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When is a Physician a Drug Pusher… Standard of Care is the Best Defense

Standard of Care is the Best Defense

The CSA makes it a crime for a person to unlawfully dispense or distribute a Schedule II controlled substance and provides for a maximum sentence of twenty years of imprisonment. To convict a doctor for violating 21 U.S.C. § 841, the Government must prove: “(1) that the defendant distributed or dispensed a controlled substance; (2) that the defendant acted knowingly and intentionally; and (3) that the defendant’s actions were not for legitimate medical purposes in the usual course of his professional medical practice or were beyond the bounds of medical practice.” Ignasiak, 667 F.3d at 1228; Tobin, 676 F.3d at 1279-80 (internal quotation marks and alteration omitted). “[G]ood faith is a defense to a charge [against a physician] under § 841(a)(1),” United States v. Merril, 2008 U.S. App. Lexis 982, but good faith must be evaluated by an objective, not a subjective, standard, United States v. Williams, 445 F.3d 1302, 1309 (11th Cir. 2006).

In United States v. Rosen, the Court held that conduct that suggests that a defendant distributed a prescription without a legitimate medical purpose and outside the usual course of professional practice includes conduct where “an inordinately large quantity of controlled substances was prescribed; large numbers of prescriptions were issued; no physical examination was given; the physician issued prescriptions to a patient known to be delivering the drugs to others, and there was no logical relationship between the drugs prescribed and treatment of the condition.” 582 F.2d 1032, 1036 (5th Cir. 1978); United States v. Joseph, 709 F. 3d 1082.

The Eleventh Circuit upheld a conviction against a physician based on evidence that the prescriptions he issued were “excessive and inappropriate quantities and combinations of controlled substances and that in doing so he acted “outside the usual course of professional practice.” United States v. Merril, 2008 U.S. App. Lexis 982. The government could only prove “excessive and inappropriate quantities and combinations” by presenting evidence on the quantities and combinations themselves and then comparing those quantities and combinations to a relevant norm to show that they were excessive and inappropriate.

Moreover, the Eleventh Circuit stated that “[g]ood faith is not merely a doctor[‘s] sincere intention towards the people who come to see him, but rather it involves his sincerity in attempting to conduct himself in accordance with a standard of practice generally recognized and accepted in the United States.” United States v. Williams, 445 F.3d 1302, 1309 (11th Cir. 2006); see also United States v. Lewis, 492 F.3d 1219, 2007 WL 2033823 (11th Cir. 2007) (“Good faith in this context means good intentions in the honest exercise of best professional judgment as to a patient’s need. It means the doctor acted in accordance with what he believed to be proper medical practice”). A finding of good faith requires a verdict of not guilty.  United States v. Moore, 423 U.S. 122, 139, 96 S. Ct. 335, 46 L. Ed. 2d 333 (1975).

Recent 11th Circuit cases

Although “legitimate medical purpose” and “usual professional practice” are not defined in the Controlled Substances Act or its regulations, courts have refused to find the language void for vagueness. Whether a doctor’s act exceeds the bounds of professional practice, therefore, is determined on a case-by-case basis.  Id.

Information a finder of fact can consider in determining whether a doctor is not acting for a legitimate medical purpose includes “evidence that a doctor warns his patients to fill their prescription at different drug stores, prescribes drugs without performing any physical examinations or only very superficial ones, or ask[s] patients about the amount or type of drugs they want. . . .[However, t]hese examples are neither conclusive nor exhaustive.”  Tran Trong Cuong, 18 F.3d at 1138.

In Orta-Rosario, for example, a finding that the defendants’ acts were beyond the bounds of professional practice, was supported by evidence that the defendants did not conduct any physical examinations before prescribing controlled substances over the Internet,[1] defendants permitted non-medical personnel to write prescriptions with pre-signed blank prescription forms, the dosage amounts were questionable, and liberal prescription refills were not based on legitimate medical purposes. Id. at 144.  In United States v. Moore, 423 U.S. 122 (1975), the U.S. Supreme Court found that a jury’s conclusion that the defendant’s “conduct exceeded the bounds of ‘professional practice’” was supported by evidence that: he gave inadequate physical examinations or none at all. He ignored the results of the tests he did make. He did give methadone at the clinic and took no precautions against its misuse and diversion. He did not regulate the dosage at all, prescribing as much and as frequently as the patient demanded. He did not charge for medical services rendered but graduated his fee according to the number of tablets desired. In practical effect, he acted as a large-scale “pusher”, not as a physician.

Id. at 142–43.[2]  Similarly, in McIver, the defendant’s conviction for unlawful distribution of controlled substances was supported by evidence that he:

[1] In Orta-Rosario, defendants were prosecuted for their role in the sale of controlled substances over the Internet.  21 U.S.C. § 829(e)(2)(A)(i) defines a valid prescription, in part, as one issued by a practitioner who has “conducted at least 1 in-person medical evaluation of the patient.” Except in the case of Internet sales, there is no specific requirement in the Controlled Substances Act or the regulations as to the need for face-to-face meetings with the patient. Thus, those standards are determined by evidence of generally accepted practice in the United States.

[2] The “large scale pusher” language is often referenced by courts upholding a conviction, apparently to show just how horrible the doctor’s actions are. See, e.g., United States v. McIver, 470 F.3d 550, 564 (4th Cir. 2006), cert. denied, 550 U.S. 936 (2007) (“This evidence amply supports a finding that McIver’s actions went beyond the legitimate practice of medicine and were ‘no different than [those of] a large-scale pusher’”) (citation omitted). Arguably, a physician does not step beyond the bounds of legitimate professional practice unless he acts as a large scale drug pusher.

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[1] In Orta-Rosario, defendants were prosecuted for their role in the sale of controlled substances over the Internet.  21 U.S.C. § 829(e)(2)(A)(i) defines a valid prescription, in part, as one issued by a practitioner who has “conducted at least 1 in-person medical evaluation of the patient.” Except in the case of Internet sales, there is no specific requirement in the Controlled Substances Act or the regulations as to the need for face-to-face meetings with the patient. Thus, those standards are determined by evidence of generally accepted practice in the United States.

[1] The “large-scale pusher” language is often referenced by courts upholding a conviction, apparently to show just how horrible the doctor’s actions are.  See, e.g., United States v. McIver, 470 F.3d 550, 564 (4th Cir. 2006), cert. denied, 550 U.S. 936 (2007) (“This evidence amply freely distributed prescriptions for large amounts of controlled substances that are highly addictive, difficult to obtain, and sought after for nonmedical purposes. For one patient, he prescribed more than 20,000 pills in a single year. He prescribed drugs to patients that he either knew or had reason to believe would not take them as directed. Some of his patients were drug addicts who sought treatment from him specifically to obtain controlled substances to use or to sell. That Appellant knew or suspected his patients of drug abuse is reflected by the fact that he wrote to state authorities to express concern that his patients might be selling their medications. Appellant exercised minimal medical oversight of his patients’ dosing practices. He ignored evidence of the danger of prescribing drugs to certain patients, the drug-seeking behavior of others, and the drug abuse of still others. After several of the Appellant’s patients stopped seeing him, they suffered significant drug withdrawal effects, at least in one instance requiring hospitalization. Dr. Storick testified at length about the extent to which the Appellant’s procedures went beyond the parameters of legitimate medical practice.

470 F.3d at 564 (record references omitted).

Finally, in Tran Trong Cuong the court found that there was sufficient evidence to support 52 charges that a physician illegally distributed controlled substances based on evidence that the defendant prescribed controlled substances for patients complaining of “such nebulous things as headaches, neck aches, backaches and nervousness, conditions that normally do not require the prescription of controlled substances initially, and certainly not over a period extending for many months and in some cases for years.”  18 F.3d at 1139. The defendant “was also aware that some of these patients were obtaining the same drugs from other doctors. Most of the patients were given very superficial physical examinations and even after months of the same complaints of pain and the same prescriptions of drugs, they were not given more complete examinations, nor were they subjected to x-rays or blood analysis or referred to specialists in an effort to identify and correct the cause of the pain.”  Id. Many patients were addicts or became addicts due to the defendant’s treatment. Some even asked for drugs by their street names.  Id. at 1139-40. However, in spite of the wealth of evidence against the defendant on these 52 charges, the court reversed the convictions because the Government improperly elicited testimony about the defendant’s reputation as an easy source of prescription drugs, id. at 1136-37, and the court erroneously permitted the Government’s expert to bolster his opinion evidence by testifying that his conclusions as to the defendant’s actions were “essentially the same” as those of another expert who did not testify and whose report supports a finding that McIver’s actions went beyond the legitimate practice of medicine and were ‘no different than [those of] a large-scale pusher'”) (citation omitted). Arguably a physician does not step beyond the bounds of legitimate professional practice unless he acts as a large-scale drug pusher was not introduced into evidence, id. at 1143-44. Moreover, calling it “a classic example of ‘overkill’ by the prosecution,” id. at 1142, the Court dismissed 80 additional charges for lack of evidence that the defendant’s actions were not for legitimate medical purposes in the usual course of his professional medical practice or beyond the bounds of medical practice. The decisive factor seems to be that the individual patients did not testify as to these 80 counts. The Government’s case on those charges consisted on expert testimony on the standard of care, copies of the prescriptions, and a report summarizing the medical expert’s examination of 33 patient files taken from the defendant’s office.  Id. at 1141.

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Juan Santos, JD, LL.M. is a senior healthcare litigator working out of our Miami office. Mr. Santos dedicates his legal career to helping professionals facing criminal prosecution and civil fraud or compliance charges, as well as professional licensing and peer review matters. Mr. Santos can be reached by calling 305-712-7177.

Ronald W. Chapman, Sr. MPA, JD, LL.M. is the founder and shareholder of Chapman Law Group. Mr. Chapman has defended thousands of health care providers in his 30+ year career. Mr. Chaman is licensed in Michigan and Florida and actively practices in both states. Mr. Chapman is rated AV by Martin Dale Hubbell, Superlawyers, and was awarded the distinguished leadership in law recognition. Mr. Chapman handles criminal as well as civil health care matters including False Claim, Anti-kickback, Stark, overprescribing/distribution charges, as well as compliance, peer review, credentialing and other healthcare related matters. Mr. Chapman can be reached by calling 41-893-3449 or 248-644-6326