Good Manufacturing Practice (GMP) Violations
Serving Clients Nationwide
As the world’s largest purchaser of prescription drugs under Medicare, Medicaid, the Veterans Administration, and other government healthcare programs, the United States government has a vested interest in ensuring that prescription drugs are safe and effective. Good Manufacturing Practices (GMP) regulations are already in place for public safety reasons, requiring that all prescription medications are manufactured in a way that meets FDA standards for safety, identity, strength, and purity under the Federal Food, Drug, and Cosmetic Act. While the FDA already enforces these standards, a pharmaceutical company that is aware of or is indifferent to GMP violations in the manufacturing of drugs purchased by the government may be held to have made a false claim under the False Claims Act.
The basis for holding a pharmaceutical company liable under the False Claims Act is that in knowingly covering up GMP violations in written records already required under GMP standards, the manufacturer has generated false records. These false GMP records are required for the government to purchase their drugs. Therefore, hiding GMP violations in those records resulted in the government paying a false claim when purchasing those drugs, resulting in pharmaceutical fraud.
Becoming a Whistleblower on GMP Violations
Because there are alternative strategies for the U.S. government to pursue legal action against GMP violators, the federal government has not yet sought to recover damages for GMP violations under the False Claims Act. However, the legal rationale for bringing a False Claims Act case stands and has been the basis already for qui tam whistleblower lawsuits.
If you have knowledge of significant, persistent GMP violations at a pharmaceutical manufacturer, you may have grounds for a qui tam action. Minor violations or technicalities, even when covered up in GMP documentation, may not be actionable under the False Claims Act. The qui tam law firm of Kenney & McCafferty, P.C. has extensive experience litigating whistleblower actions, and we will help you determine if your knowledge can be used to build a qui tam case.
Kenney & McCafferty is one of the country’s foremost qui tam public interest law firms, representing whistleblowers nationwide for fifteen years and taking part in some of the largest recoveries in the history of the False Claims Act. Kenney & McCafferty is dedicated to rooting out and fighting fraud against the government. Most importantly, we are committed to guaranteeing maximum whistleblower protection and exceptional representation which will help you maximize your whistleblower reward.
If you have knowledge of a fraud or false claim against the government, please contact our qui tam lawyers today. Kenney & McCafferty attorneys will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys during these consultation services are confidential and protected by the attorney-client privilege.
