Jennifer L. Bragg

Ms. Bragg’s recent experience includes representing: 

Litigation/Investigations

• Purdue Pharma in connection with emerging developments relating to the marketing of opioid medications, including 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, in which Ms. Bragg convinced the FDA to reverse its decision and clear the product for sale*

*Matter handled prior to joining Latham