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Stryker Biotech Off-Label Lawsuit

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Los Angeles, CA: A California woman thought she was going to have routine back surgery in 2008 after suffering a herniated disc from a car accident. Instead, she allegedly took part in a human “research project” without her knowledge. April Cabana was implanted with two Stryker Biotech medical products, OP-1 Putty and Calstrux, both of which were used off-label. As a result, she is now permanently disabled.

Stryker Biotech Off-Label LawsuitBaum, Hedlund, Aristei & Goldman filed a lawsuit against Stryker Biotech in 2011 that accused Medtronic and Stryker of off-label promotion. The lawsuit charged that Stryker’s sales representatives had encouraged surgeons to mix OP-1 Putty with Calstrux even though the mixture was never tested in clinical trials, nor was it FDA-approved. Further, Stryker medical sales associates falsified hospital records in order to authorize the use of OP-1 Putty.

Stryker pleaded guilty in January 2012 to a misdemeanor and more than15 million dollars in fines for illegally marketing the use of OP-1 Putty. Two Stryker sales managers also pled guilty to engaging in illegal off-label promotion.

But Cabana’s problems worsened. Her spinal fusion surgery caused excessive bone growth and migration in her lower back, resulting in nerve compression and severe pain. Cabana had a second surgery to remove the “bone of unknown origin.” But the Medtronic infuse bone graft was used in this second surgery - again, off-label. According to Cabana’s complaint, Medtronic illegally promoted its medical device, and rather than the surgery alleviate Cabana’s condition, the pain worsened.

After Cabana’s lawsuit was filed, alleging that Medtronic Infuse and a Stryker bone growth product were used experimentally without telling her and 17 other patients, The California Health Department began investigating the Pomona Valley hospital.

According to MassDevice.com, “Pomona Valley Hospital Medical Center strongly disputes both the allegations of the complaint and the assertions made by the plaintiff’s counsel in the media,” company spokesperson Katherine Roche said. “We believe that the allegations are unfounded and have released a statement to the media that have inquired.”

OP-1 Putty is a surgical putty in a class of devices known as Bone Morphogenic Proteins (BMP), which are used to promote bone growth. The FDA approved the putty in 2004 as a “humanitarian use device,” which means that the device’s effectiveness has not been established, and it can only be used to treat rare conditions and only used as specified by the FDA. It also means that permission to use 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. (Like other Medtronic infuse patients Cabana’s lawsuit argues that she never gave consent.)

Calstrux, a bone void filler that is used in orthopedic surgery, is also manufactured by Stryker Biotech. It can be used when someone sustains an injury or when a surgical procedure results in a gap in the bone. In 2009, Stryker Biotech was indicted 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.

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