San Diego-based Valor Medical, Inc., a biomedical device manufacturer, and four of its employees have reportedly pleaded guilty to counts of failing to provide the Food and Drug Administration (FDA) with required information on unfavor- able safety tests for Neucrylate, a product developed to treat aneurysms. The company, which faces a February 19, 2014, sentencing hearing, entered a guilty plea to a felony violation that carries a maximum penalty of five years’ probation, a $500,000 fine and a $400 special assessment. A federal magistrate judge has already sentenced former Valor CEO H. Clark Adams, who pleaded guilty to a misdemeanor charge, to one year of probation and a $5,000 fine. Valor’s Regulatory and Clinical Manager Cathy Bacquet drew a sentence of one year of probation and a $2,500 fine. Two additional defendants reportedly faced a February 3 status hearing.
According to U.S. Attorney Laura Duffy, “Our nation’s system of evaluating medical device safety and effectiveness depends upon the submission of truthful data to the FDA. When manufacturers like these defendants place their profits above their duty to honestly report the results of product testing, they place the American public’s health and safety in jeopardy. This office will continue to vigorously enforce laws designed to protect the health and safety of our citizens through cases like this.”
Court records show that the company filed two investigational device exemption (IDE) applications, which must be obtained to perform the human clinical trials that would provide the data needed to support an application for premarket approval. IDE applicants must submit “reports of all prior clinical, animal and laboratory testing of the device.”Valor allegedly sent Neucrylate samples to a lab for testing and, when the lab found that all of the chromosomes in the chromosomal assay (CAA) were destroyed by initial contact with the device, Valor declined to retest the samples, which would have been standard protocol. Preliminary results of the mouse lymphoma assay (MLA) were similarly unfavorable, with the “test article” found to be “mutagenic.”The company provided neither the CAA nor the MLA test results to FDA. On later investigation, Bacquet allegedly told the agency that the CAA and MLA tests were inadvertently left out of the IDE application and that company management and regulatory staff were unaware of the results. Emails apparently contradicted these representations. See U.S. Attorney News Release, January 30, 2014.