Manufacturers Medical Devices

News & Analysis as of

China's Medical Device Market: New Policies, Higher Stakes

The recent introduction of the Regulations on the Supervision and Administration of Medical Devices (also known as State Council Order 650) has created significant impact in the medical device industry in China. The changes...more

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

Bad News from Europe for Makers of Life-Saving Medical Devices

In over eight years, we’ve never before blogged about a European development in prescription medical product liability. The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston...more

Medicinal Product Regulation and Product Liability in Australia: Overview

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

The Internet of Things

In this Presentation: - Internet of Things - definition - But what is it all about? - But not just that... - The IoT market in figures... - Beecham Research - view of the World - The Connected...more

OIG Advisory Opinion Approves Patient Subsidies For Clinical Study

On June 4, 2015, OIG published an advisory opinion (No. 15-07) stating that it will not impose administrative sanctions on a medical device manufacturer that planned to pay for copayments and certain other costs for Medicare...more

3D Printing, Innovation Protection, and Manufacturing: The Big Change is Now

Intellectual property (IP) law is undergoing a major transformation just as additive manufacturing? or 3D printing? has begun to revolutionize the manufacturing industry. The interplay between these two forces could end up...more

CMS Releases Latest Medicare Hospital and Physician Utilization, Payment Data

CMS has released detailed Medicare inpatient hospital, outpatient hospital, and physician utilization and payment data for 2013, including data analysis such as spending breakdowns by specialty and region. The hospital data...more

Adopting a Safety Policy and Assembling a Safety Team

Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand,...more

FDA launches medical device database: AccessGUDID

On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and...more

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more

Tenth Circuit affirms federal preemption of state law tort claims for medical devices

In Caplinger v. Medtronic, __ F.3d __ (10th Cir. 2015), the Tenth Circuit Court of Appeals affirmed dismissal of a patient’s state law tort claims against a medical device manufacturer as preempted by federal law. The Tenth...more

Guest Post - Product Liability Cases Are No Longer Quintessential Class Actions In Ontario

What follows is a guest post about a recent favorable development in Canadian drug/device litigation. We're not Canadian lawyers, so we gladly outsource Canadian developments to those who are, such as these guys - Mike A....more

Connecticut Legislature Reduces Mandatory Reporting of Payments to APRNs

On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

Blog: Connecticut Delays Payment Reporting Until 2017

Under a Connecticut law enacted in 2014, pharmaceutical and medical device manufacturers were required to begin reporting payments made to advanced practice registered nurses (APRNs) on July 1, 2015. ...more

3D Printing Medical Devices

The recent news that certain Lowe’s stores will offer customers the ability to custom-make 3D printed items has garnered a lot of attention. But perhaps even more exciting is that 3D printing (also known as additive...more

Sorin-Cyberonics Deal Gets US Antitrust Clearance

Sorin S.p.A. and Cyberonics, Inc. recently announced that the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for their pending merger has ended. In February, the two companies...more

Are hospitals or medical scope companies to blame for Superbug breakouts?

The price of liability can be extremely high. A medical malpractice lawyer in Lake County understands that when doctors, staff or manufacturers make medical mistakes, they are not likely to readily admit their errors. ...more

Federal District Court Rules Favorably for Medical Device Manufacturer in Off-Label Promotion Lawsuits

On April 13, 2015, in the case of Kathleen Hafer v. Medtronic, Inc., the United States District Court for the Western District of Tennessee issued a favorable opinion to a medical device manufacturer in the context of...more

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

Medtronic Settles Federal Lawsuit for $4.41 Million

On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over...more

Successful Rule 9(b) Defense of False Claims Act Whistleblower Litigation

The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more

Open Payments/Sunshine Act Year Two: Guidance for Physicians

On June 30, 2015, the Centers for Medicare and Medicaid Services (CMS) will publish the first full-year report of payments to physicians from pharmaceutical and medical device manufacturers. Physicians who want to review...more

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