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SURGICAL CLIP MANUFACTURER MAY FACE FAILURE-TO-WARN LITIGATION

SURGICAL CLIP MANUFACTURER MAY FACE FAILURE-TO-WARN LITIGATION

California product liability claims typically fall under one of three legal theories: design defects, manufacturing defects and failure-to-warn of known hazards. CNN reports that manufacturers of surgical clips may face failure-to-warn product liability litigation from kidney donors who suffered serious injuries when the clips slid off after surgery.

Surgical clips are widely used to close arteries after surgeries. These clips may be unsafe for kidney donors, however, because so little of the renal artery is left after a kidney donation. This makes it easy for a surgical clip to slide off and for patients to die from severe blood loss.

Many surgeons are aware that surgical clips are inappropriate to use on kidney donors, but the U.S. Food and Drug Administration has largely ignored letters by concerned transplant doctors.

"We were just in shock and deep sorrow to learn that our actions thus far and our efforts to try to stop the practice had been ineffective," one transplant surgeon said, adding that she routinely publishes articles and gives presentations to other surgeons concerning the practice.

CNN reports that the medical device manufacturer Teleflex, which makes the clips, sent several letters to hospitals warning them not to use the clips on kidney donors. These letters were largely ignored and inadequate because they failed to mention the fact that kidney donors have died after the clips were used.

"It's shocking that it doesn't say that even a single donor died," a transplant surgeon said of the warning letter. "It's meaningless without saying that."

The surgeon added that it would better for the clips to have a warning printed directly on them, instead of sending letters that could be ignored. "I think it would be great to say, 'Don't use on a kidney donor,' " the surgeon said.

Source: CNN, "Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings," John Bonifield andElizabeth Cohen, June 21, 2012

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