PopeK. S.GutheilT. G., “Psychologists Abandon the Nuremberg Ethic: Concerns for Detainee Interrogations,”International Journal of Law and Psychiatry (2009):161–166, at 161.
2.
See LiftonR. J., “Doctors and Torture,”New England Journal of Medicine351 (2004): 415–416, at 416. See also PowellA., “Why Good Doctors Do Bad Things,”Harvard Gazette, March 3, 2005; AnnasG. J., “Unspeakably Cruel – Torture, Medical Ethics, and the Law,”New England Journal of Medicine352 (2005): 2127–2132, at 2127.
See, e.g., MilesS. H., “Abu Ghraib: Its Legacy for Military Medicine,”Lancet364, no. 9435 (2004): 725–729.
5.
See ClarkP. A., “Medical Ethics at Guantanamo Bay and Abu Ghraib: The Problem of Dual Loyalty,”Journal of Law, Medicine & Ethics34, no. 3 (2006): 570–580, at 574.
6.
See, e.g., BlocheM. G.MarksJ. H., “Doctors and Interrogators at Guantanamo Bay,”New England Journal of Medicine353, no. 1 (2005): 6–8, at 6.
7.
Recent literature has discussed the behavior of health professionals at Guantánamo and Abu Ghraib, the ethical issues that arise when health professionals have dual loyalty to both institutional clients (the military) and individual clients (the detainees), and whether or not health professionals should ever participate in interrogations. Indeed, one author, Kenneth S. Pope, compiled a list of over 320 articles. That list is available at <http://kspope.com/interrogation/index.php> (last visited February 1, 2012). Articles have provided recommendations for reform, calling for independent investigations into the role of military health professionals in the abuse of detainees, and the development of further guidelines for health professionals. See, e.g., CostanzoM.GerrityE.LykesM. B., “Psychologists and the Use of Torture in Interrogations,”Analysis of Social Issues and Public Policy7, no. 1 (2007): 7–20, at 16.
8.
Dr. Reisner is currently a professor of clinical psychology at New York University School of Medicine and a supervisor at the International Trauma Studies Program. See Center for Justice & Accountability Website, “Dr. Steven Reisner, PhD,”available at <http://www.cja.org/article.php?id=798> (last visited February 1, 2012).
9.
The author is currently involved in a matter, Bond v. Ohio State Bd. of Psychology, involving a former military psychologist in Ohio, Dr. Larry C. James, who was a chief psychologist at Guantánamo.
10.
Licensing Complaint Against Dr. John Francis Leso State of New York, License number 013492, available at <http://cja.org/article.php?id=876> [hereinafter cited as Complaint].
See Letter from Kathy Roberts to Louis J. Catone, Director (August 2010), available at <http://cja.org/article.php?id=909> (last visited February 1, 2012).
15.
See generally Verified Petition, available at <http://www.cja.org/downloads/Verified%20Petition%20Leso.pdf> (last visited February 1, 2012). This is an Article 78 proceeding, like a mandamus action, which is used to challenge final decisions by state officers. See N.Y. CVP. LAW § 7801.
16.
Id., at 11.
17.
See Memorandum of Law in Support of the Respondents' Cross-Motion To Dismiss the Verified Petition, available at <http://www.cja.org/downloads/NYAGMTD%201.14.pdf> (last visited February 1, 2012) [hereinafter cited as Respondents' Motion to Dismiss].
18.
See Reisner v. Catone, 929 N.Y.S.2d 403 (N.Y. Sup. 2011).
19.
Furthermore, an appeal is possible. Dr. Reisner has not yet announced whether he will be appealing the decision.
20.
See Complaint, supra note 10, at 1.
21.
Memorandum on BSCT Standard Operating Procedures (November 11, 2002) at 1, available at <http://cja.org/article.php?id=910> (last visited February 1, 2012).
See Complaint, supra note 10, at 5. The Complaint specified that this behavior violated New York professional statutes and regulations that prohibit “gross incompetence and negligence, unprofessional conduct, conduct exhibiting moral unfitness to practice the profession, unauthorized treatment, neglect of a patient in need of immediate care, and willful abuse and harassment.” Id. The Complaint cites N.Y. Educ. Law §§ 6509 (2), (9) and Rules of Regents §§ 29 (b)(5), (11), 29.2(a)(1), (2), (7).
24.
U.S. Department of Justice Office of the Inspector General, A Review of the FBI's Involvement in and Observations of Detainee Interrogations in Guantanamo Bay, Afghanistan, and Iraq (May 2008), at 171, available at <http://cja.org/article.php?id=833> (last visited February 1, 2012).
25.
See Complaint, supra note 10, at 17.
26.
WoodwardB., “Guantanamo Detainee Was Tortured, Says Official Overseeing Military Trials,”Washington Post, January 14, 2009.
27.
N.Y. Ed. Law Art.153 §7601-a (2010).
28.
“The fact that Dr. Leso may have possessed special knowledge gained through his education, training, and/or experience as a psychologist that made him useful to the military in developing interrogation techniques does not mean that Dr. Leso's conduct in that regard constituted the practice of psychology.” See OPD Response, supra note 13, at 2.
29.
See OPD Response, supra note 13, at 3 (“I can only interpret the phrase 'modification of behavior for the purpose of … eliminating … undesired behavior' in the definition of the practice of psychology as referring to behavior undesired by one's patient, not behavior undesired by third parties.”); see also Respondents' Motion to Dismiss, supra note 17, at 21 (“The statutory language focuses on therapeutic, healing type activities. … Nothing in the statute remotely suggests that it extends to the type of activity alleged in this case – providing assistance for the aggressive interrogation of military detainees.”).
30.
See OPD Response, supra note 13, at 2.
31.
See LewisN. A., “Interrogators Cite Doctors' Aid at Guantánamo Prison Camp,”New York Times, June 24, 2005 (explaining the views of Bryan Whitman, a Pentagon spokesman, who “suggested that the doctors advising interrogators were not covered by ethics strictures because they were not treating patients but rather were acting as behavioral scientists”), available at <http://www.nytimes.com/2005/06/24/politics/24gitmo.html?pagewanted=all> (last visited February 1, 2012); see also BlocheM. G.MarksJ. H., “When Doctors Go to War,”New England Journal of Medicine352, no. 1 (2005): 3–6, at 3 (describing Dr. David Tornberg's, Deputy Assistant Secretary for the Defense for Health Affairs, views: “Physicians assigned to military intelligence, he contended, have no doctor-patient relationship with detainees and, in the absence of life-threatening emergency, have no obligation to offer medical aid.”)
32.
Memorandum of Law in Support of Petitioner's Verified Petition, at 6, available at <http://www.cja.org/downloads/reisner%20v%20catone%20memorandum%20of%20law.pdf> (last visited February 1, 2012) [hereinafter cited as Memo in Support of Verified Petition]. In response to Dr. Resiner's argument that even if the statute did require that relationship (a point he disputes), the detainees were Dr. Leso's patients under the meaning of the statute, the OPD claimed that this “def[ed] … reality – They were suspected terrorists. … Dr. Leso obviously was not acting as … counselor, therapist or health care provider when his alleged role was to devise ‘harmful and abusive psychological techniques.’” See Respondents' Motion to Dismiss, supra note 17 at 19 (citing Verified Petition ¶19).
33.
Id., at 9–10.
34.
Id.
35.
Memorandum of Law in Opposition to Respondents' Cross-Motion To Dismiss The Verified Petition, at 14, available at <http://www.cja.org/downloads/Response%20MTD%202.1.pdf> (last visited February 1, 2012) [hereinafter cited as Memo in Opposition to Motion to Dismiss].
See Respondents' Motion to Dismiss, supra note 17, at 19.
39.
Reisner v. Catone, 929 N.Y.S.2d at 406 (citing Roberts v. Health & Hosps. Corp., 928 N.Y.S.2d 236, 242 (1st Dep't. 2011) quoting New York State Assn. of Nurse Anesthetists v. Novello, 2 N.Y.3d 207, 211 (2004)).
40.
See Memo in Opposition to Motion to Dismiss, supra note 35, at 16.
41.
See Society of Plastics Indus. v. County of Suffolk, 77 N.Y.2d 761, 778 (1991) (holding that a plaintiffs must show a “cognizable injury” that is “different in kind or degree from the public at large.”)
42.
See Respondents' Motion to Dismiss, supra note 17 at 11–14.
43.
Id.
44.
Id., at 11.
45.
Matter of Hebel v. West, 25 A.D.3d 172, 176 (3d. Dept. 2005). See also Memo in Opposition to Motion to Dismiss, supra note 35 at 18 (“Individual citizens have standing to sue despite the absence of strict injury in fact ‘where the matter is one of general public interest.’”) (citing Police Conference of N.Y. v. Municipal Police Training Council, 405 N.Y.S.2d 511, 512 (3d Dept 1978)).
46.
See Memo in Opposition to Motion to Dismiss, supra note 35, at 18.
47.
See Respondents' Motion to Dismiss, supra note 17, at 14.
See generally Sanctions for Torture: Domestic Medical Associations Take Action, supra note 3.
54.
131 S. Ct. 2567 (2011).
55.
555 U.S. 555, 129 S. Ct. 1187 (2009).
56.
See, e.g., PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2592–93 (2011) (Sotomayor, J., dissenting); ChemerinskyE., “A Devastating Decision”, Trial47 (2011): 54–56.
57.
555 U.S. 555, 129 S. Ct. 1187, 1191 (2009).
58.
Promethazine hydrochloride is an antihistamine used to treat nausea. Id., at 1191.
59.
Levine, 129 S. Ct. at 1196.
60.
See, e.g., Altria Group, Inc. v. Good, 555 U.S. 70, 76–77 (2008).
61.
Levine, 129 S. Ct. at 1196.
62.
Id., at 1196 (citing 21 C.F.R. §§ 314.70(c) (6)(iii)(A), (C) (2008) (“Changes in the labeling to reflect newly acquired information … [may be made] to accomplish any of the following [purposes]: (A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under § 201.57(c) of this chapter.”)). In 2008, the FDA clarified its “longstanding view” of when a label change under the CBE process is appropriate, amending § 314.70(c)(6) (iii)(A) to require that “newly acquired information” be premised upon “evidence of a causal association.” 73 Fed. Reg. 49,604, 49,605 (August 22, 2008). The FDA further commented that such “newly acquired information” – which includes not only new clinical studies but “new analyses of previously submitted data” – must be of a “different type or greater severity or frequency than previously included in submissions to FDA.” 73 Fed. Reg. at 49,604.
63.
Levine, 129 S. Ct. at 1197. See also § 314.70(c)(7) (2008) (“If the agency disapproves the supplemental application, it may order the manufacturer to cease distribution of the drug product(s) made with the manufacturing change.”).
64.
Levine, 129 S. Ct. at 1197–98.
65.
Id., at 1198.
66.
See, e.g., Wyeth v. Levine, 129 S. Ct. 1187, 1217 (2009) (Alito, J., dissenting) (criticizing the majority for holding that “a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs”); KinsleyM., “Wyeth v. Levine – When FDA Approval Isn't Good Enough,”Washington Post (March 13, 2009).
67.
See, e.g., AlmonE. S., Note, “Preemption of State Failure-to-Warn Claims After Wyeth v. Levine: The Regulatory Function of State Tort Law,”University of San Francisco Law Review45 (2010): 215–241, at 230–241; Senator Patrick Leahy, Press Release, Leahy Joins Kennedy, Others to Introduce Bill to Reverse Supreme Court Medical Device Decision (March 6, 2009), available at <http://leahy.senate.gov/press/press_releases/release/?id=0502041b-32de-409a-93d4–34e4bc05dd8d> (last visited February 2, 2012).
68.
Generic drug manufacturers need not go through the extensive application process which pioneer drugs must complete as a prerequisite to FDA approval. Instead, a company seeking to market a generic product files an abbreviated new drug application (ANDA) showing that the drug is bioequivalent to a reference listed drug, which is generally a brand-name version. See, e.g., Brief for the United States as Amicus Curiae Supporting Respondents at 2–4, PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (Nos. 09–993, 09–1039, 09–1501), 2011 WL 741927, at 2–4. (citing 21 U.S.C. §§ 355(j)(2)(A)(ii), (iv) (2010)) [hereinafter cited as Brief for the United States Supporting Mensing].
69.
See, e.g., Gaeta v. Perrigo Pharm. Co., 562 F. Supp. 2d 1091, 1096–98 (N.D. Cal. 2008); Morris v. Wyeth, Inc., 582 F. Supp. 2d 861, 866–68 (W.D. Ky. 2008) (collecting cases that had previously considered whether state failure-to-warn claims against generic drug manufacturers are pre-empted and noting that a majority of courts found pre-emption).
70.
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2572 (2011). Justice Thomas delivered the opinion of the court, joined by Justices Roberts, Scalia, Alito, and Kennedy. Justice Sotomayor wrote the dissent, joined by Justices Ginsburg, Breyer, and Kagan. Although the Court divided along familiar lines, the split was unique in that the typically more conservative Justices upheld federal power and agency expertise, while the traditionally liberal voting bloc championed states' rights.
71.
A drug used to treat disorders related to the digestive tract. Id., at 2572.
72.
Id., at 2573.
73.
Id., at 2575.
74.
Brief for the United States Supporting Mensing, supra note 15, at 15.
75.
Id., at 15–16 (citing 21 U.S.C. § 355(j) (4)(G) (2010); 21 C.F.R. § 314.94(a) (8)(iii) (2011) (a generic drug's ANDA must contain “proposed labeling [that is] … the same as the labeling approved for the reference listed drug”); 21 C.F.R. § 314.150(b)(10) (2008) (the FDA “may … withdraw approval” of a generic drug if its labeling “is no longer consistent with that for the [reference listed drug]”)).
76.
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2576 (2011).
77.
Id., at 2576. Dear Doctor letters, also known as Dear Health Care Provider Letters, allow companies to disseminate “important new safety information” to health care practitioners. See generally U.S. Department of Health and Human Services, Food and Drug Administration, Dear Health Care Provider Letters: Improving Communication of Important Safety Information, DRAFT GUIDANCE (November 2010).
78.
Brief for the United States Supporting Mensing, supra note 15, at 18.
79.
Id., at 19.
80.
Mensing, 131 S. Ct. at 2576. During the time period when Mensing and Demahy took metoclopramide, 2001–02, the FDA did not have statutory authority to require a drug company to change its label. Congress granted the FDA this authority in 2007. See Wyeth v. Levine, 129 S. Ct. 1187, 1198 (2009) (citing 121 Stat. 924–926). Prior to 2007, if a company refused to follow an FDA suggestion that it modify a brand-name drug's label, the only recourse for the FDA would have been the draconian solution of withdrawing the brand and generic drugs from the market, on the basis of their now-inadequate labeling. Brief for the United States Supporting Mensing, supra note 15, at 21–22. Aspects of the Court's opinion appear to interpret the role of the brand-name manufacturer in this pre-2007 label modification process as an extra hurdle. See Mensing, 131 S. Ct. at 2578 (“Here, what federal law permitted the Manufacturers to do could have changed … depending on the actions of the FDA and the brand-name manufacturer.”). However, the holding ultimately defines impossibility solely in terms of an entity's dealings with a federal agency. Id., at 2580–81 (“To decide these cases, it is enough to hold that when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”).
81.
“If an ANDA applicant believes new safety information should be added to a product's labeling, it should contact FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised.” 57 Fed. Reg. 17,950, 17,961 (April 28, 1992). The generic manufacturers and the FDA disagreed over whether this language imposed a duty on generic companies to approach the FDA if they are aware of safety information that should be addressed through a label change. Because the Court found pre-emption, it did not decide the issue. Mensing, 131 S. Ct. at 2576–77.
82.
Brief for the United States Supporting Mensing, supra note 15, at 20.
83.
Mensing, 131 S. Ct. at 2578.
84.
Id., at 2578–79. Cf. Wyeth v. Levine, 129 S. Ct. 1187, 1197 (2009) (“But absent clear evidence that the FDA would not have approved a change to Phenergan's label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements. Wyeth has offered no such evidence. It does not argue that it attempted to give the kind of warning required by the Vermont jury but was prohibited from doing so by the FDA.”).
85.
Mensing, 131 S. Ct. at 2578–79.
86.
Id., at 2579.
87.
Id., at 2581.
88.
Id., at 2579.
89.
The dissent criticized this distinction as nothing more than a matter of timing. In either scenario, according to the dissenters, whether a company is able to obtain a permanent label change is dependent upon FDA approval: For generic companies the approval occurs prior to the label change going into effect, for brand-name companies the approval occurs after the label change goes into initial effect. Claiming that only companies in the former position are “dependent on the exercise of judgment by a federal agency” is a false dichotomy. The dissent would have simply focused the inquiry on whether the defendant company could have obtained that FDA approval. As in Levine, the defendant companies in Mensing had not produced evidence indicating the FDA would have disapproved the label change, and thus under the dissent's view, they were not entitled to a defense of impossibility pre-emption. See id., at 2587–88 (SotomayorJ., dissenting).
90.
See Schedin v. Ortho-McNeil-Janssen Pharm., Inc., No. 08–5743 JRT, 2011 WL 3837104 (D. Minn. August 26, 2011) (Mensing, which found “impossibility pre-emption of state law failure to warn claims [against] generic manufacturers,” does not “apply to brand-name manufacturers.”).
91.
See Mensing, 131 S. Ct. at 2580–81 (“To decide these cases, it is enough to hold that when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”).
92.
See Schork v. Baxter Healthcare Corp., No. 4:10-CV-00005-RLY, 2011 WL 4402602 (S.D. Ind. September 22, 2011) (“[T]he United States Supreme Court had ruled in Wyeth v. Levine that state law claims against manufacturers of brand name drugs for failure to warn are not preempted by federal law. … In June, the Supreme Court held in PLIVA, Inc. v. Mensing that its holding in Wyeth did not extend to manufacturers of generic drugs. In other words, the Court found that state law claims against manufacturers of generic drugs for failure to warn are preempted by federal law.” (citations omitted)).
93.
See Wyeth v. Levine, 129 S. Ct. 1187, 1197 (2009).
94.
Smith v. Wyeth, Inc., No. 09–5460, 2011 WL 4389211 (6th Cir. September 22, 2011) (“The Supreme Court held unequivocally, however, that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug's label, thus barring the plaintiffs' state-law tort claims.”).
95.
Mensing, 131 S. Ct. at 2576 (citing Brief for the United States Supporting Mensing, supra note 15, at 18).
96.
Brief for the United States as Amicus Curiae at 17, Nos. 09–993, 09–1039, 09–1501 (8th Cir. 2009), 2010 WL 4339894, at 17 [hereinafter cited as Brief for the United States Urging Denial of Certiorari]. In this amicus curiae brief, the Solicitor General urged the Supreme Court to deny certiorari. The United States brief cited earlier was submitted in advance of oral arguments, after the Supreme Court had granted certiorari.
97.
Id., at 17. See also supra note 22. When a generic company sends out a Dear Doctor letter, is it thus put in a position analogous to a company utilizing the CBE process: In both situations the company is vulnerable to subsequent FDA disapproval. The FDA in both scenarios has permissive, rather than mandatory, authority to withdraw a drug if it is disagrees with the appropriateness of the label change or communication. See id. and Wyeth v. Levine, 129 S. Ct. 1187, 1197 (2009). The Supreme Court expressed skepticism in Wyeth v. Levine over “the very idea that the FDA would bring an enforcement action against a manufacturer for strengthening a warning.” Id. While the Supreme Court discounted any likelihood of the FDA exercising its permissive authority in response to a CBE label change, the FDA's comments regarding the importance of generic companies maintaining consistent labels indicates withdrawal is more than merely a hypothetical repercussion of creating inconsistent labeling, even if a generic manufacturer does so as an incidental byproduct of providing supplemental information. See Brief for the United States Supporting Mensing, supra note 15, at 15–16.
98.
Brief for the United States Urging Denial of Certiorari, supra note 43, at 17.
99.
Brasley-Thrash v. Teva Pharm., Inc., No. 10–00031-KD-N, 2011 WL 4025734 (S.D. Ala. September 12, 2011).
100.
Id., at 1, 3.
101.
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2572 (2011). As of 1985, the Reglan label warned that tardive dsykinesia “may develop” in patients, and that use of the drug for longer than 12 weeks had “not been evaluated and cannot be recommended.” In 2004, the brand-name manufacturer of Reglan asked the FDA to approve its proposal to strengthen the warning label, and the FDA approved a new label stating that use of the drug “should not exceed twelve weeks.” The FDA on its own initiative sought a more stringent warning in 2009, and ordered the addition of a black box warning cautioning that “[t]reatment with metoclopramide can cause tardive dyskinesia … [and treatment] for longer than 12 weeks should be avoided in all but rare cases.” Id. at 2572–73.
102.
Brasley-Thrash, 2011 WL 4025734, at 1.
103.
Id., at 2.
104.
Id. (quoting 21 U.S.C. § 355–1(i) (2007) (“A drug that is the subject of an abbreviated new drug application under section 355(j) of this title is subject to only the following elements of the risk evaluation and mitigation strategy required under subsection (a) of this section for the applicable listed drug: For an applicable listed drug for which a drug is approved under section 355(j) of this title, the Secretary – (A) shall undertake any communication plan to health care providers required under subsection (e)(3) of this section for the applicable listed drug; and (B) shall inform the responsible person for the drug that is so approved if the risk evaluation and mitigation strategy for the applicable listed drug is modified.”)).
105.
Id., at 3.
106.
Id. (quoting Brief for the United States Urging Denial of Certiorari, supra note 43, at 17–18).
107.
Id.
108.
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2577 (2011).
109.
Brasley-Thrash, 2011 WL 4025734, at 3. The District of South Carolina has also indicated some receptiveness to this claim. See Fisher v. Pelstring, No. 4:09-CV-00252-TLW, 2011 WL 4552464, at 8–9 (D. S.C. September 30, 2011) (denying defendant PLIVA's motion for summary judgment because a jury could find that PLIVA should have done more to warn the plaintiff's prescribing physician about metoclopramide's risk of tardive dyskinesia, including sending a Dear Doctor letter describing recent label changes to Reglan and its generic counterparts).
110.
U.S. Department of Health and Human Services, Office of Inspector General, “Exclusions Program,”available at <http://oig.hhs.gov/exclusions/index.asp> (last visited February 2, 2012).
111.
Id. The OIG has permissive exclusion authority over: “misdemeanor convictions related to healthcare fraud other than Medicare or a State health program, fraud in a program (other than a healthcare program) funded by any Federal, State or local government agency; misdemeanor convictions relating to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances; suspension, revocation, or surrender of a license to provide healthcare for reasons bearing on professional competence, professional performance, or financial integrity; provision of unnecessary or substandard services; submission of false or fraudulent claims to a Federal healthcare program; engaging in unlawful kickback arrangements; and defaulting on health education loan or scholarship obligations; and controlling a sanctioned entity as an owner, officer, or managing employee.” Office of Inspector General, Exclusions Program, available at <http://oig.hhs.gov/exclusions/index.asp> (February 2, 2012).
U.S. Department of Health and Human Services, Office of Inspector General, The Effect of Exclusion From Participation in Federal Health Care Programs, September 1999, available at <http://oig.hhs.gov/exclusions/effects_of_exclusion.asp> (last visited February 2, 2012).
114.
U.S. Department of Health and Human Services, Office of Inspector General, Exclusions Program, available at <http://oig.hhs.gov/exclusions/index.asp> (last visited February 2, 2012).
115.
See U.S. Department of Health and Human Services, supra note 4.
116.
42 USC § 1320a-7(b)(15).
117.
Managing employee is defined in this section as “an individual, including a general manager, business manager, administrator, and director, who exercises operational or managerial control over the entity, or who directly or indirectly conducts the day-to-day operations of the entity.” 42 USCS § 1320a-5(b).
118.
42 USC § 1320a-7(b)(15).
119.
42 USC § 1320a-7(b)(15).
120.
United States v. Park, 421 U.S. 658, 670.
121.
United States v. Park, 421 U.S. 658, 670.
122.
Id., at 671.
123.
Id., at 672.
124.
Id., at 668, citing United States v. Dotterweich, 320 U.S. 277, 280.
In 2008, the OIG excluded 3 former executives of Purdue Frederick, based on their status as responsible corporate officers, for their convictions resulting from the pharmaceutical company's misbranding of the painkiller Oxycontin. See Morris testimony. The executives have appealed their exclusion (which was under §1320(a)(7) (b)(1) and (b)(3)). See HeiseyGucciardo, supra note 27. These convictions (under 42 U.S.C. § 1128(b)(1) and 42 U.S.C. § 1128(b)(3)) were upheld by the US District Court for the District of Columbia in Friedman, et al., v. Sebelius, Civil Action No. 09–2028 (D.C. Dec. 13, 2010).
U.S. Attorney's Office, Eastern District of Michigan, “Eighteen Charged for Medicare Fraud Schemes Detroit Involving $28 Million in False Billings,” September 1, 2011, available at <http://www.justice.gov/usao/mie/news/2011/2011_9_1_medicare_fraud.html> (last visited February 2, 2012).
