The Fourth Circuit Court of Appeals’ decision in United States v. Hurwitz: An important victory for pain management professionals and those living with pain
DOI:
https://doi.org/10.5055/jom.2006.0039Keywords:
-Abstract
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Several groups or stakeholders filed amicus curiae (“friends of the court”) briefs with the Fourth Circuit. The American Academy of Pain Medicine filed such a brief in an effort to set forth the interests of its members. I believe this brief, and others, had a large impact on the Fourth Circuit’s decision in this case and certainly helped the appellate court understand the larger interests at stake. This is significant because of the nature of the expert witness testimony during the Hurwitz trial and its potential impact on the pain management community as a whole.
Federal appellate courts are referred to by circuit number. For example, the Fourth Circuit Court of Appeals covers multiple states, and the federal district courts within each of those states feed into the Fourth Circuit according to federal law and the rules of appellate procedure. By example, the State of Virginia has two federal districts—Eastern and Western—and a defendant’s appeal of a jury trial conviction in either of those districts goes to the Fourth Circuit Court of Appeals. The basic order of the federal criminal court system is 1) district court (trial), 2) court of appeals (appeal), and 3) US Supreme Court (assuming there is a prerequisite for Supreme Court jurisdiction). If you want more information on the specifics of the federal court system, see www.uscourts.gov.
The government is not the only source of problem expert testimony in this area. There are many examples of civil cases against pharmaceutical companies and physicians brought by plaintiffs’ attorneys whereby medical experts support lawsuits founded on “you got me addicted” or “you caused my daughter/son to overdose and die” allegations. Any party or expert putting forward allegations that lack the support of generally accepted standards of care jeopardizes the pain management community.
This may also be stated as expert testimony that fails to recognize the lack of literature on a specific issue when the issue has not been studied or has only recently been identified or that fails to recognize the many approaches to pain management and the varied state laws and regulations on the use of controlled substances to treat pain.
Released September 6, 2006, and available at www.dea diversion.usdoj.gov or through links set up on my Web site at www.legalsideofpain.com.
Hurwitz, 2006 US App. LEXIS 21425 (August 22, 2006).
When a sentence is vacated, it means that it is set aside. However, in this case this is a temporary situation, because the Fourth Circuit also sent the case back to the district court for a new trial with instructions that the trial judge follow the law regarding the use of the proper jury instructions. The government is very likely to retry this case, unless Hurwitz can convince the government that it will have big problems during the retrial with expert testimony, the concept of good faith, and the pain management community’s current accepted standards of care on the use of high-dose opioid therapy. The government can use its old charges against Hurwitz in the second trial, or it can use a “superseding indictment” and proceed against Hurwitz in a slightly different manner. The government’s decision will likely be based on how it views its expert testimony at this point, and given all the potential points of attack that this expert or one like him will face, the government’s decision will be more difficult the second time around, especially now that it must operate under the law that it knew existed from the very beginning: the objective good faith standard.
The Fourth Circuit acknowledged that the more challenging issue is the government’s claim that the trial evidence so “overwhelmingly demonstrated that Hurwitz was acting well beyond the bounds of accepted medical practice that the jury could not reasonably have found that he acted in good faith.” In rejecting the government’s claim, the Fourth Circuit said that “while the government’s evidence [in Hurwitz] was powerful and strongly indicative of a doctor acting outside the bounds of accepted medical practice, we cannot say that no reasonable juror could have concluded that Hurwitz’s conduct fell within an objectively-defined good-faith standard.” Significantly, the Fourth Circuit pointed out that Hurwitz presented expert testimony showing that it was proper to use opioids when treating addicts who suffered from pain, that Hurwitz’s high-dose opioid therapy was a medically appropriate way to treat intractable pain, and that the quantities of opioids he prescribed were appropriate. “Even as to the patients whose dosages appeared extraordinarily high, such as the patient who was prescribed over 500,000 pills during the course of his treatment, the record contains expert testimony showing that Hurwitz’s treatment and the quantities of opioids prescribed was medically proper.” The Fourth Circuit cited other evidence at trial supporting Hurwitz’s position on the good faith jury instruction, including Hurwitz’s testimony about his own practice, his use of medical history questionnaires, discussions with other physicians outside his practice about accepted procedures, and Hurwitz’s reliance on information obtained at professional medical conferences. The Fourth Circuit believed the trial court effectively deprived the Hurwitz jury of the opportunity to consider Hurwitz’s defense. Although it recognized that the government’s evidence against Hurwitz “was strong,” the Fourth Circuit said it could not “conclude that the district court’s error in removing the good faith from the jury’s consideration was harmless.” Thus, it concluded that good faith is relevant to Section 841 charges against a registered physician and that the trial court erred by incorrectly instructing the jury that Hurwitz’s good faith was relevant only to the healthcare fraud charges. On remand, the Fourth Circuit specifically told the district court to include a good faith instruction using an objective standard (if requested by Hurwitz and if supported by the evidence presented at retrial).
Health plan providers may be one of the largest stakeholder groups and continue to make decisions that, in many ways, impede physicians’ ability to both comply with the laws and regulations on controlled substance prescribing and care for patients according to generally accepted standards of care in the pain management community, especially regarding the long-term use of controlled substances to treat pain alone or in special patient populations.
See 21 USC § 822(b).
21 CFR 1306.04(a)(2006).
21 USC 841(a)(1).
The same argument would apply to the Section 846 charge of conspiracy because the elements are essentially the same.
At trial, the district court did give a good faith instruction to the jury on the two healthcare fraud charges against Hurwitz and told the jury that “it could not convict Dr. Hurwitz if he ‘acted in good faith in dispensing any of the prescriptions alleged to constitute the crime of healthcare fraud.’” However, the trial court also told the jury that “good faith applies only” to the healthcare fraud counts, and “not only declined to give a good-faith instruction with regard to the drug counts, but also informed the jury that it could not consider good faith when deciding whether to convict Hurwitz of drug trafficking under Section 841.” The Fourth Circuit held that the trial court’s actions further supported its decision to reverse the case because of legal error.
United States v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995); see also Alerre, 430 F.3d at 689-690; United States v. Daniel, 3 F.3d 775, 778 (4th Cir. 1993); United States v. Tran Trong Cuong, 18 F.3d 1132, 1141 (4th Cir. 1994). Note: according to the Hurwitz court, the issue of whether the defendant’s actions were for legitimate medical purposes or were beyond the bounds of medical practice is not an essential element of a § 841 charge against a doctor (see United States v. Steele, 147 F.3d 1316, 1318 [11th Cir. 1998] [en banc]; United States v. Polan, 970 F.2d 1280, 1282 [3rd Cir. 1992]; United States v. Seelig, 622 F.2d 207, 211-212 [6th Cir. 1980]).
Moore, 423 US at 142 n.20.
Here are the cases cited by the Fourth Circuit in Hurwitz: Alerre, 430 F.3d at 692 (noting that “the jury was correctly instructed on the applicable legal principles,” and that the jury was instructed that the defendant-doctors “could not be convicted if they had dispensed the controlled substances at issue ‘in good faith’”); United States v. Hughes, 895 F.2d 1135, 1141-1142 (6th Cir. 1990) (citing Moore’s standard that physicians can not be convicted if they “dispens[e] controlled substances in the course of professional practice” and explaining that “[b]ecause Dudley was a licensed physician, the jury could not find him guilty of distributing controlled substances, as long as he acted in ‘good faith’”); United States v. Vamos, 797 F.2d 1146, 1151 (2nd Cir. 1986) (“[T]he doctor must act in the good faith belief that his distribution of the controlled substance is for a legitimate medical purpose and in accordance with the usual course of generally accepted medical practice”); United States v. Hayes, 794 F.2d 1348, 1351-1352 (9th Cir. 1986) (finding no error in the charge that required the jury to determine that the physician acted other than in good faith and defined good faith as “an honest effort to prescribe for a patient’s condition in accordance with the standard of medical practice generally recognized and accepted in the country”); United States v. Norris, 780 F.2d 1207, 1209 n.2 (5th Cir. 1986) (finding proper the district court’s instruction to the jury that “[a] controlled substance is prescribed by a physician in the usual course of a professional practice, and, therefore, lawfully, if the substance is prescribed by him in good faith, medically treating a patient in accordance with a standard of medical practice generally recognized and accepted in the United States”); United States v. Carroll, 518 F.2d 187, 189 (6th Cir. 1975) (reversing conviction because the trial court “did not advise [the jury] that physicians are exempt from the provisions of the drug abuse statute when they dispense or prescribe controlled substances in good faith to patients in the regular course of professional practice”).
Hurwitz, 2006 US App. LEXIS 21425 (August 22, 2006), quoting Vamos, 797 F.2d at 1151, 1153; see also United States v. Williams, 445 F.3d 1302, 1309 (11th Cir. 2006) (“Williams’s proposed instruction fails to introduce any objective standard by which a physician’s prescribing behavior can be judged. Under Williams’s proposed instruction, if it is a physician’s subjective belief that he is meeting a patient’s medical needs by prescribing that patient a controlled substance, then that physician cannot be convicted of violating the Controlled Substances Act even if he acts outside all accepted standards of medical practice. Thus, the proposed instruction is contrary to Moore.”); Norris, 780 F.2d at 1209 (rejecting defendant’s claim “that a standard medical practice may be based on an entirely subjective standard” because “[o]ne person’s treatment methods do not alone constitute a medical practice”); 3 Leonard B. Sand et al., Modern Federal Jury Instructions, Instruction 56-19, comment (2003) (“Every court to examine the issue has held that the objective standard that the doctor acted in accordance with what he reasonably believed to be proper medical practice should apply.”).
See references in the note above. This argument can easily be applied to government experts who substitute their own views of what is good medical practice for standards generally recognized and accepted in the United States, which would weaken pain management; see note 20 below and related text.
Specifically, the government hired Michael Ashburn, MD, as its medical expert. Ashburn testified that it was his expert opinion that the daily ceiling dose of opioids is 195 mg morphine equivalent and that physicians are limited by law to prescribing a 30-day supply of any Schedule II controlled substance. Medical experts testifying on Dr. Hurwitz’s behalf and those who wrote the trial judge during the sentencing phase of Hurwitz’s case took a strong stance against Ashburn’s position, stating that it did not accurately reflect generally accepted standards of care among pain professionals. My purpose in pointing this out is not to “pick on” Dr. Ashburn but to illustrate the damage that can be done when one testifies without doing so according to generally accepted standards of care or the good faith standard discussed by the Fourth Circuit in the Hurwitz opinion. A careful reading of Dr. Ashburn’s testimony before the jury reveals he sometimes used a subjective standard of care in pain management or even a specific rule of law applicable to physicians in Utah (where Dr. Ashburn practiced) but not in Virginia (where Dr. Hurwitz practiced), referring to the 30-day limit on a Schedule II controlled substance prescription. This is significant because testimony like this has the ability to mislead a jury into thinking that such a limit applies nationwide (whether a daily or monthly dosage limit). The DEA has recently stated that every patient’s case is different, and state laws on this issue vary. Better yet, the DEA has acknowledged—and the Hurwitz prosecutors should have known—that the federal law does not have a monthly dosage quantity limit when it comes to Schedule II medications. Because of the Fourth Circuit’s decision, the pain management community is in a better position to stand up to government medical experts who take positions contrary to generally accepted standards of care in their field and to set the record straight so that in future cases their prescribing rights are not jeopardized.
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