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.
But the question under § 6(c) is not whether the device could have been designed without cobalt and nickel so that it is better suited for a particular patient or class of patients. It’s whether the device, as designed, would be used by a reasonable doctor with “any” class of patients. In other words, would it be prescribed for a class of patients without such allergies? That question will often answer itself. The Haffner court answered it for us:
Prescription medical devices are not the same as ordinary consumer products. 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 medical device is defectively designed. The Restatement (Second) considered 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. The plaintiff has failed to state a plausible claim that the Knee System is defectively designed. Therefore, this claim is dismissed.
Id. at *7-8. That’s the crux of it. Under § 6(c), the device need only be of a type that a reasonable doctor would prescribe to some patients. That is almost always the case with a device approved or cleared by the FDA. And therein lies the power of § 6(c).
Now, § 6(c) is not all protective. It does not necessarily protect against failure to warn claims, and so the Haffner court allowed plaintiff’s strict liability and negligent failure to warn claims to go forward.
But the defendants are in a better place. They no longer have to deal with, arguably, the most difficult claim to defend – design defect – particularly if they had to conduct that defense under law that allows consideration of alternative designs. With that in mind, this was a very good result.