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Brodie v. United States Dep't of Health and Human Services

June 4, 2010


The opinion of the court was delivered by: Paul L. Friedman United States District Court


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.*fn1


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).*fn2

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 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 Disbarrment

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.

The ALJ agreed with ORI. He examined in detail the falsified information contained in Dr. Brodie's documents and concluded that "there are only two reasonable inferences that I can draw from Respondent's systematic publication of false or fabricated information. Either he published information that he knew to be false or fabricated, or he published it with indifference to the truth of its contents. The sheer volume and pattern of false items that [Dr. Brodie] published or attempted to publish lead inescapably to my conclusion that [he] had contempt for the truth." R.D. at 8-9. In support of that conclusion, the ALJ examined in detail numerous instances in which Dr. Brodie had published or submitted for publication documents containing obviously falsified images (often called "figures") or other data. For example, the ALJ found that the evidence showed conclusively that, in a grant application, Dr. Brodie had included a figure purporting to represent tissue from the "lingual tonsil." Id. at 15. Elsewhere in the same application appeared the exact same figure, inverted and with selected data removed. Id. at 15-16. In that instance, the figure was labelled as "rectal mucosa" - an entirely different source of tissue. Id. at 16. The ALJ rejected Dr. Brodie's explanation that this circumstance was merely the product of "error," concluding that the contradictory uses to which the figure was put constituted "such an obvious fabrication that [Dr. Brodie] could only have made it deliberately or used the falsified image with reckless disregard for the truth or falseness of what he published." Id.

The ALJ reached the same conclusion with regard to numerous other similar circumstances: again and again, he pointed out that in one document, Dr. Brodie had labeled a figure in a certain way, while in other documents, he had given the same figure or a slightly altered version of it a contradictory label. See, e.g., R.D. at 13-14 (same image described as representing cells at 97.7 percent purity or cells at 99.7 percent purity); id. at 15 (figure described as "lymphoid tissue from pediatric lung" in one document, but as tissue from "lingual tonsil" in another). Dr. Brodie's defense as to each incident was the same. He claimed that the inconsistent use of the images was accidental, or that someone else had altered/falsified the image in question and given him the description of it, and that he was unaware that the description or depiction of data was inaccurate. See, e.g., id. at 13-16. The ALJ rejected this defense, finding that even if Dr. Brodie had not altered the images or their descriptions himself, he was culpable for their inclusion in his papers because the images were "palpably false." Id. at 18. Given the obvious inconsistencies in the manner in which the images appeared and were described, Dr. Brodie must have known, at the very least, that they might have been false. With regard to one figure, for example, the ALJ concluded that he could reach only one conclusion: "Either [Dr. Brodie] personally altered the figure, or he submitted the figure without verifying its truthfulness." Id. at 14.*fn3

Ultimately, the ALJ concluded that "[t]he undisputed facts establish this to be an extremely serious case of misconduct" and that Dr. Brodie had "committed research misconduct on a grand scale by publishing or attempting to publish false and fabricated images and information in numerous documents." Id. at 27. In light of those conclusions, the ALJ determined that debarment for seven years was a "reasonable remedy" for Dr. Brodie's misconduct, and he recommended that remedy to the HHS debarring official. Id. at 27.

Dr. Brodie initiated this lawsuit on April 2, 2010. On some unknown date, but not later than April 19, 2010, his name was "placed in the General Services Administration's [Excluded Parties List System ("EPLS")] database," in which Dr. Brodie is identified as a person debarred from engaging in any transactions with a federal agency for committing one or more of a variety of forms of misconduct. Mot. at 7 & n.1. Dr. Brodie moved for a preliminary injunction preventing his debarment and requiring the removal of his name from the EPLS database on April 28, 2010. On May 5, 2010, a notice announcing Dr. Brodie's debarment and describing the fifteen specifications of research misconduct adjudicated against him was published in the Federal Register. 75 Fed. Reg. 24,703, 24,703-704 (May 5, 2010).


A preliminary injunction is "an extraordinary remedy that should be granted only when the party seeking the relief, by a clear showing, carries the burden of persuasion." Chaplaincy of Full Gospel Churches v. England, 454 F.3d 290, 297 (D.C. Cir. 2006) (quoting Cobell v. Norton, 391 F.3d 251, 258 (D.C. Cir. 2004)) (internal quotation marks omitted). To warrant preliminary injunctive relief, the moving party must show: (1) that there is a substantial likelihood that he will succeed on the merits of his claim, (2) that he will suffer irreparable injury in the absence of an injunction, (3) that an injunction would not substantially harm the defendants or other interested parties (balance of harms), and (4) that the public interest would be furthered, or at least not adversely affected, by the injunction. See id.; Davis v. Pension Benefit Guar. Corp., 571 F.3d 1288, 1291 (D.C. Cir. 2009); Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1317-18 (D.C. Cir. 1998).

The plaintiff is not required to prevail on each of these factors. Rather, these factors must be viewed as a continuum, with more of one factor compensating for less of another. Davis v. Pension Benefit Guar. Corp., 571 F.3d at 1291-92. "If the arguments for one factor are particularly strong, an injunction may issue even if the arguments in other areas are rather weak." CityFed Fin. Corp. v. Office of Thrift Supervision, 58 F.3d 738, 747 (D.C. Cir. 1995). An injunction may be justified "where there is a particularly strong likelihood of success on the merits even if there is a relatively slight showing of irreparable injury." Id. Conversely, when the other three factors strongly favor interim relief, a court may grant injunctive relief when the moving party has merely made out a "substantial" case on the merits. The necessary level or degree of likelihood of success that must be shown will vary according to the Court's assessment of the other factors. Washington Metro. Area Transit ...

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