Some of the executives could face up to 20 years in prison along with fines, there are a number of management individuals named in the case. Earlier this year we had another company charged with unlawful clinical trials when 3 patients died on the operating table, and one other interesting fact somewhat ties this together was that Norian was in a legal battle with Stryker over patent issues.
At Norian Four Executives Charged in Connection With Unlawful Clinical Trials – 3 Patients Died on the Operating Table
In addition to the “recipes” in question, there was also the question of the number of patients allowed by the FDA to be treated with OP-1. The company released a statement about the indictment and that can be read here. BD
BOSTON, Oct. 28 /PRNewswire-USNewswire/ -- Stryker Biotech, LLC, a corporation based in Hopkinton, Massachusetts, and its former president, Mark Philip of Lexington, Massachusetts, and its current sales managers, William Heppner of Illinois, David Ard of California, and Jeff Whitaker of North Carolina, were charged today in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries. Stryker Biotech and Mark Philip were also charged with making false statements to the United States Food and Drug Administration ("FDA").
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 have defrauded medical professionals and the FDA. Inparticular, the defendants are alleged to have promoted devices known as OP-1Implant and OP-1 Putty.
It is alleged that some of these untested "recipes" called formedical personnel to mold the combined product into "cigars," "tootsie rolls"or "Vienna sausages." The Indictment charges that the defendants knew thatsuch a combination had never been studied in a clinical trial and had neverbeen presented to or approved by the FDA. It is alleged that the reason thedefendants promoted the OP-1 products in a mixture with Calstrux was becausewithout a mixing agent, the OP-1 products were at a competitive disadvantagewith other legal products. The Indictment also alleges that serious medicalproblems arose in a number of patients from this untested mix of products.