Multistate Coalition of AGs Supports FDA’s Denial of Marketing Authorization for Flavored Vape Products

On September 3, 2024, a multistate coalition of 20 attorneys general filed an amicus brief before the U.S. Supreme Court in support of a decision by the U.S. Food and Drug Administration (FDA) to deny companies the ability to market and sell certain flavored e-cigarette products across state lines.

The amicus brief emphasized what the attorneys general described as the “serious health risks” of flavored e-cigarettes (particularly for youth), and argued that the FDA’s statutory authority over the introduction of new tobacco products into interstate commerce is a crucial complement to state and local regulation of flavored e-cigarettes.  The attorneys general explained that while states have adopted a variety of measures to restrict sales of flavored e-cigarettes, these products continue to flow through interstate commerce, necessitating continued FDA oversight.

The case is Food and Drug Administration v. Wages and White Lion Investments, LLC, dba Triton Distribution, et al., and arises from a lawsuit filed by companies challenging the FDA’s denial of their applications to market and sell flavored e-cigarette products across state lines.  In January 2024, the Fifth Circuit Court of Appeals ruled in favor of the applicants’ challenge.  The attorneys general encourage the Supreme Court to reverse that decision.

The amicus brief was filed by the attorneys general for Arizona, California, Colorado, Connecticut, the District of Columbia, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington.  A copy of the brief may be found here

State Attorneys General Advocate for Surgeon General’s Warning Labels on Social Media Platforms

On September 9, 42 state attorneys general joined a National Association of Attorneys General Letter to House and Senate leadership supporting legislation to establish a surgeon general’s warning label on algorithm-driven social medial platforms, stating that social media is associated with significant mental health harms for adolescents. According to the state AGs, such platforms represent a serious public mental health threat, closely linked to youth depression, anxiety and suicidal ideation.

The Letter follows previous efforts taken by state attorneys general— including Arkansas, Indiana, Iowa, Kansas, Nebraska, New Hampshire, and Utah—but  advocates for federal intervention. 

According to the AGs’ letter, a federally mandated surgeon general’s warning “would be a consequential step toward mitigating the risk of harm to youth.” The authors urge Congress to seriously consider this and other steps to protect youth in the face of emerging technologies, citing the Senate’s passage of the Kids Online Safety Act and Children and Teens’ Online Privacy Protection Act as evidencing bipartisan commitment to protecting youth online.

The following state attorneys general signed the Letter: Alabama, Arkansas,  American Samoa, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, U.S. Virgin Islands, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming.

Eight State Attorneys General Join DOJ Antitrust Lawsuit Against RealPage

On August 23, 2024, the Attorneys General of North Carolina, California, Colorado, Connecticut, Minnesota, Oregon, Tennessee, and Washington, joined the DOJ Antitrust Division in suing RealPage, Inc., alleging an unlawful scheme to decrease competition among landlords in apartment pricing and to monopolize the market for commercial revenue management software that landlords use to price apartments.

The complaint alleges that landlords share with RealPage their nonpublic, competitively sensitive data, which RealPage then uses to generate rental pricing recommendations, suppressing competition among landlords to the detriment of renters throughout the country.  The state attorneys general assert their independent authority under Section 16 of the Clayton Act to bring actions to obtain injunctive relief for violations of Sections 1 and 2 of the Sherman Act.

The attorneys general of the District of Columbia and Arizona previously sued RealPage for the same conduct, in November 2023 and February 2024, respectively.  Those lawsuits—like a complaint filed by a proposed class of renters in October 2022—allege that RealPage’s conduct constitutes per se price-fixing. The allegations by the DOJ and the eight state attorneys general do not go that far, alleging instead information sharing and vertical agreements with landlords, claims that are typically decided under the rule of reason.

Massachusetts Attorney General Reaches $600 Million Settlement with Tobacco Companies

On August 12, 2024, the Massachusetts Attorney General’s Office, announced that it had reached a settlement for in excess of $600 million with tobacco manufacturers. The settlement resolves several years’ worth of disputes between the Attorney General’s Office and tobacco manufacturers concerning annual payments arising from a 1998 Master Settlement Agreement (MSA).  That 1998 MSA required tobacco manufacturers to make annual payments to address the public health effects from smoking and the marketing of tobacco products.  The $600 million settlement resolves disputes in arbitration about amounts withheld from those annual payments to states. In announcing the settlement, the AGO emphasized that it is “part of the AGO’s ongoing efforts to improve public health.”

California AG Says Further Consolidation in “Core” Markets Bad for Consumers

By Dillon Denio and Karen Alexander

The office of California Attorney General Rob Bonta recently suggested in an interview with the online publication MLex that his office believes that further consolidation in markets that are “core” to American life—including the financial sector and the agriculture, airline, and grocery industries—does not serve the economy, consumers, or competition well.

The comments align with the California Attorneys General’s Office’s recent opposition to mergers and joint ventures in the airline and grocery industries. In 2021, California joined the Department of Justice’s (DOJ) successful lawsuit to prevent American Airlines and JetBlue Airways from consolidating their operations in Boston and New York City. In early 2024, California, along with six other state attorneys general, joined the DOJ’s lawsuit to prevent the $3.8 billion acquisition by JetBlue of Spirit Airlines. And in 2024, California was among the several states that joined the Federal Trade Commission’s (FTC) lawsuit to block the proposed merger between grocery giants Kroger and Albertsons.

The Attorney General’s comments and recent actions show California’s continuing opposition to mergers in the financial sector and the agriculture, airline, and grocery industries. Businesses in these “core” markets looking to consolidate with competitors should be aware that California’s Attorney General’s Office may challenge the deal.

Vermont Attorney General Sues Two of Largest PBMs for Driving Up Drug Prices

On July 17, 2024, the Vermont Attorney General, Charity R. Clark, filed a lawsuit in Vermont Superior Court against two of the largest pharmacy benefit managers (“PBMs”) in the country, CVS Caremark and Express Scripts.  The suit alleges that these two PBMs—which, according to the complaint, together control approximately 95% of the commercial PBM market in Vermont—have violated the Vermont Consumer Protection Act by engaging in deceptive and unfair practices that have had the effect of driving up pharmaceutical prices for consumers and squeezing independent pharmacies.

PBMs act as intermediaries in the health care system—they manage prescription drug benefits, including by negotiating discounts, rebates and fees with drug manufacturers, creating drug formularies (lists of medications that are covered by insurance) and policies, and reimbursing pharmacies for drugs covered by prescription-drug plans.

The Vermont AG’s complaint alleges that because they control which drugs are placed on the formularies, CVS Caremark and Express Scripts are able to extract payments from the manufacturers in return for favorable placement, which the PBMs retain as profits instead of passing along to payors and patients.  It alleges that these PBMs drive up drug prices by giving preference on their formularies to drugs with high list prices—and correspondingly high manufacturer payments—over lower priced drugs.  The complaint also alleges that CVS Caremark and Express Scripts pay lower reimbursement rates to pharmacies that are not affiliated with them, resulting in harm to independent pharmacies.

The allegations in the Vermont complaint echo the Federal Trade Commission’s interim conclusions of its ongoing study of the PBM industry.

Coalition of 11 State Attorneys General Call for Increased Efforts to Rein In Private Equity in Healthcare

On June 5, 2024, the Attorneys General of California, Connecticut, Delaware, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Washington, and Washington D.C. submitted a 29-page comment letter in response to the Request for Information on Consolidation in Healthcare Markets issued jointly by the U.S. Department of Justice Antitrust Division (DOJ), the Federal Trade Commission (FTC), and U.S. Department of Health and Human Services (HHS).  In the letter, the attorneys general expressed their concern about the adverse effects of consolidation in healthcare markets, particularly through transactions driven by private equity.

In particular, antitrust enforcers have focused on private equity “roll-ups”, consolidation of multiple smaller providers into a larger provider network. Over the last 14 years, healthcare consolidation propelled by private equity has steadily increased; between 2010 and 2020, the estimated private equity deal values in healthcare totaled about $750 billion. Many of those transactions involved the acquisition of physician practices, hospices, nursing homes, hospitals, and behavioral healthcare facilities. In their letter, the attorneys general stated, without empirical evidence, that this consolidation has led to increased prices, decreased access and quality of care, and harm to patients and communities.

The attorneys general urged the DOJ, FTC, and HHS to “explore all avenues to prevent conduct by private equity in healthcare that harms patients, healthcare workers, and taxpayers who often end up footing the bill.”  They made several concrete recommendations, including (1) increased transparency of ownership and payments; (2) a ban on anticompetitive contracting in federal programs; and (3) joint enforcement against anticompetitive conduct and mergers.  The letter shows that a significant number of states are ready to partner with federal authorities in reining in private equity’s influence in health care.

California AG Reminds Major Pharmacy Chains and Health Data Companies to Comply with New Requirements of Confidentiality of Medical Information Act

On June 26, 2024, California Attorney General Rob Bonta sent letters to eight major pharmacy chains and five health data companies reminding them of their obligations to conform to the new California law concerning protected health information related to reproductive care. Companies receiving letters include CVS, Walgreens, Walmart, Kroger, and Rite Aid.

New requirements of the California Confidentiality of Medical Information Act (CMIA), under Assembly Bill 352 (2023), effective July 1, 2024, provide additional protections for confidential patient information. Law enforcement cannot gain access to information concerning patients’ reproductive health or gender-affirming care without a warrant. In addition, pharmacies and health data companies are prohibited from disclosing patients’ abortions to anyone from another state without the patient’s consent. These companies must also enable security features to segregate and protect data concerning abortion, contraception, and gender-affirming care.

Attorney General Bonta spoke out to reinforce compliance with these new requirements, stressing that protecting patient information “is now more imperative than ever.” The letters asked these companies to provide the Attorney General with their policies demonstrating their compliance with AB 352 by July 31, 2024.

Coalition of State Attorneys General Supports Registry of Consumer Protection Law Violations

On June 11, 2024, the attorneys general of New York, California, Colorado, Connecticut, Illinois, Maryland, Minnesota, Oregon, Pennsylvania, and Vermont wrote a letter to Rohit Chopra, the Director of the Consumer Financial Protection Bureau (CFPB), in support of the CFPB’s Nonbank Registration of Orders Rule. The Rule, which becomes effective September 16, 2024, will require nonbank entities that offer consumer financial products and services to register with the CFPB all final orders issued by courts or by federal, state, or local law enforcement agencies finding violations of consumer protection laws. The CFPB will use this information to compile a searchable online registry available to the public. Failure to register will be a violation of federal consumer financial law subject to CFPB enforcement, and remedies include potential civil monetary penaltie

In their letter, the state attorneys general stated that they support the Rule because the registry will enable them to spot emerging problems and engage in early prevention efforts.  They also believe that the registry will be useful in prioritizing certain targets of investigations over others, targeting state-level or regional actors that might not draw attention from federal agencies, and negotiating resolutions with entities engaged in similar conduct.

Nonbank entities that offer consumer financial products and services should ensure that they are in compliance with the Rule following its effective date. Such entities should also be aware that the registry could result in increased enforcement from the CFPB and state attorneys general. As the state attorneys general point out in their letter, the registry may also be useful to such entities in identifying instances of specific conduct that courts or agencies have previously determined to be unlawful, deceptive, unfair, or abusive, and to shape their own marketing and compliance efforts accordingly.

State Attorneys General Urge Supreme Court to Protect State Regulation of PBMs

A group of 32 state attorneys general filed an amicus brief on Tuesday, June 11, urging the Supreme Court to review a Tenth Circuit decision which held that federal law—specifically ERISA and Medicare Part D—preempted sections of an Oklahoma state law regulating pharmacy benefit managers (“PBMs”), and that those sections were therefore unenforceable.

PBMs act as intermediaries in the health care system—they manage prescription drug benefits, including by negotiating discounts, rebates and fees with drug manufacturers, creating drug formularies (lists of medications that are covered by insurance) and policies, and reimbursing pharmacies for drugs covered by prescription-drug plans. In their amicus brief, the attorneys general argue that states should be allowed to regulate PBMs.  The attorneys general argue that PBMs have become too powerful, have contributed to higher drug costs, and have devastated independent pharmacies, which disproportionately serve minority populations.

A Supreme Court decision could provide guidance to states (all 50 states have laws regulating PBMs to some degree) concerning the limits of state regulation of  PBMs. Recognizing the importance of a potential decision, multiple pharmacy-related associations have joined the attorneys general in filing amicus briefs in support of state regulation of PBMs (including one filed by Duane Morris on behalf of the National Association of Specialty Pharmacy). Their briefs echo the attorneys general’s brief in addressing the market impact of PBMs and their impact on vulnerable communities.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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