This post is from the non-Reed Smith side of the blog.
As we pointed out earlier this week, we are typically more interested in defense victories on this blog. But every once and a while, we find cases that go the other way that we believe merit a mention. Sometimes that is because the decision is too significant to ignore. Sometimes it is because of the court that renders the decision. Sometimes – like yesterday and today – it is because we want to remind our readers of issues that while not common, are nonetheless real. Unfortunate issues that crop up from time to time. Yesterday, that was about a loss on fraudulent joinder involving claims against a sales representative. As we mentioned then, more often than not – defendants win that issue.
Today’s case continues the sales representative theme. A couple of years ago, we posted a cumulative piece on cases dealing with sales representatives who are present in the operating room. It isn’t something that we come across very often and from our review, the decisions are split (largely based on the particular facts) as to whether the actions of a sales representative create a cause of action against the device manufacturer. The issue, boiled down to basics, is whether the sales rep got too involved in the actual treatment of the patient or use of equipment during surgery.
It was on that basis that the plaintiff in Medtronic, Inc. v. Malander, 2013 Ind. App. LEXIS 499 (Ind. Ct. App. Oct. 11, 2013) brought a negligence claim against the manufacturer of her husband’s defibrillator. The defibrillator, a Class III PMA medical device, was implanted in 1997 and upgraded in 2004. In 2006, plaintiff’s husband began experiencing a problem with the device known as V-V intervals. Id. at *3. During another upgrade surgery, one of defendant’s “clinical specialists” was present to assist with testing the device. The test revealed no problems. During the procedure, plaintiff’s surgeon also called defendant’s “technical services department” requesting information on V-V intervals and lead failures. Id. at *4. Defendant’s technicians responded: “Don’t worry about that; it doesn’t mean anything . . . I don’t think that’s a problem . . .” Id. The surgeon did not replace the device. Plaintiff’s husband died a month later, following more episodes of V-V intervals.
Plaintiff’s claims against the defendant included design defect, failure to warn, failure to recall, and failure to recommend removal during the 2006 surgery. Id. at *5. Defendant argued and plaintiff conceded that the first three claims were preempted under Riegel v. Medtronic, 522 U.S. 312. Plaintiff argued that her final negligence claim – negligent oral representations by defendant’s technicians -- survived preemption because defendant “assumed a duty” when its technicians offered advice to the surgeon. Id. at *6. Defendant moved for summary judgment arguing that plaintiff’s claim was that the technicians “should have provided additional warnings above and beyond the warnings on the device’s label” – which is a preempted failure to warn claim. Id. at *12.
In its analysis, the court references some of the cases from our prior post on this subject. Like we said, it appears that courts are significantly persuaded by the facts in these cases. Just what was the role of the defendant’s representative during the procedure? Did the rep observe the patient’s condition? Did he/she consult with the surgeon regarding the needs of this particular patient? Did the rep have a hands-on role with the device during surgery? In this case, these questions were considered in the court’s discussion of assumption of a duty. Defendant argued that it did not assume any duty to plaintiff because it did not “control” the device during surgery and it did not have knowledge superior to plaintiff’s surgeon:
Dr. Klein was in charge of the surgical procedure regardless of any advice given by the technicians, Dr. Klein had the same information that the technicians had, and its technicians are prohibited from practicing medicine.
Id. at *22. Courts that have found in favor of defendants tend to agree with this reasoning -- that the surgeon is in charge of his operating room and of the procedure. Even if he seeks out advice from a manufacturer’s representative, it is the surgeon who has the specialized skill and knowledge and as such he doesn’t abdicate his role by asking for assistance. Unfortunately, the Malander court didn’t agree with the surgeon as captain of the ship argument. It was persuaded that there was a genuine issue of fact for the jury based on defendant’s technician’s presence in the operating room, that the surgeon spoke with additional technicians during the surgery, and conflicting evidence regarding the impact of the V-V intervals. Id. at *23.
The court appears to agree that defendant was not responsible for deciding whether to replace the device and was not involved in the physician/patient relationship. Id. at *22. But that wasn’t enough. Rather, the court found that “having voluntarily agreed to give technical support, the technical support should [be] made in a reasonable and prudent matter.” Id. And reasonableness is a question of fact precluding summary judgment.
While this isn’t a ruling we agree with, it is not alone in its conclusion on assumption of a duty. What is more uncommon about Malander is its direct ruling that this type of claim is not preempted. The court’s conclusion is short, so here it is:
[W]e conclude that the Malanders' claim concerns the allegedly negligent interaction between the physician and Medtronic's technicians. . . . [T]he Malanders' claim does not involve the mere restatement of information given in the labeling. . . . [T]heir claim does not concern the design, manufacture, or labeling of the [device]. Rather, the Malanders' challenge involves negligence of Medtronic's technicians in giving [plaintiff]'s physician allegedly faulty advice regarding the performance of one specific lead. As such, we conclude that the Malanders' claim is not preempted by the MDA, and the trial court properly denied Medtronic's motion for summary judgment on this issue.
Id. at *18-19. We never like to see a medical device claim survive preemption – we fully embrace the “narrow gap” that recent courts have created. But, we don’t see enough of this type of claim for it to worry us too much. We still firmly believe that these cases turn on the facts, and therefore, more often than not concern substance rather than preemption. So, why do we bring you cases such as this? They are cautionary tales. In the modern world of medicine, it might be impossible not to have technicians on hand to assist and advise surgeons. So, cases like this should remind us to remind our clients of the importance of vigorously training their representatives. You know what they say about an ounce of prevention . . .