Bonds v. Leavitt

Decision Date03 January 2011
Docket NumberNo. 09-2179,09-2179
PartiesDuane R. BONDS, M.D., Plaintiff-Appellant, v. Michael LEAVITT, Secretary Department of Health and Human Services; Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute of the National Institutes of Health, Defendants-Appellees. Project on Government Oversight; Public Employees for Environmental Responsibility, Amici Supporting Appellant.
CourtU.S. Court of Appeals — Fourth Circuit

ARGUED: Michael Kohn, Kohn, Kohn & Colapinto, LLP, Washington, D.C., for Appellant. Allen F. Loucks, Office of the United States Attorney, Baltimore, Maryland, for Appellees. ON BRIEF: Richard R. Renner, Kohn, Kohn & Colapinto, LLP, Washington, D.C., for Appellant. Rod J. Rosenstein, United States Attorney, Baltimore, Maryland, for Appellees. R. Scott Oswald, Jason Zuckerman, The Employment Law Group, PC, Washington, D.C.; Paula Dinerstein, Senior Counsel, Public Employees for Environmental Responsibility, Washington, D.C.; Scott H. Amey, General Counsel, Project on Government Oversight, Washington, D.C., for Amici Supporting Appellant.

Before TRAXLER, Chief Judge, GREGORY, Circuit Judge, and HAMILTON, Senior Circuit Judge.

Affirmed in part, reversed in part, and remanded by published opinion. Chief Judge TRAXLER wrote the opinion, in which Judge GREGORY and Senior Judge HAMILTON joined.

OPINION

TRAXLER, Chief Judge:

Dr. Duane Bonds appeals district court orders dismissing some of her employment claims and granting summary judgment against her on the others. We affirm in part, reverse in part, and remand for further proceedings.

I.

Bonds is an African-American female doctor who has worked during her medical career to fight "sickle cell disease and other medical disorders that severely impact fetal and maternal health." 1 J.A. 442-43. In 1990, after years in private practice and academia, she became Deputy Chief of the Sickle Cell Disease Branch of the Division of Blood Diseases and Resources ("DBDR"), a division of the National Heart, Lung, and Blood Institute ("NHLBI") of the National Institutes of Health ("NIH"). In 1998, Dr. Charles Peterson, Director of the DBDR at NHLBI, became Bonds's second-line supervisor. Dr. Blaine Moore, Program Director for the DBDR's Blood Diseases Program, became Bonds's first-line supervisor in late 2003.2 For much of her NIH career, Bonds received consistently high performance appraisals, promotions, and awards,and she was recognized as a leading researcher of Sickle Cell Disease.

In October 1999, Bonds filed an administrative Equal Employment Opportunity ("EEO") complaint against Peterson alleging that he sexually harassed her by asking her to share a hotel room with him during an overnight business trip and that he began interfering with her professional duties when she refused him. 3 Peterson subsequently removed Bonds from her position as NHLBI's Sickle Cell Disease Group Leader, prompting Bonds to file a second EEO complaint in March 2003. In settlement of that dispute, the NHLBI in April 2004 created a new position for Bonds: the Division of Blood Diseases and Resources Sickle Cell Coordinator.

During Bonds's time at NIH, NHLBI initiated two sickle-cell clinical drug trials, "Baby Hug" and "SWiTCH," which Bonds initially led as project officer ("PO"). The two trials began in the years 2000 and 2005, respectively. Baby Hug studied whether administering the drug Hydroxyurea to infants could prevent the onset of end-organ damage, the major source of morbidity and mortality in sickle cell disease patients. SWiTCH studied the effect of the same drug on infants who had suffered a stroke. Baby Hug was a contract-funded study, which means that while NIH provides the funding, outside doctors and researchers perform the recruitment, collection, and analysis. The investigator responsible for processing specimens collected for the trial was Dr. Russell Ware, who was employed by St. Jude Children's Research Hospital in Tennessee.

Central to the present appeal is a process known as Epstein-Barr virus ("EBV") cell line transformation, under which EBV is mixed with blood cells from study participants, causing the cells to transform and grow indefinitely. This technique can be used to create an unlimited DNA supply without drawing new blood from study participants. According to Ware, he first discussed utilizing EBV cell line transformation in 2003, when he attended a conference at the NIH at which the process was recommended. Ware asserts that Bonds approved the use of the process for Baby Hug in late 2003 or early 2004.

The controversy regarding this process began in early September 2005 at a monthly steering committee meeting when Ware presented a report that he had established cell lines from DNA samples that had been collected from study participants using EBV cell line transformation. Bonds stated in an e-mail to Ware that she had been "dismayed" to learn that Ware had been immortalizing cell lines derived from the Baby Hug subjects.4 J.A. 545. The e-mail asserted that "NHLBI did not authorize this work, it is not in the protocol, and the work is not specifically mentioned in the consent forms." 5 J.A. 545. Accordingly, the message requested that Ware destroythe cell lines immediately. When Moore and Peterson refused to support her decision, Bonds raised her concerns to the Data and Safety Monitoring Board ("DSMB"), which is tasked with protecting study participants' interests. On October 5, 2005, the DSMB recommended that the cell lines be destroyed unless the proper consent was obtained.

Not satisfied with that result, and believing that destruction of the lines was the only appropriate course of action, Bonds brought her concerns to Dr. Elizabeth Nabel, who was the Director of NHLBI and the person to whom Peterson reported. At Bonds's urging, Nabel initially ordered that the lines be destroyed. However, Nabel was subsequently contacted by Dr. John Cunningham, the Chair of the Institutional Review Board ("IRB") at St. Jude. He advised Nabel that the individual IRBs at the various Baby Hug clinical sites had jurisdiction over the immortalized cells. Accepting this assessment, Nabel sent letters to the IRBs urging them to either destroy the lines or obtain specific consent from the patients for retention of the lines.

Nabel received varying responses. Some IRBs believed the consent forms already covered the immortalization, while others believed efforts should be made to "re-consent" the study participants. This latter group reasoned that once the cell lines were immortalized, the study participants themselves should be able to express their preference regarding whether the biological material would be destroyed. Unbeknownst at the time to Moore and Peterson, Bonds eventually contacted the Office of Special Counsel ("OSC") regarding the cell lines in late December 2005, asserting that retention of the lines violated federal law. See 45 C.F.R. § 46.116 (2010) (providing that "[e]xcept as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or of the subject's legally authorized representative"); 45 C.F.R. § 46.122 (2010) ( "Federal funds administered by a department or agency may not be expended for research involving human subjects unless the requirement of this policy have been satisfied.").

Deciding that Bonds's cell line concerns warranted investigation, the OSC forwarded them to the Secretary of the Department of Health and Human Services ("HHS"). As a result, HHS's Office of Inspector General ("OIG") initiated an investigation, interviewing Nabel, Peterson, Moore, and others in early 2006. After receiving a report from OIG in June 2006, the OSC issued its final report in December 2007 concluding that NIH officials "participated in the violation of federal law." J.A. 458.

Besides being the subject of an OSC investigation, the cell line controversy also marked the final straw for Ware in his relationship with Bonds. On October 11, 2005, he wrote to Moore requesting that Bonds be removed as PO for SWiTCH, for which Ware was the principal investigator. Prior to making that request, Ware had conferred with several key consultants in the then-recently funded project who agreed the trial would be best served if Bonds were replaced. In his affidavit, Ware explains that while his prior experienceswith Bonds had been "decidedly negative," their relationship had taken a particularly ugly turn with the cell line controversy in that Ware viewed Bonds as having unfairly attacked his motives in an "accusatory, abrasive manner." J.A. 98. Additionally, Ware and Dr. Winifred Wang, who were chair and deputy chair of the Baby Hug Steering Committee, both complained that often the information Bonds provided them concerning decisions made by the DSMB was incorrect to the point that they no longer trusted Bonds. Ware further maintained that Bonds's "abrasive, controlling style of managing the study" was a significant problem. J.A. 99. Dr. Susan Shurin, NHLBI's deputy director, also "experienced significant difficulties relating to [Bonds'] management of the study," primarily relating to Bonds' "bypass[ing] the group process" and her "[i]nformal and misleading communication of DSMB recommendations." J.A. 106-07.

Moore voiced concern over these issues and also expressed worry that Bonds's involvement as SWiTCH PO would be too much for her to effectively handle in light of her numerous other duties, including serving as Baby Hug PO. (These concerns had been documented in Bonds' mid-year performance review four months earlier in July 2005.) In light of all of these factors, Moore decided to remove Bonds from her position as SWiTCH PO. He explained to Bonds in person his reasons for her removal and also drafted a memorandum documenting the...

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