Manufacturers, FDCA | JD Supra Law News

A Narrow Exception To The Mensing Preemption Defense

by Erin M. Bosman, Jeffrey M. David, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 4/8/2013

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...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

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

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

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Manufacturers › Food, Drug and Cosmetic Act

A Narrow Exception To The Mensing Preemption Defense

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

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

IRS Releases Final Rule on Medical Device Tax

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

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