Government Investigations
When a company in the food or drug industry is under government investigation, it is crucial to have representation by lawyers who are fully versed in the intricacies of regulation and who have a robust track record of litigation before regulatory agencies. Amin Wasserman Gurnani’s multidisciplinary approach provides clients under investigation with deep industry and regulatory knowledge, in addition to strong scientific and vigorous advocacy capabilities. Ultimately, we aim to resolve our clients’ problems as quickly as possible.
Amin Wasserman Gurnani’s clients turn to us when they receive subpoenas, investigative demands, notices of seizures, forfeitures, injunctions and lawsuits from agencies such as the FDA, FTC and State Attorney Generals. We represent pharmaceutical companies faced with False Claims Act investigations and consumer product companies being investigated for reporting requirements of the U.S. Consumer Product Safety Commission.
We understand the dramatic implications that these actions may have on the business processes of our clients: not only the impact on production calendars and contracts, but product reputation, financial liability and long term market value.
First, we endeavor to anticipate and prepare for investigations at the onset by guiding our clients in the development of products, concurrent labeling and advertising that comply with all relevant regulations.
We frequently implement internal investigations, advising on how and when to present findings to the government. We also design front-end compliance programs that can help our clients avoid similar future investigations.
If a client is confronted with an investigative process, we then engage with the agency in question. As our attorneys have long-standing positive relations with all of the agencies governing our core industries, we are often successful in negotiating favorable settlements.
When necessary, we have deep experience litigating claims arising from government investigations, including:
- FTC, Section 5 Truthful Advertising claims – civil investigative demands and complaints
- FDA, USDA, State AG and Departments of Health Regulatory Actions
- Defending against product import detentions, seizures, recalls, injunctions and criminal proceedings
- CPSC investigations into whether companies are in compliance with the reporting requirements of Section 15(b) of the Consumer Product Safety Act.
- Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act of 1986)
- DEA enforcement proceedings involving product and asset seizures, prosecutions of DEA licenses and other DEA regulatory proceedings
- Negotiating consent orders with the EPA and other related state agencies
Finally, we guide our clients through the post-judgment phase to make sure they comply with agency rulings, making any manufacturing or distributorship adjustments that are necessary for our clients to continue with their course of business.
