UPDATE 1-US charges Synthes over spine product marketing

* Company accused of marketing without approval

* Synthes since withdrew product

By Jon Hurdle

PHILADELPHIA, June 16 (Reuters) - U.S. prosecutors on Tuesday indicted Swiss medical device manufacturer Synthes Inc (SYST.VX), and its U.S. unit Norian Corp with marketing a spinal cement without approval of regulators.

Three patients died during spinal surgery while the company was conducting unauthorized clinical trials using two kinds of bone cement -- "SRS" and "CRS" -- between 2002 and 2004, Michael Levy, the U.S. Attorney for the Eastern District of Pennsylvania Michael Levy, told reporters.

The companies encouraged doctors to use the cement -- which was designed to prevent compression of the spine -- without the product being approved by the U.S. Food and Drug Administration, Levy said. About 200 people were treated with the product, which the company withdrew after the third death.

The patients died on the operating table at hospitals in Texas and California because of a rapid drop in blood pressure, Levy said. While there is no certain link between the deaths and the bone cement, doctors involved could not rule it out as the cause, the prosecutor said.

The indictment said that before the marketing program began pilot studies showed the bone cement reacted chemically with human blood in a test tube to cause blood clots.

The 97-count criminal indictment charges include impairing the functions of the FDA, making false statements to that agency and shipping misbranded product across state lines.

A spokesman for Synthes declined to comment.

"We are not commenting as long as we have not officially received something from the government," said spokesman Gilgian Eisner.

While doctors routinely use medical products for "off-label" treatment, companies are not permitted to encourage the medical community to use those products unless they have been cleared by the FDA, Levy said. The companies made little money from the product, prosecutors said.

"It's not proper for companies to do that without getting approval from the FDA," he said.

The defendants deliberately made false statements to the FDA in an attempt to cover up their promotion of the cement to doctors, the indictment said.

Norian, based in West Chester, Pennsylvania, faces a fine of up to $26 million while Synthes faces a fine of up to $8.8 million. The grand jury indictment also charges four officers who each face prison terms of up to a year, and fines of as much as $100,000.

The indictment names company executives Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh. They are charged with misdemeanors.

(Reporting by Jon Hurdle; Additional reporting by Lewis Krauskopf; Editing by Richard Chang)