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Source: MedPage Today

Surgical Cement Manufacturer Indicted for Spine Surgery Clinical Trial Fraud, Killing 3 People

A medical device maker, Synthes Inc., and four of its executives were indicted Tuesday on federal charges that they improperly promoted a bone filler for purposes not approved by the Food and Drug Administration, including encouraging its use in what prosecutors called “unauthorized” human trials in which three patients died, according to the U.S. Department of Justice.

The company, Norian Corporation, of Cupertino, Calif., faces 52 felony counts, including conspiracy to impede the lawful functions of the FDA, seven counts of making false statements, and 44 counts of shipping an adulterated product. Its parent company, Synthes, of Switzerland and West Chester, Pa., faces 44 misdemeanor counts of shipping an adulterated product.

The four executives -- Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner, and John J. Walsh -- are each charged with one misdemeanor count of shipping an adulterated and misbranded product. The charges center around illegal trials of Norian XR, a bone void filler used during surgery to repair certain fractures.

The indictment, sought by the United States attorney in Philadelphia, is one of the strongest actions taken in recent years against a maker of drugs or medical devices. Federal prosecutors typically file civil lawsuits seeking fines for such infractions, rarely bringing criminal charges against corporate executives.

The indictment charges that, from May 2002 to fall 2004, Norian conspired with parent company Synthes and four top executives to use Norian XR and Norian SRS to surgically treat vertebral compression fractures of the spine.

Norian XR is an injectable cement used to fill defects in areas of compromised bone during surgery. The filler was approved in 2002 by the F.D.A. for use in general bone repair, but regulators insisted that Synthes not promote its use for spinal procedures.

In the summer of 2002, the company approached selected spine surgeons and asked them to use a "predecessor device," Norian SRS, in vertebral compression fracture procedures as part of a test market, according to the Department of Justice. Ultimately, 52 surgeons were trained on use of the product in such procedures.

The surgeries were performed despite a warning on the FDA approved label for Norian XR against such use -- preliminary studies had found that the cement reacted chemically with human blood, resulting in clotting. Animal studies had shown that the blood clots became lodged in the lungs, according to the Department of Justice.

The agency said the company did not get permission from the FDA to conduct its "test market" trials in what it labeled as an attempt to "rush XR to the market first, before its competitors, and to generate published studies that it could use later to convince other surgeons to use XR off-label to treat vertebral compression fractures."

Norian conducted three of the training sessions, canceling others after three patients in whom Norian XR was used died on the operating table. The company did not recall the product from the market -- doing so would have required a disclosure about the deaths to the FDA. Instead, the Department of Justice charges that the company carried out a cover-up in which they lied to the FDA during inspections in May and June 2004.

According to a statement, the company said it sold only 200 units of the product, realizing total net sales of about $400,000, and it has had no revenues related to the product since 2004.

The company was previously subpoenaed in 2006 regarding off-label use of Norian XR.

"The FDA requires its independent review of the tests to ensure that companies do not put their financial interests ahead of the health and safety of the American people," U.S. Attorney Michael L. Levy, said in a statement.

"The defendants charged today bypassed the process, with the knowledge that the product they were marketing posed potentially significant risks," he continued.

"When predictable bad results occurred, they lied to the FDA. They put their profits ahead of responsible business practices and the truth," Levy said.

Norian faces a fine of $26 million, five years probation, and forfeiture of $469,800. Parent-company Synthes faces a fine of $8.8 million, five years probation, a forfeiture of $469,800, and full restitution.

The executives face a maximum of one year in prison and a fine of $100,000.