Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class action complaint in the Central District of California on August 30, 2023, by users of Medtronic’s InPen® system. The lawsuit alleges...more
Objective Evidence in Determining Obviousness - In Medtronic, Inc. v. Teleflex Innovations, Appeal No. 21-2357, the Federal Circuit held that a close prima facie case of obviousness can be overcome by strong evidence of...more
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS - Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board. Summary: A close prima facie case of obviousness can be overcome by strong evidence of objective...more
Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more
DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more
Medtronic plc and DaVita Inc. are joining forces to form a new, independent medical device company to provide enhanced kidney health care. The new company will focus on making different dialysis treatments more accessible to...more
Medtronic announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic...more
Massachusetts federal and state courts issued several important product liability decisions in 2021. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows...more
The federal Food and Drug Administration too often fails to protect patients from defective and dangerous medical devices because it lets manufacturers self-police themselves, cozies up to companies rather than trying to...more
Medical device manufacturer, Medtronic, began its second trial on June 14 in the US Tax Court in a $1.36 billion transfer pricing dispute with the IRS. The trial concluded on June 25 and is among the most significant transfer...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer,...more
In my 25 years in the data privacy and cybersecurity profession, this is the first time that I believe a medical device has been recalled because of a cybersecurity risk. This week, Medtronic recalled its 508 Insulin pumps...more
Federal Circuit Summary - Before Chief Judge Prost, Moore, and Taranto. Appeal from the United States District Court for the Eastern District of Texas. Summary: An invention is not “ready for patenting” to trigger...more
On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc. The ‘141 Patent is...more
Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is...more
Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According to Medtronic, the Intellis platform features the world’s smallest...more
According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons...more
It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of...more
Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary...more
On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection. Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the...more
Medtronic, Inc. v. Robert Bosch Healthcare (No. 2015-1977, -1986, -1987, 10/20/16) (Lourie, Dyk, Hughes) - Dyk, J. Denying petition for rehearing and confirming the Court's earlier order. “The Board's vacatur of its...more
Medtronic’s MiniMed 670G system was recently approved by the FDA – this marks the first-ever FDA approval of a hybrid closed-loop insulin delivery system. Medtronic explains that the system uses a computer algorithm in...more
Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples...more
Addressing whether certain intercompany technology license agreements were negotiated at arm’s length, the US Tax Court rejected the Internal Revenue Service’s (IRS’s) alleged $1.36 billion tax deficiency and determined that...more