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,
The U.S. Food and Drug Administration (FDA) opened an investigation of Bayer pharmaceuticals in response to a citizen’s petition filed March 26th on behalf of over 2100 women regarding the Essure permanent birth control device. Bayer, who acquired the product’s maker, Conceptus in 2013, is being accused of hiding falsified medical records and reports of
The orders from the March JPML panel hearing have been posted, and the JPML issued an order denying a motion by a plaintiff to centralize her case in the Mirena IUD device litigation MDL proceeding in the SDNY. In its order, the JPML indicated that centralization into the pending MDL was denied because the potential