McCombs v. Synthes (USA), A01A0006.

• Decision Date: 13 July 2001
• Docket Number: No. A01A0006.,A01A0006.
• Citation: 250 Ga. App. 543,553 S.E.2d 17
• Parties: McCOMBS v. SYNTHES (U.S.A.) et al.
• Court: Georgia Court of Appeals

553 S.E.2d 17

250 Ga. App. 543

McCOMBS v. SYNTHES (U.S.A.) et al.

No. A01A0006.

Court of Appeals of Georgia.

July 13, 2001.

Webb, Stuckey & Lindsey, James H. Webb, Jr., Peachtree City, Martin C. Jones, Stockbridge, Sharon S. Whitwell, Locust Grove, for appellant.

Kilpatrick Stockton, Susan A. Cahoon, Jeffrey J. Toney, Atlanta, for appellees. ANDREWS, Presiding Judge.

This is the second appearance of this products liability case before us.¹ Plaintiff Linda B. McCombs appeals from the trial court's grant of partial summary judgment to defendant Synthes Spine Company, L.P. (Synthes Spine) on its duty to warn McCombs under the learned intermediary doctrine (duty to warn claim). McCombs also appeals from the trial court's order finding a proper case and granting the renewed motion to open default, pursuant to OCGA § 9-11-55(b), filed by defendants Synthes, Inc., Synthes North America, Inc., and Synthes Ltd., U.S.A. (defaulting Synthes defendants).

When this case first appeared before this Court in McCombs I,² we affirmed that part of the trial court's order granting defendants Southern Regional Medical Center, Inc.'s (Southern Regional Medical Center) and its parent corporation, Georgia MedCorp, Inc.'s (Georgia MedCorp), motion to dismiss McCombs' breach of warranty claims and reversed that part of the order denying McCombs' motion for default judgment against the defaulting defendants and remanded the case "for consideration of any pending motion to open default of [the defaulting defendants]." Id. at 681-682(2), 504 S.E.2d 747.

The evidence construed in the light most favorable to McCombs shows that Dr. Achecar³ operated on McCombs on July 26, 1994, as a result of a cervical disk herniation. Dr. Achecar installed a plate device, manufactured by Synthes (U.S.A.) and distributed by Synthes Spine to Southern Regional Medical Center, in McCombs' back in order to facilitate fusion of three vertebrae. That such a device is not available except upon prescription, surgical insertion, and under the supervision of the treating physician is undisputed in this product liability action.

McCombs was a smoker, and Dr. Achecar explained to her that smoking could be detrimental to the fusing of her vertebrae because smoking slows healing. Although McCombs used the Nicoderm patch, she was not able to quit smoking.

After surgery, McCombs was monitored by Dr. Achecar and, during office visits on August 22 and September 6, 1994, the bone grafts and plate were in position and fusion was beginning. On November 21, 1994, nearly four months after the surgery, x-rays determined that the plate had fractured.

Dr. Achecar acknowledged that fracture of a fixation device is a risk of such surgery. The package insert included with the Synthes plate contained the following warning to the operating surgeon:

These devices can break when subjected to the increased loading associated with delayed union or nonunion. Internal fixation appliances are load sharing devices which hold a fracture in alignment until healing occurs. If healing is delayed, or does not occur, the implant could eventually break due to metal fatigue. Loads produced by weight bearing and activity levels will dictate the longevity of the implant. The patient should understand that stress on an implant can involve more than weight bearing. In the absence of solid bony union, the weight of the limb alone, muscular forces associated with moving a limb, or repeated stresses of apparent relatively small magnitude, can result in failure of the implant. Notches or scratches put in the implant during the course of surgery may also contribute to breakage. (Emphasis in original.)

Also, Dr. Pettine, upon whose deposition McCombs relied in opposing summary judgment, acknowledged that manufacturers of fixation devices warn that there is risk of plate breakage if the patient does not achieve fusion and that smoking can interfere with fusion.

In two enumerations of error, McCombs contends that the state court erred in granting Synthes Spine partial summary judgment as to her duty to warn claim because: (1) the grant of partial summary judgment was issued sua sponte denying her a full and fair opportunity to respond, Synthes Spine having neither briefed the issue nor argued it at the hearing on motion for summary judgment; and (2) there exists a jury question as to the adequacy of the warning given McCombs' doctor by the Synthes defendants. In three additional enumerations of error, McCombs contends that the state court erred in granting the defaulting Synthes defendants' renewed motion to open default for violation of the law of the case rule in that no motion to open default was "pending" in the trial court after this Court's decision in McCombs I, which, among other things, remanded the case for consideration of any pending motion to open default of the defaulting Synthes defendants. In the alternative, McCombs contends that the state court abused its discretion in granting the motion to open default because the verified answer of the defaulting defendants failed to contain factual assertions under oath sufficient to show a meritorious defense under OCGA § 9-11-55(b), and, in any event, the defaulting Synthes defendants' mistaken belief claim as to the validity of their answer was insufficient as a matter of law to authorize opening default on the grounds of "excusable neglect" or "proper case." Because these claims of error are without merit, as set out below, we affirm.

1. (a) The state court did not err in granting Synthes Spine's partial summary judgment as to McCombs' duty to warn claim for its failure to afford her an opportunity to controvert the claims against her. Citing Aycock v. Calk, 222 Ga.App. 763-764, 476 S.E.2d 274 (1996), McCombs correctly argues that a trial court errs in sua sponte granting summary judgment in circumstances where the nonmoving party has not been afforded a full and final opportunity to respond to the claims against that party. She also correctly cites Dixon v. MARTA, 242 Ga.App. 262, 266(3), 529 S.E.2d 398 (2000), for the proposition that the nonmoving party is denied such an opportunity in circumstances where the record shows that neither party briefed or presented oral argument on the claim struck. Here, however, the record reflects that Synthes Spine briefed the duty to warn claim in its brief in response to plaintiff's motion for entry of default as to the defaulting Synthes defendants. The issue was not argued at the hearing on motion for summary judgment, but, in view of the foregoing, this is of no legal significance.

(b) It is well settled that the "learned intermediary" rule of Hawkins v. Richardson-Merrell, Inc., 147 Ga.App. 481, 249 S.E.2d 286 (1978), is applicable to medical devices implanted in patients under the supervision of a physician. The rationale regarding medical devices is the same as that applicable to drugs prescribed by a physician, i.e., that the duty to warn the patient should rest, not with the manufacturer, designer, or distributor, but solely with the treating physician, in that "the decision to employ prescription medication involves professional assessment of medical risks in light of the physician's knowledge of a patient's particular needs and susceptibilities. Walker v. Jack Eckerd Corp., 209 Ga.App. 517, [521(2), 434 S.E.2d 63 (1993) (whole court)]." Lance v. American Edwards Laboratories, 215 Ga.App. 713, 716, 452 S.E.2d 185 (1994) (physical precedent).

As reiterated in Presto v. Sandoz Pharmaceuticals Corp., 226 Ga.App. 547, 548-549(1), 487 S.E.2d 70 (1997),, "[a]s we stated in Hawkins, supra at 483(1), 249 S.E.2d 286, [t]his special standard [(learned intermediary rule)] is an understandable exception to the... general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products." The recent case of Williams v. American Med. Systems, 248 Ga.App. 682, 685(3), 548 S.E.2d 371 (2001) is factually very similar to McCombs and reemphasizes the viability of the learned intermediary rule. There, a penile implant had to be removed because of infection. The strict liability claim remained viable based on the theory that tubing in the implant became disconnected and caused the infection. The failure to warn claim, however, was correctly disposed of in favor of the manufacturer because "when a device can be prescribed and inserted only by a physician, that treating physician has sole responsibility for advising the patient of dangers associated with the use of the device. The designer, manufacturer, and distributor are under no duty to the patient." Id.

While recognizing the "learned intermediary" rule, the dissent attempts to eviscerate the rule by analogizing it to the duty imposed by OCGA § 51-1-11(c). Below, however, McCombs did not argue that the "learned intermediary" rule did not apply or should be "expanded" as argued by the dissent.

"`Appellate courts review enumerations for correction of errors of law committed by the trial court—where motions or objections are properly presented for a ruling by the trial court.' Cohen v. Lowe Aviation Co., 221 Ga.App. 259, 261(2), 470 S.E.2d 813 (1996)." Williamson v. Harvey Smith, Inc., 246 Ga. App. 745, 748(2), 542 S.E.2d 151 (2000).

Therefore, the trial court's grant of summary judgment based on the learned intermediary rule was correct.

2. We find no error in granting the defaulting Synthes defendants' motion to open default as a proper case. Upon the payment of costs, as in this case, a prejudgment motion to open default under OCGA § 9-11-55(b),

may be opened on one of three grounds if four conditions are met. The three grounds are: (1)providential cause, (2) excusable neglect, and (3) proper case; the four conditions are: (1) showing made under oath, (2) offer to plead instanter, (3) announcement of ready to proceed with trial, and (4) setting up a meritorious defense. This court has previously held that the "s

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