Anne K. Walsh

Government Investigations

• Sought and won dismissal of a civil qui tam matter alleging FCA violations against Orthofix, a medical device manufacturer.
• Conducted an internal investigation at a mid-sized OTC drug product manufacturer to minimize exposure against a potential whistleblower complaint.
• Obtained a declination of federal criminal prosecution on behalf of an OTC drug manufacturer related to allegations of off-label promotion of its product.
• Negotiated with HHS Office of Inspector General on behalf of a drug manufacturer to avoid a Corporate Integrity Agreement or potential exclusion based on a conviction related to off-label promotion.
• Negotiated on behalf of a software application developer a 90% reduction from the original demand made by the New York State Attorney General’s Office for alleged violations of New York consumer protection law based on health-related claims.

FDA Compliance and Enforcement

• Prepared responses to FDA for Agfa, a medical device manufacturer, concerning inspections of its domestic and international sites, and obtained prompt closeouts of those inspections.
• Prepared a warning letter response to FDA on behalf of a South Korean device manufacturer, using Korean language skills to translate for the company, its customers, and FDA.
• Successfully challenged FDA under the APA for acting arbitrarily and capriciously in a classification decision, on behalf of PREVOR, a medical device client.

Corporate Transactions

• Advised Nichi-Iko Pharmaceutical Co., Ltd., the largest generic drug manufacturer in Japan by sales, in a $736 million   deal to acquire Sagent Pharmaceuticals, Inc.
• Conducted due diligence on behalf of the acquiring company for an asset purchase involving 15 different drug products.
• Provided advisory services to Owens & Minor on regulatory matters in acquisition of Halyard Health, Inc.’s Surgical & Infection Prevention business, at a purchase price of $710 million in cash.
• Advised venture capital firm on deal to acquire mid-sized company specializing in the manufacture of component parts used in implantable medical devices and finished medical devices.
• Conducted diligence on behalf of Chinese company to acquire a U.S. medical device manufacturer of surgical and dental instruments.

• DOJ Attorney General’s Award for Exceptional Service
  DOJ’s highest award for employee performance
  2010
• Award of Appreciation
  FDA Office of Criminal Investigations
  2010
• Award of Recognition
  U.S. Attorney’s Office, E.D.N.Y.
  2010
• Cooperative Achievement Award
  HHS Office of Inspector General
  2010
• Group Recognition Award
  FDA
  2010
• Commissioner’s Special Citation
  FDA
  2009
• Award of Recognition and Appreciation
  U.S. Attorney’s Office, N.D. Cal.
  2009
• Outstanding Service Award
  FDA
  2008
• Director’s Award for Superior Performance
  Executive Office for U.S. Attorneys
  2006
• Cooperative Achievement Award
  Office of Inspector General
  2006
• Award of Merit
  FDA
  2005

• Q1 Pharmacovigilance & Drug Safety Conference, Compliance: Post-Market Approaches to Drug Safety from Adverse Event Reporting to Mandated Studies, March 12-13, 2019
• Moderator, Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference for the Drug, Device, Food and Tobacco Industries, Top FDA Enforcement Cases in 2018, December 12, 2018
• Customer Centric Medical Information Conference, Interpreting New Guidance Based on Risk Tolerance, July 24-25, 2017
• Customer Centric Medical Information Conference, Product Communication Consistent  With Label & First Amendment Considerations, July 24-25, 2017

• DOJ Wants It Both Ways: Case Satisfies Materiality Standard, but Still Merits DismissalDecember 20, 2018

  By Anne K. Walsh —

• Failure to File Adverse Event Reports Results in Criminal Pleas for Medical Device Company and Quality ManagerDecember 12, 2018

  By Anne K. Walsh —

• The Other Shoe Drops on ev3December 7, 2018

  By Jennifer M. Thomas & Anne K. Walsh —

• DOJ Slackens Focus on Individual Liability to Facilitate Corporate ResolutionsDecember 5, 2018

  By Anne K. Walsh —

• Medical Device Enforcement and Quality ReportDecember 3, 2018

  By Anne K. Walsh & Adrienne R. Lenz, Senior Medical Device Regulation Expert —

• Co-Editor, FDA Deskbook: A Compliance and Enforcement Guide (PLI)December 26, 2018
• Court deals blow to mysteriously named whistleblower, blowing off precedentOctober 24, 2017
• Congress Seeks a Statutory Fix to Stymied Off-Label DiscussionsMay 2, 2017
• DOJ Uses False Claims Act to Enforce FDA Manufacturing RulesApril 7, 2017
• Ninth Circuit Confounds Practice of Medicine and Off-Label Use IssuesNovember 1, 2016
• A Wolf in Sheep's Clothing: When the Failure to Obtain a 510(k) for a Modification Is More Than a Regulatory ViolationSeptember 7, 2016
• Top Food and Drug Cases 2015 and Cases to Watch 2016: United States v. Quality Egg, LLCMay 24, 2016