Jennifer L. Bragg

Jennifer’s recent experience includes representing:

Litigation/Investigations

• A pharmaceutical company in successfully resolving a DOJ investigation of its patient affordability programs through securing a declination
• A pharmaceutical company in successfully resolving enforcement proceedings brought by the FDA and the DOJ manufacturing issues
• Purdue Pharma in successfully resolving DOJ civil and criminal investigations*
• Pfizer in securing an order to vacate an amended consent decree entered into with the FDA and DOJ*
• Miraca Holdings in securing the dismissal of claims brought by a qui tam relator under the federal False Claims Act and the California and North Carolina state analogues*
• A leading medical device company’s senior executive in securing a dismissal after being individually named in a consent decree of permanent injunction for the company with the FDA and the DOJ Civil Division’s Consumer Protection Branch*
• CTD Holdings in Freedom of Information Act litigation against the US, securing a settlement and attorneys’ fees*

Regulatory

• A pharmaceutical company in connection with strategic regulatory and litigation issues associated with a competing product’s orphan exclusivity*
• A major medical system in connection with a voluntary self-disclosure regarding financial relationships with secondary care facilities*
• A biopharmaceutical company in connection with a request to the FDA to change the determination to permanently bar a former FDA employee that the company subsequently employed from participating in matters involving the company’s nondisclosure agreement*
• An international medical device company in successfully persuading the FDA to issue an export certificate, despite ongoing FDA inspection issues*
• An international medical device company in appealing an FDA decision to reject the company’s flagship medical device for marketing in the US; secured an FDA revers al decision clearing the product for sale*

Compliance/Internal Investigations

• A board special committee in connection with an internal investigation of various whistleblower allegations
• A life sciences company in connection with an internal investigation relating to data breach issues
• A life sciences company in connection with an internal investigation relating to the adequacy of its compliance program
• A pharmaceutical company in its response to an FDA Form 483 
• A tobacco company in its response to an FDA Warning Letter
• A pharmaceutical company in connection with an audit of its drug pricing compliance
• A life sciences company in connection with an internal investigation relating to its patient support program
• A charitable foundation in developing compliance training for patient support programs

*Matter handled prior to joining Latham