The Supreme Court is set to hear the first arguments Tuesday in a vaccine injury case that pediatricians and medical malpractice lawyers worry will drastically change how patients sue vaccine manufacturers in this country.
By law, families who want to sue for vaccine injuries must first go through a special "vaccine court" created by the 1986 National Childhood Vaccine Injury Act (NCVIA). The Supreme Court must now decide whether a family can sue without going through vaccine court, on the grounds there was a defect in the design of the vaccine.
Russell and Robalee Bruesewitz, the plaintiffs in Tuesday's case, are not the first to try to sue outside of vaccine court, but their case may decide how the cases of hundreds of other families suing vaccine manufacturers proceed.
Their daughter, Hannah Bruesewitz, was 6 months old in 1992 when she received her third scheduled dose of the whooping cough-tetanus-diphtheria (DTP) childhood vaccine. Soon after, doctors diagnosed her with a seizure disorder, developmental problems and encephalopathy, a condition that can lead to permanent brain damage according to a bulletin hosted by Cornell University Law School.
When the vaccine court ruled DTP vaccine did not cause Hannah's medical conditions, the Bruesewitz family brought a civil case against vaccine-maker Wyeth on the grounds that their vaccine was defective by design. The vaccine court is officially known as the Office of Special Masters, and was established within the U.S. Court of Federal Claims.
Wyeth countered that the family had no right to sue outside vaccine court on grounds of a defect in vaccine design, and the 3rd U.S. Circuit Court of Appeals agreed.
The American Academy of Pediatrics (AAP) says if the Supreme Court reverses the decision, it will flood civil courts with expensive lawsuits that may put the nation's supply of childhood vaccines at risk.
"We very much wanted to make sure vaccine manufacturers are out of the line of lawsuits," said Dr. O. Marion Burton, president of the AAP. "Otherwise, we end up with nobody producing vaccines, and nobody making new vaccines."
However, vaccine injury lawyers say if the court finds in favor of Wyeth (now owned by Pfizer, Inc.), the decision will block crucial lawsuits that could reveal unknown risks of vaccines.
"It would be a pretty narrow exception it really narrows the scope of what you can bring out of the vaccine court," said Jennifer Maglio, an attorney with Maglio Christopher Toale & Pitts, a Sarasota, Fla., firm that specializes in vaccine injury cases. Maglio said a ruling in favor of Wyeth would limit civil lawsuits to rare situations where the design of a vaccine was not in question. For example, cases in which the manufacturer allegedly mislabeled the vaccine, or contaminated it.
The creation of vaccine court
In the early 1980s, a high volume of vaccine injury cases with large settlements had pushed vaccine makers out of business. Only one manufacturer of DTP remained, and it threatened to stop production, according to a letter published in 2007 in the New England Journal of Medicine.
In response, Congress created NCVIA and the new "vaccine court," which had no jury, no-fault decisions and fewer requirements to prove injury than in civil court.
Instead of relying on juries and the wide range of rulings inherently possible with juries the vaccine court turns to the official Vaccine Injury Table of known side effects from medical literature to decide if the vaccine caused the injury.
The court may add or remove complications from the Vaccine Injury Table if emerging research reveals a condition is or is not connected to vaccines.
By the time Hannah Bruesewitz appeared before the vaccine court, her complications had been removed from the Vaccine Injury Table.
"When it [DTP] went out in 1982, there was a one-hour documentary that made that [the Bruesewitz'] claim," said Dr. Paul Offit, who is chief of Infectious Diseases at Children's Hospital of Philadelphia. "It scared a lot of people, including doctors."
Offit said 10 years of research showed no link between DTP and conditions like the ones Hannah Bruesewitz experienced.
What a change would mean
If the Supreme Court decides in favor of the Brueswitzes, families bringing lawsuits could sidestep the vaccine court. This means the cases would be decided by a jury, and would not be held to the standards set by the Vaccine Injury Table.
"But you can imagine how sympathetic a jury would be, even if the medical literature said the opposite," said Offit.
Offit pointed to the example of Bendectin, a morning sickness pill that was taken off the U.S. market after high-cost civil lawsuits alleged the drug caused birth defects. The drug is still used in Canada, and medical literature has not shown it to cause birth defects.
However, Maglio points to Vioxx as a counter example.
Merck removed its popular pain reliever Vioxx from the market in 2004, because it was found to the increase risk of heart attacks . Maglio said civil lawsuits were crucial to uncovering the side effects.
"It really wasn't until people sued that all those studies were released," Maglio said.
Maglio worries the same opportunity for the "discovery" of complications from new vaccines such as Gardasil will disappear if the court finds in favor of Wyeth.
"Because of the way the vaccine court is set up, there is no time for 'discovery,'" Maglio said.