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Claims Against Compounding Pharmacists Are Health Care Liability Claims


A woman had been diagnosed with Hepatitis C. The doctor treated her for her Hepatitis C symptoms and prescribed and administered weekly intravenous injections of 200 mg/ml lipoic acid, an antioxidant supplement. She underwent nine weeks of treatment without incident. However, she suffered a severe adverse reaction while receiving her tenth lipoic-acid treatment. She was hospitalized for several weeks, received multiple blood transfusions, and became permanently blind in both eyes.

 

A licensed compounding pharmacy compounded the particular vial of lipoic acid to which the woman reacted. Drug compounding is the process by which a pharmacist mixes or alters drugs to create a medication that is tailored to the needs of an individual patient and that is not otherwise commercially available. The lipoid acid was prepared as part of an order her doctor had placed with the compounding pharmacy for 23-30 ml vials of lipoic acid for office use, without reference to any particular patient.

 

The woman sued the compounding pharmacy and several of its licensed-pharmacist employees. The complaint alleged that because of negligence in compounding, inadequate and inappropriate warnings and instructions for use, the compounded lipoic acid was defective, ineffective, and unreasonably dangerous. The complaint went on to allege that the pharmacists breached their implied warranties in the design, manufacture, inspection, marketing, and distribution of the lipoic acid. Specifically, the complaint alleged that the pharmacists failed to confirm the identity, strength, and sterility of the lipoic acid prior to its release, failed to implement a reasonably safe design, failed to manufacture the lipoic acid in a reasonably safe condition, and failed to accompany the lipoic acid with proper warnings regarding possible adverse side effects and with adequate information to medical care providers regarding appropriate use. The woman did not serve the pharmacy and pharmacists with an expert report within 120 days of filing suit.

 

The pharmacy and pharmacists moved to dismiss the woman’s claims with prejudice for failure to serve an expert report within 120 days from her filing suit because her claims were health care liability claims governed by the Texas Medical Liability Act (TMLA). The 348th Judicial District Court of Texas, Tarrant County, held that the pharmacists were not health care providers and the woman’s causes of action were not health care liability claims, and, thus, denied the pharmacy and pharmacists’ motion to dismiss. The Court of Appeals of Texas, Fort Worth, affirmed.

 

The Supreme Court of Texas reversed. The court held that the woman’s claims against the pharmacy and its pharmacists were health care liability claims subject to the requirements of the TMLA. Thus, her failure to serve them with an expert report pursuant to the TMLA required dismissal of her suit.

 

The woman’s claims against the pharmacy and its pharmacists were health care liability claims subject to the requirements of the TMLA. Thus, her failure to serve them with an expert report pursuant to the TMLA required dismissal of her suit. Only claims brought against physicians or health care providers may qualify as health care liability claims. Licensed pharmacists and pharmacies are health care providers for purposes of the TMLA with respect to those activities limited to the dispensing of prescription medicines that result in health care liability claims. Licensed pharmacists and pharmacies are not considered health care providers with respect to any other cause of action that may exist at common law against them, including but not limited to causes of action for the sale of mishandled or defective products. The court determined that a pharmacist who compounds a drug for office use pursuant to a practitioner's lawful order, as authorized by the Pharmacy Act, is dispensing the drug whether or not the order identifies the patients to whom the drug will be administered. Specifically, the court held that the pharmacists’ act of compounding the injectable lipoic acid that the doctor administered to the woman constituted the dispensing of prescription medicines. Even though the doctor’s order for lipoic acid did not identify the patient to whom the drug would be administered, the court held that the injectable lipoic acid compounded by the pharmacy and administered to the woman was a prescription medicine under the TMLA. The court reasoned that, in compounding the lipoic acid for the doctor's office use, the pharmacists were engaged in activities limited to the dispensing of prescription medicines. The court held that the pharmacists were “pharmacists” under the TMLA for purposes of this lawsuit and that the woman had asserted health care liability claims against them.

 

The Supreme Court of Texas reversed the trial court’s denial of the pharmacy and pharmacists’ motion to dismiss.

 

See: Randol Mill Pharmacy v. Miller, 2015 WL 1870058 (Tex., April 24, 2015) (not designated for publication).

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives, September 2014 Report: Hepatitis: Provider Malpractice and Patient Injury

 

See the Medical Law Perspectives February 16, 2015, Blog: Pharmacy Owes Duty To Patient Not To Fill Excessive Prescriptions for Opioids

 

 

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