The plaintiff, Mr. Lyles, underwent anterior corpectomy and discectomy surgery, in which a “Verte-Stack” vertebral body replacement device was implanted in Lyles’s cervical spine, along with Progenix, a putty-like bone graft material that was mixed with bone dust.  In addition, an Atlantis Translations Anterior Cervical Plate System was used to stabilize the Verte-Stack and to promote fusion. Some time after the surgery, the Atlantis Plate either broke or became displaced. This Atlantis Plate, the Verte-Stack and Progenix were all manufactured by Medtronic.

The district court granted summary judgment on design and manufacturing defect claims dealing with the Atlantis Plate on March 23, 2016.  Three days later, Lyles moved for relief from judgment under Rule 60, based on newly discovered evidence regarding the Verte-Stack, which the district court denied.  The U.S. Fifth Circuit affirmed.

Under the LPLA, “a claimant must show not only what a manufacturer’s specifications or performance standards are for a particular product, but how the product in question materially deviated from those standards so as to render it ‘unreasonably dangerous’.  Lyles produced no evidence below showing either what MSD’s specifications or performance standards were for the Atlantis Plate or how the Atlantis Plate used in his surgery deviated from those specifications or performance standards. Instead, Lyles relies solely on the res ispa loquitur doctrine to argue that the only reasonable inference that would explain the Atlantis Plate’s breakage is that there was a defect in its construction….

“Lyles made no attempt to identify and exclude any other explanations for his injuries, instead relying on Dr. Stringer’s statements that, based on the information provided to him, he had no other reason for the Atlantis Plate’s breakage other than a defect. MSD, however, has pointed to multiple potential explanations, such as those listed in the Atlantis Plate’s documentation or malpractice by Dr. Sin, which Lyles did not exclude below….  Furthermore, the cases cited by Lyles in support of his argument that the timing of the break invites the inference of a defect are not persuasive. Of those cases, only Williams applies the res ipsa loquitur doctrine, and in that case, no other reasonable explanation for the ladder’s failure was posited…. Lyles makes the additional arguments that there is no evidence for these alternate explanations for the breakage and that Dr. Stringer’s report that the procedure was ‘done properly’ excludes these other explanations. However …. to succeed on the theory of res ipsa loquitur, Lyles has the burden of producing evidence excluding other reasonable explanations. Though Lyles argues that there is no evidence for any other cause for the Atlantis Plate’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 Atlantis Plate’s breakage posited by MSD are equally as likely as a manufacturing defect. It is Lyles who has the burden to adduce evidence excluding them.”

As to the Rule 60 Motion, “Lyles argues that the Verte-Stack and Progenix documents should have been produced in response to his Request for Production No. 5, which asked for ‘all information retained by Medtronic concerning the medical devices implanted in Bryant Lyles’s spine on May 10, 2013 [sic] including date of design, manufacture, sale and all information required to be retained by Medtronic pursuant to 21 CFR 821.25.’ MSD’s response to this request dealt only with Infuse and the Atlantis Plate. Lyles also contends that his Interrogatory No. 2 should have elicited information as to the Verte-Stack and Progenix, as it asked MDS to ‘identify any and all devices or products manufactured or sold by Medtronic which were used on Bryant Lyles at any time.’ In response to this, MSD directed Lyles to the hospital records from LSUHSC. The district court found that the Verte-Stack and Progenix had been identified ‘numerous’ times throughout the litigation and pointed specifically to Dr. Mathews’ report in May 2015 as identifying the Verte-Stack as a device used in Lyles’s surgery. It further found that even if Lyles’s Production Request No. 5 and Interrogatory No. 2 ‘were designed to elicit documentation on the Verte-Stack and Progenix, then his actions following the receipt of MSD’s September 2015 discovery responses do not constitute due diligence.’ Because Lyles and his attorneys knew these products were manufactured by MSD and used in Lyles’s surgery, the district court found that he did not exercise due diligence because he failed to make any further inquiry ‘as to why MSD failed to produce documentation or make an objection to the production of such evidence’ and failed to ‘file a motion to compel’ regarding this documentation.”


Lyles v. Medtronic, No.16-30517, 2017 WL 3976306 (5th Cir. Sept. 11, 2017).