As a follow up to our previous infographic explaining compounding pharmacies, we will review some notable case outcomes involving compounding pharmacies.  It has questioned whether lawsuit outcomes have been appropriately classified as product liability claims or professional malpractice claims.  How these claims are classified can impact the type of insurance policies and coverages for the pharmacies.  Let's review some notable case outcomes involving compounding pharmacies.

• In Texas, the Texas Supreme Court considered the issue and held, in Randol Mill Pharmacy, et al. v. Miller, the compounding pharmacy and its employees were engaged in the dispensing of prescription drugs when they worked to compound medications.  As a result, the court ruled such actions as healthcare liability claims under Texas law.
• In Indiana, an appellate court reached a similar decision in Robertson v. Anonymous Clinic. Patients were injected with a compound steroid intended to relieve chronic back pain, but as a result, they contracted meningitis from a fungal growth in the steroid used in the epidural steroid injection. Plaintiffs alleged the compounding pharmacy should be liable under a theory of product liability for the heightened risk of harm to consumers resulting from contaminated or expired medications. Defense argued protections under the Indiana Medical Malpractice Act. By rule, a claim falls under the Medical Malpractice Act when there is a causal connection between the patient and the healthcare provider.  The court ruled the defendant's choice to select a preservative-free steroid was one a lay person would not be able to make without reference to the standard of care for pharmacy professionals.  As a result, it ruled the case was one to which the state's Medical Malpractice Act applied and dismissed the case.

In our next Deutsch Kerrigan insight, we will dive deeper into the significance of these two court rulings.