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Vaccine Makers Targeted In Lawsuit

Vaccine makers targeted in lawsuit [Pittsburgh Post-Gazette]

From Pittsburgh Post-Gazette (PA) (October 11, 2010)

Oct. 11--On April 1, 1992, Hannah Bruesewitz was a healthy infant. She had reached all of her developmental milestones for a 6-month-old, and that morning went to get her third round of the diphtheria, tetanus and pertussis vaccine.

That afternoon, as Hannah sat in her seat watching her mom fix lunch, the little girl startled, and her entire body stiffened.

"I didn’t realize it was a seizure at first," said Robalee Bruesewitz, of Mt. Lebanon. "Her arms would shoot out, and she would look through me."

During one episode late in the afternoon, her mother knew something was terribly wrong.

"Within minutes, she let out this horrific scream. She stiffened and turned blue."

Hannah was rushed to the hospital, but doctors couldn’t help her.

"The seizures continued and continued and continued," Mrs. Bruesewitz said. "Nothing could stop them for an entire week."

Over 16 days, the previously healthy infant had 125 seizures.

Instead of getting better, Hannah progressively worsened, to the point where -- now at age 18 -- she is completely non-verbal and needs 24-hour care.

After years spent unsuccessfully fighting in a federal administrative court to recover compensation for what they believe are vaccine-related injuries, the Bruesewitz family turned to the civil court system.

They filed a lawsuit against Wyeth Inc., the DTP manufacturer responsible for Hannah’s injection, but the suit was thrown out in federal court.

Last year, the 3rd U.S. Circuit Court of Appeals upheld the lower court’s decision. But in March, the U.S. Supreme Court agreed to hear the case.

It will be argued Tuesday.

At the center of the debate is whether the National Childhood Vaccine Injury Act of 1986 -- created to help shield vaccine makers from costly lawsuits, while at the same time providing compensation to children who suffered severe side effects from vaccines -- precludes civil litigation against vaccine manufacturers.

Under the act, a manufacturer cannot be held liable for design defects "if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Wyeth argues that the passage clearly absolves them from civil liability.

But the Bruesewitz family argues that the preclusion turns on the word "unavoidable," in the act.

"The reality is, they had a safer vaccine at the time, and they withheld it from the market, said Russell Bruesewitz, Hannah’s father.

The family claims in its Supreme Court brief that Tri-Immunol -- the vaccine Hannah received -- "had long been superseded by a more modern design, but Wyeth declined to change its DTP vaccine’s design because it viewed the economic costs as outweighing any potential gain in market share."

"Hannah’s vaccine was known to cause seizures," Ms. Bruesewitz said.

According to the family’s Supreme Court brief, the lot number associated with Hannah’s vaccine had an unusually high number of severe side effects, including two deaths and 60 adverse events.

Tri-Immunol, which first hit the market in the 1940s, was ultimately pulled by Wyeth in 1998.

But the vaccine maker argues in its Supreme Court brief that, contrary to the Bruesewitzes’ claims, the company could not have sold a safer alternative because one was not approved by the U.S. Food and Drug Administration for children under the age of 2 until 1996.

A large part of the frustration experienced by the Bruesewitzes is their perceived failure of the National Vaccine Injury Compensation Program.

Designed, they thought, to specifically help families like theirs, the program, instead, led them on an 8-year roller coaster, eventually ending in disappointment.

The Bruesewitz family filed their claim with the program in April 1995.

Up until a month before their claim was filed, residual seizure disorder -- what Hannah has -- was a covered injury. All the family had to do is show that Hannah had the disorder, and under a table of listed vaccine-related injuries, it would be presumed that the DTP vaccine caused it, and they would be compensated. The vaccine compensation program is funded by an excise tax put on every vaccine.

But in March 1995, the U.S. Department of Health and Human Services removed residual seizure disorder from the list of compensable claims for the DTP vaccine.

Because it was removed, the Bruesewitzes were told they would have to prove that the vaccine caused Hannah’s injuries.

Despite eight years of trying, they failed to prove causation, and their claim was refused.

"It was contrary to the whole concept -- to make it expeditious and generous," Mr. Bruesewitz said.

In fact, a study by the U.S. General Accountability Office in 1999 showed that there was debate whether the vaccine program was serving its purpose of providing compensation "quickly, easily, with certainty and generosity."

The study showed that the department of Health and Human Services had removed more compensable injuries from the table than had been added -- despite an increase in the number of childhood vaccinations -- and that there was no clear and transparent methodology being used to do so.

Further, it was often taking years to process the claims. In February 1999, 57 percent of cases had taken more than two years, and 18 percent of those had taken longer than five years.

According to a September 2010 statistics report from the U.S. Health Resources and Services Administration, since fiscal year 1999, a total of 2,503 vaccine claims were awarded $1.9 billion. That averages out to more than $774,000 per claim.

However, another 2,293 claims have been dismissed.

And a report from August shows that since the Vaccine Court program began, there have been vastly more claims filed related to the DTP vaccine than for any other, with a total of 3,978. Of those, 696 claims were for the death of a child.

Out of all DTP claims, only 1,265 received compensation, while the majority were dismissed.

Before residual seizure disorder caused by DTP was removed from the list of compensable injuries, 1,713 claims were filed listing that problem. Of those, 654 received compensation totaling $480.9 million, according to the Health Resources and Services Administration.

It is the federal government that controls what injuries are covered and what claims receive awards. According to the Department of Health and Human Services, residual seizure disorder was removed from the list of covered injuries because reviews by the Institute of Medicine concluded that there was no evidence showing a causal relationship between pertussis vaccine and seizures.

Vaccine manufacturers were not involved in that process.

Curtis L. Allen, a spokesman for Pfizer Inc., now the parent company of Wyeth, said it is their hope that the Supreme Court upholds what they believe was the intent of Congress -- to have issues about the proper design of vaccines be decided by FDA and CDC experts, not state court juries.

"While we have great sympathy for the Bruesewitz family and understand how conditions of the type Hannah Bruesewitz suffers from can take an extraordinary emotional and physical toll on a family, it is important to recognize that her claims received full consideration in Vaccine Court, and that court determined that her condition was not caused by vaccination," Mr. Allen said.

Wyeth and its supporters argue that if the Bruesewitzes succeed in their claim, the potential for large payouts in civil litigation will drive the few remaining vaccine makers from the market.

Much of the driving force behind the 1986 legislation was that manufacturers were facing increased civil lawsuits and large awards.

They were being driven from the market, said Dr. Marion Burton, the president of the American Academy of Pediatrics, which has filed a brief in support of Wyeth.

"We had a potential crisis in getting the seven vaccines recommended for children," Dr. Burton said.

With the passing of the 1986 vaccine act, he continued, the vaccine market stabilized. The protection from litigation provided by the act has even allowed drug manufacturers to develop an additional eight vaccines now recommended for children.

"This is the most effective public health program of this century," Dr. Burton said. "You have to take the manufacturers out of the line of fire, unless they’ve done something profoundly negligent."

If the Supreme Court finds in favor of the Bruesewitz family, Dr. Burton fears it could bring a cascade of lawsuits against the manufacturers.

"We’re going to be back in the same dilemma," he said.

But the Bruesewitzes, who are not opposed to vaccinations in general, don’t think that’s the case.

"We want the government to hold the manufacturers of these vaccines accountable," Mr. Bruesewitz said. "They’re totally immune. We do need to know they’re making safe vaccines and being held responsible.

"There’s an altruistic part of it, too. We can carry the burden for others in similar situations."

Paula Reed Ward: or 412-263-2620.

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Posted: October 2010