From patent infringement lawsuits to False Claims Act violations and an upcoming Supreme Court decision, here are five court battles involving orthopedic device companies this year:
1. In April, a lawsuit was revived against Medtronic, which is accused of violating the False Claims Act by misrepresenting select spine devices to the FDA for clearance. The company allegedly represented certain devices that could only be used in the cervical spine as being applicable to the thoracolumbar spine in an FDA clearance application as a class 2 device.
2. A preliminary injunction was issued in April against Aegis Spine to prevent the marketing and sale of its AccelFix-XT line of expandable cages, which a court determined were reverse engineered from Life Spine's ProLift expandable cage.
3. An upcoming Supreme Court decision stemming from the patent dispute between Arthrex and Smith+Nephew could affect future patent cases. Smith+Nephew filed suit against Arthrex, leading to a panel of patent judges deeming Arthrex's patents invalid. Arthrex won an appeal, arguing the judges weren't properly appointed and their decision should be tossed. The Supreme Court is now considering whether the appointment of 250 judges hearing patent disputes violates the constitution.
4. Spine surgeon Roger Jackson, MD, filed a patent infringement lawsuit against NuVasive in January. The lawsuit alleges NuVasive is selling spinal screws that infringe up to eight of Dr. Jackson's patents. He is seeking cash compensation and a court order blocking "further unauthorized use" of his inventions.
5. Arthrodesis, a company owned by Rama Chandran, MD, filed a patent infringement suit against Wright Medical in January. The case alleges Wright Medical's Valor Hindfoot Fusion System infringes on a patent granted to Dr. Chandran in 2003 related to a surgical rod-and-screw kit for ankle arthrodesis. Wright Medical was acquired by Stryker in 2020 and continues to make and sell the device.