On Friday, we posted about a Florida court that allowed negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written (Oleckna). As you can imagine, we had some reservations about the ruling. Well, those reservations were driven home when we happened upon another recent pharmacy liability case, this one in Indiana – Kadambi v. Express Scripts, 2015 U.S. Dist. LEXIS 13607 (N.D. Ind. Feb. 5, 2015).
If we call Oleckna a “damned if you don’t” case, thenKadambi is the example of “damned if you do.” Which leaves the question – what is a pharmacy to do?
Plaintiffs in Kadambi are an endocrinologist, Dr. Kadambi, and 8 of his patients for whom he prescribed human growth hormone (HIGH). While plaintiffs allege that the prescriptions were medically necessary, the defendant pharmacies refused to fill HIGH prescriptions from Dr. Kadambi because they believe the prescriptions might violate federal law making it a "crime to knowingly distribute HIGH" for improper purposes. Id. at *3. Defendants alleged that they had a good faith belief that Dr. Kadambi was prescribing HIGH for non-medically acceptable reasons and/or that he was affiliated with organizations that advocate off-label use of HIGH. Id. at *4.
Plaintiffs advanced essentially two causes of action against the pharmacies – violation of Indiana’s statute governing pharmacies and defamation. While the court dismissed the statutory claim, it allowed the defamation action. We’ll go through the court’s ruling, but our real interest lies in the fact that both Kadambi and Oleckna are moving forward.
Plaintiffs first allege that the pharmacies violated the Indiana statute that requires a pharmacist to “exercise his professional judgment in the best interest of the patient’s health” and provides that “a pharmacist has a duty to honor all prescriptions from a [doctor].” Id. at *6. Under Indiana law, the pharmacist should take “reasonable steps” to determine whether a prescription has been issued lawfully and the pharmacist is immune from liability (both criminal and civil) for refusing to fill a prescription if doing so would be “contrary to law,” “against the best interest of the patient,” aid an addiction, or “be contrary to the health and safety of the patient.” Id.
Defendants argued and the court agreed that plaintiffs’ claim for violation of this law failed because the statute does not provide a private right of action. Id. at *7-15. It should come as no surprise that we agree with the position of the pharmacies in the case that unless the Indiana legislature intended to create a private right of action, a cause of action does not exist and the courts may not create one. We've written often about various ways in which plaintiffs attempt to bring actions alleging violations of the FDCA even though there is clearly no private right of action under that statute. Fortunately, most courts reject those efforts.
That left only plaintiffs’ defamation claim. Defendants argued two primary defenses. First, they moved to dismiss under Indiana’s Anti-SLAPP (“Strategic Lawsuit Against Public Participation”) Act. To prevail on this defense, the pharmacies would have to demonstrate that statements made to patients regarding their refusal to honor Dr. Kadambi’s HIGH prescriptions, were made in furtherance of free speech on a public issue or matter of public interest. Id. at *19. Defendants argued that because the occupation of being a pharmacist impacts public health and safety, their actions should be afforded anti-SLAPP protection. The court, agreeing with plaintiffs, ruled that the statements and actions at issue were less concerned with public interest and more focused on the narrow question of the patients’ individual health. Id. at *20-21.
Defendants’ second argument on defamation turned on qualified privilege. Under Indiana law, “[t]he essential elements of the defense of qualified privilege are good faith, an interest to be upheld, a statement limited in its scope to this purpose, a proper occasion, and publication in a proper manner to the appropriate parties only.” Id. at *26. Plaintiffs only challenged the good faith element and on that point the court found genuine questions of material fact that precluded granting summary judgment. Id. at *26-28.
So, what is a pharmacy to do? Simply fill prescriptions as presented? Nope – that gets you into Oleckna trouble. Refuse to fill prescriptions where there is a concern about medical necessity or some other potential impropriety? Nope – that gets you into Kadambi trouble (where at a minimum a doctor could sue for defamation). While Oleckna is the more traditional negligence action, both cases raise significant issues regarding what precisely is the scope of a pharmacist’s duty. Oleckna says it includes questioning the volume and frequency of narcotics prescriptions. Kadambi suggests it is filling facially valid prescriptions without question. Application of these decisions together is a pharmacist's version of the Kobayashi Maru (non Trekkies see here or here for the no-win scenario). While the truth probably lies somewhere in the middle, the middle is vast.
These decisions don’t have a tremendous impact on our clients – the drug and device manufacturers (outside potentially creating removal and fraudulent joinder complications). But, we don’t like the creation of new, ill-defined duties in any context. Certainly not when they pertain to prescription medical products; and certainly not if they have any tendency to move the focal point of the prescribing decision off the physician. That's the core of the learned intermediary doctrine and we don't want that boat rocked under any circumstances.