By Joe Messa
Medical malpractice lawyers previously reported that patients who have defibrillators with defective Riata wires, also called leads, have tough choices to make regarding their health. Heart device specialists say they aren’t even sure how to treat patients with defective leads. Leaving the damaged wires in is dangerous, but the removing them poses its own set of risks. A defibrillator is implanted by threading the lead through a blood vessel until it reaches the heart. In time, scar tissue can build up around it, making removal of the leads risky. Instead of immediate removal, the Food and Drug Administration has recommended all patients with the Riata device undergo imaging to see if their lead was failing. However, the agency points out that the issue of defective lead removal is “complex and needs to take into account additional patient circumstances.”
The Riata leads are manufactured by St. Jude Medical. The company recalled the faulty wires in December after warning doctors that internal cables were poking through the outer casing, causing unwanted shocks or functional failures. St. Jude now has a newer lead on the market, called Durata, but the safety of that lead has also been questioned. Along with the recommendation of image monitoring of Riata patients, the FDA has also ordered St. Jude to conduct additional studies of the Riata and the Durata.
Some patients have complained that St. Jude and the FDA did not contact patients directly about the Riata recall. In addition, some physicians have also not advised their patients of the device’s risks, citing that it could cause “unnecessary worry.” Patients have reported learning of the problems with the Riata device through their own research.
Consumer advocates have also voiced criticism of St. Jude and the FDA for inadequately testing medical devices before approving them and putting on the market. Once they are on the market, advocates say the system for identifying problems is flawed. Still, both the FDA and St. Jude say they continue to work to get the best information available to physicians and patients in order to provide the best possible care to Riata and Durata patients.
The Philadelphia medical malpractice lawyers at Messa & Associates are experienced at handling medical malpractice cases resulting from medical errors. Our extremely skilled team of medical malpractice lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one has suffered personal injuries as a result of a medical error, defective medical device or any other type of negligent care received by a medical provider, contact the medical malpractice lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More