William McDougald et al. v. St. Francis North Hospital Inc. No. 48,955 (La. App. 2nd Cir. April 9, 2014) 137 So.3d 1233 writ denied 2014-0815 (La. 6/3/14), 140 So.3d 1191.
In this medical malpractice wrongful death action, the plaintiffs contended that the defendant physician breached the standard of care in temporarily discontinuing the patient’s Plavix and aspirin in anticipation of orthopedic surgery without informing the patient of the associated risks. The patient died of a myocardial infarction several days after stopping the medications and just one day before the planned surgery.
Ms. McDougald was a 58 year old woman with a history of heart disease and smoking and had undergone placement of stents as her heart disease advanced. The patient had been maintained on Plavix and aspirin for over two years since her last stent placement in 2007. In 2009, Ms. McDougald planned to undergo knee surgery and was referred to defendant, her cardiologist, for a medical clearance.
Evidence was presented at trial that medical clearance was provided after the defendant’s head nurse (1) spoke with the patient’s primary care physician to confirm that the patient had not presented with any cardiac issues in the preceding year; (2) confirmed this with the patient directly as well; and then (3) discussed with the patient the need to temporarily discontinue the Plavix and aspirin seven days prior to the planned knee surgery. Nurse Gibson stamped the defendant physician’s signature on the clearance for the knee surgery. The patient was not seen by the defendant physician as part of this surgical clearance.
Ms. McDougald’s family filed a PCF claim alleging that the defendant physician committed malpractice by failing to inform Ms. McDougald of the risks associated with the cessation of Plavix and aspirin, including the possibility of death. Plaintiffs alleged that the physician had a duty to inform the patient of these risks pursuant to the Louisiana Uniform Consent Law (LUCL), La. R.S. 40:1299.40. Plaintiffs contended that the defendant physician never spoke to Ms. McDougald and therefore breached the standard of care by failing to obtain informed consent.
The Medical Review Panel found that the order to discontinue Plavix was appropriate because the accepted practice guidelines for Plavix therapy after stent placement called for 12 months of administration only and it had been two years since Ms. McDougald’s last stent. The panel further found that the standard of care did not require a doctor to discuss the discontinuance of Plavix because the risk of having a stent thrombosis due to discontinuation of Plavix was so minimal that it was not a material risk.
At time of trial, the court ruled that the Louisiana Uniform Consent Law did not apply to the decision to discontinue medications prior to surgery. However, the issue of informed consent was again raised during argument over jury instructions. Plaintiffs again sought a jury instruction regarding the LUCL and the general principles of its disclosure requirements.
Ultimately the trial judge accepted the defense argument that informed consent was not required when temporarily stopping medications such as Plavix or aspirin for surgery. Defendant successfully argued that physicians are not required to comply with the informed consent law when undertaking routine actions. Further defendant had argued that, even if the informed consent law were found to be applicable, a physician is only required to disclose a material risk, and plaintiff bears the burden of establishing materiality.
After jury verdict was returned for the defense, plaintiffs appealed arguing the trial court had erred in finding the LUCL to be inapplicable. The Louisiana Second Circuit affirmed the trial court decision, confirming that La. R.S. 40:1299.40 did not apply to the facts of this case and thus lack of informed consent was not an issue.
In rejecting the application of the informed consent statute to these facts, the Second Circuit cited with approval the Third Circuit decision in Novak v. Texada, Miller, Masterson & Davis Clinic, 514 So.2d 807 (La. 1987) which found that the administration of a flu shot did not fall within the scope of La. R.S. 40:1299.40 because it was a routine procedure not requiring written consent. The Second Circuit also cited the Third Circuit’s decision in Daniels v. State, through Department of Health & Human Resources, 532 So.2d 218 (La. App. 3d Cir. 1988) which held that the nonsurgical treatment of a closed wrist fracture was a routine medical procedure in which surgery was not involved and to which the informed consent statute did not apply.
Thus, in McDougal, the Second Circuit concluded that “the clearance of a patient for surgery and the recommendation that the patient should cease taking Plavix and aspirin seven to ten days prior to surgery is a routine, nonsurgical decision made on a daily basis. It is not a ‘medical or surgical procedure’ as contemplated in the LUCL to which the duty of informed consent applies.” Emphasis added. Thus the appellate court affirmed the trial court determination that the LUCL did not apply to the facts of this case and lack of informed consent was not an issue.
Plaintiffs often argue for the application of the LUCL requirements to physician decisions regarding selection of medications and other nonsurgical treatment decisions. This Second Circuit’s decision provides further support for limitation on the scope of the Louisiana Uniform Consent Law and its required disclosures. Where the challenged medical decision is a routine, nonsurgical decision such as the cancellation of a medication; or a decision to pursue nonsurgical treatment options, according to the Second and Third Circuits, physicians will not have to demonstrate compliance with the Louisiana Uniform Consent Law.
Of course there is no brightline as to what will be deemed a routine medical decision, and the materiality of risks of all treatment decisions must be assessed on a case by case basis. However, this Second Circuit opinion offers important clarification on the scope of the LUCL and its application in the clinic or non-operative setting.