Most medical devices available today are approved by the Federal Drug Administration (“FDA”) through a process known as 510(k) Clearance. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This process allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. If the FDA finds that a device is equivalent to a device already approved then the new device does not have to go through safety and effectiveness testing that most people would expect.
According to a May 2012 Consumer Reports investigation (click here to read the full report), “for most implants and other high-risk devices brought to the market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients.”
In its investigation, Consumer Reports studied three medical devices approved through the FDA’s streamlined 510(k) process, two of which were approved without clinical trials and all of which have failed miserably. Attorneys at Pope, McGlamry are currently investigating and filing lawsuits against the manufactures of two of the products investigated by Consumer Reports – transvaginal mesh products and metal on metal hips.
The first product investigated by Consumer Reports was the transvaginal mesh product designed to repair prolapse, where the bladder and uterus drop out of their normal position within the pelvis. Since transvaginal mesh’s FDA approval, hundreds of thousands of women have suffered from infection and severe pain caused by the defective transvaginal mesh product. One consumer reported that “she was in such pain she couldn’t sit, she couldn’t stand, and she could hardly walk.” The transvaginal mesh kits were cleared by the FDA based on their “substantial equivalence” to an earlier mesh used to repair abdominal hernias that was sold as long ago as the 1950s, even though the kits were designed to be used in a different part of the body and inserted laparoscopically, not through open surgery.
In January 2012, nearly 10 years after the first transvaginal mesh kits hit the market, the FDA finally took action to protect consumers. The FDA ordered 33 companies to conduct the first-ever post-market safety studies of the products. The FDA is thinking of reclassifying those mesh kits to the highest-risk Class III.
The second product investigated by Consumer Reports was an artificial hip known as the ASR XL, which was introduced in 2005 by DePuy, the orthopedic division of Johnson & Johnson. Once again, the FDA cleared the device without clinical testing based on “substantial equivalence” to earlier devices, though such metal-on-metal hips had long been on the FDA’s high-priority list for requiring advance clinical trials. Consumer Reports interviewed an orthopedic surgeon who was implanted with the DePuy ASR device. The surgeon turned patient stated that only one year after his surgery, it became clear that something was wrong. His hip was “pretty much constantly painful” and the chromium and cobalt levels in his blood “were notably high.” Then he started noticing other problems, such as disturbed sleep, mood swings and anxiety, hearing loss, visual problems, and tinnitus.
Consumer Reports’ investigation placed much of the blame on the FDA’s inefficient inability to monitor the post-market success of products. For instance, although the hip was invented and manufactured by an American company, DePuy recalled the defective ASR device because as early as three years prior to the American recall, regulators in Australia, England, and Wales were noticing serious problems. Those countries were able to do so because they have national joint registries—a list of every joint implanted—and the ability to track how patients fare with various models. There is no such national registry in the U.S.
Rather than monitor the products approved through the streamlined 510(k) process, the FDA has a voluntary system whereby doctors, manufacturers, and patients can report problems with medical devices. Experts estimate that only a fraction of device problems ever get reported. However, from 2009 through 2011, the FDA received 20,518 reports of injuries from metal-on-metal total hip replacements. Of those, 15,137 concerned the now recalled DePuy hip. Many of the remaining complaints concerned several other brands and models that are still on the market in the U.S., including the defective Wright Medical Conserve hip device.
The 2011 Institute of Medicine panel concluded that the FDA’s ability to spot problems is so inadequate that it’s “impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market.”
The FDA has failed to adequately hold manufacturers accountable for their gross injustice to innocent consumers. Attorneys at Pope, McGlamry are currently taking and filing cases against those manufactures to hold them liable for distributing defective products. If you or a loved one has suffered from the defective transvaginal mesh, DePuy ASR metal on metal hip device, or Wright Medical metal on metal hip device contact our Georgia product liability litigation attorneys today and schedule a free consultation.