On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations.  For the near term, FDA reports that it will continue to prioritize critical inspections of both domestic and foreign facilities, including preapproval inspections for priority products and inspections in reaction to recalls or other safety issues.  For the long term, the agency likely will employ the remote monitoring strategies it has implemented during the pandemic and expand its remote…
In Ford v. TD Ameritrade Holding Corp., 2021 U.S. App. LEXIS 12008 (8th Cir. Apr. 23, 2021), the United States Court of Appeals for the Eighth Circuit reversed a district court’s order certifying a class of customers who had used the defendant’s brokerage services to trade securities and were allegedly injured by defendant’s undisclosed “order routing practices.”  The Eighth Circuit determined that plaintiff’s expert’s proposed algorithm could not overcome the complex, trade-by-trade inquiry needed to adjudicate each class member’s economic loss, and so failed to satisfy Federal Rule of Civil Procedure 23(b)(3)’s requirement that common issues of law…
In Ford v. TD Ameritrade Holding Corp., 2021 U.S. App. LEXIS 12008 (8th Cir. Apr. 23, 2021), the United States Court of Appeals for the Eighth Circuit reversed a district court’s order certifying a class of customers who had used the defendant’s brokerage services to trade securities and were allegedly injured by defendant’s undisclosed “order routing practices.”  The Eighth Circuit determined that plaintiff’s expert’s proposed algorithm could not overcome the complex, trade-by-trade inquiry needed to adjudicate each class member’s economic loss, and so failed to satisfy Federal Rule of Civil Procedure 23(b)(3)’s requirement that common issues of law…
Providing business teams with advice for sending text messages can be nothing short of frustrating. For businesses used to sending email marketing, the laws for texting are unexpected. Unlike the CAN-SPAM Act, TCPA requires prior express written consent if autodialed messages are sent that contain advertising content. And unlike CAN-SPAM, TCPA has a private right of action. On its face, the recent Supreme Court decision in Facebook, Inc. v. Duguid seemed to bring good news. The decision suggests that companies may be able to send, in several circumstances, automated texts to databases of current customers without running afoul of TCPA.…
When trade secret lawyers advise executives transitioning to a job with a competitor, they typically tell them to “take nothing with you” on the way out – meaning that no confidential, proprietary or trade secret information should be retained or transferred to their new employer – lest they be accused of misappropriating trade secrets.  For good measure, lawyers also typically remind their clients to be especially careful about information maintained electronically, since the rules apply to electronic as well as hard copy information.  A recent decision from the Southern District of New York serves as a useful reminder that these…
Montana Makes Telehealth Expansion Permanent On April 19, 2021, Montana Governor, Greg Gianforte, signed House Bill 43 (“HB43” or the “Bill”) into law. The Bill, which is effective on January 1, 2022, expands access to telehealth services in Montana that was originally extended because of the public health emergency (the “Pandemic”).  HB43 continues in a long line of legislation across the country that have made permanent changes to telehealth exceptions implemented at the height of the Pandemic. The Bill permanently lifts telehealth limitations that were paused during the Pandemic, like requiring an established patient-provider relationship in order to enable a…
Texas Makes Significant Strides to Expand Telehealth On April 14, 2021, the Texas House passed House Bill 4 (the “Bill” or “HB4”), a telehealth bill seeking to make permanent the temporary waivers issued during the public health emergency (the “Pandemic”) to expand telemedicine. The Bill, sponsored by State Rep. Walter Thomas Price, IV, is intended to provide expansive coverage to Texas citizens and address the technology gaps that exist in more rural communities by incorporating audio-only services into the scope of the telehealth exceptions in the state. The Bill follows the trend of recent legislation across the country by expanding…
On March 31, 2021, New York Governor Andrew Cuomo signed the Marihuana Regulation and Taxation Act (the “MRTA”) into law, making New York the latest state to legalize recreational marijuana.  The MRTA allows adults aged 21 and older to possess, purchase, display, obtain, and transport marijuana in limited quantities.  The MRTA takes effect immediately, although the sale of recreational-use marijuana is not expected to become legal for at least another year.  The legalization of marijuana will have significant effects on many aspects of society in New York, including in the workplace. Even before the MRTA was signed into law, New…
On Monday, May 3, 2021, the New York City Planning Commission (CPC) “referred” the Department of City Planning’s (DCP) proposed zoning text that would mandate a Special Permit for all new hotels in New York City, beginning the City’s public review process for approval of the proposed text.  This proposed Hotel Special Permit will be applicable to all new hotel developments, changes of use, conversions or enlargements to a hotel use in a building that did not previously contain a hotel use, or an enlargement of an existing hotel use that increases the existing floor area by 20% or more. …
The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944) aimed to reduce dependence on foreign drugs and devices critical to the U.S. public health sector, in part by requiring that the U.S. Trade Representative remove those essential items from the coverage of any international free trade agreement. On April 20, 2021, the Biden Administration withdrew just…
The Biden Administration used the annual rulemaking that governs health plans sold on the Affordable Care Act’s exchanges to lower health care costs for consumers and improve access to health care. Part 2 of the Notice of Benefit and Payment Parameters for 2022 Final Rule (the Payment Notice), issued April 30, 2021, is the second in a series of rulemakings addressing exchange plans.[1]  The Department of Health and Human Services (HHS) anticipates additional rulemakings on the 2022 Payment Notice later this year.[2] The rulemaking announced changes to out-of-pocket costs, special enrollment periods, risk adjustment, and HHS’s audit…
Last week, the Biden Administration through the Department of Energy, took actions regarding Executive Order 13920  (the “Bulk Power Order”).  Such actions effectively established a clean slate for how the Biden Administration will implement the Trump-Era order.  This article summarizes the timeline of the Bulk Power Order since its issuance last year, including the actions taken by the Biden Administration last week, and the Biden Administration’s initiatives going forward. Timeline On May 1, 2020, former President Trump issued the Bulk Power Order, which prohibited certain transactions involving bulk-power system electric equipment manufactured or supplied by persons owned by, controlled by,…
On April 29, 2021 Governor Newsom signed California A.B. 80, largely conforming to Federal rules relating to deductibility of expenses paid with funds from forgiven Paycheck Protection Program (PPP) loans.  The $150,000 limitation in prior versions of A.B. 80 was removed, and replaced with a requirement that only non-publicly traded companies who reported losses of at least 25% in gross receipts during one quarter of 2020 can deduct such expenses.  That 25% decrease in gross receipts was also a condition for receiving a PPP loan in the second round of loans made available in late 2020.  Publicly traded companies cannot…
On March 31, 2021, New York Governor Andrew Cuomo signed the Marihuana Regulation and Taxation Act (the “MRTA”) into law, making New York the latest state to legalize recreational marijuana.  The MRTA allows adults aged 21 and older to possess, purchase, display, obtain, and transport marijuana in limited quantities.  The MRTA takes effect immediately, although the sale of recreational-use marijuana is not expected to become legal for at least another year.  The legalization of marijuana will have significant effects on many aspects of society in New York, including in the workplace.…
The Dutch Data Protection Authority recently imposed a €475,000 fine ($558,000) against the hotel website Booking.com for waiting longer than 72 hours to report a data breach. According to the Dutch DPA press release, Booking.com learned of the breach on January 13, 2019 and reported it to the DPA on February 7, 2019. The DPA did not make it clear in that release whether Booking.com had, in fact, determined on January 13, 2019 that a security breach impacting personal information of Dutch citizens had occurred or whether January 13, 2019 was date that Booking.com was first alerted to suspicious activity.…
As of this week, Apple’s requirements for apps to follow its AppTrackingTransparency are now in effect. These requirements went hand-in-hand with the iOS 14.5 launch, and impacts how an app can track users and access their advertising device IDs. In particular, consumer consent is now required if the app collects consumer information and shares it with others “for purposes of tracking across apps and web sites.” Apple has provided developers with specific implementation steps, which will be reviewed when apps are submitted to Apple for approval. As part of the submission, companies need to explain why they want to…