As drug and device lawyers we live in a comment k dominated world.  When we say comment k on this blog, everyone knows what we mean.  We aren’t talking about a scientific discovery regarding potassium.  We aren’t reviewing a new flavor of k-cup for the Keurig.  We aren’t posting about breakfast cereals.  And we definitely are not passing comment on the Kardashians, Kobe, Keanu, or K-Fed.

But just in case you need a refresher, here is the comment k that concerns us:

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts §402A, comment k (1965) (emphasis added).  As you can see from the highlighted language, comment k recognizes that some products – drugs and medical devices in particular – are “unavoidably unsafe” and therefore not defective if properly prepared and accompanied by an adequate warning.  Most courts to have considered the issue have interpreted comment k to mean that manufacturers do not face strict liability for properly manufactured prescription drugs that are accompanied by adequate warnings.  That is true in Washington.  Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”).

That is the background against which our case for today is set.  In Payne v. Paugh, 2015 Wash. App. LEXIS 2276 (Wash. Ct. App. Sept. 28, 2015), plaintiff appealed from a jury verdict in favor of Medtronic, the manufacturer of the endotracheal tube used during her tracheal laser surgery.  On appeal, plaintiff claimed that the trial court erred in giving the jury only the comment k negligence instruction and that it should have included a strict liability instruction as well.  Id. at *20-21.

It is important to note that at no time before, during or after trial did plaintiff challenge that the comment k negligence standard applied to the design defect claim against Medtronic.  Id. at *8 (confirmed at summary judgment stage); *10-11 (agreed to pre-trial instructions); *41-42 (proposing strict liability instruction as supplement to negligence instruction).   So the instruction that all parties concede was properly given was:

As to the plaintiff's claim against the Medtronic Defendants, a medical device manufacturer has a duty to use reasonable care to design medical devices that are reasonably safe. "Reasonable care" means the care that a reasonably prudent medical device manufacturer would exercise in the same or similar circumstances. A failure to use reasonable care is negligence.

The question of whether a medical device manufacturer exercised reasonable care is to be determined by what the manufacturer knew or reasonably should have known at the time the device left its control.

In determining what a medical device manufacturer reasonably should have known in regard to designing its device, you should consider the following:

A medical device manufacturer has a duty to use reasonable care to test, analyze, and inspect the products it sells, and is presumed to know what such tests would have revealed.

A medical device manufacturer has a duty to use reasonable care to keep abreast of scientific knowledge, discoveries, advances, and research in the field, and is presumed to know what is imparted thereby.

Id. at *41-42.  Plaintiff’s post-trial argument was that the above jury instruction advises that a manufacturer must use “reasonable care” to design a device that is “reasonably safe,” but then only defines what the jury should consider in determining “reasonable care.”  Plaintiff argued that the definition of “reasonably safe” should come from the strict liability instructions.  Id. at *20-21.  Aha!  So, plaintiff is giving lip service to comment k, but really is asking the court to expand the doctrine to include the more liberal and jury-friendly strict liability standards.  In Washington the strict liability standards for determining whether a product is “not reasonably safe” include both the risk-utility test -- whether a product's risks outweigh the intended benefits -- and the even worse, more subjective consumer-expectation test – whether the device functioned as safely as a reasonable consumer would expect.  Id. at *37-39. 

Those are standards used to determine whether a product is “not reasonably safe.”  But that is not a decision that needs to be made in a comment k case.  Washington, like so many other states, has already determined that drugs and medical devices are “unavoidably unsafe.”  The only question that remains is whether the manufacturer took reasonable care to warn of the known risks that make the product “unavoidably unsafe” in the first place. Plaintiffs are trying to add on a standard for the jury to decide a question which has already been decided as a matter of law.

The Washington Court of Appeals agreed that the comment k instruction that was given properly and completely described the duty of a manufacturer of unavoidably unsafe products: 

Under the WPLA and case law, the risk utility and consumer expectations tests are used to determine whether a manufacturer is strictly liable and do not apply to a negligence design defect claim under comment k. And contrary to the assertion of [plaintiff], the Comment K Negligence Instruction addresses the factors the jury should consider in determining whether a medical device manufacturer used reasonable care to design a medical device that is reasonably safe.

Id. at *44. 

We applaud the appellate court for adhering to the original interpretation of comment k and keeping the focus on the warnings. Allowing either the risk-utility or the consumer expectation test to creep into prescription drug and device cases is very dangerous. Permitting the former in the context of an FDA-approved drug or device is tantamount to allowing a jury to toss away the FDA’s conclusion in approving the product that its benefits outweigh its risks.  As for the consumer-expectation test, drugs and medical devices are the epitome of “complex” products as to which an “ordinary consumer” would have no expectations.  That is precisely why plaintiffs are limited to warning defect claims in these cases. 

Back to other interesting k comments, did you know that potassium is the seventh-most abundant element in the Earth's crust?  Or that Special K has a limited autumn edition flavor --Apple Cinnamon Crunch?