Last week, the North Carolina Court of Appeals analyzed the language of this statute which outlines the affirmative defense of modification or alteration of a product in Stark v. Ford Motor Co., No. COA09-286, 2010 WL 1959851 (N.C. Ct. App. May 18, 2010) [PDF]. In Stark, the case was originally filed in the name of all of the members of a family. The parents’ claims, along with the claims of one of the children, were dismissed pursuant to the defendant’s motion for summary judgment. Stark at *2. The only plaintiffs remaining in the case at the start of the trial were Cheyenne Stark (age 5 at the time of the accident) and her brother Cody Stark (age 9 at the time of the accident). Id. The minor plaintiffs were injured when their parents’ vehicle allegedly and unexpectedly accelerated while the mother was operating the vehicle in a parking lot. Id. The remaining plaintiffs’ theory was that their injuries were enhanced by an alleged design defect with the seat belts of the vehicle. Id.

The defendant asserted the affirmative defense of “Alteration or Modification of Product” available under N.C. Gen. Stat 99B-3. Specifically, the defendant argued that Cheyenne Stark had the shoulder belt behind her back at the time of the accident and thus the alleged design defect of “film spool” could not have been the cause of her injuries. Id. at *2. At the end of the trial, the jury returned a verdict finding the defendant “act[ed] unreasonably in designing the 1998 Ford Taurus and its component parts, proximately causing enhanced injury to Cheyenne Stark.” Id. at *3. However, the jury also found that Cheyenne’s enhanced injuries were caused by an alteration or modification of the vehicle. Id. Finally, the jury found that the defendant’s product did not cause the enhanced injury of the other minor plaintiff, Cody Stark. Id.

On appeal, the plaintiffs presented two arguments. First, since Cheyenne Stark was only 5 years old at the time of the accident, she was legally incapable of negligence and therefore unable to foresee that any modification or alteration could proximately cause her injury. Id. at *5. Second, the plaintiffs rebutted the defendant’s argument that Cheyenne’s parents modified the seat belt by putting the shoulder belt behind her back by relying on the statutory language that the modifier must be a party to the action. Id. at *6.

As to the plaintiff’s first argument, the court reasoned that the alteration or modification of a product must be the proximate cause of the injury in order for the defense to apply. As such, the court then engaged in a “foreseeability” analysis and pointed to longstanding North Carolina case law which held that children under the age of 7, as a matter of law, are incapable of negligence. Id. at *5. Thus, the court reasoned that under the appropriate standard of care for a child under the age of 7, the “…[d]efendant is unable, as a matter of law, to prove the requisite element of foreseeability inherent in the proximate cause portion of its N.C.G.S. 99B-3 defense.” Id. Since the defendant would be unable to establish proximate cause, the defense was unavailable as to any alleged modification or alteration performed by Cheyenne Stark herself.

With regard to the plaintiffs’ second argument, the court essentially applied the rules of statutory construction and held that “the plain language of N.C.G.S. 99B-3 states that he entity responsible for the modification or alteration of the product must be a party to the action in order for the defense to apply.” Id. at *7. The court recognized that the requirement that the modifier or alterer be a party to the case was an issue not previously determined by the courts in North Carolina. Therefore, the affirmative defense available under N.C. Gen. Stat. 99B-3 is only available if the one that modifies or alters the product is a party to the action. Which begs the question: was it really party time when the parents were kicked out the case shortly before the trial began? To be fair, hindsight is 20-20.

From July 2002 to April 2007, Plaintiff Mary Cleo Couick took generic metoclopramide pills for treatment of gastroesophasgeal reflux. Reglan, the name-brand version of the drug, was manufactured by Wyeth, Inc. and Schwarz Pharma, Inc. Couick stipulated that she only took the generic version of this drug. However, Couick filed suit against both the name-brand manufacturers and generic manufacturers claiming that they failed to adequately warn her doctors about the risks associated with metoclopradmide, which caused her to develop tardive dyskinesia.

Against name-brand manufacturers, Couick brought claims for negligence, breach of undertaking special duty, misrepresentation by omission, negligent misrepresentation, constructive fraud, fraud by concealment, intentional infliction of emotional distress, negligent infliction of emotional distress, unfair and deceptive trade practices, breach of express warranty, and breach of implied warranties. In response, name-brand manufacturers filed a motion for summary judgment.

The Court first found that since “[e]ach of [Couick's] claims [are] based on the premise that Wyeth and Schwarz are liable for Couick’s physical condition because they failed to adequately warn Couick’s doctors about the dangers of metoclopramide,” Couick’s claims, while masked in various legal theories, were a single claim for products liability.

The Court then held that under clear North Carolina and Fourth Circuit authority, a “name-brand manufacturer’s statements regarding its drug [cannot] serve as the basis for liability for injuries caused by another manufacturer’s drug.” As a result, the Court granted name-brand manufacturers’ motion for summary judgment.

This case is instructive to products liability practitioners in two main respects. First, despite a plaintiff’s artful pleading, claims based upon personal injury or property damage as a result of the manufacture, construction, design, selling, advertising, etc. of the product, is generally considered only one claim under a state’s products liability law. Second, the rule that a name-brand manufacturer is not liable for injuries caused by another manufacturer remains intact. See Foster v. Am. Home Products Corp., 29 F.3d 165 (4th Cir. 1994). Recently, we have reported on a number of cases here against drug manufacturers. This re-affirmed rule will become particularly important as these types of suits increase.