Source: United States Department of Justice

The Justice Department announced today that it and the Department of Health and Human Services (HHS) issued a joint letter to state Medicaid administrators urging them to ensure, in accordance with the Americans with Disabilities Act (ADA), that their Medicaid programs allow people who have both Hepatitis C (HCV) and substance use disorder (SUD) to access life-saving HCV medications called direct-acting antivirals (DAAs). 

More than two million adults in the United States have HCV, which can result in a range of serious health conditions including liver disease, liver cancer and death. However, highly effective DAA medications cure HCV in more than 95% of cases.

“Medicaid recipients with substance use disorders are entitled to the same access as others to a cure for Hepatitis C,” said Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division. “This letter reminds state Medicaid administrators that they have an obligation to ensure their programs are in compliance with federal civil rights law. The Justice Department stands ready to enforce the ADA in order to eliminate unnecessary barriers that stand in the way of equal access to health care.”

The letter highlights a settlement agreement between the Justice Department and Alabama’s Medicaid Agency (Alabama Medicaid) to address a policy that denied Medicaid coverage for DAAs to patients who had consumed any alcohol or illicit drugs within the six months prior to starting treatment. Alabama Medicaid’s policy meant that people with HCV and SUD, who also had evidence of recent use of alcohol and/or illicit drugs, were denied potentially life-saving medication. Following the initiation of an investigation by the department, Alabama Medicaid withdrew this policy and entered into an agreement to secure Medicaid coverage for such patients going forward.

The letter explains that both the Justice Department and HHS enforce the ADA with respect to state Medicaid programs. The ADA requires that states, in administering their Medicaid programs, provide individuals with disabilities, including SUD, equal opportunity to participate in and benefit from a state’s Medicaid program. The letter urges all state Medicaid administrators to review their current and forthcoming policies and practices, including those on HCV treatment, to determine if any changes are necessary to comply with the ADA.    

For more information on the Civil Rights Division, please visit www.justice.gov/crt. For more information on the ADA, please call the department’s toll-free ADA Information Line at 800-514-0301 (TTY 833-610-1264) or visit www.ada.gov. ADA complaints may be filed online at www.civilrights.justice.gov/report.

Source: United States Department of Justice

Good morning. I want to start by thanking Chair Marván and COFECE for inviting me to speak today. I am honored to help celebrate COFECE’s 10th anniversary and the 30th anniversary of the Federal Economic Competition Law. Chair Marván, congratulations. As your agency looks to its next decade, I am confident that COFECE is in excellent hands.

COFECE’s founding and its successes reflect values we hold dear in the United States. Antitrust is for the people. We believe in robust antitrust enforcement to keep markets free and working for our people instead of exploiting and excluding them.

Both of our agencies recognize this foundational view of competition. Mexico’s Federal Economic Competition law opposes activity that “impedes or distorts the process of competition and free market access.”[1] The U.S. merger guidelines similarly explain that “competition is a process of rivalry” that delivers lower prices, more choices, higher wages and increased innovation, resiliency and choice. At the same time, competition and the competitive process preserve economic freedom and are essential ingredients for a free and democratic society.[2]

Healthy and fair competition results in real benefits for real people. Competition means better pay for workers, lower prices for consumers and the opportunity for anyone to build a business and compete on their merits.

COFECE and the Antitrust Division therefore have, in many ways, a similar mission with a similar vision at its heart. Through our work protecting competition, we maintain structural protections for the economic liberty of our people.

We also have in common an understanding that it takes hard work to make that vision a reality. We must fight one case at a time to ensure the benefits of competition for our people.

Today I’d like to highlight three areas where both of our agencies are making antitrust work for the people.

First, our agencies have had a similar focus on the importance of competition in transportation. The impact of competition on our people’s economic liberty is easy to see in the transportation industry. Competitive markets for travel mean the freedom to visit loved ones, travel to school or take a vacation.

COFECE took this seriously in its findings related to bus transportation at the Mexico City International Airport.[3] Exclusionary conduct that limits competition and raises prices for transportation to and from the airport prevents people from traveling and exploits those that do pay the price with higher costs and fewer choices. I commend COFECE on the significant fine that resulted from that matter.

The Antitrust Division has been similarly focused on competition in transportation. After decades of consolidation in the United States, our airline industry has become too concentrated. Our people suffer the consequences of that oligopoly every day, with too little competition driving prices up and reducing service, choice and innovation.

Twice in the last year we have made that argument to our federal courts, and twice they have agreed. In one matter, we successfully challenged a tie-up between two airlines that stifled competition for a significant portion of the United States. After a lengthy hearing, the judge found that our antitrust laws are “not concerned with making individual competitors larger or more powerful.” The judge blocked the alliance because he recognized that antitrust law “preserve[s] the free functioning of markets.”

That was the first time in 40 years of consolidation that the Antitrust Division won a litigated judgment in court to preserve competition in airlines.  

We had to wait less than a year for the next win. Just last week, another federal judge enjoined a multibillion-dollar airline merger after a hard-fought trial by the Antitrust Division’s litigators. Our case was about preserving affordable fares for the most cost-conscious consumers.

In a thorough 113-page opinion carefully analyzing the facts of the industry, the judge agreed and went to great lengths to issue an opinion that prioritizes the interests of travelers and those who can least afford air travel.

Antitrust is for the people.

Second, our agencies recognize that people deserve and need competition in housing. Housing is usually the single biggest cost in a family’s budget. Competition in housing means lower rent and real estate costs for families. Competition in housing means being able to move up to a bigger house when you have a newborn or moving to a new city to pursue your career. And competition in housing means more money for a family to spend on the other necessities of life.

That is why the Antitrust Division has prioritized promoting competition in real estate and housing. We have multiple active matters involving the costs of buying a home or renting an apartment.  

COFECE’s work similarly shows the impact that competition enforcement in housing markets can have. As most of you know, COFECE uncovered a real estate broker cartel whose monopolistic practices increased broker commission rates, setting commission rates above 7% for certain transactions. Economic analysis showed the real-world impact of stopping this cartel, with real estate sales in the area doubling in relation to national figures following the fine.[4]

When real estate sales increase, more people can move into a new home that better fits their lives. Antitrust is for them. 

Third, our agencies are both fighting to ensure that concentrated corporate power does not suppress the wages and working conditions in our labor markets. Our economies suffer from abuses of monopoly and monopsony power alike. Competition matters for workers just as it does for end consumers.

COFECE’s enforcement program reflects this reality. Its landmark action against 17 Liga MX clubs and the Mexican Football Federation for fixing the wages of women players showed that competition in labor markets is an essential priority under the antitrust laws.

The Antitrust Division has also increased its emphasis on labor issues. Take for example, our 2023 Merger Guidelines, which prioritize labor competition and recognize that “labor markets are important buyer markets” and that harm in a labor market alone is a sufficient basis to challenge a merger.

As in many other places, that part of the guidelines reflects how we have been enforcing the antitrust laws in recent years. We demonstrated our commitment to protecting workers and creators in a pathbreaking publishing industry case last year. A proposed merger would have consolidated the “big 5” publishers into a new “big 4.” The merger would have further tightened an oligopoly facing writers — including both established authors of best-selling books and those working hard to break through. Authors and books are more than just economic units. They are vital to the marketplace of ideas, free speech and the public discourse.

Authors depend on competition among publishers to earn their advances and be able to do their work. A federal court agreed with our case, and entered an opinion prohibiting the merger and reaffirming that harm to a labor market is reason enough to prohibit a merger.

We saw another critical win for labor market competition in a court of appeals case last year. Leinani Deslandes was a fry cook at McDonald’s earning $7 an hour who worked her way up and was offered a management position. That’s supposed to be the upward mobility you can earn with free market capitalism.

Ms. Deslandes faced a problem, though. The management offer she got was from a competing McDonald’s. The corporation’s contracts with franchises stood in the way because they commit franchises not to hire each other’s workers. So, they said that Ms. Deslandes could not take the new management role or the better hours and better pay. And a federal district court agreed, dismissing the case.

The Antitrust Division participated in the appeal of that decision because we believe that agreements among employers not to hire each other’s workers restrain competition and deprive those workers of economic justice. Ms. Deslandes earned and deserved that promotion.

The good news is that the court of appeals agreed with our position, reversing the lower court and sending the case back for further proceedings. The court reaffirmed that the law does not treat benefits to consumers as justifying detriments to workers. Antitrust law, the court held, is also concerned with competition in the markets for inputs like labor.

Whether you are an author or a McDonald’s employee like Leinani Deslandes, we all benefit from competition in labor markets. Antitrust is for workers.  

I should add that when we talk about the people impacted by competition, our cases connect better with both the public and the courts. In the United States, we are seeing that across our work. Our new merger guidelines, designed to use more accessible and direct language, received tens of thousands of overwhelmingly supportive public comments. In the past, we typically received only a few dozen comments when revising the guidelines. Among other things, this was a byproduct of dependence on an overly technocratic process and often impenetrable language that largely excluded, rather than invited, participation from the general public. This time around, we took a different approach, which produced an outpouring of interests from all segments of our society. Our new guidelines use accessible language that invites public engagement with merger reviews that impact their lives and livelihoods. Not only is this good process, but it is also good policy as well.

Meanwhile the courts are connecting with these stories as well. In fact, in the last year the DOJ and FTC have seen an incredible string of successes in important merger cases in the federal courts.  

I believe those wins stem, in part, from the way our teams have emphasized the importance of competition in protecting the economic liberty of real people. Our litigators are telling human stories and seeing those stories resonate with the courts and the broader public.

I’d like to conclude by underscoring that transportation, housing and labor are not the only areas where COFECE has been a global leader and an important partner. Effective competition enforcement increasingly requires cross-border collaboration. We draw insight from the lessons you learn and encouragement from your achievements. Despite our different antitrust regimes, we have much to gain from this dialogue with each other.

That cooperation will necessarily increase further as we prepare together for the 2026 World Cup. Just a few months ago, our agencies launched a joint initiative to deter, detect and prosecute collusive schemes, fraud and corruption related to the provision of goods and services for the World Cup. As Chair Marván pointed out at the time, this event gives us the opportunity to make the benefits of competition tangible for the people of our nations.[5] I look forward to working closely with COFECE and the CCB on the initiative.

More broadly, as COFECE turns to its next 10 years, we at the Antitrust Division look forward to continued partnership and collaboration as we work to protect competition for the people of our nations. Congratulations again.

Source: United States Department of Justice

The Justice Department announced today that a federal judge sentenced a Philadelphia-area man to prison yesterday for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance.

Peter Stoll III, 35, pleaded guilty last year to one felony count of violating the Federal Food, Drug and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce. U.S. District Judge Joseph F. Leeson sentenced Stoll to 12 months in prison and one year of supervised release.

According to court documents, Stoll was a regulatory affairs specialist at a medical device manufacturer located in the Eastern District of Pennsylvania and was responsible for making submissions to the FDA that were required before the company could sell its medical devices. In pleading guilty, Stoll admitted that in 2017, he created two false letters that purported to show that FDA had granted clearance to sell two different medical devices. As a result, the company illegally sold tens of thousands of dollars’ worth of medical devices throughout the United States.

According to court documents, Stoll was responsible for shepherding two of the company’s devices through the FDA’s 510(k) clearance process: the ELAN-4 Air Drill, a high-speed surgical drill used for bone cutting, sawing and drilling, and the JS Series SterilContainer S2, a reusable sterilization container for medical instruments. Stoll admitted that he never submitted any 510(k) documents to FDA regarding either device. Instead, Stoll created a fraudulent letter using FDA letterhead and bearing the forged digital signature of an FDA official that falsely stated that FDA had cleared the ELAN-4 Air to be marketed. Stoll later created another, similarly fraudulent letter on FDA letterhead for the SterilContainer JS Series medical device.

“Individuals who subvert the FDA clearance process for medical devices put patients’ lives at risk,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will work with its law enforcement partners to prosecute individuals who falsify documents and violate the law.”

“The FDA’s checks and balances exist for one reason: to protect the public,” said U.S. Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania. “One of the medical devices illegally sold in this case is meant to be used in invasive surgeries; the other, to sterilize instruments, preventing infection or contamination. Evading the prescribed FDA clearance process can literally be a matter of life and death, which is why we take these cases so seriously and work to hold perpetrators responsible for their actions.”

“The FDA must be notified and given the opportunity to clear certain medical devices before they are distributed into interstate commerce,” said Assistant Commissioner for Criminal Investigations Justin D. Green of the FDA. “A medical device distributed without FDA clearance can put patients at risk. Our office will aggressively pursue those who place patients at risk by failing to follow the law. The FDA’s Office of Criminal Investigations (OCI) protects the American public by rigorously investigating allegations involving FDA-regulated products and violations of the FDCA. In this case, OCI worked with the Justice Department to ensure a just resolution, and we applaud the exceptional work done by the team.”

FDA’s OCI investigated the case.

Trial Attorney Max Goldman and Assistant Director Ross S. Goldstein of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney and Health Care and Government Fraud Chief Mary Mary Beth Leahy for the Eastern District of Pennsylvania are prosecuting the case.

Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.