WASHINGTON (AP) — The Supreme Court is trying to sort out whether drug
companies can be sued for claims of serious side effects from childhood vaccines without driving vaccine makers from the market and risking a public health
The court heard arguments Tuesday in an appeal filed by Pittsburgh-area
parents who want to sue drug maker Wyeth, which is owned by Pfizer Inc., for the
health problems they say their 18-year-old daughter suffered from a vaccine she
received in infancy.
Several justices appeared sympathetic to the parents’ plea to be allowed to
make their case in court.
Wyeth, backed by the Obama administration and many public health groups,
argued that Congress shielded drug companies from most vaccine lawsuits when it
created a special vaccine court 24 years ago to handle the claims.
But if lawmakers wanted to prevent lawsuits like the one at issue Tuesday,
“they could have said simply that no vaccine manufacturer may be held civilly
liable if the vaccine is properly prepared and accompanied by proper directions
and adequate warnings,” Justice Ruth Bader Ginsburg said.
On the other hand, Chief Justice John Roberts said, it could be argued “that
because they set up a compensation scheme, that was a good sign that they didn’t
want to allow state law claims.”
The vaccine court has paid out more than $1.9 billion to more than 2,500
people who claimed a connection between a vaccine and serious health problems.
The court has dismissed more than 5,000 other claims and has another 5,000
pending, mostly alleging links between vaccines and autism.
Justice Stephen Breyer sketched the argument made in court papers by
pediatricians, other doctors and public health organizations that if the drug
companies lose, judges and juries will be making decisions about vaccines,
instead of the Food and Drug Administration. “The result could well be driving
certain vaccines from the market, and basically, a lot of children will die,”
David Frederick, the lawyer for the parents, tried to assure the court that
most people still would accept decisions by the vaccine court because of the
time and cost of filing lawsuits.
But the drug companies say drug makers could face a flood of lawsuits over
the side effects of vaccines in the event of an unfavorable Supreme Court
decision. Among the claims would be those from families of autistic children who
say the vaccines, or mercury-based thimerosal that once was used to preserve
them, are linked to autism. Numerous studies have addressed vaccines and autism
and found no link, including with the preservative.
“That is 5,000 potential claimants in state court,” said Kathleen Sullivan,
Wyeth’s lawyer at the Supreme Court. Sullivan said Congress set up the vaccine
court as a way to keep companies making enough vaccines for American
But Frederick said Congress did not explicitly rule out the kind of lawsuit
Russell and Robalee Bruesewitz filed against Wyeth, asserting that the company
was slow to move ahead with a safer vaccine because it would not be as
profitable. Frederick said the threat of such claims would motivate drug
companies to introduce safer vaccines more quickly.
“We’re talking about trying to eliminate the most horrifying and horrible
incidents of injury from vaccines that we compel children to take,” Frederick
A federal trial judge and the Philadelphia-based 3rd U.S. Circuit Court of
Appeals ruled in favor of Wyeth.
According to the lawsuit, Hannah Bruesewitz was a healthy infant until she
received the diphtheria, tetanus and pertussis vaccine in April 1992. Within
hours of getting the DPT shot, the third in a series of five, the baby suffered
a series of debilitating seizures. Now a teenager, Hannah suffers from residual
seizure disorder, the suit says.
The vaccine court earlier rejected the family’s claims. But Frederick said
the rules of the vaccine court, unlike traditional courts, restrict the kind of
information plaintiffs can seek from the drug companies.
Justice Elena Kagan did not take part in the argument because of her work on
the case while she served as a top Justice Department official.