Posts Tagged ‘whistleblower’

Karen Wilson, secretary at a Graham County, N.C. agency, notified state officials of misuse regarding federal aid money intended to be directed toward a flood cleanup operation. Wilson notified officials in 1996, but did not file a False Claims Act suit until 2001 against Graham and Cherokee Counties, as well as other conservation districts and other individual defendants. In between the time Wilson notified officials of the alleged conduct and the time she filed her suit, Graham County hired local accountants to identify the irregular spending. The state followed up and included these findings in its own report.

The False Claims Act does not allow what it calls “parasitic” whistleblower lawsuits that attempt to capitalize on public information. In 2007, federal district court judge Lacy Thornberg found the local audit and state follow-up report to constitute public disclosure under the FCA, thereby barring Wilson’s claim. The question of whether a local or state report constituting public disclosure under the FCA is one that has the federal circuits split almost evenly. The Supreme Court has granted certiorari to Wilson’s case and will address this issue and make a specific determination as to what exactly is meant by public disclosure. For more information on whistleblower lawsuits and the False Claims Act, contact a whistleblower lawyer.

The U.S. Attorney’s Office in the Eastern District of Pennsylvania announced yesterday that a grand jury incited Norian Corporation, Synthes, Inc. and four top Synthes executives, including Michael Huggins, Thomas Higgins, Richard Bhner and John Walsh with conducting medical device clinical trials without FDA approval.  Norian is charged in 52 felony counts of the indictment and the parent company, Synthes, is charged in 44 misdemeanor counts.  Each of the executives are charged with misdemeanors. 

The allegations center around obstructing an FDA investigation of adulterated and misbranded Norian XR and Norian SRS bone cements used in treating fractures.  The defendants allegedly prevented “the FDA from carrying out its role of supervising clinical trials of significant risk devices, and deprived patients of the safeguards provied by FDDA oversight of clinical trials.”

Synthes is a Delaware Corporation based in West Chester, Pennsylvania.  It is the U.S. branch of a large multinational medical device manufaturer that specializes in trauma products to treat damaged human bone.  Norian is a subsidiary of Synthes that specializes in the manufactuer of osteobiologic medical devices. 

The medical devices at issue, Norian XR and Norian SRS were used to treat “vertebral compression fractures of the spine (”VCFs”), a painful condition commonly suffered by elderly individuals.”  The surgeries were allegedly done despite the FDA-cleared label for the Norian XR specifically exclusing the device for this use and “in the face of serious medical concerns about the safety of the devices when used in the spine.”  Early studies in animals and by other means showed that the bone cement reacted chemcally with blood to cause clots.  Despite knowledge of this problem, the company allegedly prceeded to market the device for VCFs without putting it through FDA required testing. 

The company allegedly did not stop marketing the Norian XR until a third patient had died on the operating table in January 2004.  Indeed, even after the third patient died, the indictment allegeds that Synthes did not recall the Norian XR from the market because doign so would have required the company to disclose details of the three deaths to the FDA.  The defendants allegedly compounded their crimes by carrying out a coverup in which they lied to the FDA during official inspections in 2004. 

One of Synthes’s own surgeron consultants that conducted a “test market” of the device pleaded with the company that doing such tests would “amount to human experimentation whose only defense seems to be that it will be a small study.”  If the surgeron consultant had simply retained a whistleblower lawyer and reported the potential crime to the government, perhaps deaths could have been avoided.