Ex-BD Official Seeks DoJ Referral Against Company
A former Becton Dickinson (BD) medical director and safety monitor has petitioned FDA to refer the company to the U.S. Justice Department for allegedly violating the False Claims Act related to a safety defect with the company’s 510(k)-cleared Genesis Sterilization Containers. The devices are intended to keep surgical equipment under sterile conditions, but the petitioner contends the devices had been failing a safety-related “aerosol test” at a high rate for the past decade.
The petitioner is cardiac surgeon Hooman Noorchashm, known to FDA for his opposition to power morcellation, who alleges his BD employment was terminated in August after he continually objected to the company’s alleged practice of not reporting the device defect to FDA. Noorchashm’s petition claims that BD and its associates “deliberately concealed a critical product safety defect in the Genesis line of sterilization containers from FDA and consumers in violation of federal law” from 2011 to 2022. He also notes in the petition that BD “changed course” last month and recalled the Genesis device from the marketplace.
Noorchashm, whose wife died of cancer caused by power morcellation, appears to be opening a second front against BD products following his termination. Earlier this month, he petitioned the agency asking it to change the classification of BD’s poly 4-hydroxybutyrate (P4HB)-based Phasix and GalaFlex products from medical devices to biologicals so that they undergo proper clinical safety and efficacy testing. That petition argues that FDA misclassified the products as devices, which has led to their “potentially unsafe introduction into the oncology space without adequate preclinical and clinical testing to ensure safety.”
The petition further says the misclassification of P4HB-based bioactive mesh and scaffold material as medical devices is posing a potential threat to public health in the oncology space, specifically their use in breast cancer reconstruction. It says it is unclear whether P4HB-induced inflammation of the mastectomy reconstruction space in women would (1) interfere with radiological surveillance for recurrent cancer, and (2) potentiate cancer recurrence rates. “These metrics are critically important to public health and safety in the breast cancer space anytime a biologically active substance is placed in direct contact with an oncological resection space,” Noorchashm says.