IN THE SUPREME COURT, STATE OF GEORGIA

LINDA B. MCCOMBS, Appellant,

v.

SYNTHES, INC. et. al., Appellees

CASE NO. SO1G1633

AMICUS CURIAE BRIEF OF THE

GEORGIA TRIAL LAWYERS ASSOCIATION

The GTLA is a voluntary organization comprised of approximately 2100 trial lawyers licensed to practice in this State whose clients have an interest in this Court's rulings on the important issues presented by this appeal.

In the past few years, the GTLA has consistently appeared as Amicus Curiae in various matters presented before the appellate courts of Georgia. The intent of the GTLA is not to support the petitioner or the respondent as Amicus Curiae. Rather, the GTLA desires and attempts to aid the Court to a proper resolution of this case by seeing that the law is correctly and thoroughly followed.

The Court of Appeals erred by holding that the defendant's discussion of a defense in response to a motion for entry of default provided the plaintiff with adequate notice that the court was considering granting summary judgment. More than simply erring, this decision establishes dangerous precedent that will require plaintiffs to respond to any brief discussing a defense as though the defendant has filed a summary judgment motion. Here, the Court of Appeals not only held that the plaintiff had adequate notice, but it also refused to consider additional arguments by the plaintiff - on the grounds that the plaintiff did not raise those arguments below. In effect, the Court of Appeals severely punished the plaintiff for treating the defendant's brief on the default issue as a brief on the default issue and not as a summary judgment motion. This was wrong, and it establishes a dangerous precedent.

Equally wrong is the Court of Appeals' substantive ruling on the learned intermediary doctrine. The effect of the Court of Appeals' ruling is that there is no duty to warn on the part of the medical device manufacturer because the learned intermediary doctrine absolves the manufacturer from any liability for failure to warn. The result is that the ruling eliminates any remedy for an injured person where the manufacturer has failed properly to warn the intermediary. This decision is both flawed and is poor public policy as shown below.

1. The Court of Appeals Has Established Dangerous Precedent That Will Require Plaintiffs to Respond to Any Brief Raising a Defense as Though the Defendant has Moved for Summary Judgment.

a. The Court of Appeals' decision was wrong.

GTLA amicus is concerned that the Court of Appeals decision establishes dangerous precedent that will require plaintiffs to respond as if a defendant has filed a summary judgment motion anytime a defendant files a pleading raising a particular defense. The facts as recited by the Court of Appeals in its McCombs decision are clear that the defendant moved for summary judgment on issues unrelated to Plaintiff's failure to warn claim. The Court of Appeals specifically states that the learned intermediary/failure to warn "issue was not argued at the hearing on motion for summary judgment." McCombs v. Synthes, 250 Ga. App. 543, 545 (2001). The only argument made by the defendant on this claim was contained in briefing submitted by the defendant earlier in the litigation as part of an effort to reopen default. See O.C.G.A. § 9-11-55(b)("setting up a meritorious defense" one condition required for opening default). Despite the fact that no summary judgment motion had been filed on the subject, the trial court granted summary judgment on plaintiffs' failure to warn claim.

The plaintiff appealed arguing, inter alia, that summary judgment was improper because she "had not been afforded a full and final opportunity to respond to the claims against [her]." Id. Remarkably, the Court of Appeals held that the defendant's argument in a brief on the default issue was somehow sufficient to afford the plaintiffs with notice that the trial court was considering granting summary judgment:

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 forgoing, this is of no legal significance.

Id.⁽¹⁾

With this holding, the Court of Appeals has now come dangerously close to establishing as law in this state that an issue is ripe for summary judgment if a defendant raises the issue in any pleading filed on any subject -- such as a brief responding to a motion for entry of default judgment. This is wrong. Georgia law has long held that a trial court must "insure that the party against whom summary judgment is sought has had a full and final opportunity to meet and attempt to controvert the assertions against him." Martin v. Newman, 162 Ga. App. 725, 726 (1982); see also Royston v. Royston, 236 Ga. 648, 650 (1976). Including a section in a brief responding to a motion for entry of default provides no notice to a plaintiff that the trial court is considering granting summary judgment on that issue, particularly when a summary judgment motion is filed on other issues and omits that issue. Compounding the problem, the Court of Appeals refused to consider arguments and evidence on appeal relating to the learned intermediary doctrine - because plaintiffs had not made those arguments before the trial court.

It was wrong for the Court of Appeals to permit summary judgment on the failure to warn claim with no motion on the subject. It was doubly wrong for the Court of Appeals to refuse to consider arguments that plaintiffs failed to raise in response to a motion that was never filed. This Court should correct the Court of Appeals decision.

b. The Court of Appeals' decision establishes precedent that will unnecessarily burden the court system and litigants, particularly plaintiffs.

The Court of Appeals held that the plaintiff had an opportunity to respond to questions regarding the sufficiency of evidence supporting her failure to warn claim because the defendant had briefed its defense on this issue in response to the plaintiffs' motion for entry of default. According to the Court of Appeals, once the defendant filed its brief responding to the motion for entry of default, the plaintiff should have acted as though the defendant had filed a summary judgment motion. Nothing about a response to a motion for entry of default should put a plaintiff on notice that the court might grant summary judgment.

An examination of the rules governing default makes clear that the issues involved in opening a default are very different than those involved in summary judgment. One of the requirements for opening a default is that the party in default "set up a meritorious defense." O.C.G.A. § 9-11-55(b). To meet this requirement, a defendant need only satisfy a very slight burden. "Establishing a meritorious defense 'does not require a defendant to show that it will completely defeat plaintiff's claim; rather, the defendant must demonstrate that if relief from default is granted, the outcome of the suit may be different from the result if the default stands." Henderson v. Quadramed Corp., 2003 WL 402222 *2 (Ga. App. 2003)(quoting Johnson v. American National Red Cross, 253 Ga. App. 587, 590 (2002). Thus, the McCombs defendant's brief on the default issue merely needed to show that it had a defense on the failure to warn claim that was sufficient to create the possibility that it might ultimately prevail on that issue. It was not required to satisfy the rigid summary judgment standards. See O.C.G.A. § 9-11-56. Nonetheless, according to the Court of Appeals, the defendant's argument that it had a meritorious defense that might prevail was sufficient to place the plaintiff on notice that the court was considering granting summary judgment.

If the Court of Appeals decision stands, plaintiffs will be forced to act as though the defendant has filed a summary judgment any time a defendant raises an issue in a brief. There is no substantive difference between a brief responding to a motion for entry of default and a brief on a discovery issue or on any other issue a party might brief during the course of litigation. Indeed, by discussing an issue in a brief, a defendant simply informs the plaintiff that it believes that defense is applicable in that particular case. As such, there is no substantive difference between discussing a defense in a brief and raising the defense in an answer. Under McCombs, plaintiffs will need to respond to any mention of a defense as though the defendant has filed a summary judgment motion or risk suffering the same fate as the McCombs plaintiff. Such a practice will overly burden the court system and litigants, particularly plaintiffs since most summary judgment rulings are directed toward plaintiffs. This Court should reverse the Court of Appeals and make clear that the mere discussion of a defense in an unrelated motion or brief does not give a trial court authority to grant summary judgment.

2. The Court of Appeals has improperly applied the learned intermediary doctrine in a way that immunizes manufacturers from failure to warn claims.

a. Georgia law imposes a duty of reasonable care upon manufacturers at all stages of the manufacturing process, and the reasonableness of a manufacturer's decision is a jury question.

Georgia law imposes a general duty on the creator of a hazard to remove the hazard or warn of it, so as to prevent foreseeable injuries. In United States v. Aretz, 248 Ga. 19 (1981), this Court stated the general principle as follows:

[W]here one by his own act, although without negligence on his part, creates a dangerous situation, he is under a duty to remove the hazard or give warning of the danger so as to prevent others from being injured where it is reasonably foreseeable that this will occur.

In Banks v. ICI Americas, Inc., 262 Ga. 732, 450 S.E.2d 671 (1994), this Court adopted a risk utility test for product liability case. This test is a manifestation of the general duty of reasonable care all of us owe. This Court has stated that the "heart" of a product liability case is the reasonableness of a manufacturer's decisions. Jones v. Nordictrack, Inc., 274 Ga. 115, 550 S.E.2d 101, 103 (2001). This Court has also recognized that a manufacturer's "duty to warn arises... whenever the manufacturer knows or reasonably should know of the danger arising from the use of its product." Chrysler Corp. v. Batten, 264 Ga. 723, 724, 450 S.E. 2d 208 (1994).

The adequacy of warnings is generally a jury question In Carter v. EI DuPont deNemours & Co., Inc., 217 Ga. App.139, 143, 456 S.E. 2d 661 (1995), the Court of Appeals addressed the factors that must be balanced in determining whether the warning is adequate: the burden of the warning, the likelihood that the intermediary will warn end users; the likely efficacy of the warning; the degree of danger posed by absence of warning; and the nature of the potential harm.

b. The Court of Appeals' ruling improperly applies the learned intermediary doctrine.

The learned intermediary doctrine is merely a manifestation of the manufacturer's duty to act reasonably in issuing warnings about its products. It in no way changes a manufacturer's duty but merely designates the person to be warned as the intermediary, not the end consumer. In this case, the Court of Appeals' decision can easily be read to grant immunity to manufacturers in any case in which there is a learned intermediary between the manufacturer and consumer. First, there is a logical fallacy in the ruling. The use of the term "learned" in the learned intermediary doctrine implies that the intermediary brings to the table all the information necessary fully to apprize the ultimate consumer of all the pertinent information necessary for the consumer to make informed decisions. However, in many situations, the intermediary is dependent upon the manufacturer to inform him about the potential risks of the device or drug. This is particularly true in cases of new medical devices and new drugs where the manufacturer is far and away the best entity to test and evaluate its product or drug. The reality is that the intermediary should not be expected to know more that the manufacturer, and a rule that assumes equal knowledge is simply flawed logically.

Second, the ruling is poor public policy because it removes a manufacturer's incentive to ensure that the intermediary, and in turn the consumer, has full knowledge. The policy underlying the general duty to warn is that relevant information should be provided to the consumer. Any ruling that removes the manufacturer's incentive to send relevant information down the line undermines one of the fundamental purposes of tort law. This ruling is analogous to the now discredited open and obvious danger rule. That rule immunized the manufacturer from liability based upon the presumption that end users of a product were assumed to be fully informed about the product's dangers. Ogletree v. Navistar, 269 Ga. 443, 500 S.E.2d (1988). Essentially the doctrine was one of "let the consumers fend for themselves." By rejecting this doctrine, this Court advanced the purpose of the law in terms of encouraging safer products and protecting consumers. The ruling below here is actually a step in reverse.

The Amicus brief submitted by the PLAC seeks to have the Court expand far beyond even the Court of Appeals' ruling and effectively immunize manufacturers based upon a preemption-like argument. The PLAC would have this Court abdicate any involvement by Georgia juries in assessing the reasonableness of a manufacturer's conduct. Under the PLAC's position, every warning or instruction would be immune from challenge since it would be approved by the FDA. Effectively, the PLAC is asking the Court to find that all warning claims involving medical devices and drugs are preempted. Obviously, the PLAC seeks to go far beyond what this Court asked of the parties in granting certiorari. Moreover, the rationale behind the PLAC's position has been thoroughly repudiated by this Court.

In Doyle v. .Volkswagenwerk Aktiengesellschaft , 267 Ga 574, 481 S.E.2d 518 (1997), this Court was called to decide whether the so-called Kimbrel doctrine survived this Court's adoption of the risk utility analysis as announced in Banks. The Kimbrel doctrine held that in product liability cases a manufacturer that had complied with Federal Motor Vehicle Safety Standards could not be held liable as a matter of law. The rationale for the rule was that to subject manufacturers to varying state law duties more stringent that minimum federal standards was inappropriate. In Doyle, this Court held that a manufacture was not immunized merely because its product met federal standards. As the Court held, such a rule is inconsistent with the risk-utility analysis:

The Kimbrel doctrine predated our decision in Banks and is inconsistent with a risk-utility analysis. Under the risk-utility test, compliance with federal standards or regulations is a factor for the jury to consider in deciding the question of reasonableness, that is, whether the product design selected was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware. It does not render a manufacturer's choice of design immune from liability. That is not to say that evidence of such compliance is not significant, for it is. But, instead of acting as an impenetrable shield from liability, compliance, more appropriately, is to be a piece of the evidentiary puzzle.

Id. at 521.

The lower court's ruling sets dangerous precedent on both procedural and substantive grounds. Left undisturbed, it leaves the door open for defendants to seek dispositive rulings on issues that are not fully briefed and thus can result, as here, in rulings being entered in a process that simply is not fair to the litigants. Moreover, the lower court's misapplication of the learned intermediary doctrine can be read as altering the rule that a manufacturer adequately warn the intermediary so that the intermediary can then properly advise and warn the consumer. For these reasons, the decision below should be reversed.

Respectfully submitted,

This _____day of June, 2003.

/s/ R. Hutton Brown

1. GTLA amicus acknowledges that the Court of Appeals may have been incorrect in its discussion of the procedural history of this case. Such an error is irrelevant to GTLA's position because trial courts will apply the Court of Appeals' decision as written unless this Court reverses it.