Brodie v. United States Department of Health and Human Services

District Court, District of Columbia·Decided June 4, 2010·No. Civil Action No. 2010-0544·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

)

SCOTT J. BRODIE, )

)

Plaintiff, )

)

v. ) Civil Action No. 10-0544 (PLF)

)

UNITED STATES DEPARTMENT OF HEALTH ) AND HUMAN SERVICES, et al., )

)

Defendants. )

__________________________________________)

OPINION

In January 2010, an administrative law judge in the Department of Health and Human Services (“HHS”) issued a decision in which he found that plaintiff Dr. Scott J. Brodie had committed serious scientific misconduct and should be barred from participating in programs or projects funded by the federal government for seven years. Proceeding under the Administrative Procedure Act, 5 U.S.C. §§ 701 et seq., Dr. Brodie has moved for a preliminary injunction that would stay his debarment pending the ultimate outcome of this action. The Court heard oral argument on the plaintiff’s motion on June 3, 2010. After careful consideration of the parties’ arguments and the relevant legal standards, the Court will deny the motion for a preliminary injunction.1

1 The papers reviewed by the Court include the following: plaintif’s complaint (“Compl.”); plaintiff’s motion for a preliminary injunction (“Mot.”); defendant’s opposition to the plaintiff’s motion (“Opp.”); plaintiff’s reply to defendant’s opposition (“Reply”); Mot., Ex. 1 (Recommended Decision Granting Summary Disposition to the Office of Research Integrity) (“R.D.”); and the affidavit of Scott J. Brodie (attached to plaintiff’s motion for a preliminary injunction) (“Brodie Affid.”).

I. BACKGROUND

A. Debarment Proceedings at HHS The Public Health Service (“PHS”), a major division of the Department of Health and Human Services, provides grants and other support “for biomedical [and] behavioral research,” training, and “activities related to that research or research training.” 42 C.F.R. § 93.100(b) (2009). HHS regulations provide that “[r]esearch misconduct involving PHS support is contrary to the interests of the PHS and the Federal government and to the health and safety of the public, to the integrity of research, and to the conservation of public funds.” Id. § 93.100(a). To facilitate the identification, sanction, and prevention of research misconduct, HHS has promulgated regulations that require institutional recipients of PHS funding to investigate and report allegations of misconduct by their own employees. See generally 42 C.F.R. §§ 93.100-.319 (2009); 42 C.F.R. §§ 50.101-.105 (2004).2 Institutions that receive PHS funding are required to report the results of their investigations into alleged misconduct to the Office of Research Integrity (“ORI”), an office within HHS. See 42 C.F.R. §§ 93.313, 93.315 (2009); 42 C.F.R. § 50.104 (2004). ORI may then review the case and make its own independent determination as to whether misconduct occurred. 42 C.F.R. §§ 93.403-.404 (2009). If the office does conclude that a researcher committed misconduct, it notifies the researcher by sending him a “charge letter” in which it describes the

2 HHS considerably expanded its regulations governing institutional monitoring and reporting of internal research misconduct in 2005. See 70 Fed. Reg. 28, 370-400 (May 17, 2005). Because periods of time occurring before and after 2005 are relevant to this case, citations to both the pre- and post-2005 sets of regulations are provided where appropriate. Where a citation to the Code of Federal Regulations does not specify a year of publication, it refers to the 2009 version of the Code.

misconduct found and the sanctions proposed, which may consist of “debarment or suspension” — “the Government wide exclusion, whether temporary or for a set term, of a person from eligibility for Federal grants, contracts, and cooperative agreements under the HHS regulations [for procurement and nonprocurement].” Id. §§ 93.205, .405. The researcher may contest the charges of misconduct by requesting a hearing before an administrative law judge (“ALJ”). See 42 C.F.R. §§ 93.501-.523.

Once the ALJ is prepared to render a decision on the merits of the misconduct charges, he must issue a ruling in writing, which “constitutes a recommended decision to the Assistant Secretary for Health.” 42 C.F.R. § 93.522. The Assistant Secretary may then, after review of the decision, approve, reject, or modify it. Id. If the Assistant Secretary determines that misconduct was committed and decides to order suspension or debarment as a sanction, his or her decision is transmitted to a “debarring official.” Id. That “decision . . . constitute[s] findings of fact [for] the debarring official,” who then makes a final decision regarding debarment or suspension. Id. “The decision of the debarring official . . . is the final HHS decision on those administrative actions.” Id.

B. Dr. Brodie’s Disbarment Proceedings From at least 1999 through 2002, Dr. Brodie performed medical and scientific research at the University of Washington (“UW”). Compl. ¶¶ 8-9. In 2002, UW began investigating Dr. Brodie to determine whether he had committed research misconduct between 1999 and 2001. Id. ¶ 9. In 2003, UW issued a report in which it concluded that Dr. Brodie had

committed misconduct; the university subsequently notified Dr. Brodie that he was “‘banned from future employment at UW.’” Id. ¶ 16.

Although UW apparently concluded its investigation of Dr. Brodie by 2004, several years elapsed before ORI took any action against him. On September 17, 2008, ORI sent him a charge letter, informing him that the agency had determined that he had engaged in research misconduct and intended to debar him from conducting research supported by PHS funds for a period of seven years. Compl. ¶ 17. Dr. Brodie notified ORI that he would contest the decision and requested a hearing. Id. ¶ 18. After an ALJ was assigned to the case, ORI moved to dismiss Dr. Brodie’s hearing request. Id. ¶ 27. That motion was granted in part and denied in part. Id. ¶ 29. Specifically, the ALJ determined that Dr. Brodie had raised no triable objections to ORI’s charges that he had submitted grant applications, articles, and other documents containing “materially false statements and data”; according to the ALJ, the doctor had certainly done so. Id. The ALJ also concluded, however, that Dr. Brodie had “raised a triable issue concerning his intent in submitting or publishing the documents and presentations containing the false statements and data.” Id.

The parties then began to prepare for a hearing on that second issue — Dr.

Brodie’s mens rea with regard to the falsifications contained in documents he had authored. Prior to the hearing date, on November 10, 2009, ORI moved for summary disposition of Dr. Brodie’s case, contending that the evidence gathered by the parties supported only one reasonable inference with regard to Dr. Brodie’s state of mind: he had “intentionally, knowingly or recklessly submitted or published or caused the submission or publication of the materially false information” contained in the documents he had authored. Compl. ¶¶ 34, 42.

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