7/2/2015 In what may be the largest whistleblower lawsuit ever, the Justice Department, along with 11 states, are accusing Swiss pharmaceutical titan, Novartis, of running a massive kickback scheme through the U.S. Medicare and Medicaid programs. Specifically, the U.S. is accusing the drugmaker of referring patients to a handful of specialty pharmacies who sent in
7/1/2015 In a press release on Monday, Massachusetts-based medical device manufacturer, Abiomed, notified the public that the U.S. Department of Justice has dropped its investigation of the company’s Impella 2.5 heart pump. In the press release, Company CEO, Michael Minogue said, “We are pleased that the Department of Justice has chosen to close its investigation
6/24/2015 Two reports released on Tuesday highlight the persistence of Medicare fraud, especially involving the Part D prescription drug program. The reports follow the largest Healthcare Fraud takedown in history last week, as officials charged 46 doctors and pharmacy owners, as well as nearly 200 others for Medicare fraud. This includes the arrest of 44
6/18/2015 The House of Representatives will vote Thursday to repeal two controversial provisions to the Affordable Care Act (ACA), better known as Obamacare. Amidst a considerable degree of bipartisan support, Ways and Means Committee chairman, Paul Ryan (R-WI) successfully advanced measures to a vote earlier this month to cut the unpopular 2.3 percent tax on
6/9/2015 A new class of cholesterol drugs will undergo a preliminary review this week from a Food and Drug Administration (FDA) advisory panel. The drugs, Amgen’s Evolocumab and Alirocumab from Sanofi SA and partner, Regeneron Pharmaceuticals, block a protein called PCSK9, which can prevent the liver from eliminating bad cholesterol. Early studies show the drugs
6/5/2015 An FDA advisory committee voted 18-6 on Thursday, April 4th to recommend the approval of the drug, flibanserin, a medicine designed to increase the sexual desire in women. Known colloquially as “female Viagra,” two prior attempts at moving the drug through the Food and Drug Administration (FDA) process had been rejected. Drug developer Boehringer
5/29/2015 Despite the ongoing FBI investigation of Johnson & Johnson’s manufacturing division, Ethicon, and a strong Food and Drug Administration (FDA) warning issued last year, power morcellators are still legal. The device grinds up tissue mass, and is then removed through a series of small incisions. The device, which is used to provide minimally invasive
5/19/2015 The Food and Drug Administration’s (FDA) May 15th warning of potential ketoacidosis among Type II diabetes patients who use a new class of oral treatments known as SGLT2 inhibitors should not be completely surprising. The first such medicine approved by the FDA in March, 2013 was Invokana (canagliflozin), manufactured by Janssen Pharmaceuticals in conjunction
5/18/15 The U.S. Food and Drug Administration (FDA) issued a warning on its website on Friday, May 15th regarding a popular oral type II diabetes class of medications known as SGLT2 inhibitors. The FDA warned that the increasingly popular class of drugs, which help blood sugar to be secreted in urine, has led to ketoacidosis,
The Tenth Circuit issued an opinion on Tuesday, finding that state law claims asserted against Medtronic, manufacturer of the InFuse bone growth stimulator were preempted by FDA approval of the medical device under the Medical Device Act (“MDA”). Plaintiff in the case alleged that Medtronic representatives promoted an off-label, posterior surgical approach for the device,