In Haffner v. Stryker Corp., No. 14-cv-186, 2014 WL 4821107 (D. Colo. Sept. 29, 2014), the United States District Court for the District of Colorado issued a significant opinion applying the Restatement (Third) of Torts § 6 to preclude a design defect claim against a medical device manufacturer.
In Haffner, Plaintiff alleged he was injured by the implantation of a Stryker Triathlon Total Knee System (Knee System), a medical device, because he was allergic to two of its components -- cobalt and nickel. Id. at *1. Based on these allegations, Plaintiff asserted several claims, including a cause of action for design defect under a theory of strict product liability. Id. Relying in part on a Colorado Court of Appeals case that had cited the Restatement (Third) of Torts § 6 regarding the learned intermediary doctrine, O'Connell v. Biomet, Inc., 250 P.3d 1278, 1281 (Colo. App. 2010), the court predicted that the Colorado Supreme Court would adopt that section's test for design defect with respect to prescription drugs and medical devices: "'A prescription drug or medical device is not reasonably safe due to defective design if . . . reasonable health-care providers . . . would not prescribe the drug or medical device for any class of patients.'" Id. at *3 (quoting Restatement (Third) of Torts § 6(c)) (emphasis added). In addition, the court noted that the drafters' comment states that "'a prescription drug or medical device that has usefulness to any class of patients is not defective in design even if it is harmful to other patients.'" Id. (quoting Restatement (Third) of Torts § 6 cmt. b) (emphasis added).
In applying that test, the court rejected Plaintiff's contention that the Knee System was defectively designed because it contained cobalt and nickel, substances to which 19% of the population was alleged to be allergic or sensitive, despite the availability of hypoallergenic alternatives. Id. "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 medical device is defectively designed." Id. Thus, the court dismissed Plaintiff's design defect cause of action. Id.
The Restatement (Third) of Torts § 6 limits liability against pharmaceutical and medical device manufacturers by recognizing that drugs and medical devices are not one-size-fits-all medical solutions. The Haffner decision joins a growing number of courts that have adopted that rationale to bar design defect claims against pharmaceutical and medical device manufacturers.