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Texas Supreme Court Holds That Compounding Pharmacies Are Health Care Providers Under Texas Medical Liability Act, by Elinor H. Murarova, Duane Morris Health Law Blog


On April 24, 2015, the Texas Supreme Court dismissed claims against a compounding pharmacy and its individual pharmacists which alleged negligence in compounding a lipoic acid medication, finding that the defendants were health care providers entitled to the protections in the Texas Medical Liability Act (‘TMLA’).

In the case Randol Mill Pharmacy et al. v. Miller et al., Case No. 13-1014 (Tex. Sup. Ct.), the plaintiff’s physician prescribed and administered weekly intravenous injections of 200 mg/ml lipoic acid, an antioxidant supplement. The plaintiff alleged that she underwent nine weeks of treatment without incident, but in the tenth treatment she suffered a severe adverse reaction and as a result was hospitalized for several weeks, received multiple blood transfusions, and went permanently blind in both eyes. Randol Mill Pharmacy compounded the lipoic acid that allegedly caused the adverse reaction.

In her complaint against the compounding pharmacy and its individual pharmacists, the plaintiff alleged that these defendants gave inadequate and inappropriate warnings and instructions for using the compounded lipoid acid; that the compounded lipoid acid was defective, ineffective and unreasonably dangerous; and that the compounding pharmacy and pharmacists generally breached implied warranties with respect to the design, manufacture, inspection, marketing, and/or distribution of the compounded lipoid acid. . . .