The heat waves of summer haven't been gone long enough for those of us in the North East to be longing for 90° days anytime soon. But we have no problem reaching back to the dog days of summer for today's decision. Which got us thinking, what are the dog days of summer? Days that are so hot all you can do is lie around like a panting dog? Not exactly. It turns out the dog days are typically considered to run from somewhere around July 20th to August 20th and are said to coincide with the time when the Sun occupies the same region of the sky as Sirius, the Dog Star. We're sure many of you knew that already, but we (at least this member of the Blog) had to Google it. So, yes in most parts of the United States you are talking about the hottest days of the year. But that has nothing to do with dogs, and really nothing to do with Sirius either. That's just when the Earth is tilted at an angle that lets the sun's rays hit it more directly and for a longer period of time. And yes, we may also be eavesdropping on the virtual middle-school science class going on down the hall.
Which brings us to Cleeton v. Siu Healthare, Inc., 2020 WL 5875947 (Ill. Cir. Ct. Aug. 21, 2020), decided over a month ago just on the cusp of those dog days. It is a defense win in another attempt by plaintiffs to avoid preemption by blaming a PMA device manufacturer's sales representatives for not supervising plaintiff's treating physician. The Illinois trial court saw through the preemption dodge and granted summary judgment.
The device at issue is a multi-component drug infusion pump used in the treatment of chronic pain. There was no dispute that it was pre-market approved by the FDA. Therefore, plaintiff had the Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) preemption analysis to withstand - meaning his claims would be barred if they imposed any different or additional requirements beyond those mandated by the FDA. But as that applies to the manufacturer, plaintiff opted to focus his attention on two sales representatives, suing them both.
The first question the court tackled was whether the sales representatives owed a duty to plaintiff. The answer was no. While plaintiff tried to recast the representatives as healthcare providers, their sole role was to provide "technical support and assistance" upon the request of a healthcare provider. Cleeton, at *1. The sales representatives' job is to be available to provide information to the treating physician who in turn could use that information in his clinical judgment to treat his patient. The sales reps "owed no duty to diagnose, . . . offer medical advice, or insert themselves into the middle of the doctor/patient relationship." Id. at *2.
Indeed, one of the sales reps was never present during any of plaintiff's treatments. Rather she was contacted about providing equipment that might be necessary to perform a procedure that the physician ultimately elected not to do. Id. Other than a 20-year old nursing history, the sales reps had no medical training and they were not responsible for plaintiff's medical care.
The physician is responsible for providing medical care. Putting such a duty on the [sales reps] would exceed the scope of their duties as field representatives and impose a burden on [the manufacturer] to monitor the actions of medical providers.
Id. The sales representatives undertook no duty beyond their role as technical support for the treating physician.
That left plaintiff's failure to warn claim. Here, plaintiff alleged that the sales representatives failed to give the treating physician "additional copies of the FDA-approved guidelines." Id. It appears there was no argument by plaintiff that the FDA-approved guidelines were in some way deficient or inadequate. Not that those would have survived either, but this claim is really thin. The FDA-approved warnings are good enough, the manufacturer just didn't give the treater an extra copy.
Plaintiff did not produce any evidence that the defendant failed to comply with FDA requirements in the distribution of its warnings. In fact, the hospital requested a copy and defendant provided them. Id. at *3. Manufacturers "are not required to provide warnings above and beyond what has already been approved by the FDA." Id. And, plaintiff could point to no federal requirement that defendant's sales representatives had a duty to provide a separate copy of information that was already provided. Because that would impose a requirement different from or in addition to federal requirements, plaintiff's failure to warn claim was dismissed.
It was sunny and in the mid-80s in Springfield, Illinois the day this decision was entered. A memory to cling to when the high only reaches 40° and the sun sets before 4 o'clock in the afternoon.
This article is presented for informational purposes only and is not intended to constitute legal advice.