In Althen v. Sec'y of HHS, a landmark decision by the Court of Appeals for the Federal Circuit, the Court lightened the burden of proof for petitioners in the Vaccine Program. Previously, the courts had described a petitioner's burden as "heavy lifting." However, the Court made clear a person need only show a vaccine was the likely cause of the injury. While expert testimony will still be necessary to prove a claim, the expert may base the opinion on circumstantial evidence, rather than direct, objective conclusive scientific evidence. A petitioner need only show: (1) a medical theory causally connecting the vaccine and the injury; (2) a logical sequence of cause and effect showing the vaccine is the reason for the injury; and (3) a proximate temporal relationship between the vaccine and the injury. Close questions of causation, the Court ruled, should be decided in favor of the petitioner.
Margaret Althen received a tetanus toxoid ("TT") vaccine. Shortly thereafter, she had the onset of symptoms of multiple sclerosis ("MS"). She believed the vaccine caused her MS. Margaret conceded that there are no scientific studies proving that TT can cause MS, but strongly believed the timing of the symptoms soon after the vaccine, and the elimination of other known causes of MS, showed in her case the vaccine was the culprit. So did Dr. Derek Smith, a professor of neuroimmunology at Harvard Medical School. At the hearing, Dr. Smith testified that the TT triggered Margaret's MS. He based his opinion on novel, but sound, theories of science that showed a possible mechanism as to how the vaccine may have caused Margaret's injury. The special master strongly disagreed, found Margaret's proof inadequate, and ruled against her. To prove her case, the special master believed Margaret had to show objective scientific proof that the TT caused her MS. At a minimum, the special master said, Margaret needed to show "general acceptance" in the medical community of the notion that TT can cause MS. Overruling the special master, the Court said he required too much evidence from Margaret. To be compensated, she did not need to show "general acceptance" by the medical community that TT causes MS. It was enough that the "timing" was right, that there was no other likely cause of her MS, and that she had the opinion of Dr. Smith.
Click here to view the Court of Appeals for the Federal Circuit Decision
