Brodie v. United States Department of Health and Human Services

CourtDistrict Court, District of Columbia
DecidedJune 4, 2010
DocketCivil Action No. 2010-0544
StatusPublished

This text of Brodie v. United States Department of Health and Human Services (Brodie v. United States Department of Health and Human Services) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Brodie v. United States Department of Health and Human Services, (D.D.C. 2010).

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.

2 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

3 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.

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