Former Hershey medical researcher charged in federal criminal case
A federal judge will have to decide whether it is better for society to have Dr. William J. Zinnanti, a prolific medical researcher, in the hospital laboratory or behind bars.
A prison term is on the table for Zinnanti, a former Hershey resident and a graduate of the Penn State College of Medicine, after a criminal charge was filed against him Monday in U.S. Middle District Court in Harrisburg.
The charge stems from allegations that a now-defunct Hershey-based business Zinnanti owned, Zinnanti Surgical Design LLC, supplied surgical devices that federal investigators contend were not sterile.
Zinnanti, 42, now a pediatric neurology fellow at the Stanford University School of Medicine in California, has a tentative deal with prosecutors to plead guilty to a charge of introducing adulterated medical devices into interstate commerce. The count carries a penalty of up to 3 years in federal prison, plus a year of probation and $250,000 in fines.
Zinnanti’s lawyer, Alan P. Caplan, said today that he hopes Zinnanti’s ongoing work in the medical research field dissuades Senior Judge William W. Caldwell from sending his client to jail. “Dr. Zinnanti is a brilliant doctor,” Caplan said during a phone interview from his Nevada office. “He has done some groundbreaking research in Pennsylvania and in California.
“Obviously, he’s admitting his error. He is paying a price for it,” Caplan said. “We’re hoping for leniency so Dr. Zinnanti is given the opportunity to keep helping people.”
U.S. Attorney Peter J. Smith said the accusation against Zinnanti stems from a U.S. Food & Drug Administration investigation concerning the Bayonet Electrosurgical Pencil that Zinnanti Surgical Design manufactured from 2005 to 2007. Such devices are used in electrosurgery, which employs high-frequency electric current to cut, cauterize and destroy tissue. Zinnanti’s pencils were mostly sold to hospitals and were used in back surgery, Smith said.
He said the FDA probe showed that Zinnanti, the president of the surgical design firm, didn’t have proper manufacturing controls in place to ensure that his company’s products were sterile. Also, Zinnanti is accused of trying to mislead the FDA regarding his manufacturing procedures, Smith said. Concerns that arose in 2006 prompted an an international recall of Zinnanti’s pencils.
In a warning letter issued in September 2007, the FDA criticized Zinnanti for not instituting quality control measures it had demanded after a 2006 inspection. The agency claimed that a March 2007 inspection had found hair and other foreign particles in several pouches containing the pencils.
A tentative plea agreement signed by Zinnanti and Smith’s office was filed simultaneously with the criminal charge. Terms of the agreement won’t be final unless sanctioned by a judge.
In the agreement, Zinnanti agrees to plead guilty as charged. There is no guarantee regarding his sentence, although it states that Smith’s office can make a sentencing recommendation. Also, the agreement doesn’t protect any professional licenses, such as medical licensing, that Zinnanti holds. It states that the fate of such licensing “is solely within the discretion of the appropriate licensing authority.”
Caplan said he is hopeful that Zinnanti’s record of medical research will “come into play” to ease the penalty when Caldwell sentences his client at an as yet undetermined date. Zinnanti has authored and co-authored research papers in array of medical areas, including the prevention of brain injury and the treatment of glutaric aciduria, an inherited disorder that can cause physical impairment and brain damage.