Wednesday, October 6, 2010

The Supreme Court may tell families with autistic children whether they can sue vaccine makers

When Yates Hazlehurst got the measles, mumps and rubella vaccine in February 2001, three days before his first birthday, he had just begun to talk, uttering words like Mama, Dada and please.

Within a few months, Yates stopped speaking—in words, anyway—and instead became obsessed with numbers and letters. He also stopped looking people in the eye. And he developed physical ailments, including severe stomach problems and recurrent infections. He also became so rambunctious that his family started restraining him with a harness.

The changes alarmed Yates’ mother, though his father initially took it all in stride. “I thought, ‘Boys will be boys; he’s fine,’” recalls Rolf Hazlehurst, an assistant district attorney in Jackson, Tenn.

Eventually, however, when Yates started hitting his head against the wall, Rolf couldn’t deny something was wrong. “He had become a wild, uncontrollable maniac,” he says.

Yates now requires intensive therapy. He talks only in one-word commands. Yates’ mother, Angela, quit her job as a sales rep for GlaxoSmithKline to take care of him. The Hazlehursts recently sold their house, downsizing from 4,400 square feet to 2,000 to pay the growing medical bills.

Out-of-pocket expenses for Yates’ treatment, including speech therapy and behavioral therapy, have totaled $250,000, his father estimates. Only four people can calm Yates when he has an outburst: Rolf, Angela, her mother and one baby sitter.

When Yates was still younger than 2, the family sought medical help from a battery of doctors, including a neurologist, Dr. Jean-Ronel Corbier of Concord, N.C. He diagnosed Yates as suffering from “regressive autism”—a form of autism that doesn’t manifest itself until after a child’s first birthday.

Corbier also proposed a controversial theory about what caused Yates’ condition: the measles, mumps and rubella vaccine. A battery of tests had ruled out known genetic causes or structural defects that can cause autism. He said that the measles virus was present in Yates’ gut.

Yates, Corbier would later testify, would not have developed autism had he not received the MMR vaccine.

His family filed a claim in 2003 with the Office of Special Masters of the U.S. Court of Federal Claims, known as the “vaccine court,” which compensates families whose children have been injured by vaccines.

A report in the late 1990s suggested a link between autism and vaccines. The Hazlehursts were among more than 5,000 parents of autistic children to bring cases in the vaccine court since 1999 alleging that their children developed autism as a result of vaccines. An additional 350 cases are believed to be pending in civil courts throughout the country.

They began to see vaccines as the potential next big toxic-tort battleground, on the order of Vioxx or asbestos. The cases drew the attention of toxic-tort lawyers from around the country, including the likes of Kevin Conway —one of the plaintiffs lawyers depicted in the movie A Civil Action.

But the vaccine court rejected the plaintiffs’ medical theories and threw out all of the omnibus cases in six separate rulings issued in February 2009 and this past March. The Hazlehursts and a second family, the Cedillos of Yuma, Ariz., appealed to the U.S. Court of Appeals for the Federal Circuit, which rejected both of their claims this year. The families are now considering going to civil court.

Standing in the way, however, is the U.S. Supreme Court, which will decide a case this term on whether the 1986 federal National Childhood Vaccine Injury Act, which created the special vaccine court, pre-empts their claims. Argument in Bruesewitz v. Wyeth is scheduled for Oct. 12.

The 3rd U.S. Circuit Court of Appeals upheld the dismissal of a lawsuit against drugmaker Wyeth by the family of Hannah Bruesewitz, who experienced seizures after receiving a DPT (diphtheria-pertussis-tetanus) shot at age 6 months in April 1992. Hannah’s doctors said she had residual seizure disorder and developmental delay.

The Bruesewitz family brought a claim in vaccine court in April 1995, alleging that Hannah had suffered residual seizure disorder and encephalopathy after receiving the DPT vaccine. When the vaccine court was first launched, residual seizure disorder was considered a “table injury”—meaning it was on the table of injuries listed as caused by the DPT vaccine.

But the injury was deleted from the table by regulations effective March 10, 1995—one month before the family’s petition.

The vaccine court ruled that the Bruesewitzes hadn’t proved the shot caused Hannah’s injuries and dismissed the petition. The family then refiled in Philadelphia Common Pleas Court in October 2005, alleging several theories, including negligent failure to design a safer vaccine. The suit was later moved to federal court.

Eventually the Philadelphia-based 3rd Circuit said the federal law creating the vaccine court pre-empted all civil actions alleging design defects—including those that resulted from negligence.

The Bruesewitz family argues that the statute itself only discusses pre-emption of unavoidable design defects, not negligent ones. The statute says that vaccine manufacturers shall not be liable in civil actions “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 also sought Supreme Court review and, in its petition, specifically warned that a wave of autism claims could hit the courts unless the 3rd Circuit opinion is upheld. “Today, a new litigation threat to the nation’s vaccine supply exists,” Wyeth wrote, referencing not only the 5,000 autism cases in vaccine court but also the 350-plus civil actions in various federal and state courts.

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