The safety of vaccines is at the heart of a case expected to be heard on Tuesday by the United States Supreme Court, one that could have implications for hundreds of lawsuits that contend there is a link between vaccines and autism.
At issue is whether a no-fault system established by Congress about 25 years ago to compensate children and others injured by commonly used vaccines should protect manufacturers from virtually all product liability lawsuits. The law was an effort to strike a balance between the need to provide care for those injured by vaccines, some of them severely, and the need to protect manufacturers from undue litigation.
Under the 1986 National Childhood Vaccine Injury Act, such claims typically proceed through an alternative legal system known as “vaccine court.” Under that system, a person is compensated if their injury is among those officially recognized as caused by a vaccine. That person, or their parents, can choose to reject that award and sue the vaccine’s manufacturer, but they then face severe legal hurdles created by law to deter such actions.
The case before the Supreme Court is not related to autism. But the biggest effect of the court’s ruling, lawyers said, will be on hundreds of pending lawsuits that contend a link exists between childhood vaccines and autism. Repeated scientific studies have found no such connection.
Also, in several test case rulings over the last two years, administrative judges in vaccine court have held that autism-related cases did not qualify for compensation. During the last decade, about 5,800 of the 7,900 claims filed in vaccine court, or about 75 percent, have been autism-related, federal data show.
Federal data shows that $154 million was paid in fiscal 2010 to 154 claimants involved in vaccine court proceedings. That figure was significantly higher than in preceding years and reflected several unusually high awards, officials involved in the program said.
In the five preceding fiscal years, an average of $68 million in compensation was paid out on an annual basis, federal data indicates. A compensation fund is financed by an excise tax on vaccinations.
The case to be heard on Oct. 12 involves an 18-year-old woman, Hannah Bruesewitz (pictured), who suffered seizures when she was 6 months old and subsequently suffered developmental problems, her parents say, after receiving a type of D.T.P. vaccine that is no longer sold. The D.T.P. vaccine protects against three potentially deadly childhood diseases: diphtheria; pertussis, which is also known as whooping cough; and tetanus.
Ms. Bruesewitz’s parents have contended in court papers that the vaccine’s manufacturer, which is now a part of Pfizer, knew at the time that their daughter was immunized that there was a safer version of the D.T.P. vaccine but did not produce it. The company rejected that contention
Initially, Ms. Bruesewitz’s parents brought a claim on her behalf to the vaccine court, but the severe injuries that she reportedly suffered were removed from the list of those that qualified for compensation a month before the case was heard. An administrative judge in vaccine court subsequently rejected her claim, so her parents filed a product liability lawsuit against Wyeth, a Pfizer unit that had acquired the vaccine’s manufacturer, Lederle Laboratories.
Lower court judges have ruled that her claims are barred by the federal Vaccine Act. As a result, Ms. Bruesewitz, who lives with her family in Pittsburgh and requires specialized care, has not received any compensation, her father, Russell Bruesewitz, said in a telephone interview.
“The cost of her care is an ongoing burden,” Mr. Bruesewitz said.
The Supreme Court review revolves around the narrow question of whether Congress in passing the Vaccine Act intended to bar lawsuits against vaccine manufacturers based on so-called design defect claims. A vaccine design defect claim essentially asserts that the manufacturer should have sold a different vaccine, which plaintiffs say would have been safer than the one used.
Those filing briefs arguing that Congress intended to permit such lawsuits include the American Association for Justice, a plaintiffs’ lawyers group, and the National Vaccine Information Center, an advocacy group.
Those filing briefs arguing that Congress intended to bar them include the solicitor general of the United States, the Chamber of Commerce and several professional medical groups, including the American Academy of Pediatrics.
James M. Beck, a lawyer in Philadelphia who defends makers of drugs and medical devices, said in a phone interview that a ruling in favor of the Bruesewitzes would allow hundreds of lawsuits asserting a link between vaccines and autism to go forward.
“If these cases go forward, it will make it economically unfeasible for anyone to make vaccines in this country,” said Mr. Beck.
Mr. Bruesewitz said that he and his wife were not opposed to vaccination. Instead, he said they pressed his daughter’s claim because he thought that vaccine producers needed to face the threat of litigation to produce safer medications.
“What we want and are concerned about is to make sure that the safety of vaccines in this country is constantly enhanced,” Mr. Bruesewitz said.
Tuesday, October 12, 2010
The NY Times:
Posted by BA Haller at 9:29 AM