Swiss Company, U.S. Affiliate Charged with Unapproved Marketing of Spinal Cement Products

A Swiss medical device maker and a U.S. subsidiary broke the law by marketing two spinal cement products without regulatory approval, prosecutors said today.

Synthes Inc. and its Norian Corp. unit conducted unauthorized clinical trials of the products, called SRS and CRS, from May 2002 to 2004, during which time at least three of about 200 patients involved in the trials died, according to Michael Levy, the U.S. Attorney for the Eastern District of Pennsylvania.

Norian is based in West Chester, Pennsylvania.

The bone cement products were designed to prevent compression following spinal fractures. The illegal clinical trials were conducted at undisclosed U.S. Veterans Affairs facilities and other hospitals across the United States, officials said.

Illegal Promotion Alleged

Synthes and Norian officials are accused of encouraging surgeons to use the cement in patients, even though the products were not approved by the Food and Drug Administration. While doctors are allowed to and commonly do use medical devices and drugs for unapproved “off-label” treatments in patients, companies cannot promote those uses or encourage doctors to use them unless they have been FDA-approved for some therapies.

Three patients died at hospitals in Texas and California during surgeries using the bone cement products after suffering from rapid drops in blood pressure. The deaths may or may have not been caused by the use of the unapproved bone cements, prosecutors said.

Company officials reportedly knew before the pushed the products that the bone cement could negatively chemically react with human blood, causing blood clots to form, prosecutors said. After authorities caught on to the companies’ promotion of the unapproved medical devices, Synthes and Norian officials reportedly lied to the FDA in an attempt to cover up the wrongdoing, according to the indictment.

Felony Charges Filed, Fines Sought

The indictment, unsealed today, charges the companies and various executives with conspiracy and 96 other counts, including 51 felonies, prosecutors said. Synthes and Norian officials Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh are named as defendants in the criminal complaint.

Synthes faces a maximum fine of $8.8 million while Norian could be fined $26 million, officials said.

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