Bohner v. Burwell
| Decision Date | 01 December 2016 |
| Docket Number | CIVIL ACTION NO. 15-4088 |
| Parties | RICHARD BOHNER, Plaintiff, v. SYLVIA MATTHEWS BURWELL, Secretary of Health and Human Services, Defendant. |
| Court | U.S. District Court — Eastern District of Pennsylvania |
MEMORANDUM
Richard Bohner ("Plaintiff"), was one of four Synthes executives prosecuted as "responsible corporate officers" after Synthes promoted the off label use of surgical bone cement manufactured by its corporate subsidiary. Plaintiff and the other executives pled guilty to a single strict liability misdemeanor offense under the Federal Food Drug and Cosmetics Act ("FDCA"). For his involvement, Plaintiff was sentenced to an eight-month term of imprisonment and a $100,000 fine. As a result of and soon after Plaintiff's conviction, Sylvia Burwell ("Defendant"), Secretary of the Department of Health and Human Services ("HHS"), elected to exclude Plaintiff from federal health care program participation for a period of four years, pursuant to 42 U.S.C. § 1320a-7(b)(1).1 Plaintiff unsuccessfully challenged the exclusion decision before an administrative law judge, and then again before the Departmental Appeals Board ('DAB") of HHS, arguing that the crime for which he was convicted could not justify exclusion under § 1320a-7(b)(1). In Plaintiff's view, Defendant erred when Plaintiff's conduct, and not his offense of conviction, served as the basis of Defendant's decision to exclude Plaintiff from programparticipation. Plaintiff advances that same argument before this Court today, and we are similarly unpersuaded.
Plaintiff initiated the present action appealing the decision of the DAB to uphold Plaintiff's exclusion from participation in federal health care programs under § 1320a-7(b)(1). The parties filed cross motions for summary judgment, which this Court considered in turn. For the reasons set forth herein, this Court will DENY Plaintiff's Motion for Summary Judgment and GRANT Defendant's Motion for Summary Judgment. Defendant's decision to exclude Plaintiff under § 1320a-7(b)(1) is affirmed.
The factual record in this case is extensive, but is largely undisputed. Synthes, Inc. served as the American branch of a multinational corporation specializing in the manufacture of medical devices. (Pl. SUMF ¶1; Def. SUMF ¶1). Plaintiff, Richard Bohner, worked as Synthes's Vice President of Human Resources and Regulatory Affairs from 1997 to 2002, and then as the Vice President of Operations from January 2002 until 2004. (Def. SUMF ¶3). Norian Corporation was a Synthes subsidiary that manufactured bone cement used in surgical bone repairs. (Pl. SUMF ¶2; Def. SUMF ¶2). At the heart of Plaintiff's conviction are two Norian products manufactured for use as bone void fillers: Norian Skeletal Repair System ("SRS") and Norian XR ("XR"). (Def. SUMF ¶8). During Plaintiff's executive tenure at Synthes, the Food and Drug Administration ("FDA") cleared both SRS and its successor XR for limited surgical use, but with an explicit warning that the products were not to be mixed with any other substance. (Pl. SUMF ¶4, 5). The FDA classified both SRS and XR as "significant risk devices," indicating thatthe products posed a significant risk to the health and safety of patients. (Pl. SUMF ¶3; Def. SUMF ¶9).
Despite the FDA classifications, restrictions, and warnings, Synthes and Norian promoted the off label, unauthorized use of SRS and XR to treat vertebral compression fractures. (Pl. SUMF ¶6). Synthes and Norian trained spine surgeons in the unapproved use of the Norian bone void fillers, and assisted as the surgeons went on to conduct clinical trials on human patients with the Norian bone fillers. (Def. SUMF ¶18, 20; A.R. 1376-1383). Two patients died during unauthorized clinical trials involving Norian bone fillers. (A.R. 1376-183). No autopsy was conducted for either patient to determine the cause of death, and the death of the first patient went unreported altogether. (A.R. 1376-1383).
As a result of their participation in the unauthorized use of SRS and XR, Synthes and Norian were each charged with, inter alia, upwards of 45 counts of introducing adulterated and misbranded medical devices into interstate commerce, in violation of 21 U.S.C. §§ 331(a), 352(a), and 333(a). (Def. SUMF ¶12, 13). Both companies ultimately plead guilty to a variety of charges related to their promotion and unauthorized dissemination of SRS and XR. (Pl. SUMF ¶7, 8; Def. SUMF ¶24, 25).
Plaintiff and three other Synthes executives were charged with one misdemeanor count of introducing adulterated and misbranded medical devices into interstate commerce in violation of the FDCA, 21 U.S.C. §§ 331(a), 352(a), and 333(a)(1). (Def. SUMF ¶14, 15). On May 26, 2009, Plaintiff signed an agreement to plead guilty to one count of misdemeanor misbranding, a violation of 21 U.S.C. §§ 331(a). (Pl. SUMF ¶9; Def. SUMF ¶16). The crime to which Plaintiff pled guilty was a strict liability offense, requiring no evidence of intent. Plaintiff was convictedunder the "responsible corporate officer" doctrine of United States v. Park, which was introduced as a means of holding senior corporate officials responsible for their companies' misconduct where the officials had the power and responsibility to intervene. 421 U.S. 658 (1975). (Pl. SUMF ¶10; Def. SUMF ¶16). Plaintiff's plea agreement detailed the facts of Synthes' illegal test marketing and promotion of SRS and XR, Plaintiff's knowledge that the companies' conduct violated the FDA, Plaintiff's responsibility to prevent such violations, and Plaintiff's complicity in "knowingly ma[king] a series of false statements to the FDA investigator." (Def. SUMF ¶18).
On December 13, 2011 Plaintiff was sentenced to an eight-month term of imprisonment, four months of supervised release, and a maximum fine of $100,000. (Def. SUMF ¶26). Plaintiff's term of imprisonment represented an upward variance from the applicable Sentencing Guidelines range of zero to six months. (Def. SUMF ¶28). The sentencing judge, Judge Legrome Davis, found that the departure from the Guidelines was supported by the "unprecedented nature of the criminal conduct" of each Synthes executive charged. (Def. SUMF ¶28; A.R. 1397).
Judge Davis went on to conclude that this case was one of the most egregious that had come before him. (Def. SUMF ¶28; A.R. 1387-1388). Addressing the Synthes officials' complicity in the unlawful clinical trials conducted on uninformed patients, Judge Davis had the following to say:
With specific reference to Plaintiff's involvement in Synthes and Norian's "scheme," Judge Davis found that "[Plaintiff] knew and was aware that the Spine Division was conducting 'test markets' that amounted to unauthorized clinical trials of SRS and XR in violation of the FDCA, and [Plaintiff] participated in conducting those trials." (Def. SUMF ¶29; A.R. 974). Judge Davis further found as fact that Plaintiff "knew at the time the clinical trials were planned and were conducted that the trials violated the FDCA." (Def. SUMF ¶29; A.R. 974).
Based on Plaintiff's conviction, the Health and Human Services' (HHS) Office of the Inspector General notified Plaintiff that he would be excluded from participation in any federal healthcare program for a period of four years, pursuant to 42 U.S.C. §1320(a)-7(b)(1). (Pl. SUMF ¶12; Def. SUMF ¶31; A.R. 753). §1320(a)-7(b)(1) reads in pertinent part:
The Secretary may exclude...any individual or entity that has been convicted...under Federal or State law...of a criminal offense consisting of a misdemeanor relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct (i) in connection with the delivery of a health care item or service, or with respect to any act or omission in a health care program....
Plaintiff requested a hearing before a HHS administrative law judge (ALJ) to challenge Defendant's exclusion decision. (Pl. SUMF ¶14). At the hearing, Plaintiff argued that Defendant, HHS Secretary Sylvia Burwell, erred in her interpretation of §1320(a)-7(b)(1) to permit Plaintiff's exclusion from program participation on the basis of his conviction for a strict liability crime. (Pl. SUMF ¶14). According to Plaintiff, §1320(a)-7(b)(1) required Defendant to apply the categorical approach to assess whether the generic elements of his offense of conviction constitute an offense "relating to fraud," as opposed to assessing whether the circumstances of Plaintiff's conduct relates to fraud. (Pl. SUMF ¶ 14). Plaintiff further argued that the D.C. Circuit case - Friedman v. Sibelius, 686 F.3d. 813 (D.C. Cir. 2012) - supporting Defendant's construction of §1320(a)-7(b)(1) to require a circumstance specific approach, was similarly erroneously decided. (Pl. SUMF ¶ 14). In a 23 page opinion, the ALJ, citing Friedman, rejected Plaintiff's challenge and affirmed the four year exclusion. (Pl. SUMF ¶ 15; Def. SUMF ¶ 32; A.R. 1-23).
Plaintiff then appealed the ALJ's decision to HHS' Departmental Appeals Board (DAB), again arguing that his conviction for a strict liability offense did...
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