Characteristics of Lawsuits against Physicians Charged with Opioid-Related Crimes in the United States, 1995-2019

Background: Pharmaceutical companies and drug distributors are intensely scrutinized in numerous lawsuits for their role in instigating the opioid epidemic. Many individual physicians have also been held accountable for activities related to prescribing opioid medications. The purpose of this study was to examine the epidemiologic patterns of lawsuits against physicians charged with opioid-related crimes in the United States. Methods : We searched the Nexis Uni ® database for newspaper reports on physicians who had been arrested, indicted or criminally charged for illegally prescribing opioids between January 1995 and December 2019. Data collected from the newspaper reports include defendant’s age, sex, clinical specialty, type of crime and legal consequences. Results : The annual number of lawsuits against physicians charged with opioid-related crimes reported by US newspapers increased from 0 in 1995 to 43 in 2019. Of the 384 physician defendants in these lawsuits, 90.4% were male, 28.0% were 65 years and older (mean=59.5 ± 15.8 years), and 23.4% were charged in Florida. Of the 373 physician defendants with known clinical specialty, 243 (65.1%) practiced in internal medicine, family medicine, or pain management. Of the 248 lawsuits with known outcomes, 244 (98.4%) of the defendants were convicted of criminal charges and 4 were acquitted. Drug tracking was the most commonly convicted crime (accounting for 54.2% of all convicted crimes), followed by fraud (19.1%), money laundering (11.0%) and manslaughter (5.6%). Of the convicted physicians with known sentences, 89.5% were sentenced to jail with an average jail time of 127.3 ± 120.3 months. Conclusions : An increasing number of physicians from a wide variety of clinical specialties is prosecuted for opioid-related crimes with high conviction rates and severe penalties. The most common crime charged is drug tracking, followed by fraud, money laundering, and manslaughter.


Background
Misuse and overdose of opioids is a public health crisis in the United States and many other countries.
The opioid epidemic was triggered in the 1990s by physician overprescribing of opioid analgesics (Brady et al, 2014;Chihuri and Li, 2019;Hedegaard et al, 2020;Li and Chihuri, 2020). While a signi cant proportion of those prescriptions might be well-intentioned, clinical treatment for a variety of pain syndromes, there are some medical professionals who prescribe and dispense opioid prescriptions for personal pro t. It is illegal for physicians to prescribe a controlled substance with no legitimate medical purpose and outside the usual course of professional practice (Rigg et al, 2010). Such physicians can be charged with drug tra cking and face severe legal consequences (Rigg et al, 2010). Many of the physicians and clinics responsible for these illegal prescriptions are known as "pill mills," and common characteristics of which include physicians prescribing narcotics without conducting physical examinations or consulting medical records, allowing patients to pick their own medicine, treating pain with pills only, prescribing a set number of pills and giving the patient a speci c date to return for more, accepting cash only and crowded waiting rooms (Rigg et al, 2011). These physicians have played an important part in perpetuating the opioid epidemic in the United States (Kennedy-Hendricks et al, 2016).
From 1999 to 2018, nearly 450,000 people in the United States died from overdoses involving prescription opioids (CDC, 2020;Hedegaard et al, 2020).
Reducing opioid prescriptions could help limit the overall quantity of opiates being distributed to the communities and thereby decrease the availability and consumption of these addictive drugs. In recent years, pharmaceutical companies and drug distributors have been intensely scrutinized in numerous lawsuits for their role in instigating the opioid epidemic. Many individual physicians have also been held accountable for activities related to prescribing opioid medications. The purpose of this study was to examine the epidemiologic patterns of criminal cases against physicians charged with opioid-related offenses reported in the US news media.

Methods
Nexis Uni ® is an electronic database that houses an archive of public record documents, such as full-text newspapers, business and legal publications, and journals. An initial search was conducted on the database with search terms "overprescribing opioids", "overprescribe opioids", "overprescribed opioids", and "pill mill." The search was re ned with terms ("doctor" or "dr." or "MD") AND ("sentenced" or "charged" or "convicted" or "sentence" or "charge") AND ("years" or " ned" or "months" or "prison") AND ("pill mill") AND ("opioid" or "narcotic" or "drugs") and limited to publications released after January 1 st , 1995. The database was queried with these terms so as to identify newspaper articles that reported incidents of physicians overprescribing opioids since 1995. The search yielded over 2,000 results of full-text newspapers and court reports, which were manually examined to extract a list of physicians, who, according to the news media reports, had been arrested, criminally charged, or indicted for illegally prescribing opioids. Duplicate physicians were manually excluded by reviewing names.
Next, individual searches for each physician were executed on Nexis Uni ® ; the database was queried using only the physician name, in order to produce narrower, more focused results. From these searches, the following information was ascertained: name, state in which the incident occurred, type of medical facility in which the physician worked (hospital, private practice, etc.), medical specialty, age at the time of incident, sex, type of criminal charge, and outcome of the legal proceeding. Multiple news media reports were examined for each physician. Further, these articles uncovered other physicians who t the search criteria but had not come up in the initial search; these physicians were added to the list. Searches on Google News were carried out for physicians with incomplete information. Data collected from news media reports for each physician involved in these incidents were analyzed using descriptive statistics such as frequencies, percentages, means, and standard deviations.

Results
During January 1995 through December 2019, the US news media reported on a total of 372 physicians who were involved in opioid-related criminal cases, exclusive of 12 physicians involved in civil lawsuits for negligent opioid prescribing behaviors. There were no opioid-related criminal cases against physicians reported in the US news media between 1995 and 1998. Of the 372 criminal cases covered by the US news media, 231 (86.3%) occurred between January, 2010 and December, 2019 (Fig. 1), and nearly a quarter (23.4%) occurred in Florida, followed by Pennsylvania (12.1%), Georgia (6.5%), West Virginia (5.6%), Ohio (5.4%), New York (5.4%) and Tennessee (5.1%).
The vast majority (90.1%) of physicians involved in the criminal cases were male. Ages of the physicians ranged from 33 to 87 (mean=58.6 ± 10.7 years), with 27.4% being 65 years and older. Information on clinical specialty was available for358 physicians. These physicians practiced in a variety of clinical specialties, with25.7% in family medicine, 24.9% in internal medicine, and 17.9% in pain management (Fig. 2).
Nearly all the physicians prosecuted for opioid-related offenses (98.8%) worked in private practices. Of the 250 cases with known outcomes, 246 physicians (98.4%) were convicted and 4 (1.6%) were acquitted. Drug tra cking accounted for 54.2% of the crimes convicted, followed by fraud (19.1%), money laundering (11.0%), manslaughter (5.6%), and other or unknown (10.1%). Of the convicted physicians with known sentences, 85.0% served time in prison, with an average prison term of 127.3 (± 120.3) months and an average probation term of 65.5 (± 61.0) months.

Discussion
Results of this study indicate that criminal cases against physicians charged with opioid-related offenses increased over time between 1995 and 2019, with the majority of the cases occurring between 2010 and 2019. This temporal pattern is generally consistent with the time trend of the opioid epidemic in the United States (Skolnick, 2018;Hedegaard et al, 2020). The geographic pattern of the criminal cases against physicians, however, might be more re ective of enforcement intensity on the state level. For instance, Florida passed laws in 2010 and 2011 that considerably reduced physicians' ability to distribute opioids at the site of care, and subsequently, Florida law enforcement implemented initiatives to arrest and prosecute physicians who did not abide by these laws, resulting in an immediate hike in criminal cases against physicians charged with opioid-related offenses (Kennedy-Hendricks et al, 2015).
Our study also found that the vast majority of physicians involved in these criminal cases were male and worked in private practice. While men are known to be more prone than women to commit crimes due mainly to less self-control (Burton et al, 1998), private practice presents a work environment that is less strictly regulated and supervised than hospitals. It is also noteworthy that over a quarter of the criminal cases included in the study involved physicians aged 65 years and older. As of 2018, about 17% of US physicians were older than 65 years. The overrepresentation of older physicians in opioid-related criminal cases is likely multifactorial, including inadequate training in pain management and heightened risk associated with the private practice environment. Further, physicians involved in opioid-related criminal cases reported in the US news media came from a broad range of clinical specialties, underscoring the needs for continuing education and vigilance about adherence to best practice and clinical guidelines in the entire medical community. It is evident that physicians with higher quality medical education are less likely to overprescribe opioids than their counterparts with lower quality medical education (Schnell and Currie, 2017). This study is limited by the availability of information in the news media reports. Although news media has long been used for sentinel surveillance on infrequent, newsworthy events, such as drowning involving children with autism (Guan and Li, 2017) and alcohol-impaired airline pilots (Kraus and Li, 2006), they tend to capture the more severe incidents (Rainey and Runyan, 1992). Therefore, our ndings are likely biased toward criminal cases involving serious offenses. Finally, our study was limited to physicians criminally charged with opioid-related offenses. It is necessary to point out that many other advanced healthcare practitioners are also prescribers of opioid analgesics and thus are susceptible to the same legal risk as physicians.

Conclusions
Our study sheds light on the issue of legal liability and accountability of physicians amid the opioid epidemic. The results suggest that there have been increasing prosecutions for opioid-related crimes against physicians in the past decade, with severe legal consequences such as long-term prison sentences. The most commonly convicted offense in these criminal cases is drug tra cking (i.e., illegal distribution of controlled substances), followed by fraud, money laundering, and manslaughter. These ndings underscore the increased scrutiny and prosecution of physicians for opioid-related offenses in recent years. Although criminal cases included in this study may involve only the most unscrupulous physicians who seek pro ts over patient safety, the severe legal consequences should serve as a warning to all practitioners.

Declarations
Role of funder/sponsor