August 28th, 2008 laurie
The FDA has added thoracic aortic aneurysm stent grafts to the list of devices subject to tracking requirements, according to a final guidance released last week, the Wall Street Journal reports. The FDA may require tracking for Class II or III devices for which failure would probably have serious adverse health consequences, that are intended […]
August 27th, 2008 laurie
A federal judge ruled that a family may proceed with its lawsuit against device manufacturers, saying preemption is not an issue in this case because the family’s claims are based on violations of federal law. Scott and Pamela Purcel filed suit last Sept. 27 against Advanced Bionics and Astro Seal in the U.S. District Court […]
August 26th, 2008 joshua
In an age where information is a Google search away, the Food and Drug Administration is having a difficult time creating a national registry of implanted orthopedic joints.
Several other nations have such registries already begun, and the FDA has talked about starting such a registry, but when it comes time to actually compile it, it […]
August 18th, 2008 joshua
A Monroeville, Pa. medical devices supplier has filed a lawsuit against six major device manufacturers, alleging they have attempted to corner the market through kickbacks to physicians.
Richard and Holly McCullough, owners of Intermedics-McCullough, believe payments totaling more than $8 million were attempts to persuade physicians into buying directly from the manufacturer and not do business […]
August 15th, 2008 laurie
Boston Scientific has issued a Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach […]
August 14th, 2008 laurie
Boston Scientific is awaiting approval for a new heart stent, the Taxus Liberte, which the company claims did well in a clinical trial. After viewing the data, the Wall Street Journal reports that this success is based on flawed research.
The WSJ reports that Boston Scientific Boston Scientific’s claim was based on a flawed statistical equation […]
August 13th, 2008 laurie
Since 2001, the Bush administration has steadily whittled away the ability of consumers and other groups to sue corporations for damages related to their products, including defective medical devices. The Wall Street Journal reports that plaintiffs’ lawyers are fighting back by raising money to battle a Supreme Court case and to support candidates seen as […]
August 12th, 2008 amy
A bill designed to slow Massachusetts’ soaring health care costs has been signed by Gov. Deval Patrick. The law also requires pharmaceutical companies and medical device manufacturers to report all gifts to doctors over $50, the Associated Press reports.
The new law requires hospitals and doctors to adopt a statewide electronic records-keeping system by 2015. It […]
August 6th, 2008 joshua
Johnson & Johnson revealed in its regulatory filing at the beginning of the week that lawyers from the U.S. Attorney’s Office in Massachusetts have subpoenaed the company regarding the marketing of its bile duct stents, namely Cordis.
These biliary stents are used to carry digestive fluids to the intestines via open bile ducts. Stents are also […]
August 4th, 2008 amy
Levitronix, Inc has issued a Class I Recall, the most serious kind of recall, for its CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles. The blood pumping system is being recalled because use of the Valleylab Force FX-C or Valleylab SSE2L with the CentriMag Blood Pumping System may result in stoppage of the […]
