News & Analysis as of

First FDA Approval of Closed-Loop Insulin Pump

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

“World’s Smallest Pacemaker” Experiences Sizeable Success

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

California Court Clears The Way For Express Preemption

Not everyone sees eye to eye on federal preemption, including judges. Take for example the conflicting opinions from the California Court of Appeal applying the express preemption provision of the Medicare Prescription Drug,...more

Arm’s Length Royalty Rates Save Medtronic from $1.36 Billion Tax Deficiency

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

FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven...more

Medtronic Acquires HeartWare for $1.1 Billion

Medtronic PLC has announced it has agreed to acquire HeartWare International Inc. for $1.1 billion in cash. According to the press release, the acquisition will expand Medtronic’s portfolio of diagnostic tools and treatments...more

Examples of Brexit Disclosures in SEC Filings

As Broc Romanek noted on the, a number of SEC filings discussing Brexit have been made. I have noted some of the disclosures below, focusing on those that have been made since the vote result was...more

Smith & Nephew Sells Its Gynecology Business for $350 Million

Smith & Nephew recently announced that it will sell its gynecology business to Medtronic for $350 million. As part of the sale, Medtronic will obtain Smith & Nephew’s key gynecological surgical solution, called the TRUCLEAR...more

Supreme Court Ruling on at Least Five Patent-Related Cases

To date, the Supreme Court has granted certiorari (commonly referred to as cert) to five patent-related cases this term, which will result in three oral arguments likely to be decided before the end of the term. Two of the...more

Federal Circuit Tasked With Analyzing Evidence For Proof That Defendant Had the State of Mind Necessary For Induced Infringement

On January 19, 2016, the Supreme Court issued a grant-vacate-remand order in a dispute between rival medical device companies Medtronic and NuVasive. The order directs the Federal Circuit to revisit its decision in light of...more

Remembering Scalia, Remembering Riegel

For the second time in a week we are considering a former professor at our law school, though this occasion swims in sorrow. Before he became a Justice on the Supreme Court, before he became a Judge on the DC Circuit, Antonin...more

Blog: Senator Calls on Med Device Leaders to Improve Cybersecurity

Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in...more

APA Review of IPR Decisions to Institute Proving to be a Dead-end

The recent ruling in Medtronic v. Lee, No. 1-15-cv-946 (E.D. Va. Jan. 21, 2016) clarifies certain important questions about whether APA review is available when a petitioner is dissatisfied with the PTAB institution decision....more

Medtronic Launches FDA-Cleared OsteoCool RF Ablation System

According to Medtronic, the OsteoCool RF Ablation System has received U.S. Food and Drug Administration (FDA) 510(k) clearance and they are launching the device in the United States. However, this news may not be...more

Minnesota Court of Appeals Articulates Test for Direct Shareholder Claims in In re Medtronic, Inc. Shareholder Litigation

On January 25, 2016, the Minnesota Court of Appeals decided In re Medtronic, Inc. Shareholder Litigation, holding that a shareholder’s claim is properly characterized as a direct claim, not a derivative claim, even where all...more

FDA Approves First App-Based Pacemaker Monitor

Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable...more

Proper Claim Construction Requires Context - Atlas IP, LLC v. Medtronic, Inc.

Addressing claim construction issues, the U.S. Court of Appeals for the Federal Circuit affirmed in part, reversed in part and remanded a district court’s summary judgment rulings finding that the district court did not...more

Medtronic to Acquire Transcatheter Mitral Valve Startup

Medtronic recently agreed to pay up to $458 million for California-based Twelve, Inc., a privately-held developer of transcatheter mitral valve replacement devices. The terms of the deal include $408 million at closing and...more

Warning Letters and Jurisfiction

“Jurisfiction” is a word coined by Jasper Fforde, author of the Tuesday Next series, one of the more sophisticated set of children’s works that has come to populate this post-Harry Potter era. To be very brief, Jurisfiction...more

Ninth Circuit Addresses Preemption in Recent Labeling Cases

The Ninth Circuit Court of Appeals recently addressed preemption in the context of food and cosmetic labeling. Food Manufacturers Can Label Honey as “Honey” - In June, the Ninth Circuit issued an opinion in Brod v....more

Trade Secret Legislation Reintroduced in Congress (3rd Time)

Maybe the third time is the charm. After trying twice before, Congress is making another run at creating a federal claim for trade secret misappropriation. A bipartisan group of legislators from both congressional chambers,...more

Medtronic Announces Plans to Acquire RF Surgical Systems for $235 Million

Medtronic has agreed to acquire RF Surgical Systems Inc., for $235 million, according to a report by Nasdaq. According to the news article, Medtronic plans to incorporate RF Surgical’s surgical sponge tracking and detection...more

Food for Thought: Ninth Circuit Holds Cosmetic Labeling Claims Not Preempted by FDCA, Primary Jurisdiction Appropriately Invoked

In April 2015, the Ninth Circuit held in a cosmetic labeling class action that the Food, Drug, and Cosmetic Act (FDCA) did not expressly preempt state causes of action predicated on federal cosmetics labeling laws and that...more

Medtronic Acquires Aptus Endosystems for $110 Million

Medtronic PLC recently announced its acquisition of Aptus Endosystems, further adding to its portfolio of medical device products. The acquisition was reported to be valued at approximately $110 million. According to its...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

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