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Stryker Biotech, several employees indicted regarding product marketing
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A federal grand jury in the District of Massachusetts has charged Stryker Biotech LLC, its former president and several of its current sales managers with allegedly promoting medical devices used for invasive spinal and long bone procedures in an improper manner.
Stryker Biotech LLC; the unit’s former president, Mark Phillip of Lexington, Mass.; and sales managers William Heppner of Illinois, David Ard of California and Jeff Whitaker of North Carolina, were charged with five counts of alleged wire fraud and one count of conspiracy.
The biotech division, Ard and Whitaker have also been charged with one count of alleged misbranding of a product. In addition, Stryker Biotech and Phillip have been charged with allegedly making false statements to the FDA regarding the number of patients treated with the brand’s OP-1 putty, according to a Department of Justice (DOJ) release issued by the acting U.S. Attorney for the District of Massachusetts.
“The company is disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter,” Stryker stated in a press release shortly after the indictment announcement. “Conviction of these charges could result in significant monetary fines and Stryker Biotech’s exclusion from participating in federal and state health care programs, which could have a material effect on Stryker Biotech's business. As a matter of company policy, Stryker will not have any further comment on these allegations.”
If convicted on all charges, the company’s biotech division could face fines of more than $500,000 on each count.
“The indictment alleges that all of the defendants participated in an illegal marketing scheme to promote medical devices used during invasive surgeries, and in doing so having defrauded medical professionals and the FDA,” the DOJ release read. “In particular, the defendants are alleged to have promoted devices known as OP-1 Implant and OP-1 Putty. These devices were used to stimulate bone growth in long bones and the spine. These devices were approved by the FDA only pursuant to a highly restrictive Humanitarian Device Exemption.”
The indictment alleges that the defendants promoted these devices for non-FDA approved uses, including combining these devices with the bone void filler Calstrux, and charges that the promotions provided medical professionals with recipes for mixing the OP-1 products with Calstrux. The formal allegation also holds that the defendants were aware that these combinations had not been examined in a clinical trial and were not FDA-approved.
“It is alleged that the reason the defendants promoted the OP-1 products in a mixture with Calstrux was because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products,” according to the DOJ release. The charges also allege that some patients treated with the mixed products experienced serious medical problems.
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