Today’s guest post is by Reed Smith‘s Jenn Eppensteiner. In it she discusses a recurring theme on the Blog – claimed product “defects” arising from nothing more than the failure of an implanted medical device. Case after case has recognized that the human body is a hostile environment for implants, surrounded by the equivalent of salt water that corrodes metal and plays havoc with electronics (like dropping a cell phone or a watch in a tide pool, only worse), and in the case of weight-bearing implants, producing constant stress cycles that eventually overcome the strongest metals. Still, plaintiffs persist in bringing cases with nothing more than the allegation, “it broke.” Jenn discusses another decision dismissing such a claim. As always, our guest posters deserve 100% of the credit (and any blame) for the contents of their posts.
Things I’ve said to my toddlers today:
- Stop that!
- You’ll break it!
- Someone is going to get hurt!
- You are entitled to a reasonable product—not a perfect, unbreakable one!
Okay maybe not that last one. But if I was the betting kind, and I am, I’d wager that the plaintiff’s doctors in Miller v. Depuy Synthes Sales, Inc., 2019 WL 4016207 (D. Nev. Aug. 26, 2019), likely said some version of the first three to plaintiff, and maybe even the last one. The United States District Court for the District of the Nevada did, at least. Id. at *5.
But let me back up. In Miller, the Court granted summary judgment in a broken device case. The device in question was a prescription medical orthopedic implant. Id. at *1. The plaintiff had it surgically installed after fracturing two bones in his lower right leg. Id. The defendant device manufacturer included a package insert that warned that the device could fail if a patient bears weight on it, if the healing process is delayed, or if it is subjected to muscular forces from movement or repeated stresses. Id. at *1-2. Prior to implanting the device in the plaintiff, his surgeon provided the plaintiff with a page of instructions consistent with that warning. Id. at *2.
The plaintiff’s implant surgery took place in 2013. Id. at *1. About ten weeks later, the plaintiff returned to his surgeon complaining of pain. Id. The doctor found that “there was a delayed union of the bones and that the device was broken, because the Plaintiff was weight bearing.” Id. (emphasis added). The plaintiff contested this fact. Id.
Over the next year, the plaintiff’s injury worsened. Id. His implanting surgeon transferred the plaintiff’s care to an associate. Id. This second surgeon replaced the original implant with another similar, which had a more robust plate. Id. Presumably the plaintiff understands the need to take it easy now, right? Stop that, I hear myself saying, you’ll break it. Someone is going to get hurt. The second device broke four months later. Id.
The plaintiff filed suit against the manufacturer alleging five causes of action, including: strict products liability; negligent products liability; breach of an implied warranty of merchantability; breach of implied warranty of fitness for a particular purpose; and breach of an express warranty. Because the plaintiff could not show that the device failed to function as expected—a fatal flaw for all his claims—the Court granted summary judgment in the defendant’s favor. Id.
Before taking up the issue of summary judgment, though, the Court addressed the plaintiff’s motion in limine wherein he asked the Court to exclude his treating physicians’ testimony as to the cause of the device’s failure. Id. at *2. The plaintiff argued that such exclusion was proper because his physicians were retained experts without the necessary Rule 26 disclosures. Id. The Court disagreed. The physicians were experts, yes, because of their degrees, training, experience, and expertise with the product, but they were non-retained experts, and accordingly were not required to submit detailed reports. Id.; see also Fed. R. Civ. Pro. 26(a)(2)(c).
The Court also noted that the defendant had not retained the physicians, and also that both physicians formed their opinions while actually treating the plaintiff. Id. at *3. As noted above, when the break was first identified, the initial surgeon noted in his records that the break was “secondary to weight bearing.” Id. Likewise, the second surgeon’s records contemporaneous with time of treatment indicated his opinion was that the device broke because the plaintiff “had walked on [his leg] against recommendations.” Id. The deposition testimony was consistent with this belief. Id. This kind of motion in limine—to exclude one’s own treaters’ testimony—means the plaintiff is in big trouble.
The Court then turned to the issue of summary judgment, devoting the bulk to the discussion to the strict products liability claim. To prevail under Nevada law, a plaintiff alleging strict products liability must prove that (1) the defendant placed a defective product in the market and (2) the plaintiff suffered an injury which was caused by the defect. Id. (citing Allison v. Merck & Co., Inc., 878 P.2d 948, 952 (Nev. 1994)). The defendant argued that (1) the plaintiff failed to show a defect; (2) the plaintiff’s misuse caused his injuries; (3) the plaintiff failed to produce a medical expert for causation; and (4) the learned intermediary doctrines shields the defendant from liability. Id. at *4. The Court agreed with the defendant as to their first argument—the plaintiff failed to prove the device was defective.
For design and manufacturing defects, what the plaintiff alleged, Nevada applies the consumer expectation test, which states that a product is defective when it “fail[s] to perform in the manner reasonably to be expected in light of its nature and intended function and was more dangerous than would be contemplated by the ordinary user.” Id. (quoting Ford Motor Co. v. Trejo, 402 P.3d 649, 650 (Nev. 2017) (additional citations omitted)). The reasonable expectation may be influenced by warnings that accompany a product. Id.
Here, the defendant had provided a warning insert to the plaintiff’s implanters. The plaintiff did not challenge the contents of the warning, but the Court pointed out that such an argument would have failed anyway:
The warning stated, in bold and underlined font, that the device can break when the bones fail to unionize. The warning continued, in regular font, that “If healing is delayed … the implant will eventually break due to metal fatigue.” Additionally, the warning unambiguously cautioned: “In the absence of solid bony union, the weight of the limb alone, muscular forces associated with moving a limb, or repeated stresses of apparent relatively small magnitude, can result in failure of the implant.” Furthermore, the warning listed the injuries that could result under an enlarged, bold, and underlined heading: breakage of the implant, nonunion of the bone, and pain.
Id. Although it was only material that the plaintiff’s first implanter was adequately warned, both doctors showed a strong command of these dangers. Both testified to understanding that the device could fail from weight bearing, delayed bony union, or from normal stresses and forces. Id. at *5. And even though he was given a copy of the warnings, whether the plaintiff saw, read, or understood the warning was irrelevant. Id. Stop that. You’ll break it. The warning was adequate as a matter of law, and the reasonable expectation must accompany the warning. Id.
Moreover, the plaintiff had no commercially feasible alternative, and adequate warnings negate liability absent such a showing. Id. The Court discounted the plaintiff’s two additional arguments, first that mere evidence of a malfunction is sufficient evidence of a defect, and also that the device was not sufficiently strong, since it should never break absent abuse. A reasonable consumer, the Court stated, could not expect the plaintiff’s “idealized product”. Id. The warning alerted consumers that the device could, in fact, break. Id. The plaintiff was entitled to a reasonable product—not a perfect, unbreakable one. Id. Without evidence of a defect, all of the plaintiff’s claims necessarily failed. Id. at *5-7.
The Court did briefly address the defendant’s product misuse argument, finding the defendant’s case “compelling.” Id. at *5. The defense presented Facebook pictures, medical records, and the physicians’ testimony to evidence the plaintiff’s noncompliance. Id. [Ed. note: see our cheat sheet on discovery of plaintiffs’ social media, here] However, because the plaintiff contested these facts, supporting his position with an affidavit from his supervisor that he relied on a knee scooter during the time in question, the Court found there was a genuine dispute sufficient to defeat summary judgment. Id.
With regards to the defendant’s additional arguments, neither was a sufficient basis on which to grant summary judgment, but neither was necessary, either. The Court held that the plaintiff could rely on his treating physicians for the necessary causation testimony. Id. at *6. Regardless of the plaintiff’s noncompliance, his physicians do not dispute that the device failed and this caused him harm. Id. Someone is going to get hurt. Finally, the Court declined to speculate as to whether Nevada would apply the learned intermediary doctrine outside of failure to warn cases, especially when the Court had another adequate basis for granting summary judgment. Id.
The Court then briefly addressed the plaintiff’s remaining claims. All failed for lack of defect. Id. at *6-7.
That’s the law. Time and time again the Blog has reported on cases holding that a broken implant alone is not sufficient to establish a defect.
My toddlers do not have reasonable expectations. Apparently, in this case, neither did the plaintiff. Stop that. You’re going to break it. Someone’s going to get hurt.