When someone suffers a serious injury or death as a result of a medical error, a patient or the patient’s family may decide to file a civil lawsuit. One of the goals of most medical malpractice lawsuits is to see that the error doesn’t happen again to another patient. But in many cases, it does — often at another hospital far away, where doctors haven’t been warned about the potential for the error. These cases are especially troubling because they’re often easily preventable.
Consider the case of a woman who donated a kidney to her brother. Kidney transplant surgery is performed thousands of times a year and is considered a fairly low-risk procedure. The problem in this case was a tiny surgical clip used to close off the renal artery. The clips are used successfully in many other types of surgery, but shouldn’t be used in kidney donors because they can easily slip off the artery. That’s what happened in this case, which caused the woman to die from internal bleeding.
Transplant surgeons became aware of this problem as far back at 2004, when concerned doctors began notifying the U.S. Food and Drug Administration, presenting the problem at surgical conferences and publishing articles in journals. Yet no warning exists on the surgical clips not to use them in kidney transplant surgeries. The manufacturers said they began sending warning letters to hospitals in 2006, but the hospital where the woman in this case died didn’t start using the clips until years later. By that time, the letter it had received was long forgotten.
The hospital settled a civil lawsuit filed by the woman’s family, but still, the closest the clips come to having a warning is a symbol telling surgeons to read instructions on a device used to insert the clips. These instructions say not to use the clips on kidney donors, but they’re rarely kept in operating rooms. The letters the manufacturer sent also don’t indicate that people have died from their use, rendering the letters “meaningless,” according to one transplant surgeon.
After the woman’s death, the FDA issued a safety notification about the clips. But what are the chances all hospitals who use the clips now or in the future will take note of it? It’s frightening to think more people undergoing surgery to save someone else’s life will lose their own as a result.
Source: CNN, “Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings,” John Bonifield and Elizabeth Cohen, June 21, 2012
