PHILADELPHIA — A medical device company near Philadelphia pleaded guilty to dozens of crimes Tuesday for conducting unauthorized tests of its bone cement on about 200 spinal surgery patients, three of whom died on the operating table.
Synthes Inc. and its subsidiary, Norian Corp., performed the tests from 2002 to 2004.
The product was approved for use in the arm, but not in the weight-bearing spine. Synthes, though, had trained surgeons to use it "off-label" so the company could gather data to support its expanded use. Doctors are allowed to use drugs and medical products for "off-label" uses, but companies cannot promote them that way.
Synthes executives put profits over patient safety as they bypassed the long, expensive process of getting U.S. Food and Drug Administration approval for the clinical trial, the 2009 indictment charged.
Norian pleaded guilty Tuesday to a single felony, conspiring to impede FDA functions, along with 110 misdemeanor counts of shipping a mislabeled product. Synthes pleaded guilty to the shipping misdemeanor.
The West Chester-based companies will also pay the maximum $23 million in fines.
Four former Synthes executives have also pleaded guilty to a related misdemeanor in the case.
If prosecutors get their way, the four could become the first white-collar defendants sent to jail under the 1975 "Park Doctrine," which holds them responsible as corporate officers whether they intended to break the law or not.
In court papers, prosecutors argue that the four acted knowingly, especially after a Synthes medical consultant warned early on that the tests amounted to "human experimentation."
Defense lawyers deny their clients had any specific intent to defraud the FDA. The defendants are: former Synthes North America President Michael D. Huggins, 51, of West Chester, Pa.; former senior vice president Thomas B. Higgins, 52, of Berwyn, Pa.; vice president Richard E. Bohner, 55, of Malvern, Pa.; and director of regulatory and clinical affairs John J. Walsh, 46, of Coatesville, Pa.. Their lawyers have declined to comment before sentencing, which are not yet scheduled.
According to the June 2009 indictment, the company's pilot studies showed the bone cement 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 bone cement, authorities said. None of the surgeons could rule out the product as a factor in the deaths, an FDA investigator has said.
However, nor was it ever ruled the cause of death.
As part of the corporate plea agreement approved Tuesday by U.S. District Judge Legrome D. Davis, Norian will be sold to an outside buyer.
Synthes' defense lawyer, Donald J. Goldberg, declined to comment on the company's behalf. Norian lawyer James T. Smith did not immediately return a call for comment.