The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s spine. This medical device is used to treat primary or metastatic cancer, chronic pain and severe spasticity. There […]
Category: Defective Medical Devices
The FDA recently announced that it is investigating allegations of improprieties in conjunction with clinical trials that were conducted by Bayer and Conceptus with regard to the Essure device, which is utilized in sterilization procedures. Bayer Corporation, a German pharmaceutical giant, purchased Conceptus, the original designer of the Essure device, […]
In August of 2010, DePuy shocked the orthopedic community and thousands of patients by announcing the recall of its ASR metal-on-metal hip implant due to an excessive failure rate. Following this product recall, more than 13,000 individual lawsuits were filed on behalf of patients who suffered significant injuries, including the […]
The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of a debate in the medical community since the Food and Drug Administration (“FDA”) discouraged its use in April, 2014. The FDA discouraged the use […]
When did Olympus first learn about the design problems inherent in the specialized medical scopes it peddles? Did they have plans to redesign these scopes to make them safer for patients? These are the questions at the top of U.S. Representative Ted Lieu’s (D-CA) mind after he sent a letter […]
Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities. The other two goals focus on 1) striking a better balance between data collection requirements and the time […]
In January 2011, Martha Salazar was implanted with the Obtryx, which was manufactured by Boston Scientific. Following the surgery, she asserts that she had experienced dyspareunia, pain, and nerve damage. She has undergone multiple surgeries to remove the polypropylene mesh and walks with a limp due to her right hip […]
Judge Goodwin is presiding over seven different federal multidistrict litigation established for similar cases filed against various medical device manufacturers, including American Medical Systems, Boston Scientific, Coloplast Corp., Cook Medical, Ethicon , C.R. Bard, and Neomedic. Each of the complaints involves allegations by women who experienced painful complications following the […]
Debra Kilmer filed suit against Stryker Corporation, Stryker Sales Corporation and Howmedica Osteonics Corporation (“Defendants”), asserting that she had been injured by a defective knee implanted in her in Florida state court. Defendants removed the action to the United States District Court for the Middle District of Florida citing diversity […]
Several plaintiffs that were implanted with Boston Scientific’s Obtryx transobturator Mid-Urethral Sling System alleged in their lawsuits that the manufacturer, Boston Scientific, ignored warning that devices containing polypropylene should not be implanted in humans. These plaintiffs assert that Boston Scientific was aware that the polypropylene used in the Obtryx device […]