WASHINGTON (Legal Newsline) - A pair of cases now pending before the U.S. Supreme Court might decide whether the government can pursue billions of dollars in damages from Walmart for filling “invalid” opioid prescriptions. At the core of the cases is the question of when a doctor – and by extension, a pharmacist – crosses the line from practicing legitimate medicine to illegally selling drugs like a street-corner pusher.
The Justice Department sued Walmart in December 2020, accusing it of violating the federal Controlled Substances Act by filling thousands of prescriptions “that were not issued for legitimate medical purposes or in the usual course of medical practice.” The judge overseeing the government’s civil lawsuit ordered a halt to the proceedings last November, however, after Walmart argued two criminal cases pending before the Supreme Court would determine “what it means for a prescriber to depart from the usual course of medical practice.”
In Ruan v. U.S. and Kahn v. U.S., the government argues doctors lose the protection of their license to prescribe opioids if they act outside of what experts consider to be usual medical practice. The defendants, who were convicted of violating the CSA, say the standard should be the same as in other criminal cases, where prosecutors must prove they acted with criminal intent, not just in a way other physicians consider to be improper.
Walmart and other pharmacy chain operators are watching closely, since how the Supreme Court decides these cases will determine how aggressively the government can pursue civil claims they violated the law by filling supposedly invalid prescriptions.
“This is not an abstract concern,” the National Association of Chain Stores said in a brief it submitted in the Ruan case.
While the primary responsibility for prescribing opioids is on doctors, federal law assigns pharmacists with a “corresponding responsibility” not to knowingly fill improper scrips. The chain stores argue the DOJ asserts an excessively loose standard in the Walmart lawsuit, under which pharmacists break the law if they fill a prescription with any one of a number of “red flags,” such as whether the prescribing doctor is from another city or the patient is paying in cash.
“Under DOJ’s theory, the presence of one or more `red flags’ not only proves that a prescription is illegitimate but that a pharmacist who fills it must be doing so `knowingly,’” the chain stores say. “When presented with a facially valid prescription, however, a pharmacist cannot be expected to second-guess the prescriber’s medical judgment that the prescribed medicine is appropriate, to interrogate the patient regarding whether they actually need the prescribed medication, or to obstruct th e patient’s care by withholding it.”
At oral arguments in March, Supreme Court justices wrestled with the meaning of the Controlled Substances Act and how the traditional requirement the government prove mens rea, or guilty knowledge, in criminal cases fits with subjective standards for practicing medicine. The government argued defendants only need to prove they engaged in an “honest effort” to practice medicine, meaning they didn’t completely abandon their professional training by handing out prescriptions without performing a medical examination or assessing the patient’s needs.
Justice Neil Gorsuch had a problem with that, at one point saying to the government’s lawyer, Eric Feigen, “objective honest efforts is like a -- a contradiction in terms.”
Chief Justice John Roberts later said: “Is there a book that tells us what the right amount of medication is for a certain kind of disability? The answer is there is no such book, and that's the whole problem.”
Lawyers for Ruan and Kahn urged the court to adopt a stricter definition, under which doctors can be subjected to criminal liability only if they knowingly violate the law. The pharmacy chains agree, saying the government’s stance in the Walmart lawsuit is equivalent to strict liability, where any violation of a professional standard, written or unwritten, renders a prescription invalid and illegal to fill.
In his Nov. 19 order staying the Walmart case, U.S. District Judge Colm F. Connolly said the criminal cases before the Supreme Court will determine “what it means for a prescriber to depart from the usual course of medical practice in writing prescriptions; the answer to that question will shed considerable light on what it means for a pharmacist to depart from the usual course of pharmacy practice when filling them.”
The high court will also decide when a doctor has crossed the line from legitimate medical practice to writing invalid prescriptions, the judge said.
“The Supreme Court’s description of those circumstances will likely affect how pharmacists may be held liable for knowingly filling invalid prescriptions,” he concluded.
The Supreme Court is expected to return decisions by June.