System designed to aid vaccine victims adds to their suffering, report finds

Oct. 24, 2014: In this photo, Jeffrey McCord, who suffered from violent and unexplained seizures as a baby, demonstrates his guitar at home in St. John, Virgin Islands. (AP)

All but broken by her son's violent and unexplained seizures, by so many panicked trips from the crib to the emergency room, Jeffrey McCord's mom thought her desperate search for both answers and help was finally over.

A respected neurologist had drawn a connection that a dozen other doctors missed: Jeffrey's convulsions began days after a routine vaccination, the kind given safely to millions of American children.

While Jeffrey's injuries were devastating, his parents were told they might not have to bear the costs alone. The doctor explained that Jeffrey could apply for lifelong care paid for by the federal government. The program's premise is simple: quickly and generously support people in the rare cases when a shot to prevent a sickness such as flu or measles instead is the likely cause of serious health complications.

But 11 years would pass before the McCord family would receive its first check.

And they are not alone in their frustration. A system intended to speed help to vaccine-injured Americans has instead heaped additional suffering on thousands of families, The Associated Press has found.

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To investigate vaccine court in depth, the AP read hundreds of decisions, conducted more than 100 interviews, and analyzed a database of more than 14,500 cases. That database was current as of January 2013; the government has refused to release an updated version since.

Among the AP's findings:

-- Private attorneys have been paid tens of millions of taxpayer dollars even as they clog the court with more cases than they can handle, some of which the court rejected as totally inadequate. The court offers a financial incentive to over-file -- unlike typical civil court cases, attorneys are paid whether or not they win, as was the case with more than 5,000 losing claims that vaccines caused the developmental disability autism. Those who double-bill for their time or consistently submit questionable expenses are not disciplined.

-- Prominent attorneys have enlisted expert witnesses whose own work has been widely discredited, including one who treated autism with a potent drug used to chemically castrate serial rapists. Another doctor cribbed his material from an anti-vaccine website. Some of the most prominent experts set up nonprofits questioning vaccine safety, further fueling public skepticism. Meanwhile, many doctors hired by the government to defend vaccine safety in court have ties to the pharmaceutical industry.

-- Lawmakers designed vaccine court to favor payouts, but the government fights legitimate claims and fails its obligation to publicize the court, worried that if they concede a vaccine caused harm, the public will react by skipping shots. The court was created with relaxed standards of evidence and a burden of proof more easily met than civil lawsuits. Lawmakers expected some children would get help even though their injuries weren't truly caused by a vaccine. If government doctors had their way, though, 1,600 families would not have gotten more than $1.1 billion in cash and future medical care between the court's opening in 1988 and then end of 2012.

-- Cases are supposed to be resolved within 240 days, with options for another 150 days of extensions. Less than 7 percent of 7,876 claims not involving autism met the 240-day target. Add in autism claims, which were postponed so the court could hear all of them at once, and just 4.5 percent took fewer than 240 days. Most non-autism cases take at least two and a half years, with the average case length more than three years, not including cases unresolved at the end of 2012. Hundreds have surpassed the decade mark. Several people died before getting any money.

Caught in the middle are families that need help.

"The system is not working," said Richard Topping, a former U.S. Department of Justice attorney who handled vaccine injury claims but resigned after concluding his bosses had no desire to fix the major flaws he saw. "People who need help aren't getting it."

The vanquishing of polio, measles and other preventable diseases was the transcendent public health accomplishment of the 20th century.

And yet, by the mid-1980s, those gains seemed fragile. Pharmaceutical companies were facing a barrage of lawsuits from parents who believed the diphtheria-tetanus-pertussis shot had disabled their kids. Their profits imperiled, vaccine makers signaled they would leave the U.S. market.

In response, Congress gave a break both to pharmaceutical companies and to those who received a vaccine to prevent one illness, yet suffered another.

To protect the nation's supply, lawmakers shielded companies from jury verdicts, shifting liability for injuries to the U.S. government. That part worked: Vaccines are widely available, and profitable.

To help people harmed by shots, Congress created the National Vaccine Injury Compensation Program. Government doctors and lawyers review claims. If they believe it is more likely than not that a vaccine -- and not something else -- caused the injury, they tap a $3.5 billion fund to pay for future care and lost wages. That fund is replenished by a 75-cent tax on each vaccine.

If the government concludes the vaccination was not likely the cause, it contests the claim in a special vaccine court, based several blocks from the White House.

Though much is in dispute regarding the vaccines and their side effects, the court remains obscure. But largely due to an influx of adult flu claims, the volume of new cases has increased, averaging more than 400 annually in recent years.

To be sure, many of those who received the $2.8 billion that the government says it distributed through March 2014 would not have won a civil trial. But the system has not worked as Congress envisioned.

Many claims fall into a vast gray area: The science is clear on only nine of 144 vaccine-injury combinations that a shot could -- or could not -- cause the illness. Amid this fundamental uncertainty, the kind of litigation the court was created to avoid is routine.

Days before his DPT shot, a minor traffic accident sent Jeffrey McCord to the emergency room. A precautionary brain scan showed he was fine.

Within 48 hours of his September 1995 vaccination, the seizures began. An MRI showed black lesions where there had been gray matter.

For three years Jeffrey's parents struggled to care for their only child. His mother quit her job. His father worked out of their northern Virginia home. They ploughed tens of thousands of dollars into treatments, borrowing on credit cards.

Not until an appointment with Dr. Yuval Shafrir did the family consider that a vaccine could have caused Jeffrey's epilepsy.

Jeffrey's parents knew nothing about vaccine court, which operates under the U.S. Court of Federal Claims. Shafrir did because he had testified for the government against vaccine claims. In Jeffrey's case, he blamed the vaccine. In 1998, the family filed.

Justice Department lawyers fought -- hard. They questioned the family's motives. They assailed Shafrir's credibility.

"We needed the help -- we knew our baby could die at any moment," said Jeffrey's mother, Martha Toomey, who still doesn't leave her now 19-year-old son alone for fear of seizures. "We didn't expect the government to attack us."

In March 2005, DOJ lawyers began negotiating a settlement. Four months later, they abruptly took the case to trial.

Though vaccine court is part of the federal judiciary, those who oversee cases are called "special masters," not judges. The special master handling McCord's case wrote that the government showed "total disregard" for the family.

Eight years after the claim was filed, the special master ruled Jeffrey was entitled to $7 million in cash and future medical care. It took another three years before the family received a check, as the family and the government haggled over details of how to care for Jeffrey.

As for Shafrir, the government never hired him to testify again.

In the first 20 years of vaccine court, government doctors recommended compensation up front in 18 percent of non-autism cases. From 2008 through 2012 -- the most recent data the government would release under a Freedom of Information Act request -- they recommended compensation in just 5 percent of claims.

What changed?

One important factor was a growing fear that concessions could erode the public's confidence in vaccine safety. Vaccine skeptics are a resilient and effective minority. Vaccination rates have dropped in some affluent, coastal cities -- but also across other regions, including areas of the upper Midwest.

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Seven former federal officials acknowledged in interviews what one called a "large concern" that vaccine court cases could reduce vaccination rates. One called it "part of the daily work context."

Never was this threat greater than the 5,640 cases claiming that vaccines caused autism.

On March 6, 2008, the parents of 7-year-old Hannah Poling revealed that the government had agreed to compensate their claim. Though the government never conceded that a vaccine caused Hannah's autism, that was the implication during a family news conference highlighted on cable TV and the evening news.

That day, the doctor who oversaw the medical analysis of claims cited the Poling case in defending the government's wariness to pay out.

"There is this other side to compensation that we have to worry about," Dr. Geoffrey Evans told a commission that advises the program, referring to parents who might resist vaccinating if they conclude payouts mean shots are unsafe. "It's not going to be long before there's going to be public health consequences."

Before the Poling news conference, attorneys handling the autism cases proposed settling with the government.

In a January 2008 letter, autism attorney John R. Fabry recounted that Department of Justice attorney Vincent Matanoski told him federal doctors "would not want a settlement to be perceived as an admission that vaccines are dangerous, which could lead to a reduction in the vaccination rate."

The court ultimately dismissed any link between vaccines and autism.

The court in December 2012 compensated two cases filed years earlier as autism claims. In both, Special Master Patricia Campbell-Smith ruled that vaccines injured the children's brains -- but did not cause autism -- and awarded their families more than a million dollars each in compensation. One case took six years to adjudicate; the other nearly a decade.

Both the Justice Department and Division of Vaccine Injury Compensation, whose doctors within the Department of Health and Human Services assess claims, said in written statements that while perception of vaccine safety is important, individual claims are evaluated based on scientific evidence and legal standards.

Both also defended the compensation program, which has "succeeded in providing a less adversarial, less expensive, and less time-consuming system of recovery than the traditional tort system that governs medical malpractice, personal injury and product liability cases," Justice Department spokeswoman Nicole Navas said.

The legal standards governing vaccine court have shifted over time. The program's original rules favored compensation. Gradually, compensation became harder due to rule changes and precedent from court decisions.

In 2005, a higher court ruled it had become too hard to show that a vaccine "more likely than not" caused the injury. Winning compensation became easier.

The government began settling far more cases. Vaccine program officials argue that settlements are resolved more quickly and claimants get money they might not at trial. AP's data analysis shows that settlements are not significantly faster than court decisions, and in many cases take longer. And some claimants accept lowball offers because they need money now.

Settlements offer the government several advantages. There is no admission that the vaccine caused harm, and they are confidential.

Indeed, the government seems intent on keeping the National Vaccine Injury Compensation Program's public profile low.

Several years ago, the program paid a consulting firm $300,000 to develop a comprehensive publicity plan. Few of the suggestions have been implemented. Less than $20,000 of its $6.5 million annual budget is dedicated to public outreach, primarily for trips to hand out pamphlets at health professional meetings.

After The AP published this story in November, officials vowed to publicize the program better. They told investigators with the Government Accountability Office they would use "plain language" in program literature, improve its website and target promotions to "health care providers, parents and expectant parents, adults aged 50 years and older (including Spanish-speaking older adults), and civil litigation and health attorneys."

In vaccine court, private attorneys make the same money whether they win or lose -- even when they file cases with no medical merit. By pushing quantity of cases over quality, a practice known as "churning,"

Churning is necessary to make good money, several attorneys said.

One was Michael Kerensky, a Houston lawyer who filed 81 cases claiming injury from diphtheria-tetanus-pertussis vaccines. Though he won just nine, Kerensky received $221,842 to cover his hours and expenses, government data show.

Kerensky acknowledged that many cases lacked basic medical records. He figured he could get those later -- but often couldn't, or didn't.

He abandoned vaccine law after concluding he'd have to keep churning cases.

Waiting to investigate a case until after filing can make financial sense. File the claim, then do the research -- and the court pays billable hours.

One special master wrote that this dynamic encourages "gaming the system." It certainly clogs the court.

In the summer of 1999, attorney Clifford Shoemaker was juggling a heavy caseload. The court had set an August deadline for filing Hepatitis B claims. Paperwork was flooding his small office.

Shoemaker filed 118 cases, often failing to get required medical records first.

It was a matter of principle, he explained: "I'm not going to turn away people who need help."

The cases dragged out for years -- some longer than a decade -- while Shoemaker asked for more time to file basic paperwork or find an expert. Shoemaker said he delayed cases because he knew they would be difficult to win unless he could get Congress to make it easier to prove that vaccines cause injuries. That did not happen.

Special masters obliged his requests for delays, though several wrote stinging rebukes. In dismissing a case in which Shoemaker couldn't even prove his client had been vaccinated, one wrote that the claim "borders the line -- if not actually crosses the line -- marking frivolous petitions." In this case, compensation was denied.

Shoemaker is among vaccine court's most prolific filers and has been an effective advocate for the likes of Jeffrey McCord and Hannah Poling. He has received more than $11 million from 390 adjudicated non-autism cases, according to government data. He lost 58 percent of the time, receiving $4.1 million in those cases. Most of the money is for billable hours; some covers expenses.

Some attorneys consistently have requested excessive fees and dubious costs.

Shoemaker once submitted a bill that the special master said could "easily exceed the hours available in a day." Other special masters said he would submit "unreasonable or duplicative" hours, then say the entries were in error. His payments would be reduced, but AP found no evidence he had been sanctioned.

In one early case, he tried to charge the court for repairs to his car, which broke down on the way to a hearing. In another, Shoemaker billed for travel to Paris and Italy, including a stay at a Ritz Carlton.

Shoemaker said his billing problems were honest mistakes and that he now has a better tracking system. He said the European trip was necessary to meet with experts.

"I'm not ashamed of anything that was done at that time," he said.