Mass., Stryker settle suit

Stryker Biotech will pay $1.35 million to Massachusetts to resolve allegations that it marketed certain orthopedic products for uses that had not been reviewed or approved by FDA and misled healthcare providers about the appropriate uses of its products, Attorney General Martha Coakley has announced.

The investigation alleged that Stryker had engaged in unfair and deceptive trade practices that boosted sales of products used to promote bone growth. Under the terms of a settlement, Stryker will pay $325,000 in civil penalties, $875,000 to fund efforts to combat unlawful marketing and other programs to benefit health care consumers, and $150,000 to cover attorneys' fees and investigative costs.

The investigation focused on the company's marketing of OP-1 Implant and OP-1 Putty, which are bone morphogenetic protein products designed to promote bone growth and are used to treat orthopedic conditions involving weakened or deteriorated bones.   The OP-1 products were granted a limited approval by the FDA that restricted the use of the products.  With this limited form of approval, the OP-1 products could only be used in patients after a hospital's institutional review board reviewed and approved their use. 

The AG's office had alleged that Stryker promoted OP-1 products for unapproved uses and withheld information from healthcare professionals about the restrictions imposed on use of the products. The complaint also maintained that a Stryker salesperson falsified IRB documentation for several Massachusetts hospitals, resulting in the use of OP-1 products in patients without the required review. 

Stryker also allegedly promoted the use of its OP-1 products in combination with Calstrux, a bone void filler, even though the mixture of the two products had not been studied or approved.  Stryker continued to promote the mixture even after company officials became aware of reports that the mixture had caused adverse effects in patients, including poor wound healing and inflammation, according to the complaint.

- see Coakley's release
- get more from the Boston Business Journal