Hospital Under Fire for Allged Off-Label Use of Stryker, Medtronic Bone Growth ProductsAug 7, 2012 | Parker Waichman LLP
A California hospital is facing accusations that it admitted patients into a secret research project investigating potential new uses for Stryker’s new bone growth products. The hospital is also accused of using Medtronic's Infuse Bone Graft product in an off-label manner without a patient's consent.
According to a MassDevice.com report, at least 17 patients at Pomona Valley Hospital Medical Center were unknowingly admitted into a secret study where they would receive a Stryker bone growth product. The patients were admitted to the hospital for surgery and believed they were to have a routine surgery.
These are the allegations made in a recent lawsuit against the hospital in which it called on the California Dept. of Health to investigate the claims. The lawsuit alleges that internal hospital memos reveal a plan to secretly volunteer patients scheduled for routine surgeries to have a Stryker bone growth product used.
The lawsuit was filed on behalf of the Plaintiff known as “Ms. Cabana” and it asserts that she was scheduled for routine surgery to help relieve back pain at the Pomona Valley Hospital. Prior to the procedure, Cabana states that her surgeon assured her the surgery was routine and he does it “20 times a month.”
During the procedure however, Cabana received the Stryker OP-1 bone growth putty in combination with Calstrux bone filler. She only learned this when she examined her medical records two years after the surgery.
The Stryker OP-1 putty is only available on the market through a humanitarian-use exemption, according to the report. A hospital Board of Directors must approve the use of the product at their facility for it to be legally used. Furthermore, the Food and Drug Administration has never approved or tested the use of OP-1 putty with Calstrux and that fact has the Plaintiff in this case believing she was “a guinea pig” in the testing of this product.
She also blames the OP-1 putty for causing excessive bone growth and continued pain. She has suffered nerve compression and has needed a corrective surgery since her initial procedure. In that subsequent procedure, surgeons removed the excess bone growth and then used the equally-controversial Medtronic Infuse bone growth product.
In that surgery, too, Cabana claims she was not informed that Infuse would be used in an off-label manner, with the surgeon opting for a posterior procedure rather than an anterior.