Last week we gave you a lot of Medtronic decisions to mull over and to mostly be happy about. And, like we mentioned, Medtronic is no stranger to preemption issues. So, when we found yet another new Medtronic favorable device preemption case, at first we thought we might add it to one of our scorecards or cheat sheets and call it a day. But, this is a win in a Ninth Circuit court and after Stengel, that can’t go overlooked. But, we’ll keep it short and simple nonetheless.
The case is Suckow v. Medtronic, Inc., No. 2:12-cv-01870-GMN-CWH, slip op. (D. Nev. Sept. 20, 2013) and it involves a pacemaker manufactured by Medtronic that was implanted in plaintiff in 2006. Plaintiff had to have the device removed on an emergent basis in December 2010 and alleges she suffered injuries as a result of the removal surgery. In addition to strict liability and breach of express warranty claims against Medtronic, plaintiff also brought negligence and misrepresentation claims against a Medtronic sales representative alleging that a few months before the removal, he evaluated the device and found it was operating normally and was fit and safe for continued use. Slip op. at 2.
Medtronic removed the case to federal court and argued that the sales representative was improperly joined. Medtronic challenged the plaintiff’s claims against the sales representative on two grounds. First, the sales rep had no contact with the plaintiff before December 2010. Second, if the sales rep evaluated the device, it was at the request of the physician and it is the physician who “interprets any data and makes decisions.” Id. at 6. While plaintiff argued that her claims against the sales rep weren’t preempted, she apparently neglected to address any of the arguments on fraudulent joinder. Id. So, it really was a no-brainer for the court to uphold removal and move on to decide Medtronic’s preemption motion. But, we just want to take a minute to remind our readers that there are more substantive decisions out there about the risks of liability from the involvement of sales reps in the care and treatment of patients. See our post here. In Suckow, while the court didn’t have to reach it, it looks like defendants had a strong learned intermediary defense because the sales rep’s role was limited to the evaluation of the performance of the device, not in rendering advice, opinions, or direct care to the plaintiff.
On preemption, plaintiff did try to use Stengel to argue that her defective manufacture and breach of express warranty claims were not preempted. Id. at 7. And so the court acknowledged that the Stengel rule is “that the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.” Id. at 8. But the court then went on to agree with defendant that plaintiff’s claims “are brought pursuant to Nevada law that do not parallel a federal-law duty under the MDA, but instead are different from, or in addition to, requirements under the MD that relate to the safety or effectiveness of the Medtronic pacemaker.” Id. at 9 (quotation marks omitted).
Finally, since at least one of the cases in our post last week declined to find an express warranty claim preempted, we note that this court went with the majority, finding that “[t]o the extent that Plaintiff’s allegations contradict the FDA’s conclusions in the PMA process, these claims are preempted by §360k(a).” Id. at 10.
Plaintiff has a few weeks to try to fix her pleadings and re-state her claims, but from the looks of things we don’t think this one is going to fit through the Riegel/Buckman “narrow gap.”