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    • Supreme Court Addresses Degree of Deference Owed to “Gap-Filling” Government Regulations and InterpretationsJune 26th, 2007

      Earlier this month, the Supreme Court issued its unanimous decision in Long Island Care At Home, Ltd. v. Coke, a case concerning compensation for in-home caregivers and the Department of Labor’s (“DOL’s”) interpretation of the Fair Labor Standards Act (“FLSA”).  The Court’s decision, although anticipated, …

    • West Virginia Prescription Drug Advertising Expense Reporting Rule RevisedMay 23rd, 2007

      West Virginia continues to move forward with implementing its prescription drug advertising expense reporting law.  On April 24, the West Virginia Secretary of State filed the West Virginia Pharmaceutical Cost Management Council’s revised emergency rule for Prescription Drug Advertising Expense Reporting.  The rule will go …

    • U.S. Senate Passes Omnibus FDA Reform BillMay 11th, 2007

      Earlier this week, the U.S. Senate passed S. 1082, the “Food and Drug Administration Revitalization Act” (“FDARA”) by a vote of 93-1 (Sen. Bernie Sanders (I-VT) was the lone “nay” vote).  The bill is an omnibus FDA reform and user fee package that, among other …

    • HPM Announces Forum on FDA Device Regulation & Medicare Device Reimbursement, June 6, Research Triangle Park, NCMay 9th, 2007

      The Council for Entrepreneurial Development will hold a “MedTech” forum on June 6, 2007 in Research Triangle Park, NC to discuss FDA’s regulation of medical devices and device reimbursement under the Medicare program.  HPM’s own Marc Shapiro will moderate the program.  Jeff Gibbs and Kirk …

    • HPM Announces New DirectorMay 1st, 2007

      Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & Hartson. Mr. Shapiro’s practice focuses primarily on assisting medical device and …

    • HPM Announces New AssociateApril 19th, 2007

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Carrie S. Martin has joined the firm as an associate.  Ms. Martin earned a law degree with honors from The George Washington University Law School in 2004. She served as an Articles Editor for the …

    • Is Advice Provided by Food and Drug Lawyers Legal Advice Protected from Discovery?April 2nd, 2007

      A recent California case, In re CV Therapeutics, Inc. Securities Litigation, raised the question of whether, within the context of the attorney-client privilege, regulatory advice provided by food and drug attorneys qualifies as “legal” (protected) advice or “business” (generally not protected) advice.  The court concluded …