Month: May 2022

Source: United States Department of Justice News

The United States has filed a lawsuit against The Prometheus Group (Prometheus), a New Hampshire manufacturer of pelvic muscle therapeutic systems and related rectal probes, and Richard Poore, its president and sole owner. The complaint, filed in the U.S. District Court for the Western District of Michigan, alleges that the defendants violated the False Claims Act by causing health care providers to bill Medicare for services in which the providers improperly re-used single-user rectal sensors and single-use catheters on multiple patients. The United States alleges that the reuse of these devices on multiple patients unnecessarily exposed vulnerable Medicare beneficiaries to the risks of serious bacterial, fungal and viral infections.

“Providers and suppliers who participate in federal health care programs are expected to maintain the highest standards of patient care,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will hold parties accountable for causing the use of unsafe procedures that may put patients’ health at risk.”

“The Medicare Program is designed to serve an already-vulnerable population,” said U.S. Attorney Mark Totten for the Western District of Michigan. “Device manufacturers must not train providers who bill Medicare for services to use devices in a way that fails to protect patient health.”

“By encouraging the improper reuse of medical devices for financial gain, this manufacturer significantly endangered the health and safety of patients,” said Special Agent in Charge Mario Pinto with the Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “HHS-OIG is committed to working with our law enforcement partners to hold accountable any medical device manufacturers who exploit federal health care programs and threaten the health and safety of beneficiaries.”

Prometheus manufactures and sells device systems for use in pelvic muscle rehabilitation (PMR), a non-surgical therapy to eliminate or reduce symptoms of pelvic floor disorders, including urinary and fecal incontinence. Specifically, Prometheus has manufactured and marketed the Pathway CTS 2000 Pelvic Floor Training System and the Morpheus System. Both systems required the use of a rectal pressure probe that is inserted into a patient’s rectum during therapy. Prometheus manufactured its own sensor for use with the Pathway System and encouraged its customers to use another company’s anorectal manometry catheter with the Morpheus System.

The U.S. Food and Drug Administration (FDA) cleared the Prometheus rectal pressure sensor to be used as a single-user device and the anorectal manometry catheter to be used as a single-use device. For example, the instructions for use identify the rectal pressure sensor as “a potential bio-hazard” and state: “This sensor is restricted for single person use only. Use by another person is strictly prohibited by Federal Regulations.” Similarly, the anorectal manometry catheter was cleared by the FDA as a disposable single-use device, with packaging that states: “Do not re-use.”

According to the United States’ complaint, the defendants knew of these restrictions, but for years encouraged and instructed health care providers to reuse the rectal pressure sensors and anorectal manometry catheters on multiple patients, using a glove or condom to cover the probes, as a way to reduce the overhead costs associated with Prometheus’s systems. This reuse, which exposed patients to unnecessary risk of infections, was not reasonable or necessary, and thus was ineligible for Medicare coverage. In addition to the safety risks, Prometheus allegedly made no attempt to determine if the probes worked effectively when re-used under those conditions. 

The lawsuit is captioned United States v. The Prometheus Group., et al., No. 1:22-CV-446 (W.D. Mich.), and is being handled by the Civil Division’s Commercial Litigation Branch (Fraud Section) and the U.S. Attorney’s Office for the Western District of Michigan. Lead counsel are Senior Trial Counsel Jay D. Majors and Assistant U.S. Attorney Andrew J. Hull.  Investigative support is being provided by HHS-OIG, FDA and FBI.   

The claims asserted in the United States’ complaint are allegations only, and there has been no determination of liability.

Source: United States Department of Justice News

Christopher James Davis, of Venice, California, pleaded guilty in federal court in Mobile, Alabama, to one count of falsifying and using a document to obtain approval from the Environmental Protection Agency (EPA) to manufacture a pesticide.

According to court documents, Davis, a product manager for a pesticide manufacturer, submitted documents supporting a pesticide’s U.S. registration that he knew falsely indicated that the pesticide had been approved for manufacture and use in Canada, when in fact Davis knew it had not. Relying on the submission with this false information, the EPA approved the pesticide’s U.S. application.

“The honesty of individuals applying to manufacture pesticides is vital to protecting the public’s health and the environment,” said Assistant Attorney General Todd Kim of the Justice Department’s Environment and Natural Resources Division. “We will prosecute those who falsify records and submit them to obtain regulatory approvals.”

“In order to safeguard the environment, it is essential that the Environmental Protection Agency’s pesticide programs receive accurate and honest information from pesticide producers and their employees,” said Special Agent in Charge Chuck Carfagno of EPA’s Criminal Investigation Division. “This guilty plea sends a clear message that EPA and its law enforcement partners will continue to hold individuals fully accountable for illegal conduct that jeopardizes the environment.”

The case was investigated by the EPA Criminal Investigation Division. The case is being prosecuted by Senior Counsel Kris Dighe of the Environmental Crimes Section of the Department of Justice’s Environment and Natural Resources Division, Assistant U.S. Attorney Michael Anderson, and Special Assistant U.S. Attorney Jennifer Lewis.

Source: United States Department of Justice News

Gregoire Tournant, Chief Investment Officer of Allianz Global Investors U.S.’s Structured Products Group, and Two Others Charged with Fraud Offenses

Source: United States Department of Justice News

Remarks as Prepared

Good morning and thank you for that warm welcome. President Schmoke; Interim Provost Andersen; my friend and Justice Department alum Dean Weich; Regent Hur; distinguished faculty; proud parents, mentors, and friends; restless siblings; and over-achieving graduates about to become overworked lawyers — thank you for the honor to speak before you.

Especially in light of the horrific violence in Buffalo, New York, I am deeply grateful to share this space of inclusion and community with all of you. We mourn for the victims and their families, and the entire Buffalo community. The Justice Department is investigating this tragedy as a hate crime and an act of racially motivated violent extremism. All of us must pledge to combat the hatred that motivates these crimes and honor our shared humanity.

It’s good to back be in this city that I’ve come to love so much — not only because my sister and her family live here! It is especially humbling to return to the University of Baltimore School of Law — a place that has meant so much to me professionally. In the legal community, we often talk about the promise of the law; how it can serve as a powerful tool to transform our highest values into real protections for people. Here at UBalt, that isn’t just talk. It isn’t just an ideal to strive for. It is how this school engages with the people outside of campus. This is an institution that cares about the community it calls home.

I experienced that firsthand at a time of deep fracture in Baltimore and across the nation. In 2015, I was serving at the Justice Department as the head of the Civil Rights Division. We were working tirelessly to forge new paths toward public safety, racial justice, and police-community trust, when tragedy struck here in Baltimore. Freddie Gray died in police custody, igniting an already charged atmosphere. On the day he was laid to rest, my new boss, Attorney General Loretta Lynch, was sworn into office. She immediately called and asked me and my team to head straight to Baltimore.

We drove up early the next morning. We met with the Gray family. We met with community leaders and organizers. We met with police officers. The city’s collective pain was profound.

As we held those first meetings, and again when the Justice Department opened our formal investigation into the Baltimore Police Department, this law school opened its doors to us and to a grieving community. Dean Weich offered our team space in the law building to do the necessary work of bringing different parts of the Baltimore community together and listening to their perspectives on what seemed like an intractable crisis.

Over the 15-month investigation, we were often at the law school. We held community town halls. We talked to residents from every corner of Baltimore — from Mount Vernon to Sandtown.

That dialogue was painful. It was raw. The divides — not just in opinions but in real, lived experiences — sometimes felt irreconcilable. But perhaps because of that pain, we found threads of commonality in those conversations. Everyone agreed that we were confronting grave challenges. Everyone shared an immense love for this city — and a belief in the possibility of building something better, something worthy of the people who call it home.

While the work of building police-community trust in Baltimore is ongoing, there has been meaningful, important progress. I am grateful to those who are continuing that work today.

I tell this story not just because of my gratitude to the UBalt Law community. I also tell it because it transformed me — and I’d like to share three lessons that have stayed with me, and that I hope can guide you on this next phase of your professional lives.

First, in all of your work, listen — really listen.

Change is most effective when everyone with a stake in the problem sees themselves in the solution. That’s why in Baltimore, I spent time with and listened to those on the front lines of the crisis — police officers and community members alike. When you’re confronting a difficult problem, keep an open and curious mind. We can’t drive real change when everyone is backed into their own corners.

I understand there is great temptation during difficult times to close ranks — to retreat to what is most comfortable. To what is safe. But the most meaningful things I’ve ever done have been in times of crisis, when I have been out of my comfort zone and pushed myself to find a path forward when none seemed possible.

As you do that work, remember none of us owns the whole truth. Any time you think you do — pause and question yourself. It may reveal your own areas of narrow thinking, which if unchecked, will stop you from being effective. I promise it is possible to hold fast to your principles, act with integrity, and be pragmatic all at the same time. Indeed, it’s often the only way to get things done.

My second lesson is this: Do not give into despair.

I stand here before you today from the Department of Justice, the only agency in our federal government that bears the name of a value.

The department was created in the aftermath of the Civil War. Its very first charge was securing the rights promised by the Thirteenth, Fourteenth, and Fifteenth Amendments, at a time when the Ku Klux Klan was engaged in a campaign of violence and lynchings of Black Americans.

Today, we have come so far, and yet there is still so much left to do. Ensuring equal justice for all is an awesome and never-ending responsibility. Attorney General Garland has made protecting civil rights a top priority for the department, across everything we do.

You, too, can strive for equal justice no matter what you do or where you work. You can fulfill our obligation to provide legal representation to those who cannot otherwise access lawyers — like UBalt’s Associate Dean Vicki Schultz, who I want to congratulate for becoming the next head of Maryland Legal Aid.

Whether in government or elsewhere, you will find opportunities to uncover and reckon with hard truths. To hold people, companies and institutions accountable. To drive change where there is injustice. And to heal a nation that craves hope and decency.

But there will also be times when the weight of the work, and the work left to do, will feel overwhelming. Stay hopeful. Remember that hope is a discipline; you must practice it every day.

The beauty of this country and the promise of our legal framework is not that we are perfect, but that we never stop trying to live up to our highest ideals. We can change. We can make progress when people work to close the gap between what the law guarantees on paper and what people experience in their lives.

You’ve learned about change-makers in history books, seen them on screens, or maybe known them in your lives. Those people do not fall from the sky. They are the community and city leaders working in Baltimore in 2015 and today. They are you.

No matter what path you take, keep faith in yourself, in the people around you, and in the power of this profession to make extraordinary change. You may not find all of the answers or move in a linear path. But when people roll up their sleeves and refuse to back down, when they stay in the fight against all odds — then real and lasting change is possible.

Third, treat people with kindness and grace.

That starts with the people closest to you in your life, including yourself.

Remember all that you have accomplished just by getting here today. After all, you’ve spent most of your time in law school also getting through a global pandemic.

Remember all that you are outside of being a law school graduate and soon-to-be attorney.

And remember all who helped you get here today. Hold your family and friends close. Thank them. We must take time to care for each other.

Regardless of what kind of law you decide to practice, I can assure you that your job will feel overwhelming at times.

My job can be stressful. I know I’m not alone in that. And there are moments when it would be easy to put off calling my parents or spending time with my family. But that’s no way to live. Even when you are doing important work, find grounding with the important people who make it all possible.

This world can be hard, and this profession can be harsh. Be kind to yourself. It is a necessary part of the work.

As the mother of two boys, trying to be there for my friends, and attempting to read more novels, even with a husband who does so much every day to support me, I still struggle with work-life balance. It isn’t easy. But we need to glance up from the screens every now and then and look people in the eyes. Express our gratitude. Support, love and inspire one another. And have fun, too.

Trust me. You’ll need your anchors, especially now.

I won’t sugar coat the context in which you are becoming lawyers.

During the last few years alone, the rule of law has been challenged. Our democracy has been challenged. Longstanding precedent upholding our fundamental freedoms is being challenged.

And you will be challenged.

We’ll need your talent in the days ahead. We’ll need your conviction. Your hope.

This law degree confers on you amazing privilege. Be courageous in how you exercise it. No matter where you practice law, you will have opportunities to pursue justice and serve the public good. Take them.

Class of 2022: looking out at you fills me with hope.

Listen, don’t give into despair, and always lead with kindness and compassion, and I know you will change this profession and this world for the better. 

Congratulations. I wish you all the very best of luck.