On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and well-being of its staff and those who conduct the inspections for the agency under contract at the state level, and due to industry concerns regarding visitors. During this interim period, the FDA conducted only a limited number of mission critical inspections using a risk-based approach. On July 10, 2020, FDA announced its plans to resume on-site inspections during the week of July 20th with the assistance of a newly developed COVID-19 Advisory Rating System for assessing the risk of carrying out an inspection in a particular location.
Monthly Archives: July 2020
FDA to Resume Domestic Inspections with New Safety Measures after Temporary Pause Due to COVID-19 Health and Safety Concerns
As summer kicks into high gear, and the Americans with Disabilities Act’s 30th anniversary looms large at the end of this month, businesses in many jurisdictions are in the process of gradually reopening to the public.
And if the long and difficult spring wasn’t trying enough, businesses now face yet another challenge — balancing maintaining the safety of employees and patrons against complying with Title III of the ADA, and applicable state and local laws, which can significantly vary depending on the jurisdiction.
The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements, FDA has signaled its intent to create a lawful marketing pathway for these products. Also, while FDA has issued Warning Letters to companies who made egregious claims about their products curing serious diseases and conditions like Alzheimer’s disease and cancer, FDA has also signaled a willingness to exercise enforcement discretion over CBD products that pose less serious safety concerns. What has resulted is CBD manufacturers, retailers, and other businesses living in FDA regulatory purgatory. Fortunately, several courts have recently held that CBD companies will not face consumer product liability, at least while their FDA regulatory fate is being decided.
We were delighted to advise our client Ellab A/S, supported by EQT Partners, on their recent strategic acquisition of Instrument Technology Limited and, subsequently, Qualus in Ireland. These acquisitions form part of Ellab’s expansion in qualification and validation services in Ireland.
In its 2020 guide, Chambers High Net Worth ranked Connolly Gallagher LLP for Private Wealth Law in Delaware. Sources report the Trusts & Estates team “has wonderful depth and people.” As well as, “Connolly Gallagher’s service is always extremely timely, professional, and we receive fantastic value for the price involved.”
New Maryland Law Requires Applicant Consent Prior to Using Facial Recognition Technology in Job Interviews
In a recent Bloomberg Law article, we reported on legislative developments regulating the use of artificial intelligence (“AI”) in employment law decisions. On May 11, 2020, one of the pieces of proposed legislation we discussed, Maryland’s H.B. 1202, became law without Governor Larry Hogan’s signature. As we reported, H.B. 1202 prohibits employers from using facial recognition technology during pre-employment job interviews without the applicant’s consent. To use facial recognition services in interviewing employees, an employer must obtain an applicant’s written consent and waiver that states the applicant’s name, the date of the interview, that the applicant consents to the use of facial recognition during the interview and that the applicant has read the waiver. Although the law defines terms such as “facial template” and “facial recognition services,” the terms provide little guidance and leave broad gaps for interpretation.
In this week’s Rainmaking Recommendation, trainer and expert Jaimie Field talks about the importance of having a plan – and changing that plan.
In part one of this series, I wrote that to finish 2020 strong, you will need to adjust your mindset from all of the anxiety and stress that this year has initiated. In other words, you need to change your mind.
Joe Mittag is a partner with OMF Otto Mittag & Partner, a law firm in Germany and a member of the International Lawyers Network. In this episode, Lindsay and Joe talk about how Germany’s handling of the pandemic has allowed them to open up after a three-week quarantine, considering clients as part of your firm’s team, and a theme for many of our firms, the importance of communication.
THE SUPREME COURT CONFIRMED THAT RUSSIAN USERS MAY FILE A LAWSUIT AGAINST AN AMERICAN SOCIAL NETWORK TO A RUSSIAN COURT
The Supreme Court of the Russian Federation reviewed a case initiated by a number of Internet users against the American social network Facebook Inc.
The Russian users filed a lawsuit against Facebook Inc. based on the Terms of Service violations. Moreover, the users also motivated their lawsuit by illegal use of their personal data.
A Double First: Jurisprudence on YouTube and First Dismissal of a Claim for Business Interruption Following the Coronavirus
By Chantal Noël, from our Insurance Law Practice Group
July 8, 2020 — On July 1, Michigan Circuit Court Judge Joyce Draganchuk heard a motion by teleconference via Zoom. However, the hearing and the summary judgment rendered on the bench were broadcast live on YouTube on behalf of Judge Draganchuk. It is therefore a first and it will be interesting to see if our Quebec Courts will admit the video format, the recording of which is still available on YouTube, to plead precedents.
In this case (Gavrilides Management Co. v. Michigan Insurance Co., j. Joyce Draganchuk, July 1, 2020, Mason, 30th Circuit, Michigan, USA, https://youtu.be/Dsy4pA5NoPw), the insured, owner of two restaurants, claimed from its insurer the loss of business interruption since it had to close the restaurants following the orders of the authorities in the context of the pandemic linked to the coronavirus. The insurer brought a motion to dismiss this claim for which this judgment was rendered. It claimed that there was no direct physical damage as required by the terms of the insurance cover, namely that there would be coverage if the commercial activities were suspended but only if the suspension was caused by physical damage to the insured property. Finally, the insurer argued in the alternative that the virus exclusion applied.