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Jul 22, 2013 - Blog by Ingrid Evans | Share
ATTORNEY NEWSLETTER A large Indian pharmaceutical manufacturer has agreed to settle with the United States and states’ attorneys general in a whistleblower lawsuit. The pharmaceutical manufacturer was alleged to have falsified data, violated Current Good Manufacturing and Laboratory Practices, and sold substandard and unapproved drugs. This settlement happened due of […]
Jul 19, 2013 - Blog by Ingrid Evans | Share
ATTORNEY NEWSLETTER In November of 2012 congress unanimously approved the passage of the whistleblowers could not protect themselves against associated retaliation by employers because of loopholes by the Federal Circuit Court of Appeals. By passing the Whistleblower Protection Enhancement Act, congress acknowledged that bad administrative and court rulings had undermined […]
Jul 8, 2013 - Blog by Ingrid Evans | Share
ATTORNEY NEWSLETTER In the past, the Food and Drug Administration (FDA) took the lead role in investigating pharmaceutical manufacturing facilities for violations of good manufacturing practices (cGMP’s). Recently, the Department of Justice (DOJ) became a more actively involved in enforcement actions against pharmaceutical manufacturing facilities due to whistleblowers. The DOJ […]
Jul 3, 2013 - Blog by Ingrid Evans | Share
ATTORNEY NEWSLETTER        One lawsuit against Novartis alleges that the pharmaceutical company paid kickbacks to doctors to induce them to prescribe Novartis products over those from other companies. Those Novartis products were then reimbursed by federal health care programs. As a result, the federal government is alleged to have paid […]
Apr 24, 2013 - Blog by Ingrid Evans | Share
– ATTORNEY NEWSLETTER - The Food and Drug Administration recalled two powerful acid concentrates in March of 2012. Both products, GranuFlo, a powder-based concentrate, and Naturalyte, a liquid-based concentrate, were sold to numerous dialysis centers nationwide. Medical directors and physicals anonymously reported “troubling findings†associated with both concentrates’ dosing measurements […]
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