A federal court recently placed Colorado amongst the states that apply Restatement (Third) of Torts §6(c) in design defect cases.  That’s a good place to be when you’re defending a medical device company.  Section 6(c) creates a tougher burden for design defect plaintiffs than does Restatement (Second) of Torts.  Showing a safer alternative design isn’t enough.  And that’s important, because there are often alternative designs for medical devices.  Section §6(c) instead focuses on prescribing doctors and their risk-benefit analysis:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Restatement (Third) of Torts § 6(c).  In short, if a reasonable doctor would choose to use the device for any class of patients, knowing the risks, it is not defectively designed – regardless of whether there might be an alternative design.

The facts of the Colorado case, Haffner v. Stryker Corp., No 2014 U.S. Dist. LEXIS 137214 (D. Col. Sep. 29, 2014), show how this can work.  The plaintiff had knee replacement surgery, but later needed revision surgery.  He was allergic to the cobalt and nickel contained in the knee replacement system.  So he sued, claiming, amongst other things, that the system was defectively designed.  Id. at *1, 2, 7.Continue Reading A Colorado Federal Court Adopts Restatement (Third) of Torts Section 6(c)