Plaintiffs tend to assert a bunch of different claims. For prescription medical device cases, setting aside preemption, our experience is that plaintiffs do best—that is, avoid summary judgment and directed verdict—with design defect (strict liability or negligence) claims. One reason for that is that it tends not to be hard to make up some theory, working backwards from the alleged injury, of how the design posed a risk and it could have been made better. There also tend to be experts out there who will support these hindsight exercises. Another reason is that law on design defect is pretty inconsistent in various ways. Is the focus on the device, the defendant’s conduct, or the doctors who use it? Does a risk-utility test or a consumer expectations test apply? What about comment k? What about alternative design? Does the plaintiff have to identify a specific defect and prove that the defect caused the injuries? Can the plaintiff just say the device caused the injuries and shift some burden to the manufacturer to disprove that or establish that the device had benefits exceeding its risks (in the abstract)? How does the choice of the physician about what type of device to use or how to use it, especially with implanted devices, play into all this? Faced with so many decisions—again, we are not even including preemption in the mix here—some courts seem to throw up their hands and say “Eh, there are jury questions here” without drilling down on what the law requires and what evidence the plaintiff has.
We think, of course, that such punting is shameful. We also have some thoughts about what design defect law should require for prescription medical devices, especially if you care about encouraging innovations and the quality of medical care. See here, for instance. One thought is that it is better to have a risk-utility test than a consumer expectation test. Consumer expectations makes more sense with consumer products—things you might buy at a store—not with complicated medical devices available only with the prescription of a licensed medical professional, and that cannot be sold absent specific regulatory clearances/approvals. Unfortunately, some states apply a consumer expectation test for the latter category of products too.
Nevada is one of those states and we recall winning summary judgment there in a prescription (implanted) medical device that included a design defect claim. One argument raised in the summary judgment motion was that design defect claim failed because the warnings were adequate as a matter of law. In granting summary judgment on design defect, and on warnings, the court never reached this issue. We cannot say the lack of a decision on that issue haunted us in the years since, but we ran across a case where an appellate court applying Nevada law did address this argument with an implanted prescription medical device. Miller v. DePuy Synthes Sales, Inc., No. 19016821, 2020 WL 7258638 (9th Cir. Dec. 10, 2020), affirmed summary judgment for the defendant manufacturer in an orthopedic implant case. We commented on the decision below here and, unfortunately, the Ninth Circuit decision is unpublished.
Nonetheless, we thought the affirmance deserved a little virtual ink. The decision is light on fact, but our prior post reveals the critical fact: the surgeon concluded “there was a delayed union of the bones and that the device was broken, because the Plaintiff was weight bearing.” Nevada law dictated that a “consumer’s reasonable expectation may be influenced by warnings that accompany a product,” id. at *1, so the relevant warnings would have to affect the expectations on issues of delayed healing, weight bearing, and breaking the device. They did:
Here, the package inserts that accompanied the device were more than adequate to satisfy the consumer-expectation test. [The manufacturer] provided a warning insert with the device indicating it could fail if the healing process is delayed, regardless of whether the patient put weight on the healing bone. The warning further indicated that all implants are subject to repeated stresses in use and can break at any time. Even assuming [plaintiff] complied with [the surgeon’s] instructions and did not put weight on his healing leg, the product’s warning put a reasonable consumer on notice that in the worst case, the device could fail from wear fatigue.
The court did not proceed to belabor why the warnings were sufficient to require summary judgment. But we will. Per the law the court had quoted, the plaintiff has to prove the device “fail[s] to perform in the manner reasonably to be expected in light of its nature and intended function and [is] more dangerous than would be contemplated by the ordinary user.” Id. (citation omitted). If the label makes clear that the device could fail and that such failure could harm the patient, while providing instructions on how to reduce the risk of failure, then a reasonable consumer should have understood the circumstances under which the device could fail and that injuries could result. That means the device did not fail to meet reasonable expectations and was not defectively designed, even though it had more than a 0% risk of failure. Whether the consumer at issue is the doctor or the patient, it cannot be reasonable to “expect” 100% success with surgery, whether or not it utilizes an implanted medical device. Surgeons tend not to offer money back guarantees with their surgeries. A patient, faced with such an offer, might reasonably conclude something was amiss. Instead, in maybe 99.99% of non-emergency surgeries, the patient first signs an informed consent form identifying risks and disclaiming that promises of success have been made.