Spinal surgery patients may have been injured or killed as a result of illegal clinical testing of a bone-mending cement, the government has charged in an indictment against Pennsylvania-based Norian Corp.
A federal grand jury leveled 52 felony counts against the firm for using the bone cement on some 200 patients from 2002 to 2004 in clinical tests, which were halted after three patients died on the operating table. The indictment, announced in June 2009, said pilot studies had shown the bone cement caused blood clots in humans.
Prosecutors said Norian trained dozens of surgeons to use the bone cement even though company executives were aware it “posed potentially significant risks.” Reports said the material, Norian XR, was approved for use in arms but not the spine and that an FDA-approved label had even warned against such a use.
News reports said studies showed the bone cement could cause blood clots in humans and that animal research suggested clots could move to the lungs. Reports quoted authorities as saying the patients who died in the clinical tests suffered severe hypotension, or low blood pressure, after being injected with the bone cement.
Many of the surgeries in which Norian bone cement was used were conducted on older patients, including those in Veterans Administration hospitals. Prosecutors claimed the tests subverted safeguards established by the U.S. Food and Drug Administration.
The indictment alleged that Norian, though stopping the clinical tests, never recalled the bone cement, thus avoiding alerting the FDA. It also said that executives with Norian’s parent company lied about the testing when the agency started investigating.
Norian is based in West Chester, Pa., and is a unit of Synthes Inc., the world’s largest manufacturer of bone-related medical devices. Synthes North America is also based in West Chester, while Synthes Inc. has its global headquarters in Switzerland.
Kline & Specter, PC with some 30 attorneys, several of whom are also highly regarded doctors, has had great success in investigating and litigating defective medical device lawsuits. At this time, we are no longer accepting bone cement claims.