Recently, St. Jude’s Medical removed its Riata and Riata ST defibrillator lead wires from the market after it was found the devices were coming apart inside the body and may have been responsible for shocks and shorts that led to defibrillator failures and deaths in patients.
Although the devices were removed from the market, thousands of patients still have the leads implanted since it was deemed that removing them might be more dangerous than retaining them – despite studies that suggest one in five of the devices may malfunction. According to the Wall Street Journal (WSJ), more doctors are suggesting that the leads be removed and replaced as the extent of the problems with the leads become clearer.
The WSJ story reports that patients who do undergo revision surgery can be left owing a substantial amount for copayments, travel expenses, and other bills. While Medicare will pay $873 for each lead removal procedure, if serious complications arise during or after surgery, the cost of the revision can run as high as $18,000.
While St. Jude Medical has a five-year warranty on the Riata leads, it only covers $600 and requires that doctors use the company’s newer Durata leads as a replacement. Those leads have been receiving scrutiny from the U.S. Food and Drug Administration (FDA) due to design similarities to the recalled Riata leads.
Do you think it’s fair to foot the bill for a revision surgery resulting from a defective medical device? Call a Florida medical device injury attorney at Farah & Farah to see what your legal options might be if you have to undergo a revision surgery due to a defective medical product. Call us at (800) 533-3555 for a no-obligation consultation today.