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Oren J. Warshavsky Joins Troutman Sanders LLP In Its New York Office
The law firm of Troutman Sanders LLP is pleased to announce the addition of Oren J. Warshavsky as partner to its Intellectual Property practice group in its New York office.

Warshavsky comes to Troutman Sanders from Gibbons, Del Deo, Dolan, Griffinger & Vecchione, where he was a partner and head of its trademark practice. He previously practiced at Cobrin Gittes & Samuel from 1996 until its merger with Gibbons in 2002.

“Oren has made a name for himself in the music and entertainment industry, and software industry over the past 10 years,” said Aurora Cassirer - managing partner, Troutman Sanders’ New York office. “In addition, he has extensive experience in litigating all areas of intellectual property, including copyrights, patents, trademarks and transactions.”

“We are thrilled to welcome Oren to the firm,” said Robert W. Webb Jr. - chairman and managing partner, Troutman Sanders. “He brings to Troutman Sanders a wealth of intellectual property litigation experience.”

Warshavsky has advised and litigated cases – both bench and jury trials – throughout the United States. He has successfully litigated trademark, trade dress, unfair competition, dilution and right of publicity actions. Warshavsky has extensive patent litigation experience, including a vast array of technology, such as local and wide-area networks, videoconferencing, telephone networks, nutritional supplements, medical devices, laser apparatuses, scanning devices, optical discs, and product packaging and display.

Warshavsky’s copyright litigation practice predominantly has focused on the music and entertainment industry. He has represented artists and music acts in all genres, as well as producers and record companies.

In addition to litigation, Warshavsky has advised clients on patent, trademark and copyright licensing, entertainment transactional representation, due diligence and opinion work, and intellectual property portfolio management.

Warshavsky received a Bachelor of Arts from Skidmore College in 1990 and earned his J.D. from the Fordham University School of Law in 1996. He was also a staff member for the Fordham International Law Journal.

11-07-2006

Sanford G. Hausner Joins Troutman Sanders LLP In Its International Group
The law firm of Troutman Sanders LLP is pleased to announce the addition of Sanford G. Hausner as a partner to its International practice group in New York City.

Hausner comes to Troutman Sanders from Buchanan Ingersoll & Rooney PC, where he was a member of the firm’s Corporate Finance & Technology group.

Hausner has been counseling clients in their international activities for the past two decades. He has worked with clients in consummating transactions in over 40 countries with an emphasis on emerging markets.

Hausner’s broad experience includes advising issuers, underwriters, investors and governments in all aspects of corporate law, including international public and private debt and equity offerings, financial restructurings, privatizations, and mergers and acquisitions. He has represented clients in a wide range of industries, including aviation, consumer products, gaming, real estate, technology and telecommunications.

“We are thrilled to welcome Sandy to the firm,” said Aurora Cassirer - managing partner, Troutman Sanders’ New York office. “He has gained tremendous experience practicing for some of the largest law firms in the world that Troutman Sanders and its clients will benefit from."

“We welcome Sandy’s strong international experience that the firm will utilize in further assisting our clients, focusing on global opportunities,” said Robert W. Webb Jr. - chairman and managing partner, Troutman Sanders.

“I was very attracted to Troutman Sanders based upon its strong commitment to further develop its international practice, particularly in the nascent markets, its continued desire to grow its New York office, as well as its stellar reputation in the energy sector – a necessity for any law firm serious about being a leader in the international legal community,” said Hausner.

Hausner received a Bachelor of Science degree in accounting and finance from New York University Stern School of Business, a J.D. from Brooklyn Law School and an LL.M. in taxation from New York University School of Law.

11-07-2006

Paz-Soldan Invited to Join Latin America Advisor Board
Carlos Mateo Paz-Soldan, a Partner and Chair of the International Trade and Government Relations Practice Group in the Washington, D.C. office, was mentioned in this edition of Latin America Advisor after joining the publication's Board of Advisors. Mr. Paz-Soldan is a regular contributor for this daily publication of the Inter-American Dialogue, which focuses on U.S.-Latin America relations and provides readers with up-to-date analysis and news about critical economic, business and political developments in Latin America.

The linked PDF document was posted on Saul Ewing's website with the permission of the Inter-American Dialogue.

11-07-2006

13 RUDEN McCLOSKY ATTORNEYS NAMED TO SOUTH FLORIDA LEGAL GUIDE TOP ATTORNEYS LIST
Fort Lauderdale: Congratulations to the following attorneys who were recognized among "Top Attorneys" in the South Florida Legal Guide, 2007 Edition. Ruden McClosky was also named among "Top Law Firms" in the Guide. Stanley Kim and Matt Nelles's article, The Patent Troll Threat in the Wake of Ebay Inc.v Mercexchange LLC is also published in the Guide.

Top Attorneys
James R. George : Probate Litigation
Mark F. Grant : Commercial Real Estate
Thomas O. Katz : Taxation, Corporate
Beth-Anne Krimsky : Commercial Litigation, Real Estate Litigation
Donald C. McClosky : Zoning, Land Use
Dennis D. Mele : Zoning
Steven R. Parson : Real Estate, Commercial
Harry B. Smith : Real Estate
Barry Somerstein : Real Estate
Mark K. Somerstein : Banking and Finance, Real Estate
Peter L. Wechsler :Torts, Product Liability (Defense)
E. Lee Worsham : Environmental

11-07-2006

European Commission consults on Distance Selling Directive
Directive 1997/7/EC of the European Parliament and of the Council of 20 May 1997 on the Protection of Consumers in respect of Distance Contracts (“Distance Selling Directive”) aims at ensuring that consumers, who buy goods or services via distance selling means (and, thus, without any face-to-face contact with the supplier), are in no worse a position than consumers purchasing with face-to-face contact.
The Distance Selling Directive covers both goods and services. However, Article 3 limits the application of the Distance Selling Directive by excluding certain types of contracts from all or some of the Distance Selling Directive’s provisions.

Financial services, due to their complexity and their value, are amongst these exemptions and have been covered in the Distance Marketing of Financial Services Directive 2002/65/EC4 (“Financial Services Distance Marketing Directive”). It is proposed that this directive will undergo a review in the near future. The European Communities (Distance Marketing of Consumer Financial Services) Regulations 2004 and 2005 implement the Financial Services Distance Marketing Directive in Ireland.

All twenty five Member States have transposed the Distance Selling Directive into national law. The European Communities (Protection of Consumers in Respect of Contracts Made by Means of Distance Communication) Regulations 2001 and 2005 implement the Distance Selling Directive in Ireland.

In accordance with Article 15(4) of the Distance Selling Directive, the European Commission has issued a report (“Report”) to the Council, the European Parliament and the European Economic and Social Committee on the implementation of the Distance Selling Directive.

Consultation

The Commission wishes to collect the Member States’ and stakeholders’ views on the application of the Distance Selling Directive and its suitability for new market conditions and/or products. Accordingly, following from the Report, the European Commission has launched a consultation on the Distance Selling Directive through the publication of a questionnaire on the implementation of the Distance Selling Directive which interested parties are invited to respond to.

The Distance Selling Directive contains various regulatory options which were open to the Member States in implementing the Distance Selling Directive. Further, Article 14 (known as the minimal clause) allowed Member States to introduce or maintain more stringent provisions to ensure higher levels of consumer protection. This has created variation between the national laws implementing the Distance Selling Directive. The Commission proposes to look at whether the national divergences in transposition of the Distance Selling Directive emanating from these freedoms have had an impact on the Internal Market and affected business and consumer confidence in cross border trade. In addition, issues have been raised in relation to the Distance Selling Directive's practical application in view of new technologies.

The consultation addresses, among other things:

* possible failings in relation to consumer protection, particularly in view of new technologies and market practices;
* whether the current exemptions from protection under the Distance Selling Directive need to be revised;
* whether the cooling off period, which allows consumers to cancel their purchase within a period of time after the sale, should be harmonised across Member States; and
* whether the minimal clause, which allows Member States to impose a higher standard of consumer protection, has affected cross-border trade and competition.

On the basis of the outcome of the consultation launched by the questionnaire and of the results of the review, the Commission will consider the need for further legislative initiatives in the field of distance selling in accordance with the better regulation objectives pursued by the Commission in terms of simplification of the regulatory environment.

11-07-2006

Husch & Eppenberger, LLC Announces New Leaders to the Executive Committee
Husch & Eppenberger, LLC has announced the firm has approved the addition of Caroline L. Hermeling and Christine F. Miller to its firm-wide Executive Committee. Other members of the firm's Executive Committee are Joseph P. Conran, Thomas M. Carney, Gregory R. Smith and Charles Christian Kirley.

Effective January 1, 2007, Carrie Hermeling will assume the role of Chief Executive Officer of the firm. Over the past 7 years Hermeling served in various leadership positions within the firm's Litigation/Dispute Resolution Department, most recently heading up the management of the litigation associates and legal assistants. Hermeling was featured in the November 13, 2006 edition of Missouri Lawyers Weekly in an article entitled Smashed Ceiling.

Chris Miller currently serves as Vice-Chair of the firm's Litigation/Dispute Resolution Department and is a member of the firm's Management Committee.

Carrie Hermeling and Chris Miller have maintained active litigation practices for over 20 years. Hermeling specializes in the representation of developers, property owners, and municipalities in condemnations and real estate development disputes. In August 2004, she headed up the foreclosure sale of the St. Louis Centre Mall and more recently has been involved in a variety of highly publicized land development disputes throughout the Midwest region. Miller has served as lead trial lawyer in over 30 jury trials resulting in successful verdicts in the areas of commercial, products liability and employment litigation. In 2000, she received a defense verdict in an employment discrimination case that was selected as one of the National Law Journal's "Top Ten Defense Verdicts for 2000."

"Both Carrie and Chris are outstanding trial lawyers and have been leaders within our firm for years. We look forward to their continuing contributions as they take on an active role in the management of the entire firm." said Joe Conran, Chairman of the firm's Management Committee.

Husch & Eppenberger has over 300 attorneys in eight cities across the Midwest and Mid-South. For more than eighty years, Husch has served local, regional, national and international businesses; financial institutions; charitable and governmental organizations; and individuals in sophisticated litigation and business representation.

11-07-2006

InterMune’s $36 million Off-Label Promotion Settlement Could Signal Important Trends for Enforcement
Healthlaw partner Kathleen McDermott is quoted in Rx Compliance Report regarding the Department of Justice’s (DOJ) investigation and criminal deferred prosecution agreement with Intermune, for illegal off-sales and marketing activities.

Here is a rundown of some noteworthy features of the InterMune settlement, according to experts in this area:

1. The first deferred prosecution agreement for an FDA-related offense. The InterMune settlement is the first deferred prosecution agreement in a pharmaceutical marketing or pricing case and the first non-criminal resolution of an offlabel case. All previous settlements in this area have included a criminal component (although Eli Lilly’s was a misdemeanor).

According to former federal prosecutor Kathleen McDermott, this case signals that, while the Department of Justice still views off-label promotion issues in terms of criminal liability, the DOJ appears to be willing to defer the resolution of criminal liability where there has been a “significant compliance response” by management.

Notably, she adds, the deferred prosecution agreement does not resolve the controversial issue of whether off-label promotion activities are best addressed in a criminal arena. Apart from the process issue of using a deferred prosecution agreement, “the substance of the underlying conduct and charges is interesting,” says McDermott, a partner with Blank Rome in Washington, D.C., because it involves the conduct of another entity, a clinical trials process, and a violation of both the FDA statute and the health care fraud statute. “It is not clear how damages were determined to establish economic harm,” she adds.

According to McDermott, the terms of the deferred prosecution agreement also aptly illustrate that it is “a vehicle for a tough resolution” with the government where liability is basically conceded and substantial rights waived. The result for InterMune remains significant, she says, and includes a large fine, a five-year corporate integrity agreement, waiver of the statute of limitations, and a prohibition from being part of any joint defense agreement,. Nevertheless, if all goes well, says McDermott, the criminal information will be dismissed and the potential for a judgment of conviction will be avoided.

“The fact that the government is willing to use a deferred prosecution agreement in the context of voluntary compliance efforts by a company would suggest that cases may be more expeditiously resolved,” says McDermott.

“I find it extraordinary that the government gave a deferred prosecution,” says a former DOJ attorney. Although the company offered some witnesses and shared its internal investigation, he points out, these are not generally considered extraordinary measures. “It was not privileged information that was handed over,” he says, “and it did not lead to any convictions.”

Prosecutors typically dislike deferred prosecutions, he says, because other companies, encouraged by the precedent, will resist accepting pleas. There is an argument that it is good enforcement policy, he adds. “However, it takes some leverage away from the government when you start down this path.”

2. The case was handled by the U.S Attorney’s Office in Northern California. To date, the vast majority of pharma settlements have been handled by the U.S. Attorney’s Offices in Boston and Philadelphia. This settlement bears out recent reports that other offices have active pharma cases as well.

3. The losses apply beyond Medicare and Medicaid. Another significant feature of the settlement, according to McDermott, is that, unlike most previous settlements in this area, the losses apply beyond the Medicare program to include the Veterans Administration and the Federal Employees Health Benefit program. “This is an important illustration that off-label issues to the government are public health issues that cut across the board for all federal health care programs,” she explains.

4. InterMune is a small biotech company, not an industry giant. Unlike most recent pharma marketing fraud cases, which targeted industry giants, InterMune is a small biotech company.

Kathleen McDermott represents health care providers and government contractors in the areas of compliance counseling, internal investigations, government investigations and complex health care litigation. She has been involved in over 100 False Claims Act matters and has been recognized by Washingtonian magazine as one of the top attorneys in Washington DC to handle qui tam whistleblower suits and disclosures to the government. She provides legal guidance to the provider, payor, pharma, device and clinical research industries on structuring business arrangements for compliance with State and federal fraud and abuse regulations. Ms. McDermott is a former assistant U.S. attorney and health care fraud coordinator for the District of Maryland, and currently serves as a vice-chair of the American Health Lawyer’s Association Fraud & Abuse Practice Group.

Rx Compliance Report is the only news source devoted exclusively to the government's crackdown on pharmaceutical sales and marketing practices. This 12-page bi-weekly newsletter uncovers emerging investigations and offers practical firsthand advice on implementing effective compliance programs. Rx Compliance Report focuses on the state and federal agencies leading these fraud and abuse investigations including the U.S. Dept. of Justice, the HHS OIG, state Attorneys General, state Medicaid Fraud Control Units, the Securities and Exchange Commission and the Federal Trade Commission. Readers include legal, regulatory, and compliance officers from nearly every major pharma company, and numerous biotech and medical device companies. Dozens of law firms, CME providers, and others also subscribe as well as DOJ, the OIG, and the FDA.

11-07-2006

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