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Thursday, July 2, 2009

Federal Circuit Reverses Denial of Vaccine Injury Claim

Sheri Qualters
The National Law Journal
June 26, 2009

A recent U.S. Court of Appeals for the Federal Circuit decision reversing the U.S. Court of Federal Claims' denial of a vaccine injury claim highlights the widening gulf between the Federal Circuit and Federal Claims court on vaccine cases.

On June 18, the Federal Circuit reversed the Federal Claims court's decision to deny the petitioner compensation under the National Vaccine Injury Compensation Program. The Federal Circuit case, brought on behalf of Enrique Andreu, alleged that he began having seizures the day after receiving a diphtheria, whole-cell pertussis and tetanus (DPT) vaccine at the age of eight weeks. According to the case, the seizure disorder ultimately led to a low IQ and language and developmental delays. Andreu v. Secretary of Health and Human Services, No. 2008-5184 (Fed. Cir.).

The vaccine compensation program is a no-fault system for injury claims from a variety of vaccines. The U.S. Department of Health and Human Services administers the program with the U.S. Department of Justice and the U.S. Court of Federal Claims in Washington. Special masters hear cases filed at the Federal Claims Court, but either side can appeal rulings to the court and ultimately to the Federal Circuit.

The Federal Circuit ruling in the Andreu case comes in the wake of the special masters' initial rejection of claims in three test cases, in an omnibus proceeding of more than 5,000 cases. The cases claim that the measles, mumps, rubella (MMR) vaccine and a vaccine containing mercury in the preservative thimerosal caused autism, whether administered separately or simultaneously.

Oral arguments for two of those appeals are slated for July, and one wrapped up earlier this month.

The Federal Claims court has yet to rule on three other test cases involving autism injury claims.

The Andreu case, authored by Circuit Judge Haldane Robert Mayer, said that the special master's decision is inconsistent with two previous Federal Circuit rulings: Althen v. Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005); and Capizzano v. Secretary of Health and Human Services, 440 F. 3d 1317 (Fed. Cir. 2006).

Mayer wrote that "three fundamental errors infected the special master's decision" to deny compensation. Mayer cited the special master's ruling that the doctor's testimony was insufficient to establish a causal link between the vaccine and seizures, her requirement that the claimant's injury find proof in medical literature and her conclusion that the claimant's "clinical picture" didn't show a link between the seizures and vaccine.

The decision affirms that the special master can't require too high of a burden of proof from plaintiffs because it's a remedial compensation program, said Cliff Shoemaker of Vienna, Va.-based Shoemaker & Associates, who represented the injured party who appealed to the Federal Circuit.

"It's a no-fault compensation program designed to compensate people injured by vaccines," he said. "But it's a very adversarial and litigious [process involving] complex litigation. It's not what Congress intended."

The Justice Department represented the Health and Human Services secretary in the case, and spokesman Charles Miller said the agency declined to comment.

The special masters are very protective of vaccines and "require too much science to prove a case," said vaccine lawyer Kevin Conway of Boston-based Conway, Homer & Chin-Caplan.

"It's seems that petitioners have to go all the way to the Federal Circuit to get relief," Conway said. "[The ruling is] again saying you don't need scientific certainty to prove the case. You need legal evidence."

Conway's firm is handling two out of three autism test cases.

The Andreu case "does give us hope" that the special masters will be more receptive to claims in the future, Conway said.

The standards laid out in prior cases are particularly important in DPT cases because residual seizure disorder is no longer on the Vaccine Injury Table, but claimants can make causation in fact claims, said Robert J. Krakow, a Garden City, N.Y., lawyer, who has a vaccine injury specialty. The Vaccine Injury Table lists medical conditions and injuries that the compensation program assumes are caused by vaccines, and a time period after the vaccine when the condition must appear in order for the claimant to collect compensation.

"You have to prove a medical theory causally connected to the vaccine and the injury, but it doesn't have to be accepted as proven, and you don't have to reach scientific causality," Krakow said. "It's a legal definition of causation. You have to prove that the medical theory is plausible."

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