Revolving Door Informal Admonition
The District of Columbia Disciplinary Counsel has issued an informal admonition for a former federal government attorney’s revolving door ethical violation.
The attorney did not “switch sides.” Rather, the representation was adverse to the subject of her investigation as a public employee.
From the admonition
You were employed as Associate Chief Counsel for the Food and Drug Administration’s Office of Chief Counsel between 2004 and 20 l 0. In late 2005, you were assigned to work on an investigation of Ranbaxy Laboratories, LTD., a generic drug manufacturer. You participated personally and substantially in that investigation from 2005 to 2008. One of your assignments was to assist in the drafting of an affidavit in support of a search warrant of Ranbaxy. The affidavit contained specific, detailed allegations from multiple informants concerning Ranbaxy’s fraudulent conduct in manufacturing and testing generic drugs and filing falsified Abbreviated New Drug Applications (ANDAs) with FDA. You attended frequent meetings with law enforcement agents and government lawyers involved in the investigation.
The search warrant was executed in 2007, and you were involved in reviewing the seized documents, which amounted to more than 400 boxes. These documents confirmed information from informants that certain Ranbaxy facilities had falsified data in the submitted ADAs.
Then
In 2008, you were reassigned to other matters. In 2010, you left FDA, and in 2011, you joined the law firm, Hyman, Phelps & McNamara.
After your departure from FDA, the investigation of Ranbaxy was resolved with a Consent Decree of Permanent Injunction, a guilty plea, and the settlement of a False Claims Act civil complaint. You had no involvement in the resolution of the investigation. The Consent Decree was entered into in January 2012. It required Ranbaxy to withdraw certain ANDAs that were premised on false data and to relinquish market exclusivity, based upon first-to-file status, for the generic products that had been approved as a result of those ANDAs. The Consent Decree exempted certain AND As from this requirement, and the identity of these drugs were filed under seal and not otherwise made public. The exempted drugs included Varsartan, Esomeprazole Magnesium, and Valganciclovir Hydrochloride.
On May 5, 2014, you signed a Citizen Petition to FDA on behalf of an anonymous competitor of Ranbaxy. You participated in the drafting of this document, particularly the factual part, which set forth the facts and history of Ranbaxy’s fraudulent conduct. The petition requested FDA to determine that Ranbaxy was not eligible for first-to-file market exclusivity and to revoke pending ANDAs for Valsartan, Esomeprazole Magnesium, and Valganciclovir Hydrochloride, three of the products that had been exempted, under seal, from the Consent Decree. The petition further asked FDA to approve ANDAs for these drugs from Ranbaxy’s competitors. The basis for these requests was Ranbaxy’s fraud, and the petition criticized the Consent Decree as inadequate. The petition asserted “upon information and belief’ that Ranbaxy’s ANDAs for these three drugs had relied on data from one of the facilities that was shown to have generated falsified data in FDA’s investigation.
…We find that your participation in drafting the Citizen Petition was substantially related to your participation in the criminal investigation of Ranbaxy.
Disciplinary Counsel’s analysis
You have said that because of the passage of time, you no longer remembered in 2014 any confidential information that you might have learned during the investigation of Ranbaxy, where your involvement ended in 2008. Moreover, you took the precaution of having a paralegal gather only publicly-available information about Ranbaxy and the investigation, and you wrote the factual part of the petition based only on that public information. (The statement in the petition based on information and belief as to the origin of data in support of certain ANDAs was not based on the readily available public information. You have told us, however, that your client and others in your firm ascertained this information and were the sources for its inclusion in the Citizen Petition.) You also evaluated and sought advice from others within your firm about whether your work on the Citizen Petition would be substantially related to your work on the criminal investigation at FDA and believed in good faith that it was not. We do not dispute your statements in this regard. Rule l. ll(a), however, is a prophylactic rule, intended to prevent any possibility that former government lawyers will use information they learned while representing the government to benefit private clients. It does not require a showing that you actually used confidential information learned during your government employment in private practice…
The case is In re Anne K. Walsh, Docket No. 2015-D248 and can be accessed through this link. (Mike Frisch)