Becker's Spine Review

21 DEVICES & IMPLANTS Medtronic to Pay Dr. Mark Barry $23.5M for 2 Spine Device Patent Infringements: 5 Things to Know By Megan Wood U .S. District Judge Ron Clark, a Texas federal judge, ordered Medtronic to pay a spine surgeon $23.5 million in a patent infringement case on May 16, ac- cording to Law 360. Here are five things to know: 1. The case dates back to 2014, when Texas spine surgeon Mark Barry, MD, sued Medtronic in the U.S. District Court for Eastern Texas, claiming multiple patent infringements, accord- ing to Mass Device. He alleged Medtronic infringed his patent: "System and Method for Aligning Vertebrae in the Ameliorat- ing of Aberrant Spinal Column Deviation Conditions." 2. The case went to court in November 2016, where the jury found Medtronic "actively induced" infringement on two of Dr. Barry's patents, noting the "conduct was willful," Law 360 reports. Dr. Barry was awarded $15.1 million for one patent and $2.6 million for the other. Dr. Barry then filed for supplemental damages. 3. Medtronic argued Dr. Barry presented no "authority to support the supplemental damages he seeks," Law 360 re- ports. Additionally, the company claimed Dr. Barry should not receive prejudgment interest because his "calculation is flawed." Judge Clark disagreed, however. 4. The final judgment on the case requires Medtronic pay- ing $17.7 million for two patent infringements, plus a 20 percent enhancement on both patents' damages and about $2.4 million in prejudgment interest. 5. During the November trial, Medtronic turned to the Pat- ent Trial and Appeal Board, arguing two of the patents were invalid. The company alleged Dr. Barry's patents didn't de- scribe anything inventive, Law 360 reports. The board de- nied Medtronic's claims and the company appealed in the Federal Circuit. Judge Clark also denied Medtronic's claims that Dr. Barry's U.S. patent numbers were invalid. n Medtronic Emphasizes Spine Device Should Only be Used with Medtronic Instruments After 2 Deaths — 5 Things to Know By Megan Wood M edtronic notified the FDA of two patient deaths following spine sur- geries where the NavLock Tracker was used with non-Medtronic instruments as part of the procedure. e tracker serves as an accessory to the Medtronic StealthStation surgical navigation system, providing nav- igation during spinal fusion and interbody procedures. Here are five things to know: 1. In the two patient death cases, third-party surgical stereotaxic navigation instruments were used with the NavLock Tracker. 2. No patient deaths have occurred when surgeons used the NavLock Tracker with Medtronic or FDA-cleared third-party manu- facturer surgical stereotaxic instruments. 3. In response to the patient deaths and other injuries, Medtronic is strengthening the cur- rent warning and updating NavLock's product labeling, emphasizing that NavLock Trackers should only be used with Medtronic instru- ments. e company's existing warning on the product states: "e NavLock Tracker is de- signed and tested for use only with Medtronic instruments. Use with any unapproved instru- ment could compromise accuracy and safety." e FDA reports the updated labeling will read: • Revised Indications for Use: "e NavLock Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic Stealth- Station surgical navigation system. e NavLock Trackers should only be used with Medtronic instruments." • Strengthened Warning: "e Nav- Lock Tracker is designed and tested for use only with Medtronic instruments. e use of non-Medtronic instruments with NavLock Tracker may result in inaccuracy, leading to serious injury or death." 4. Medtronic reported the majority of injuries associated with the NavLock Tracker involved spinal injury because of misaligned or mis- placed screws. 5. e FDA is aware of 196 medical device re- ports related to the NavLock Tracker between Jan. 1, 2013 and March 22, 2017. e associa- tion emphasizes, however, that "contributing factors associated with accuracy and precision problems when using stereotaxic navigation systems are multifactorial." n

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