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So far Green Mellen has created 44 blog entries.

Client Alert – Members of Congress Call for Review of FDA Guidance on Compounding under Section 503A

June 27, 2017 - Earlier this year, we focused one of our client alerts on a new Guidance issued by the Food and Drug Administration (FDA) concerning certain prescription requirements for compounding human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act. See "FDA Issues Guidance on Prescription Requirement for Compounded [...]

Intellectual Property Law Update – June 2017 IP newsletter

Summertime – what a great time to address IP issues which directly impact your bottom line: Implications of recent Supreme Court ruling allowing copyrighting of some fashion designs; Implications – legal and commercial – of recent Supreme Court case restricting where patent infringement cases may be brought; Deciphering some key cyber-security terms; Fame and confusion [...]

Anthem Settles Multidistrict Litigation over 2015 Data Breach $115 Deal Sets Record for a Data-Breach Settlement

Health insurance giant Anthem Inc. reported on February 4, 2015, that its computer systems had been targeted in a “very sophisticated external cyber attack.” The hackers stole personal information from nearly 80 million Anthem employees and customers, including names, birthdates, Social Security numbers, and addresses. Anthem reported at the time that all of its product [...]

Client Alert – Trump Administration Tightens Sanctions Against Cuba

June 16, 2017, the Trump Administration issued its National Security Presidential Memorandum on Strengthening the Policy of the United States Toward Cuba (the “Memorandum”).  Pursuant to the Memorandum, the U.S. Department of the Treasury (“Treasury Department”) and the U.S. Department of Commerce (“Commerce Department”), in coordination with the U.S. Department of State (“State Department”) and [...]

Reining in Medicare Costs: New Facilities Fees Rule is now in Effect

Under Medicare rules in effect since 2000, hospital systems have been permitted to charge so called "facility fees" on top of their normal charges for professional care based on where the care took place. Reports issued in both 2012 and 2014 by the Medicare Payment Advisory Commission (MedPAC) found that Medicare often pays double for [...]

Georgia Pharmacy Agrees to Settle False Claims Act Allegations for $2 Million

The Rhine Drug Company (Rhine) and its owner Carter Clements agreed last week to a settlement with the U.S. Attorney’s Office for the Southern District of Georgia to resolve allegations of violating the False Claims Act and Controlled Substance Act. Rhine and Clements will pay $2.175 million, making it the largest False Claims Act recovery [...]

Express Scripts Requiring Performance Bonds

June 15, 2017 Express Scripts is now requiring some applicants who wish to contract with them to furnish a $500,000 performance bond for at least the first two years of the contract. This bond, per Express Scripts, “guarantees to the obligee (Express Scripts) that the principal will carry out the performance of their contract according [...]

Geoffrey Goodale and Michael Kuhn to Speak at Seminar on the Trump Administration’s International Agenda on June 21

Geoffrey Goodale, a Partner in the Washington, DC office of FisherBroyles and Co-Chair of the D.C. Bar International Law Section’s International Trade Committee, and Michael Kuhn, a Partner in the Atlanta office of FisherBroyles, will be speaking at a seminar on What Should International Practitioners Expect from the Trump Administration that is being held on June 21 from 1:00 p.m. to 4:15 p.m. [...]

FisherBroyles Announces New Intellectual Property Partner, Susan Oiler

(Cincinnati, Ohio — June 12, 2017) — FisherBroyles, LLP (“FisherBroyles”) is pleased to announce that Susan M. Oiler has joined its Cincinnati office as a partner in its Intellectual Property Law Group.  Ms. Oiler is an experienced patent attorney with a passion for client service and a genuine desire to work with the client to [...]