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COMPLAINT FILED AGAINST SYMBION

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The federal government has filed a criminal complaint against the company that once marketed Dr. Robert Jarvik's artificial heart, claiming it filed false reports with the FDA.

The misdemeanor complaint is part of an agreement between Symbion Inc. and the government, said Ty Cobb, attorney for Symbion. "The company is delighted to have this resolved," Cobb said.Symbion failed to properly monitor the clinical work done on its projects and in 1989 submitted a false report on its acute ventricular assist device, the complaint says. The Jarvik artificial heart was first implanted in dentist Barney Clark at the University of Utah Hospital in 1982. It kept him alive for 112 days.

The criminal complaint does not fault the performance of the artificial heart or the ventricular assist device. In fact, the artificial hearts developed by Symbion are still being implanted in critically ill patients to keep them alive until they can get human heart transplants.

The complaint against Symbion - a Utah company founded by Jarvik - was filed in U.S. District Court Monday. Jarvik was fired as chairman of Symbion in 1987, shortly after a venture capital company acquired a controlling interest in Symbion.

About six years ago, Symbion moved from Salt Lake City to Tempe, Ariz.

While Symbion went out of business, it did not file bankruptcy, according to Don B. Olsen, head of the University of Utah's Institute for Biomedical Engineering, which includes the U.'s artificial heart laboratory.

The company faces a potential fine of $200,000 if convicted, said assistant U.S. attorney Stanley Olsen. No individual with the company will be prosecuted, he said.

Symbion has already agreed to pay as much as $200,000, Cobb said.

According to the complaint, Symbion was required to monitor its clinical investigations of the total artificial heart and the ventricular assist device and submit reports of that monitoring to the Food and Drug Administration.

In mid-1989, Symbion sent a report to the FDA that included an inaccurate list of clinical monitoring visits, the complaint says. Some of the visits either hadn't been made as reported or were made for reasons other than monitoring, the complaint says.

The company also gave the FDA a misleading annual report on its ventricular assist device that implied that the necessary visits had been made, according to the allegation.

In January 1990, the FDA withdrew Symbion's permit, called an Investigational Device Exemption. In effect, that ended Symbion's participation in the artificial heart business.

At that time, legal rights to the artificial heart reverted to the University of Utah, which was instrumental in developing the device. The Medforte Research Foundation was formed to keep the program alive.

Medforte, based in Salt Lake City, formed a partnership with the University of Arizona called CardioWest Technologies, based in Tucson. Don B. Olsen, the president of CardioWest, said CardioWest took over the inventory and some of the equipment once owned by Symbion.

CardioWest has a manufacturing center in Vancouver, British Columbia, and has been shipping Jarvik artificial hearts to other countries. It also got approval to implant them in patients in this country.

"We have not done anything with the ventricular assist device," Don Olsen said of CardioWest.

"But we have been working with the total artificial heart. In 1992, we implanted six devices in patients, and in 1993 we implanted 18."

Centers in Ottawa, Canada, and Paris and Nice, France, use the hearts. In addition, the FDA has approved CardioWest's petition for limited clinical trials in the United States. So far, CardioWest has signed up five medical centers in Arizona, Illinois, Wisconsin, Pennsylvania and Texas.

Asked if the criminal charge indicates anything is wrong with the artificial heart mechanically, Don Olsen said, "Absolutely not. The device didn't fail, the company (Symbion) failed."

According to Don Olsen, the heart and the ventricular assist device didn't have problems themselves.

"Mechanically and reliably, they were very good. The reliability and safety of the devices was never an item of issue with the Food and Drug Administration."

Don Olsen said the government believes that in 1989 Symbion did not carry out proper monitoring of patients or devices.

"The Food and Drug Administration relied . . . upon the corporation to do the monitoring and the reporting," he said. The FDA's role was to make certain that the proper reports were filed.

If reports were not filed in an appropriate manner and in sufficient detail, "then their (FDA officials') mandate from Congress would be to stop the sale of the device."

Symbion is currently a liquidating trust. The settlement with the government now allows Symbion's trustee to start tying up loose ends, ultimately giving any assets left to shareholders and any creditors, Cobb said.