Search for Medtronic on this blog and you’re going to find preemption cases. Lots of preemption cases. Mostly preemption victories for the defense. An overwhelming body of preemption law has been made by Medtronic. They’ve certainly led the charge. So, if we say today’s post is a Medtronic case about a spinal implant, you’re likely thinking more preemption. While that wouldn’t be a bad thing, even here at the DDL blog we can get a little tired of beating the preemption drum (don’t let Bexis know). Everyone once and a while we like to sing a different tune.
After all, if you never flipped over to the B-side, you may have missed some really good music. We’ll now pause to explain B-sides to the iPod generation who may be completely unfamiliar with the old 45-rpm single. The single was meant to showcase an album’s prospective hit on its A-side with an additional song on the B-side. The B-sides were typically throw away tracks. But sometimes, an equally good, and some may argue better, song could be found by flipping the single over. For example, ‘I Am the Walrus’ was on the B-side of the Beatles ‘Hello Goodbye’ (that was a John v. Paul thing). Pearl Jam’s ‘Yellow Ledbetter’ was the B-side of ‘Jeremy’ until radio DJs made it a hit on its own. U2 originally only released ‘The Sweetest Thing’ as the B-side to ‘Where the Streets Have No Name.’ And, perhaps one of the best songs of all time (says this blogger and Sir Paul McCartney) – ‘God Only Knows’ was a B-side. To be fair it was the B-side to the Beach Boys ‘Wouldn’t It Be Nice?’ so isn’t that really like two A-sides?
In the case we’re bringing you today, Medtronic had previously won a motion to dismiss plaintiff’s fraud and consumer protection claims on the grounds of preemption (among other reasons). See our post here. So, you’ve already heard the A-side. But following that decision, plaintiff’s design defect and manufacturing defect claims under the Louisiana Products Liability Act (LPLA) remained. So Medtronic moved for summary judgement. As to design defect, plaintiff had to concede that it had no evidence of an alternative design, so that claim was dismissed with prejudice. SeeLyles v. Medtronic Sofamor Danek, USA, 2016 U.S. Dist. LEXIS 38550, at *15 (W.D.La. Mar. 23, 2016). On manufacturing defect, plaintiff alleged res ipsa loquitur — welcome to the B-side of this record. The district court granted summary judgment. See id. at *21-23. Plaintiff appealed. But the Fifth Circuit said the district court got it right. Like the Stones got it right with ‘You Can’t Always Get What You Want’ on the flip side of ‘Honky Tonk Women’.
Plaintiff had multiple medical device components implanted in his spine to treat his spinal stenosis and cervical cord compression. Lyles v. Medtronic Sofamor Danek, USA, 2017 U.S. App. LEXIS 17534, at *3 (5th Cir. Sept. 11, 2017). X-rays taken within the first day of surgery showed something amiss with one of the implanted plates (experts disagree regarding whether the plate was broken or just misaligned). Id. at *3-4. Plaintiff sought additional treatment and underwent a second surgery, but the plate was not explanted and remains in plaintiff’s spine. Id. at *4-5.
To maintain a manufacturing defect claim under the LPLA, plaintiff has to prove that at the time the medical device left the manufacturer’s control, it materially deviated from its specifications or from other identical products from the same manufacturer. Id. at *9. Plaintiff offered no proof of either the device’s specifications or how the device used in his surgery deviated from those specifications. He relied instead on res ipsa loquitur – arguing that the only reasonable inference that would explain the device breaking was that there was a defect in how it was made. Id. at *10.
The Fifth Circuit does a nice job of explaining both how the doctrine is to be applied sparingly and then discussing those rare situations in which a plaintiff has been allowed and not allowed to use it in the products liability context. See id. at *10-13. In sum, “where there are other potential causes of injury, a plaintiff’s inability to exclude all known potential causes other than a manufacturing defect preclude his reliance on the doctrine.” Id. at *13.
In his opposition to defendant’s motion for summary judgment, plaintiff relied exclusively on two things – the short time between implant and breakage and his expert’s conclusion that he had no other reason for the breakage other than a defect. Id. at *13-15. What plaintiff failed to do was address any of the “multiple potential explanations,” offered by the defendant. Id. at *14. Putting aside for a minute that plaintiff can’t make an argument on appeal that he didn’t make below, his new argument to the Fifth Circuit was that there was no evidence for defendant’s alternative explanations. But plaintiff lost sight of his burden of proof:
[T]o succeed on the theory of res ipsa loquitur, [plaintiff] has the burden of producing evidence excluding other reasonable explanations. Though [plaintiff] argues that there is no evidence for any other cause for the [device’s] breakage, there is no evidence for a manufacturing defect either, which is why he is invoking res ipsa loquitur. The other reasonable explanations for the [device’s] breakage posited by [defendant] are equally as likely as a manufacturing defect. It is [plaintiff] who has the burden to adduce evidence excluding them.
Id. at *15-16. The issue isn’t whether there is evidence to support the other reasonable explanations, but rather what evidence plaintiff has adduced to exclude the other reasonable explanations. Id. at *18.
Further, plaintiff didn’t offer any evidence that any alleged defect existed when the device left the manufacturer’s control. Prior to plaintiff’s surgery, the device was stored at the hospital and any number of people had access to it. Id. at *16-17. The Fifth Circuit concluded that even if the district court had been wrong in not applying res ipsa loquitur, which it wasn’t, plaintiff’s manufacturing defect failed on this ground as well. Id. at *17.
Res ipsa loquitur is definitely a B-side to preemption but don’t overlook the B-sides or you might miss out on a winner.