Charges laid after US medical testing deaths

A US subsidiary of a Swiss medical device firm has been charged in the United States with illegally testing a type of bone cement on 200 patients, three of whom died.

Norian Corporation, which is owned by Solothurn-based Synthes, allegedly trained dozens of surgeons to unofficially test the product, Norian XR, on humans. Prosecutors say the surgeries took place from 2002 to 2004.

Doctors conducted around 200 tests and stopped after a third patient died during the surgery. Norian is charged with conspiracy and 51 other felonies.

According to the indictment, the company’s pilot studies showed the product could cause blood clots in humans, while pig research suggested such clots could move to the lungs.

The patients who died suffered severe hypotension, or low blood pressure, following injections of Norian, authorities said.

In a statement, Synthes said it planned to fight the charges and said Norian XR was approved by the FDA to treat bone defects “in the skeletal system.” The company said it sold 200 units of the product, for $400,000 (SFr434,000) from 2002 to 2004.

“Synthes has fully cooperated with the government’s investigation, which began in 2006, and believes that its marketing practices in connection with Norian XR were proper,” the statement said.

swissinfo.ch with agencies