Defective Medical Devices

With greater frequency, we undergo surgery to have artificial devices implanted to restore us to full and complete health, not further injury. You have a right to expect no less from a manufacturer. Yet, inadequate testing or improper follow-up by the device manufactures often lead to further pain, suffering, and possible death.

Active Investigations and Litigation

Zimmer Persona

A manufacturer of orthopedic surgical devices and implants, Zimmer has voluntarily recalled more than 11,600 Zimmer Persona Trabecular Metal Tibial Plates. An urgent Medical Device Recall notice had been sent out in February 2015 warning surgeon and hospitals that these plates may “loosen”. Zimmer has also recalled the Zimmer Person Tibial Articular Provisional Shim tool. Ball bearings from this device may have been left in the actual surgical site, increasing the risk of infection and additional surgeries. Though used world-wide, Zimmer sent these devices specifically to surgeons in Alaska, Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.

Trans-vaginal Mesh

For years, thousands women suffering from Pelvic Organ Prolapse (POP) or Stress Urininary Incontinence (SUI) were treated with transvaginal mesh and bladder slings. Unfortunately, severe complications, such as pain, infection, vaginal scarring, mesh erosion, and perforation of the bowel, bladder or blood vessels, have occurred. The treatment of these complications often require surgical repair, IV therapy, drainage of hematomas, and blood transfusions.

These mesh devices were manufactured by large drug companies such as Johnson & Johnson, American Medical Systems, Boston Scientific, Ethicon, a division of Johnson and Johnson, and C.R. Bard. Despite numerous injuries reported to the Food and Drug Administration, these devices are still sold and implanted in women today, placing them at risk of serious harm.

Recently, after tens of thousands of lawsuits by women suffering severe vaginal mesh complications, however, the FDA has reclassified transvaginal mesh products and designate them as Class III, which generally includes high-risk devices. The FDA has also strengthened the approval process requirements for surgical mesh for transvaginal repair of POP.

Today, over ten trials have proceeded to verdict against these manufacturers. In many, the jury has awarded punitive damages against one or manufacturers for the harm they caused.