Three federal appellate judges from the Tenth Circuit heard oral arguments on March 9 in TMJI’s appeal of $340,000 in civil money penalties for not filing MDRs for 17 events. They seemed skeptical of HHS and FDA processes that led to the case. All Republican appointees in the Denver-seated courthouse, they asked nearly three times as many questions of the Department of Justice attorney, Peter Maier, as they did of the company’s attorney, Lynn Watwood. Senior judge and Reagan appointee David Ebel was concerned about the due process FDA had afforded the company. He observed that 21 CFR Part 10 does not preclude the agency from proceeding with an enforcement action during an appeal, but noted that it does not authorize progression of such an action to imposition of civil money penalties. In questioning Watwood, Judge Ebel wanted to know how TMJI had “read into” a letter from CDRH director Daniel Schultz that a pending appeal meant no enforcement action. Reagan appointee Deanell Reece Tacha asked whether TMJI had been lulled into complacency by the letter it received from Schultz, which stated that its protests were being treated as an appeal and being handled by the Office of the Commissioner. Maier retorted: “To their peril!” Watwood responded that the earlier warning letter TMJI had received demanding the MDRs came from “a lower branch, i.e., CDRH. It was only an opinion from that lower branch and not final disposition of that dispute.” FDA has repeatedly argued in previous cases that appeals can only be disposed of by the commissioner. Watwood further stated that, consistent with FDA’s position in earlier court cases, Schultz had said that he would personally treat further communication by TMJI as an appeal to the commissioner for his ruling. However, Watwood said, the record shows that before the commissioner could rule on the appeal, the company was served with the civil money penalties order. —James G. Dickinson