Parker Waichman LLP

Stryker’s Off-Label OP-1 Putty/Calstrux Combination Associated with Serious Injuries

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 […]

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.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Parker Waichman is a great law firm. They are very professional and always follow up with me to make sure my appointments went well. They always return my emails and telephone calls in a timely manner. It is a great pleasure to work with Julie, Maryann and Jorge, they are making me feel stress free during this process. I will definitely recommend all my friends to Parker Waichman.
Adrien peniche
5 years ago
5 Star Reviews 150
Mrs. Josama is phenomenal! She was extremely thorough, attentive, and knowledgeable.
Karema Brown
4 years ago
5 Star Reviews 150
Thank you Parker Waichman. Working with Christina Morace through this long process made it easy and rewarding. Always pleasant to speak with and answered any of my questions and concerns. She kept me informed on all the documents needed on a timely basis and all the updates on my case. I sincerely recommend this Law Firm for the professional and knowledgeable workers. Thank you Carrie Hargrove Erskine
Carrie Hargrove
4 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038