Details of the report

In recent hearings before Congress, the Government Accountability Office (GAO) released a report showing that the FDA, which oversees medical devices, "has not met statutory requirements to inspect medical device manufacturing facilities." The report states that the FDA's "information technology infrastructure is obsolete and unstable; provides an insufficient basis to access, integrate and analyze data and is subject to frequent system failures." In the same hearings, FDA Commissioner, Dr. Andrew von Eschenbach, told Congress that the FDA "needs more resources."

Medical device failures

Medical device failures have reached staggering proportions. Countless recalls have been issued by the FDA and manufacturers alike. However, what may be even more frightening are those products that have been deemed just as dangerous, but have not been recalled or may have slipped through the cracks.

To add to problems, in February 2008, the U.S. Supreme Court ruled 8-1 in Riegel v. Medtronics that patients injured by certain medical devices approved by the FDA cannot sue the product's manufacturer. As of August 2008, the Supreme Court's ruling is being challenged in both the U.S. Senate and House of Representatives. Also, in November 2008, the Supreme Court will hear oral arguments in Wyeth v. Levine, which asks whether a patient harmed by a drug can sue under state law if the drug was produced and marketed under terms approved by the FDA.The following is just a small percentage of the sheer volume of medical devices associated with failure in the past year:

• Medtronic's Sprint Fidelis lead wires. In October of 2007, Medtronic Inc. recalled 235,000 of its Sprint Fidelis defibrillator lead wires that have been linked to at least five deaths. The wires, which connect the defibrillator device directly to the heart, have a high incidence of fracturing – which causes the defibrillator to either not work at all or to unnecessarily shock patients. Many lawsuits have been filed against the company.
• Defibrillator wires in November 2007 after discovering that the wires may puncture patients' hearts.
• Stryker Trident hip implants. In January of 2008, Stryker Inc. recalled its Trident PSL and Hemispherical Acetabular Cups that were manufactured in its Cork, Ireland manufacturing facility after hundreds of customer complaints about the product squeaking, causing pain and chipping. Many have had to undergo further surgeries to correct the problems.
• Boston Scientific implantable cardioverter defibrillator (ICD). Boston Scientific issued a product advisory on January 4th, 2008 on several of its implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices that are used to shock or pace the heart. The advisory reported that these devices had failed 13 times and that current estimated failure rates are between three and four percent.
• Shoulder pain pumps. Recent studies have shown that shoulder pain pumps may actually deliver too much medication to the shoulder after surgery, permanently deteriorating and eventually destroying cartilage in that area and causing Postarthroscopic Glenohumeral Chondrolysis, or PAGCL, a painful condition that may become permanent and cause loss of mobility. Although neither the FDA, nor any of the manufacturers of these pumps, have instituted a recall, countless lawsuits have been filed in the past year against manufacturers such as Stryker, DJO Inc., I-Flow and BREG Inc.
• Cardinal Health's Alaris Pump Cardinal Health recalled 200,000 units of its Alaris pumps (infusion devices) that have been linked to two patients' deaths. The company reported that the units were misassembled.

Industry experts say that medical device manufacturers are leery about recalling products as they don't want sales to drop or their reputations to become tarnished. As such, many manufacturers won't recall products until patients report injuries – or even die. That, coupled with the FDA's inability to adequately regulate the industry, leaves consumers subject to serious health risks – and often with no one to turn to. If you or a loved one has been injured due to a defective medical device, consult with an attorney whose practice focuses in this area of the law to discuss your situation. To contact a qualified attorney for a free, no-obligation and confidential consultation, please click here.