Aug 14, 2015 | Medical Device Failure, Uncategorized
All medical devices must be approved by the FDA prior to use by doctors, however, most people don’t realize that there are two methods of approval, 1) pre-market approval (PMA), and 2) 510(k). With a PMA approval, the manufacturer must submit a lengthy application...
Apr 30, 2015 | Medical Device Failure, Medical Malpractice, Uncategorized
If you or someone you know has a Medtronic implantable medicine pump, it is important to know about a recent Complaint Filed by the U.S. Attorney’s Office in regards to manufacturing problems. This injunction filed April 27, 2015 against Medtronic and its CEO, seeks...
Feb 26, 2014 | Medical Device Failure, Medical Malpractice, Uncategorized
On February 28, 2012, our client Edith went in for surgery where the doctor used the NVM5 neuromonitor manufactured by Nuvasive, Inc. In the middle of the surgery, the orthopedic doctor aborted the procedure. Nuvasive admitted in emails to the doctor that their...
Oct 22, 2012 | Medical Device Failure, Uncategorized
The Meyerson Law Firm recently settled on behalf of a client with Verticor, Ltd., the manufacturer of a spherical spinal implant called an Eclipse Sphere as well as Dr. James Hansen. This device was cleared via the FDA’s 510k process using the predicate of Medtronic’s...
Aug 30, 2010 | Medical Device Failure, Product Liability, Uncategorized
Austin law firm Meyerson Cagle, P.C. has begun investigating an eye surgery device manufactured by Alcon Medical Devices, LLC. The Alcon CONSTELLATION Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various types of eye surgery....
