Medical Devices

News & Analysis as of

You Should Know - April 2015

In This Issue: - Devices Go Awry - Protect Against Risks - Insiders Talk - Excerpt from Faulty Products Put Patients at Risk: Some Popular Medical Devices Escape FDA Scrutiny: Countless patients around the...more

PilotFish Announces MedDevice Connection App

Applied PilotFish Healthcare Integration, Inc. (APHII) recently announced a new application called HealthConnect. APHII is the healthcare division of PilotFish Technology, a provider of middleware solutions for the...more

Blog: The Trade Agreements Act and Sales of Medical Devices to the U.S. Government

Does your company sell medical devices to the U.S. Government, either directly or through a reseller or distributor? Are those devices or supplies manufactured at least partly in a country other than the U.S.? ...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

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA [Video]

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...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

SEC Creates New Financing Opportunity

Chairwoman Mary Jo White recently presided over an open meeting of the U.S. Securities and Exchange Commission at which the Commission followed the recommendation of the Division of Corporation Finance to adopt final rules...more

Recent research suggests medical device interoperability poses cybersecurity risks

While improved interoperability between medical devices will certainly lead to better care management and more efficient, effective medical treatment, new cybersecurity issues for hospitals and health care organizations are...more

Failure to Identify Fax Recipients Shows Putative Class Is Not Ascertainable

A court in the Northern District of Illinois recently denied class certification in a “fax blast” case because the plaintiff failed to meet its burden of proof in showing that the putative class was ascertainable where there...more

Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers

On March 19, 2015, the U.S. Department of Justice and the U.S. Department of Health and Human Services issued their joint annual report on health care fraud and abuse control. The annual report states that during fiscal year...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

FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan

Last week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter aortic...more

Intellirod Spine Signs Licensing and Distribution Agreements With X-Spine Systems Inc.

Intellirod Spine LLC is, according to its website, a medical device company developing wireless sensing technologies for use in spinal care.  According to Orthopedic Design and Technology, Loadpro is the company’s forthcoming...more

Orthofix secures option to acquire eNeura for $65 million

On March 31, 2015, Orthofix International N.V. announced it entered into an 18-month option agreement to acquire eNeura, Inc. Orthofix’s website states that the focus of the company is on “improving patients’ lives by...more

Shift Labs Continues Trend Toward Consumer Wireless Healthcare Devices

The medical device market is expanding into more private healthcare products in hopes of bringing healthcare directly to the user.  For example, the increase in popularity of wearable diagnostic devices, such as FitBit,...more

Brick By Brick, The Learned Intermediary Doctrine Paves A West Virginia Path

Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine. In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23,...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

Failure to Warn About Dangers of Off-Label Use of Medical Device Preempted Under Federal Law

In Thorn v. Medtronic Sofamor Danek, USA, the Honorable Janet T. Neff dismissed the plaintiff's state law claims of failure to warn and negligence as preempted under the Medical Device Amendments of 1976 ("MDA"), 28 U.S.C. §...more

Product Liability 2014 Year in Review

In This Issue: - Letter From The Chair - Key Practice Trends + Highlights - Consumer Products - Pharmaceutical Products and Medical Devices - Aviation - Toxics Regulation and Toxic...more

Punitive Damages Awarded in J&J Transvaginal Mesh Lawsuit

Reuters recently reported that a California state court jury (in the case of Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123) awarded $5.7 Million to plaintiff Coleen...more

Fox Hollow Technologies Agrees to Settle False Claims Act Allegations

The United States Department of Justice recently announced that ev3 Inc., a company that recently acquired Fox Hollow Technologies, agreed to pay a $1.25 million penalty to settle accusations that Fox Hollow had committed...more

Heraeus Medical Components to Acquire NeoMetrics

In a press release issued March 18, 2015, Heraeus Medical Components, a global business unit of Heraeus Holding GmbH, announced that it will acquire NeoMetrics, Inc. According to the press release, Heraeus Medical Components...more

Medical Device Industry Organizations Support STRONG Patents Act

(March 3, 2015) Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued a statement regarding the Support Technology and Research for Our Nation’s Growth (STRONG) Patents Act of 2015. ...more

Medical Device Companies Face Severe FCA Penalties for TAA Violations

A spate of recent multi-million dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act (FCA) if they misstate the country of origin of their products in...more

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

Publicly Traded Life Sciences Companies in the United States Are an Increasingly Popular Target of Securities Fraud Class Action Lawsuits - The past year was particularly noteworthy with respect to the relative number...more

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