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FDA System for Tracking and Announcing Medical Device Recalls Faulted as Recalls Soar

By October 7, 2009July 16th, 2019Defective Medical Device litigation

As a defective medical device attorney, I was alarmed to read a detailed article on medical device recall problems from the Associated Press Oct. 5. In short, the article exposes the federal government’s dangerous lack of a centralized system to track down people using medical devices that have been recalled for safety reasons. When a device is recalled, the FDA and manufacturers send out press releases and may make it into the news — but only certain devices are registered and tracked so that patients may be personally notified. As a result, health care providers, medical professionals and patients may continue to use the recalled products for months or years before realizing the problem.
The FDA currently requires comprehensive registries for 14 medical devices, including pacemakers and breast implants, and a registry for artificial joints is in the works. However, thousands of devices are excluded from these registries, meaning patients must rely on medical providers to keep track of which devices have been recalled. Most hospitals note the serial number of a device in paper records, which can be time-consuming to sift through; some health insurers and nonprofit medical organizations are building their own databases. A comprehensive national medical device registry is part of the health care legislation that Congress is currently considering, but the medical device industry says it would be too costly and unnecessary. However, a study of 2,200 hospitals by a hospital umbrella group found that even after one device was recalled, doctors continued to implant it in at least 50 patients.
The article focuses on the sad story of married couple Michael and ShellyAnn King of New York. Michael King agreed to donate a kidney to his dialysis-dependent wife, but after the surgery to remove the kidney, a Hem-o-lock brand surgical clip popped off his renal artery. Before the problem was discovered, he bled to death in the hospital at the age of 29. After the incident, the King family discovered that the Hem-o-lock clips had been recalled about two years earlier out of concerns that they could dislodge from the renal artery and cause deadly uncontrolled bleeding — precisely what happened to Michael King. The family’s dangerous medical device lawyer said the hospital had been notified of the recall but never took action. They are suing the hospital, the medical center and the surgeon involved.
This is disturbing news. Patients rely on medical devices to sustain or save their lives, or help them live normal, healthy lives. If our doctors and regulatory agencies don’t have the information they need to stay up to date on which devices have safety problems, they can’t give us the information and the excellent care that we deserve — and that they want to provide. As a defective medical device lawyer and a longtime observer of the pharmaceutical and device industries, I know that both the use of medical devices and the number of medical device recalls have grown rapidly; the article notes a 164% increase in medical device recalls since 2000. Millions of patients are using devices in an industry with a spotty safety record. If even 1% of those devices slip through the cracks, that still leaves thousands of patients with potentially life-altering or fatal problems from devices implanted in their own bodies.

Based in St. Louis, the Lowe Law Firm represents families throughout the United States that were seriously injured by a defective medical device. As with prescription drugs, we trust medical devices to help us feel better — but when manufacturers fail to uncover serious problems, or find them and cover them up, patients can be killed or seriously disabled. Our defective medical device attorneys help patients and families in this situation hold the manufacturer responsible for the results. In a lawsuit, families can recover all of the financial costs the defective device caused as well as compensation for their injuries, pain, suffering and any wrongful death or lifelong disability. Our goal is to help our clients alleviate the effects of their injuries and return as much as possible to a normal, healthy life.
If you received a medical device whose defects seriously harmed you and you’d like to know more about your legal options, you should talk to the Lowe Law Firm right away. To speak confidentially about your case at no cost or obligation, please contact us through our Web site or call 1-877-678-3400 today.