Consumer Product & FDA Fraud Attorney in Nashville, TN

Written by Kimberly S. Hodde, National Chair of Criminal Defense at Meister Seelig & Schuster

Federal investigations into consumer product fraud and FDA violations often target deceptive marketing, adulterated goods, pharmaceutical diversion, clinical trial fraud and data falsification, executive liability under the Park Doctrine, and misbranded medical items.

The FDA Office of Criminal Investigations (OCI) and the Department of Justice’s Consumer Protection Branch handle these cases, sometimes with the FBI or DEA. Investigations can result in both criminal and civil penalties. Those penalties can include imprisonment, corporate compliance mandates, heavy financial restitution, and FDA Debarment from regulated industries. When the alleged conduct involves claims submitted to Medicare or Medicaid, the investigation may also require an experienced Medicare and healthcare fraud defense strategy.

Misbranding

The FDCA strictly prohibits introducing a “misbranded” drug or medical device into interstate commerce. A product is misbranded if its labeling is false or misleading, if it lacks adequate directions for use, or if it is marketed for an unapproved use.

In the healthcare sector, providers and corporate executives are often charged with misbranding when they actively promote a drug or device for “off-label” uses or make false representations about a medication’s safety profile.

Adulteration

Adulteration charges apply when a drug or medical device is manufactured, processed, or held under substandard conditions, or when its strength, purity, or quality falls below established standards.

Providers or manufacturers can face criminal charges for shipping, distributing, or administering adulterated products, such as medications that have been illegally repackaged, compromised, or contaminated, even if only a single order is involved.

False Claims Act (FCA) Violations

While the FDA regulates the safety and marketing of medical products, violations often trigger significant civil liability under the False Claims Act. Providers and companies face FCA charges for knowingly submitting, or causing others to submit, fraudulent claims to government healthcare programs such as Medicare and Medicaid.

In FDA-related fraud, this often manifests as billing for medically unnecessary services, “upcoding” (billing for a more expensive procedure than performed), or submitting claims for treatments involving unapproved or fraudulently marketed medical devices.

Responsible Corporate Officer (RCO) or Park Doctrine Offenses

Under the Park doctrine (United States v. Park, 421 U.S. 658 (1975)), healthcare executives and corporate officers can be held strictly liable for FDCA violations (such as misbranding or adulteration) committed by their companies. Prosecutors do not have to prove that the executive had direct knowledge of the fraud, intended to commit a crime, or was even personally involved. In fact, the FDA can hold “responsible corporate officers” strictly liable for misdemeanor violations of the Food, Drug, and Cosmetic Act under 21 U.S.C. § 331, such as CGMP deviations, even without actual knowledge or criminal intent.

A conviction only requires proving that the executive held a position of authority and failed to prevent or promptly correct the violation. This is typically a misdemeanor, but it can be elevated to a felony if evidence shows intent to defraud.

Mail and Wire Fraud

Because fraudulent medical schemes almost always involve electronic billing systems, the postal service, or interstate communications, prosecutors in DEA cases frequently add mail and wire fraud charges. These broad federal statutes allow prosecutors to charge individuals who devise a scheme to defraud patients or insurers by using the mail or wire communications to carry out fraudulent marketing or distribution of FDA-regulated products.

Defense Counsel for FDA and Consumer Product Fraud Investigations

If you or your business are in the midst of a consumer protection or FDA fraud investigation or have been charged in such a case, you should engage experienced federal criminal defense counsel with litigation experience in this area. Kim Hodde and her team at MSS are highly experienced in defending FDA fraud and consumer product fraud investigations.

Kim Hodde leads her Nashville-based team and serves as the National Chair of Criminal Defense at Meister Seelig & Schuster (MSS), partnering with attorneys across the firm’s offices in New York, New Jersey, Connecticut, California and Tennessee. This expanded national platform provides clients with the resources of a sophisticated, multi-office law firm while maintaining the personalized, strategic representation for which Ms. Hodde is known.

Together, Kim Hodde and her team at Meister Seelig & Schuster (MSS) provide high-level representation for executives, business owners, professionals, organizations, and other individuals facing fraud charges in Nashville, throughout Tennessee, and across the United States. If you or your business is facing an FDA or consumer product fraud investigation, contact Kim Hodde and MSS-Nashville to discuss your defense.