Opinion ID: 1602016
Heading Depth: 2
Heading Rank: 4

Heading: whether the trial judge erred in refusing to grant a peremptory instruction on the issue of the use of a prescription medical device without a prescription.

Text: ¶ 27. The plaintiffs requested the following peremptory instruction, P-4, regarding the impropriety of the use of the heating blanket: The Court instructs the jury that under certain circumstances negligence is conclusively presumed as a matter of law and cannot be rebutted. In this case, a prescription medical device was used by hospital personnel without a doctor's order. Such action is a violation of FDA rules and regulation and constitutes negligence as a matter of law. If you find by a preponderance of the evidence that such negligence proximately caused the Plaintiff's injuries, then you must return a verdict for the Plaintiff and against Defendant [BCH]. The trial judge summarily refused this instruction. The plaintiffs argue that this was error. Wright and BCH both contended at trial and now on appeal that the blanket is not a prescription device, however, they have yet to put forth any proof of this contention. Rather, they have continued to argue that the plaintiffs did not put forth any evidence beyond the Blanketrol II instruction manual. They argue further that use of the blanket was a necessity, and thus it could not have been negligence to use the blanket. ¶ 28. The manual states that [t]he desired setpoint temperature should be set only as prescribed and under the order of a physician. In the pre-trial statement pursuant to court order, Sub-Zero stated that [t]he Blanketrol is a prescription device to be used only under order of a physician and used at a temperature ordered by a physician. Circulating Nurse Tolbert admitted on cross-examination that she had read in the manual that the Blanketrol II was a prescription medical device and that it should not be used except with the order of a physician. This Court has stated that in regard to prescription medicine '[The package insert] is not conclusive evidence of standard or accepted practice in the use of the drug by physicians or surgeons, nor that a departure from such directions is negligent. But it is prima facie proof of a proper method of use, given by the maker, which must be presumed qualified to give directions for its use and warnings of any danger inherent therein.' The prescribing physician can be permitted to rebut this implication and explain its deviation from the manufacturer's recommended use on dosage. The holding will shift the burden of persuasion to the physician to provide a sound reason for his deviating from the directions for its use, and will require corroborative evidence to determine whether the physician met or violated the appropriate standard. Thompson v. Carter, 518 So.2d 609, 613 (Miss.1988) (quoting Julien v. Barker, 75 Idaho 413, 272 P.2d 718 (1954)). The plaintiffs argue that the manual is prima facie evidence that the unit is a prescription device. They contend further that because Miss.Code Ann. § 73-25-33 (Rev. 2000) defines the practice of medicine as prescribing such a device for cure or relief of an injury and Miss.Code Ann. § 73-25-1 (Rev.2000) requires one to obtain a license prior to practicing medicine, it was negligence per se for the staff to have utilized the blanket without the order of a physician. ¶ 29. Wright and the plaintiffs' expert, Tucker, testified that the use of the heating blanket was required because of Tammy's low core temperature prior to surgery. Further, Wright testified that the nurses were responsible for the unit. He also stated that the use of the blanket was an absolute medical necessity under the circumstances and that it was the proper standard of care. We find, however, that this testimony does not rise to the level of rebuttal as to the allegation that the Blanketrol II unit is a prescription medical device. The jury found no liability as to BCH or Wright. Thus, it would appear that the jury found either that her injury was not due to the heating blanket or that it was not negligence to have used it. The denial of the instruction was harmless, particularly considering the fact that the jury heard testimony that the device was a prescription medical device. We find this allegation of error meritless, or at the most harmless error.