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NO. COA98-840 NORTH CAROLINA COURT OF APPEALS Filed: 19 October 1999 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. Appeal by plaintiffs from orders and judgments entered in Buncombe County Superior Court, including order entered 12 December 1997 and judgment entered 29 August 1997 by Judge Ronald K. Payne; and order entered 10 July 1997 and order and judgment entered 22 May 1997 by Judge Forrest A. Ferrell. Court of Appeals 25 February 1999. Donald B. Hunt for plaintiff-appellants. Smith, Helms, Mulliss & Moore, L.L.P., by J. Donald Cowan, Jr. and Lisa Frye Garrison, 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, 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, for St. Joseph's Hospital, defendantappellee. JOHN, Judge. Plaintiffs Gregory Osburn (Osburn) and wife Joy C. Osburn appeal certain orders and judgments entered in the trial court. Heard in the

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. claims: Plaintiffs asserted the following

(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. negligence. At trial, the jury returned a verdict of no 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.

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