Medical device manufacturer Stryker Orthopaedics has offered to pay a minimum amount of $33 million to settle Department of Justice charges associated with its OtisKnee device. The company came under fire after marketing the device before receiving clearance from the Food and Drug Administration (FDA).
Marketing an unapproved device is bad enough, but further complicating matters is that the knee replacement devices were proven to cause dangerous complications in patients implanted with them. Eventually, the implant was recalled.
Among other problems, the Stryker knee implant failed at a much higher rate than other devices, forcing patients to undergo painful revision surgeries. The leading causes of revision surgery were:
- Implant loosening
- Disease progression
- Pain and swelling in the operated knee beyond normal surgical recovery times
Stryker knees were not the only devices that caused problems to patients; the company's Trident PSL and Hemispherical Acetabular hip implants were also recalled due to higher than normal failure rates, which caused serious pain, uneven wear, difficulty walking, 'squeakiness' in the implanted hip and broken devices.
News of medical device recalls like these is unfortunately not unusual. Even when the companies responsible for marketing flawed or defective devices agree to pay up, as Stryker is doing, the settlements cannot take back the damage and pain inflicted by faulty devices.
To try and prevent mass implantations of faulty devices, Congress passed a law in 2007 calling for the implementation of a tracking system for medical devices. Known as Unique Device Identification (UDI), the law requires all new medical devices manufactured in the country to be equipped with an individual tracking number, allowing the FDA to monitor and identify device failures early on, before they can cause widespread injury. The agency already monitors medications in a similar fashion but, prior to the 2007 law, nothing required the FDA to keep track of medical devices.
While UDI seems like a simple solution to the growing number of mass medical device recalls, the FDA has yet to implement the system five years after Congress passed its creation into law. Now, as Congress places the final touches on its FDA reauthorization bill, consumer safety advocates are urging government to impose a deadline for the FDA to implement the UDI system.
Unless and until medical devices in this country are monitored in the same way that prescription drugs are, dangerous products will continue to be implanted in patients long after initial reports of design flaws are made available. Without UDI, the attorneys at Arnold & Itkin expect to see many more high profile recalls like those affecting the Stryker knee and hip implants, the DePuy hip implants and other dangerous devices like vaginal mesh implants. In the name of consumer health and safety, we call on the FDA to improve their medical device tracking system and, in the absence of their voluntary assumption of this responsibility, our product injury attorneys hope that the government will step in and mandate this type of device regulation.