http://www.reedsmith.com/ en-us © Copyright 2013 Reed Smith LLP. All rights reserved. Mon, 20 May 2013 03:37:52 GMT Mon, 20 May 2013 03:37:52 GMT http://www.reedsmith.com/events/detail.aspx?firmEvent=3498 Event http://www.reedsmith.com/events/detail.aspx?firmEvent=3498 Wed, 16 Oct 2013 05:00:00 GMT 10/16/2013 12:00:00 AM http://www.reedsmith.com/events/detail.aspx?firmEvent=3207 Event http://www.reedsmith.com/events/detail.aspx?firmEvent=3207 Tue, 04 Jun 2013 23:45:00 GMT 6/4/2013 11:45:00 AM Chemical manufacturers, distributors and employers of all types need to take note of new Occupational Safety and Health Administration (OSHA) requirements contained in OSHA’s recently modified hazard communication standard (HCS). The modifications make the new HCS consistent with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The United States now joins the EU and numerous other countries in making this move. Note that currently 27 states or U.S. territories have OSHA-approved plans. These states have six months from the publication of the new standard to adopt comparable versions. State governments may also enact federally approved plans that impose stricter (but not less strict) requirements on employers. Businesses must be aware of any such state rules and adjust their programs accordingly. The new HCS changes many things for manufactures and distributors of hazardous chemicals, and fewer things for other employers who merely use hazardous chemicals in the workplace. A "hazardous chemical" is "any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified." In addition to making minor changes to familiar terminology – for example, "Material Safety Data Sheets" will now be known as "Safety Data Sheets" (SDS) – the new HCS contains a number of broad-ranging substantive changes. The schedule for compliance with the new HCS is staggered, as further described below, with December 1, 2013, being a notable deadline for employee training and chemical container re-labeling. http://www.reedsmith.com/publications/detail.aspx?publication=12397 Publication http://www.reedsmith.com/publications/detail.aspx?publication=12397 Fri, 17 May 2013 00:00:00 GMT DRI’s 29th annual Drug and Medical Device Seminar is the preeminent program for in-house and outside counsel who represent pharmaceutical and medical device manufacturers. DRI is pleased to feature a number of nationally recognized judges, attorneys (in-house and outside counsel), and other professionals who will address cutting-edge topics that are relevant to all who practice in this area, whether they are outside counsel, in-house attorneys, or others involved in the defense of pharmaceutical and medical device companies. This year’s program will offer a variety of presentations, including trial skills demonstrations, a panel discussion with a judge, a plaintiffs lawyer, and a defense lawyer involved in coordinated pharmaceutical proceedings in a unique venue, and litigation insights from leading defenders of drug and device cases. In addition to the outstanding program, there will be numerous networking opportunities, including our annual Young Lawyers Blockbuster and an exclusive in-house counsel only breakout. What You Will Learn: How to use your advocacy skills to persuade the toughest audience The latest on consolidated drug and device proceedings in Philadelphia What jurors are thinking about the FDA How to help a jury understand a state-of-the-art case The latest on “judicial hellholes” How to try a multiple-plaintiff pharmaceutical case How to take the “junk” out of junk science Reed Smith is sponsoring the program, and Reed Smith partner, Steven M. Kohn, is speaking at this program. For more information, please visit DRI's website. http://www.reedsmith.com/events/detail.aspx?firmEvent=3166 Event http://www.reedsmith.com/events/detail.aspx?firmEvent=3166 Thu, 16 May 2013 05:00:00 GMT 5/16/2013 12:00:00 AM Pharmaceuticals, Medical Devices, Health Care & Life Sciences Drugs Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23) Given the significance of generic drugs within China’s health care system, the duplication of generic drug research and development is a serious concern. Currently, certain generic drugs are facing both surplus and shortage problems in the domestic market. To address these problems, China’s Food and Drug Administration ("CFDA") intends to give priority to the examination and approval of both innovative drugs and key sector generic drugs, including anti-tumor, anti-tuberculosis, anti-HIV and cardiovascular drugs. http://www.reedsmith.com/publications/detail.aspx?publication=12365 Publication http://www.reedsmith.com/publications/detail.aspx?publication=12365 Wed, 15 May 2013 00:00:00 GMT The CLE webinar will provide hospital counsel with a review of key issues involved when hospitals consider directly employing physicians, including applicable laws, regulations and strategies for structuring employment contracts. Changes in the law, declining reimbursement, and increased operating expenses are driving more physicians to close their practices and pursue direct employment with hospitals. Hospitals considering hiring physicians must carefully evaluate the implications. Hospitals must comply with employment and tax laws, the Stark Law, and the Anti-Kickback Statute when selecting an employment/operational model, recruiting physicians, structuring employment contracts, and planning for ongoing physician-hospital alignment. Listen as our panel of healthcare attorneys explains the key considerations with hospital employment of physicians. The panel will offer strategies for structuring employment relationships that meet federal and state compliance requirements and for negotiating the employment agreement. http://www.reedsmith.com/events/detail.aspx?firmEvent=3532 Event http://www.reedsmith.com/events/detail.aspx?firmEvent=3532 Thu, 09 May 2013 06:00:00 GMT 5/9/2013 1:00:00 AM Among the many provisions of the Patient Protection and Affordable Care Act (PPACA)designed to expand access to health insurance in the United States, two significant components have engaged public policymakers in the Commonwealth of Virginia: Medicaid expansion and the question of the state operating an insurance exchange. To improve access to health coverage, section 2001 of the PPACA established a new state option, beginning Jan. 1, 2011, to provide Medicaid coverage to additional individuals in each state through an amendment to its state plan of medical assistance. Eligible individuals include those under age 65, who are not pregnant and not entitled to Medicare. The law created a mandatory Medicaid eligibility category for individuals with income at or below 133 percent of the Federal Poverty Level (FPL) beginning Jan. 1, 2014. Also, the mandatory Medicaid income eligibility level for children ages 6 to 19 changes from 100 percent FPL to 133 percent FPL. States have the option to provide Medicaid coverage to all individuals under the age of 65 and above 133 percent of FPL through a state Medicaid plan amendment. One of the most-discussed features of the PPACA is the federal share of the cost of Medicaid expansion. From 2014 through 2016, the federal government will pay a state with an expanded Medicaid eligibility 100 percent of the cost of covering the new Medicaid recipients. Then these federal Medicaid matching payments decline: 95 percent in 2017, 94 percent in 2018, 93 percent in 2019 and 90 percent thereafter. http://www.reedsmith.com/publications/detail.aspx?publication=12288 Publication http://www.reedsmith.com/publications/detail.aspx?publication=12288 Fri, 03 May 2013 00:00:00 GMT On April 26, 2013, the Centers for Medicare & Medicaid Services (“CMS”) released the proposed update to the Medicare long-term acute care hospital prospective payment system (“LTCH PPS”) policies and payment rates for fiscal year (“FY”) 2014. The proposed changes would apply to discharges occurring on or after October 1, 2013 through September 30, 2014. CMS will accept comments on the proposed rule until June 25, 2013, and will respond to comments in a final rule to be issued by August 1, 2013. The proposed rule will appear in the May 10, 2013 Federal Register. This Client Alert provides a summary of the most significant proposed changes to the LTCH PPS in the proposed rule. http://www.reedsmith.com/publications/detail.aspx?publication=12281 Publication http://www.reedsmith.com/publications/detail.aspx?publication=12281 Tue, 30 Apr 2013 00:00:00 GMT Eighteen lawyers at Reed Smith LLP, a leading international law firm, were announced as Washington, D.C. Super Lawyers for 2013. Three others were named D.C. Rising Stars. http://www.reedsmith.com/knowledge/detail.aspx?news=1924 News http://www.reedsmith.com/knowledge/detail.aspx?news=1924 Mon, 29 Apr 2013 00:00:00 GMT 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 Administration (“CFDA,” previously known as “SFDA”) issued a draft Notice on Soliciting Public Comments on the Special Approval Procedures for Innovative Medical Devices for Trial Implementation (“Draft Special Procedures”). The Draft Special Procedures provide for a separate approval process aimed at encouraging the development of qualified, innovative products. According to the Draft Special Procedures, medical device manufacturers and their products must meet the following conditions to qualify for the special approval procedures: The medical device manufacturer must hold the patent right to the medical device on its own, either as the registrant and owner, or as the owner or authorized user, of the relevant invention patent in China through transfer/assignment. The medical device shall have predominant clinical values and incorporate operational principles and functions that are completely new in China, and as compared with leading technologies in other parts of the world. The efficiency or safety of the medical device must be fundamentally improved as compared with similar, existing products. The medical device manufacturer must complete the initial research based on a research process that is accurate and well-controlled. Research data must be complete, with clear sources, to generate a fairly mature product. The medical device manufacturer must be an enterprise incorporated in China, with a valid medical device manufacturing license, and the relevant product must be manufactured in China. In order to be qualified for the special approval procedures, the Draft Special Procedures appear to require only "Chinese patents, Chinese developer and manufacturing in China" with respect to innovative medical devices. However, the draft provisions do not appear to prevent Chinese subsidiaries of foreign medical device developers from applying for the special approval procedures. http://www.reedsmith.com/publications/detail.aspx?publication=12237 Publication http://www.reedsmith.com/publications/detail.aspx?publication=12237 Fri, 26 Apr 2013 00:00:00 GMT Pharmaceutical manufacturers and other state contractors are increasingly subject to suits brought by state attorneys general (AG). Such suits may claim a variety of alleged misdeeds, but frequently concern scientific statements about the effectiveness of off-label uses, regardless of the scientific accuracy of the information. Because state attorneys general act on behalf of the population of an entire state, their litigation inherently carries with it the coercive potential of large damages. Thus, the pressure to settle such actions can be extreme. A recent decision, however, demonstrates that there can be a silver lining, at least potentially, around at least some of those big, dark clouds of state attorney general litigation. Companies considering the settlement of such actions should be cognizant of the recent Minnesota Supreme Court decision, Curtis v. Altria Group, Inc. The legal principles underlying the Curtis decision, under analogous facts, should be applicable to all attorney general actions, with respect to both the state litigation and subsequent private copycat actions, no matter the product or other allegations upon which such suits might be based. http://www.reedsmith.com/publications/detail.aspx?publication=12329 Publication http://www.reedsmith.com/publications/detail.aspx?publication=12329 Wed, 24 Apr 2013 00:00:00 GMT http://www.reedsmith.com/events/detail.aspx?firmEvent=3210 Event http://www.reedsmith.com/events/detail.aspx?firmEvent=3210 Tue, 23 Apr 2013 23:30:00 GMT 4/23/2013 5:30:00 PM