Manufacturing Adulterated Drugs and Devices

Drugs and medical devices are held to strict quality control standards to ensure the purity and quality of their products. For example, FDA regulations require that facilities used to source the active ingredients in drugs must meet “good manufacturing standards,” and such facilities must be registered and approved by the FDA. Unscrupulous drug and device companies, however, often cut corners and source their drugs from unapproved facilities, or otherwise use adulterated materials in manufacturing their drugs and devices. While this may increase profits, it puts patients’ health and safety at risk. When these adulterated drugs or devices are reimbursed by Medicare, Medicaid, or other government programs, the reimbursement claims are false, and the drug and device companies likely have significant liability under the False Claims Act.