December 30, 2014 — Law360 reports that Stryker Biotech LLC will face a lawsuit alleging that the company marketed the off-label combination of OP-1 Putty and Calstrux, despite knowing about the increased risk of side effects.

The lawsuit was filed by William F. Boutte Jr., who had spinal fusion surgery in November 2006. His surgeons used Calstrux, a bone void filler, and OP-1, a protein that promotes bone growth.

He allegedly suffered “debilitating injuries” when the products caused bone formation in other areas of his body.

Stryker attempted to dismiss the lawsuit, but a federal judge in Louisiana preserved much of the claims. U.S. District Judge Brian A. Jackson decided that Boutte’s design defect claim was reasonable because there was a viable alternative that would not have caused his injuries.

Bouette’s claim was also supported by a formal warning from the U.S. Food and Drug Administration (FDA) after inspectors found that Stryker was illegally promoting the OP-1/Calstrux combination “off-label” and failing to report serious side effects.

Judge Jackson also noted that Stryker withheld information about dangerous side effects of the combination from the medical community, while promoting Calstrux as the “preferred” and “perfect carrier for OP-1.”

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. Some of the most serious side effects linked to this problem include:

  • Excess bone growth
  • Migration of bone growth
  • Nerve compression
  • Severe, chronic pain
  • Revision surgery

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