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Reed Smith
 
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By Michelle Yeary
Today's case is not our usual fare. But we've never seen this kind of appeal succeed before, so we're going to spare a few minutes for something a little odd but important.
By James Beck
The FDA has recently released a proposed rule "to establish requirements for the medical device De Novo classification process" provided in 21 U.S.C. §360c(f)(2). FDA
By Gail Daubert, Debra McCurdy
Responding to longstanding industry criticisms, the Centers for Medicare & Medicaid Services (CMS) has announced a number of changes to the Healthcare Common Procedure Coding System (HCPCS) coding process for 2019.
By Steven Boranian
A federal court in Utah ruled the other day that it had no personal jurisdiction over a corporate parent, even though the plaintiffs alleged that the defendant subsidiary was the "alter ego"...
By John Feldman, Andrew Bernasconi
Over a spirited dissent, and in a 3-1 decision issued on November 14, the FTC Commissioners held that 1-800 Contacts violated Section 5 of the FTC Action ...
By Thomas Greeson, James F Hennessy
In a transmittal issued last week, the Centers for Medicare & Medicaid Services (CMS) extended newly-revised supervision rules for certain diagnostic tests paid via the Medicare Physician Fee Schedule ...
By Emily Hussey, Sung W. Park
On November 26, 2018, the FDA announced its intent "to modernize the FDA's 510(k) clearance pathway" by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices ...
By James Beck
Late last month Bexis attended the annual ACI Drug and Medical Device Conference in New York. In between helping to lead the discussion in the pre-conference Defense Counsel War Room...
By Debra McCurdy
The Health Resources and Services Administration (HRSA) has announced that it will implement its January 5, 2017 340B drug pricing program rule on January 1, 2019.
By John Sullivan
Last year, we favorably cited Canary v. Medtronic, Inc. 2017 WL 1382298 (E.D. Mich. April 18, 2017), on two occasions, once to highlight its use of TwIqbal at the motion to dismiss stage...
By Stephen J. McConnell
We typically steer clear of discussing any opioid cases for client reasons.
By C. Neil Gray, Herbert Kozlov, Jessica Stumacher
On November 28, 2018, the U.S. Securities and Exchange Commission's (SEC) request for a preliminary injunction against Defendants Blockvest
By Jason Gordon, Michael S. Isselin
They engaged Inside Publications, which publishes Inside Gymnastics magazine, to help advertise the product – including the use of athlete endorsers.
By James Beck
That is the intriguing title of the latest law review article written by the "Rabbi of Torts," Prof. Aaron Twerski (we're not making this up, Prof. Twerski's Wikipedia page is the fifth result...
By C. Neil Gray, Herbert Kozlov, Jessica Stumacher
On November 28, 2018, the United States District Court for the Southern District of California denied the U.S. Securities and Exchange Commission's (SEC) request for a preliminary injunction against Defendants Blockvest.
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