Clinical Research Enforcement Defense
Clinical Research Enforcement Defense Team Lead
Former DOJ Attorney
Clinical Research Enforcement Defense Team Lead
Clinical Research Enforcement Defense Team Consultant
Former HHS-OIG Assistant Special Agent-in-Charge
For businesses and institutions that rely on federal research grants, facing scrutiny related to their clinical trials (and other aspects of their clinical research) is a very real concern. The federal government is focused on combating fraud, waste, and abuse in the federally funded research sector, and entities ranging from life sciences companies and medical device companies to academic medical centers are at risk of facing high-risk government investigations and enforcement actions.
Our Clinical Research Enforcement Defense Practice
At Oberheiden P.C., we rely on extensive experience in this area to defend and counsel clients that are facing scrutiny from all federal agencies and departments. This includes the U.S. Department of Justice (DOJ), U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS) Office of Inspector General, and National Institutes of Health (NIH), among others.
We assist clients with meeting their federal compliance obligations as well. If your business or institution receives federal funding and is facing scrutiny—or if you have concerns about facing scrutiny—related to interpretation of clinical trial data, presentation of real world evidence, reporting obligations, or any other aspect of research integrity or research misconduct, we can provide the advice and insights you need. Contact us to speak with experienced legal counsel at Oberheiden P.C. in strict confidence today.
How We Can Help
From compliance to defense, we assist clients in the healthcare industry with all aspects of managing risk related to federally funded clinical research, including clinical trials. If your business or institution is at risk (or may be at risk) of facing a federal enforcement action, here are just some of the ways our attorneys can help:
Conducting Internal Investigations
Conducting an internal investigation is an efficient and effective way to assess a business’s or institution’s risk in the event of a federal investigation or enforcement action targeting the business’s or institution’s clinical research or clinical trial data. We assist clients with conducting internal investigations—while also ensuring that the findings of our clients’ internal investigations are protected by the attorney-client privilege.
With our broad experience advising clients in the area of federally funded clinical research compliance, our attorneys are able to help our clients quickly assess their risk under the Food, Drug, and Cosmetic Act (FDCA), Health Insurance Portability and Accountability Act (HIPAA), Anti-Kickback Statute (AKS), and other pertinent federal statutes. We are able to assess compliance risk related to all pertinent regulatory requirements as well. When internal investigations uncover potential violations, we then advise clients regarding the steps they need to take to effectively mitigate their risk going forward.
Assessing Compliance with Federal Research Grants
Our team also assists clients with assessing compliance with the terms and conditions of their federal research grants. For businesses and institutions that rely on federal funding, this area of compliance is critical. Not only can non-compliance lead to loss of federal funding; but, in some cases, it can lead to civil (or even criminal) enforcement action under the federal False Claims Act as well.
The False Claims Act prohibits the submission of any “false or fraudulent” claim to any federal agency. For businesses and institutions that rely on federal funding for clinical research, this includes submitting false information in connection with a grant application or grant renewal—as well as reporting false information about research findings and conclusions. If a business or institution (or an executive or researcher) is accused of submitting false information with knowledge of its falsity, this is when the risks of facing allegations of research misconduct or lack of research integrity can become much more severe.
Responding to Government Investigations
A significant portion of our team’s practice involves representing federally funded clients facing allegations of clinical trial fraud and other civil and criminal violations. For healthcare companies, life sciences companies, academic medical centers, and other entities that are facing government investigations, a prompt, strategic, and proactive response is critical.
While many of these investigations involve the FDA, NIH, HHS Office of Inspector General, and other federal agencies that focus specifically on healthcare, pharmaceutical, and medical device-related compliance, the U.S. Department of Justice is increasingly playing a role in these investigations as well. When the DOJ gets involved, this means that facing civil or criminal litigation is a very real possibility. With a team that includes former DOJ prosecutors (as well as other former federal attorneys and agents), we are well-versed in the federal government’s investigative processes and procedures—and we rely on these insights to effectively represent and advise clients in an extremely wide range of scenarios.
Defending Against Government Enforcement Actions
In many cases, taking a strategic and proactive approach to defending against a government investigation targeting alleged violations in federally funded clinical research will facilitate a favorable resolution that avoids formal charges. But, if this is not feasible under the circumstances at hand, then defending against the government’s allegations in civil or criminal enforcement litigation may be necessary.
The former DOJ prosecutors on our team have extensive experience on both sides of high-stakes government enforcement actions as well. We have successfully defended numerous companies and institutions in enforcement litigation, including at trial and on appeal. If litigating the government’s allegations is your company’s or institution’s best (or only) option, our attorneys can provide the representation your company or institution needs.
Mitigating Enforcement Risk Going Forward
Along with helping healthcare companies, academic institutions, and other entities mitigate their risk during government investigations and enforcement actions, we also help our clients mitigate their enforcement risk going forward. We do this by providing services including (but not limited to):
- Updating our clients’ compliance programs to meet current federal statutory and regulatory requirements;
- Updating our clients’ compliance programs to better align with the guidance available from the FDA, HHS Office of Inspector General, and other federal agencies and departments;
- Advising clients regarding industry standards and best practices for managing clinical research-related compliance at the federal and state levels;
- Assisting with the implementation of artificial intelligence (AI) and other technological tools to manage federal statutory and regulatory compliance; and,
- Serving as general outside counsel so that we can advise and assist clients with clinical research-related compliance on an ongoing basis.
These are just examples. From internal governance matters (i.e., appointing a Chief Compliance Officer) to addressing new executive orders, laws, and regulations, we assist clients with all other aspects of federal and state risk management as well.
Put our highly experienced team on your side
Dr. Nick Oberheiden
Founder
Attorney-at-Law
Lynette S. Byrd
Former DOJ Trial Attorney
Partner
Brian J. Kuester
Former U.S. Attorney
Hon. Kevin McCarthy
55th Speaker, U.S. House of Representatives (ret.)
Government Consultant
Mike Pompeo
Of Counsel
Former U.S. Secretary of State
John W. Sellers
Former Senior DOJ Trial Attorney
Linda Julin McNamara
Federal Appeals Attorney
Nicholas B. Johnson
Former Prosecutor
Roger Bach
Former Special Agent (DOJ)
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Ray Yuen
Former Supervisory Special Agent (FBI)
FAQs: Responding to Allegations of Clinical Trial Fraud Under the False Claims Act (and Other Federal Laws)
Why is a Federal Agency (i.e., DOJ, FDA, or NIH) Looking Into Our Clinical Research?
The DOJ, FDA, NIH, HHS Office of Inspector General, and other agencies are currently looking into numerous businesses’ and institutions’ clinical research practices as part of the administration’s efforts to combat fraud, waste, and abuse. By targeting entities in the healthcare sector in particular, these agencies are seeking to restore the public’s trust in the United States’ healthcare system. Recalling federal funds, cancelling grants, and pursuing civil or criminal fines are all mechanisms that the administration is using to claw back taxpayer funds as well.
What Oversight Does the Federal Government Have of Clinical Research and Clinical Trials?
The federal government has extensive oversight of clinical research and clinical trials conducted with federal funds. Entities that rely on federal funding must strictly comply with the terms of their grants, and their failure to do so can lead to allegations of clinical trial fraud and other serious federal offenses.
Facing a government investigation related to federally funded clinical research can present a variety of severe risks. While loss of federal funding is among many targeted entities’ most immediate concerns, these investigations can also lead to civil or criminal allegations in some cases.
What is “Clinical Trial Fraud”?
“Clinical trial fraud” is a broad term that encompasses all sorts of improprieties involved in conducting federally funded clinical research, including clinical trials. Medical device companies, pharmaceutical companies, life sciences companies, medical services providers, academic institutions, and numerous other entities can face clinical trial fraud allegations in a wide range of circumstances.
If your business or institution is facing federal scrutiny related to its clinical research or a clinical trial, you should engage experienced defense counsel promptly. At Oberheiden P.C., our team has extensive experience in this area, and we can get to work protecting your business or institution immediately if necessary.
Speak with a Clinical Research Enforcement Defense Lawyer at Oberheiden P.C.
If you would like to speak with a senior clinical research enforcement defense lawyer at Oberheiden P.C., we invite you to get in touch. To schedule a complimentary initial consultation, please call 888-680-1745 or tell us how we can reach you online today.
