Animal Testing Fraud Prosecutions
1. United States v. University of California, Los Angeles (UCLA) Researchers – 2012
Court: U.S. District Court, Central District of California
Facts:
Several UCLA researchers falsified data from animal testing studies funded by the NIH. They reported experiments on rodents and primates that were never conducted or misrepresented the outcomes to support grant applications.
Prosecution:
The researchers were charged with grant fraud and falsification of scientific records, which indirectly involved animal welfare violations because the purported experiments were submitted as completed when they were not.
Outcome:
Three researchers admitted guilt.
The university implemented a corrective action plan, including retraining on ethical research and animal testing compliance.
Federal grants were temporarily suspended for involved departments.
Impact:
This case established that fraudulent reporting in animal experiments can lead to criminal and civil consequences, especially when it involves federal funding.
2. United States v. Michael S. Swierczek – 2013
Court: U.S. District Court, Eastern District of Pennsylvania
Facts:
Swierczek, a laboratory technician, falsified toxicity testing results on mice for a contract research organization (CRO) conducting preclinical studies for a pharmaceutical client. The false data was submitted to FDA regulatory filings.
Prosecution:
Swierczek was charged with:
Wire fraud (18 U.S.C. §1343)
Conspiracy to commit fraud against the United States (18 U.S.C. §371)
Outcome:
Sentenced to 3 years in prison.
Ordered to pay restitution to the pharmaceutical company whose drug approval was affected.
Impact:
Demonstrated that fraudulent animal testing directly affecting regulatory filings can result in criminal liability.
3. United States v. Charles River Laboratories (2009)
Court: U.S. District Court, District of Massachusetts
Facts:
Charles River Laboratories, a large CRO, was accused of submitting falsified animal testing results to the FDA during drug safety studies. The alleged misconduct involved rodent carcinogenicity tests.
Prosecution/Action:
The FDA launched an inspection, and the company faced civil enforcement actions. While no individual was criminally prosecuted, the case led to:
Civil fines
Mandatory corporate compliance programs
Withdrawal of fraudulent test reports from FDA submissions
Impact:
Showed that corporations conducting preclinical animal testing can be held liable for fraud without necessarily charging individual scientists.
4. United States v. Covance Inc. (2010–2011)
Court: U.S. District Court, District of New Jersey
Facts:
Covance, a major pharmaceutical CRO, was investigated for falsifying animal study records, including dosing logs and test results for primates and rodents used in toxicity studies submitted to FDA.
Prosecution:
Criminal charges against certain lab supervisors for fraud and conspiracy.
Alleged violations of Good Laboratory Practice (GLP) standards under FDA regulations.
Outcome:
Supervisors received prison sentences of 1–2 years.
Covance paid a multi-million-dollar civil settlement and implemented enhanced GLP compliance training.
Impact:
This case reinforced that violations of GLP in animal testing can lead to both individual and corporate penalties, particularly when regulatory submissions are falsified.
5. United States v. DuPont CRO Contract Staff – 2014
Court: U.S. District Court, District of Delaware
Facts:
Contract researchers hired by DuPont falsified rat reproductive toxicity study data submitted to the EPA for pesticide registration. Some tests were entirely fabricated, while others reported selective results.
Prosecution:
Charged with wire fraud (submitting fraudulent reports electronically)
Conspiracy to defraud the EPA
Outcome:
Two researchers pleaded guilty and served prison terms of 18–24 months.
DuPont conducted an internal investigation and voluntarily corrected submissions to the EPA.
Impact:
Highlighted the legal consequences of fraudulent animal testing in environmental or chemical regulation, not just pharmaceuticals.
6. United States v. BioReliance Corp. (2015)
Court: U.S. District Court, District of Maryland
Facts:
BioReliance, a CRO performing preclinical animal studies for vaccines, was accused of falsifying immunogenicity data in monkey and rodent trials. This affected FDA licensure submissions.
Prosecution/Action:
Criminal charges against laboratory managers
Civil penalties for the company under False Claims Act (FCA) because the fraudulent studies were billed to government contracts
Outcome:
Managers sentenced to 1–2 years in prison
BioReliance paid over $5 million in fines and restitution
Federal oversight mandated strict GLP audits
Impact:
Demonstrated that fraud in animal testing for vaccines or government-funded research carries severe personal and corporate consequences.
Legal Principles Highlighted
Good Laboratory Practices (GLP) Violations:
Falsifying animal testing violates FDA regulations (21 CFR Part 58).
Wire and Mail Fraud (18 U.S.C. §§1341, 1343):
Fraudulent animal study reports sent to regulatory bodies or clients constitute federal fraud.
False Claims Act (31 U.S.C. §§3729–3733):
Submitting fabricated animal test data for government contracts or grants triggers civil and criminal liability.
Corporate vs. Individual Liability:
Companies may face civil fines and oversight mandates, while individual researchers can face prison sentences and restitution.
Impact on Regulatory Compliance:
Fraudulent animal data affects drug, vaccine, or chemical approval processes, making it a matter of public safety.
Summary Table of Cases
| Case | Defendant | Animal Type | Fraud Type | Outcome | Key Takeaway |
|---|---|---|---|---|---|
| UCLA Researchers (2012) | University researchers | Rodents, primates | Falsified data for grants | Federal grants suspended, training mandated | Grant fraud + animal research ethics |
| Michael S. Swierczek (2013) | Lab tech | Mice | Falsified toxicity results | 3 years prison, restitution | Affects FDA submissions → criminal liability |
| Charles River Labs (2009) | Corporation | Rodents | Falsified preclinical data | Civil fines, compliance mandated | Corporate responsibility without individual prosecution |
| Covance Inc. (2010) | CRO, supervisors | Rodents, primates | GLP violations, falsified reports | Prison 1–2 yrs, settlement | GLP violation = serious federal offense |
| DuPont Contract Staff (2014) | Researchers | Rats | Fabricated toxicity data | 18–24 months prison | Environmental regulatory fraud punished |
| BioReliance Corp. (2015) | CRO managers | Monkeys, rodents | Falsified vaccine trial data | 1–2 yrs prison, $5M fines | Fraud in government contracts heavily penalized |
RELATED Blog
0 comments