December 30, 2014 — Stryker Biotech LLC must face a lawsuit from a man who was injured when his surgeon used an “off-label” combination of OP-1 bone putty and Calstrux during his spinal fusion surgery, according to Law360.
U.S. District Judge Brian A. Jackson refused to dismiss the case, preserving most of the claims by the plaintiff, William F. Bouette Jr.
During his spinal surgery in November 2006, doctors used an “off-label” (unapproved) combination of Stryker’s OP-1 bone-growth putty and Calstrux bone void filler. He developed “debilitating injuries” from excess bone growth in unintended areas of his body.
Bouette claimed Stryker knew about the safety risks of the OP-1 Calstrux combination, but withheld this information from doctors and promoted Calstrux as the “preferred” and “perfect carrier for OP-1.”
Judge Jackson also preserved Bouette’s claim that the combination was defective. He claimed there was another, safer alternative that would not have caused his injuries.
In addition, the FDA issued Stryker a warning letter after inspectors found that the company was not reporting side effects while promoting the OP-1 Calstrux combination “off-label.” In 2012, Stryker paid $15 million in criminal fines for this illegal promotion.
Side effects linked to OP-1 Calstrux combination include:
- Excess bone growth
- Migration of bone growth
- Nerve compression
- Severe, chronic pain
- Revision surgery