Regulatory issues form the core of most compliance work, but related legal risks may actually pose a
larger financial and public relations threat.
Plaintiffs may bring private lawsuits alleging
failures by doctors, clinics, drug manufactur-
ers, and — increasingly in the case
of opioid injuries — pharmacists.
The courts provide a means
for plaintiffs to achieve high
financial awards in parallel to any
regulatory consequences separately suffered by the defendant.
As plaintiffs’ attorneys develop
their cases and theories, it is advis-
able for compliance and legal professionals
to track litigation results, establish proto-
cols to avoid lawsuits, and stay ahead of
Case law trends
Of course, not all state supreme courts have
reviewed pharmacist liability, but recent decisions from three states — New Mexico, Texas,
and Florida — provide food for thought to
One litigation strategy bases tort claims on
existing state law. Negligence per se claims
argue that defendants failed in their duty to
plaintiffs through their failure to follow the
law. A recent appeals case in New Mexico
illustrates this theory. In Estate of Lucero v. May
Maple Pharmacy,1 the defendant pharmacy
refilled prescribed opioids early on seven or
more occasions; these early refills occurred up
to 23 days in advance of the normal refill date.
The plaintiff’s claims included the negligence per se theory that the defendant
“breached regulatory duties to ‘properly
and reasonably dispense controlled medications’” mandated by the state’s administrative
by Stacey Supina
Courts and compliance:
Controlling legal risks
» The opioid epidemic has resulted in plaintiffs seeking compensation from a variety of sources, including pharmacies.
» Private causes of action against pharmacies may arise from regulatory compliance failures.
» Pharmacies may also face liability for negligence if professional “duty of care” standards are not met.
» Even if the pharmacy overcomes these claims in court, the process is still expensive.
» The best practice is to track relevant court decisions and to update compliance programs accordingly.
Stacey Supina ( Stacey.firstname.lastname@example.org) is Managing Director –
GRC and General Counsel at Legal Research.com in Minneapolis, MN.