Manufacturers, Medical Devices

da Vinci Lawsuit Testimony Focuses on Aggressive Marketing by Manufacturer

by Audet & Partners, LLP on 5/8/2013

As of January 2013, 2,585 da Vinci Surgical Systems are being used in 2,025 hospitals worldwide, according to a report from Intuitive Surgical, Inc., the manufacturer of the robot. Last year 367,000 surgeries were performed...more

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 4/29/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

by Matthew A. Reed | Sedgwick LLP on 4/26/2013

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

OIG Calls PODs "Inherently Suspect"

by Julie Kass, William Mathias, Sanford Teplitzky | Ober|Kaler on 3/29/2013

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling...more

Getting Ready For The Physician Payment ‘Sunshine’ Rule

by Kathleen Howard, Joel R. Levin, Charles Mulaney, Jerica L. Peters | Perkins Coie on 3/22/2013

Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more

CMS Issues Rules On Physician Payments Sunshine Act

by Michael Volkov on 3/15/2013

People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more

Final Sunshine Act Arrives: Now the Hard Part

by Michele L. Buenafe, Jonathan Havens, Kathleen McDermott, Rebecca Osowski, Albert Shay | Morgan Lewis on 3/8/2013

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

Physician Payment Sunshine Act Final Rule Released

by Thomas Donohoe, Lauren Groebe, Lindsay Kessler, Matthew Murer | Polsinelli on 3/7/2013

In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more

The Sunshine Physician Payment Final Rule Overview and Analysis

by Nancy Bonifant, Elizabeth Carder-Thompson, Katie Pawlitz | Reed Smith on 3/6/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule (Rule) to implement the “Sunshine” provisions of the Affordable...more

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

by Frederick Ball, Elinor Hart, Michael A. Swit | Duane Morris LLP on 3/6/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls

by Ropes & Gray LLP on 2/27/2013

On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more

Sellers of Medical Devices May Need to Collect Sales Tax on Excise Surcharges

by Amol Jain | Berkeley Research Group, LLC on 2/25/2013

Starting this year, manufacturers and importers of certain medical devices must remit to the federal government a 2.3-percent excise tax on the sale of these devices (as discussed previously in this post). Many sellers pass...more

Sales of Certain Medical Devices Now Subject To The Medical Device Excise Tax

by Daniel Cooper | Armstrong Teasdale LLP on 2/11/2013

Effective January 1, 2013, manufacturers, importers and producers of certain medical devices are subject to an excise tax equal to 2.3 percent of the price at which the medical device is sold. You should note that this excise...more

Health Law Alert: Final Sunshine Act Regulations Released

by Ryan McGary, Sheva J. Sanders | Leonard, Street and Deinard on 2/5/2013

On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Sunshine Act regulations. The Sunshine Act requires disclosure of payments and value transfers (Payments) from drug and...more

CMS Publishes Final Sunshine Act Rule

by Mintz Levin - Health Law on 2/4/2013

This afternoon, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule (Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act). The Sunshine Act requires manufacturers of...more

Ninth Circuit limits Medical Device Amendment preemption of post-PMA tort claims

by Gregory Wartman | Saul Ewing LLP on 1/30/2013

Medical Device Companies should be aware of a recent en banc ruling by the Court of Appeals for the Ninth Circuit that has the potential to increase litigation involving class III medical devices....more

Chinese MOH Announced Centralized Procurement of High Value Medical Consumables

by Katherine Wang | Ropes & Gray LLP on 1/18/2013

On December 17, 2012, the Ministry of Health (“MOH”) issued the Tentative Guidelines for Centralized Procurement of High Value Medical Consumables (the “Guidelines”) with immediate effect, with an aim to control health care...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

by Erin M. Bosman, Julie Y. Park, Joanna Simon | Morrison & Foerster LLP on 1/15/2013

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

Excise Tax Kicks In Jan. 1 On Certain Medical Devices

by Scott D. Alfree, Lawrence P. Burns, Pamela Emenheiser, Zachary J. Meyer | Varnum LLP on 12/28/2012

Beginning January 1, 2013, manufacturers and importers of certain medical devices will be required by the U.S. Internal Revenue Service (IRS) to pay a new 2.3 percent medical device excise tax on the sales of taxable medical...more

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

by Thomas Barker, Ross Margulies | Foley Hoag LLP on 12/24/2012

Foley Hoag and the Advanced Medical Technology Association (AdvaMed) collaborated on an important resource guiding manufacturers, importers, and producers of taxable medical devices through the newly released Internal Revenue...more

Strict Products Liability Claims Based On Design Defect Are Inapplicable To Implanted Medical Devices That Are Available Only...

by CMCP - California Minority Counsel Program on 12/21/2012

A recent California Court of Appeal decision out of the Second District has provided further clarity to the scope of California products liability law by reasserting the general rule that precludes strict liability for design...more

IRS Releases Final Rule on Medical Device Tax

by King & Spalding on 12/18/2012

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

by Felicia Leborgne Nowels | Akerman Senterfitt on 12/18/2012

Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more

New Rules Will Be “Taxing” On Medical Device Manufacturers

by Christine J. Kim, Richard (Rich) E. Peterson | Perkins Coie on 12/13/2012

The U.S. Department of the Treasury and the Internal Revenue Service (IRS) recently issued much-anticipated final regulations under Section 4191 of the Internal Revenue Code (Code), which imposes a 2.3% tax on sales of any...more

Update on Federal and State Developments: Regulation of Financial Interactions between Health Care Providers and Pharmaceutical...

by Ropes & Gray LLP on 12/13/2012

Recent weeks have seen two significant developments with respect to federal and state laws regulating financial interactions between pharmaceutical and medical device companies and health care providers: (1) the Centers for...more

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