August 3, 2012 — According to a report from MassDevice, the California Health Department is investigating Pomona Valley Hospital Medical Center in Pomona, California, after a lawsuit was filed alleging that the hospital used patients as “unwitting guinea pigs” to test experimental bone-growth products manufactured by Stryker. The plaintiff who filed the lawsuit claims that at least 17 people were not informed of the experimental nature of Stryker’s OP-1 Putty, a type of bone-growth protein.
According to the complaint, April Cabana claims that the hospital and her surgeon, Dr. Ali Mesiwala, failed to inform her about the experimental nature of the products they were using for her back surgery.
Cabana’s surgeon allegedly used Stryker’s OB-1 Putty in combination with a Calstrux bone-filler. The putty was approved by the FDA under the “humanitarian use” section, which allows companies to avoid conducting safety studies when their product is intended for a small population. However, the FDA did not approve the putty to be used in combination with the bone-filler. Surgeons are allowed to use products off-label.
Cabana claims that the combination of the putty and the bone-filler caused excessive bone growth in her lower back. A nerve became compressed and caused debilitating pain. She was forced to undergo an additional back surgery to relieve the pain.
When she went in for a second surgery, her surgeon used Medtronic’s Infuse bone graft — again, off-label. Medtronic is currently facing numerous lawsuits from people who were seriously injured when the product caused excessive bone growth.
Stryker has already been forced to pay $15 million for a misdemeanor charge of promoting the OP-1 for off-label uses. Although doctors are allowed to use products off-label, medical device companies are not allowed to promote them for off-label uses. Stryker was charged with falsifying hospital records that authorized use of the OP-1 products.
Pomona Hospital disputes the allegations and they have released a statement to the media. According to the statement, “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.”