Medical Devices

News & Analysis as of

Federal Circuit Reverses Judgment for Willful Infringement

Through its recent decision in Stryker Corp. v. Zimmer, Inc., the Federal Circuit gave Zimmer an early Christmas gift worth approximately $140 million by reversing a district court’s determination of willfulness and vacating...more

OSHA: Kinesiology Tape is “Medical Treatment” for Recordkeeping Purposes

You have probably seen kinesiology tape, also known as KT Tape or Kinesio Tape: those bright, neon-colored tape strips worn by runners, cyclists, athletes, triathletes, and folks at the gym. In a December 12 letter of...more

CMS Releases Final Rule That Increases Difficulty of Medicare Enrollment

In early December, CMS released a final rule that implements certain provider (i.e., Hospitals, SNFs, physicians, etc.) and supplier (i.e., DME companies, etc.) enrollment requirements (“Rule”). The goal of CMS’...more

FDA Science Chief Reports Quicker Medical Device Clinical Trial Approvals

In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel- the science chief of the U.S. Food and Drug Administration’s center to oversee approval of...more

Stryker Sues Zimmer For Patent Infringement

Stryker Corp. and Stryker Sales Corp. sued Zimmer, Inc. and Zimmer Surgical, Inc. in the Western District of Michigan on November 21, 2014. In its complaint, Stryker alleges that Zimmer’s “TotalShield Surgical Helmet System“...more

Federal Circuit Says Secret Prior Art Is Prior Art for All Purposes

In Tyco Healthcare Group LP v. Ethicon Endo-Surgery, Inc., the Federal Circuit agreed with the district court that Ethicon’s prototype constituted prior art under 35 USC § 102(g) based on its earlier date of conception, but...more

Sophisticated Hackers Target Insider Information

A security consulting firm has discovered a sophisticated hacking campaign that has targeted more than 100 public companies, investment banks and law firms. In a report released December 1, cybersecurity firm FireEye...more

Patent Ever-Greening: Not So Obvious

Although the Federal Circuit recently affirmed a district court’s decision on patent invalidity based on obviousness-type double patenting, the case provides an impetus to review terminal disclaimer practice within a patent...more

US and EU Regulatory Agencies Approve $43B Medtronic & Covidien Merger US and EU Regulatory Agencies Approve $43B Medtronic &...

Med Device Online reports that Medtronic has been cleared by the Federal Trade Commission (“FTC”) and EU’s European Commission to merge with Covidien. Also according to Med Device Online, the companies had to agree that...more

IP Newsflash - December 2014

Federal Circuit Vacates Lower Court’s Obviousness Finding Based on Incorrect Application of Inherency Doctrine - In Par Pharmaceutical, the Federal Circuit vacated an obviousness ruling by the district court, finding...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

Bonutti Skeletal Innovations Sues Globus Medical

Bonutti Skeletal Innovations, LLC brought a patent infringement suit against Globus Medical, Inc. in the Eastern District of Pennsylvania on November 19, 2014. The lawsuit alleges that several of Globus Medical’s spinal...more

Judge Román stays case because of IPRs based on parties’ joint request.

CDx Diagnostics, Inc. et al. v. U.S. Endoscopy Group, Inc. et al. Case Number: 7:13-cv-05669-NSR - Judge Román stayed the litigation after the PTAB instituted IPR Case Nos. IPR2014-00639 and IPR2014-00641 for...more

Cybersecurity Litigation Monthly Newsletter

In August, Paytime, Inc., a payroll services company, moved to dismiss a putative class action filed in the wake of a data breach in which the personal and financial information of more than 230,000 people was compromised. ...more

Growing Safety Risk for Hospitals: Spiraling Medical Device Recalls

Everyone knows that the number of medical device recalls is on the rise. Here are two telling examples of the growth. In 2003 a total of 604 recalls were reported to the FDA, while last August a single manufacturer recalled...more

Essential Medical, Inc. Successfully Completes First in Man Studies for MANTA Large Bore Vascular Closure Device

Essential Medical, Inc., a privately held medical device company aiming to create and commercialize new vascular closure devices for femoral punctures after cardiac catheterization procedures, announced that it has...more

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

OIG's 2015 Work Plan Highlights Departmental Priorities

Each year the Department of Health and Human Services, Office of the Inspector General (OIG) issues its Work Plan to identify for the provider community the key fraud and abuse issues on which it will focus on in the coming...more

Why We Need Our Patent System: Masimo, Orange County’s Shining Example

Did you ever wonder how people can call for the end of our patent system? The answer is simple. They have no experience with great inspiring inventors. We at Knobbe Martens have the honor of frequently working with great...more

Medical Device Update

In This Presentation: • Medical device patent statistics • Non-practicing entity (NPE) litigation • Inter partes reexam (IPR) update • Important litigation – Edwards v. Medtronic – Masimo v. Philips –...more

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

CMS Updates Manual Instructions to Implement CY 2014 MPFS Changes for Reimbursement of Investigational Devices and Related...

On November 6, 2014, CMS announced changes to its Medicare Benefit Policy Manual and Medicare Claims Processing Manual related to coverage of items and services in Category A and B Investigational Device Exemption (IDE)...more

Student Health & Safety and Discipline Related Legislative Changes

This update of student health & safety and discipline related legislative changes is issued by Kronick as part of a series of Legal Alerts about new education related laws from this latest 2014 legislative session. All laws...more

New FDA Cybersecurity Guidance for Medical Device Manufacturers

Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more

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