Court Denies Pharmacists Protections as Health Care Providers

The Supreme Court of Texas recently heard arguments in an appeal from a state appellate court decision that sided with a woman who sued a pharmacy and its pharmacists after she became blind due to a compounded drug.

The compounding pharmacists at Randol Mill Pharmacy requested the lawsuit be dismissed since the Texas Medical Liability Acts (TMLA) calls for the plaintiff suing a pharmacist to file an expert report. They also argued that they should be protected under the TMLA as health care providers.

The Texas Court of Appeals disagreed, and it made a distinction between a pharmacist providing drugs for a bulk order versus an individual basis. In doing so, it determined that pharmacists do not qualify as health care providers if they deliver medications in bulk, as opposed to filling a prescription for a specific individual.

Challenging that finding, the Texas Pharmacy Association and Alliance of Independent Pharmacists requested last year that the court grant the defendants a Petition for Review. The Supreme Court of Texas heard arguments on January 14, 2015.

In 2011, Stacey Miller was undergoing treatment from her doctor, Ricardo Tan, MD, for symptoms related to hepatitis C virus (HCV). She received weekly intravenous injections of lipoic acid, a compounded drug. While visiting Dr. Tan’s office in December 2011, Miller experienced “an episode of violent nausea and vomiting,” according to court records.

Miller was then taken to the hospital, where she experienced more nausea and vomiting alongside a litany of other serious side effects, including tachycardia, severe back pain, abdominal pain, diarrhea, acidosis, electrolyte abnormality, fever, irritability, confusion, lethargy, muscle weakness, blurry vision with dark spots, hemorrhages in both eyes, and hypotension, among others.

After weeks of treatment in the hospital, Miller was discharged with blindness in both eyes. The lipoic acid that she received—which was later found to be adulterated—had been provided by Randol Mill Pharmacy and its pharmacists.

The state appellate court determined that the pharmacists “could not provide evidence to the state health department of the identity, strength, and sterility of lipoic acid injectable 200 mg/ml or that it was tested prior to release to Dr. Tan,” according to court documents. Further, it ruled that Randol Mill Pharmacy did not have a prescription from Dr. Tan specifically for Miller; rather, he used the lipoic acid from the pharmacy for multiple patients.

The plaintiff argued that the pharmacy should have warned Dr. Tan of the risks of using lipoic acid, especially since there are other ways to treat HCV.