North America

FDA Accepting Comments On A Proposed Rule For Direct-To-Consumer ("DTC") Advertisements

On March 29, 2010, the U.S. Food and Drug Administration (“FDA“) published a proposed rule titled Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (“Proposed Rule“).[i] The Proposed Rule would require direct-to-consumer (“DTC“) television and radio advertisements to present the mandated “Major Statement” for major side effects and contraindications “in a clear, conspicuous, and neutral manner.” The FDA is accepting written comments on the Proposed Rule until June 28, 2010.

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Welcome to the Whistleblowing & Compliance Law Blog

This blog is dedicated to the many facets of whistleblowing and the tensions and contradictions that inhere in defining compliance objectives and the permissible means by which they will be attained and preserved. At its core, whistleblowing should be about corporate compliance and the common institutional and individual purpose of assuring that internal and external standards of conduct are respected. Reality may draw a another picture, perceived differently from the perspective of the individual and the institution – and by public opinion, media comment, markets, administrative, regulatory, enforcement or legislative bodies or by courts and juries.

Is the whistleblower a selfless altruist properly advancing compliance objectives or an individual bent on undeserved personal advantage by way of protection or windfall gain?

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HEALTH REFORM: Changes to the Federal Physician Self-Referral Law Included in the Patient Protection and Affordable Care Act

Narrowing the Ability of Physicians to Own an Interest in a Hospital

In 2003, Congress modified the federal physician self-referral law (commonly referred to as the “Stark Law”) and adopted an 18-month moratorium on the ability of physicians to own an interest in a specialty hospital.[1] Although the moratorium officially lapsed in June 2005, over the last several years, Congress has continued to monitor and debate the issue of whether this exception to the Stark Law should be modified.

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HEALTH REFORM: Health Care Reform: What Employers Need to Know

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“Act”), which provides for significant changes in the delivery of health care. The Health Care and Education Reconciliation Act of 2010 (“Reconciliation Bill”), which reconciles and amends certain provisions of the Act, was signed into law by President Obama on March 30, 2010. The following is a high-level summary that identifies some of the key provisions of the Act, as amended by the Reconciliation Bill. 

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DAVIS MALM ATTORNEYS WILLIAM F. GRIFFIN, JR. AND SOPHIE C. MIGLIAZZO SERVE AS FACULTY MEMBERS AT MCLE SEMINAR ON NEGOTIATING AND DRAFTING ACQUISITION AGREEMENTS

April 07, 2010 – Boston, MA
For more information contact: Jeanie Griggs
(617) 589-3895; jgriggs@davismalm.com

On Tuesday, April 6, Davis Malm attorneys William F. Griffin, Jr. and Sophie C. Migliazzo served as Faculty Members in a Massachusetts Continuing Legal Education seminar, “A Practical Guide to Business Acquisition Agreements.” This seminar provided an overview of the business acquisition process and is designed for attorneys seeking to improve their practical skills in drafting, negotiating, and closing business acquisition agreements. Mr. Griffin served as chair of the seminar and shared knowledge from his years of experience representing business clients in a variety of business acquisitions. He described the business acquisition process from inception (the seller’s decision to put the company up for sale) to closing the deal, emphasizing practical negotiating strategies. Ms. Migliazzo served as a faculty member and discussed trends in specific provisions of acquisition agreements, such as caps, baskets, material adverse change clauses, and various representations and warranties.

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DAVIS MALM ATTORNEY REBECCA ANDREWS PARTICIPATES IN WOMEN’S BAR ASSOCIATION LAW STUDENT COMMITTEE’S ANNUAL EVENT "WHAT THEY DIDN’T TEACH YOU IN LAW SCHOOL"

April 07, 2010 – Boston, MA
For more information contact: Jeanie Griggs
(617) 589-3895; jgriggs@davismalm.com

On April 6, Davis Malm attorney Rebecca L. Andrews participated in the Women’s Bar Association Law Student Committee’s annual event, “What They Didn’t Teach You in Law School.” The event featured a variety of current practicing female attorneys – including judges, mediators, government attorneys, solo practitioners, and private practice attorneys – discussing their choice of career paths and their diverse experiences. The program was structured in a speed-networking format, allowing students helpful one-on-one time with the practicing attorneys. As in past years, the event provided the students with invaluable insight into the “ins and outs” of certain career paths and the actuality of practicing law day-to-day. Ms. Andrews focussed her discussions on her experiences as a litigator and practicing law at a private practice firm.

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U.S. Department of Labor Ramps Up Enforcement Efforts With We Can Help Campaign

On April 1, 2010, the U.S. Department of Labor (DOL) delivered on its promise to focus its agenda and resources on enforcement efforts, launching a new public awareness campaign called We Can Help.

The campaign is designed to educate workers about their rights under the federal Fair Labor Standards Act (FLSA), but its implications are more significant and far-reaching. According to the DOL’s Web site, the Wage and Hour Division is targeting workers’ rights and pay issues—and it is doing so regardless of their immigration status, reaching out to employees who are traditionally among the lowest paid, including non-citizens and/or undocumented workers. The Webs site directs workers how to file a complaint with the Wage and Hour Division, and it encourages them to provide information to the Division, including copies of pay stubs, hours of work and any information related to the employer’s pay practices.

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NJ Supreme Court Restricts Employer’s Ability To Review Employee’s Communications With Personal Attorney on Employer’s Computers

While many employers worry that some court decisions will add “insult to injury,” New Jersey employers must now be aware of Stengart v. Loving Care Agency Inc., — A.2d –, — N.J. — (2010), decided March 30, 2010, which presages adding “injury to injury.” That is because it first injures employers’ interests by stating that an employer cannot write an enforceable policy that “ban[s] all personal computer use and provide[s] unambiguous notice that an employer could retrieve and read” all emails that an employee wrote through a personal email account using an employer’s computer. Slip op. at 28. InStengart, this meant that an employee’s communications with personal counsel concerning matters adverse to the company may occur during work time using the employer’s resources. And if that were not injury enough to the employer’s interests in having employees actually work on company business while at the office using the company’s resources, the Stengart Court then went on to add another possible injury—on remand, the trial court should consider disqualifying the company’s counsel for not immediately upon finding such communications on the employer’s computer returning to the departed employee (or her counsel) all copies of such communications. The Stengartdecision demands that employers, especially in New Jersey, not only revisit their written policies, but also that they consider how such policies are actually being applied and enforced. Decisions like Stengart can also directly impact on steps that have become part of best practices responses in trade secret and restrictive covenant cases involving departing employees, and which occur in all manner of employment situations.

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New York State Emergency Regulations Modify NY Employers’ WARN Responsibilities

With very little fanfare, the New York State Department of Labor (the “Department”) recently filed a Notice of Emergency Adoption and Proposed Rule Making (the “Emergency Regulations”) that significantly amends the existing regulations to the New York State Worker Adjustment and Retraining Notification Act (the “NYS WARN Act” or the “Act”). The Emergency Regulations became effective on February 12, 2010. For additional information about the Emergency Regulations, visit the Department’s Web site at http://www.labor.ny.gov/workforcenypartners/warn/warnportal.shtm.

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HEALTH REFORM: Health Care Reform: Tax Provisions Affecting Large Employers

The Patient Protection and Affordable Care Act (the “Act“) was signed into law by President Obama on March 23, 2010. The Health Care and Education Reconciliation Act of 2010 (the “Reconciliation Bill“), which reconciles and amends certain provisions of the Act, was signed into law by President Obama on March 30, 2010. The tax provisions in the Act, as amended by the Reconciliation Bill, will significantly impact how large employers structure their health benefits. At a minimum, employers will be subject to new administrative obligations relating to their employee health benefits. Given that some of the more significant provisions will not become effective for a number of years, employers will have time to become familiar with and plan accordingly for such new demands. The tax-related provisions of the Act that affect large companies and employers include:

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