Nathan House v. HHS - Hepatitis B, Crohn's disease (2013)

Nathan House was born on December 17, 1970, and has a family history of Crohn's disease and colon cancer. Prior to receiving hepatitis B vaccinations, he had experienced episodic symptoms of weakness, nausea, shakiness, vomiting, and diarrhea, but had never been formally diagnosed with Crohn's disease or irritable bowel syndrome.

Mr. House received his first hepatitis B vaccination on September 9, 1993, his second on October 22, 1993, and his third on February 24, 1994.

Within hours of the first vaccination he experienced chills, body aches, diarrhea, and cramping; two days later he reported these symptoms to his family physician, Dr. Thomas Devlin, who diagnosed him — for the first time — with irritable bowel syndrome.

Three days after the second vaccination he reported burning in his stomach, chest burning, and green bowel movements. After the third vaccination his symptoms were so severe that he could not go to work; he was fired on the spot.

His condition progressively worsened, and he was eventually referred to the Cleveland Clinic, where physicians diagnosed him with Crohn's disease. Multiple subsequent treating physicians — including gastroenterologists, colorectal surgeons, and hospital specialists — also confirmed the Crohn's diagnosis.

Mr. House filed a petition for compensation on June 28, 1999.

Record development was stayed in 2003 while the Office of Special Masters addressed hepatitis B causation issues in omnibus proceedings. The omnibus proceedings were discontinued in 2006, and development in Mr.

House's case resumed. After factual and expert hearings, Chief Special Master Patricia E.

Campbell-Smith denied compensation in a decision issued on March 3, 2011. Under the three-factor Althen test for off-table vaccine injuries, the Special Master found that petitioner had failed to establish any of the three required elements: (1) a medical theory causally connecting the vaccine to his injury; (2) a logical sequence of cause and effect; and (3) a proximate temporal relationship.

Petitioner filed a timely motion for review. Judge George W.

Miller, writing for the Court of Federal Claims on January 28, 2013, granted petitioner's motion for review, reversed the Compensation Decision, and remanded the case to the Special Master. The court found that the Compensation Decision had misapplied the law as to all three Althen factors.

On the third factor (temporal relationship), the court affirmed that petitioner had established it as a matter of law. The temporal connection between the three vaccinations and petitioner's symptoms was described by the court as "could scarcely be more stark" — symptoms arose within hours to three days after each dose, and petitioner was diagnosed with IBS for the first time in his life two days after his first vaccination.

On the first factor (biologically plausible medical theory), the court found that the Special Master had imposed an improperly elevated standard. The first factor requires only a "biologically plausible" theory showing that the vaccine can cause the type of injury alleged — it does not require, at the first-factor stage, proof that the vaccine was the specific but-for or substantial factor cause of petitioner's injury in this particular case.

The Special Master had conflated first-factor requirements with second-factor and overall causation burdens, and had also improperly required petitioner to rule out alternative causes as part of the first factor. On the second factor (logical sequence of cause and effect), the court found that the Special Master's analysis rested on an internally contradictory factual premise: the Special Master herself had found that petitioner suffered from "an extremely mild case of Crohn's disease," yet she relied on the absence of chronic gastrointestinal inflammation to undermine petitioner's causation theory.

A decision cannot rest on the notion that petitioner may not have the disease when the Special Master's own finding confirms that he does. The case was remanded to the Special Master for reconsideration of the first and second Althen factors under correct legal standards, with the direction that petitioner be evaluated under the confirmed premise that he has Crohn's disease.