There were no press releases from congressional offices and no mention in the news – maybe no one wanted to take credit for this latest assault on the 14th amendment. The so-called “Frist provision” – named after the ethically-challenged physician-turned-politician Bill Frist – will immunize Big Pharma from responsibility for vaccine-related injuries. The main rationale for this latest gift to industry at the expense of the public is – you guessed it! – the War on Terror.

Our representatives in Congress pled that corporations like Merck, GlaxoSmithKline, Wyeth, and Eli Lilly might just have to close up shop if they were forced to take responsibility for injuries caused by their products. These companies hardly need the help. Pharmaceuticals, despite their whining about risk, are some of the most profitable businesses in the country with the median profit margin of the top 10 companies more than five times that of all other industries on the Fortune 500 list.

Vaccine-induced injury has been around for as long as vaccines. The most famous case is the 1955 “Cutter incident” in which massive scientific, regulatory and industrial failure led to hundreds of thousands of people being injected with live polio virus. 70,000 people contracted the disease within days of being vaccinated, 200 were permanently paralyzed and 10 died. Two vaccines came into question in the 1990s: measles-mumps-rubella (MMR) and hepatitis B. According to research reported in 1998 by British physician Andrew Wakefield and since confirmed by others, the MMR vaccine may cause gastrointestinal problems that can lead to autism. In 1998, France became the first country to stop requiring hepatitis B vaccination for school children, following reports that French children were developing chronic arthritis and symptoms resembling multiple sclerosis following administration of the vaccine.

By 1999, the American Academy of Pediatrics (AAP) and the Centers for Disease Control (CDC) had suspended the hep B vaccine for low-risk newborns. These cases pale in significance compared to the mercury-based vaccine preservative thimerosal. Lilly introduced thimerosal in the 1930s after testing it on a group of patients already suffering from meningococcal meningitis. Doctors injected 22 patients with high levels of thimerosal. Most died within days, from meningitis. Thus, no adverse thimerosal effects were observed.

By the 1990s, American children were routinely receiving vaccinations exposing them to up to 87 times the EPA safety limit for adult mercury exposure. Government agencies and the medical establishment argue that there’s no proven connection between high levels of exposure to the mercury in thimerosal and a sixty-fold spike in cases of childhood autism. Others disagree.

In metropolitan Chicago, Homefirst Health Services serves several thousand children whose families have taken advantage of the religious exemption in Illinois state immunization mandates. According to Dr. Mayer Eisenstein, Homefirst’s medical director, of the 35,000 children served by Homefirst over the past thirty years not a single case of autism has been noted among unvaccinated children. Statistically, there should have been over 200 cases of full-blown autism. Similar results have been noted among the Amish in Pennsylvania. No vaccinations, no autism.

American politics is a pay-to-play system. Big Pharma pays big time. Tens of millions of dollars are given to politicians like Senator Frist each and every election cycle to insure that corporate interests trump the rights of mere mortals, including vaccine-injured children and families. The parents of autistic children, who face costs of $3 to $5 million over their child’s lifetime, reasonably seek out the courts as recourse. However, in order for a “vaccine-adverse event” to be compensated in the federally-established Vaccine Court, it must be listed on the federally-established Vaccine Injury Table. Autism is not listed. This is because the Institute of Medicine (IOM) has “failed to find evidence tha thimerosal in vaccines is a causal factor in autism.”

The IOM maintains that while such a link is “plausible,” the evidence is insufficient. Recently, the CDC tacked in a different direction, with director Julie Gerberding calling for new studies of the link.

But this begs a prickly and potentially very expensive question: Why have the Centers allowed a huge increase in the exposure of American children to thimerosal without first guaranteeing its safety? After all, mercury has long been known to be a neurotoxin and one of the most dangerous substances on the planet.

With the president signing the Frist provision into law, the pharmaceutical industry has secured immunity from legal liability for vaccines and drugs administered to fight “epidemics, pandemics, and bioterror agents.” While the presumption is that this law will be applied prospectively, in treating an avian flu outbreak for example, parents of autistic children are justifiably concerned that it will be applied in a blanket fashion. In other words, total immunity from allegations of harm related to vaccines: past, present, and future. Injured persons would be forced to prove “willful intent to harm” – an extraordinarily high standard – in order to be eligible for compensation. And – surprise! – the new law provides no funds for compensation.

We are well down the road of sacrificing our once great country to a flaccid and corrupt government in bed with profit-obsessed, amoral corporations. When will the American people finally say “Enough! We demand our country back!” Dan Hamburg is a former member of Congress. He is currently executive director of Voice of the Environment, a Marin-based nonprofit.

 

From Rick Rollens  RRollens@aol.com

For Immediate Release:
    Contact: Mark Corallo/ Beth Frigola
February 13, 2002
    (202) 225-5074

Lawmakers Seek Reforms in 
Vaccine Injury Compensation Program

Washington, D.C. -  A bipartisan group of lawmakers led by Government Reform Committee Chairman Dan Burton (R-IN) and Ranking Member Henry Waxman (D-CA) today introduced legislation to make the Vaccine Injury Compensation Program more generous and compassionate.

During two days of hearings before the Government Reform Committee, families of injured children complained about long delays, overly adversarial tactics employed by government lawyers, and other difficulties with the program.  The legislation introduced today would:

Increase the compensation for vaccine-related deaths to $300,000; Make the compensation for lost earnings more generous; Allow compensation for the costs of family counseling and creating a guardianship; Allow for the payment of interim attorneys fees and costs while a case is under review; Extend the statute of limitations for filing a petition to six years; and Establish a two-year window for families to file a petition if they were previously excluded from the program by the existing two-year statute of limitations.

"Vaccine-related injuries are devastating for families that have to deal with them," said Burton.  "Congress intended this program to be swift, compassionate and generous. However, too many times, these families are confronted by bureaucratic indifference, long delays and overly adversarial tactics.  We heard testimony from parents who fought for ten years to win compensation for their children.  That's not acceptable.  This bill won't fix every problem that people have experienced, but it's a good first step. We have bipartisan support for this bill, and I hope we can get it signed into law this year.  I want to thank Congressmen Waxman, Congressman Weldon, and all of the other cosponsors who helped put this bill together."

"The Vaccine Injury Compensation Program has been largely successful in stabilizing the vaccine industry; in maintaining public confidence in immunizations; and in compensating people who have been injured by vaccines.  However, the system is not perfect.  This legislation would help to improve the program and help to make sure that it is as generous and easy as it can be," said Waxman. 

Immunizations are considered the most important public health achievement of the 20th Century.  Because of immunizations, children are no longer disabled by polio, suffer brain damage from measles, or die from smallpox. However, immunizations are not risk-free.  In rare cases, they can cause serious injuries.

Congress created the Vaccine Injury Compensation Program in 1986 to compensate families quickly and generously when vaccine injuries occur.  At the time, vaccine manufacturers were facing numerous vaccine injury lawsuits and were threatening to leave the market.  Creation of the VICP helped keep manufacturers in the market and stabilize vaccine supply. Under the program, vaccine makers are partially shielded from liability for vaccine-related injuries.  An excise tax is charged with each dose of vaccine.  The proceeds go into a Federal fund used to compensate victims.   

Joining Burton and Waxman as original cosponsors of the bill are:
Rep. Dave Weldon (R-FL)
Rep. Jerrold Nadler (D-NY)  
Rep. Ben Gilman (R-NY)
Rep. Steve Horn (R-CA)
Rep. John Duncan, Jr. (R-TN)
Rep. Martin Frost (D-TX)
Rep. Connie Morella (R-MD)
Rep. Dennis Kucinich (D-OH)
Rep. Jo Ann Davis (R-VA)
Rep. Tom Davis (R-VA)

The legislation expands on a set of reforms proposed by the Advisory Commission on Childhood Vaccines in 1999.  It also addresses problems identified by parents of injured children who testified at two Government Reform Committee hearings last fall.

Galveston Fed. Judge Rules Parents Cannot File Suit Against Vax
Manufacturers Without First Bringing Child's Claim To Vaccine Court

      A federal judge in Galveston, Texas has ruled against the parental claims of a vaccine-injured child, dismissing those claims filed in federal district court.  The claim was brought on behalf of the parents for "loss of consortium" due to an injury, specifically, autism, caused by vaccines. The parents' derivative claim for loss of consortium is based on their inability to enjoy the relationship they expected to have with their child.   Judge Samuel B. Kent explains in his ruling: "Simply put, individuals who qualify as Program claimants must file petitions in the Vaccine Court in order to pursue any vaccine-related claims at all." (cite) The message that Judge Kent is sending is clear: if parents hope to bring a claim that is based on an injury caused by a vaccine, they must bring a claim for their child in the Vaccine Court as directed by federal statute within the time period defined by that statute.  Parents must be vigilant in pursuing their claims, and bring those claims on behalf of their children to preserve any related claims they may have.     

 The National Vaccine Injury Compensation Program (NVICP) was established by Congress to compensate those persons who may be injured by routine vaccinations.  It requires any claim for compensation relating to a vaccine covered by the NVICP to be filed in the Program.  The NVICP created the Vaccine Program Courts in Washington, D.C., which specialize in vaccine injuries and, by law, are required to be the "first line" in determining whether a vaccine-related claim is valid.  Vaccine-related claims may be brought in civil court after Program claims are decided, but only if a claim is first brought in the Vaccine Program Court within 36 months of the onset of the first symptoms of injury, or, in death cases, within 24 months from the date of death or 48 months of the date of injury, whichever comes first.      

 "Families should be aware of the NVICP's time limitations, and make sure they consult with an attorney in time to preserve their claims," advises Jeffrey Thompson, lead attorney with The Vaccine Injury Alliance. According to Thompson, "Attorneys who specialize in vaccine injury are available to make sure that claims are brought in the proper court at the proper time, but parents must seek out an attorney as soon as they suspect a vaccine injury has occurred."

For more information on the Vaccine Injury Alliance, the NVICP, and to view a copy of Judge Kent's order, please visit the VIA website at www.vaccineinjury.org or call 1-888-709-6674.
 

Drug Co. Lilly in lawyers' Cross Hairs Again
Lawsuits suggest vaccine may be linked to autism

     [By Jeff Swiatek.]
http://click.topica.com/maaarooaaSNU1a4JiD8b/

      No one knows for sure why autism is spreading among young children, but that hasn't stopped some trial lawyers from targeting a prime suspect in their eyes: Eli Lilly and Co.  The Indianapolis drugmaker faces at least 45 lawsuits over its role in developing and selling for more than 40 years a mercury-based preservative used in childhood vaccines and now suspected of causing autism.

Though the first case won't come to trial before next year, the lawsuits pose a potential costly threat to Lilly and a handful of vaccine makers also named as defendants. In an era when product-liability suits against big companies can result in jury awards in the millions or even billions of dollars, few cases can compare in jury-awakening pathos to toddlers stricken with autism. A puzzling neurological condition, autism can trigger profound mental problems in a healthy child within months and wreak havoc with families.  Since the alarm was sounded in 1999 that mercury-based preservatives in vaccines might be linked to autism, trial lawyers have met regularly to plan their legal assaults on behalf of autistic children and their parents. "I think the damages are catastrophic. One case certainly could be worth millions," said Michael J. Miller, senior partner for Miller & Associates, an Alexandria, Va., law firm that's filed three lawsuits against  vaccine makers and Lilly.

 Nationally, more than 60 lawsuits have been filed against vaccine makers, including such big firms as Aventis, GlaxoSmithKline, Merck, and Johnson & Johnson. The litigation has the potential to sign on thousands of plaintiffs, said attorney C. Andrew Waters, whose Dallas firm Waters & Kraus has taken a leading role in autism cases with more than 50 filed.

 Waters thinks juries will sympathize with plaintiffs who can show that drugmakers knowingly sold vaccines containing mercury in doses much higher than allowed under federal guidelines. "It just boggles the mind (how) you inject someone, much less an 8-pound baby, with one of the most toxic substances known to man."   Mercury is a notoriously toxic metal that accumulates in the body and can cause severe brain damage.

Bad timing  Getting caught up in the autism litigation could hardly come at a worse time for Lilly. It already faces the loss of more than $2 billion a year in revenue from Prozac, its former best-selling drug that lost patent protection last year. And it's spending millions of dollars and redeployed hundreds of workers to respond to tougher Food and Drug Administration scrutiny that has delayed approvals of at least three key upcoming drugs and forced an overhaul of manufacturing quality-control procedures.  To defend itself in the autism cases, Lilly has turned to the same Kansas City law firm, Shook, Hardy & Bacon, it has used in Prozac wrongful-death lawsuits nationally and in a flurry of drug-tampering cases in Missouri.

      Lilly's lawyers will fight the charge that thimerosal, the scientific name for the mercury-based preservative, can cause autism, said Lilly spokeswoman Joan S. Todd.  "No causal link has been established between thimerosal and adverse reactions in vaccines," she said. She criticized trial lawyers in the autism cases for "putting up these Web sites and trying to drum up business." Lilly scientists developed thimerosal (pronounced thigh-MARE-uh-sol) in the late 1920s and early 1930s and began selling it as a preservative in vaccines in the 1940s. Marketed for some uses under the brand name Merthiolate, thimerosal also has been used as a skin disinfectant and a preservative in blood, cosmetics and cleansers.    Lilly stopped selling thimerosal in 1991 "because it was not a significant source of revenue," Todd said. Lilly hasn't sold childhood vaccines since the 1970s.

      Trial lawyers believe Lilly still is liable for damages arising from thimerosal, despite not having sold any for the past 11 years.   "You can't design a product that's lethal and then just step away from it. They made an enormous amount of money on it over the years," Miller said.  Waters, whose firm took the first depositions in the autism cases and may bring the first case to trial early next year, said Lilly also is open to fraud and conspiracy charges, based on evidence he dug up from the 1930s.  Waters charges that Lilly "flim-flammed scientists" for years with a 1931 study that concluded thimerosal wasn't harmful to humans.  The study, published in the American Journal of Hygiene, reported that Merthiolate has "a very low order of toxicity . . . for man." Digging further, Waters found out the study's toxicity data came from experimental use of thimerosal by doctors from Lilly and Indianapolis City Hospital on meningitis patients during a severe outbreak in 1929-30.

      The 1931 study on severely ill people ended up being "quoted in Lilly brochures into the 1980s," Waters said. "It very clearly demonstrates an effort to do an unethical study and then paint the results in a certain way that help them sell this product." Lilly ignored or covered up later evidence that thimerosal, which contains 50 percent mercury by weight, can be dangerous to humans, Waters said. Lilly's Todd said the drug firm knows of "two doctors mentioning using this (thimerosal on an experimental basis) in a study in 1929. They were not our doctors." Waters and other trial lawyers concede that the lawsuits they've filed outpace the state of science on the key question of whether thimerosal causes autism.   "It is uncertain. It is controversial. It's conceivable we won't be able to establish that to the satisfaction of a judge or a jury," Waters said.  He said his firm is carefully picking clients to include only children who suffered autism soon after getting injected with mercury-containing vaccines. The firm also looks for clients who have medical records showing high mercury levels in the child's body.  Experts remain far from convinced thimerosal can cause brain disorders.

 "The evidence is inadequate to accept or reject a causal relationship between thimerosal exposures from childhood vaccines and the neurodevelopmental disorders of autism, ADHD and speech or language delay," concluded the Immunization Safety Review Committee of the National Academy of Sciences last year.   As a precaution, the committee recommended the use of thimerosal-free vaccines. It also called for further study of the issue.  The Autism Society of America, the nation's largest autism group for patients and their families, is following the lawsuits but hasn't publicly supported them because the science is unclear that thimerosal causes autism, said Lee Grossman, the society's president. "If there is a connection . . . why are there millions of children being vaccinated that have not gotten autism?" he asked.

      "We just don't know why there's this huge explosion of children being diagnosed (with autism). Vaccines may be part of the issue, but that doesn't seem to explain the tremendous growth in numbers we're seeing. The evidence is still out." Autism affects 500,000 to 1.5 million Americans and has grown at an annual rate of 10 percent to 17 percent since the late 1980s. That span coincides with the addition of new government-required childhood vaccinations that increased the levels of mercury that children were exposed to, according to lawsuits. In Indiana, where vaccinations are now required against up to eight diseases before a child may start school, the number of autistic children registered in schools has grown from 116 in 1989 to 3,789 last year. 

Burton takes interest
"We have an epidemic on our hands," said Rep. Dan Burton, R-Ind., in a hearing he held on the issue in April as chairman of the Committee on Government Reform. Burton has publicly suggested thimerosal might be to blame.  The Indiana congressman said his own grandson Christian became autistic shortly after getting a round of childhood vaccinations in his second year of life.  "Shortly after receiving his mandated vaccinations, he became a different child," Burton said at the hearing. "He no longer spoke. He would not look anyone in the eye. He cried endlessly, banging his head. He began running around flapping his hands. We now know he was suffering from an adverse reaction to his vaccines. We also know that he may have received more mercury in his vaccines than is considered safe by federal standards." Since 1999, when the FDA and other government agencies warned of potential harm from thimerosal in vaccines, manufacturers have begun supplying doctors with thimerosal-free vaccines, which are now widely used.  Even so, the long use of mercury-containing vaccines left a legacy that could be costly and tragic, said Dr. James J. Bradstreet, director of research at the International Autism Research Center in Palm Bay, Fla., in a report to Burton's committee.   "We must deal with the reality that our vaccine policy exposed a generation of newborns to a neurotoxin -- thimerosal." Copyright 2002 The Indianapolis Star
 

THE DRUG SALESMAN & THE PHRMA'S DAUGHTER

Health Sciences Institute e-Alert
September 23, 2002

Dear Reader,

Did you hear the one about the PhRMA guidelines?

Last summer I sent you an e-Alert ("Barbarians at the Garden  Gate" 6/27/02) about the new marketing code of the Pharmaceutical Research and Manufacturers of America (PhRMA), designed to govern the pharmaceutical industry's  relationships with physicians. The sweet ride was over, PhRMA said, because its new set of strict guidelines detailed exactly how far a drug salesperson could go to influence physicians to prescribe, prescribe, prescribe, and (when in doubt) over-prescribe. 

But PhRMA is an advocacy group for the drug industry. They have no regulatory power, so the most they can do is to ask salespeople to stick to these guidelines on a voluntary basis.

So how do you suppose that's been working out? Influence - bought & sold

The new "PhRMA Code on Interactions with Healthcare Professionals" started off with two strikes against it: ten years ago the American Medical Association initiated similar guidelines (which nobody followed); and the PhRMA guidelines are filled with language that provides plenty of loopholes. Under these circumstances, it's easy to imagine how pharmaceutical companies might not be motivated to voluntarily pull back on the methods they've used for many years to influence and persuade their clients.

Even though the new code has been in effect for only two and a half months, the "Newark Star Ledger" decided to get the jump on everyone, reporting that some doctors claim the guidelines are being ignored. For instance, one of the PhRMA rules calls for drug salespeople to treat healthcare providers to only modestly priced meals. But the drug giant GlaxoSmithKline recently booked an expensive French restaurant to host a lecture for doctors from the University of Pennsylvania Hospital.

Similar incidents of other drug companies stepping over the PhRMA guidelines have been reported by doctors at the U. Penn Hospital. And although the Star Ledger highlighted only these isolated events, I believe we'll be hearing similar reports from other sources nationwide. And, really, did we expect not to? The PhRMA guidelines have no teeth. Their primary purpose is public relations: to show the world that the industry is at least making an effort. But while PhRMA is sending a message to the public, I hope the word is getting through to the one group that most needs to hear and understand the concept that influence should not be bought and sold: the doctors.

I'm convinced that the pharmaceutical industry can only be regulated by the health care professionals it serves. When a drug salesperson attempts to influence a doctor with gifts and other perks, there are two parties present at that point of contact. If a doctor accepts the special offers of a salesperson and in return prescribes patent drugs instead of less expensive generic drugs, that doctor is serving himself and the drug company. Meanwhile, his patients - who trust him to provide the best quality care at the lowest cost - are not being served. But if the doctor simply refuses the gifts and perks, then the problem vanishes along with the need for unnecessary regulations.

Needless to say, when your doctor prescribes a name brand drug, you should always ask if a generic is available.

--------------------------------------------------------------
Whistle blowing
--------------------------------------------------------------

But I don't want to let the drug companies off the hook here. Time and time again they've demonstrated marketing practices that would make an organized crime boss blush.

In last Thursday's e-Alert ("Taking Pity" 9/19/02) I told you how the drug companies are not above flexing their economic influence and leaning on business partners outside of their industry who might be inclined to support legislation unfavorable to the pharmaceutical conglomerates. Last week I also came across an article with this chilling headline: "Insider: Drug Safety Not FDA Priority." And guess who's right in the middle of this story, doing everything they can to press the FDA to speed along approvals of new drugs while downplaying safety issues. Did you answer "drug companies"? Right on the money! 

The "insider" mentioned in the headline is Paul Stolley, M.D., M.P.H., a former FDA advisor who served as an FDA safety-consultant for two years. Now he's blowing the whistle, charging that the drug approval process is heavily influenced by drug companies who pay "product review" fees. Among other claims, Dr. Stolley says that the drug giants fully expect the reviews to speed through as quickly as possible in return for the payment of these fees. 

I'm sure this story will soon be followed with additional rebuttals and accusations. So I'll keep watch for further reports, and then I'll bring you a full accounting of Dr. Stolley's insider-insights.

.

A measure slipped in the homeland security bill would mean those injured by childhood vaccines could collect only $250,000.

By SARA FRITZ, Times Washington Bureau Chief
© St. Petersburg Times
published November 16, 2002
----------

WASHINGTON -- If the long-awaited homeland security bill passes Congress next week as expected, it could mean a big setback for parents of autistic children like 4-year-old Nicholas Liu.

Kevin and Mache Liu are among the parents of some 150 autistic children who have filed suit against the drug industry in the past two years, alleging their children's conditions were caused by Thimerosal, a mercury preservative once included in childhood vaccines designed to prevent measles, mumps and rubella.

Although the bill is intended to create a federal Homeland Security Department, it includes a little-known, last-minute amendment that will effectively end legal battles for compensation from several major drug manufacturers.

The amendment would keep the lawsuits out of state courts, preventing huge judgments, and instead send complaints to a 14-year-old federal program limiting compensation for children who suffer side effects of vaccines to $250,000. The amendment is one of more than a half-dozen tacked onto the bill. The homeland security bill has been agreed to by House and Senate leaders, but it is not expected to come to a final vote in the Senate until shortly before Congress adjourns next week.

Some Senate Democrats want to challenge the amendments, but that would be difficult because the House went home for the year after passing the bill. House members would have to be called back to Washington to approve the amended bill and get it to President Bush. House leaders have said they don't want to call representatives back. "Does this have anything at all to do with homeland security? The answer is no," Sen. Byron Dorgan, D-N.D., told the Associated Press. "This is bad legislation."

As usual, nobody in Congress is taking direct responsibility for adding the drugmaker amendment, which will save the pharmaceutical industry millions, if not billions, of dollars.

Rep. Dick Armey, R-Texas, has denied reports that he wrote the amendment at the urging of White House officials. Armey's spokesman said it came from Sen. Bill Frist, R-Tenn. Frist's aides said that while he wrote a similar provision that never passed, he had nothing to do with putting it into the
homeland security bill.

Executives of Eli Lilly & Co., a leading defendant in the parents' lawsuits, say they are pleased with the amendment but have no idea how it wound up being attached to the homeland security bill. The pharmaceutical industry contributed more than $14-million to congressional candidates before the Nov. 5 election, more than three-quarters of it to Republicans. Lilly alone contributed $1.6-million, making it the most generous political donor in the industry. Democrats, meanwhile, were heavily backed by trial lawyers in this year's elections.

Attorneys for the autistic children were stunned to learn of the amendment.

"Holy smokes!" declared Jack Marstall, a lawyer in Louisiana. "I guess my 4-year-old client represents a threat to homeland security," added Charles S. Siegel of Dallas. "The industry has seized the opportunity presented by a Republican House and Senate to immediately pass legislation to get the industry off the hook," Dallas lawyer Andrew Waters told the Washington Post. "To me, it looks like payback for the fact that the industry spent millions bankrolling Republican campaigns."

Siegel's clients, the Liu family, are seeking compensation from the drug companies for medical and educational expenses, as well as for pain and suffering, on grounds the industry failed to warn parents of the potential danger of Thimerosal. No compensation figure is specified in their suit. According to Siegel, Lilly executives told top White House officials recently that their company would not participate in the administration's program to produce smallpox vaccine unless it got immunity from suits filed by those who suffer from side effects of the vaccine.

Lilly spokesman Edward Sagbiel said the allegation was "absolutely false." He said the purpose of the amendment was to "stem the tide of frivolous lawsuits" filed by plaintiffs' lawyers against pharmaceutical and other industries. Sidney Taurel, Lilly's chairman, president and chief executive, is a member of the White House Advisory Council on Homeland Security.

By executive order after Sept. 11, 2001, President Bush declared that makers of smallpox vaccine will be protected from any liability by the government if they are sued in the future for adverse reactions among patients. The administration has already indemnified Wyeth and Aventis Pasteur on that basis, and a third company is awaiting approval.

Both Sagbiel and Richard Diamond, spokesman for Armey, said the legislation was simply designed to clarify the intent of the 14-year-old National Childhood Vaccine Injury Act. Lilly has not manufactured Thimerosal for 20 years, Sagbiel said, and the industry now relies on a different preservative in MMR vaccine. Medical research has not established a link between autism and Thimerosal. Siegel said he does not understand why the drug industry needs help from Congress if their legal case is already so strong. "To say this is not an Eli Lilly bailout is ridiculous," he added.

Nicholas Liu of Pflugerville, Texas, was developing normally until he turned 16 months old, Siegel said. "Then he completely changed, as his parents say, retreating into his own world." He said the parents are convinced the change was linked to the vaccine he received from his physician.
 

Only Quebec pays out for vaccine injuries

http://www.globeandmail.com/servlet/ArticleNews/PEstory/TGAM/20021118/USIDEN
/Health/health/health_temp/5/5/8/

By ANDRé PICARD
PUBLIC HEALTH REPORTER

Monday, November 18, 2002 - Page A7

In Canada, only the Quebec government compensates people who suffer severe injuries from vaccines. The little-known program, a form of no-fault insurance, is held up as a model by public-health officials around the world. In place since 1986, the compensation plan came about in an unusual way. The parents of Nathalie Lapierre, a girl who contracted encephalitis and suffered severe neurological damage after a measles vaccine, sued the doctor, the vaccine manufacturer and the provincial government. The case made its way to the Supreme Court of Canada and, in 1985, the claim was rejected.

However, in its ruling, the court said that while there was no legal obligation for the state to compensate, it would be an "excellent thing" to do so.

"What the court said, essentially, is that people exposed to potential harm while undergoing an intervention that is in the greater public good, particularly when it is at the urging of the state, should be compensated by the state," said Yves Robert, a consulting public-health physician with the Quebec Ministry of Health. "It's hard to argue with that logic." Yet, no other province has followed the Supreme Court's advice, though Manitoba and British Columbia are looking at implementing similar plans. To date, there have been about 100 claims in Quebec, two dozen of which have been approved. All of those compensated contracted polio from a child who received the oral polio vaccine (a product that stopped being used in Canada in 1996.)

Dr. Robert said there have been claims from flu-shot recipients who developed Guillain Barré syndrome, but they have been rejected because the program is only for those who are permanently disabled. GBS symptoms are almost entirely reversible. Quebec's vaccine-compensation plan is administered by the Société de l'assurance automobile du Québec, the provincial no-fault automobile insurance program. A person disabled by a reaction to a vaccine is compensated in the same manner as a person injured in a motor-vehicle collision, using actuarial tables of earning potential and medical costs.

But unlike under the auto-insurance plan, those damaged by vaccines retain their ability to take legal action. "You can choose between a no-fault award or a civil suit, but you can't have both," Dr. Robert said. Some U.S. states have compensation programs for those harmed by vaccines, but they are funded by taxes on vaccines rather than the state.

 

http://www.cambridge-news.co.uk/news/news.asp?sec=1&id=332893
Parents of autistic boy in fight for MMR damages
THE parents of a boy who developed autism after being given the MMR vaccination are suing its producers for thousands of pounds. Nurse Karen Goodall and her husband Peter are part of a legal action involving parents from all over the country. They are claiming unspecified damages of more than £50,000 from Merck and Co, based in Hertfordshire, for their son, Michael.

The couple, who live in Appletree Grove, Burwell, have joined other parents in the High Court action over the vaccination for mumps, measles and rubella. Mrs Goodall, 41, said that Michael, now aged 10, seemed a normal baby until he was given the vaccine at 17 months when the family was living in Plymouth. "As a nurse I believe in vaccination. My daughter Natalie, who is three years older than Michael, had it and was fine," she said. "Michael was walking before he was a year old and was chattering away as most little ones do. But after he had the MMR it all stopped. He wouldn't respond and he wouldn't look at us."

Michael, who was diagnosed as having autistic tendencies in February, 1995,now attends a special school, Green Hedges at Stapleford. But when he is not at school he requires 24-hour attention. "He does not speak and he gets very frustrated and agitated when he can't make himself understood," said Mrs Goodall. "He is 5ft tall and weighs eight and a half stone and has smashed four doors in the house as well as no end of videos. He has no sense of danger so we have to watch him all the time.

"I can only work part-time because of the need to look after him. "I understand why the Government wants people to give their children the vaccine. But the incidence of autism is so high now that I want 100 per cent proof that it isn't caused by the vaccination."

She said that she and her husband hoped to win damages to pay for Michael's future care.
 

A consortium of law firms representing children exposed to mercury in vaccines, led by attorneys Michael Williams, of Portland, Oregon, and Richard S. Lewis of Washington, D.C., have vowed to continue litigation against manufacturers of thimerosal, a mercury-based preservative found in some childhood vaccines, despite the "Eli Lilly" rider attached to the Homeland Security Bill and signed into law by President Bush yesterday.

The national consortium, lead by Williams, of Williams, Dailey, O'Leary, Crane & Love, and Lewis with Cohen, Milstein, Hausfeld & Toll, is seeking to have vaccine manufacturers set up court-administered funds that would allow children to get needed medical tests in order to mitigate potential neurological damage caused by thimerosal exposure.

Thimerosal, which is fifty percent mercury, was added to vaccines to prevent bacteria contamination when a doctor repeatedly drew vaccine doses from the same vial. After scientists and parents raised concerns about injecting children with mercury, thimerosal was taken out of vaccines in the late 1990s. Lawyers contend, however, that thimerosal and vaccine manufacturers' documents indicate that these companies knew about the health problems associated with thimerosal since at least the early 1970s. The Institute of Medicine has also concluded it is "biologically plausible" that thimerosal is causing neurodevelopmental disorders. While the rider attached to the Homeland Security Bill forced thimerosal personal injury claims into the Vaccine Injury Compensation Program, a federal program designed to protect vaccine manufacturers from liability and reduce compensation levels for victims, the rider will not have any effect on cases seeking "medical monitoring" injunctive relief which gives medical tests to children, not cash awards. Lawyers contend, however, that it is likely that lobbyists will push for additional special interest legislation in the new session of Congress to wipe out the medical monitoring cases, completely depriving mercury-exposed children of any remedy in the court system and shutting down fact investigation into what the drug companies knew about the dangers of thimerosal and when they knew it.

Richard S. Lewis responded to the Homeland Security Bill signing by stating that, "We are troubled that this provision was made a part of this bill; we will actively continue our efforts to seek testing for kids who were exposed to excessive mercury levels so that we can mitigate brain damage before it becomes irreversible."

Michael Williams added, "The `Eli Lilly' rider merely reinforces the importance and public health necessity of this law suit. The back-room deal that put these anti-child amendments into the Homeland Security Bill is just the first step in the drug companies' efforts to completely avoid any responsibility for what they did to a generation of children."

Other members of the consortium include: Larry Cohan of Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley in Philadelphia, Pennsylvania; Tobias Millrood of Schiffrin & Barroway in Philadelphia, Pennsylvania; and David Klein of Klein and Lyons of Vancouver, British Columbia, Canada.

By Ori Twersky

WASHINGTON (Reuters Health) Dec 04 - The growing number of vaccine-related autism claims could threaten to overwhelm the US government's tax-based injury compensation program and force it into entering numerous costly settlements despite the lack of an established connection, according to federal officials.

Created by a congressional act in 1986, the National Vaccine Injury Compensation Program was designed to provide individuals injured by a vaccine with compensation while limiting litigation and keeping vaccines widely available. The rationale was that vaccines would always be easy targets for litigation because they have inherent side effects and almost everyone is vaccinated.

At question now is whether the program will be able to withstand a potential flood of new claims, alleging that the once commonly used vaccine preservative thimerosal caused hundreds of American children to develop autism, officials from the US Department of justice (DOJ) told the HHS Advisory Commission on Childhood Vaccinations on Wednesday.

Thimerosal is no longer used in most childhood vaccinations, and its alleged connection to autism has not been established. But a recently passed federal law has now effectively ensured that virtually all such existing and future claims would be filed under the federal  compensation program, the officials noted before a Department of Health and Human Service (HHS) advisory committee.

Passed as a provision of the Homeland Security Act, the November law extended the vaccine liability protection to manufacturers of  vaccine components such as thimerosal. As in 1986, the rationale was that such liability protection is needed to ensure that the US will  always have
adequate access to needed vaccines.

Justice officials deny that the newly passed law actually served to change the landscape. "It was always our view that even under the old law, they (the litigants) had to come here first," Mark W. Rogers, assistant director of the DOJ's Torts Branch, told Reuters Health.

But the number of actual claims filed so far and the expected number of new claims filed because of the Homeland Security Act is raising some concern that such claims could overwhelm the system, he said. "We simply don't know," Rogers said. "It will all depend upon the number of claims
filed."

Still, federal figures paint a potentially grim picture. Thanks in large part to the thimerosal controversy, the number of claims filed under the compensation program grew more than four-fold in fiscal 2002, according to the federal figures, and are on record pace for the fiscal 2003 year that
began in October.

At present, the government is trying to establish whether such claims have any merit, making them eligible for out-of-court settlements.

"We cannot litigate thousands of cases," explained Gary Golkiewicz, a representative of the US court that adjudicates such claims, to the government advisory committee. "There have already been about 1,100 petitions filed and who knows how many more are coming."

Golkiewicz said until specific standards are established for judging these cases, the court was also likely to continue struggle, making the  no-fault out-of-court settlements more likely. "The present game plan is to try to isolate it," he said. "Keep the chaos in one corner." Even if a connection is never established, the sheer number of claims could force such out-of-court settlements, Golkiewicz said. "These autism/thimerosal cases are going to test the program, stress the program," he said.

On the plus side, the program is solvent and has reserves amounting to about $1.8 billion, said Thomas E. Balbier, Jr., director of the of Vaccine Injury Compensation division at HHS. As of November, there were also only six outstanding claims dating from before 1988,  suggesting that the government is moving faster to adjudicate these claims and get them resolved, he said. Omitting controversial claims such as the autism cases, the average time to closing on such claims has been reduced to about 11 weeks, Golkiewicz said. "The vital signs are otherwise good," he said.
 

MMR deaths awarded by VDPU but denied by UK government

"Jabs has also had reports of 24 deaths, which contrasts with the government's claim of parents that one dose of MMR does not cause death. The VDPU, for example, has made a payment to the parents of Hannah Buxton, who died of a massive fit after receiving MMR at 18 months. The parents of Chloe Dwyer, who died of Guillaine-Barre syndrome after receiving her first MMR at four-and-half, also secured a payment.

As Jackie Fletcher of Jabs said: "The drug companies acknowledge side effects; scientific studies shows there have been side effects. Parents report them. But the government says it can't happen."--Private Eye MMR Report p13  May 2002

"Despite this, the Department of Health insists no child has ever died from MMR." http://www.whale.to/v/mmr101.html

 "The conclusion time and time again is that the (MMR) vaccine is safe."  Dr Elizabeth Miller Public Health Laboratory Service, 22 January, 2001

"This (MMR)  is a safe vaccine."-------Dr David Salisbury, Government immunisation programme

Parents uniting on MMR Dec 13 2002
      http://icbirmingham.icnetwork.co.uk/0100news/0100localnews/
page.cfm?objectid=12450863&method=full
         
      By Krysia Diver, Evenign Mail
    
       
      A Birmingham woman with two autistic children is joining more than 1,000 people in a UK-wide legal claim against the makers of the MMR jab. Charlene Ward, of Bartley Green, says she is delighted that Alexander Harris solicitors has agreed to fund her claim against Aventis Pasteur, SmithKline Beecham and Merck & Co.  The move follows a blunder at Bellevue Medical Centre, in Ladywood, in which eight-week-old Shannon Whitter was accidentally given the MMR vaccine.

      Mrs Ward, whose sons Shane, aged eight, and Adam, 14, have autism, said: "I'm so relieved that we are going to be able to join this group action. "We want to drag the manufacturers of this vaccine through the courts. "They are experimenting with their precious MMR vaccine and it is our children who are the victims. "Shane is going to need care long after my husband and I die, so he will need as much compensation as he can get."

      A spokesman for Alexander Harris said: "More than 3,000 people have contacted us with complaints about MMR and Mrs Ward is one of 1,000 that we have agreed to take on. "In the first instance, we have to prove that the MMR vaccine has caused damage to a range of children and then we will be able to assess every individual case."

      In 1992 Alexander Harris solicitor Richard Barr was contacted by a concerned mother whose son had developed autism after receiving the vaccine.  Since then, the law firm has beenfloodedwithcalls from parents complaining of bowel problems, autism, epilepsy and brain damage in their children following the jab.      The Department of Health continues to point to conflicting evidence which rules out a connection between autism and MMR. The case will be heard at the High Court in October 2003.

      After the Bellevue blunder Shannon's parents, George Whitter and Christine Fullen, took her to hospital where she was given the all-clear, but doctors said she might suffer mild side effects.
    
 

http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=1808546
 
US Government Asks Court to Seal Vaccine Records
Tue November 26, 2002 10:47 AM ET
By Todd Zwillich

WASHINGTON (Reuters Health) - Attorneys for the Bush Administration asked a federal court on Monday to order that documents on hundreds of cases of autism allegedly caused by childhood vaccines be kept from the public.

Department of Justice lawyers asked a special master in the US Court of Federal Claims to seal the documents, arguing that allowing their automatic disclosure would take away the right of federal agencies to decide when and how the material should be released. Attorneys for the families of hundreds of autistic children charged that the government was trying to keep the information out of civil courts, where juries might be convinced to award large judgments against vaccine manufacturers.  The court is currently hearing approximately 1,000 claims brought by the families of autistic children. The suits charge that the measles-mumps-rubella (MMR) vaccine, which until recently included a mercury-containing preservative known as thimerosal, can cause neurological damage leading to autism.

Federal law requires suits against vaccine makers to go before a special federal "vaccine court" before any civil lawsuit is allowed. The court was set up by Congress to speed compensation claims and to help protect vaccine makers from having to pay large punitive awards decided by juries in state civil courts. Plaintiffs are free to take their cases to state courts if they lose in the federal vaccine court or if they don't accept the court's
judgment.

The current 1,000 or so autism cases are unusual for the court. Because it received so many claims, much of the fact-finding and evidence-gathering is going on for all of the cases as a block. Monday's request by the Bush Administration would prevent plaintiffs who later go to civil court from using some relevant evidence generated during the required vaccine court proceedings. Plaintiffs' attorneys said that the order amounted to punishment of the families of injured children because it would require them to incur the time and expense of regenerating evidence for a civil suit.

"Wouldn't it be a shame if at the end of the day our policy would be to compensate lawyers," said Jeff Kim, an attorney with Gallagher Boland Meiburger & Brosnan. The firm represents about 400 families of autistic
children who received the MMR vaccine.

Kim accused the government of trying to lower "a shroud of secrecy over these documents" in order to protect vaccine manufacturers, who he said were "the only entities" that would benefit if the documents are sealed.  While federal law clearly seals most documents generated in individual vaccine cases, it has never been applied to a block proceeding like the one generating evidence in the autism cases.  Administration lawyers told Special Master George Hastings that they requested the seal in order to preserve the legal right of the Secretary of Health and Human Services to decide when vaccine evidence can be released to the public.

Justice Department attorney Vincent Matanoski argued that to let plaintiffs use the vaccine court evidence in a later civil suit would confer an advantage on plaintiffs who chose to forgo federal compensation.  "There is no secret here. What the petitioners are arguing for are enhanced rights in a subsequent civil action," Matanoski said of the plaintiffs. "They're still going to have unfettered use within the proceedings." Hastings would not say when he would issue a ruling on whether to seal the court documents, but did say that his decision would be "very prompt."
 

Bush Admin. Withdraws Motion to Seal Thimerosal Documents Advocacy Groups Question Whether Future Cases Will Be Subject to the Secrecy Order

library.northernlight.com/FF2002121946
0000086.html?cb=0&dx=1006&sc=0#doc

      PRNewswire via COMTEX - The US Department of Justice agreed today to withdraw its motion to the US Court of Federal Claims Office of Special Master to seal all documents related to present thimerosal-autism claims.
The Mercury Policy Project and SAFE MINDs said that the withdrawal of the motion was a step in the right direction. However, the groups questioned whether documents in future cases would be subject to the secrecy order.
      "The Bush Administration has overreached in its attempt to seal documents in thimerosal cases and the withdrawal of their motion bears that out," said Michael Bender, director of the Mercury Policy Project. "Unfortunately, this agreement only addresses half the loaf of bread. While the motion's withdrawal may help those involved in current litigation, it leaves unresolved what this means for future cases."

      While the groups acknowledge that some information unearthed in court should be kept private -- like trade secrets -- they maintain that scientific studies and information should not qualify. In addition to the documents obtained through discovery from Eli Lilly, these also include unreleased confidential documents from the Centers for Disease Control stating that mercury in children's vaccines is a potential source of neurological damage in children including ADD/ADHD, speech and language delays and other neurological disorders including autism.

      "We question the Bush Administration's blatant attempt to hide from the American public documents affecting the health and safety of millions of children -- especially when the material in question is as dangerous as mercury," said Lyn Redwood, Pres. SAFE MINDs. "What are they trying to hide?"

      While federal law typically seals documents in individual cases, it has not been applied to omnibus proceedings like the autism cases.  "What's the policy argument for such incredible secrecy?" said Sallie Bernard, executive director of SAFE MINDs. "The timing and the scope of this unprecedented secrecy action by the Bush Administration raises serious questions, considering that lawmakers have pledged to revisit the thimerosal liability shield provision in the Homeland Security Act when they return in January."

      "The Bush Administration's secrecy request was premature, highly unusual and went against federal rules that impose severe restrictions on sealing of documents," said MPP director Bender. "The public -- and especially families of autistic children -- have a right to know about