Commercial Litigation Update

As the dietary supplement industry continues to draw attention from Congress, state attorneys general, and class action lawyers, now comes another state law trying to prohibit the sale of over-the-counter (“OTC”) dietary supplements that target weight loss and muscle building to minors – this time, in New Jersey.

On October 28, 2024, by a majority vote of 56 to 17, with four abstentions, the New Jersey General Assembly passed Assembly Bill No. 1848, which, if it goes into effect, will prohibit the sale or delivery of OTC diet pills, weight loss, and muscle building supplements to minors, unless the minor is accompanied by a parent or guardian. Bill No 1848 is an exemplar of efforts intended to combat the misuse and abuse of these products and the potential causal relationship between these dietary supplements and eating disorders. Violators, including employees of retail establishments, may face a civil penalty of not more than $750.

The legislation sets forth that:

“no person, firm, corporation, partnership, association, limited liability company, or other entity shall sell, offer to sell, or offer for promotional purposes, either directly or indirectly by an agent or an employee, any over-the-counter diet pull or dietary supplement for weight loss or muscle building to a minor under 18 years of age, unless the minor is accompanied by a parent or guardian.”

On June 27, 2024, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced the annual National Health Care Fraud Enforcement Action using criminal enforcement to target a wide variety of alleged health care fraud schemes.

What Has Stayed the Same and What Has Changed?

Similar to last year’s all-encompassing “takedown,” this year’s enforcement action charged defendants with schemes related to telemedicine and laboratory fraud; diversion of controlled substances (HIV medications and prescription stimulants); addiction treatment schemes; opioids and other familiar types of health care fraud (such as home health, DME and kickbacks).  However, the “headline” this year was a $900 million case in Arizona involving medically unnecessary amniotic wound grafts.

The 2024 enforcement action charged 193 defendants who allegedly have committed over $2.75 billion in fraud. The cases were brought by 32 different U.S. Attorneys’ Offices and 11 State Attorney Generals’ Offices. Although the dollar figure at issue is slightly higher than the 2023 enforcement action, the number of defendants is strikingly higher, with almost two and a half times as many defendants charged. Similarly, the cases were brought in almost twice as many federal districts as last year, suggesting that the Fraud Section is building more partnerships with U.S. Attorney’s Offices nationwide.  

On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a nationwide health care fraud enforcement action targeting a variety of alleged health care fraud schemes. As has been the case over the last few years, DOJ and HHS-OIG have moved away from categorizing the enforcement action as a “takedown”. The government has not explained the naming change, but one explanation is that it is no longer properly considered a true “takedown” because the enforcement activity (charges, arrests) occurs over many weeks leading up to the day it is announced.  

It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.

The Judicial Conference of the United States’ Committee on Rules of Practice and Procedure seems poised to advance proposed amendments to Federal Rule of Evidence 702, after the Advisory Committee on Evidence unanimously voted to approve the proposed amendments and recommended that the Committee on Rules of Practice and Procedure refer the amendments to the Judicial Conference for a full vote.