North America

Federal Appellate Courts Ring In the New Year by Taking Up Website and Mobile Application Accessibility 

As expected given the extreme volume of website accessibility lawsuits filed over the last few years, in the first few weeks of the new year, United States’ Circuit courts have finally begun to weigh in on the law as it pertains to the accessibility of websites and mobile applications, and the results are generally disappointing for businesses.

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FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices

On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability… [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1]

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California’s Governor Proposes the Most Generous Parental Leave in the Country

On January 10, 2019, newly elected California Governor Gavin Newsom proposed funding six months of partial-paid leave for new parents. The plan, which was announced as part of the governor’s budget, would compensate new parents or caretakers up to 70 percent of their wages to care and bond with a newborn or adopted baby. Newsom stated that “public health and economic research shows that providing up to six months of paid parental leave leads to positive health and educational outcomes for children, greater economic security for parents, and less strain on finding and affording infant child care.”

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New York State Renews its Efforts to Regulate Employee Scheduling

The New York State Department of Labor (“DOL”) recently issued proposed statewide regulations that would require employers to pay employees “call-in pay” when employers use “on call” scheduling or change employees’ work shifts on short notice. This is not the DOL’s first foray into this area – in November 2017, the DOL released similar proposed regulations but ultimately declined to adopt them. The DOL’s new set of proposed regulations would apply to the vast majority of employers operating in New York, but are of particular interest to New York City retail employers, who regularly use “on call” scheduling, and who are already subject to the New York City Fair Workweek laws.

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Effective Management of Cybersecurity Risk in Transactional Due Diligence

According to a report by West Monroe Partners, Approximately 40% of companies engaged in corporate transactions reported finding a cybersecurity issue during post-acquisition integration of the target company.  While companies routinely conduct robust transactional due diligence to manage legal risk, many fail to adequately conduct cybersecurity due diligence. As a consequence, many companies and investors are leaving themselves vulnerable to potentially severe latent cyber risks.

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Epstein Becker Green Maintains Its ISO 27001 Certification for 2nd Year, the Highest Accreditation for Information Protection and Security

Epstein Becker Green (EBG) is pleased to announce that, for the second year, it has attained ISO 27001 certification in Information Security Management.

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How the California Consumer Privacy Act of 2018 could impact your business

Has the European Union’s latest data privacy regulation, the General Data Protection Regulation (GDPR), come to the United States? All U.S. businesses that ignored the GDPR, or made a determination that the GDPR did not apply to their operations, should now take special note of the requirements imposed by the California Consumer Privacy Act of 2018.

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Kirk A. Damman Named among Small Business Monthly‘s Best Patent Attorneys in St. Louis

Lewis Rice is proud to announce that Kirk A. Damman was named in Small Business Monthly‘s (SBM‘s) Best Patent Attorneys in St. Louis. Kirk has been included in this list every year since 2016. The honorees are selected based on insights and feedback from SBM’s readers. SBM acts as a resource to the St. Louis business community to understand and connect with the best service providers in the area. St. Louis SBM is a locally owned business publication, bringing business tips, strategies, and analysis to top executives of 17,000 businesses in the St. Louis metropolitan area.

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FDA’s New Year Resolution: Breakthrough Barriers and STeP Up Device Innovation

On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for advancement of the Safer Technologies Program (“STeP”).  In the announcement, FDA Commissioner Scott Gottlieb emphasized the FDA’s efforts to promote innovation in medical devices that advance patient safety. This new medical device guidance could signal a year of opportunity for innovative medical device manufacturers that seek to advance patient safety.

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Do You Need To Threaten Litigation To Trigger Declaratory Judgment Subject Matter Jurisdiction?

Erbaviva, LLC, a California LLC, sent a demand letter to Era Organics, a Florida company.  The letter identified a number of Erbaviva federal trademark registrations, and “request[ed]” Era Organics:

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