News & Analysis as of

Medical Devices

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

Congressional Committees Propose Restructuring of User Fees in Draft Language

by Morgan Lewis on

The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases. On April 14, the health committees for both the US Senate and the US House of Representatives released a...more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

The Importance of Aligning Your Regulatory and IP Strategies

by Mark Mansour on

One of the least discussed but potentially most important part of the drug and device approval process is the smooth functioning of the IP and the regulatory strategies. It is natural to focus first on the IP issues,...more

Anaphylaxis Possible Risk of Recalled EpiPen Auto-Injector, Epi-Pen Jr Auto-Injector

A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need....more

Privacy and the Internet of Medical Things: What’s a curmudgeon to do?

by Thompson Coburn LLP on

One of the authors of this piece uses a medical device that is wirelessly networked to the device’s vendor. The author recently received a text message from the vendor, sending “congratulations” for using the device for an...more

Another One Bites the Dust: Plaintiff’s Causation Expert Excluded in Hernia Mesh Litigation

by Reed Smith on

We spent Sunday evening in the familiar confines of a top-notch local professional theatre. The production was a short (80-minute), two-character play. It was entirely dialogue-driven, so everything the audience learned came...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Jury Returns Massive Verdict in Hospital Gown Fraud Lawsuit

On Friday, April 8, 2017, a federal jury in California sent shockwaves throughout the healthcare and legal community when it returned a $454 million verdict against Kimberly-Clark Corp. and its affiliate Halyard Health Inc....more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

New York Attorney General Enters Digital Health App and Privacy Enforcement Fray: Announces Three Settlements with Health and...

by Ropes & Gray LLP on

On March 23, the New York Office of the Attorney General (“NY OAG”) announced Assurances of Discontinuance (“Settlements”) with three developers of health and fitness mobile apps. The Settlements appear to mark the NY OAG’s...more

EU Addresses the Use of Nanomaterials in Medical Devices

by Bergeson & Campbell, P.C. on

On April 5, 2017, the European Parliament (EP) approved a regulation on medical devices, as well as a regulation on in vitro diagnostic medical devices. The EP’s April 5, 2017, press release states that the medical devices...more

Guest Post – Come Together: Is UK Product Liability Law Getting More Like the U.S.?

by Reed Smith on

This guest post – only our second post ever on European issues is brought to you by Reed Smith partners Marilyn Moberg and (in the UK) associate Bond, Kathryn Bond (sorry, couldn’t resist). Our previous (and only) foray into...more

NY AG Enters Mobile Health App Enforcement Arena with Settlements Targeting Health Claims and Privacy Practices

by Kelley Drye & Warren LLP on

New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they made deceptive advertisements and had irresponsible privacy practices. The...more

Health Alert (Australia) April 10, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 5 April 2017 - Reckitt Benckiser (Australia) Pty Ltd v Australian Competition and Consumer Commission [2017] HCASL 86 - The High...more

I’m Not Dead (Yet): FDA Continues to Enforce Unlawful Product Promotion

by Arnall Golden Gregory LLP on

Many of us remember the classic bit in the epic 1975 Monty Python and the Holy Grail movie, where the Dead Collector asks the pestilence-infested community to bring out its dead, and one hapless individual calls out, “I’m not...more

Plaintiffs’ Causation Expert Renounces His Own Conclusions – and Withdraws – in Mirena IIH Litigation

by Reed Smith on

We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York but summary judgment was granted...more

Novocure Announces Optune™ Wearable Device Improves Glioblastoma Survival Rates

Novocure recently announced final results from a phase III EF-14 clinical trial of its Optune device for treatment of newly diagnosed glioblastoma (GBM)....more

Medical Device Manufacturers’ Duty to Warn Expands

The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of...more

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

by Ruder Ware on

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more

MedPlast Completes Acquisition of Vention Medical

MedPlast, Inc. recently announced that it has completed its acquisition of Vention Medical‘s device manufacturing services arm. The press release states that the acquisition “broadens MedPlast’s manufacturing capabilities...more

Michigan District Court Won’t Hear Lanham Act Claim Against Tinnitus Treatment Certifier

Last week, we covered a summary judgment decision holding that posts on the “Science-Based Medicine” blog were not “commercial speech” under the Lanham Act, and therefore the defendant in that case was not liable for false...more

[Webinar] Investment Decisions for Investors and Entrepreneurs Considering 505(b)(2) Drug Applications: How to Make Sure Your...

by Robins Kaplan LLP on

Wednesday, April 19, 2017, 1:00 P.M. CST -- Are you an investor or entrepreneur considering 505(b)(2) drug applications? Join Jake Holdreith, Robins Kaplan, and Ken Phelps, Camargo Pharmaceutical Services for a complimentary...more

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