Hospital Investigated for Experimental Bone Surgery

August 3, 2012 — MassDevice is reporting that Pomona Valley Hospital Medical Center is being investigated by the California Health Department after a lawsuit was filed on behalf of a woman who was severely injured when her surgeon used two bone-growth products off-label. She claims that she and 17 other patients were not informed of the experimental nature of the procedures.

April Cabana filed the complaint against the Pomona hospital and her surgeon, Dr. Ali Mesiwala. She claims she believed she was undergoing routine back surgery to cure chronic pain, but instead, she was used as an “unwitting guinea pigs” when her surgeon used Stryker’s OB-1 Putty in combination with a Calstrux bone-filler. The U.S. Food and Drug Administration (FDA) approved the putty under a humanitarian use condition, which allows manufacturers to avoid conducting safety tests so long as the product is intended to be used in a small group of patients. The FDA never approved the putty for use in combination with the Calstrux bone-filler.

Soon after the surgery, the combination of products caused excessive bone growth in her spine. The overgrown bones impinged a nerve in her spine, causing severe pain and debilitation. When she returned to have a corrective operation, her surgeon used the Medtronic Infuse Bone Graft — again, off-label. The bone graft also caused excessive bone growth, and Cabana now suffers from severe back pain.

Both Medtronic and Stryker have faced lawsuits over problems with these two products. Stryker was convicted of a misdemeanor charge of promoting the bone putty off-label — including falsifying medical records giving authorization for the product’s use. Medtronic is facing numerous lawsuits from people who were seriously injured when the Infuse caused excessive bone growth.

Pomona Hospital has denied any wrongdoing in the lawsuit. In a statement released to the media, they said, “Pomona Valley Hospital Medical Center complies with all state and federal laws and has procedures in place to oversee studies conducted at the hospital. We adhere to the regulations and guidance of the Food and Drug Administration.”