A manufacturer of an electronic stimulation device for the treatment of arthritic knees submitted claims for the sale to or use of these devices by Medicare patients. The Department of Health and Human Services denied these claims and those denials were affirmed in ad hoc adjudicative proceedings and on review. The trustee of the manufacture’s bankruptcy estate sued to have the denials overturned. The district court affirmed the denials and the panel affirmed as well. It first held use of adjudicative proceedings instead of formal rulemaking was permissible and the choice was the Department’s to make. It next held the proper standard was used in the adjudicative process and the result was reasonable based on the lack of objective medical studies demonstrating safety and efficacy of the device. The panel also held FDA approval to market the device did not bind the department in its determination of safety and efficacy nor did initial approvals of some of the claims at lower levels of review.
Bauer sought an arrest warrant for Merchant charging impersonating an officer based on her comments and behavior during an interview in a parking lot. She told Bauer that she worked in the corrections department in a Maryland County and she had a badge in her pocket. After the case against merchant was dismissed for failure to prove the charge, Merchant sued for violation of her 4th Amendment rights. Bauer sought dismissal based on qualified immunity. The district court denied his motion and the panel affirmed. It held that under the facts, no reasonable officer would have concluded Merchant impersonated an officer and the right to be free from arrest without probable cause was clearly established when the warrant was sought. The panel noted that immunity could be available at trial if the jury accepted Bauer’s version of what he learned about the badge during his investigation.