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Colorado Federal Court Considers Motion to Dismiss in Knee Replacement Case

James M. Dedman, IV

Recently, a Colorado federal court considered a motion to dismiss in a medical device product liability action arising from a plaintiff’s allergic reaction to a cobalt and nickel knee replacement system. See Haffner v. Stryker Corp., et al, No. 14-CV-00186, 2014 WL 4821107 (D. Colo. Sept. 29, 2014) (unpublished). Observing that there appeared to be “few medical device tort cases in Colorado,” the court addressed the defendant’s motion to dismiss the plaintiff’s four causes of action: strict product liability, negligent product liability, the breach of implied warranties of merchantability and fitness, and the breach of an express warranty.

The case arose after the plaintiff underwent a surgical procedure in which his left knee was removed and replaced with a knee system manufactured by Stryker Corporation. The plaintiff alleged that he was unaware of his apparent allergy to cobalt and nickel, certain components of the system. As a result of his allergy, he experienced a reaction that caused “pain, inflammation, swelling, bone loss, and limited mobility.” He ultimately underwent a revision surgery to ameliorate the issue and to replace the original knee system. The plaintiff filed a product liability lawsuit in the state court in Colorado, but as you might suspect, the defendants removed the case to the federal court.

After a series of amendments to the initial pleadings, Stryker Corporation filed a motion to dismiss for failure to state a claim, which was, for some reason, followed by a later show-cause order from the court directing the parties to address the issue of preemption of the claims by the Medical Devices Amendment to the Food, Drug & Cosmetic Act. In response to the motion to dismiss, U.S. District Court Judge R. Brooke Jackson granted it in part and denied it in part.

After analyzing the history of strict product liability in Colorado, the court dismissed the strict liability claim based upon the theory of design defect. Recognizing that the Restatement (Second) of Torts notes that certain “unavoidably unsafe products” are “especially common in the field of drugs,” the court cited § 402A cmt. k for the proposition that certain such devices “cannot legally be sold except to physicians, or under the prescription of a physician,” a provision that Colorado state courts had previously adopted as a defense for manufacturers.

Essentially, the plaintiff alleged that the knee system was defectively designed merely because it was composed of cobalt and nickel, substances to which he claimed a sizable percentage of the general public may be allergic. (In fact, the plaintiff alleged that 19 percent of the population was allergic or sensitive to these components, although the Court did not identify in its opinion the source of the plaintiff’s representation.) Further, the plaintiff alleged that there may be certain hypoallergenic options that the defendant did not consider in its design of the knee replacement. After considering the provisions of the Restatement (Third) of Torts, the court rejected the plaintiff’s arguments, finding that “prescription medical devices are not the same as ordinary consumer products.” Further, the court noted:

A variety of similar devices made with different materials can be developed and manufactured to address the needs of different classes of patients. Simply because a product would not be compatible with a certain class of individuals—in this case, those with cobalt and nickel allergies—does not mean the device is defectively designed. The Restatement (Second) consider the possibility that certain drugs could be unavoidably unsafe while still remaining beneficial. The Restatement (Third) took this conclusion one step further, reasoning that medical devices can be safe for certain patient populations and not others without their risk outweighing their utility. It is for this reason that these devices can only be sold to doctors and administered by prescription.

Thus, the court dismissed the strict liability design-defect claim.

However, in considering the other components of the strict liability claim, the court permitted the plaintiff to proceed with his failure-to-warn claim. The plaintiff had argued that the knee system “was not accompanied by adequate instructions or warnings to inform a healthcare provider of the full nature and extent of the risks associated with the product’s use.” Specifically, the plaintiff contended that the warnings contained in the “Adverse Effects” section of the product inserts, which noted that “metal sensitivity reactions have been reported following joint replacement” and “adverse effects (of any type) may necessitate reoperation,” which lacked specificity with respect to potential allergic reactions due to metals. On this point, the court noted:

There is no reason to believe that individuals with metal sensitivities would be aware of them, especially sensitivities to metals that are not typically handled in our day-to-day lives or that would not cause a severe reaction unless implanted into a person’s body. Furthermore, the Plaintiff has alleged that a substantial percentage of the population suffers from these sensitivities. As such, [the plaintiff] has sufficiently plead that the Defendant had a duty to warn of this specific dangers that could accompany the ordinary use of the Knee System and to include an instruction that individuals be tested prior to the implantation of the device.

With respect to the negligence claim, the plaintiff alleged that Stryker breached its duty of care in multiple ways. Essentially, the negligence allegations involved a purported failure to include an allergy testing kit relating to potential metal allergies and sensitivities. (Of the five allegations of negligence, the court dismissed two without discussion and focused on the allergy test kit issue.) Having previously found that the product was not defectively designed because certain users might be allergic to its components (and therefore Striker could not be held liable on a similar negligence theory), the court focused on Stryker’s conduct—separate and apart from the design of the product at issue—and turned to the plaintiff’s argument that a “reasonable medical device manufacturer would have included an allergy test kit with a product containing cobalt and nickel.” Although Stryker argued that it had no duty to warn, the court responded that even though the knee system was “metal,” a user might not know which specific metal components—such as cobalt and nickel—were part of a particular metal product. Because the plaintiff argued that “a reasonably prudent medical device manufacturer would inform users of the component metals, warn them of the likelihood of suffering an allergic reaction, and instruct them to be tested for sensitivity prior to implantation of the device,” the court found that he sufficiently pleaded a negligent failure-to-warn claim.

With respect to the implied and express warranty claims, the court analyzed those together and concluded that they should be dismissed. In so doing, the court found that “just because some individuals were allergic to materials in the Knee System does not mean that the product was not merchantable, safe, effective, fit, or proper for its intended use as a knee replacement system.” The court further observed that the express warranty claim must “fail because . . . the inserts expressly indicated that some individuals may have sensitivity to the metal in the product, and that such a reaction may require revisionary surgery.” Finally, the court concluded that “[a]n item can be fit for the ordinary purposes for which it is used—here as a knee-replacement device—without being safe for every possible user.”

James M. Dedman, IV, is a partner in Gallivan White & Boyd P.A.’s Charlotte office. Mr. Dedman is an experienced litigator with extensive experience in handling complex personal injury and business litigation. He focuses his practice on transportation law, torts and insurance practice, drug and medical device litigation, and product liability litigation. Mr. Dedman is a member of the DRI Product Liability Committee.

DRIThe Voice
October 29, 2014