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
The first conference in the Xarelto MDL (In Re: Xarelto (Rivoroxaban) Products Liability Litigation, MDL 2592, proceeding in the Eastern District of Louisiana, before the Hon. Eldon E. Fallon, took place on January 29, 2015. Judge Fallon, an experienced MDL presiding judge, has already set up a website for the MDL (http://www.laed.uscourts.gov/xarelto), with posts of
This year, a team of medical researchers from Harvard Medical School published a study in JAMA that demonstrated men who used Viagra (sildenafil) were more than twice as likely to suffer melanoma as men who never used the drug. Here, we’ll discuss another article from Harvard University that raised concerns similar to those found in
On November 24th, the United States Food and Drug Administration issued a news release suggesting that more safety information be added to the packaging of power morcellators, medical devices used in laparoscopic procedures (minimally-invasive surgeries) such as hysterectomy and myomectomy. As hysterectomy is the second most common surgery undergone by women, safe medical devices for
Have you ever seen one of those metal head massagers, the ones with thin, spider-like metal legs that bend and flex to tickle your scalp? That’s pretty much exactly how inferior vena cava filters look, except IVC filters are much smaller – they fit inside a vein, and are used to catch blood clots before