Chain is Liable in Drug Interaction Case

ISSUE OF THE CASE

When 2 medications are dispensed to the same patient, leading to her demise, and her mother sues the national pharmacy chain for damages, what is the role of the federal Omnibus Budget Reconciliation Act of 1990 (OBRA 1990) statute and state pharmacy statutes in the lawsuit?

FACTS OF THE CASE

The staff at the pharmacy in a Southern state dispensed amitriptyline for the patient and then, 19 days later, dispensed morphine to the same patient. Six days after that, the patient died as a result of the interaction of the 2 medications. The mother of the deceased patient filed a lawsuit against the pharmacy chain claiming that the failure of the pharmacy staff to review her daughter’s prescription history at the time of the second dispensing caused the death.

The plaintiff alleged that the pharmacy staff had a duty under the law to:

• Warn about the adverse effects of mixing the 2 medications
• Refuse to dispense the morphine after dispensing the amitriptyline
• Monitor the patient’s prescription drug history
• Disclose material facts about the prescription medications
• Create and follow guidelines to ensure that prescriptions do not adversely interact
• Contact the prescribers about the appropriateness of using the 2 medications simultaneously

The pharmacy chain filed a motion with the federal trial court to dismiss the case because it had no legal duty, attributable to either a legislatively enacted statute or under common law principles derived from court decisions, “to review her drug profile, warn of adverse effects, or refrain from filling her prescriptions.” This is known in the law as a motion for dismissal because of failure to state a claim, a pretrial motion by the defendant to avoid going to trial. The attorney for the chain argued in the motion to dismiss that “those duties rest with the prescribing physician.”

In response, the attorney for the plaintiff argued that there were 2 possible sources of such legal duties: the federal OBRA 1990 statute and obligations created by a state statute.

THE COURT’S RULING

After examining both possible bases for the legal action advanced by the plaintiff, the federal trial court judge denied the pharmacy chain’s motion to dismiss the lawsuit.

THE COURT’S REASONING

The judge turned first to the argument that these legal duties or obligations to review the patient’s medication use arose under the federal OBRA 1990. The court properly pointed out that the OBRA 1990 mandates were directed at state governments, not at pharmacies or pharmacists. If states wanted to continue receiving federal matching funds for operation of their Medicaid programs, sometimes as high as a 70% match, they were directed to adopt, either through regulation or statute, various requirements for pharmacies and pharmacists when dispensing medications to Medicaid beneficiaries. Consequently, the court dismissed the claims of the plaintiff hinged on that OBRA 1990 argument.

Turning to the other basis for the requirementadvanced by the plaintiff, a legal duty created under state law rather than federal, the judge reviewed 2 prior state court decisions that arguably said that no such duty on the part of a pharmacist existed. However, those 2 decisions were from cases decided before legislature enacted the current state law governing the facts of this case or from cases presenting different factual issues. Accordingly, these were not binding as precedent.

The judge then focused on the wording of the state statute enacted as directed following the mandate of the OBRA 1990. The court concluded that “the risk of

harm at issue in this case [ie, drug-drug interaction] is covered” by the statute. An important area of emphasis from the judge was that the statute specified that “the pharmacist shall review the patient record” to look for a variety of potential challenges. He concluded that “the court finds that the [pharmacy chain] had a duty under [state statute] to review the patient’s prescription record, identify potential drug-drug interactions, and take ‘appropriate steps’ to mitigate the risk of those interactions.”

This decision highlights the importance of paying strict attention to the wording of regulations and statutes governing pharmacy practice. In this matter, the word shall was pivotal. It reflected the legal imperative intended by the legislature. Remember, the law is all about the words being used.