Justice Lehrmann, delivered the opinion of the Court.
After suffering a severe adverse reaction to a compounded drug administered by her physician, Stacey Miller sued the compounding pharmacy and several of its licensed-pharmacist employees. We are asked whether Miller's claims against these defendants are health care liability claims subject to the requirements of the Texas Medical Liability Act. If they are, then Miller's failure to serve them with an expert report pursuant to the Act requires dismissal of her suit. Holding that Miller's causes of action are not health care liability claims, the trial court denied the defendants' motion to dismiss, and the court of appeals affirmed. We disagree and reverse the court of appeals' judgment.
In 2011, Dr. Ricardo Tan treated Miller for symptoms related to her previously diagnosed Hepatitis C. He prescribed and administered weekly intravenous injections of 200 mg/ml lipoic acid, an antioxidant supplement. According to Miller's petition, she underwent nine weeks of treatment without incident. However, she suffered a severe adverse reaction while receiving a lipoic-acid treatment on December 5, 2011. She alleged that, as a result, she was hospitalized for several weeks, received multiple blood transfusions, and is now permanently blind in both eyes. Randol Mill Pharmacy, a licensed compounding pharmacy in Arlington, compounded the particular vial of lipoic acid to which Miller reacted. It was prepared as part of an order Dr. Tan had placed with Randol Mill for twenty-three 30-ml vials of lipoic acid for office use, without reference to any particular patient.
Taking the position that Miller had asserted health care liability claims governed by the Texas Medical Liability Act, see TEX. CIV. PRAC. & REM. CODE §§ 74.001-.507, the pharmacist defendants moved to dismiss Miller's claims with prejudice for failure to serve an expert report within 120 days of her filing suit, see id. § 74.351. The trial court denied the motion, and a divided court of appeals affirmed,
This case presents issues of statutory interpretation, which we review de novo. Zanchi v. Lane, 408 S.W.3d 373, 376 (Tex.2013). In construing statutes, we start with the "ordinary meaning of the statutory text." In re Ford Motor Co., 442 S.W.3d 265, 271 (Tex.2014). We analyze that language in context, considering the specific sections at issue as well as the statute as a whole. CHCA Woman's Hosp. v. Lidji, 403 S.W.3d 228, 231-32 (Tex.2013).
The Texas Medical Liability Act provides a comprehensive statutory framework governing health care liability claims. Id. at 232. It is intended to strike "a careful balance between eradicating frivolous [health care liability] claims and preserving meritorious ones." Leland v. Brandal, 257 S.W.3d 204, 208 (Tex.2008). A key component of the Act's framework is its requirement that the plaintiff serve expert reports early in the litigation process "for each physician or health care provider against whom a [health care] liability claim is asserted." TEX. CIV. PRAC. & REM. CODE § 74.351(a).
The Act defines "health care liability claim" as
Id. § 74.001(13). Thus, only claims brought against physicians or health care providers may qualify as health care liability claims. A "health care provider" is "any person, partnership, professional association, corporation, facility, or institution duly licensed, certified, registered, or chartered by the State of Texas to provide health care, including ... a pharmacist." Id. § 74.001(12)(A)(iv). Employees and independent contractors of health care providers who are acting within the scope of the employment or contractual relationship also qualify as health care providers. Id. § 74.001(12)(B)(ii). Finally, the Act defines "pharmacist" as
Id. § 74.001(22).
As an initial matter, we address the pharmacist defendants' argument that they qualify as health care providers under the term's general definition irrespective of the more specific definition of pharmacist.
This argument has appeal when the Act's definitions are viewed in isolation, but our well-settled rules of statutory interpretation require us to "examine the entire act to glean its meaning" and to "presume that `the entire statute is intended to be effective.'" Meritor Auto., Inc. v. Ruan Leasing Co., 44 S.W.3d 86, 90 (Tex. 2001) (quoting TEX. GOV'T CODE § 311.021(2)). Further, we may not interpret a statute in a way that renders any part of it meaningless. Crosstex Energy Servs., L.P. v. Pro Plus, Inc., 430 S.W.3d 384, 390 (Tex.2014). When analyzed in this manner, the statute cannot have the meaning Randol Mill proposes.
More specifically, Randol Mill's interpretation renders the definition of pharmacist wholly superfluous because defendants who are licensed under chapter 551 of the Occupations Code — the first requirement to meet the pharmacist definition — automatically fall within the broader definition of health care provider. But the remainder of the pharmacist definition expressly narrows the circumstances in which such defendants may be considered health care providers, principally by limiting the qualifying activities to "the dispensing of prescription medicines that result in health care liability claims." TEX. CIV. PRAC. & REM. CODE § 74.001(22). And the referenced chapter 551 of the Occupations Code, which is the first chapter of the Texas Pharmacy Act, encompasses the licensing of both pharmacies like Randol Mill and individual pharmacists. See TEX. OCC. CODE §§ 551.002(c), .003(3)-(7), (28). Accordingly, both Randol Mill and the individual defendants in this case qualify as health care providers under the Medical Liability Act only if they meet the Act's definition of pharmacist.
This is our first opportunity to examine the Medical Liability Act's application to claims against pharmacists in general and compounding pharmacists in particular. In the typical case against a pharmacy involving claims of misfilled prescriptions, the courts of appeals are generally in agreement — and often the parties do not dispute — that the Act applies and an expert report is required. See, e.g., Walgreen Co. v. Hieger, 243 S.W.3d 183, 185-86 (Tex.App.-Houston [14th Dist.] 2007, pet. denied) (analyzing the sufficiency of an expert report in a claim alleging the pharmacy incorrectly filled a prescription with the wrong medication); HEB Grocery Co. v. Farenik, 243 S.W.3d 171, 173 (Tex. App.-San Antonio 2007, no pet.) (same); see also Gingrich v. Scarborough, No. 09-09-00211-CV, 2010 WL 1711067, at *5 (Tex.App.-Beaumont April 29, 2010, no pet.) (mem. op.) (holding that the plaintiff's expert report was insufficient as to a claim that the pharmacy negligently filled a prescription for "excessive" medications that led to drug toxicity). Unlike those cases, this case implicates a pharmacy's compounding services, and so we begin with a discussion of that practice.
Generally, 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
Texas is one of "[m]any States" that "specifically regulate compounding practices as part of their regulation of pharmacies." Thompson, 535 U.S. at 361, 122 S.Ct. 1497. To that end, both the Texas Pharmacy Act and the associated regulations governing compounding services define compounding as
TEX. OCC. CODE § 551.003(9); 22 TEX. ADMIN. CODE §§ 291.131(b)(3), .133(b)(14). Pertinent to this case, the Pharmacy Act permits a pharmacy to "dispense and deliver a reasonable quantity
As noted above, licensed pharmacists and pharmacies are health care providers for purposes of the Medical Liability Act with respect to "those activities limited to the dispensing of prescription medicines which result in health care liability claims." TEX. CIV. PRAC. & REM. CODE § 74.001(22). They 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." Id. The parties dispute whether the pharmacist defendants' act of compounding the injectable lipoic acid that Dr. Tan administered to Miller constituted "the dispensing of prescription medicines." We hold that it did.
The Medical Liability Act does not define the word "dispense," but the Pharmacy Act does: "`Dispense' means to prepare, package, compound, or label, in the course of professional practice, a prescription drug or device for delivery to an ultimate user or the user's agent under a practitioner's lawful order." TEX. OCC. CODE § 551.003(16). An "ultimate user" is "a person who obtains or possesses a prescription drug ... for the person's own use." Id. § 551.003(43). The court of appeals recognized that a doctor or nurse administering the drug to the ultimate user, such as Dr. Tan, may qualify as the "user's agent." 413 S.W.3d at 851. However, the court held that Randol Mill did not compound the lipoic acid "for delivery to an ultimate user or the user's agent" because Dr. Tan's order did not specify the particular patient or patients for whom the drug was intended. Id. at 849. We disagree.
As noted above, a pharmacist may "dispense and deliver a reasonable quantity of a compounded drug to a practitioner for office use." TEX. OCC. CODE § 562.152. Because a "reasonable quantity" is an amount that the practitioner "anticipates may be used" before the drug's expiration date, the Pharmacy Act specifically contemplates that a pharmacist may "dispense" a compounded drug to a practitioner without knowing the specific identity of the ultimate user. Further, and importantly, when a drug is dispensed for office use, it means that the practitioner will be administering the drug to the patient. Id. § 562.151(1) (defining "office use"). The limitations on this practice are thus designed to ensure that the compounded drug is administered in a health care setting
Miller alternatively argues that the pharmacy defendants do not fall within the Medical Liability Act's definition of pharmacist because the compounded lipoic acid that Randol Mill delivered to Dr. Tan is not a prescription medicine. TEX. CIV. PRAC. & REM. CODE § 74.001(22) (defining "pharmacist" to extend to "activities limited to the dispensing of prescription medicines"). As with the term "dispense," the Medical Liability Act does not define "prescription medicines." Neither does the Pharmacy Act, although that Act does define the term "prescription drug" as
TEX. OCC. CODE § 551.003(36). The ordinary meaning of prescription drug — "a drug that can be bought only as prescribed by a physician" — is similar to subsection (A) of the statutory definition. WEBSTER'S THIRD NEW INT'L DICTIONARY 1792 (2002). Miller argues that no evidence shows that lipoic acid, in any form, qualifies as a prescription drug.
We first note that the Legislature's choice of the term "medicine" rather than "drug" in the Medical Liability Act likely will not affect the statute's application in most circumstances. The dictionary definition of medicine is "a substance or preparation used in treating disease." Id. at 1402. The Pharmacy Act's definition of drug is broader, but includes "a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." TEX. OCC. CODE § 551.003(18)(B). The parties do not argue that the injectable lipoic acid at issue meets the definition of drug but not medicine, or vice versa. They dispute only whether a prescription is required for patient use.
To that end, the Pharmacy Act's provisions governing compounding confirm that compounded drugs may not be given to a patient absent a doctor's order. Unless incident to research, "compounding" occurs only (1) as the result of a prescription drug order, (2) in anticipation of a prescription drug order, or (3) "for administration to a patient by a practitioner as the result of a practitioner's initiative." Id. § 551.003(9). The first two categories expressly
The requirement that a compounded drug be prescribed by a practitioner is consistent with the purpose served by the practice, which is to supply a drug in a form or dose that is not commercially available, but that the practitioner has concluded will best meet her patient's needs.
Finally, we determine whether the pharmacist defendants' complained-of "activities... result[ed] in health care liability claims." Id. We thus consider whether Miller has asserted causes of action "for treatment, lack of treatment, or other claimed departure from accepted standards of medical care, or health care, or safety or professional or administrative services directly related to health care, which proximately result[ed] in injury to [Miller]."
In this case, Dr. Tan ordered compounded injectable lipoic acid for office administration to his patients, and the pharmacist defendants compounded the lipoic acid for that purpose. Dr. Tan administered the lipoic acid to Miller in the course of her treatment for Hepatitis C symptoms. Miller asserts that the pharmacist defendants' negligence in compounding the drug and their inclusion of inadequate warnings and instructions regarding its use proximately caused her injuries. Whether stated as negligence or breach of warranty, these claims rather clearly allege that the pharmacist defendants departed from accepted standards of health care. See Marks v. St. Luke's Episcopal Hosp., 319 S.W.3d 658, 665-66 (Tex.2010) ("Determining whether a pleading states a health care liability claim ... depends on its underlying substance, not its form.").
Miller asserts, however, that her claims are in the nature of product-liability claims and are excluded from the Medical Liability Act's umbrella because, while the Act defines pharmacist to include "activities limited to the dispensing of prescription medicines which result in health care liability claims," it "does not include any other cause of action that may exist at common law against [pharmacists], including but not limited to causes of action for the sale of mishandled or defective products." TEX. CIV. PRAC. & REM. CODE § 74.001(22). We cannot construe this exclusion as broadly as Miller suggests because, so construed, it would swallow the Act's application to causes of action involving negligent compounding that otherwise qualify as health care liability claims.
We note that subsection 74.001(22) references the "sale" of defective products. Presumably this would extend to a pharmacy's liability as a "retailer or other member of the marketing chain" of a defective product, as well as its right to indemnity from the manufacturer where the pharmacy "is merely a conduit for the defective product." Duncan v. Cessna Aircraft Co., 665 S.W.2d 414, 432 (Tex. 1984); see also SSP Partners v. Gladstrong Invs. (USA) Corp., 275 S.W.3d 444, 446-47 (Tex.2009) ("In Texas, the seller of a defective product is subject to strict liability for damages the product causes even though the defect was not his fault, but he is generally entitled to indemnity from the manufacturer by statute and by common law."). But the pharmacist defendants have not been sued merely as retailers of a defective product. Nor, importantly, have they been sued as manufacturers of a defective product, notwithstanding the petition's use of the "manufacturing" label to describe the pharmacist defendants' activity. See Loaisiga v. Cerda, 379 S.W.3d 248, 255 (Tex.2012) (noting that, in analyzing whether a cause of action is a health care liability claim, courts must "focus[] on the facts underlying the claim, not the form of, or artfully-phrased language in, the plaintiff's pleadings"). As noted above, the Pharmacy Act and its associated regulations expressly distinguish between compounding and manufacturing. TEX. OCC. CODE § 551.003(23) ("The term [manufacturing] does not include compounding."). Unlike manufacturing, compounding qualifies as "dispensing prescription medicines."
At their core, Miller's claims call into question Randol Mill's compliance with professional standards of care applicable to pharmacies that perform compounding services, which implicates a host of complex regulations governing compounding practices in Texas. See generally 22 TEX. ADMIN. CODE §§ 291.131, .133. Determining whether the pharmacist defendants complied with these standards will inevitably require the testimony of experts in the field. See Garland Cmty. Hosp. v. Rose,
In sum, we hold that the Medical Liability Act applies to Miller's claims against the pharmacist defendants. Under the applicable version of that Act, she was required to serve the defendants with an expert report within 120 days of filing suit. Because it is undisputed that she failed to do so, her claims must be dismissed. Accordingly, we reverse the court of appeals' judgment and remand the case to the trial court for further proceedings consistent with this opinion.