A whistleblower (“relator”) has filed a False Claims Act qui tam complaint against Baylor College of Medicine (BCM), alleging that it has defrauded federal grant programs for biomedical research awarded by the National Institutes of Health (NIH). More specifically, Relator alleges that BCM’s biomedical research program has had “serious and continuing noncompliance” problems that have threatened the validity and reliability of its biomedical research. As a result, BCM’s failures have tainted the biomedical research the Government has funded. Such knowing failures have included:
- allowing unauthorized, untrained, and unqualified individuals to conduct surgeries, leading to “serious and continuing” noncompliance with federal requirements
- botching surgeries of research animals
- failing to properly administer anesthesia during surgeries and pain relief medications
- violating DEA and NIH requirements for drug use and maintenance, and unlawfully using expired drugs on research animals
- failing to properly monitor the health of research animals post-operatively
- failing to follow government-mandated biomedical research protocols
- causing illness and death to research animals, unrelated to experimental causes
As a result, significant taxpayer money and animal lives are wasted, according to the complaint filed in the U.S. District Court for the Southern District of Texas. Federally funded research is big business for BCM. Since 2016, BCM received over $2 billion from NIH. Over $325 million was for Government claims paid to BCM labs in which there has been “serious or continuing noncompliance.”
Because these failures are systemic, the complaint alleges that BCM also put at risk state grants awarded by funders such as Cancer Prevention and Research Institute of Texas (CPRIT) and private grants awarded by funders such as the American Heart Association, March of Dimes, McNair Medical Institute, Albert and Margaret Alkek Foundation, John S. Dunn Foundation, National Multiple Sclerosis Society, American Cancer Society, and Helis Medical Research Foundations.
BCM is paid taxpayer money to advance the scientific understanding and treatment of human disease and conditions such as breast and prostate cancer, heart disease, central nervous system disease, diabetes, liver and digestive diseases, neurological disorders like epilepsy, eye diseases, newborn health and development, genetic health, allergies, and asthma. The American College of Laboratory Animal Medicine states that “pain and distress are undesirable variables in most scientific research projects and, if not relieved, can result in […] invalid scientific outcomes.” BCM should not be using taxpayer money for research that leads to invalid outcomes.
Some of the BCM labs that received the most federal funding were the worst of the worst violators, according to the complaint. In one example, an untrained individual improperly laced a wire (telemetry lead) through the skin externally on a research mouse instead of implanting it, in violation of research protocols, as shown by this photo.
This botched surgery rendered the animal useless for the study and the mouse was euthanized. This was a direct result of untrained individuals at BCM, and the death was unrelated to experimental causes. Other untrained researchers in the same lab failed to administer required pain medication. Even worse, the whistleblower alleges, BCM falsely reported to NIH that there were no problems with the research animals in this experiment and failed to report the death of two more research animals.
BCM has already found itself in the hotseat with NIH and its accrediting agency in recent years. In 2017, the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) found BCM was committing serious violations of federal requirements and BCM hid these findings from the NIH until forced to report them and even then, failed to report the full nature of the violations to NIH. In 2018, NIH placed BCM on “enhanced reporting” because of “ongoing serious programmatic noncompliance”—one step removed from termination of federal funding. NIH warned BCM that it had better not be hiding noncompliance, warning BCM that a “cover up is worse than the crime.”
The whistleblower is highly respected and widely known in the lab animal care scientific research community and worked in a senior position at BCM for 15 years until she was fired for repeatedly raising and trying to require BCM to get its act together. The Whistleblower tried to stop BCM from allowing untrained individuals from continuing to perform surgeries on research animals, a major cause of the serious and continuing noncompliance.
One lab, which received over $9 million in NIH money, was studying interventions to improve the growth and health of premature human infants, using young pigs as animal models. The lab allegedly and knowingly allowed untrained and unqualified individuals to conduct surgeries, resulting in botched surgeries and piglet deaths.
The False Claims Act is a powerful tool to recover misspent taxpayer money, deter future misconduct, allow whistleblowers to report unlawful activities, receive protection from retaliation, and receive a share of the Government’s recovery. A whistleblower successfully pursued a grant fraud qui tam lawsuit against Duke University in 2019, alleging the university submitted falsified data in reports about the research conducted using grant money.
The whistleblower is represented by Renée Brooker and Eva Gunasekera of Tycko & Zavareei LLP, Jack Kolar of the Government Accountability Project, and John R. Thomas, Jr. of Hafemann, Magee & Thomas. Mr. Thomas was lead counsel for the whistleblower in the case against Duke University, which led to an over $100 million False Claims Act settlement.