By: Paula Reed Ward, ‘Pittsburg Post Gazette’
11 October 2010
Hanna Bruesewitz’s parents think DPT vaccination caused the child’s seizure disorder, but the vaccine maker is protected from suits by federal law.
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.
(Note from SaneVax: This case is critical to any vaccine-injury case pending, or future. Please read, ‘U.S. Supreme Court will Rule on an Important Vaccine Case,’ by Emily Tarsell. The article can be accessed by searching this blog for Emily’s name.)