The U.S. Food and Drug Administration (FDA) recently proposed a new way to fast-track medical devices to the market. Scott Gottlieb, Commissioner of the FDA, proposed making a quicker route to market for certain products that might not meet the current criteria for clearance under the agency’s 510(k) fast-track pathway. Gottlieb’s reasoning for the proposal is that it would foster innovation. This ...
A $5.25 million pharmacy fraud settlement has been reached between the US Department of Justice and RxAmerica stemming from two whistleblower lawsuits filed under the False Claims Act. The CVS Caremark Subsidiary is accused of misrepresenting the prices of drugs to senior citizens that were part of the Medicare Part D Prescription drug benefit program. One of the complaints was filed by Max and ...
In the US District Court for the Middle District of Florida, Judge Anne C. Conway has paved the way for the federal government to take the lead in a Florida whistleblower complaint accusing Hospice of the Comforter, a nonprofit facility, of regularly overbilling Medicare for patients that don’t actually meet the qualification of terminally ill (allegedly even allowing some of them to receive ...
Two former Merck virologists, Joan Wlochowski and Stephen Krahlin, have filed a whistleblower complaint against Merck accusing it of overstating the effectiveness of its vaccine for rubella, mumps, and measles and, as a result, causing the US government, which bought about four million doses of MMR vaccines that were misbranded and mislabeled every year for at least 10 years, to be defrauded. They ...
According to officials, the government has recovered $2.8 billion in false claims cases with the assistance of whistleblowers. This monetary amount is a yearly record high. During fiscal year 2011, 636 qui tam lawsuits filed by whistleblowers. (In past years, about 300-400 complaints were submitted annually.) The Justice Department secured over $3 billion in judgments and settlements in civil ...