Government Investigations

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 Talati Wasserman’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 Talati Wasserman’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.

Practice Group Leader(s)

George R. Spatz

Partner

gspatz@amintalati.com

312.784.1062 PHONE

Matthew R. Orr

Partner

matt@amintalati.com

213.985.7219 PHONE

William P. Cole

Partner

william@amintalati.com

213.985.7206 PHONE

ATTORNEYS IN THIS PRACTICE

Ashish R. Talati

Partner

ashish@amintalati.com

312.327.3381 PHONE

Ivan J. Wasserman

Managing Partner

ivan@amintalati.com

202.496.4966 PHONE

Abhishek K. Gurnani

Partner

abhishek@amintalati.com

312.327.3325 PHONE

Rend Al-Mondhiry

Partner

rend@amintalati.com

202.918.7852 PHONE

Jacqueline Kuler

Partner

jacqueline@amintalati.com

312.784.1075 PHONE

Sanjay S. Karnik

Senior Counsel

sanjay@amintalati.com

312.327.3327 PHONE

Jennifer Adams

Associate

jennifer@amintalati.com

312.327.3383 PHONE

Karmina Fefferman

Associate

karmina@amintalati.com

312.784.1085 PHONE

Natascia Roman

Associate

natascia@amintalati.com

312.784.1073 PHONE

Javier Gonzalez Rivera

Associate

javier@amintalati.com

202.918.7854 PHONE

Manon Burns

Associate

manon@amintalati.com

312.784.3018 PHONE