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BOIS v. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
DR. PHILIPPE BOIS, Plaintiff,
v.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants.
Civil Action No. 11-1563 (ABJ).
United States District Court, District of Columbia.
March 2, 2012.
PHILIPPE BOIS, Dr., Plaintiff, represented by Elizabeth Fletcher Getman, SANDLER, REIFF, YOUNG & LAMB, Bruce Singal, DONOGHUE BARRETT & SINGAL, P.C., Pro Hac Vice & Richard Goldstein, DONOGHUE BARRETT & SINGAL, P.C., Pro Hac Vice.
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendant, represented by Carl Ezekiel Ross, U.S. ATTORNEY'S OFFICE.
KATHLEEN G. SEBELIUS, Secretary of Health and Human Services, Defendant, represented by Carl Ezekiel Ross, U.S. ATTORNEY'S OFFICE.
HOWARD K. KOH, Assistant Secretary of Health and Human Services, Defendant, represented by Carl Ezekiel Ross, U.S. ATTORNEY'S OFFICE.
NANCY GUNDERSON, Deputy Assistant Secretary Office of Grants and Acquisition Policy and Accountability, Defendant, represented by Carl Ezekiel Ross, U.S. ATTORNEY'S OFFICE.
DONALD WRIGHT, Acting Director, Office of Research Integrity, Defendant, represented by Carl Ezekiel Ross, U.S. ATTORNEY'S OFFICE.
MEMORANDUM OPINIONAMY BERMAN JACKSON, District Judge. Plaintiff Philippe Bois, Ph.D. ("Dr. Bois") brought this action against the United States Department of Health and Human Services ("HHS") and a number of HHS officials in their official capacities. Dr. Bois was debarred for three years from contracting, subcontracting, and conducting non-procurement transactions with the federal government after HHS found that he had committed scientific misconduct, and an administrative law judge ("ALJ") denied his request for a hearing on the findings. He now alleges that the ALJ's decision violated the Administrative Procedure Act ("APA") and the Fifth Amendment to the Constitution of the United States. Plaintiff moved for a preliminary injunction, which the Court consolidated with the merits under Fed. R. Civ. P. 65 on September 2, 2012. [Dkt. # 3]. Defendant was directed to file a combined motion for summary judgment and opposition to the preliminary injunction, which it did. [Dkt. # 11]. Plaintiff filed a memorandum in opposition to the motion for summary judgment and in further support of his motion for preliminary injunction, which requested that the Court grant preliminary injunctive relief and deny defendants' motion for summary judgment. [Dkt. # 15]. In the opposition, plaintiff also noted that the Court could grant judgment in favor of the plaintiff sua sponte. Pl.'s Mem. in Opp. to Def.s' Mot. for Summ. J. and in Supp. of Pl.'s Mot. for P.I. ("Pl.'s Opp.") at 1 n.1. The Court finds that the ALJ's dismissal of Dr. Bois's hearing request was arbitrary and capricious under the APA because the request raised affirmative defenses that turned upon the resolution of genuine disputes of fact material to the finding of misconduct. Therefore, the Court will deny defendants' motion for summary judgment, reverse the hearing officer's dismissal of Dr. Bois's hearing request, vacate the HHS debarment of Dr. Bois, and remand the matter to HHS for further proceedings. BACKGROUNDDr. Bois was a postdoctoral fellow in the laboratory of Dr. Gerard Grosveld, Ph.D. in the Department of Genetics and Tumor Biology at St. Jude Children's Research Center from 1999 to 2004, when he transferred to the laboratory of John Cleveland, Ph.D. in the Department of Biochemistry at St. Jude. Def.'s Opp. to Pl.'s Mot. for P.I. and Mem. in Supp. of Def.'s Mot. for Summ. J. ("Def.'s MSJ") at 3. He later became an Assistant Professor in the Department of Cancer Biology at Scripps Florida, employed under Dr. Cleveland. AR 733, Mem. of Law in Supp. of Pl.'s Mot. for Hr'g Req. ("Pl.'s Hr'g Req.") at 10; AR 820 (Office of Research Integrity Report ("ORI Report") at 3). After Dr. Bois transferred to Dr. Cleveland's laboratory, St. Jude began investigating allegations that Dr. Bois had engaged in research misconduct and gratuitous authorship. Id. at 839-40. In its final report, the St. Jude Investigation Committee found that Dr. Bois had intentionally engaged in research misconduct by falsifying or fabricating figures in two separate published articles, and found that the evidence was insufficient or did not support findings of research misconduct as to four other allegations. Id. at 837-52. The findings of that investigation were transmitted to the HHS Office of Research Integrity ("ORI") on March 16, 2007. Id. at 813. ORI reviewed St. Jude's findings and conducted additional analysis. Id. at 818 (ORI Report at 1). On January 8, 2010, ORI notified Dr. Bois by letter ("charge letter") that it had made two findings of research misconduct based on evidence that he knowingly, intentionally or recklessly fabricated and falsified two figures reported in two separate articles: (1) The FOXO1a Immunoblot in Figure IA of P.R. Bois, K. Izeradjene, P.J. Houghton, J.L. Cleveland, J.A. Houghton, G.C. Grosveld, FOXO1a Acts as a Selective Tumor Suppressor in Alveolar Rhabdomysarcoma, 170 J. Cell Biol. 903-12 (Sept. 2005) (Corrected August 2007) ("JCB Article"); and (2) Figure 4(b) of P.R. Bois, R.A. Borgon, C. Vornhein, and T. Izard, Structural Dynamics of α-Actinin-Vinculin Interactions., 25 Mol. Cell. Biol. 6122 (July 2005) (Retracted May 5, 2007) ("MCB Article"). Id. at 813-15.
1. The request for hearing also challenged HHS's jurisdiction to impose administrative sanctions on Dr. Bois, which the ALJ rejected. See AR 724-25, 730-31, 35-48 (Pl.'s Hr'g Req. at 1-2, 7-8, 12-25). Dr. Bois does not challenge the jurisdiction determination in the instant case.
2. Since the Court's ruling on Count I will result in a remand of the matter for a hearing, it need not reach Count II.
Dr. Bois also challenges the ALJ's statement in the Amended Decision that a dismissal of a hearing request is not a ruling on the merits that, under 42 C.F.R. § 93.500 (c), would be subject to review by the Assistant Secretary for Health in accordance with § 93.523. The Court has difficulty accepting the defendants' contention that a summary disposition that results in the adoption of findings of research misconduct and that forms the predicate for the imposition of significant sanctions is somehow not a "ruling on the merits" for purposes of these regulations. But since the matter is being remanded to the ALJ, it need not reach that question either.
Finally, Dr. Bois alleges that the ALJ engaged in inappropriate ex parte communications with ORI, which led the ALJ to amend her opinion sua sponte, adding a footnote which indicated that the decision was not subject to the extra level of review. See Pl.'s Opp. at 13-15. Again, since the matter will be remanded for a hearing on the merits, the Court need not address this argument.
3. This is an awkwardly crafted regulation that, on the one hand, expressly places the burden on the respondent to establish an affirmative defense by a preponderance of the evidence, but at the same time, seems to shift the burden back to ORI to disprove the defense after the respondent has come forward with "admissible, credible evidence." Since the Court's ruling that a hearing is necessary does not rest on a finding that either party met or failed to meet the burdens assigned to them by this provision, the Court will not undertake to interpret the regulation further.
4. The Journal of Cellular Biology retracted the article on May 7, 2007. AR 733 (Pl.'s Hr'g Req. at 10); AR 822 (ORI Report at 5).
5. Dr. Bois argued that he did not have access to his laboratory notebooks, but the ALJ concludes that this argument was disproved because he initially drafted the article that eventually became his publication while he was still in Dr. Grosveld's lab and he composed Figure 1A while still at Dr. Grosveld's lab. AR 27 (ALJ Am. Decision at 8).
6. The letter states:
Dear Peter,
Just wanted to show you the WB results from the primary tumor. The differences between ARMS and ERMS are pretty obvious!!! I had to redo the FOXOs WB 3 times to convince myself that there was no mess up. . . (100ug protein loaded in each lane, FOXOs exposure is 15min for the ERMS, over 2 hrs for MIXED and ARMS). Interesting to see the Myosin heavy chain really expressed in ERMS and not in ARMS. These 2 subtype [sic] are really 2 different beasts . . . Have a good week end, Philippe
7. The authors published a correction to the MCB article in August 2007, which stated that: "Page 6118, top right panel: Lanes 1, 3, and 5 were inadvertently erroneous. The VBS peptide. was not always detectable with the silver stain used to produce this figure, which resulted in wrong images for these lanes. This error does not affect the results or conclusions of the study." See AR 757 (Pl.'s Hr'g Req. at 34); AR 831 (ORI Report at 14).
8. Interviewer: So the blot that's on the inquiry page 16 was E-mailed on the 7th of January, but not with a key. The key that's on inquiry page 16 is taken from here. Are you confident that the loading matches the key that's here?
Borgon: Yes, I can look at it again and see to make sure. Let me look at my book. It will be easier.
Dr. Conley: So he's looking at his notebook, page 77, to make sure that the key matches the loading.
B: Yes, that's exactly accurate.
I: Then you said in your response to the inquiry, "Under Dr. Bois' guidance we pieced together the figure shown in Figure 4B, using different bands for various gels and here I E-mailed him the file for further editing." We're not sure exactly what you mean by that.
B: I remember when this figure came out, when we were working on it, I remember messing with these bars. That's why I said with the lines that were dividing the figure up. And so I remember being involved and I remember Phil was there and he was like, well, you know you can use this clone-stamp tool and he was doing that type of thing to like clone stamp another band or copy bands. And after we got it set up he said, well, just E-mail me the file. We just had the picture. He said, just E-mail it to me and then he added everything else to it or, I don't know what further editing he did."
AR 804-05 (Ex. H to Pl.'s Hr'g Req.).
9. The Amended Decision states:
[C]ontrary to Respondent's implication, establishing honest error is an affirmative defense, for which Respondent bears the burden of going forward and the burden of proving by a preponderance of evidence. 42 C.F.R. § 93.516(b)(2). The drafters of Part 93 (which are the regulations that govern these proceedings) recognized an overlap between a respondent's responsibility to prove an affirmative defense and the agency's responsibility to prove that research misconduct was committed intentionally, knowingly or recklessly. So, as ORI has done here, the agency must show that the research misconduct was intentional, knowing, or reckless. . . . The drafters explicitly retained `honest error or difference of opinion' as an affirmative defense that the respondent has the burden of proving by a preponderance of the evidence. 42 C.F.R. § 93.106; see 70 Fed. Reg. at 28,372.
AR 30 (ALJ Am. Decision at 11).
10. Documents proffered by the government indicate that Dr. Bois had supervised access to his notebooks during the course of the St. Jude investigation and he obtained scanned copies of the pages that he requested in order to respond to the misconduct allegations. See AR 326-29, 617-18, 622-33. However, there is no evidence, and the government does not argue, that Dr. Bois was able to revisit his laboratory notebooks — other than the scanned copies of pages in his possession — at any point after ORI released its findings.
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