Final Verdict: $7 Million After Device Misuse Causes Death
Medical devices include a broad range of tools, technology, and materials intended to help save lives, simplify surgery, and improve patient quality of life. However, the approval mechanism for medical devices is slightly different than that for prescription drugs, and accordingly, their use can be controversial. There is less regulatory oversight for the use of tools by a surgeon during a procedure than for a new “miracle” drug. When patients are harmed due to the use of a medical device, there is a potential medical malpractice claim.
Malpractice claims resulting from the use of medical devices can come in a variety of presentations. When the use of a medical device is the result of a poor or inaccurate diagnosis, the blame lies squarely with the diagnosing physician. In other cases, the diagnosis may be correct, but the use of the device may not be consistent with that diagnosis, or it may be contraindicated for that particular patient due to other facts. A physician may use a medical device but do so improperly, causing unforeseen but preventable injuries. Finally, even if a physician uses the device correctly, the device itself may malfunction. This can result in a claim against the device manufacturer if the risk was not disclosed by the manufacturer, or against the physician if the risk was known to the physician but not disclosed to the patient.
Sadly, many medical devices have led to serious harm or death for patients across the United States. When medical devices are given to patients to be used, the rate of misuse can be extremely high; one study found that the Epi-Pen, used for the treatment of allergic reaction, was used properly by patients in only one time out of five. Vaginal mesh implants, once touted as a highly promising benefit for treating pelvic organ prolapse, has been the cause of many lawsuits and significant injury. Cohen & Cohen, P.C.
In 2013, 55-year-old accounts manager Karen Ebersole experienced a bifurcation aneurysm of the rightmost artery leading to the brain. She was sedated and placed under anesthesia. In a brain aneurysm, the blood often cannot clot quickly enough and so can result in irreparable harm. To treat the aneurysm, metal coils were inserted into the vessel to slow blood flow and induce clotting. A balloon catheter was used to hold the coils in place. Unfortunately, the balloon catheter punctured the right middle cerebral artery, causing a brain bleed. Karen passed away three days later.
Karen’s estate, administered by her two adult children, sued for medical malpractice and wrongful death. During the week-long trial, the doctor who had performed the procedure, neuroradiologist Richard Pegolizzi, attempted to blame anesthesiologist Dung Nguyen, arguing that he had used insufficient anesthesia and Karen had moved during the surgery. However, Dr. Nguyen brought evidence showing that Karen’s head had been taped down during the procedure and could not have moved.
Experts during the trial testified that the balloon catheter had been misused. Dr. Pegolizzi had inflated it too much and it had caused the brain bleed. The Virginia jury, with the expertise of the medical malpractice attorneys, agreed, finding in favor of the estate and awarding $7 million in damages.