Former Pharmaceutical CEO Sent To Prison: On August 31, 2022, a former owner and CEO of a Broward County drug manufacturing company who lied to the FDA and allowed contaminated products to make their way to pediatric hospitals was sentenced to 37 months in federal prison.
Background Allegations
Raidel Figueroa co-owned Pharmatech, LLC, a company that from 2016 to 2017 manufactured and distributed the laxative Diocto Liquid. In July 2016, as part of a larger investigation into an outbreak of infections linked to bacteria known as Burkholderia cepacia (“B. cepacia”), the FDA inspected Pharmatech’s operations. Typically found in water and soil, and transmissible through contaminated medications, B. cepacia can lead to respiratory and other infections for people with weak immune systems, chronic lung disease, and other conditions.
The FDA notified Figueroa in August 2016 that a sample taken from Pharmatech’s water system had tested positive for B. cepacia. Figueroa assured the FDA that Pharmatech would re-engineer its purified water system to prevent future contaminations.
In March 2017, the FDA again inspected Pharmatech’s operations and asked Figueroa to disclose all products that the company had manufactured since its supposed water system upgrade. Figueroa lied to the FDA investigators by knowingly excluding Diocto Liquid from its products distribution list (even though Pharmatech shipped over 7,000 units of the drug earlier that month) and by telling the FDA that Pharmatech’s new water system had met “acceptance criteria,” which was not true.
In July 2017, the CDC notified the FDA of multiple B. cepacia infections in pediatric patients at Stanford Children’s Health Lucile Packard Children’s Hospital in Palo Alto, California and Johns Hopkins Children’s Center in Baltimore, Maryland. The FDA investigated, collecting bottles of Diocto Liquid from these medical centers. Several of the bottles contained unacceptable amounts of bacteria, yeast, and mold. Some bottles tested positive for B. cepacia. The FDA’s investigation revealed that Pharmatech had distributed those same bottles in March 2017 – something that Figueroa knowingly failed to disclose to the FDA.
In June 2022, Raidel pled guilty to conspiring to defraud the FDA, falsifying records in an FDA investigation, obstructing proceedings before the FDA, and distributing adulterated drugs.
PharmatechLLC states on its website: “PharmaTech LLC is a Contract Development Manufacturing Organization (CDMO) offering one-stop solutions in developing and manufacturing both Rx & OTC products accordingly to Current Good Manufacturing Practices. All products are manufactured at our USA facility with a focus in delivering quality products & quality service every step of the way. Whether you are a current pharmaceutical marketing company, wholesaler/distributor, exporter or even a contract manufacturer that needs to meet market demands, PharmaTech LLC has a very knowledgeable and energetic team in place to put any size project to work. Our experienced team of chemists, formulators, project coordinators and dynamic quality assurance team allows us to continue to offer top quality Rx & OTC products while meeting and exceeding FDA standards and regulations.”
If you or a loved one suffered injuries (or worse) as a result of a bad drug/defective drug in the United States, you should promptly seek the legal advice of a pharmaceutical claim lawyer in your state who may investigate your drug claim for you and represent you in a claim against a pharmaceutical company, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find drug claim lawyers in your state who may assist you.
Turn to us when you don’t know where to turn.