by
Brendon Nafziger, DOTmed News Associate Editor | March 11, 2011
iCad, Inc. is faced with a $14.5 million patient lawsuit over recalled shielding used for a brachytherapy device the radiology software company inherited from its December purchase of Xoft Inc.
Two unidentified people filed suit in Orange County Superior Court against Xoft, iCad and Hoag Hospital in Newport Beach, Calif. after special shielding used with the the Axxent Electronic Brachytherapy System allegedly left tungsten particles in a woman's breasts, according to court documents.
Jeff Milman, an attorney for one of the plaintiffs, says "Jane Doe," a 58-year-old clinical psychologist, claims she might have to have one or both breasts removed, according to an OC Register write up of the case. The tungsten particles allegedly turned up on a follow-up mammogram.
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iCad voluntarily pulled the Flexishield Mini off the market last month after hearing of the report. However, a February 3 recall notice issued by the company said there appeared to be little danger from the tungsten.
"Based upon the company's preliminary analysis, it believes that the particles were non-toxic," iCad said in a Securities and Exchange Commission filing last week. "The Company is working closely with the FDA on this matter."
iCad said the shielding recall also has no effect on the safety or efficacy of the Axxent device, which delivers radioactive seeds into tissues to zap cancers. However, the company recommends patients who have been treated with the device follow up with their doctor for additional tests for tungsten, according to reports.
In its SEC filing, iCad reported that the shielding accessory had been sold on a "very limited basis" and that it is looking for a replacement.
The Nashua, N.H.-based company also does expect the recall to have a "material impact" on its revenues and said it was looking into possible "indemnification claims against Xoft as well as insurance coverage." It also said it plans to "vigorously defend" the lawsuit.
"Jane Doe" was the first person at Hoag hospital to be treated on the new device on June 24, after waiting weeks for it to receive U.S. Food and Drug Administration approval, according to reports. iCad said she is one of 27 people believed to have been treated with the Flexishield at the hospital.
iCad bought Xoft last December in an approximately $13 million cash-and-stock purchase.
