Michigan-based Stryker Corporation’s BioTech division has been accused of fraudulent activity regarding the promotion, sale and reporting requirements for its bone regeneration products. A Massachusetts federal grand jury is investigating the allegations.

Fraudulent promotion, sale & reporting

According to a recent filing with the Securities & Exchange Commission (SEC), Stryker Corporation’s BioTech division in Hopkinton Massachusetts is the target of a federal grand jury investigation which alleges that BioTech employees illegally promoted two of its bone regeneration products, knowingly sold misbranded medical devices and reported false information on those products to the U.S. Food & Drug Administration (FDA) regarding the status of patients using its bone regeneration products.

Several former Stryker and BioTech employees have already pled guilty to charges relating to felony misbranding and making false statements about the company’s OP-1 bone regeneration products – a protein that promotes bone growth – and its Calstrux bone filler.

FDA warnings

Last summer, the FDA warned doctors about BioTech’s bone regeneration products and advised them not to use those products for the treatment of spinal injuries as there was a possibility of severe injury or death. The FDA also demanded that BioTech change the way it operates. In May of 2008, the company received a letter from the FDA regarding poor quality and compliance issues at all of the company’s plants and, although the issues have not been resolved, the company has stated that it is spending approximately $50 million to address those issues.

Stryker no stranger to controversy

Stryker Corporation is certainly no stranger to controversy. The company has been plagued by lawsuits over its shoulder pain pumps which have been linked to PAGCL (Postarthroscopic Glenohumeral Chondrolysis), a very painful condition that occurs in the shoulder when the cartilage between the ball and socket of your shoulder has broken down to the point where bone meets bone.

It has also been defending lawsuits over its Trident PSL and Hemispherical Acetabular Cup hip replacement products. Patients have complained that the cups squeak so loudly that it has seriously affected their quality of life.

If you’ve been injured due to one of Stryker’s products, contact an experienced products liability attorney to discuss your situation and evaluate your options. Consultations are free, without obligation and are strictly confidential.