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Former Shire Subsidiary Executive Reaches $2.5M Settlement

USA - June 16 2019 Kevin Rakin, former president of a Shire PLC subsidiary, has reached a settlement with the Department of Justice, resolving False Claims Act...

Eve Costopoulos, Scott S. Liebman.

FDA Regulatory and Compliance Monthly Recap May 2019

USA - June 6 2019 According to the letter, the diagnostics company made changes impacting the performance of its potassium assay without notifying the FDA. Since the...

Jenny Stohlmann, Scott S. Liebman.

U.S. Supreme Court Decision in Merck Sharp & Dohme v. Albrecht

USA - May 28 2019 Unanimous decision of the U.S. Supreme Court confirming its 2009 decision in Wyeth v. Levine that state law “failure to warn” claims are pre-empted...

Eve Costopoulos, Scott S. Liebman.

Department of Justice Joins Mallinckrodt Whistleblower Suits

USA - May 16 2019 The U.S. Department of Justice joined a pair of whistleblower lawsuits alleging pharmaceutical manufacturer Questcor improperly promoted H.P. Acthar...

Eve Costopoulos, Scott S. Liebman.

CMS Finalizes Rule Requiring Disclosure of List Price in DTC Advertising

USA - May 16 2019 The U.S. Department the Health and Human Services (HHS) has finalized the Centers for Medicare & Medicaid Services (CMS) rule requiring drug...

Eve Costopoulos, Scott S. Liebman.