The mixed use of these products has not been approved by the U.S. Food and Drug Administration (FDA), and is thereby an off-label use. According to the complaint, Stryker knew or should have known that the mixed use of these two products was ineffective and could lead to unwanted bone growth. Nonetheless, Stryker engaged in extensive and illegal promotion of the off-label mixed use of these two products. As a result, Stryker was criminally indicted for its illegal promotion of the combined use of OP-1 Putty and Calstrux, and forced to pay a $15 million fine.
Our Stryker medical device injury attorneys believe that there are many other victims out there who were implanted with this dangerous mixture during surgery and have suffered symptoms similar to Ms. Cabana, which include:
excessive bone growth
migration of bone growth
What is Stryker OP-1 Putty?
Manufactured by Stryker Biotech, OP-1 Putty is a surgical putty in a class of devices known as Bone Morphogenetic Proteins (BMP), which are used to promote bone growth. Unlike medical devices that are approved by the FDA after being deemed safe and effective, Stryker OP-1 Putty was approved in 2004 as a “humanitarian use device.” This means that Stryker OP-1 Putty’s effectiveness has not been established, and the device can only be used to treat rare conditions. Even then, it could only be used as specified by the FDA. It also means that permission to use Stryker OP-1 Putty on a patient must be granted by an Institutional Review Board (IRB) prior to use and only after receiving the patient’s consent.
What is Calstrux?
Also manufactured by Stryker Biotech, Calstrux is a bone void filler that is used in orthopedic surgery. It can be used when someone sustains an injury or when a surgical procedure results in a gap in the bone. Stryker Biotech was indicted in 2009 for failing to inform surgeons about possible side effects from Calstrux, such as the device migrating to different parts of the body and growing bone in potentially problematic or dangerous places.
Off-Label Use of Stryker OP-1 Putty and Calstrux
In January 2012, Stryker Biotech pleaded guilty to a misdemeanor and paid a fine of over 15 million dollars for illegally marketing the use of OP-1 Putty. Stryker, through its sales representatives, was charged with encouraging surgeons to mix OP-1 Putty with Calstrux even though the mixture had never been formally tested in clinical trials and had not received FDA approval. This illegal promotion is referred to as “off-label marketing,” and Stryker used this tactic to get surgeons to use the mixture of Stryker OP-1 Putty and Calstrux without establishing the safety and effectiveness of the treatment. Stryker medical sales associates were also charged with falsifying hospital records in order to authorize the use of Stryker OP-1 Putty.
Symptoms Associated With Stryker OP-1 Putty and Calstrux Mixture
Excessive bone growth
Migration of bone growth
Death (in rare cases)
April Cabana’s Story
When 35-year-old April Cabana went to Pomona Valley Hospital Medical Center in 2008 for a routine back surgery, she had no idea that she was about to be an unwitting participant in a human “research project” conducted by the hospital. Instead of undergoing a routine spinal fusion surgery using conventional methods, Ms. Cabana was implanted with the mixture of two medical devices, Stryker OP-1 Putty and Calstrux without her knowledge or consent. She, allegedly, was one of 17 other patients operated on in a similar manner by Pomona Hospital between 2006 and 2011.
Ms. Cabana sustained life-altering and debilitating injuries as a result of the experimental surgery, experiencing unwanted bone growth in her back, which led to nerve compression and tremendous pain. She was forced to undergo a second surgery to remove the unwanted bone growth in her back. It was unsuccessful and caused her even more pain. Ms. Cabana is now permanently disabled. The identities and the conditions of the other patients involved in the human experiment at Pomona Hospital are currently unknown.
The preeminent law firm of Baum, Hedlund, Aristei & Goldman handled Stryker lawsuits around the country. Our team has successfully handled personal injury, wrongful death and product liability cases against major pharmaceutical companies and medical device companies for over 20 years.
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