Off-Label Use of Stryker OP-1 Putty and Calstrux

Off-Label Use of Stryker OP-1 Putty and Calstrux

Baum Hedlund: Leading the Litigation Against Stryker Biotech

Note: We are no longer accepting OP-1 Putty medical device cases. This page is purely informational for those who are interested in learning about our past record on defective medical device cases.

Baum Hedlund Aristei & Goldman filed a lawsuit against Stryker Biotech in 2011 for illegally promoting a mixture of two products (OP-1 Putty and Calstrux) during spinal fusion surgery, which caused excessive bone growth and migration in victim April Cabana’s lower back resulting in nerve compression, severe pain and additional surgeries.

Lawyers Investigate Hospitals Where Spine Surgeries Caused Complications

April Cabana is suffering from severe injuries after being implanted during two different spinal fusion surgeries with Stryker OP-1 Putty, Calstrux, and Medtronic Infuse Bone Graft.

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
  • nerve compression
  • severe pain
  • repeated surgeries.

Need to speak with a defective medical device lawyer? We are no longer accepting Stryker OP-1 Putty and Calstrux off-label use, but our team is available at (855) 948-5098 to help you with other serious legal matters.

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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. 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.

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Combining 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
  • Nerve compression
  • Severe pain
  • Repeated surgeries
  • Death (in rare cases)

Experience Litigating Against Medtronic and Stryker®

Our preeminent Los Angeles trial attorneys at Baum Hedlund Aristei & Goldman handled Stryker lawsuits around the country. We persevered on numerous occasions against both Stryker® and Medtronic in their attempts at having our clients’ cases preempted by federal law—a tactic used by medical device makers and drug companies to seek immunity from lawsuits filed after their products inflict harm on consumers.

In addition to these cases, Baum Hedlund Aristei & Goldman has been on the winning side of cases against some of the largest device manufacturers and pharmaceutical companies in the world, securing settlements and verdicts that not only helped our clients, but exposed harmful industry practices and marketing schemes that put the general public in danger. 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, successfully recovering more than $4 billion for our clients in all areas of practice. Many of our attorneys have earned Martindale-Hubbell’s highest AV® Preeminent™ Peer Review Rating, and we are also listed in Martindale-Hubbell’s Bar Register Preeminent Lawyers, The Best Lawyers in America®, Top Ranked Law Firms™ and U.S. News & World Report Best Lawyers® Best Law Firms.

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