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Medical device sales representatives are often present in the operating room during surgical procedures, especially with procedures involving orthopedic devices.  With those kinds of devices (and others), the hospital typically contacts the sales representative in advance, and he or she is charged with delivering the device in the specified size and providing any specialized instrumentation required for implantation.  The system is logical and effective, but it still comes as a surprise to many lay people that an industry representative is involved at all.  Plaintiffs’ attorneys sometimes emphasize this disconnect to suggest that something untoward is going on, although surgeons and nurses will tell you that a sales consultant’s presence in real time is an integral part of the process.  Many surgeons will tell you that they always expect the consultant to be there.

We were thus surprised to see the tables turned in Parker v. Orthofix Inc., No. 3:17-cv-248, 2019 U.S. Dist. LEXIS 24271 (D. Or. Feb. 14, 2019), where the plaintiff faulted the medical device sales representative for not being present for her surgical procedure.  At first blush, it seems like a damned-if-you-do-damned-if-you-don’t situation, but in the end the district court’s order rejecting the plaintiff’s claim came down to the evidence.  The court granted summary judgment for the manufacturer because the plaintiff could not produce evidence suggesting that the defendant’s representative should have been there (with instruments in tow), let alone that any duty existed or was breached.

Here is what happened.  The plaintiff underwent vertebral fusion surgery using the defendant’s plating system, but her pain persisted.  She therefore went to another surgeon, who determined that a second surgery was required to remove the defendant’s plate and re-perform the procedure using a competitor’s plate.  Id. at *4-*5.

This is where things went off track.  The hospital’s supply office arranged to have the competitor’s replacement plate available (apparently delivered by the competitor’s sales consultant), but after the surgeon started the procedure, he realized that he did not have the specialized tool required to remove the defendant’s plate.  It is not entirely clear why.  The hospital’s clinic supervisor said she never requested the specialized tool because the surgeon did not note in his pre-surgery report that he intended to remove the defendant’s device.  Id. at *6-*7.  The surgeon wrote in his post-operative note (and later testified) that he believed that someone had contacted the defendant beforehand to secure the specialized tool and was told that the surgeon could use instruments from the hospital’s universal tray.  Id. *7.

Whatever occurred before the procedure, the evidence was uniform that the surgeon telephoned the defendant during the surgery and learned that he needed the specialized tool, resulting in the surgeon ending the procedure.  The plaintiff required a third surgery, which also failed to resolve her pain.  Id. at *7-*9.

The plaintiff sued only the medical device manufacturer, and instead of alleging the usual defect allegations against the defendant’s plating system, the plaintiff claimed only that the defendant “negligently misinformed [the hospital] and the surgical team before the unsuccessful surgery about the tool needed to remove the [plate] being contained within a universal tray” and that “this misinformation caused the surgical team to begin operating on Plaintiff without having the correct tool, resulting in the surgical team needing to abandon that surgery.”  Id. at *8-*9.

It turns out, however, that the plaintiff did not have admissible evidence that anyone had ever contacted the defendant before the surgery, which would explain why the defendant’s sale consultant was not there.  The surgeon wrote in his post-operative note that he believed that someone had contacted the defendant, only to be told that the universal tools would do.  But what “someone” was told is obvious hearsay, and there was no other evidence of that purported conversation.  Throughout discovery, no one could even identify the person who placed this call nor the person who received it.  Thus, while the surgeon’s post-operative note met the business-records exception to the hearsay rule, the plaintiff could not account for the second and third levels of hearsay.  Id. at *10-*15.  That is to say, writing down that “someone told me that someone told him or her” is not admissible evidence.  See Fed. R. Evid. 805 (separate exception required for each level of hearsay within hearsay).

The surgeon’s deposition testimony met the same fate:  “I can remember in this case someone telling me that they had talked to Orthofix, and . . . saying that . . . the plate was easy to take out . . . with what I believe is called a universal system.”  (Id. at *16-*17) (emphasis in original).  Again, hearsay within hearsay, as was the testimony of the competitor’s sales representative:  “I had spoken with [the surgeon] and it was his understanding that we would only need the universal system . . . he thought the hospital had contacted the Orthofix rep to get the product there.”  Id. at *20-*21.  This piling on did not help because hearsay problems cannot be cured with still more inadmissible hearsay.

Beyond that, the plaintiff opposed summary judgment with evidence of the contact made with the defendant during surgery.  But that evidence did not raise a dispute of material fact.  The plaintiff’s claim alleged that the defendant misrepresented the tools required to remove the defendant’s plate, which caused the surgical team to start and later abandon the second surgery.  Thus, undisputed evidence that the defendant provided information after the surgery commenced was irrelevant:

Because Plaintiff alleges that Defendant supposedly gave this misinformation to the surgical team before surgery, evidence of a statement made by an employee or agent of Defendant during the unsuccessful surgery would not provide support for Plaintiff’s claim or create a genuine dispute of material fact.  By that time, the surgery had begun and any misstatements made during that surgery cannot be the cause of that surgery having occurred.

Id. at *19-*20 (emphasis in original).  So something fell through the cracks here, and it was no fault of the plaintiff.  It was likewise not the defendant’s fault.  As the district court concluded, “[S]omeone dropped the ball . . . .  Whether that someone was [the surgeon], someone on his surgical team, someone working for [the hospital], someone working for Defendant, or someone else, the Court cannot determine, and on the evidence presented by Plaintiff neither can a jury.”  Id. at *22.  Summary judgment granted.