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HTMLBeware of Citizen Suits for Storm Water Violations
Albert M. Cohen; Loeb & Loeb LLP;
Legal Alert/Article
February 26, 2015, previously published on February 2015
In recent months several private organizations have sent letters to California businesses informing them that they are in violation of their storm water permits and threatening to sue them under the citizen suit provision of the Clean Water Act, which authorizes private parties to enforce...

 

HTMLPanoramic Stock Images, Ltd v. Mcgraw-Hill Global Education Loldings, LLC
Tal Dickstein, W. Allan Edmiston, David A. Grossman, Jonathan Neil Strauss, Jonathan Zavin; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 25, 2014
District court denies textbook publisher McGraw-Hill’s motion for summary judgment on its statute of limitations defense to stock photography agency’s copyright infringement claims, holding that “discovery rule” is still law of the Seventh Circuit even after Supreme Court...

 

HTMLFDA Proposes Three Studies on Direct-To-Consumer Prescription Drug Ads in a Bid to Better Understand the Impact of Ad Exposure Frequency, Spousal Influence and Risk Understanding
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The agency announced three proposed studies on how people view direct-to-consumer advertising, as it continues to assess factors that influence assessments of risks and benefits in a bid to ensure its regulations adequately protect public health.

 

HTMLOffice of Inspector General’s 2015 Work Plan Shows Agency Will Examine Medical Device Security, FDA’s Regulation
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The Department of Health and Human Services’ watchdog agency released a 2015 work plan that calls for federal auditors to assess medical device cybersecurity amid intensifying scrutiny in the area, as well as areas that may be in need of some revamping by the FDA.

 

HTMLMil-Spec Monkey, Inc. v. Activision Blizzard, Inc.
Tal Dickstein, W. Allan Edmiston, David A. Grossman, Jonathan Neil Strauss, Jonathan Zavin; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 24, 2014
District court grants summary judgment in favor of publisher of military-action video game Call of Duty: Ghosts on trademark infringement claims brought by military supply and outfitting company, finding that inclusion of plaintiff's trademarked "angry monkey" military patch in video game...

 

HTMLBeastie Boys v. Monster Energy Company
Tal Dickstein, W. Allan Edmiston, David A. Grossman, Jonathan Neil Strauss, Jonathan Zavin; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on December 4, 2014
Following jury verdict in favor of Beastie Boys on copyright infringement and Lanham Act claims, district court denies defendant Monster Energy Company’s motions for judgment as matter of law, for new trial, and for reduction in damages, finding that trial evidence supported jury’s...

 

HTMLThe Department of Health and Human Services Proposes Tougher Reporting Rules in a Bid to Increase Clinical Trial Transparency
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The DHHS is seeking to expand the scope of information on clinical trials that must be submitted to the NIH’s online data set of experiments in the midst of ongoing concerns that too many trial results are withheld.

 

HTMLIn An Unusual Move, The FDA Takes Issue With The Accuracy Of Sciecure’s Studies In A Warning Letter Over Sales Promotion Material For The Company’s Sleeping Pill
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
In addition to criticizing the pharmaceutical company for leaving out risk information from its sales materials and making unsupported superiority claims, the regulator unusually disputed the accuracy of the sources Sciecure used to bolster its assertions.

 

HTMLWhat Will 2015 Look Like? Trends in the Securities Industry
Loeb Loeb LLP;
Legal Alert/Article
February 20, 2015, previously published on January 2015
While it's still only January (at least for a few more days) and people are still greeting each other with "Happy New Year," it's never too early to look into the future to see how the year might unfold in the securities industry. Here are some trends and predictions for early 2015:

 

HTMLFDA Draft Guidance Provides Framework for the Classification and Approval of Medical Device Accessories
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 20, 2015, previously published on January 2015
A new CDRH draft guidance helps disambiguate the regulation of device accessories by outlining intended application of classification policies and automatic Class III designation.

 


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