North America

Drug and Pharmacy Alert: Florida pharmacy compounders beware: New dispensing requirements for physician in-office use

Florida compounding pharmacies should be aware the DEA’s Five Percent Rule for in-office use does not apply in Florida and that they must comply with more-stringent restrictions of Florida law.

What is “wholesale distribution”?

Generally, “wholesale distribution” is the provision of a drug product (whether commercially available or not) to an individual who is not the ultimate user. For example, providing a compounded product for resale to third parties could be construed as a form of wholesale distribution. Another form of wholesale distribution is providing a prescription drug to physicians for so-called “in-office use.” It is well settled that pharmacies are permitted to legally dispense prescription medication pursuant to a prescriber’s valid prescription for a specific and identifiable patient. “In-office use” involves distributing a product to a physician office without a presently identifiable patient, but for the physician to use when treating future patients. A third and more remote situation of wholesale distribution might be dispensing samples of compounded products to healthcare providers.

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DAVIS MALM ATTORNEYS NAMED TO BEST LAWYERS IN AMERICA© FOR 2014

August 21, 2013 – Boston, MA
For more information contact: Joanne Thorud
(617) 589-3896; jthorud@davismalm.com

Davis Malm is pleased to announce that four of its shareholders have been selected by their peers for inclusion in The Best Lawyers in America© 2014 (copyright 2013 by Woodward/White, Inc., Aiden, SC). Best Lawyers® is considered among many as the oldest and most respected peer-review publication in the legal profession.

We congratulate the following shareholders chosen for work in their respective fields:Paul L. Feldman - Environmental Litigation and Real Estate Law
Tamsin R. Kaplan - Litigation-Labor & Employment
C. Michael Malm - Corporate Law
Michael D. Weisman - Personal Injury Litigation-Plaintiffs More…

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DIGITAL ADVERTISING ALLIANCE OFFERS NEW PRIVACY GUIDANCE FOR MOBILE ENVIRONMENT

The core provisions of the Digital Advertising Alliance (DAA) new guidance are not yet in effect and will not be enforced while the mobile industry works on implementation issues, but the “implementation phase” has begun.

BACKGROUND

The DAA has issued new guidance explaining how its Self-Regulatory Principles for Online Behavioral Advertising (OBA Principles) and Multi-Site Data (MSD Principles) (together, the Self-Regulatory Principles) apply to certain types of data in the mobile environment. The DAA said that the new guidance clarifies that

its previously-issued Self-Regulatory Principles apply to the mobile environment as well. The themes from the OBA Principles of transparency, consumer control, sensitive data, data security and accountability are all part of the new guidance. More…

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"Dog Ate My Emails" No Defense Against Spoliation Sanction

On a motion for spoliation sanctions, it makes no difference that a party destroyed emails without “malevolent” purpose. For a sanctions motion to be granted, it is necessary only to demonstrate that the evidence was destroyed deliberately.

In an article, August 19, 2013, titled “Sanctions Imposed for Non-Malevolent Destruction of Emails,” the New York Law Journal  reported on a decision handed down by the Hon. Shira Scheindlin in the Southern District of New York on August 15, 2013 in Sekisui Medical America v. Hart, 1:12-cv-03479, 2013 U.S. Dist. LEXIS 115533 (S.D.N.Y. 2013).

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Mark Spognardi authors article on recent Illinois medical marijuana law

Arnstein & Lehr

Mark Spognardi

Arnstein & Lehr Chicago Partner Mark A. Spognardi authored an article titled, “Labor: Medical marijuana law comes to Illinois, employers prepare to deal with workplace issues concerning the Act” that was published on Inside Counsel’s website on August 19. In this article, Mr. Spognardi outlines the parameters of the newly passed Compassionate Use of Medical Cannabis Pilot Program Act. He then goes on to explain how this new law will affect employers in the workplace.

To read the article in full, please click here.

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Once again, RSS wins its case !

In an important case argued by Mes Patrick Henry and Catherine Du Pont (“Société immobilière du Québec et CSSSTR c. Hervé Pomerleau inc. et al“) for nearly three months in Quebec City, and after 18 months of deliberation, Superior Court Justice Danielle Blondin dismissed, for all practical purposes, two recourses taken against RSS’ client claiming nearly $ 20 million, including interest and costs. The judge accepted the arguments presented by Mes Henry and Du Pont and their client was held not responsibile, 100% responsibility being attributed to a co-defendant represented by other lawyers. This is an important victory, not just because of the large amount at stake, but also because of the lengthy trial. This result shows the strength and experience of the RSS litigation team.

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Robert E. McKenzie writes blog post for Forbes website

Arnstein & Lehr

Robert E. McKenzie

Arnstein & Lehr Chicago Partner Robert E. McKenzie recently wrote a blog post for Forbes’ website titled, “Darrell Issa, This Generation’s Joe McCarthy,” which was published on August 16. Mr. McKenzie discusses his thoughts on recent comments Lois Lerner of the IRS Tax-Exempt and Government Entities Division made at a May ABA Tax Section meeting. Her comments about the IRS and tax exemption status of social welfare groups sparked the attention of Darrell Issa, chairman of the House subcommittee on Oversight and Government Reform.

To read the post in full, please click here.

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Second Circuit Holds That Participation In FLSA Collective Actions Can Be Waived In Favor Of Individual Arbitration

by John F. Fullerton III

The U.S. Court of Appeals for the Second Circuit recently took a significant step toward bringing uniformity to the law of class and collective action waivers under the Fair Labor Standards Act (FLSA).

In Sutherland v. Ernst & Young LLP, the court held that employees can be contractually compelled to arbitrate their claims on an individual basis, and thereby waive their right to participate in a FLSA collective action. The decision is another in a series of cases that have required employees to arbitrate employment-related claims on an individual basis when they have clearly agreed to do so.

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Me Andrea Sterling recognized as one of the women who is changing the face of world shipping

To view the article “Women changing the face of world shipping” in Maritime Magazine, click here.

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Me Philippe-André Tessier, nommé par le Conseil des ministres du Québec

Congratulations to Me Philippe-André Tessier who has been named by the “Conseil des ministres du Québec” on July 23rd, 2013, to the Board of Directors of the “Société québécoise d’information juridique” (SOQUIJ).

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