Until this year, the Food and Drug Administration’s (FDA or agency) Office of Prescription Drug Promotion (“OPDP”) enforcement activity had settled into a relatively predictable pattern. In both 2023 and 2024, OPDP issued five enforcement letters each year, reinforcing a perception that the agency was exercising restraint and directing its limited resources toward more complex promotional claims, particularly those in patient-facing materials. However, that perception shifted dramatically in September 2025, when OPDP released nearly 100 enforcement letters (both
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Hang Up and Try Again: U.S. Supreme Court Ruling Gives New Life to Defenses in TCPA Lawsuits
The Telephone Consumer Protection Act (TCPA), which regulates telemarketing, fax advertising, and the National Do Not Call Registry, has been around for over 30 years. During this time, the Federal Communications Commission (FCC) has issued multiple orders and regulations interpreting the TCPA, which most courts and litigants believed were binding. This is because of a federal statute called the Administrative Orders Review Act, also known as the Hobbs Act, which stated that a federal court of appeals had
Wisconsin Appellate Court Interprets Construction Defect Exclusion and Fungi Exclusion
Cincinnati Insurance Company v. James Ropicky, et al., No. 2023AP588, 2024 WL 5220615 (Wis. Ct. App. Dec. 26, 2024)
On December 26, 2024, the Court of Appeals of Wisconsin issued is decision in Cincinnati Insurance Company v. James Ropicky, et al., No. 2023AP588, 2024 WL 5220615 (Wis. Ct. App. Dec. 26, 2024), addressing whether an ensuing cause of loss exception to a Construction Defect Exclusion, Fungi Exclusion, and Fungi Additional Coverage endorsement contained in a homeowner’s insurance policy issued
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Wisconsin’s New Regulation of AI and Deepfakes in Political Communications
As the capabilities of generative artificial intelligence have increased, so have concerns that generative AI might be used to manipulate voters and the administration of elections in the 2024 presidential election and primaries. The first warning shot came in New Hampshire on January 21, 2024, two days before the New Hampshire Presidential Primary Election, when numerous New Hampshire residents received robocalls that played a message with what appeared to be an AI-generated voice clone of President Joe Biden’s voice,
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5 Types of Injuries That Can Occur in Wisconsin Boat Accidents
During the warm summer months, boating is a popular activity for many Wisconsinites. However, like many other recreational activities, boating comes with some risks. There are a variety of boat accidents that can occur due to issues such as negligent operation or equipment failure, and these accidents can lead to serious injuries. Those who are injured in these situations may be able to work with an attorney to identify the parties who were responsible and pursue compensation for
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Significant Changes to Medical Collection Debt Reporting: How Might it Affect Business?
In March of this year, the three major nationwide credit reporting agencies (Equifax, Experian, and TransUnion) announced there would be substantial changes to medical collection debt reporting coming this summer in an effort to help consumers faced with unexpected medical bills. The changes will remove nearly 70% of medical collection debt tradelines from consumer credit reports.
The decision was based on months of industry research which showed that around two-thirds of medical debts are the result of one-time or
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Consumer Collections in Wisconsin
Now that the COVID-19 pandemic has subsided to some extent, banks and lenders are beginning to resume collections. Further, as interest rates and inflation continue to rise, it is likely that the number of past due accounts will also rise. One of the issues with collections are the slough of regulations that come with collections from consumers. Consumer collections must be compliant with the Federal Fair Debt Collection Practices Act (the FDCPA), and in Wisconsin, the more stringent Wisconsin
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How the Grinch Stole Your Holiday Gifts!
As we approach the holiday season, many marketing directors start to think about sending holiday items to clients such as a basket of cheese, a tin of popcorn, or a bottle of wine. In the insurance industry, this type of marketing activity is regulated as unfair inducements.
Unfair inducements, sometimes referred to as “rebating,” are a subset of unfair marketing practices. Under section 628.34(4) of the Wisconsin Statutes, no insurance company, employee, or intermediary may influence another person to
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The FTC is Cracking Down on False “Made in the USA” Claims
The FTC has a new rule to crack down on false “Made in the USA” claims. The “Made in USA Labeling Rule” – which became effective on August 13, 2021 – gives the FTC the authority to seek substantial monetary penalties from manufacturers who falsely label products as made in the USA.
The Rule Allows the FTC to Crack Down on Made in USA Fraud
With its new Made in USA Labeling Rule, the FTC aims to crack down
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Narrow Auto-Dialing Definition Broadens Text
I wrote this post last year, but the US Supreme Court has been busy since then addressing the Telephone Consumer Protection Act (TCPA). In April of 2021, they unanimously overturned the Ninth Circuit’s broad interpretation of an autodialer in Facebook v. Duguin. The opinion states that a notification system that neither stores nor produces numbers “using a random or sequential number generator” is not an autodialer. “In sum, Congress’ definition of an autodialer requires that in all cases,
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