The Supreme Court considered arguments this week in a vaccine injury case that may change the way effected patients sue vaccine manufacturers.
The case before justices, Bruesewitz v. Wyeth No. 09-152, contends that a third dose of diptheria-tetanus-pertussis (TDP) vaccine administered to healthy 6-month old Hannah Bruesewitz in 1992 resulted in debilitating seizures. Now 18, Bruesewitz continues to experience developmental delays and residual seizure disorder allegedly associated with the vaccine, David C. Frederic, a Washington lawyer representing the family told the court.
Passed in 1986, the National Childhood Vaccine Injury Act (NCVIA) requires individuals who wish to sue for vaccine injury to file suit in a special vaccine court. The law is intended to provide adequate compensation for those injured by vaccines while protecting vaccine manufacturers from excessive liability claims that could potentially hinder vaccine production.
“The way this law has worked over the years has really been one of the better pieces of legislation in preventing multiple lawsuits,” Julee Waldrop, DNP, ARNP, associate professor at the University of Central Florida College of Nursing in Orlando, Fla., told The Clinical Advisor.
NCVIA bars ordinary vaccine-injury lawsuits “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.”
However, Frederic argued that the Bruesewitz case falls outside of vaccine court jurisdiction because the TDP vaccine in question, the now discontinued Tri-Immunol, was defective in design and that Wyeth allegedly chose not to manufacture a safer formulation — Tri-Solgen, produced by Eli Lilly in the 1960s and withdrawn from the market in the 1970s — due to profitability concerns.
“We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury from vaccines that we compel children to take,” Frederic said during the hearing.
On the other side, Kathleen M. Sullivan, the lawyer representing Wyeth, now owned by Pfizer, argued that the FDA determined that there were fewer local reactions with Tri-Solegen, but that the agency had not deemed the vaccine safer.
She continued that NCVIA language stipulates that only lawsuits arising from manufacturing flaws and inadequate warnings can be tried in state court.
“The language that they used is certainly, to say the least, confusing,” said justice Ruth Bader Ginsberg.
National health organizations, including the American Academy of Pediatrics, have expressed concern that if the Supreme Court rules in favor of the Bruesewitzs, judges and juries will usurp the FDA and CDC’s scientific expertise, ultimately driving certain vaccines from the market and delivering a blow to public safety.
The decision may also have important implications for thousands of unrelated vaccine court cases involving the scientifically unfounded link between the measles, mumps and rubella vaccine and autism, according to Sullivan. “They have lost all six test cases, and when the individual cases are resolved, that is 5,000 potential claimants in state court,” she said.
Waldrop agreed that the Bruesewitz case may “set a scary precedent for future vaccines,” and warned of a possible “ripple effect.”
“Although vaccine manufacturers are really large and wealthy companies, in many instances they have chosen not to develop vaccines just because of financial reasons,” Waldrop said. “This could definitely have a potentially negative impact on further vaccine development, and even on the continual manufacture of very needed vaccines that manufacturers give away to developing nations at very low costs.”