January 18, 2012
According to an article published in Health Affairs, 750,000 hip and knee implant surgeries were performed in 2005 and that number is expected to double by 2030. Each year, hip and knee replacement surgery becomes more common.
Unfortunately, so is revision surgery. Revision surgery is a costly process that often requires long hospital stays, a custom prosthetic and bone grafts to correct faulty or incorrectly implanted devices. What many patients might not know is that it is their right to keep the faulty joint in question. The joint was paid for when they had their initial surgery and is now their property.
Patients also may decide to pursue legal action against the manufacturer of a faulty implant. Why? To gain compensation to pay for medical and emotional damages incurred.
Defective Implants Serve as Evidence
If a victim chooses to sue, the defective implant may be a key component of any future case a patient may pursue because it may provide valuable evidence. Since there are many reasons why an implant may fail, having the physical device available for independent examination is helpful in determining any liability.
For some victims, pursuing legal action might be the only recourse. Device manufacturers – many of which are owned by pharmaceutical companies – may be more focused on device sales than the safety of their products.
In fact, it is estimated that the profit margin of artificial joints is higher than any other medical product. The New England Journal of Medicine estimates that 100,000 DePuy metal-on-metal ASR devices were implanted worldwide until they were recalled in 2010.
Another high profile recall in 2010 involved the artificial knees created by Zimmer, NexGen CR-Flex and NexGen LPS-Flex. These metal-on-metal implants were believed to be superior to previous devices. However, because of a loophole, they were approved by the U.S. Food & Drug Administration (FDA) without testing.
Many doctors have helped patients who suffered from debilitating joint pain and lack of mobility by surgically implanting artificial joints. Hip and knee devices are among the most commonly used in implant surgery.
Faulty DePuy Devices Spur Lawsuits
In recent months, medical implants have been making headlines. This surge in interest comes after one of the most widespread examples of medical negligence in history: the Johnson & Johnson worldwide recall of its DePuy ASR XL Acetabular System hip implant device and ASR Hip Resurfacing System in August 2010.
The New York Times reported that the recall came after a study conducted by the British advisory panel that revealed an abnormally high device failure rate. Since, approximately 3,500 lawsuits were filed against Johnson & Johnson in the United States alone, and Johnson & Johnson is in the process of paying millions of dollars to victims.
During the DePuy recall, the company sent out an information packet to surgeons that had implanted ASR devices. (A revised copy is now available on DePuy’s website.)
In a letter from August 2010, DePuy encouraged surgeons to report all revisions involving ASR implants and to return explanted devices. The company also included a permission form to be signed by the patient that would give DePuy the right to examine all patient medical records. DePuy even offered some compensation to doctors for each completed form.
In April 2011, a federal court judge ruled that joint replacement patients maintain the right to keep their faulty device should a revision surgery need to be performed. In addition, the judge ruled that patients had the right to have the faulty device inspected by a company of their choosing.
The judge also ordered DePuy to send a letter to all medical providers advising them that the device belongs to the patient. Any patients questioning their legal rights should consult with a legal professional.