Osburn v. Danek Medical, Inc.

• Decision Date: 19 October 1999
• Docket Number: No. COA98-840.,COA98-840.
• Citation: 520 S.E.2d 88,135 NC App. 234
• Court: North Carolina Court of Appeals
• Parties: Gregory OSBURN and Joy C. Osburn, Plaintiff-Appellants, v. DANEK MEDICAL, INC., Sofamor-Danek Group, Inc., Warsaw Orthopaedic, Inc., Keith M. Maxwell, M.D., Keith M. Maxwell, M.D., P.A., and St. Joseph's Hospital, Defendant-Appellees.

520 S.E.2d 88

135 NC App. 234

Gregory OSBURN and Joy C. Osburn, Plaintiff-Appellants, v. DANEK MEDICAL, INC., Sofamor-Danek Group, Inc., Warsaw Orthopaedic, Inc., Keith M. Maxwell, M.D., Keith M. Maxwell, M.D., P.A., and St. Joseph's Hospital, Defendant-Appellees.

No. COA98-840.

Court of Appeals of North Carolina.

October 19, 1999.

Donald B. Hunt, Raleigh, for plaintiff-appellants.

Smith, Helms, Mulliss & Moore, L.L.P., by J. Donald Cowan, Jr. and Lisa Frye Garrison, Greensboro, for Danek Medical, Inc., Sofamor-Danek Group, Inc., and Warsaw Orthopaedic, Inc., defendant-appellees.

Young, Moore and Henderson P.A., by Joseph W. Williford and Brian O. Beverly, Raleigh, for Keith M. Maxwell, M.D., and Keith M. Maxwell, M.D., P.A., defendant-appellees.

Roberts & Stevens, P.A., by Isaac N. Northup, Jr. and Jacqueline D. Grant, Raleigh, for St. Joseph's Hospital, defendant-appellee.

JOHN, Judge.

Plaintiffs Gregory Osburn (Osburn) and wife Joy C. Osburn appeal certain orders and judgments entered in the trial court. We conclude plaintiffs' assignments of error are unfounded.

Pertinent factual and procedural background includes the following: Osburn fell and suffered injury in 1989 and subsequently sought treatment from defendant Dr. Keith M. Maxwell, M.D. (Dr. Maxwell). Dr. Maxwell performed back surgery on Osburn in October 1990, implanting an ISF Luque II plate and screw spinal fixation device (ISF Luque II device). In February 1992, Dr. Maxwell removed the ISF Luque II device, replacing it with a TSRH spinal fixation device (TSRH device). A third spinal surgery was performed on Osburn by Dr. Maxwell in 1993, and in 1994 Dr. Maxwell removed the TSRH device.

Both the ISF Luque II and the TSRH devices implanted in Osburn were manufactured by defendants Danek Medical, Inc. (Danek) and Warsaw Orthopaedic, Inc. (Warsaw), which corporations were purchased by defendant Sofamor-Danek Group (Sofamor) in 1993. Osburn's four operations were each performed at the premises of defendant St. Joseph's Hospital (St.Joseph's). Notwithstanding his extensive surgical history, Osburn continued to experience pain.

The instant suit was initiated in 1995 and an amended complaint filed in 1996. Plaintiffs asserted the following claims: (1) fraud against Danek, based upon alleged violation of Food and Drug Administration (FDA) regulations; (2) fraudulent marketing and promotion against Danek; (3) civil conspiracy, concert of action and negligence per se against all defendants; (4) medical malpractice and constructive fraud against defendants Dr. Maxwell and St. Joseph's; (5) fraud against Dr. Maxwell and St. Joseph's based upon their alleged assertions that the ISF Luque II and the TSRH devices used in Osburn's back were "safe and effective"; (6) loss of consortium against all defendants; and (7) punitive damages against all defendants.

The trial court entered summary judgment in favor of Danek, Warsaw, Sofamor, and St. Joseph's on 22 May 1997. On 10 July 1997, the trial court entered partial summary judgment in favor of defendants Dr. Maxwell and Keith M. Maxwell, M.D., P.A. (Dr. Maxwell, P.A.), Dr. Maxwell's medical practice corporation, on all plaintiffs' claims against those defendants save that of negligence. At trial, the jury returned a verdict of no negligence. The trial court thereupon entered judgment 29 August 1997 dismissing plaintiffs' claims as to Dr. Maxwell and Dr. Maxwell, P.A. Plaintiffs moved for a new trial, which motion was denied in an order entered 12 December 1997.

Plaintiffs appeal the foregoing judgment and order as well as the grant of summary judgment in favor of Danek, Warsaw, Sofamor and St. Joseph's and of partial summary judgment to Dr. Maxwell and Dr. Maxwell, P.A.

Plaintiffs first assign error to the trial court's jury instructions on the issue of informed consent. Plaintiffs argue Dr. Maxwell had a duty to inform them of the experimental nature of the ISF Lusque II and TSRH devices used by Dr. Maxwell in Osburn's back surgery, and that the trial court erred in refusing to instruct the jury as to this duty. We hold the jury was properly instructed under present applicable law.

The pertinent statute, N.C.G.S. § 90-21.13 (1993), provides as follows:

(a) No recovery shall be allowed against any health care provider upon the grounds that the health care treatment was rendered without the informed consent of the patient ... where

(1) The action of the health care provider in obtaining the consent of the patient... was in accordance with the standards of practice among members of the same health care profession with similar training and experience situated in the same or similar communities; and

(2) A reasonable person from the information provided by the health care provider under the circumstances, would have a general understanding of the procedures or treatments and of the usual and most frequent risks and hazards inherent in the proposed procedures or treatments which are recognized and followed by other health care providers engaged in the same field of practice in the same or similar communities....

To meet the statutory standard,

the health care provider must provide the patient with sufficient information about the proposed treatment and its attendant risks to conform to the customary practice of members of the same profession with similar training and experience situated in the same or similar communities. In addition, the health care provider must impart enough information to permit a reasonable person to gain a "general understanding" of both the treatment or procedure and the "usual and most frequent risks and hazards" associated with the treatment.

Foard v. Jarman, 326 N.C. 24, 26-27, 387 S.E.2d 162, 164 (1990) (quoting G.S. § 90-21.13(a)(2)).

Plaintiffs filed a written request for jury instructions on 25 August 1997, requesting that the jury be instructed that

the health care provider has a duty, in exercising reasonable care under the circumstances, to inform the patient of the experimental nature of the proposed procedure.

Plaintiffs renewed their request during the charge conference conducted 28 August 1997.

The trial court declined plaintiffs' tendered instructions, stating that the duty of a physician to inform patients that a device is experimental was not the standard of care under G.S. § 90-21.13. The court charged the jury that plaintiffs were required to prove Dr. Maxwell did not obtain Osburn's informed consent either

by failing to provide information to [Osburn] which would, under the same or similar circumstances, have given a reasonable person a general understanding of the procedures and treatments to be used, and the usual and most frequent risks and hazards inherent in them as recognized by other orthopedic surgeons in the same or similar communities[; or] by not obtaining [consent] in accordance with the standard of practice among other orthopedic surgeons with the same or similar training and experience and who were situated in the same or similar communities at the time in question.

The trial court further related to the jury the contentions of each party pertaining to the alleged investigative and experimental nature of the proposed procedures and thereafter charged, inter alia, that if it found:

[Dr. Maxwell] was negligent in that he did not inform the plaintiff that the [ISF Luque II or TSRH devices were] investigational or experimental, and that such was not in accordance with the standard of practice [for] obtaining consent among other orthopedic surgeons, which standard would require him to so inform [Osburn]...,

it should answer in favor of plaintiffs.

We believe the court's comprehensive instructions were in full accordance with G.S. § 90-21.13(a) and alerted the jury that evidence of the investigational or experimental status of the devices was properly considered in its resolution of the issue of Dr. Maxwell's negligence. Rather than requiring physicians to inform patients in every instance that a procedure is experimental in nature, G.S. § 90-21.13 directs a physician to indicate the status of a procedure and risks involved therein

in accordance with the standards of practice among members of the same health care profession with similar training and experience situated in the same or similar communities,

G.S. § 90-21.13(a)(1), and in such a manner that a reasonable person would under the circumstances derive from the information

a general understanding of the procedures or treatments and of the usual and most frequent risks and hazards inherent in the proposed procedures or treatments which are recognized and followed by other health care providers engaged in the same field of practice in the same or similar communities,

G.S. § 90-21.13(a)(2).

Plaintiffs rely heavily upon Estrada v. Jaques, 70 N.C.App. 627, 321 S.E.2d 240 (1984); however, after careful review, we conclude Estrada is inapposite. In Estrada, a physician-defendant moved for summary judgment and was thereby required to show his compliance with G.S. § 90-21.13. Estrada, 70 N.C.App. at 645, 321 S.E.2d at 251. This Court observed the physician-defendant had admitted in his pleadings that the procedure in question was experimental, and concluded such admission established "the usual and most frequent risks and hazards inherent in [the procedure or treatment]" as recognized by other orthopedic surgeons in the same or similar community. Id. at 648, 321 S.E.2d at 253-54 (quoting G.S. § 90-21.13(a)(2)). Accordingly, we continued, the physician was required to show, as a matter of law for purposes of summary judgment, that his patient had "a general understanding," G.S. § 90-21.13(a)(2), of the associated risks as recognized by other health care providers, including the experimental nature of the procedure. Id. at 648, 321 S.E.2d at 254.

Plaintiffs perceive Estrada as establishing a per se rule requiring the jury to be instructed that a health care provider in every instance has a...