LexBlog https://www.lexblog.com/ Legal news and opinions that matter Sat, 01 Jun 2024 02:12:34 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.3 https://www.lexblog.com/wp-content/uploads/2021/07/cropped-siteicon-32x32.png LexBlog https://www.lexblog.com/ 32 32 10 Creative Ways for Lawyers to Repurpose Content https://www.lexblog.com/2024/05/31/10-creative-ways-for-lawyers-to-repurpose-content/ Sat, 01 Jun 2024 00:33:21 +0000 https://www.lexblog.com/2024/05/31/10-creative-ways-for-lawyers-to-repurpose-content/ Repurposing content is a smart and effective strategy that lets lawyers get the most out of their marketing efforts. By tweaking and reusing your existing content, you can reach more people, enhance your visibility and showcase your expertise across different platforms. This strategy helps extend the lifespan of your valuable insights, keeps you visible online and connects with your audience in more effective ways.

In a world where grabbing and holding attention is harder than ever, repurposing content is an important and effective strategy.

Think about taking one well-researched piece, like a whitepaper and turning it into a series of blog posts. Each post can dive into a specific part of the topic, which you can then share on social media to spark conversations and drive traffic back to your site. You could also create an eye-catching infographic from the key points, which is perfect for platforms like LinkedIn and Instagram.

This approach not only saves you time but also helps maintain a steady online presence. Regularly updating and diversifying your content keeps your audience engaged and informed, building trust and credibility. It’s also great for SEO because new content with relevant keywords can improve your search engine rankings.

Another benefit to content repurposing is catering to different preferences. Some people love reading articles, while others might prefer watching videos or listening to podcasts. Offering your content in various formats means you can connect with a wider audience, no matter how they like to consume information.

Plus, repurposing content reinforces your status as a thought leader. By consistently sharing valuable insights on multiple channels, you establish yourself as an expert in your field. This attracts potential clients and helps build relationships with peers and influencers in the legal industry.

Repurposing content is an effective strategy that can significantly boost your law firm’s marketing efforts. It maximizes your reach, strengthens your online presence and showcases your expertise.

Why Repurposing Content Matters

Repurposing content is not just about recycling your old material; it’s about maximizing the value of your expertise and reaching your audience where they are most receptive. By repurposing content, lawyers can:

  • Extend the lifespan of their content, ensuring that valuable insights continue to resonate with audiences over time.
  • Reach new audiences across different platforms and formats, expanding their online presence and visibility.
  • Enhance engagement with their audience by catering to diverse preferences and consumption habits.
  • Establish themselves as thought leaders in their field, reinforcing their expertise and authority through consistent and valuable content dissemination.

Here are 10 Creative Ways Lawyers Can Repurpose Their Content

  1. Transform Blog Posts into Podcasts: How to do it: Record yourself reading your blog posts aloud or discussing key points. Edit the audio for clarity and quality, then publish it as a podcast episode using platforms like Spotify for Podcasters (formerly Anchor) or Libsyn.
  2. Create Infographics from Legal Insights: How to do it: Use graphic design tools like Canva or Adobe Spark to create visually appealing infographics. Condense key legal insights into bite-sized chunks and incorporate relevant images or icons to enhance understanding.
  3. Turn Webinars into Video Series: How to do it: Break down your webinar recordings into shorter segments focusing on specific topics. Edit the videos for consistency and upload them to platforms like YouTube or Vimeo as a series playlist.
  4. Compile Case Studies into E-books: How to do it: Gather your successful case studies and testimonials, organize them into a cohesive narrative and format them into an e-book using Microsoft Word, Canva or Adobe InDesign. Publish the e-book on your website or distribute it to your email list.
  5. Host Q&A Sessions on Social Media: How to do it: Announce a live Q&A session on your preferred social media platform, such as Instagram Live or LinkedIn Live. Encourage followers to submit their legal questions in advance and be prepared to answer them during the session.
  6. Republish Articles on LinkedIn: How to do it: Copy and paste your previously published articles into the LinkedIn publishing platform. Optimize the content for LinkedIn’s audience by adding relevant hashtags and engaging with comments and shares.
  7. Turn Legal Guides into Email Courses: How to do it: Break down your comprehensive legal guides into a series of email lessons. Set up an email marketing platform like Mailchimp or ConvertKit to automate the delivery of each lesson over a set period.
  8. Create Slide Decks for Speaking Engagements: How to do it: Extract key insights and visual elements from your presentations or webinars and organize them into slide decks using PowerPoint or Google Slides. Use the slides as visual aids during speaking engagements or share them as downloadable resources.
  9. Curate Content for Newsletters: How to do it: Compile relevant legal articles, case updates and industry news into a curated newsletter. Use email marketing software to create visually appealing newsletters and schedule regular distribution to your subscribers.
  10. Repurpose Testimonials into Social Proof: How to do it: Collect client testimonials and positive feedback from various sources, such as emails, reviews or social media comments. Showcase them prominently on your website, social media profiles, and marketing materials to build trust and credibility with potential clients.

It’s not easy to capture the attention of your audience and stand out from competitors, but an effective way to do so is by repurposing your content. Repurposing content offers lawyers a strategic advantage, enabling them to amplify their impact and achieve their marketing objectives more effectively.

The Social Media Butterfly
Oregon health officials ask public to fill out survey on shellfish in wake of poisoning outbreak https://www.lexblog.com/2024/05/31/oregon-health-officials-ask-public-to-fill-out-survey-on-shellfish-in-wake-of-poisoning-outbreak/ Fri, 31 May 2024 23:23:45 +0000 https://www.lexblog.com/2024/05/31/oregon-health-officials-ask-public-to-fill-out-survey-on-shellfish-in-wake-of-poisoning-outbreak/ State health officials are asking people who recently harvested or ate any shellfish from the Oregon Coast to complete a survey as part of an investigation of at least 20 illnesses linked to shellfish biotoxins.

On May 28, Oregon Health Authority (OHA) urged people to throw out mussels gathered from beaches between Seal Rock State Park north to the Washington border after cases of paralytic shellfish poisoning (PSP) were reported to the agency. The shellfish were harvested at beaches in Lincoln, Tillamook and Clatsop counties.

Among other symptoms, paralytic shellfish poisoning can paralyze respiratory muscles.

The health authority is now asking people who harvested or ate Oregon shellfish since May 13 to take a short survey to help investigators identify a possible cause of the outbreak and how many people became sick. Responses are secure and confidential, and will help OHA Public Health Division investigators learn more about the sources and size of this outbreak.

Those who already completed an interview with their local public health agency do not need to complete the survey.

Contact Rosalie Trevejo (rosalie.trevejo2@oha.oregon.gov) or June Bancroft (june.e.bancroft@oha.oregon.gov) of OHA’s Public Health Division with any questions or concerns about the survey.

On May 23, the Oregon Department of Fish and Wildlife (ODFW) and the Oregon Department of Agriculture (ODA) closed a stretch of Oregon Coast to mussel harvesting from Seal Rock State Park north to Cape Lookout due to high levels of PSP. The mussel harvest closure was extended from Seal Rock State Park north to the Washington border on May 26.

People who experience any symptoms of paralytic shellfish poisoning (PSP) – numbness of the mouth and lips, nausea, vomiting, diarrhea, weakness, and in severe cases, shortness of breath or irregular heartbeat – should immediately contact a health care provider. They can also get advice by calling the Oregon Poison Center at 800-222-1222.

PSP is a foodborne illness caused by saxitoxins produced by marine algae and caused by eating shellfish contaminated with the naturally occurring biotoxin, including scallops, mussels, clams, oysters and cockles, as well as some fish and crabs, according to the Centers for Disease Control and Prevention. There is no antidote for PSP – treatment involves supportive care and, if necessary, respiratory support.

(To sign up for a free subscription to Food Safety News,click here)

Food Safety News
Healthcare Minimum Wage Delayed Until July 1 https://www.lexblog.com/2024/05/31/healthcare-minimum-wage-delayed-until-july-1/ Fri, 31 May 2024 23:14:47 +0000 https://www.lexblog.com/2024/05/31/healthcare-minimum-wage-delayed-until-july-1/ On May 31, 2024, Governor Newsom signed Senate Bill (SB) 828, which delays the effective date of the healthcare minimum wage statute by one month.

Last October, Governor Newsom signed SB 525, which enacted a multi-tiered statewide minimum wage schedule for healthcare workers. However, in light of a significant budget shortfall, the Governor called for changes to the statute including a delay in the effective date.

Although the law was set to take effect June 1, the legislature only proposed a potential delay on May 20th, which was quickly moved through the legislature to the Governor.

Under SB 828, the initial effect date of June 1, is changed to July 1, 2024. And thereafter all increases would occur on July 1, instead of June 1.

The bill has an urgency clause and therefore takes effect immediately.

If you have questions about SB 828 or the health care minimum wage, contact a Jackson Lewis attorney to discuss.

California Workplace Law Blog
Report reveals inefficiencies in London magistrates’ courts https://www.lexblog.com/2024/05/31/report-reveals-inefficiencies-in-london-magistrates-courts/ Fri, 31 May 2024 19:12:25 +0000 https://www.lexblog.com/2024/05/31/report-reveals-inefficiencies-in-london-magistrates-courts/ Lawyers, especially prosecutors, were frequently unprepared due to high caseloads

Canadian Lawyer Mag
World Intellectual Property Organization approves landmark treaty on IP and genetic resources https://www.lexblog.com/2024/05/31/world-intellectual-property-organization-approves-landmark-treaty-on-ip-and-genetic-resources/ Fri, 31 May 2024 19:12:10 +0000 https://www.lexblog.com/2024/05/31/world-intellectual-property-organization-approves-landmark-treaty-on-ip-and-genetic-resources/ Patent applications based on genetic resources must now disclose the country of origin

Canadian Lawyer Mag
US judge orders DLA Piper to release internal records in pregnancy discrimination case https://www.lexblog.com/2024/05/31/us-judge-orders-dla-piper-to-release-internal-records-in-pregnancy-discrimination-case/ Fri, 31 May 2024 19:12:06 +0000 https://www.lexblog.com/2024/05/31/us-judge-orders-dla-piper-to-release-internal-records-in-pregnancy-discrimination-case/ A former senior associate claimed she was terminated shortly after requesting maternity leave

Canadian Lawyer Mag
Ontario Teachers’ sustainable investing head welcomes anti-ESG views https://www.lexblog.com/2024/05/31/ontario-teachers-sustainable-investing-head-welcomes-anti-esg-views/ Fri, 31 May 2024 19:12:01 +0000 https://www.lexblog.com/2024/05/31/ontario-teachers-sustainable-investing-head-welcomes-anti-esg-views/ Anna Murray offers up a surprising take on the US-led backlash

Canadian Lawyer Mag
Ontario Superior Court overturns arbitrator’s ruling, orders insurers to share liability equally https://www.lexblog.com/2024/05/31/ontario-superior-court-overturns-arbitrators-ruling-orders-insurers-to-share-liability-equally/ Fri, 31 May 2024 19:11:56 +0000 https://www.lexblog.com/2024/05/31/ontario-superior-court-overturns-arbitrators-ruling-orders-insurers-to-share-liability-equally/ Both insurers were equal in priority and must share legal responsibility: court

Canadian Lawyer Mag
Alberta Court of Appeal dismisses challenge to mobility order in family law case https://www.lexblog.com/2024/05/31/alberta-court-of-appeal-dismisses-challenge-to-mobility-order-in-family-law-case/ Fri, 31 May 2024 19:11:52 +0000 https://www.lexblog.com/2024/05/31/alberta-court-of-appeal-dismisses-challenge-to-mobility-order-in-family-law-case/ Man opposed an order allowing his ex-partner to relocate with their children to Nanaimo

Canadian Lawyer Mag
BC Supreme Court denies injunction against cap on disbursements in motor vehicle injury cases https://www.lexblog.com/2024/05/31/bc-supreme-court-denies-injunction-against-cap-on-disbursements-in-motor-vehicle-injury-cases/ Fri, 31 May 2024 19:11:47 +0000 https://www.lexblog.com/2024/05/31/bc-supreme-court-denies-injunction-against-cap-on-disbursements-in-motor-vehicle-injury-cases/ The regulation did not delay healthcare access but merely affected financial compensation: court

Canadian Lawyer Mag
Alberta court refuses psychiatrist’s plea to stay disciplinary proceedings pending judicial review https://www.lexblog.com/2024/05/31/alberta-court-refuses-psychiatrists-plea-to-stay-disciplinary-proceedings-pending-judicial-review/ Fri, 31 May 2024 19:11:41 +0000 https://www.lexblog.com/2024/05/31/alberta-court-refuses-psychiatrists-plea-to-stay-disciplinary-proceedings-pending-judicial-review/ The court cited the premature nature of the action and the lack of evidence for irreparable harm

Canadian Lawyer Mag
Federal Court certifies class action against Canadian Armed Forces for systemic negligence https://www.lexblog.com/2024/05/31/federal-court-certifies-class-action-against-canadian-armed-forces-for-systemic-negligence/ Fri, 31 May 2024 19:11:34 +0000 https://www.lexblog.com/2024/05/31/federal-court-certifies-class-action-against-canadian-armed-forces-for-systemic-negligence/ The action was initiated on behalf of CAF members with mental health disorders

Canadian Lawyer Mag
From small school to big city: UNB Law alumni forge strong network in Canada’s biggest legal market https://www.lexblog.com/2024/05/31/from-small-school-to-big-city-unb-law-alumni-forge-strong-network-in-canadas-biggest-legal-market/ Fri, 31 May 2024 19:11:28 +0000 https://www.lexblog.com/2024/05/31/from-small-school-to-big-city-unb-law-alumni-forge-strong-network-in-canadas-biggest-legal-market/ As a UNB graduate, I have seen the power of small-school camaraderie and support

Canadian Lawyer Mag
FDA issues safety alert for infant formula because of Cronobacter contamination https://www.lexblog.com/2024/05/31/fda-issues-safety-alert-for-infant-formula-because-of-cronobacter-contamination/ Fri, 31 May 2024 23:09:11 +0000 https://www.lexblog.com/2024/05/31/fda-issues-safety-alert-for-infant-formula-because-of-cronobacter-contamination/ The U.S. Food and Drug Administration is alerting parents and caregivers about Cronobacter safety concerns with Crecelac Infant Powdered Goat Milk Infant Formula and other infant formula products imported and distributed by Dairy Manufacturers Inc. 

Although the company initiated a recall of the products on May 24 because they were not in compliance with all of the FDA’s infant formula regulations, the FDA is now issuing this safety alert because of new findings of Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula. 

As part of its investigation into this matter, on May 29, 2024, the FDA found Cronobacter in a sample of Crecelac Infant Powdered Goat Milk Infant Formula collected from a retail store in Texas.

Separately, the FDA is also alerting parents and caregivers to a recall initiated by Dairy Manufacturers Inc. of the Farmalac products listed above because of their failure to meet U.S. infant formula regulations. The firm has not submitted the required premarket notification to the FDA to demonstrate the safety and nutritional adequacy of the infant formula. The FDA is continuing to work with the firm and its distributors to ensure the recall is effectively executed.

Cronobacter is a bacterium that can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively. Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death.

Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.

At this time, the FDA is not aware of any illnesses associated with these products and the FDA does not anticipate any impact on the supply of infant formula based on the recall of these products.

The FDA is issuing this advisory because infants that consume these products could be at risk of potentially severe infection because of the Cronobacter contamination. The FDA advises parents and caregivers not to feed these infant formula products to infants under their care. If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements, contact your health care provider to report their symptoms and receive immediate care.

If caregivers are looking for an alternative goat milk infant formula for sale in the U.S., they may wish to speak with their infant’s health care provider, as there are goat milk infant formulas that either have completed the required FDA premarket notification process or are currently being marketed under the FDA’s enforcement discretion policy.

(To sign up for a free subscription to Food Safety News,click here)

Food Safety News
Catch Back Up on the SECURE 2.0 Increased Catch-Up Limits for 2025 https://www.lexblog.com/2024/05/31/catch-back-up-on-the-secure-2-0-increased-catch-up-limits-for-2025/ Fri, 31 May 2024 19:03:27 +0000 https://www.lexblog.com/2024/05/31/catch-back-up-on-the-secure-2-0-increased-catch-up-limits-for-2025/ With SECURE 2.0’s increased catch-up contribution limits set to take effect next year, it’s time for 401(k) plan sponsors to brush up on the rules and consider how to administer the changes.

Under the current rules, 401(k) plans may allow participants to make catch-up contributions when they are age 50 or older.  For 2024, the catch-up contribution limit is $7.500.

SECURE 2.0 creates a window of increased catch-up contribution limits for participants ages 60–63.  Below are key things 401(k) plan sponsors should know about this change:

  1. Are the changes mandatory? Plan sponsors are not required to offer catch-up contributions.  However, further guidance is necessary to confirm whether the changes are mandatory for plans that choose to offer catch-up contributions.
  1. When do the changes take effect? The new limits take effect for tax years beginning after December 31, 2024.
  1. Which participants are eligible for the increased limit? Participants are eligible for the increased limits for the years in which they attain ages 60, 61, 62, and 63.
  1. What is the increased limit? The increased catch-up contribution limit for eligible participants is the greater of: (a) $10,000, subject to cost-of-living adjustments starting in 2026; or (b) 150% of the limit in effect for 2024 (i.e., $11,250).

While the change seems straight forward, administration may be complex. For example, plan sponsors should consider how to track eligibility for the increased limits, in addition to tracking eligibility for regular catch-up contributions, and how to re-impose the lower catch-up contribution limits when participants age out of the higher limits.  Employers may need to work with their payroll teams and update their existing processes (e.g., payroll codes) to implement these changes.

Finally, keep in mind that the increased catch-up contribution limits are separate from the SECURE 2.0 Roth catch-up rule for certain high-earning individuals, which the IRS delayed to 2026. For information about the Roth catch-up contribution rule, see our Employee Benefits Blog, “IRS Delays Roth Catch-Up Contribution Requirement.”

SW Benefits Blog
Colorado Privacy Act Amended To Include Biometric Data Provisions https://www.lexblog.com/2024/05/31/colorado-privacy-act-amended-to-include-biometric-data-provisions/ Fri, 31 May 2024 22:54:32 +0000 https://www.lexblog.com/2024/05/31/colorado-privacy-act-amended-to-include-biometric-data-provisions/ On May 31, 2024, Colorado Governor Jared Polis signed HB 1130 into law. This legislation amends the Colorado Privacy Act to add specific requirements for the processing of an individual’s biometric data. This law does not have a private right of action.

Similarly to the Illinois Biometric Information Privacy Act (BIPA), this law requires controllers to provide notice and obtain consent prior to the collection or processing of a biometric identifier. The law also prohibits controllers from selling or disclosing biometric identifiers unless the customer consents or unless disclosure is necessary to fulfill the purpose of collection, to complete a financial transaction, or is required by law.

The law contains several novel requirements. For instance, it prevents a controller from purchasing a biometric identifier unless: (a) they pay the consumer, (b) they obtain the consumer’s consent, and (c) the purchase is unrelated to the provision of a product or service to the customer. Additionally, it requires companies meeting certain thresholds to disclose detailed information about their biometric data collection and use upon consumer request, including the source from which the controller access the data and the purpose for which it was processed.

The law also sets forth retention requirements that differ from those of BIPA. Specifically, controllers processing biometric data must adopt written guidelines that require the permanent destruction of a biometric identifier by the earliest of: (a) the date upon which the initial purpose for collecting the biometric identifier has been satisfied; (b) 24 months after the consumer last interacted with the controller; or (c) the earliest reasonably feasible date. The earliest reasonably feasible date must be no more than 45 days after a controller determines that storing the biometric identifier is no longer necessary or relevant to the express processing purpose, as identified by an annual review. The controller may extend the 45 day period by up to 45 additional days if necessary given the complexity and amount of biometric identifiers to be deleted. The written policy must also establish a retention schedule for biometric identifiers and include a protocol for responding to a breach of security involving biometric data. Note that the controller need not publish policies applying only to current employees or internal protocols for responding to security incidents.

Lastly, the law contains guidance on the use of biometric systems by employers. It specifies that employers may collect biometric identifiers as a condition of employment, but only to: permit access to secure physical locations or hardware (and not to track a current employee’s location or how much time they spend using an application); to record the start and end of a work day; and to improve workplace and public safety. The collection of biometric identifiers from employees for other reasons may not be a condition of employment and may occur only with consent. The law contains a broad statement that employers may still collect and process employees’ biometric identifiers for uses aligned with the employee’s reasonable expectations based on the role.

Inside Privacy
FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company https://www.lexblog.com/2024/05/31/fda-gets-technical-on-hct-p-rules-in-warning-letter-to-human-tissue-company/ Fri, 31 May 2024 22:32:24 +0000 https://www.lexblog.com/2024/05/31/fda-gets-technical-on-hct-p-rules-in-warning-letter-to-human-tissue-company/ On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations following a back-and-forth between FDA and Akan. The Form FDA-483 highlights a number of observations about 585 vials of an Akan product, but the warning letter spends considerable time beforehand covering reasons why Akan’s product does not meet the requirements of 21 C.F.R. § 1271.10(a), which qualify certain human cells, tissues, or cellular or tissue-based products (HCT/Ps) for exemptions from key FDCA requirements, including premarket review. Akan’s product is an adipose derived, stromal vascular fraction (SVF) cellular product for allogenic use with the brand name Ayama™.

This warning letter is a quintessential example of FDA’s enforcement priorities for these products, and highlights the ongoing scrutiny placed on HCT/P manufacturers. We will have some analysis and takeaways later – including possible reasons for why FDA opted to issue a Warning Letter as opposed to an Untitled Letter – but first, let’s go through the details of the letter and what FDA highlighted:

HCT/P Regulation:

Our prior blog posts have taken a detailed look at the use of HCT/Ps and FDA’s risk-based regulatory framework for the same,[1] but it is important to note that FDA views this area as “a complex and rapidly evolving field.”[2] In short, as a reminder, if an HCT/P meets all of the following criteria, then the manufacturer can avoid the time-consuming and costly premarket review and approval process:

  • The HCT/P is minimally manipulated;
  • The HCT/P is objectively marketed for intended uses in the recipient that are consistent with its normal function in the donor’s body (i.e., homologous uses);
  • The HCT/P is not combined with another article (with some limited exceptions); and
  • The HCT/P either:
    • (1) does not have a systemic effect and is not dependent on the metabolic activity of living cells for its primary function; or
    • (2) does have a systemic effect or is dependent on the metabolic activity of living cells for its primary function, and is for:
      • (a) use in the same individual who was the source of the tissue or cells;
      • (b) use in an individual who is a first- or second-degree blood relative of the donor of the tissue or cells; or
      • (c) reproductive use.

The purpose of this test is to help FDA in differentiating HCT/Ps that pose minimal public health risks from those higher-risk products which should be subject to clinical trials and premarketing review by the agency. Accordingly, HCT/Ps that do not meet the above criteria – and do not fall into one of the enumerated exceptions under 21 CFR § 1271.15 – are considered to be drugs, devices, and/or biological products regulated under Section 351 of the PHS Act and the Federal Food, Drug, & Cosmetic Act (FDCA).[3]

Without a doubt, the two most frequently discussed and cited criteria are minimal manipulation and homologous use. In evaluating minimal manipulation, FDA looks at the processing of the product and evaluates the extent of steps involved in transforming the HCT/P from donor specimen to finished product. Over time, the agency has provided a number of examples of minimal or more-than-minimal manipulation;[4] however, FDA has also explicitly left this area open for innovation, stating that “subsequent accumulation of clinical data and experience about a particular process” may change the agency’s assessment.[5]

For homologous use, FDA considers the manner in which the product is marketed. In particular, the focus here is whether the HCT/P’s intended use is to “perform[] the same basic function or functions in the recipient as in the donor.”[6] For this step, FDA considers the manufacturer’s objective intent, as determined by product labeling, advertising, expressions of the manufacturer’s representatives, and circumstances surrounding distribution.

Here, FDA’s conclusion on the inapplicability of 21 CFR § 1271.10(a) focuses on these two subsections. FDA simply states, without explanation, that Akan’s product fails the minimal manipulation prong of the regulation because processing “alters the original relevant characteristics of the adipose tissue related to its utility for reconstruction, repair, or replacement.” On the homologous use prong, FDA provides more context. FDA notes that the product’s basic function of “cushioning and support for ... skin and internal organs, storing energy in the form of lipids, and insulating the body” is not what Akan advertises on its website—“to repair, reconstruct and replace your skin tissue.”

For these two reasons, FDA found that Akan’s product does not qualify for exemption under 21 C.F.R. § 1271.10, and therefore is regulated as a drug and biological product. FDA further noted that Akan did not possess a valid biologics license or investigational new drug application for its product. Interestingly, unlike past warning letters for unapproved non-exempt HCT/Ps, FDA did not explicitly state that Akan’s actions “violated the FD&C Act and the PHS Act.”[7] Perhaps this was an oversight on the agency’s part, but nonetheless stands out among past enforcement.

483 Observations:

In addition, FDA’s letter also cited “significant violations” of HCT/P donor screening and eligibility testing and GMP requirements. Among other things, FDA’s inspection revealed that Akan utilized inadequate methods to test and screen donors for communicable diseases. For example, FDA stated that Akan’s “Donor Screening Questionnaire” form failed to “address certain risk factors for relevant communicable disease agents and diseases, including . . . a donor’s risk of having West Nile Virus (WNV), among other risk factors.” In so doing, FDA provided an extensive list of examples of risk factors that should be included on such forms. With respect to GMPs, FDA further cited Akan for “[f]ailure to establish written procedures for production and process control” and “[f]ailure to have an adequate system for monitoring environmental conditions in an aseptic processing area.”


This warning letter serves as yet another a reminder to HCT/P manufacturers of FDA’s core enforcement priorities with respect to cell and tissue products. While FDA has issued a number of guidances over the years to help de-mystify the elements of 21 C.F.R. Part 1271 (also referred to as the “tissue rules”), the primary goal has always remained the same: prevention of the introduction, transmission, and spread of communicable disease. In achieving this goal, FDA’s tissue rules focus on three main areas:

  1. preventing unwitting use of contaminated tissues with the potential for transmitting infectious diseases such as AIDS and hepatitis;
  2. preventing improper handling or processing that might contaminate or damage tissues; [and]
  3. ensuring that clinical safety and effectiveness is demonstrated for tissues that are highly processed, are used for other than their normal function, are combined with non-tissue components, or are used for metabolic purposes.”[8]

Perhaps unsurprisingly, then, FDA keys on each of these concepts in its letter to Akan. The opening discussion of minimal manipulation and homologous use serves to further point #3, and reveals FDA’s assessment that products like Akan’s should be subject to greater oversight. Then, in addressing Akan’s inadequate donor screening and testing procedures, FDA focuses on point #1 and the prevention of unwitting use of potentially contaminated tissues. Lastly, the discussion of Akan’s GMP deficiencies focuses on the final point – prevention of improper handling and processing.

Furthermore, this letter also provides some helpful context for the types of activities that will lead to a Warning Letter versus an Untitled Letter. In terms of HCT/P enforcement, CBER has historically kept a close eye on HCT/Ps. Indeed, this year alone, CBER has issued six letters to HCT/P manufacturers. In reviewing recent letters issued by CBER, we see that the agency tends to issue Warning Letters where donor screening and testing and/or GMP deficiencies are revealed during an inspection. In contrast, Untitled Letters typically focus more on the characteristics of the product as described in publicly available marketing claims made on company websites and social media pages.

Adding to this, FDA has also advised that Warning Letters may be warranted for HCT/Ps where there are violations that “meet the threshold for regulatory significance suggesting that systemic problems exist within one or more areas of the firm’s operations.”[9] This could include “continuing pattern[s] of non-compliance, a failure to correct significant deficiencies noted during a previous inspection, or the deficiencies pose a serious threat to the public health, and voluntary action is either not appropriate or can not be readily accomplished.”[10] Aside from these examples, the “threshold for regulatory significance” is not clearly defined. However, based on past letters, unresolved issues with donor screening and testing and GMP deficiencies certainly appear to meet this threshold.

According to FDA, Akan was provided an opportunity to response to these observations, however, FDA found this response to be insufficient. Among other things, although Akan initiated a voluntary product recall of its Ayama™ product, FDA deemed that the product recall documentation report disavowed any specific safety concerns regarding the product and Akan failed to provide FDA with details regarding the remaining product on hand. Further, FDA noted that Akan’s “revised process validation report for Ayama lack[ed] significant documentation to assure that the product has the identity, strength, purity, and quality it purports or is represented to possess.” Accordingly, the agency’s motivation for issuing a Warning Letter was likely due to (1) the types of issues identified (i.e., donor screening/testing and GMPs), and (2) a failure to rectify these issues in an adequate manner, thereby suggesting systemic problems within the firm’s operations.

All in all, this letter highlights the continued importance of not only strict adherence to FDA’s tissue rules, but also taking a step back and remembering the bigger picture for why FDA has crafted and implemented these regulations. Further, if presented with a 483, companies should carefully consider what corrective actions will adequately address and alleviate the agency’s concerns. FDA’s tissue rules were intended to carefully balance the interests of innovation in regenerative medicine and the prevention of transmission of communicable disease, however, CBER has made clear that it is not afraid to take action where there are obvious signs of noncompliance. In light of this, manufacturers should be mindful of FDA’s goals when determining a commercialization and manufacturing strategy for their product.


[1] FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023; FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer.

[2] U.S. Food & Drug Admin., Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use: Guidance for Industry and Food and Drug Administration Staff, at 23 (July 2020).

[3] 21 C.F.R. § 1271.20.

[4] See, e.g.¸ 66 Fed. Reg. at 5457; Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use Guidance, at 15.

[5] See 63 Fed. Reg. at 26748.

[6] 21 C.F.R. § 1271.3.

[7] See, e.g., Warning Letter to Signature Biologics, LLC (Sept. 18, 2023); Warning Letter to Row1 Inc. dba Regenative Labs (June 21, 2023); Warning Letter to Stratus Biosystems, LLC dba CellGenuity Regenerative Science (June 5, 2023); Warning Letter to RenatiLabs Inc. (June 1, 2023).

[8] See U.S. Food & Drug Admin., Proposed Approach to Regulation of Cellular and Tissue-Based Products, at 6 (Feb. 1997).

[9] See U.S. Food & Drug Admin., Compliance Program Guidance Manual: Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002, at 17 (emphasis added).

[10] See id. at 16, 18.

FDA Law Update
Biden Administration Publishes Voluntary Carbon Markets Joint Policy Statement and Principles https://www.lexblog.com/2024/05/31/biden-administration-publishes-voluntary-carbon-markets-joint-policy-statement-and-principles/ Fri, 31 May 2024 22:05:12 +0000 https://www.lexblog.com/2024/05/31/biden-administration-publishes-voluntary-carbon-markets-joint-policy-statement-and-principles/ On May 28, the U.S. Secretaries of Treasury, Agriculture, and Energy, along with senior White House climate officials, issued the Voluntary Carbon Markets Joint Policy Statement and Principles (Policy Statement).  The Policy Statement provides observations regarding the current state of voluntary carbon markets, followed by a set of guiding principles for responsible market participation.  A White House Fact Sheet describes the Policy Statement as representing the U.S. government’s commitment to advancing the responsible development of voluntary carbon markets, “with clear incentives and guardrails.”  Notably, the Fact Sheet  states that, with such incentives and guardrails, voluntary carbon markets can drive significant progress toward the Administration’s goals of reaching global net-zero greenhouse gas (GHG) emissions by 2050 and limiting warming to 1.5 °C.

Voluntary Carbon Market Observations

The Policy Statement comes on the heels of a rocky two years for the voluntary carbon market marked by heightened regulator, media, and stakeholder scrutiny regarding the integrity of carbon offsets and associated GHG emission reduction claims.  The Policy Statement highlights specific critiques of carbon offsets relating to additionality, permanence, and credible GHG emissions accounting. Further, it notes the growing need for measures to ensure that credited activities respect local communities and human rights, and mitigate any negative environmental or social impacts. A key takeaway is that “clearer rules of the road would enhance market certainty for credit buyers and businesses and individuals undertaking activities to supply this market.”

The Policy Statement also highlights recent developments intended to address the previously mentioned concerns.  Those developments include multi-stakeholder initiatives to set high-integrity credit standards, technologies to support robust measurement, monitoring, reporting, and verification (MMRV) for carbon projects, and advancements in the development of market infrastructure to improve transparency and liquidity. In terms of federal government developments, the Policy Statement references the Commodities Futures Trading Commission’s 2023 proposed guidance for voluntary carbon credit derivatives and associated trading platforms, the Securities and Exchange Commission’s final climate risk disclosure rule requiring certain disclosures related to carbon offset purchases, and efforts by other agencies to improve emissions data collection.

Principles for Responsible Participation

Given the Administration’s observations, the Policy Statement includes seven principles for responsible participation in the voluntary carbon markets.  The Policy Statement notes that these principles echo, and are an effort to elevate, concepts developed by leading NGOs working toward ensuring high integrity in the voluntary marketplace.  The document describes a three-pronged approach to responsible carbon market development and participation: (1) credit or supply integrity (principles 1 and 2), (2) demand integrity (principles 3-5) and (3) market-level integrity (principles 6 and 7).  While the demand integrity principles may be most relevant to corporate buyers, each of the principles are relevant to all market participants:

  • Principle 1: Carbon credits and the activities that generate them should meet credible atmospheric integrity standards and represent real decarbonization.
  • Principle 2: Credit-generating activities should avoid environmental and social harm and should, where applicable, support co-benefits and transparent and inclusive benefits-sharing.
  • Principle 3: Corporate buyers that use credits (credit users) should prioritize measurable emissions reductions within their own value chains.
  • Principle 4: Credit users should publicly disclose the nature of purchased and retired credits.
  • Principle 5: Public claims by credit users should accurately reflect the climate impact of retired credits and should only rely on credits that meet high integrity standards.
  • Principle 6: Market participants should contribute to efforts that improve market integrity.
  • Principle 7: Policymakers and market participants should facilitate efficient market participation and seek to lower transaction costs.

Potential Next Steps

Principle 7, centered upon facilitating efficient market participation, is the only principle that expressly highlights a role for policymakers. But several additional actions could be taken from a policy perspective to further advance and bolster the integrity of the voluntary carbon market.   As just one example, on the same day that the Policy Statement was released, the USDA announced a request for information seeking public input to support the development of proposed regulations to implement the department’s GHG Technical Assistance Provider and Third-Party Verifier Program. The program aims to assist landowners by providing a list of qualified technical assistance providers and third-party verifiers who work with producers to generate credible carbon credits. The program will also list “widely accepted voluntary carbon credit protocols”, according to the department’s announcement, in an effort to further reduce market confusion for landowners. Comments to USDA on the request for information are due by June 28.

Inside Energy & Environment
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests https://www.lexblog.com/2024/05/31/lawsuit-filed-challenging-fda-final-rule-regulating-laboratory-developed-tests/ Fri, 31 May 2024 17:53:27 +0000 https://www.lexblog.com/2024/05/31/lawsuit-filed-challenging-fda-final-rule-regulating-laboratory-developed-tests/ On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests (“LDTs”) under the Federal Food, Drug and Cosmetic Act (“FDCA”). As detailed in our prior analysis (here), the final rule amended the FDA’s existing regulations to make explicit the agency’s interpretation that LDTs are “devices” under the FDCA, and established a five-stage plan to phaseout the agency’s current general policy of “enforcement discretion” with respect to LDTs.

With the final rule’s July 5 effective date looming, two entities—a trade association and a laboratory—filed suit in federal court to overturn the final rule. In this Insight, we briefly summarize the legal theories advanced in the lawsuit and likely next steps.

Read the full alert here.

The post Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests appeared first on Life Sciences Perspectives.

Life Sciences Perspectives
CFPB Files Suit Against Student Loan Servicer https://www.lexblog.com/2024/05/31/cfpb-files-suit-against-student-loan-servicer/ Fri, 31 May 2024 17:52:28 +0000 https://www.lexblog.com/2024/05/31/cfpb-files-suit-against-student-loan-servicer/ On May 31, 2024, the CFPB announced that it had filed suit against a Pennsylvania-based student loan servicer for engaging in allegedly unfair, deceptive and abusive acts or practices in violation of the CFPA, 12 U.S.C. §§ 5531, 5536(a)(1)(B), and for failing to establish reasonable credit reporting procedures in violation of Regulation V, 12 C.F.R. §§ 1022.40-43, and the CFPA, 12 U.S.C. § 5536(a)(1)(A).

​According to the CFPB’s complaint filed in the Middle District of Pennsylvania, the company allegedly improperly collected or attempted to collect on private student loans that had been discharged in a bankruptcy proceeding. The CFPB alleges that the company maintains a policy of resuming servicing and collection on all private student loans after the conclusion of a bankruptcy proceeding, unless explicitly directed otherwise by the consumer or it receives a court order. The CFPB asserts that the company does not track and lacks proper procedures to determine whether a loan that it services was discharged in bankruptcy.

The CFPB further alleges that the company has collected on nearly 8,​000 student loans after a bankruptcy proceeding, of which at least 177 were eligible for discharge in bankruptcy. The CFPB also contends that the company misled consumers into believing that they were required to pay loans that had been discharged in bankruptcy, by sending consumers payment schedule letters and billing statements. The CFPB further asserts that the company routinely furnishes inaccurate student loan information to credit reporting agencies, and that it lacks proper procedures to assess the accuracy of the student loan information that it provides to credit reporting agencies.

The CFPB is seeking a permanent injunction to prevent future violations of the CFPA and Regulation V, redress for consumers including injunctive relief, disgorgement and restitution, an unspecified civil money penalty, and its costs in bringing the action.

The post CFPB Files Suit Against Student Loan Servicer appeared first on Consumer Finance Insights (CFI).

LenderLaw Watch
Beltway Buzz, May 31, 2024 https://www.lexblog.com/2024/05/31/beltway-buzz-may-31-2024/ Fri, 31 May 2024 17:49:28 +0000 https://www.lexblog.com/2024/05/31/beltway-buzz-may-31-2024/

OSHA’s Walkaround Reg in Effect. The Occupational Safety and Health Administration’s (OSHA) walkaround rule takes effect today, May 31, 2024. The controversial rule, which allows third parties to access employers’ private property while accompanying an OSHA official during a workplace safety inspection, is the subject of both a legal challenge and a Congressional Review Act resolution.

Senate Republican: Administration’s Labor Policies Put Politics Over People. This week, Senator Bill Cassidy (R-LA) released a report, titled, “How Biden’s Labor Agenda Puts Politics Over People: Weaponizing the Federal Government to Benefit Political Backers at the Expense of American Workers.” The report criticizes many of the administration’s policy prescriptions that should be familiar to readers of the Buzz. It argues that the U.S. Department of Labor’s (DOL) independent contractor regulation deprives workers of opportunity and flexibility, the National Labor Relations Board’s (NLRB) joint-employer rule undermines the franchise business model, and the overtime regulation “will destroy jobs and make it harder for nonprofits to provide services.” Additionally, according to the report, the administration is providing handouts to labor unions; the report cites an August 2023 Board decision, OSHA’s walkaround regulations, and the administration’s project labor agreement and Davis-Bacon Act regulations. Should a new administration occupy the White House in 2025, the report could serve as a potential roadmap for labor policy reversals.

Republican Bill Addresses College Athletes’ Employment Status. Republicans in the U.S. House of Representatives have introduced the Protecting Student Athletes’ Economic Freedom Act, which clarifies that “a student athlete may not be considered an employee of an institution, conference, or association.” The debate concerning whether graduate students and student athletes should be classified as “employees” has been going on for years at the NLRB. Most recently, in February 2024, the Board’s Boston regional office ruled that men’s basketball players at Dartmouth were “employees” under the National Labor Relations Act.

House Republicans Push Back on White House Pension Initiative. The Buzz recently discussed a White House event in which five major pension plans agreed to “encourage their portfolio companies to remain neutral when workers seek to exercise the freedom to join together in a union; and when applicable, enter into neutrality agreements with labor organizations that include voluntary or card-check recognition, reasonable timelines to first contract, and a commitment to non-interference in union organizing.” Well, Republican leaders on the House Committee on Education and the Workforce aren’t too happy with the situation and are exploring whether the funds are violating federal retirement law. Representatives Virginia Foxx (R-NC), chair of the committee, and Bob Good (R-VA) recently sent a letter to Acting Secretary of Labor Julie Su seeking “documents and information relating to the Department of Labor’s (DOL) involvement in efforts to use pension funds to promote labor union interests.” The letter argues that “diverting pension fund assets to promote collective bargaining is contrary to statutory protections for pension funds subject to the Employee Retirement Income Security Act of 1974 (ERISA).”

Foxx Wants Union Transparency. The Buzz has covered recent Republican actions on Capitol Hill to seek more accountability and transparency from labor unions. In keeping with that theme, this week Representative Foxx introduced the “Union Members Right to Know Act” (H.R. 8573). The bill would amend the Labor-Management Reporting and Disclosure Act of 1959 to require labor unions to notify members of their right to be non-members and refrain from funding union activity unrelated to collective bargaining, contract administration, and grievance adjustment. Unions would also be required to notify members of their right to seek “a reasonable accommodation, based on the religious beliefs or practices of the individual, not to pay dues or fees to the labor organization.” Various iterations of this concept have been floated in legislative form over the years but have obviously never been enacted.

The Immigration Act of 1924. One hundred years ago this week, the Immigration Act of 1924 went into effect. By banning all immigration from Asia and establishing restrictive quotas for immigrants from the rest of the world, the xenophobic law represents a dark chapter in the history of U.S. immigration policy. Feeding fears that immigrants would negatively impact the American identity and undercut jobs by providing cheaper labor, the legislation was supported by the likes of both the Ku Klux Klan and the American Federation of Labor. According to the Office of the Historian of the Department of State, “the most basic purpose of the 1924 Immigration Act was to preserve the ideal of U.S. homogeneity.” Though the act was subsequently amended by the Immigration and Nationality Act of 1952 and replaced by the Immigration and Nationality Act of 1965, some of its features remain. For example, the act established the U.S. Border Patrol (originally contained within the DOL), as well as the requirement that potential immigrants first obtain a visa at a U.S. consulate abroad before traveling to the United States.

Ogletree Deakins Insights
CDOT Swaps Widening Highways for Greener Public Transit Projects https://www.lexblog.com/2024/05/31/cdot-swaps-widening-highways-for-greener-public-transit-projects/ Fri, 31 May 2024 23:38:01 +0000 https://www.lexblog.com/2024/05/31/cdot-swaps-widening-highways-for-greener-public-transit-projects/

More cars on the road means higher carbon emissions, and studies have found that more road actually results in more cars. In an effort to reduce greenhouse gases, Governor Polis passed a bill in 2021 that, in part, tied transportation funding approvals to agencies’ emissions targets. As a result, the Colorado Department of Transportation has indefinitely paused its plans to widen I-25 and focused instead on transportation that doesn’t center around cars.

However, the success of robust public transit depends on land use reform that makes housing more dense, affordable, and available. In the words of Will Toor, the executive director of the Colorado Energy Office, “I think where we stand now is that the real frontier is around land use.”

Read the New York Times article here.

Rocky Mountain Real Estate Law
Crowell & Moring LLP Secures Significant Legal Victory for Apiário Diamante in Antidumping Duty Case https://www.lexblog.com/2024/05/31/crowell-moring-llp-secures-significant-legal-victory-for-apiario-diamante-in-antidumping-duty-case/ Fri, 31 May 2024 21:01:41 +0000 https://www.lexblog.com/2024/05/31/crowell-moring-llp-secures-significant-legal-victory-for-apiario-diamante-in-antidumping-duty-case/ Crowell & Moring LLP is pleased to announce a significant legal victory on behalf of our clients, Apiário Diamante Comercial Exportadora Ltda. and Apiário Diamante Produção e Comercial de Mel Ltda. (collectively known as “Supermel”). The United States Court of International Trade, in a decision issued by Judge Timothy C. Stanceu on May 30, 2024, has remanded the U.S. Department of Commerce’s final determination in the antidumping duty investigation on Raw Honey from Brazil.

In its April 2022 final determination, the Department of Commerce had assigned Supermel a punitive dumping margin of 83.72%, a decision based on the application of total adverse facts available (“AFA”).  The court found that this decision was unsupported by substantial evidence, noting multiple deficiencies in Commerce’s analysis.  Notably, the court determined that the agency wrongly relied on differences between information submitted by Supermel and its beekeepers and found no deficiencies in the accounting records provided by Supermel.  The court also found that Commerce had not adequately notified Supermel of alleged discrepancies in their submissions, nor provided sufficient opportunity to remedy these deficiencies. 

The court ordered the Department of Commerce to reconsider its application of AFA and determine a new dumping margin for Supermel based on the existing record.  Commerce is required to submit the remand redetermination within 60 days, followed by a 45-day comment period. 

Crowell & Moring LLP is dedicated to advocating for fair trade and supporting our clients in navigating the complexities of international trade law. This victory exemplifies our commitment to achieving favorable outcomes for our clients through diligent representation and legal expertise.

For more information, please contact:

Daniel J. Cannistra
Partner, Crowell & Moring LLP
Phone: (202) 624-2902
Email: dcannistra@crowell.com

Pierce J. Lee
Counsel, Crowell & Moring LLP
Phone: (202) 508-8780
Email: plee@crowell.com

International Trade Law
Article: Policy over Doctrine: A Brief History of US Trust Law https://www.lexblog.com/2024/05/31/article-policy-over-doctrine-a-brief-history-of-us-trust-law/ Fri, 31 May 2024 17:00:00 +0000 https://www.lexblog.com/2024/05/31/article-policy-over-doctrine-a-brief-history-of-us-trust-law/ Lucas Clover Alcolea (University of Otago – Faculty of Law) recently published, Policy over Doctrine: A Brief History of US Trust Law, 2023. Provided below is an Abstract: US trust law is unique because whereas in English law the settlor…

Wills, Trusts & Estates Prof Blog
Transforming and Transporting: Louisiana Legislature Amends Law to Allow Pipeline Transporters Expropriation Authority for CCS Projects https://www.lexblog.com/2024/05/31/transforming-and-transporting-louisiana-legislature-amends-law-to-allow-pipeline-transporters-expropriation-authority-for-ccs-projects/ Fri, 31 May 2024 20:53:28 +0000 https://www.lexblog.com/2024/05/31/transforming-and-transporting-louisiana-legislature-amends-law-to-allow-pipeline-transporters-expropriation-authority-for-ccs-projects/ On May 31, the Louisiana Legislature passed HB 492 expressly providing that a pipeline company has authority to expropriate property rights for pipelines transporting carbon dioxide for Carbon Capture & Storage (CCS) projects.  This bill is one of several bills related to CCS projects introduced this legislative session.

Prior to HB 492, the text of Louisiana Revised Statute 19:2(12) limited expropriation authority to entities engaged in the business of CCS, arguably excluding pipeline companies who only transport carbon dioxide for CCS projects.  Additionally, the prior version of the law provided an ambiguous requirement that the expropriating authority first obtain some approval from the State of Louisiana, Department of Energy and Natural Resources, Office of Conservation (“DENR”).  However, the required approval was not defined by statute or regulation. 

Importantly, HB 492 expressly expands expropriation authority under Title 19 to clearly provide expropriation authority for legal entities created “for the purpose of, or engaged in the transportation of carbon dioxide by pipeline for underground storage, including but not limited to through connecting to an existing pipeline transporting carbon dioxide to underground storage . . . .” More simply, pipeline transporters now have expropriation authority under Title 19 for CCS projects.

HB 492 further eliminates the ambiguity of the unknown DENR approval requirement. In addressing this ambiguity, the bill clarifies that the expropriating authority must first obtain a certificate of public convenience and necessity from the DENR pursuant to Title 30 of the Louisiana Revised Statutes. HB 492 then expands Title 30 to specifically allow the DENR to issue certificates of public convenience and necessity to pipeline transporters “for the laying, maintaining, and operating of a pipeline for the transportation of carbon dioxide to a storage facility,” regardless of whether the pipeline transporter is also the storage operator.

However, while it is now clear that DENR approval through the issuance of a certificate of public convenience and necessity is required prior to expropriation, neither HB 492, nor current statutes, nor existing regulations discuss the threshold requirements for obtaining the necessary certificate from the DENR. As this particular safeguard of landowner property rights is unique to CCS and does not appear in similar enabling statutes under Title 19 for other pipeline expropriations, future statutory amendments or regulations providing for some standard for DENR approval of certificates of public convenience and necessity will likely be necessary.

While HB 492 expands expropriation authority for pipeline transporters, it further limits authority for storage operators.  HB 492 prohibits storage operators from exercising expropriation authority relative to reservoir or pore space rights for geologic storage, except for those projects already authorized by law. However, a separate bill, HB 966, was introduced instead to provide for unitization for carbon dioxide geologic storage. On May 31, the Louisiana Legislature also passed HB 966.

For further questions regarding this legislative update, contact Liskow attorneys Zachary Berryman, Matt Simone, and Neil Abramson and visit our Carbon Capture & Storage practice page.

Disclaimer: This Blog/Web Site is made available by the law firm of Liskow & Lewis, APLC (“Liskow & Lewis”) and the individual Liskow & Lewis lawyers posting to this site for educational purposes and to give you general information and a general understanding of the law only, not to provide specific legal advice as to an identified problem or issue. By using this blog site you understand and acknowledge that there is no attorney-client relationship formed between you and Liskow & Lewis and/or the individual Liskow & Lewis lawyers posting to this site by virtue of your using this site. The Blog/Web Site should not be used as a substitute for legal advice from a licensed professional attorney in your state regarding a particular matter.

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The Energy Law Blog
Webinar Replay: Privacy Class Action Litigation Trends https://www.lexblog.com/2024/05/31/webinar-replay-privacy-class-action-litigation-trends/ Fri, 31 May 2024 16:51:25 +0000 https://www.lexblog.com/2024/05/31/webinar-replay-privacy-class-action-litigation-trends/ Duane Morris Takeaways: The significant stakes and evolving legal landscape in privacy class action rulings and legislation make the defense of privacy class actions a challenge for corporations. As a new wave of wiretapping violation lawsuits target companies that use technologies to track user activity on their websites, there is significant state legislative activity regarding ...

Class Action Defense Blog
The Briefing: The Briefing: Paramount Splashes Top Gun Maverick Copyright Lawsuit https://www.lexblog.com/2024/05/31/the-briefing-the-briefing-paramount-splashes-top-gun-maverick-copyright-lawsuit/ Fri, 31 May 2024 23:50:11 +0000 https://www.lexblog.com/2024/05/31/the-briefing-the-briefing-paramount-splashes-top-gun-maverick-copyright-lawsuit/

Paramount triumphs in the Top Gun Maverick copyright case. Join Scott Hervey and Jamie Lincenberg of Weintraub Tobin on ‘The Briefing’ as they dissect the court’s ruling.

Watch this episode on the Weintraub YouTube channel here or listen to this podcast episode here.

The IP Law Blog
Supreme Court punts the NBA preemption analysis back to the Second Circuit https://www.lexblog.com/2024/05/31/supreme-court-punts-the-nba-preemption-analysis-back-to-the-second-circuit/ Fri, 31 May 2024 20:06:34 +0000 https://www.lexblog.com/2024/05/31/supreme-court-punts-the-nba-preemption-analysis-back-to-the-second-circuit/ On May 30, 2024, in a unanimous decision, the Supreme Court reversed Cantero v. Bank of America, N.A., and remanded it back to the Second Circuit and instructed the appellate court to analyze whether New York’s law requiring interest to be paid on mortgage escrow accounts is preempted under the Dodd-Frank Act by applying the Barnett Bank standard. No bright line test for preemption was articulated by the Court; instead, the Court relied on Barnett Bank and its earlier precedents dealing with National Bank Act (NBA) preemption.

The question before the Supreme Court was whether the NBA preempts application of that New York interest-on-escrow law to national banks. The District Court determined that the New York law applied to national banks and was not preempted under federal law or the NBA. The Second Circuit reversed, holding that the New York law was preempted by the NBA. The Second Circuit held that federal law preempts any state law that “purports to exercise control over a federally granted banking power,” regardless of “the magnitude of its effects.” The Second Circuit concluded that the New York law was preempted because it exerted control over a national bank’s powers to fund escrow accounts.

The Supreme Court held that the Second Circuit failed to analyze whether New York’s interest-on-escrow law is preempted as applied to national banks in a manner consistent with Dodd-Frank and Barnett Bank. Section 1044 of Dodd Frank provides that a state consumer financial law is preempted if it would have a discriminatory impact on national banks as compared to banks chartered by the same state or if “in accordance with the legal standard for preemption in the decision of the Supreme Court of the United States in Barnett Bank..., the State consumer financial law prevents or significantly interferes with the exercise by a national bank of its powers.” 12 U.S.C. §25b (1)(B). Since the New York law does not discriminate against national banks, the law is preempted only if it “prevents or significantly interferes” with a national bank’s powers. The Court noted that “[g]iven Dodd-Frank’s direction to identify significant interference ‘in accordance with’ Barnett Bank, courts addressing preemption questions in this context must do as Barnett Bank did and likewise take account of those prior decisions of this Court and similar precedents.”

The Supreme Court concluded that the Second Circuit “did not conduct that that kind of nuanced comparative analysis” required under Barnett Bank and stated:

A court applying that Barnett Bank standard must make a practical assessment of the nature and degree of the interference caused by a state law. If the state law prevents or significantly interferes with the national bank’s exercise of its powers, the law is preempted. If the state law does not prevent or significantly interfere with the national bank’s exercise of its powers, the law is not preempted. In assessing the significance of a state law’s interference, courts may consider the interference caused by the state laws in Barnett Bank, Franklin, Anderson, and the other precedents on which Barnett Bank relied. If the state law’s interference with national bank powers is more akin to the interference in cases like Franklin, Fidelity, First National Bank of San Jose, and Barnett Bank itself, then the state law is preempted. If the state law’s interference with national bank powers is more akin to the interference in cases like Anderson, National Bank v. Commonwealth, and McClellan, then the state law is not preempted.

The cases where the state laws were found to be preempted under the NBA are:

  • First National Bank of San Jose v. California, 262 U.S. 366, 369-70 (1923) (a California law allowed the state to claim deposits that went “unclaimed for more than twenty years” without requiring the account to be abandoned was preempted because it interfered with the “efficiency” of the national bank in receiving deposits);
  • Franklin National Bank of Franklin Square v. New York, 347 U.S. 373, 378-379 (1954) (a New York law prohibiting banks from using the words “saving” or “savings” in advertising their business was preempted because it interfered with the national bank’s statutory power to receive savings deposits);
  • Fidelity Federal Savings & Loan Association v. De la Cuesta, 458 U.S. 141, 155 (1982)(a California law limiting due-on-sale clauses was preempted because the savings and loan could not exercise a due-on-sale clause “solely at its option;” but case involved Federal Thrift and not NBA preemption of state laws which was field preemption); and
  • Barnett Bank of Marion Cty., N. A. v. Nelson, 517 U.S. 25, 35-36 (1996) (a Florida law prohibiting banks from selling insurance was preempted because is significantly interfered with a bank’s power authorized by federal law to sell insurance).

The cases where the state laws were not found to be preempted are:

  • Anderson National Bank v. Luckett, 321 U.S. 233, 249 (1944) (a Kentucky law that required banks to escheat abandoned property was not preempted because the law did “not infringe or interfere with any authorized function of the bank”);
  • National Bank v. Commonwealth, 9 Wall. 353, 352-363 (1870) (a Kentucky law that taxed all bank shareholders on their shares of bank stock was not preempted because it did not hinder the bank’s operations); and
  • McClellan v. Chipman, 164 U.S. 347, 358 (1896) (a generally applicable Massachusetts contract law was not preempted because it did not “in any way impai[r] the efficiency of national banks or frustrat[e] the purpose for which they were created”).

These cases that the Supreme Court suggests the Second Circuit use for comparative analysis are unlikely to be helpful in deciding on which side of the line the New York interest-on-escrow law falls.

The following statement from the opinion sums up the difficultly in preemption determinations going forward:

We appreciate the desire by both parties for a clearer preemption line one way or the other. But Congress expressly incorporated Barnett Bank into the U.S. Code. And in determining whether the Florida law at issue there was preempted, Barnett Bank did not draw a bright line.

Additionally, in a footnote at the end of the opinion, the Supreme Court indicated that the Second Circuit could consider the significance of any of the preemption rules adopted by the Office of Comptroller of the Currency (OCC) even though it implicitly rejected the preemption analyses previously done by the OCC, and whether, as provided in Section 1044(b)(1)(C) of Dodd Frank, any other federal law preempts the state consumer financial law (the District Court found no preemption under TILA, RESPA, and Dodd-Frank). The Department of Justice criticized the OCC’s “different and broader view of NBA preemption” in its amicus brief. By way of background, shortly after the enactment of Dodd-Frank, the OCC promulgated a regulation saying that many categories of state laws were automatically preempted. The new post Dodd-Frank regulation was strikingly similar to the pre-Dodd-Frank regulation. Many, if not most, national banks reasonably relied on the OCC’s categorical preemption which the Supreme Court has now rejected.

Last December, Democratic Senators sent a letter to Acting Comptroller of the Currency Michael Hsu “to address [the OCC’s] longstanding expansion of its preemption authority to undermine state consumer protections.” The letter claimed that OCC has not followed the preemption authority requirement in Section 1044 of Dodd Frank and interfered with states exercising authority for non-preempted consumer protection laws.

We have previously expressed practical concerns with relying upon the OCC’s categorical preemption after the passage of Dodd-Frank. Under Dodd-Frank, an OCC preemption determination is no longer entitled to special Chevron deference and instead receives more limited Skidmore deference, whether or not the determination is made under the Barnett Bank standard and whether or not it addresses a “State consumer financial law.”

We expect a more liberal analysis from the Second Circuit than we have seen from the Fifth Circuit with limited deference to the OCC’s preemption determinations. With no bright line test, the Barnett Bank analysis as to whether a state law like New York’s interest on escrow accounts “prevents or significantly interferes” with a national bank’s powers could vary based on a bank’s asset size. Moreover, it would seem that a law preempted at one time may later cease to be preempted if the impact on the bank changes as a result of the bank’s growth or even as the result of technological innovations implemented by the bank. The practical implication of this is that preemption analysis by banks must be a (recurring) fact intensive exercise. We will monitor the Second Circuit’s decision and see whether the appellate court rules or kicks the case back to the district court.

The takeaway from this opinion is that national banks may have to take a fresh look at all potentially applicable state laws, not just those dealing with mortgage escrow accounts, with which they are not complying and determine, after conducting a thorough “significant impairment” analysis, whether they should change their positions. This is a time consuming and costly exercise, but one that may be necessary to avoid class action litigation.

Consumer Finance Monitor
Navigating the Illinois Environmental Protection Act Through Rice v. Marathon Petroleum Corp. https://www.lexblog.com/2024/05/31/navigating-the-illinois-environmental-protection-act-through-rice-v-marathon-petroleum-corp/ Fri, 31 May 2024 20:00:14 +0000 https://www.lexblog.com/2024/05/31/navigating-the-illinois-environmental-protection-act-through-rice-v-marathon-petroleum-corp/ On May 23, 2024, the Supreme Court of Illinois rendered a judgment in Rice v. Marathon Petroleum Corp., which involved important considerations for both environmental law and personal injury claims. This case was initiated by Laura E. Rice, acting as the special representative for the estate of her late mother, Margaret L. Rice. The litigation focused on the complex relationship between statutory environmental protections provided under the Illinois Environmental Protection Act (“Act”) and the applicability of common-law negligence remedies for personal injuries.

The decision establishes a clear precedent in Illinois law, defining the boundaries of private rights of action under environmental statutes. The ruling distinguishes the purposes of environmental statutes from common-law remedies, explaining how individuals can seek redress for personal injuries from environmental violations. The decision also underscores robust governmental enforcement mechanisms, affirming the role of state agencies in managing environmental compliance and protecting public health. Lastly, the ruling may influence other jurisdictions facing similar legal questions about the scope of environmental statutes and the role of private litigation in enforcement.


The case stemmed from a tragic incident in 2017, when an explosion at Margaret Rice’s condominium complex severely injured her and caused extensive property damage. The explosion was triggered by gasoline vapors that had leaked from an underground storage tank at a Speedway gas station over a mile away. The tank, owned and operated by Marathon Petroleum Corporation, had been leaking for some time, leading to the buildup of dangerous vapors in the sewer systems connected to Margaret’s home.

At first, Laura Rice’s lawsuit included claims of strict liability and negligence. The strict liability claims were based on alleged violations of the Act. However, the Cook County Circuit Court dismissed the statutory claims, a decision the appellate court upheld. The Supreme Court of Illinois affirmed these dismissals, providing a detailed rationale with significant legal implications.

No Express Right of Action

The Supreme Court’s ruling underscores that the Act does not provide an express or implied private right of action for personal injuries caused by environmental violations. The court emphasized that the Act primarily aims to protect the environment rather than serve as a vehicle for personal injury claims. If the legislature had intended to create such a right, it would have done so explicitly, the court said. This interpretation clarifies that individuals cannot sue for damages under the Act for personal injuries, directing them instead to pursue common-law negligence claims.

In its analysis, the court applied the four-factor test established in Fisher v. Lexington Health Care, Inc., 188 Ill. 2d 455, 722 N.E.2d 1115 (Ill. 1999), to determine whether a private right of action could be implied under the Act. The court considered whether the plaintiff was a member of the class for whose benefit the statute was enacted, noting that the Act was mainly designed to protect the environment rather than provide personal injury remedies. It assessed whether the plaintiff’s injury was one that the statute was designed to prevent, emphasizing that the statute’s primary aim was environmental protection, not individual injury prevention. The court evaluated a private right of action’s consistency with the underlying purpose of the statute, concluding that such an action would not align with the Act’s primary goal of environmental protection. Finally, it examined whether a private right of action was necessary to provide an adequate remedy, determining that common-law negligence actions were sufficient, rendering the right of a private right of action unnecessary. The court ultimately found that the Act’s statutory framework and regulatory enforcement mechanisms under the Act addressed environmental violations and not claims for personal injury.

Common-Law Negligence

The court affirmed that common-law negligence actions provide an adequate remedy for personal injuries resulting from environmental violations. By allowing statutory violations to serve as prima facie evidence of negligence, the court affirmed that plaintiffs like Laura Rice could still seek compensation through traditional legal avenues. This decision maintains the balance between enforcing environmental regulations and providing avenues for personal injury redress without overburdening the statutory framework designed for environmental protection.

Governmental Enforcement Emphasis

The ruling reinforces the role of governmental agencies in enforcing environmental laws. The court noted that the Act’s framework, which includes substantial penalties and enforcement mechanisms by state and local authorities, is enough to address and remediate environmental hazards. This emphasis on governmental enforcement over private litigation aligns with the broader public policy goal of maintaining environmental protections and accountability through established regulatory channels.


The ruling in Rice v. Marathon Petroleum Corp. underscores a crucial principle in environmental law: environmental regulations are mainly designed to safeguard the environment, not to allow personal injury redress. By clarifying that the Illinois Environmental Protection Act does not provide a private right of action for personal injuries, the court emphasized that the environment is the key beneficiary of the Act. This decision reinforces the role of common-law negligence claims as the appropriate remedy for personal injuries arising from environmental violations, thereby maintaining a clear distinction between environmental protection goals and personal injury claims. The ruling also highlights the importance of robust governmental enforcement mechanisms, affirming that state agencies are adequately equipped to manage environmental compliance and address violations. Under this approach, environmental statutes remain focused on their primary objective of environmental protection while providing clear guidance for legal practitioners and policymakers.

E2 Law Blog
Why oversharing firm data is a bigger problem than ever — and how Intapp Walls for Copilot helps https://www.lexblog.com/2024/05/31/why-oversharing-firm-data-is-a-bigger-problem-than-ever-and-how-intapp-walls-for-copilot-helps/ Fri, 31 May 2024 15:53:29 +0000 https://www.lexblog.com/2024/05/31/why-oversharing-firm-data-is-a-bigger-problem-than-ever-and-how-intapp-walls-for-copilot-helps/ As firms take on new clients and engagements, they need to ensure that all corresponding data remains secure and properly structured. Typically, firms create client/engagement structures across dozens of management systems, such as Microsoft Teams, SharePoint, and their own CMS. But with so much information dispersed across so many systems, firm professionals often struggle to locate the exact data they need, diminishing their productivity.

That’s where Microsoft Copilot helps. Copilot is a generative AI assistant for Microsoft 365 that combines the power of large language models (LLMs) with your firm’s own data. Users simply type in the information they’re looking for, and Copilot will pull all relevant data from across your various Microsoft 365 applications to generate a response.

With Copilot, your teams no longer have to manually search across each individual management system for data — giving them more time to work on engagements and support their clients. But there’s still a key concern that teams need to watch out for: oversharing data.

Without the right permissions and tools in place, firms that use Copilot risk oversharing sensitive data. We’ll explore how you can prevent Copilot from sharing confidential information with your professionals — so your teams can securely and confidently work on their engagements.

The problem: Inadvertently sharing confidential data

Setting permissions within your client/engagement structures is crucial to protecting your firm’s reputation and client relationships. Imagine, for example, that Client A found out you shared some of its confidential data with Client B, a rival company. Not only would Client A likely terminate business with your firm, they might sue as well, depending on the nature of the data that was shared.

Clients need to know that their sensitive information is secure, and that only professionals assigned to their engagements can access that data. If permissions and walls aren’t established within your data systems, your professionals risk noncompliance, conflicts of interest, and insider trading.

Unfortunately, many firms still struggle with permissions management. And for firms using Copilot, the risk of unauthorized access is exacerbated.

Previously, even if someone could access restricted data, they would often be unaware that that data even existed. So there was a lower risk of professionals accessing and sharing this information.

But Copilot can’t recognize when a firm has incorrect permissions in place, or when one of your professionals has access to the wrong client/engagement structure. It will simply provide the data that the permissions structure allows.

To compound the problem, Copilot doesn’t tell users what data was pulled from which structure: It simply provides as much relevant information as possible. This means your professionals may be using and sharing confidential information without even realizing it.

The solution: Securing your systems with Intapp Walls for Copilot

To ensure Copilot doesn’t share sensitive data, you need to secure your firm’s multiple proprietary systems and ensure that permissions settings are correctly implemented. Then, you can be confident that the permissions that Copilot reads are correct and up to date.

But what’s the best way to implement these walls? And how can you update them as permissions change?

Potentially, your IT team could go through every one of your data management systems and manually implement permissions — a long, arduous process that IT would have to repeat every time your firm brings on a new engagement, client, or staff member.

There’s a much simpler way: using Intapp Walls for Copilot to uphold and update your permissions.

Intapp Walls for Copilot lets your risk team easily review and manage the data that Copilot indexes and accesses. Your risk professionals can write up, implement, and edit permissions across Microsoft 365 and

other systems — all in one place. And they can easily track and update permissions for your voluminous set of client/engagement structures — saving them valuable time and effort.

Intapp Walls for Copilot applies policies across Microsoft 365 using each application’s native security controls, which Copilot adheres to. The software also serves as the authoritative source of permissions and uses built-in monitoring to prevent unauthorized modifications. This means that professionals can’t change permissions in any management system themselves.

Intapp Walls for Copilot also offers the Oversharing Risk Assessment feature, which evaluates your firm’s sites to highlight potential oversharing risks. For example, the feature will mark a site as high-risk if it contains sensitive information and is accessible to a high number of people within your firm. This feature helps your professionals quickly determine which permissions need strengthening, and promotes better security across all systems.

Work more efficiently and securely

Professionals need to be able to efficiently collaborate on client engagements without fear of oversharing data. By combining Microsoft Copilot and Intapp Walls for Copilot, your professionals can quickly access the data they need while adhering to your firm’s permissions and security policies.

To further promote security, your firm can also leverage our Intapp Collaboration products, which help properly store and organize any incoming data within your client/engagement models. Intapp Collaboration products — which include Intapp Documents and Intapp Workspaces — also help automate and maintain security policies across Microsoft 365, allowing your teams to safely and confidently collaborate within their workspaces. Protect your clients’ sensitive information — and your firm’s reputation. Schedule a demo to learn more about Intapp Walls for Copilot.