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McGuireWoods LLP

Invitation to Participate in Debate Over Report on Capital Markets Regulation
Last week the Committee on Capital Markets Regulation issued its first set of findings, recommending 32 specific changes in the regulation of U.S. capital markets. The Committee has stated that its objective is to improve the competitiveness of those capital markets by reducing regulation and litigation while enhancing shareholders’ rights. Because of the serious public policy ramifications of the debate that the Report has engendered, we are encouraging clients and others to read the Report and make their views known. Our securities practice team members are interested to hear from you and to assist you in releasing your input to the public. Alternatively, you may take a direct route, using the addresses below.

Briefly, the Committee’s findings were that:

* U.S. capital markets have been the deepest, most liquid markets in the world, providing American companies and others with access to funding at the lowest available cost of capital globally;
* there now are several viable alternative financial markets with global trading enabled by technology;
* issuers seeking capital now are employing a cost-benefit analysis incorporating potential costs of regulation and litigation; and
* the “dramatic increase” in privatization reflects regulatory compliance and litigation as counterweights to the advantages of U.S. markets.

The Report made six principal findings that exemplified the impact of regulation and litigation:

* insufficiently coordinated market regulation and enforcement, public and private;
* high costs of compliance with Section 404 of Sarbanes-Oxley;
* open-ended responsibility of auditors in complying with Section 404 of Sarbanes-Oxley;
* insufficiently coordinated state and federal enforcement laws and activities;
* improper criminalization of entire enterprises; and
* increased liabilities arising out of class action suits ($3.5 billion in 2004).

These findings led to the Committee’s 32 recommendations in four key areas:

Expansion of Shareholders’ Rights: (i) requiring classified boards to receive shareholder approval for poison pill; (ii) majority, not plurality, voting; (iii) shareholders to decide how to resolve disputes with their companies; and (iv) the SEC to resolve disparate approaches to ballot access issues.

Effective Regulation: (i) moving to a more risk-based regulatory process that considers costs and benefits of new rules, relying upon empirical evidence in balancing costs and benefits and relying upon principles-based rules and guidance; (ii) testing of existing rules against cost/benefit standards; and (iii) coordination of public and private enforcement activities.

Enforcement: (i) clarifying legal standards under Rule 10b-5, resorting to criminal enforcement only as a last option, and eliminating the liability of outside directors who could not detect corporate malfeasance; (ii) preventing authorities from threatening corporate defendants with denial of their employees’ due process rights; (iii) limiting the liability of outside board members who have relied in good faith on audited financials; and (iv) protecting audit firms from catastrophic loss.

Sarbanes-Oxley: (i) adoption of a more reasonable standard for internal controls and financials; (ii) adoption of enhanced guidance on auditors’ role and duties in testing for compliance under Section 404; and (iii) reform of Section 404 when applied to small companies.

Public reaction has been mixed and predictable. The media has generally focused on extreme views pro and con and the inevitably conflicting viewpoints. We believe that the Committee has begun a more intelligent discourse among all interested parties than was held at the enactment of Sarbanes-Oxley. Interested parties have accumulated five years of experience under the new regime and can now separate what has been effective from what has not.

We encourage you to read the report and contribute your views. Interested parties may register their comments and opinions on several websites, including the following:

* Institutional Shareholder Services’ Corporate Governance Blog;
* The Washington Post;
* The New York Times; and
* Economist's View.

Interested parties may also submit questions regarding why the U.S. markets have fallen behind to Glenn Hubbard, co-chair of the capital markets panel, former economic adviser to President George W. Bush, and current Dean of Columbia Business School, who will be online from 7 a.m. to 8 a.m. on Tuesday by emailing ask@ft.com or by completing the online submission form.

McGuireWoods LLP assists public and private companies and other market participants in complying with federal and state securities laws and is actively engaged in monitoring developments in these areas, including under the Sarbanes-Oxley Act.

12-04-2006

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McGuireWoods LLP

FDA Advisory Panel to Review the Safety of Drug Eluting Stents
The FDA often turns to advisory panels, permitted pursuant to 21 C.F.R. § 14, to address challenges to the safety or efficacy of drugs or medical devices. The use of these panels provides some benefits, allowing specialized committees to conduct a thorough review of available scientific data and provide recommendations for the appropriate response to the challenge. At the panels’ public hearings, interested parties are permitted to present information that may assist the panel in evaluating data and in making recommendations to the Commissioner of the FDA on the appropriate course of action.

On December 7-8, 2006, the FDA’s Circulatory System Devices Advisory Panel will review the safety of drug-eluting stents, which the FDA first approved in 2003 for their usefulness in preventing restenosis, the reblocking of an artery after angioplasty. These stents have been valuable tools in preventing the condition, which requires additional surgery to repair. Some recent studies, however, suggest that the devices may create an increased risk of late stent thrombosis - blood clots occurring long after original stent placement. The Panel will meet to consider the merits of these studies, as well as treatments that may help prevent the clotting, and whether stents’ potential risks outweigh their significant benefits.

In September, 2006, the FDA’s Center for Devices and Radiological Health issued a statement regarding drug-eluting coronary stents. While it recognized the recent data suggesting increased risk of stent thrombosis, it noted that the problem occurs at low rates, and expressed a belief that “coronary drug eluting stents are safe and effective when used for approved indications.” FDA Statement on Coronary Drug-Eluting Stents, September 14, 2006. In this Statement, the FDA also referred the issue to a public meeting of the Panel in order to improve its knowledge regarding the incidence and timing of stent thrombosis, and to provide recommendations in addressing the issue.

Referral of stent safety issues to a panel, however, does not present a significant threat to the use and production of these devices, nor does it mean the stents are actually dangerous. Such review is generally conducted when the FDA finds that data are not clear-cut. See Carol Rados, “Advisory Committees: Critical to the FDA’s Product Review Process, FDA Consumer Magazine, January-February 2004; Dixie Farley, “Gettting Outside Advice for ‘Close Calls,’” FDA Consumer Special Report, January 1995. FDA panels rarely advise the Commissioner of the FDA to reject a drug or device they have reviewed; according to a study of 11 randomly selected panels, approval was recommended for 79% of the drugs and 82% of the devices reviewed by an advisory panel between 1998 and 2005. See Diana M. Zuckerman, PhD., “FDA Advisory Committees: Does Approval Mean Safety?” Report From National Research Center for Women & Families, 2006. While the Commissioner has sole discretion in making the final decision on the fate of a drug or device, history shows that the Commissioner generally follows the recommendations of advisory panels convened to review a specific drug or device, particularly when the panel has recommended approval. Since the FDA’s Statement suggests that any actions taken will include “possible changes to device labeling or the need for additional clinical studies” rather than the removal of these devices from the market, its referral to the Panel seems to be an attempt to allay criticisms, rather than an expression of serious concerns over the stents’ safety.

Some commentators are troubled by pro-approval trend in advisory panel recommendations, believing it demonstrates that panels act as rubber stamps, approving drugs and devices that should not be on the market. This trend is not surprising, however, when considering the overall purpose of the panels. Randall Lutter, Associate Commissioner for Policy and Planning at the FDA, has commented that much of the value of these panels comes not in the decision to approve a drug or device, as in some cases the FDA has already determined that it will approve the product, but rather in providing guidance on labeling and use of the product. See Shankar Vedantam, “Group Says FDA, Advisory Panels Show Bias Toward Drug Approvals,” Washington Post, August 29, 2006. Furthermore, the panels may take into account patient demand for the drug, as expressed both by the public and by consumer and patient membership on the panels. The purpose of review is to weigh the benefits and risks of a product, and any recommendations that would limit a product’s use or production could have adverse effects on patients who benefit from the product and have not experienced harmful side effects. Thus, a panel may avoid preventing the availability of beneficial treatments and instead advise other courses of action, such as specific labeling requirements or approval with conditions aimed at addressing the panel’s concerns.

In the meantime, the FDA still regards drug-eluting stents as a safe and effective treatment for patients suffering from coronary artery disease. Even the authors of the risk studies do not advise abandoning their use; Dr. Deepak Bhatt, an author of a recent Cleveland Clinic study finding increased risk of blood clotting, has stated that these findings do not mean the stents should not be used, since they do provide significant benefits and reduce the need for repeat procedures to treat restenosis. Rather, the studies may simply lead to additional studies on how best to use these devices in combination with anti-clotting medications.

12-04-2006

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McGuireWoods LLP

Human Papillomavirus Vaccine
In the past decade, enterprising plaintiffs’ lawyers have invented theories of potential recovery against makers of vaccines, particularly vaccines containing thimerosal. This type of litigation may undermine national and indeed international efforts to achieve universal vaccination against preventable diseases. In the history of the world, few, if any, public health measures have yielded as much benefit for mankind as immunization. Hence, anything that impedes the ongoing efforts to achieve universal vaccination, including litigation based on bogus theories, is a public health threat.

A new vaccine against cervical cancer is the latest break-through in disease prevention. In the late 20th Century, medicine learned that, in a significant fraction of cases, cervical cancer is caused by infection with the human papillomavirus (“HPV”), the most common sexually transmitted infection in the United States. Two types of HPV (16 and 18) are thought to cause about 70% of cases. CDC reports that about half of all sexually active Americans will contract HPV in their lifetimes. Most HPV infections -- more than 90% -- cause no symptoms and resolve spontaneously. Those infected, symptomatic or not, can nevertheless pass the virus on to others for a period of time, thought to be as much as two years. Some so infected develop cervical cancer, the second most common cancer in women worldwide. Thanks to early detection through Papanicolau (Pap) screens, many cases are caught early, when the prognosis is best. Despite this advance, cervical cancer still causes about 4,000 deaths per year in the United States. HPV also causes precancerous genital lesions and genital warts.

In the summer of 2006, FDA announced its approval of a vaccine against HPV, the first-ever vaccine to prevent cancer. It is estimated to be 95-100% effective against four types of HPV, including 16 and 18. The vaccine comes in three doses, to be administered at ages 11 or 12, ideally with a second dose two months after the first, and a third four months after that. FDA is not yet sure if a booster is necessary, because the duration of immunity is not yet established.

In the Michigan House of Representatives, a vote is scheduled soon on whether to require vaccination against human HPV for girls entering the sixth grade. The Michigan Senate has already approved the measure. Under the proposal, the state’s central registry for child immunizations will record the administration of the doses to each patient. The parent of a child who receives the first dose will get reminder notices for the second and third. One reason the proposal is drafted as it is to enhance compliance by providing convenience. Currently, children need a tetanus shot to enter sixth grade, and schools are expected to assure themselves that each child has had it. One goal of the new legislation is to make it easy for the public to follow the guidelines for HPV prevention by creating a scheduling regime that builds on one already in place.

Critics object that compelling vaccination could violate parental rights and/or encourage sexual promiscuity. But an opt-out provision for conscientious objectors seems to address the first concern. The second ignores the fact that sex with even a single partner can transmit the disease, and the grim reality that some girls and women are victims of rape.

Michigan is not the only state that is considering steps to expand protection against HPV. New Hampshire has indicated an intention to give girls HPV vaccine at no cost. The existing state vaccine program immunizes children up to the age of 18 against a variety of diseases at no charge. The current plan is to make the HPV virus available to girls ages 11 through 18.

The availability of HPV vaccine does not obviate the need for Pap smears and regular check-ups. And despite the best efforts of both manufacturers and FDA, no medical intervention is completely free of risk. It is nevertheless a tribute to the pharmaceutical industry that, despite relentless attacks from personal injury lawyers, it continues to make important and valuable contributions to public health.

12-04-2006

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McGuireWoods LLP

McGuireWoods Lawyer Named One of Only 12 in Nation as Nightingale’s Outstanding Healthcare Transactional Lawyer
McGuireWoods lawyer Thomas C. Brown Jr. has been named an “Outstanding Healthcare Transactional Lawyer” for 2006 by Nightingale’s. Brown is one of only 12 lawyers nationally who were selected for this honor.

The list of honorees is published in the November 2006 issue of Nightingale’s, a national newsletter for executives and other professionals serving the healthcare industry. In addition, the 12 lawyers will be honored at the Healthcare Transactions Conference in April 2007. Selection for the list of “Outstanding Healthcare Transactional Lawyers” is made by the Nightingale’s editorial staff based on information obtained from former honorees and other sources in the legal community.

“Tom is one of the nation’s deans in term of health care lawyers,” says Scott Becker, co-chair of McGuireWoods’ Health Care Department. “He is deeply deserving of this honor.”

Brown, a partner in McGuireWoods’ Corporate Services Department, practices corporate and health care law in the firm’s Tysons Corner, Virginia office. He regularly represents hospitals, medical practices, nursing homes and retirement homes, and has significant experience in advising tax-exempt organizations involved in educational, health care and trade association activities. He has been recognized for more than 20 years in “The Best Lawyers in America.

12-04-2006

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Robinson & Cole LLP

Robinson & Cole is Prominent at 2006 National Brownfields Conference in Boston
In November, Robinson & Cole played a major role in many facets of Brownfields 2006 – A Revolution in Redevelopment & Revitalization – the national conference sponsored by the Environmental Protection Agency (EPA) and the International City/County Management Association (ICMA) from November 13-15 and which attracted over 6000 attendees to Boston.

Robinson & Cole was the proud platinum sponsor of the Brownfields 2006 Community Reception held at the John Joseph Moakley Federal Courthouse on November 14. Brian Blaesser served as the co-chair of the organizing committee for the Reception and introduced Boston Mayor Menino to a crowd of 1500 attendees. Please click here to view photos.

LandLaw partner Pamela Elkow participated on the panel entitled "No Fine Print: Negotiating Environmental Insurance in New England," and discussed the negotiation of environmental insurance from the perspective of a lawyer representing sellers, buyers or developers of environmentally challenged property. LandLaw partner Brian Blaesser participated on the panel entitled "Recent Developments in the Exercise of Eminent Domain Power" and spoke about methods and tools to creatively resolve planned condemnations without resorting to litigation.

Robinson & Cole attorneys also played leadership roles on the national and local planning committees for the Brownfields 2006 Conference. LandLaw partner Christopher Foster was a key member of the Brownfields 2006 Education committee which selected the programs for the host community educational track. He also assisted with the organization and materials for a presentation entitled "Regional Roundup: New England State Brownfields Programs." As part of his contribution to the committee, Chris Foster, together with Robinson & Cole land use analyst Stuart Pratt, researched and compiled an "Essential Programs and Contacts for Brownfields Development Chart" as resource material for the roundtable session.

12-04-2006

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Fulbright & Jaworski L.L.P.

Fulbright Honored as Citytech Magazine’s Global Tech Law Firm of the Year
Fulbright & Jaworski was awarded Citytech Magazine’s Global Tech Law Firm of the Year for our firm’s use of technology related to “client leveraging.”

The magazine also honored practice support director Florinda Baldridge in its Global Tech Leaders Top 100 List for “leveraging technology as a true competitive advantage using FTI Ringtail.”

The magazine asked 2,000 global technologists composed of law firms, vendor, press and consultants to recommend industry leaders and determine their “most highly respected” selections. Selections could include any legal service provider who helped shape legal technological progress. Final selections were based on those who received the most nominations.

Citytech is a publishing and events company dedicated to the global technology industry with a primary focus on professional practices, the UK and USA. It features topical technology news, vendors, products, people profiles, case studies and legal IT. It covers UK and USA vendors and those involved with professional practices.

12-04-2006

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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Can E-Mail And Screen Names Infringe?
Courts are increasingly addressing whether the use of e-mail addresses and screen names run afoul of the trademark laws. Finnegan Henderson trademark practice group leader David Kelly and law clerk Taylor Foss discuss in their article recent cases that highlight the importance of these emerging issues. As the cases show, the largely self-assigned nature of e-mail addresses and screen names and the ease of obtaining them have given rise to a number of trademark disputes.

12-04-2006

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25383 matches |  13945-13951 displayed

1  1991 1992 1993 1994 1995  3627