Stryker Biotech’s OP-1 Putty is a surgical putty in the Bone Morphogenic Proteins (BMPs) class of medical devices. Designed to promote bone growth, OP-1 Putty received U.S. Food and Drug Administration (FDA) approval in 2004.
Agency approval was obtained under the very restrictive Humanitarian Device Exemption. One of the exemption’s restrictions includes that the device is would only treat a condition that afflicted less than 4,000 patients in the United States. Also, if approved, the device could not be sold for profit.
Stryker Biotech also manufactures Calstrux, which is a bone void filler that is used in orthopedic surgeries and treats patients who are injured or corrects bone when a surgical procedure requires that a hole be made into that bone.
Meanwhile, in 2009, Stryker Bioteth was indicted for not advising surgeons that there are potential side effects associated with the use of Calstrux. These side effects can include the device migrating to other body parts and growing bone in inappropriate, even dangerous, areas in the body.
Prosecutors charged that Stryker Biotech promoted a mixture of OP-1 products with Calstrux and that significant reactions were reported in numerous patients in whom this untested mixture was used. Without a mixing agent, the OP-1 products were at a competitive disadvantage when compared to other, approved products.
Last January, Stryker Biotech pleaded guilty to one misdemeanor charge and paid a fine of $15 million for illegally marketing the off-label uses of OP-1 Putty. In fact, Stryker sales representatives encouraged surgeons to mix OP-1 Putty and Calstrux, a combination that was never formally tested or approved by the FDA. Stryker medical sales associates were also charged with falsifying hospital records in order to authorize OP-1 Putty use.
Symptoms associated with the off-label combination of Stryker OP-1 Putty and Calstrux include excess bone growth and migration of bone growth; nerve compression; severe pain; and, in rare cases, death.
In one case, a then-34-year-old woman was hospitalized in 2008 for back surgery, a routine procedure involving traditional spinal fusion being accomplished using conventional surgical methods. Instead, the patient was implanted with the unapproved, off-label combination of OP-1 Putty and Calstrux, without her knowledge or consent. In fact, she was one of 17 patients who received similar surgery using the off-label combination between 2006 and 2011 at the Pomona Hospital.
The patient, April Cabana, survived the experimental surgery, but sustained debilitating injuries including that unwanted bone grew in her back, compressed her nerves, and left her in horrific pain. She was forced to undergo a second surgery—so-called “revision surgery”—to remove the excess bone; however, that procedure was unsuccessful and left her in even greater pain and permanently disabled.