2020 COA 145
Colo. Ct. App.2020Background:
- Robbin Smith underwent a transforaminal epidural steroid injection performed by Dr. Hashim Khan at Surgery Center at Lone Tree, LLC (SCLT); shortly after the procedure she became paraplegic and remains permanently paralyzed below the waist.
- Plaintiffs sued Dr. Khan (later settled), SpineOne (dismissed), and SCLT, asserting corporate negligence, failure to obtain informed consent, and negligence per se based on state and federal ambulatory surgical center (ASC) regulations.
- At trial the jury returned a $14.905 million verdict for the Smiths; the trial court reduced the award under Colorado’s Health Care Availability Act (HCAA).
- The trial court denied SCLT’s motions for judgment as a matter of law, finding SCLT had ‘‘practiced medicine’’ by maintaining a formulary (which included Kenalog) and by using its own consent form.
- On appeal the Colorado Court of Appeals reversed: it held SCLT could not be held liable under the corporate practice of medicine doctrine for Dr. Khan’s medical judgments and that the cited state and federal ASC regulations were enacted principally for licensing/Medicare purposes, not primarily to protect patient safety, so they could not support negligence per se.
- The court remanded with directions to enter judgment for SCLT and did not reach the Smiths’ constitutional challenge to the HCAA remittitur.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether SCLT may be held vicariously liable or directly liable under a corporate-negligence theory for Dr. Khan’s malpractice | Smith: SCLT had duties to supervise and ensure safe use of Kenalog and so is liable for plaintiff’s injuries | SCLT: corporate practice of medicine bars imposing liability for physician’s independent medical judgments | Held: Reversed — SCLT entitled to judgment as a matter of law under corporate practice of medicine; facility cannot direct physician’s medical decisions |
| Whether SCLT had an independent duty to obtain informed consent (or to step in if physician failed to disclose off-label use) | Smith: SCLT assumed or shared responsibility (formulary, SCLT consent form) and knew Dr. Khan had a propensity not to disclose off-label use | SCLT: duty to obtain informed consent is a physician duty; imposing it on the facility would violate the corporate practice doctrine | Held: No independent duty; hospital/facility generally does not owe informed-consent duty absent narrow credentialing exception; providing a facility form does not create that duty |
| Whether placing Kenalog on SCLT’s formulary constituted ‘‘practicing medicine’’ or an endorsement that creates liability | Smith: stocking and allowing Kenalog amounted to endorsement and assumption of responsibility for safe use | SCLT: stocking a drug for legitimate, label-consistent uses does not permit dictating physician use; creating formularies is administrative, not medical practice | Held: Formulary does not equate to practicing medicine; would impermissibly interfere with physician judgment and discourage formularies if adopted |
| Whether Colorado ASC regulations and federal Medicare ASC regulations support negligence per se | Smith: Violations of state and federal ASC regulations show negligence per se aimed at patient safety | SCLT: Regulations are primarily licensing/Medicare-payment rules, not safety statutes intended to create private negligence causes | Held: Regulations were adopted primarily for licensure/Medicare eligibility purposes; not enacted principally for public safety and thus cannot undergird negligence per se |
Key Cases Cited
- Daly v. Aspen Ctr. for Women’s Health, Inc., 134 P.3d 450 (Colo. App. 2005) (corporate-practice-of-medicine doctrine limits facility liability for physician medical judgments)
- Krane v. St. Anthony Hosp. Sys., 738 P.2d 75 (Colo. App. 1987) (hospitals generally have no duty to obtain informed consent; limited credentialing exception)
- Braden v. Saint Francis Hosp., 714 P.2d 505 (Colo. App. 1985) (hospital supervisory duties and limits regarding physicians)
- Bloskas v. Murray, 646 P.2d 907 (Colo. 1982) (informed consent is a component of medical malpractice law)
- Lombard v. Colorado Outdoor Educ. Ctr., Inc., 187 P.3d 565 (Colo. 2008) (elements and limits of negligence per se)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (off-label use discussion; FDA does not regulate the practice of medicine)