February 2010 Client Alerts

March 1, 2010

Authored by: Jeannie Osborne

SEC Publishes Interpretive Release on Climate Change Matters

Yesterday, the SEC published its interpretative release regarding disclosure requirements applicable to climate change matters. The release provides guidance on certain existing disclosure rules that may require a company to disclose the impact that business or legal developments related to climate change may have on its business.

For more information, please read the client alert published by Bryan Cave LLP’s Corporate Finance and Securities practice on February 3, 2010.

SEC Amends E-Proxy Rules to Provide Increased Flexibility

Yesterday the SEC approved amendments to the notice and access proxy, or “e-proxy,” rules.  The amendments will provide increased flexibility for companies regarding the format and content of the notice.

For more information, please read the client alert published by Bryan Cave LLP’s Corporate Finance and Securities practice on February 23, 2010.

Federal Judge Rules that Data Backup Tapes Need not be Retained for eDiscovery, Unless They are the Sole Source of Relevant Evidence

Federal Judge Shira Scheindlin of the Southern District of New York has ruled that it is not necessary for the litigants in a case now pending before her to retain and preserve all data backup tapes for eDiscovery:  “I am not requiring that all backup tapes must be preserved.  Rather, if such tapes are the sole source of relevant information (e.g., the active files of key players are no longer available), then such backup tapes should be segregated and preserved.”

For more information, please read the client alert published by Bryan Cave LLP’s Records Management team on February 9, 2010.

New Mental Health Parity Rules: What Group Health Plan Sponsors Need to Know Now

On February 2, 2010, the Departments of Labor, Treasury, and Health and Human Services published Interim Final Rules (“Rules”) under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (“Act”). Under the Act and its predecessor, the Mental Health Parity Act of 1996, a group health plan that provides both medical and surgical benefits and mental health and substance use disorder benefits cannot apply financial requirements or treatment limitations that are more restrictive than those applicable to substantially all of the plans medical and surgical benefits.

For more information please read the client alert published by Bryan Cave LLP’s Employee Benefits and Executive Compensation practice on February 5, 2010.

Analysts: Healthcare Summit Set Stage for Dems-Only Bill

Analysts reporting on yesterday’s six hour healthcare summit between Democrat and Republican leaders generally agreed that the summit’s failure to reach a bi-partisan deal likely set the stage for a party-line vote on health reform.

For more information, please read the client alert published by Bryan Cave LLP’s Food and Drug Administration practice on February 26, 2010.

White House Releases Health Care Proposal for Summit

The President released his proposal for health care reform yesterday, touting it as a starting point for the bipartisan health care summit on Thursday. The President’s proposal aims to bridge the gap between the health reform bills passed by the House and the Senate and includes provisions targeting insurance rate increases.

For more information, please read the client alert published by Bryan Cave LLP’s Food and Drug Administration practice on February 23, 2010.

USDA and FDA Issue Joint Statement to Update Public on Coordinated Efforts to Ensure Safety of Produce; FDA Invites Public Comments to Inform Rulemaking

USDA and FDA recently issued a joint statement emphasizing that the two agencies continue to work together to improve the safety and quality of fresh produce.  USDA’s Agricultural Marketing Service is evaluating a proposed marketing agreement for the leafy green industry and FDA is developing proposed produce safety regulations.

For more information, please read the client alert published by Bryan Cave LLP’s Food and Drug Administration practice on February 25, 2010.

FDA Launches Program to Improve Safety of Imports

This week, FDA Commissioner Margaret A. Hamburg announced a new FDA program to help assure the safety and quality of imported goods, the PREDICT Program, an automated system that will allow the FDA to monitor products at the port of entry.

For more information, please read the client alert published by Bryan Cave LLP’s Food and Drug Administration practice on February 5, 2010.

FDA Rethinking Serving Sizes

FDA is re-evaluating serving size portions with the idea of increasing the portion sizes to more accurately reflect what Americans actually eat.   When the serving size is smaller than what would typically be consumed, the nutrition information on the label can be misleading, perhaps most importantly by not giving consumers an accurate count of how many calories they are consuming.

For more information, please read the client alert published by Bryan Cave LLP’s Food and Drug Administration practice on February 9, 2010.

Some Predicting FDA Inspections to Increase by 50%

Some are predicting that the number of FDA inspections at foreign manufacturing facilities, and particularly in China, India and Mexico, will increase by 50% this year, due to an increase in the number of FDA offices and staff abroad.

For more information, please read the client alert published by Bryan Cave LLP’s Food and Drug Administration practice on February 5, 2010.

Stakeholders Meet to Discuss 510(k) Clearance

At the meeting convened by the FDA on February 9 for stakeholders from across the medical device industry, industry representatives and consumer groups called for transparency and notification regarding adverse events associated with legacy devices.  The FDA has stated that it will be modifying the 510(k) clearance process, and has indicated that it is considering whether the FDA should refrain from approving certain medical devices after new, safer, and more effective technologies emerge.

For more information, please read the client alert published by Bryan Cave LLP’s Food and Drug Administration practice on February 19, 2010.

Can Bribery Be All That Mysterious

The recent spate of Foreign Corrupt Practices Act (FCPA) convictions raises a basic question:  What’s so hard about the FCPA?  Reports about the DOJ giving the FCPA an enforcement priority raise similar questions as well.  What is bribery?  Is it really so difficult?

For more information, please read the client alert published by Bryan Cave LLP’s International Trade practice on February 8, 2010.

HIPAA HITECH Enforcement Date Is Here

The Health Information Technology for Economic and Clinical Health Act (“HITECH”) was passed last year as part of the American Recovery and Reinvestment Act. With HITECH, Congress amended HIPAA to address issues concerning the electronic storage of health information. HITECH imposes many new requirements and restrictions on the use and disclosure of health information, affecting both covered entities, e.g. providers and suppliers, and their business associates.

For more information, please read the client alert published by Bryan Cave LLP’s Life Sciences and Health Care practice on February 17, 2010.

Consignment Closets Compliance Standards Delayed

For the past year, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (“CMS”) has been considering new restrictions on consignment closet arrangements. A consignment closet is an arrangement where a supplier of durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) maintains inventory at a physician’s or other health care professional’s office. The physician distributes the inventory to patients as needed, and the DMEPOS supplier bills Medicare for the inventory distributed.

For more information, please read the client alert published by Bryan Cave LLP’s Life Sciences and Health Care practice on February 18, 2010.

New U.S. Sanctions In the Offing Against Iran

Congress appears poised to mandate new U.S. sanctions against Iran.  Both the House and Senate have passed bills to require the President to do so.  While there is some opposition from the White House, the betting is that a compromise will be worked out and additional sanctions subsequently imposed.

For more information, please read the client alert published by Bryan Cave LLP’s International Trade practice on February 18, 2010.

WTO Dispute Settlement Puts Philippine Excise Tax on Distilled Spirits on Agenda

On July 29, 2009, under the World Trade Organization (“WTO”) dispute settlement mechanism, the European Communities (“EC”) requested consultations with the Philippines concerning the Philippines’ current excise tax regime on distilled spirits, which has been in place since 1997. The EC contended that the Philippine regime discriminates against imported distilled spirits, taxing them at a substantially higher rate than domestically produced spirits.

For more information, please read the client alert published by Bryan Cave LLP’s International Trade practice, January-February 2010.