Medical Devices

News & Analysis as of

Huskey V. Ethicon: Case Survives Federal Preemption Argument by Ethicon

Johnson & Johnson’s Ethicon division tried, as it had before, to have its upcoming federal transvaginal mesh case thrown out of court. The healthcare giant was unsuccessful. On July 8, Judge Joseph Goodwin, who is...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

The Inversion Craze: Will Today's Routine Tax Planning Be Retroactively Outlawed?

Alongside the more typical summer fare, such as coverage of the best beach reading and the latest action movie blockbuster, this summer the media have been abuzz with seemingly daily reports on the latest so-called...more

Medical Devices: recent developments in the UK and the US

As it becomes harder for rights holders to control the flow of infringing medical products, Baker Botts’ Neil Coulson and Mark Whitaker review developing case law on both sides of the Atlantic. Whether a company...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of...

The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential...more

Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2014. ...more

FDA Proposes Guidelines for Posting Medical-Product Information Online

A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance....more

What's Safety and Effectiveness Got to Do with Substantial Equivalence? FDA Clears it Up.

On July 15, 2014, FDA issued draft guidance Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. We think of it as a...more

Federal Court Holds Manufacturer of Investigational Drug and Medical Device Responsible for Clinical Trial Investigator’s...

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more

Teaching Hospitals and Physicians Must Take Action Now to Correct Erroneous Reports about them Submitted Under the Sunshine Act

On September 1, 2014, the Centers for Medicare and Medicaid Services (CMS) will make public the reports submitted by pharmaceutical and medical device manufacturers under the Sunshine Act. These reports will disclose...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

Helpful Hints: The Revision Decision – What Should I Do?

Virtually all Rejuvenate and ABG II patients have received notice from their doctor that the devices have been recalled. These patients are all now faced with the prospect of a painful and risky revision surgery. Rejuvenate...more

New DePuy Hip Implant Targeted for Safety Concerns

How does one of the largest, well-known orthopedic device manufacturers in the world produce a hip implant that poisons, putrefies and requires premature replacement? It decides that immediate profit outweighs testing...more

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

CMS Releases New Resources, Schedules Teleconference for Sunshine Review and Dispute Process

As we informed you last week, the Open Payments review, dispute and correction process started today and will continue through September 11, 2014. This is the process that allows physicians and teaching hospitals to review...more

CMS Wants To Shine Light On CME Payments To Physicians

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more

Settlement Over Deceptive Implant Marketing

Johnson & Johnson (“J&J”) has reached a four million settlement with the state of Oregon to resolve allegations that J&J improperly marketed its DePuy ASR metal-on-metal hip implants. J&J has recalled 93,000 ASR hip...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

Retailers NOT Required to Maintain AEDs

On June 23, 2014, the California Supreme Court announced that retailers are not obligated to maintain automated external defibrillators (AEDs) in anticipation of medical emergencies. In Verdugo v. Target Corporation, the...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

Blood Clot Test Strips Voluntarily Recalled Following Three Deaths

Alere Inc. has voluntarily recalled Alere INRatio2 PT/INR Professional Test Strips after nine adverse events — including three deaths — were linked to the defective medical device. The prothrombin time test measures how long...more

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