Opinion ID: 2831360
Heading Depth: 2
Heading Rank: 3

Heading: Claimed Departure from Accepted

Text: Standards of Health Care We next determine whether Sok has rebutted the presumption. If she has not, her claim must be dismissed for failure to serve an expert report as required by the Medical Liability Act. We have already determined Sok’s claim satisfies the first element of a health care liability claim because Dr. Nguyen is a physician and Bioderm is a health care provider. And the parties agree that the third element of a health care liability claim (causation of the injury) is met. Thus, Sok may only rebut the presumption that her claim is a health care liability claim by proving her claim does not constitute an alleged “departure[] from accepted standards of medical care or health care.”10 TEX. CIV. PRAC. & REM. CODE § 74.001(a)(13); Tex. W. Oaks, 371 S.W.3d at 179–80. As explained 9 Sok asserts she was not a patient of Dr. Nguyen because she did not meet with him until he examined her burns after the fifth treatment. But as we have previously explained, “[t]he fact that a physician does not deal directly with a patient does not necessarily preclude the existence of a physician-patient relationship.” St. John v. Pope, 901 S.W.2d 420, 424 (Tex. 1995). 10 Though the statute also includes treatment, lack of treatment, safety, professional services, or administrative services directly related to health care as other forms of health care liability claims, TEX. CIV. PRAC. & REM. CODE § 74.001(a)(13), neither party asserts that these provisions control in this case. 8 below, Sok has not rebutted this presumption because expert health care testimony is needed to prove or refute the merits of her claim. The Medical Liability Act defines health care as “any act or treatment performed or furnished, or that should have been performed or furnished, by any health care provider for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.” TEX. CIV. PRAC. & REM. CODE § 74.001(a)(10). In Texas West Oaks, we considered whether a claim alleged a departure from accepted standards of health care and held that “if expert medical or health care testimony is necessary to prove or refute the merits of the claim against a physician or health care provider, the claim is a health care liability claim.” 371 S.W.3d at 182. Accordingly, in considering whether a claim alleges a departure from accepted standards of medical or health care, a court should first determine whether expert medical or health care testimony is needed to establish the requisite standard of care and breach.11 See id. And only if expert testimony is not needed should a court proceed to consider the totality of the circumstances, as a claim may still be a health care liability claim despite that “in the final analysis, expert testimony may not be necessary to support a verdict.” Murphy v. Russell, 167 S.W.3d 835, 838 (Tex. 2005).12 Therefore, we address whether expert health care testimony is needed to prove or refute the merits of Sok’s claim. 11 Treatment and a physician-patient relationship are also elements of a claimed departure from accepted standards of health care. Id. § 74.001(a)(10); Tex. W. Oaks, 371 S.W.3d at 180. But in assessing the application of the rebuttable presumption, we have already determined Sok was a patient receiving treatment. See supra Part II.B. 12 See also Tex. W. Oaks, 371 S.W.3d at 182; Haddock, 793 S.W.2d at 951 (recognizing that when the nature of the alleged malpractice and injuries are plainly within the common knowledge of laymen, no expert testimony may be required). 9 Two of our precedents—Texas West Oaks and Haddock v. Arnspiger13—offer guidance on when expert health care testimony is needed to prove a claim such as Sok’s. In Texas West Oaks, Williams—a mental health hospital employee—brought a negligence claim against his employer for injuries sustained in an altercation with a patient. 371 S.W.3d at 175–76. Williams sued the hospital, alleging negligence in training, supervising, failing to warn, and inadequately equipping employees to address such a circumstance. Id. at 182. But the crux of the allegation concerned the appropriate standards of care owed to employees, including the services, protocols, supervision, monitoring, and equipment necessary to satisfy that standard, and whether such specialized standards were breached. Id. Because the underlying basis of the claim concerned the appropriate standards of care owed to employees of a mental health hospital and whether those standards were breached, we held the plaintiff could not establish those elements without expert testimony in the health care field. Id. at 182–83. Simply stated, “[i]t would blink reality to conclude that no professional . . . health judgment is required to decide what [the required protocols and standards] should be, and whether they were in place at the time of Williams’ injury.” Id. at 182. Moreover, our opinion in Haddock illuminates the question concerning the necessity of expert medical or health care testimony when the claim, as here, involves the use of a medical device. In Haddock, the patient sued his physician for negligence when the physician perforated the patient’s colon during a routine proctological examination. 793 S.W.2d at 949, 951. The examination involved the use of a flexible colonoscope, which the record established was a medical device requiring extensive training and experience for proper use. Id. at 954. We concluded that 13 793 S.W.2d at 951. 10 expert testimony was required because “[o]bviously, the use of a flexible colonoscope for a proctological examination is not a matter plainly within the common knowledge of laymen.” Id.; see also Chambers v. Conaway, 883 S.W.2d 156, 158 (Tex. 1993) (“[U]nless the mode or form of treatment is a matter of common knowledge or is within the experience of the layman, the patient must tender expert testimony” to prove the claim.). Guided by these precedents, we conclude expert health care testimony is needed to prove or refute Sok’s claim for two primary reasons. First, federal regulations provide the laser used in this case may only be acquired by a licensed medical professional for supervised use in her medical practice. We note the Legislature began regulating laser hair removal facilities and technicians in 2009. Under the 2009 statute, laser hair removal constitutes the practice of medicine under the Texas Health and Safety Code.14 See TEX. HEALTH & SAFETY CODE § 401.521. But because Sok filed suit before this state law took effect, it is inapplicable to her claim.15 Importantly, however, even before the enactment of this state regulation, the United States Food and Drug Administration classified Bioderm’s pulsed dye laser as a Class II surgical device. 21 C.F.R. § 878.4810(b)(1) (categorizing carbon dioxide lasers intended to cut, destroy, or remove tissue as Class II surgical devices). Federal regulations restrict Class II surgical devices as being “not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and . . . [are] to be sold 14 Pursuant to the 2009 legislation, laser hair removal may only be performed by a physician, a person acting under a physician’s order, or a person otherwise authorized by law to practice medicine. TEX. HEALTH & SAFETY CODE § 401.521. Additionally, every laser hair removal facility must have a written contract with a consulting physician to: (1) establish proper protocols for the services provided at the facility; (2) audit the facility’s protocols and operations; and (3) be available for emergency consultation and appointments. Id. § 401.519. 15 The Legislation was enacted in May 2009, before Sok filed this suit. Act of May 23, 2009, 81st Leg., R.S., ch. 303, § 1, secs. 401.501–.522, 2009 Tex. Gen. Laws 822, 822–25. 11 only to or on the prescription or other order of such practitioner for use in the course of his professional practice.”16 Id. § 801.109(a)(2).17 Sok’s live pleading asserted the laser device in this dispute is “controlled and restricted to those holding a qualified license, such as the medical license held by Defendant Nguyen . . . .” Because Bioderm’s laser is a regulated surgical device, which may only be acquired by a licensed medical practitioner for supervised use in her medical practice, we conclude the testimony of a licensed medical practitioner is required to prove or refute Sok’s claim that use of the device departed from accepted standards of health care. Second, the proper operation and use of this regulated surgical device requires extensive training and experience, which indicates that such matters are not within the common knowledge of laypersons. As we have observed here, Dr. Nguyen established and maintained a six-month training program to instruct laser operators how to properly perform treatments by taking into account the variables associated with patients (such as skin type) and equipment (such as intensity settings and attachments). This training requires attendance at a medical lecture, an observation period, clinical practice, morning rounds, and a written examination. When operators begin administering treatments, Dr. Nguyen reviews each scheduled procedure. His rounds include a discussion of previous treatment settings, complications or tolerance of previous treatments, and the planned treatment details to be executed that day. And Dr. Nguyen makes the final decision regarding the intensity settings of the laser. Bioderm’s policy requires all operators, even those with 16 The provision indicates that practitioners are individuals “such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device.” 21 C.F.R. § 801.109(a)(1)(ii). 17 See 21 C.F.R. § 860.3(c) (providing Class II devices are subject to special controls). 12 previous experience, to undergo and satisfactorily complete Dr. Nguyen’s training. Dr. Nguyen trained the operator who performed Sok’s treatment. And significantly, Dr. Nguyen determined the specific laser intensity setting for each of her treatments, including the one Sok alleges caused her burns and scarring. This extensive training compels the conclusion that expert health care testimony is needed to prove or refute Sok’s claim concerning the improper use of the device. Sok suffered no burns or scarring in four previous treatments to the leg area at an intensity identified as “level five.” Laypersons cannot be expected to understand whether Dr. Nguyen should have known that use of the device on the same area would cause burns in a single treatment at the higher intensity of “level six.” We therefore hold expert health care testimony is required to prove or refute Sok’s claim, and Sok has not rebutted the presumption that her claim is a health care liability claim. See Loaisiga, 379 S.W.3d at 252; Tex. W. Oaks, 371 S.W.3d at 182–83; Haddock, 793 S.W.2d at 954. Sok argues that any required expert testimony could be elicited from a technician trained in the use of laser hair removal devices, thus rendering expert testimony from a physician unnecessary. As an initial matter, we note expert testimony does not necessarily have to be proffered by a licensed physician to constitute expert health care testimony. See TEX. CIV. PRAC. & REM. CODE § 74.402 (requiring an expert to be practicing health care in the same field as the defendant). But, we disagree with Sok’s contention that the testimony of a trained laser technician would suffice on these particular facts. Allowing a technician who could not legally acquire or supervise use of the device to testify that a physician’s use of the device violated accepted standards of health care is not a procedure the Medical Liability Act allows. See id. (expert must be licensed in the area of health 13 care related to the claim, practice in the same field as the defendant, and have knowledge of accepted standards of care). Because expert health care testimony is needed to prove or refute Sok’s claim against a physician and a health care provider, her claim is a health care liability claim.