Before we turn to today’s case, a quick update: when last we spoke, we were about to board a plane for Peoria – our first work trip in sixteen months. We were excited about it. We regret to report that we stepped out of the plane into something resembling a weird post-apocalyptic Mad Max movie. We pulled up our Uber app to get to our hotel and saw “no cars available.” Same for Lyft. We walked around to the taxi area, and there were no cabs. We called the hotel, and there was no shuttle. Luckily, a very nice person took pity on us and gave us a ride to our hotel.
By now, it was dinnertime. We had checked the website, and the hotel proudly trumpeted the quality of its restaurant and room service. We asked about these, and the answer was, “Sorry, ma’am, the restaurant hasn’t reopened yet and there’s no room service.” “No problem,” we said, “surely there are pizza places that deliver?” We were handed menus from three. We called them. All were closed. On to Plan C. On the way in, we noticed a fast food restaurant a couple of blocks away. We laced up our sneakers and walked down, to learn that we could procure food only by utilizing the drive-through window. In a car. You get our drift. Suffice it to say that things did not improve in the ensuing 24 hours.
At least we have a good appellate decision to report. In Cleeton v. SIU Healthcare, Inc., et al., 2021 Il. App. 4th 200490-U (June 3, 2021), Illinois’s intermediate appellate court reviewed a lower court decision granting summary judgment in favor of a medical device manufacturer and two of its employees. First, some background. The appellant (the plaintiff below), as executor of her son’s estate, sued over events that led to the death of her son. Years earlier, the son had suffered an accident that left him a quadriplegic. He was implanted with a programmable pump, which delivered a medication – baclofen – that reduced his involuntary muscle spasms. The pump was a Class III medical device, which means that it underwent the FDA’s full premarket approval (“PMA”) process before it was approved for marketing. More later about why that matters.
The pump ran out of baclofen and needed to be refilled at a neurology clinic. The nurse on duty tried three times to refill the pump, without success. At one point, she inserted the full length of the refill needle into the decedent’s abdomen without making contact with the pump. Eventually, she sought the assistance of a nurse practitioner, who eventually succeeded in refilling the pump.
Several days later, the decedent presented to an emergency room with abdominal pain, a headache, and a history of a recent UTI. On the advice of a neurology resident, the emergency room nurse called the pump manufacturer’s sales representative to request so-called “interrogation” of the pump. This involves “using an electronic device to read the pump to see how the pump was functioning and whether an alarm had been activated.” Cleeton, 2021 Il. App. 4th 200490-U at ¶ 6. The sales representative drove to the hospital and “interrogated” the pump, confirming that there was no “functional error” with the pump and that it was programmed correctly. She informed the doctor of these results but did not provide him with information about baclofen withdrawal and did not discuss possible issues with the catheter that delivered baclofen from the pump to the spinal cord.
The next day, the hospital requested assistance from the manufacturer in troubleshooting the pump. In response, an employee of the manufacturer faxed the emergency procedures for baclofen withdrawal to the hospital. A clinical specialist employed by the manufacturer also was contacted and was informed that the hospital was contemplating a dye study of the pump and catheter. But the study wasn’t performed, and the decedent deteriorated rapidly and died a few hours later. Post-mortem testing revealed that there were holes in the catheter.
The plaintiff/appellant originally sued several healthcare defendants, but she added wrongful death and survival claims against the manufacturer’s employees, a respondeat superior claim against the manufacturer, and an additional healthcare defendant eight months later. In her claim against the sales representative, the plaintiff asserted that the sales rep “undertook the duty to troubleshoot the . . . pump” to verify its proper functioning, “including the consideration of the disclosure of the [manufacturer’s] literature addressing emergency procedures” to be followed in the event that the patient was experiencing withdrawal syndrome. Id. at ¶ 9. (The latter was styled as a failure-to-warn claim.) The claim against the manufacturer’s clinical specialist similarly asserted that she “undertook to troubleshoot” the pump and catheter.
The manufacturer filed for summary judgment. With respect to the “voluntary assumption of duty” claims, the trial court held that the sales representative’s “limited role did not involve her assuming additional duties of a health-care provider as suggested by plaintiff.” With respect to the clinical specialist, the court held that, because she “never saw [the] decedent,” it “failed to see how she could be responsible for [his] care.” Id. at ¶ 19. The court also “emphasized [that] the physician was responsible for providing medical care” and that the manufacturer’s employees did not owe a duty to “insert themselves into the middle of the doctor/patient relationship and affirmatively intervene in [the] decedent’s care.” Id. The court “concluded [that the] plaintiff had not alleged any facts from which a reasonable trier of fact could draw an inference” that the defendants “had or voluntarily undertook any legal duty beyond those they took at the request of [the] decedent’s healthcare providers.” Id.
With respect to the failure-to-warn claim, the court commented that, “no matter how [the] plaintiff’s counsel set forth the argument, the argument essentially was [that] the [manufacturer’s employees] had a duty to advise [the] decedent’s medical providers of known information regarding the medical device that was already contained within the” product’s labeling. Id. at ¶ 20. This would “impose additional requirements,” not required by federal law, “above and beyond the on-label warning approved by the [FDA]; thus, those claims were preempted. The plaintiff appealed both holdings.
Failure to Warn
On appeal, the court explained that, after Riegel v. Medtronic, state failure-to-warn claims seeking to impose requirements that were “different or in addition to” federal requirements were preempted for Class III (“PMA”) medical devices. The plaintiff/appellant argued that her allegations did not trigger preemption because they did not involve the labeling of the device. The court disagreed, stating
Plaintiff alleged in her complaint [that the sales representative and clinical specialist] should have given decedent’s healthcare providers the emergency procedures contained in the label for the device. The information in the label is clearly controlled by the [FDA]. To suggest employees had to supply the emergency procedures in addition to the label suggests the label approved by the [FDA] was insufficient, or, stated differently, that additional warnings were required. We agree with the circuit court [that] plaintiff’s claim would impose additional requirements above the warnings approved by the [FDA].
The court held that the failure-to-warn claims were preempted by federal law, and that that there was “no reason why [the doctor’s] lack of knowledge should alter” that conclusion. Id. at ¶ 34.
The court explained that “the duty of care imposed upon the defendant under a voluntary undertaking theory is limited to the extent of the undertaking and is narrowly construed.” Id. at ¶ 43. In her deposition, the sales representative explained that she was asked only to “interrogate” the pump, during which “her role was specifically to identify whether the pump itself, the computer that drives delivery of the drug” was intact and programmed correctly.” Id. at ¶ 45. The court concluded that the sales rep undertook only to interrogate the pump and that she met the standard of care in doing it. The plaintiff protested that the sales rep “did not use reasonable care in reporting the interrogation findings because [she] failed to communicate to [the doctor] the significance and limitations of the interrogation’s findings.” Id. at ¶ 45. The court responded, “[Though the] plaintiff emphasizes [the sales rep’s] superior knowledge about the pump” as compared to the doctor, “[t]hat argument overlooks the fact [that] it was [the doctor] who was the person responsible for decedent’s care at the time of the interrogation and he was aware of his own limited knowledge about the pump. [He] could have asked . . . more questions about the pump and the interrogation,” or he could have talked to a more senior doctor.
The court concluded, “To require [the sales rep] to explain the limitations of the test and possible catheter issues would require a medical device sales representative with no medical training to volunteer theories about the cause of the patient’s symptoms and thus intervene in the patient’s treatment. . . . [We] disagree [that] reasonable care includes informing the ordering physician” about issues involving a patient’s medical treatment “or sua sponte educating the physician about the pump.” Id. at ¶ 46. (The court relied on Kennedy v. Medtronic, 366 Ill. App. 3d 298, 851 N.E.2d 778 (2006) for this proposition. We have discussed Kennedy in numerous “no duty to intervene in medical care” cases, as far back as here.) Because “the plaintiff . . . failed to identify a genuine issue of material fact showing [that the sales rep] did not use reasonable care in exercising her assumed duty to interrogate” the pump, the sales rep was entitled to summary judgment on the “voluntary undertaking” claim. Similarly, the plaintiff failed to show that the manufacturer’s clinical specialist owed a duty to the decedent. Finally, because the plaintiff’s respondeat superior claims against the manufacturer were entirely derivative of the claims against the employees, affirmance of summary judgment in favor of the employees was fatal to this claim as well.
We really like this decision. In the face of some troubling facts, the appellate court never lost sight of the reality that it is doctors who are responsible for the care of their patients. This is the principle that underlies the learned intermediary doctrine and frames the analysis in drug and device litigation. Here, it resulted in a solid decision that resisted the plaintiff’s attempts to impose liability where no legal claim supported it. And the court got the preemption decision right, to boot. Would that all judges were so clear-eyed.
Meanwhile, we are planning another work trip. The destination is Dallas, a bona fide metropolis, and we are hopeful that the “awakening” will be further along. We will keep you posted. In the meantime, stay safe out there.
Note: This case has since been published. See Cleeton v. SIU Healthcare, Inc., ___ N.E.3d ___, 2021 WL 3399851, at *6 (Ill. App. Aug. 3, 2021). Add one number to each paragraph citation. Otherwise the published decision is substantively identical to that discussed here.