FROM THE LAWHERN FILES
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, ESTHER HYATT PH.D., IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF PATRICIE LUMUMBA, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD., LEROY BAYLOR, BEVERLY C. PRINCE FACS, MD., ADRIENNE EDMUNDSON, NATASHA DUVALL PHARMD., WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“Dr. Xiulu Ruan practiced medicine as a board-certified pain specialist in Mobile, Alabama. His practice served almost 8,000 patients and employed 57 people. In 2016, he was indicted for unlawfully distributing controlled substances (opioids) and many related criminal charges. At his trial, the government argued that some of Dr. Ruan’s prescriptions fell “outside the usual course of treatment” and called numerous experts to testify to that claim. Dr. Ruan countered with his own experts who testified that his prescriptions were medically valid.
A jury convicted Dr. Ruan based on jury instructions that did not include a “good-faith” defense for doctors who truly believe they are practicing good medicine. The Eleventh Circuit, unique among all the circuits, does not allow a good-faith defense, meaning doctors can be convicted of serious crimes—Dr. Ruan was sentenced to 21 years in prison—for merely being negligent in how they write prescriptions. And doctors of course disagree in good faith on the proper standard of care all the time, but malpractice claims adjudicated by civil courts are the proper venues to punish doctors who are merely negligent in their medical practice.
The Eleventh Circuit upheld Dr. Ruan’s conviction and he appealed to the Supreme Court, which agreed to hear his case. Cato has filed an amicus brief in support, arguing that the Controlled Substances Act (CSA) requires a good-faith defense to differentiate between doctors who are earnestly practicing medicine and those who distribute controlled substances without a medical purpose—i.e. “pill pushers” or “pill mills.”
Over 100 years ago, the Harrison Narcotics Act became the first major federal drug law. It ended the practice of over‐the‐counter opioids and cocaine while allowing various medical professionals to distribute the drugs “in the course of his professional practice only.” The Harrison Act was a tax law, and it was enforced by the Treasury Department. Within a few years, treasury agents were prosecuting doctors who were alleged to have prescribed opioids to patients in order to maintain their addictions.
The Supreme Court heard many challenges to the Harrison Act from various doctors who were charged under it. In 1919, the Court ruled that prescribing “maintenance doses” to people who were addicted to opioids did not qualify as a legitimate medical purpose. At no point, however, did the Court assume that a good-faith defense was not available to doctors who legitimately believed they were practicing good medicine.
That interpretation carried over to the CSA, which became the main federal drug law in 1970. We argue that allowing doctors to use a good-faith defense is not only historically justified, but it is essential to keeping the CSA within proper constitutional boundaries. States retain the power to regulate the medical profession under their traditional police powers. Without a good-faith defense, the CSA comes close to unconstitutionally regulating the medical profession. Disagreements over standards of care are properly adjudicated in state courts, and federal jurisdiction should only kick in when a doctor has abandoned the subjective intent to practice medicine and become a drug dealer.
Moreover, prosecuting doctors for “misprescribing” has become so common that many doctors are afraid to prescribe opioids. Yet there is no agreed-upon standard for “misprescribing,” especially when it comes to chronic pain patients, of which there are about 20 million in the country. The standards are so vague that doctors don’t know when they have crossed a legal line, which undermines the Constitution’s guarantee of due process of law.
The Supreme Court should overturn Dr. Ruan’s conviction and correct the Eleventh Circuit’s erroneous interpretation of the Controlled Substances Act. Doctors who sincerely believe they are practicing good medicine should not be treated like drug dealers.”
(My Cato colleague Dr. Jeffrey Singer joined a brief as an amicus in the case).
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