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Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

FDA Law

district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. The government also suspects violative conduct if the speakers, attendees, or consultants are selected based on the volume of their past prescriptions of the company’s products or their expected future prescriptions.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law

The government asserted additional allegations that are outside our scope. Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” Zarzamora Press Release. Holiday CVS, L.L.C.

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Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

FDA Law

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. The government charged these individuals with conspiracy (18 U.S.C. §

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Risking It All For a New Business Model at Family Physicians of St. Joe

Family Physicians of St. Joseph

In 2007, Dr. Mancini joined the practice, followed by Dr. Meadows in 2012, and Dr. Gendernalik in 2015. Eggebrecht joined in 1993, at a time when family doctors still rounded in the hospital and delivered babies. Joseph followed a traditional fee-for-service model, billing insurance companies for patient care.

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HPM Welcomes 15-Year DOJ Veteran, John W.M. Claud, to the Firm

FDA Law

He also held leading roles in DOJ’s response to multiple significant national health crises, including the COVID-19 pandemic, the 2019 EVALI vaping crisis, and the 2012 New England Compounding Center fungal meningitis outbreak.

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Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders

FDA Law

Press Release , Walgreens Agrees To Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims, U.S. Attorneys Office, Northern District of Illinois, April 21, 2025.

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News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

FDA Law

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.