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Board-certified Doctor Cleared of Criminal Charges for High-dose Opioid Prescribing

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Editor’s Note: The case of United States v. Roggow is clearly the most important legal case in recent times concerning the prescribing of opioids by physicians. Its derivation was caused by a much-needed federal and state crackdown on the Oxycontin (oxycodone) pill mills in Florida. These operations were blatant, obvious, and would likely have been prevented by most other states. Debra Roggow, MD, just happened to be a legitimate and accomplished pain practitioner in Fort Myers, Florida, who had a few patients requiring high-dose opioids. In fact, one of her patients required about 40 hydromorphone tablets per day. The federal government tried unsuccessfully to claim that a high opioid dosage, per se, was criminal and caused addiction. Fortunately, Dr. Roggow kept excellent records and was able to show the jury that she systematically documented a need for these unusual patients. We owe Dr. Roggow a debt of gratitude for practicing excellent pain medicine in that she tailor-made a regimen for each patient based on severity and was able and willing to prove this to the outside world. The jury in this case made the profound judgment that high-dose opioids are necessary in some cases and they don’t cause addiction when properly prescribed.

In this exclusive interview, Practical Pain Management spoke with Jennifer Bolen, JD, who was hired by Dr. Roggow and her local legal counsel as an expert attorney to handle medical expert issues and jury instructions. Ms. Bolen spoke with us about the significance of this case and what it means for pain practitioners. Other members of the trial team included Amira Dajani Fox, Esq; Lee Hollander, Esq; Howard Heit, MD - Expert Witness; Keith Susko, MD - Consulting Expert; Eric Vinsant, JD; Forest Tennant, MD, DrPH - Consulting Expert; Lindsey Lyle, JD Candidate 2014, assistant to Ms. Bolen; Kaitlin Fox, JD Candidate 2015, assistant to Ms. Fox.

PPM: Can you please give us a brief background on the case? What was the basic premise?

Ms. Bolen: The case was against a physician who was board certified in physical medicine and rehabilitation. Initially, the case was brought as a federal criminal complaint based on the word, or affidavit, of a local police officer, who was serving on a federal drug task force. That same police officer later presented testimony to a federal grand jury, resulting in the indictment of Dr. Roggow. The indictment charged the doctor with 10 counts of drug trafficking claiming that she inappropriately prescribed prescription drugs (opioids). There were no quantities mentioned in the indictment, but the case was about the physician’s prescribing patterns, and the government focused on dose (high dose), combination drug therapy, and chronicity of prescribing. Several indictment counts covered 10 or more years per patient file.

PPM: Why is this case so relevant to practicing pain physicians?

Ms. Bolen: It’s relevant for several reasons. I believe this is the only case in the country to date brought against a board-certified physician. [Most drug trafficking charges have been brought against licensed physicians running pill mills.] The government looks at [medical pain management] as if there’s something wrong when a physician hits a certain quantity (dosage) or hits a certain timeframe of prescribing. [This type of assessment] should be a concern for all physicians. In this case, however, the physician kept very good medical records and regularly performed physical examinations and monitored her patients for functional improvements and drug side effects. Had this not been the case, you might be better able to understand how the case could be brought.

It’s like a rabbit trail; someone has the government focused on the quantities and chronicity of prescribing and that isn’t really where they should focus. I know they have to start somewhere, but somebody’s going to be the high prescriber, whether they are board certified or not. That means everyone’s potentially in trouble if their quantities vary from what some government medical expert might say is right. It has a very negative effect on clinicians—[a chilling effect on prescribing opioids].

This is not to say high-dose opioid therapy is right for everyone; that has to be individualized. But who’s to say what high dose is? That’s a huge concern. The level the government thinks triggers the allegation of drug trafficking is a moving target because it depends on who the government’s medical expert witness is. In reality, there is no ceiling dose on opioid therapy and there is not sufficient literature to identify a common ground for high-dose opioid therapy. Even if a group picks a number for high-dose opioid therapy, say 200 mg morphine equivalent daily dose as the American Academy of Pain Medicine and the American Pain Society did in their 2009 clinical guidelines, that does not mean the dose is criminal; if the government thinks it is, then we’ll continue to have board-certified doctors indicted in federal criminal court.

PM: We understand the jury took very little time deliberating this case. Why did the jury exonerate this physician so rapidly?

Ms. Bolen: The jury was trying to send a message to the government that they did not believe the evidence showed anything close to drug trafficking. They don’t want the government to interfere with bona fide patient-physician relationships. Our client exercised good faith in her efforts to follow Florida pain standards in existence at the time, and this negates criminal intent. At the worst, this case belongs in front of a licensing board if there was an issue regarding quantity and chronicity of prescribing, not in the hands of the federal government. It is my belief that the jury understood this and wanted the federal government to know that cases about licensing board standards belong before the licensing board rather than wasting taxpayer money in federal criminal court. I also believe the jury was sending a signal to the government’s main medical expert.The facts revealed that his expert witness report was inaccurate and incomplete, and his testimony revealed that he relied solely on what the government agent told him about the case. Such reliance presents ethical and legal challenges that should be considered by all.

PPM: What are the lessons of this case for physicians who prescribe opioid drugs?

Ms. Bolen: Physicians need to stay current with their state licensing board practice standards. Make sure your documentation spells out your rationale for starting, continuing, and stopping controlled medications, like opioids. Make sure you discuss the risks and benefits of these therapies with the patient and document that discussion and process, not just in the original treatment agreement—it should go beyond that. Understand the importance of following your state standards. What saved this physician, in my opinion, was that her documentation was so darn good. You could tell why she was prescribing the medications she chose; she was really doing examinations on her patients. She personalized her patient care and her medical records proved it. Because of her excellent documentation, we were able to make those records come alive in the courtroom and show the jury that our client was a real doctor treating people with very real pain problems.

We need to do more to encourage licensing boards to set clear-cut boundaries about compliance with pain management practice standards so it’s easier for law enforcement to discern a criminal case from an administrative one. In saying this, I am referring to the steps a licensing board expects a doctor to take before prescribing and during the physician-patient relationship, which involve ongoing use of controlled medications, and examples of the type of records the board wants to see in the file. Simply saying informed consent is not sufficient because everyone attaches a separate meaning to that phrase. In this court case, our client actually had informed consent right–she had a process and not just a piece of paper (often mislabeled as a treatment agreement); she actually engaged in a discussion with the patient about the risks and benefits of using opioid therapy, the available treatment alternatives, and special issues associated with such therapy, and she documented this discussion and follow up in a way that allowed the jury to see right into her examination room in a figurative sense.

PPM: How did you get involved in this case?

Ms. Bolen: I got called by the doctor’s local attorney. My name was given to them as someone who specializes in these types of cases. I was brought in to handle expert witness cross and direct examinations, and jury instructions, and to help local legal counsel understand the language and particulars of pain management. Essentially, I was a translator for our client and her local lawyers, helping them navigate the medical and legal worlds of pain management.

PPM: What do you think your greatest contribution to this case is?

Last updated on: October 4, 2012
First published on: September 1, 2012