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From where we sit, today’s post goes 0 for 2:
First, the case involves a lawsuit between health care providers and a medical device company. We don’t like to hear about those cases, because device companies don’t want to fight with anyone, let alone with health care providers, who are often the companies’ customers.
Second, the device company loses.
Ouch! We just hate that.
But the case is interesting, so we’ll swallow hard, brush away our tears, and write it up.
A Medtronic sales representative offered to leave with a group of anesthesiologists free samples of “pain pump refill kits” used to refill a Medtronic pain pump. But the representative in fact left two “pain pump refill kits” and one “catheter access kit” with the anesthesiologists. The pain kits are used for pain management, but the catheter kits are mainly a diagnostic tool and allegedly should not have been delivered to an anesthesiology department.
On April 15, 2005, an anesthesiologist tried to refill Kathy Cober’s pain pump. But a nurse picked out the “catheter access kit” and gave it to the doctor. When the doctor used that kit to try to refill the pain pump, he caused an overdose.
The hospital and physician group settled the case with Ms. Cober’s family and then sued Medtronic for contribution, to recover part of the cost of the settlement. William Beaumont Hospital v. Medtronic, Inc., No. 09-CV-11941, 2009 U.S. Dist. LEXIS 77860 (E.D. Mich. Aug. 31, 2009). Medtronic moved to dismiss on the ground that the hospital and physician group had not sufficiently pleaded the elements of a contribution claim.
Much of the court’s discussion turns on narrow issues arising under Michigan law of contribution, which isn’t of general interest to readers of this blog (or, frankly, to the two of us).
But Medtronic also asserted that the claim for contribution was based on the adequacy of the label on the catheter kit. Since the infusion system that included the catheter kit had received premarket approval from the FDA, Medtronic asserted that the contribution claim was preempted. Id. at *19-20. (See? Preemption turns up everywhere, like a bad penny.)
The court rejected this preemption argument. The court noted that any claim based on failure to warn would be preempted. Id. at *20. But the court reasoned that Medtronic’s alleged negligence was based on “sending free samples to an anesthesiology department at a hospital and holding the samples out for use in a refill procedure, when in fact one of the samples was not intended for such use and should not have been sent to an anesthesiology department. Plaintiffs do not allege a failure to adequately warn claim.” Id.
The court acknowledged that the nurse’s failure to read the label might constitute a superseding cause that would prevent Medtronic from being held liable for its alleged prior negligence, but that would be for a jury to decide at trial. Id. at *21. The court thus denied Medtronic’s motion to dismiss.
We thought we’d seen just about every context in which a device preemption argument could be made, but this one surprised us. We’ll dutifully add this decision to our device preemption scorecard, and perhaps someone can put this noteworthy curiosity to use in some future case.