May 25, 2022

Volume XII, Number 145

Advertisement
Advertisement

May 25, 2022

Subscribe to Latest Legal News and Analysis

May 24, 2022

Subscribe to Latest Legal News and Analysis

May 23, 2022

Subscribe to Latest Legal News and Analysis
Advertisement

Co-Owner of Clinical Trial Company Pleads Guilty to Obstruction of Justice in Connection with Falsification of Clinical Trial Data

On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection.  Olga Torres co-owned the clinical research site, Unlimited Medical Research (UMR).  During its years of operation, UMR was engaged as a clinical trial site by a number of pharmaceutical companies. The conduct that led to the obstruction of justice charge stemmed from a clinical trial conducted at UMR to evaluate the safety and efficacy of a pediatric asthma drug.    

A clinical trial is a research study conducted in humans designed to help clinical investigators evaluate the safety and effectiveness of a new drug.  It is governed by a protocol that describes the objectives, design, methodology, statistical considerations, and organization of the clinical trial.  Data generated in clinical trials are submitted to FDA, which relies on the truthfulness and accuracy of such data to make regulatory decisions regarding the approval of the new drug.  The FDA, pursuant to the Federal Food, Drug, and Cosmetic Act, conducts inspections of clinical investigators and clinical trial records to ensure compliance with the clinical trial protocol and applicable laws and regulations.  Pharmaceutical companies seeking to launch new drugs sponsor the clinical trials but do not conduct them directly; instead, they engage trial sites and principal investigators to enroll subjects and conduct the trials.  These sites may be academic medical centers, community hospital, physician practices, or entities like UMR established specifically to conduct clinical research.  Often, pharmaceutical companies engage a clinical research organization (CRO) to help them manage clinical trials, including the selection and oversight of sites.  In the UMR case, the sponsor of the trial had engaged a CRO and that CRO had apparently contracted with UMR.

The FDA interviewed Torres as part of its regulatory inspection of the clinical trial conducted at UMR in 2017.  In the factual proffer offered with Torres’ guilty plea, Torres agreed to facts sufficient to prove an obstruction of justice charge.  Specifically, Torres made a number of false statements to FDA investigators to create the appearance that the clinical trial had been conducted legitimately and honestly when she knew that it had not.  For example, she told FDA investigators that UMR prepared accurate and complete medical records in conjunction with the clinical trial and that study subjects were seen at UMR and not another location.  Torres knew that neither of these statements were true, yet she signed an affidavit prepared by the FDA memorializing these falsities.  In fact, the records of the study subjects had been falsified and UMR had fabricated data showing that subjects had attended study visits at UMR.    

Previously, the principal investigator and others involved in the trial had pleaded guilty to wire fraud in connection with the pediatric asthma study.

Clinical trial fraud is a fairly recent subject of federal fraud enforcement.  In December 2021, Deputy Assistant Attorney General (AAG) Arun G. Rao delivered remarks at the Food & Drug Law Institute’s (FDLI) 2021 Enforcement, Litigation and Compliance Conference indicating that the Department of Justice’s Consumer Protection Branch has focused its efforts on combatting clinical trial fraud over the past several months.  Deputy AAG Rao explained that fabricated clinical trial fraud can result in dangerous consequences if relied upon by those making material decisions about the safety and efficacy of a drug, and falsification of clinical trial data can undermine confidence in the healthcare industry as a whole.  We expect to see further clinical trial fraud actions in the coming months.

The case also speaks to the need for sponsors and CROs to be vigilant in selecting and monitoring clinical trial sites and principal investigators.

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XII, Number 18
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Jane Haviland, Mintz Levin Law Firm, Complex Commercial Litigation Product Liability & Complex Tort Securities Litigation Health Care Enforcement & Investigations
Associate

Jane’s practice focuses on litigation matters, including health care enforcement defense, complex civil and business litigation, and product liability law. Recent victories to which Jane has contributed include:

  • Defense verdicts on summary judgment in multi-jurisdictional product liability disputes involving FDA-approved pharmaceutical drugs and assay test development.
  • Defense verdict on partial summary judgment in a bet-the-company case involving a dispute between the majority owner of a multi-billion dollar company and private equity investors.

Jane...

617.348.4473
Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...

202.434.7349
Kate F. Stewart Healthcare Attorney Mintz Boston
Of Counsel

As former in-house counsel at an academic and community hospital system, Kate provides solutions on a broad range of legal issues affecting health care clients including digital health and privacy regulations, clinical trial compliance, and transactions for for-profit and non-profit clients.

Kate draws on her in-house experience to provide holistic counsel to hospitals, physician groups, clinical laboratories, retail health clinics, pharmacies, and payors, as well as new market entrants and start-ups in the digital health space.

...
617-348-4868
Advertisement
Advertisement
Advertisement