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.
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
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.
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
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.
That means everyone’s potentially in trouble if their quantities vary from what some government medical expert might say is right
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
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
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.
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.
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
the government team was so far off base in bringing charges against our client that they should be sanctioned for their inappropriate behaviors. The government’s chief medical expert should be disciplined by his licensing board and any professional society to which he belongs.
Bad law is made when government representatives misuse their power. Fortunately, the federal judge in this case knew the law and gave the correct jury instructions, making it easy for the jury to take the facts and arrive at the correct decision
You know you are in trouble, even with a not-guilty verdict, when government representatives tell a jury that all people who use pain medication become addicts, that all our client did was make addicts out of these people. That is exactly what the prosecutor said in the final argument. If this doctor had been convicted, it would have been open season for any caregivers in this area.