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Bradley Thompson Quoted on FDA Review Process for High-Risk Medical Devices

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Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted on a Government Accountability Office report recommending that certain high-risk medical devices receive more stringent reviews by the Food and Drug Administration or be reclassified.

In the article, titled, “GAO: More Stringent FDA Review Needed For Certain Devices Before Reaching Market,” Thompson said the GAO findings were generally positive, because they are a “tacit, overall validation” of how the review process works for most devices. For certain high-risk devices, Thompson said, the FDA has lacked resources to address the issues adequately.

Thompson also said there is no suggestion that the devices that reached the market through the review standards set for lower-risk devices are unsafe. Thompson expects that, for the 20 categories of devices that still could be cleared through this lower-risk process, regulators eventually will put the devices into class II, meaning pre-market approvals won’t be needed.

Edward Brown Quoted on Bailout-Funds Recipients Acquiring Failed Banks

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Edward Brown, a Member of the Firm in the Business Law practice in the Atlanta office, was quoted in a Dow Jones Newswires article on a growing number of failed banks that have been acquired by companies receiving government bailout funds.

More than half of the banks that have failed since the U.S. Treasury began recapitalizing financial institutions in October have been purchased by companies receiving government bailout funds, Dow Jones reported in the article, titled, “Bailout Recipients Snapping Up Failed Banks.”

“In this environment, a lot of banks are concerned about whether they can sell the bad assets to anybody,” said Brown. “It seems like the business decision for those that are strong enough is to wait for the failures, then buy the deposits.”

Breen Interviewed on Emerging Trends in Litigation Against Health Plans

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George B. Breen, a Member of the Firm in the Health Care and Life Sciences and Litigation Practices in the Washington, DC office, was interviewed for an article about emerging trends in lawsuits brought against health plans.

In connection with the article “It’s No Longer Just Members Who Are Suing Health Plans,” Breen noted that plans are also exposed to False Claims Act cases, often brought by whistleblowers who allege fraud against the government. He indicated that the number of states that have enacted their own false claims acts including qui tam provisions is increasing, and that there is a monetary benefit to a state when a recovery is made in a Medicaid fraud case brought pursuant to a state act.

Breen is Co-Chair of the Health Care and Life Sciences Litigation Group.

Swirsky Quoted On Labor’s Bargaining Tactics Over Executive Compensation/Federal Bailout Aid

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Steven Swirsky, a Member of the Firm in the Labor and Employment and Health Care and Life Science practices in the New York office, was quoted in an EmploymentLaw360 article on organized labor’s stance that companies that receive federal bailout money should be restricted in their ability to oppose union organizing efforts.

In the article, titled, “TARP No Help To Unions At Bargaining Table: Attys,” Swirsky said that organized labor, which has been on the defensive for the past eight years, has been seeking to take a more aggressive stance toward organizing. Increasingly, unions have been raising populist, anti-business arguments in efforts to organize workers, he said. Federal bailout efforts that have provided additional access to credit and funds are not enough to give labor the boost it is seeking. Swirsky noted that there is a good deal of popular antipathy toward business, but the current difficult economic environment with rising unemployment may still hamstring labor’s efforts.

“Labor’s going to be emboldened, to a degree,” he said, but added: “I don’t think that the fact that there’s federal money is going to give the unions more power to extract higher wages or greater benefits. They will make their arguments, they will do their homework, and I expect them to be knowledgeable. But I don’t think it gives them any greater leverage than it would otherwise.”

Morris Quoted on FMLA in Baltimore Business Journal

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Frank Morris, a Member of the Firm in the Litigation practice and head of the Labor and Employment Practice in the Washington, DC office, was quoted on important changes to the Family and Medical Leave Act that became effective in January 2009.

In the article, titled, “Family First: Changes to the FMLA benefit employers and workers,” Morris noted: “FMLA has been a source of a great deal of difficulty for employees to know what their rights were and for employers to administer.”

Marc Mandelman Quoted in “Longer Notice Now Needed for Layoffs in NY”

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Marc A. Mandelman, a Member of the Firm in the Labor and Employment practice, in the firm’s New York office, was quoted in Crain’s New York Business, in “Longer Notice Now Needed for Layoffs in NY.” (Read the full version – subscription required.)

Following is an excerpt:

Employment lawyers and business advocates say the new set of rules come at the wrong time for businesses and make it harder for them to cope with the recession.

“In this economic climate, there are going to be a lot of companies that have to make changes for business reasons,” said attorney Marc Mandelman … “These new deadlines will be extremely difficult to meet.”

The federal law required employers with 100 or more full-time employees to provide written notification of mass layoffs and closings, but the New York law applies to businesses with 50 or more full-time workers.

Morris Quoted on ADA Amendments Act

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Frank Morris, a Member of the Firm in the Litigation practice and head of the Labor and Employment Practice in the Washington, DC office, was quoted on the ADA Amendments Act, signed into law September 2008, one of many new and revised laws that human resource professionals will need to comply with in 2009.

In the HRFocus article, “Top Law Changes Employers Must Be Ready For in 2009,” Morris said that under the act, courts likely “will pass over the question of disability” and proceed to issues of discrimination, reasonable accommodation, and the like. The law provides that the definition of disability found in Section 504 of the Rehabilitation Act and decisions construing that law should be “the touchstone” for courts construing the ADA, Morris said.

Court decisions denying ADA coverage that relied on the Supreme Court’s decisions in Sutton v. United Airlines Inc. and Toyota Motor Mfg. of Ky. Inc. v. Williams are “largely no longer relevant,” since Congress disavowed those rulings, Morris said. Congress also indicated that an EEOC regulation defining “substantially limits” as “significantly restricts” is incorrect and directed the commission to revise its ADA rules, Morris said.

Morris is co-chair of the Firm’s Disability Law Group.

EBG featured on China Economic Net

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On February 1, 2009, China Economic Net, one of China”s leading sources of financial news, published on its website www.ce.cn a Chinese article by Jieling Zhang, a Correspondent in New York for China Economic Daily. The article discusses EBG’s five core practice areas, its representation of multinational businesses’ and their U.S. subsidiaries and operations, and its China Initiative and its development. The the following is the article’s Chinese link: http://intl.ce.cn/kggs/zxdt/200902/01/t20090201_18082702.shtml

SHRM Reports on Epstein Becker Green’s Post-Inauguration Labor and Employment Law Briefing

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The Society for Human Resource Management covered Epstein Becker Green’s post-inauguration briefing with an article focused on an increase in wage and hour class actions.

In the article, “Legislative Proposals Could Inflate Wage and Hour Class Actions,” SHRM reported on the concern expressed by Michael Kun, a Member of the Firm in the Labor and Employment practice in the Los Angeles office, about a proposal before the new Congress to make Fair Labor Standards Act (FLSA) class actions opt out has received peculiarly “scant attention in discussions of pending legislation.”

Proposed legislation that would call for “opt-out” class actions under the FLSA includes the Paycheck Fairness Act and the Civil Rights Act of 2008.

“This seemingly little change could quintuple real damages” under the FLSA and result in even more wage and hour class actions, Kun said.