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
5/26/2015 Perhaps no industry besides investment banks has been hit as hard by the federal court system than tobacco over the past several years. A pair of recent appeals rulings, however, indicates a substantial turn in the industry’s decades-long financial flogging. On Friday, the D.C. Court of Appeals delivered a mixed-ruling, in which some
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,
In a landmark investigation released this week, the Center for Public Integrity (CPI) uncovered the alarmingly small and insular circle of experts who are used by food manufacturers to determine if a new ingredient is “Generally Regarded As Safe,” or GRAS. The investigation discovered that at least one of 10 particular consultants participated in over
A 1958 law offers food companies who want to market new ingredients in their products a way to bypass extensive and costly FDA safety testing. The law provides the option for companies to demonstrate that the ingredient in question has been deemed “Generally Regarded As Safe” (GRAS) by a consensus panel of scientists and experts.
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
Federal preemption of claims against generic drug manufacturers has prevented (or severely limited) the ability of users of generic drugs from bringing products liability claims premised upon the failure to warn. Certain state courts have indicated that some state tort law claims may not necessarily be barred by federal preemption, but these “baby steps” potentially