West Chester firm hit for unlawful clinical trials

A West Chester medical-device manufacturer, one of its subsidiaries and four company executives were charged by a federal grand jury yesterday for allegedly scheming to conduct clinical trials using a bone cement on spinal fractures without the approval of the Food & Drug Administration.

Synthes Inc. is a $3 billion global company specializing in trauma products and devices to treat damaged bone.

Authorities alleged that from May 2002 into fall 2004 a subsidiary, Norian Corp., conspired with Synthes and four Synthes executives to conduct unauthorized clinical trials of a bone cement called Norian SRS and its successor, Norian XR, in surgeries to treat vertebral-compression fractures of the spine.

The surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use. (Norian XR had been approved by the FDA for sale only as a bone-void filler.)

The indictment charged that before the marketing program began, the company learned from pilot studies that the bone cement reacted chemically with human blood in a test tube to cause blood clots.

The indictment charged that, despite this, the company proceeded to market Norian XR for vertebral-compression fractures, and didn't stop until three patients died on the operating table.

Authorities said that all three patients were dependents of people serving in the U.S. military and died of hypotension, or a rapid drop in blood pressure.

The indictment charged that after the third patient died, in January 2004, Norian and Synthes did not recall Norian XR from the market, which would have required them to disclose the details of the three deaths to the FDA.

Instead, the indictment charged, the companies tried to cover up the details of the patient deaths by lying to FDA regulators during an official inspection in May and June 2004.

U.S. Attorney Michael L. Levy said that doctors could not determine "with certitude" whether Norian XR caused the deaths.

Norian was charged with 52 felony counts, including conspiracy, making false statements and shipping adulterated and misbranded Norian XR with intent to defraud.

Synthes was charged with 45 misdemeanor counts of shipping adulterated and misbranded Norian XR. Four Synthes executives - Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh - were each charged with one misdemeanor count of shipping adulterated and misbranded Norian XR.

Synthes and Norian "put their profits ahead of responsible business practices and the truth," Levy said.

Synthes said in a statement that it stopped selling Norian XR in 2004 and had net sales of $400,000, adding that it has "fully cooperated" with the federal investigation and intends to "vigorously defend" itself against the charges.

The executive chairman of Synthes is Hansjorg Wyss, 74, reportedly the Philadelphia area's richest man, said to be worth almost $5.7 billion, according to Forbes magazine.

Although Wyss was not named in the indictment, the indictment refers to a Person No. 7, identified as "CEO and major shareholder of Synthes."

According to Synthes' Web site, Wyss was chief executive officer of Synthes from its founding in 1999 until April 26, 2007.

The indictment said that Person No. 7 attended a high-level management meeting in November 2001 during which a proposal was made to do a clinical study to obtain the FDA's approval of Norian SRS to treat vertebral-compression fractures.

However, the indictment said,Person No. 7 decided that Synthes would not pursue such a study but instead "get a few sites to perform 60-80 procedures and help them publish their clinical results." *