Criminal Enforcement Actions

Let our Aggressive FDA Litigators Defend You

FDA's most serious enforcement activities are having unprecedented success. A noteworthy string of record-breaking penalties against medical product manufacturers have resulted from FDA enforcement actions and Federal investigations that involved the FDA in the past several years.

These include:

• $500 million for failure to comply with Good Manufacturing Practices--Schering Plough (May 2002);
• $355 million settlement for health care fraud--AstraZeneca (June 2003);
• $92.4 million for failing to report malfunctions of a medical device to the FDA--Guidant (June 2003) ;
• $33.1 million in fines and forfeitures for submitting false information to the FDA--Aventis Pharmaceuticals, Inc. (October 2001) ;
• $30 million for failure to comply with Good Manufacturing Practices--Wyeth Ayerst (October 2000); and
• $4.7 million in restitution for resale of pharmaceuticals--Northland Provider (August 2001) .

C. Humphrey & Associates P.A. advocates free-enterprise principles, responsible government, property rights, and a balanced civil and criminal justice system. Our criminal defense attorneys work to preserve our client's rights, as well as shape public policy for our clients through aggressive litigation and advocacy.

Please contact us for more information on how we may help you with any FDA criminal matters.