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A growing number of young patients have been developing arthritis in their shoulders after routine outpatient arthroscopic surgery, causing surgeons to question what could be causing the debilitating condition in otherwise healthy individuals.
The Food and Drug Administration (FDA) is notifying health care professionals of reports of a serious and destructive cartilage condition known as chondrolysis in patients who have had shoulder surgery during which they received continuously infused local anesthetics to deaden pain. The anesthetics were delivered via pain pumps, balloon-like devices that hold medication outside the body and have a catheter that delivers pain medication directly into the shoulder joint for up to 72 hours following surgery.
Dr. David S. Bailie, an orthopedic surgeon in Scottsdale, Ariz., says he’s lost hours of sleep over a rare joint condition he started seeing far too often in his patients who had had arthroscopic shoulder surgery. “There’s nothing worse than a surgeon doing something that causes a problem, not fixes a problem,” he told the New York Times.
Since 2005, Dr. Bailie says he has seen dozens of patients come to him months after surgery with worsening pain and limited mobility. The diagnosis was chondrolysis, a condition in which the cartilage in the shoulder joint wears away leaving bone to rub against bone. There is no cure for chondrolysis and in some cases, total shoulder replacement is required.
Whitney Moore was in prime physical condition just a few years ago. She played junior varsity soccer at West Virginia University before opening a strength and conditioning business for young athletes. In 2004, she injured her shoulder playing soccer and had surgery to repair it. But the surgery only made her shoulder worse. Moore developed a once-rare condition known as chondrolysis, in which the cartilage in the joint wears away causing bone to rub against bone.
Five lawsuits against manufacturers of pain pumps and pharmaceutical companies on behalf of 28 people were filed in Los Angeles County Superior Court this month, alleging fraud, breach of warranty and products liability, saying the makers of the products continued to market the pain pumps as mitigation for shoulder joints despite the specific use of those products not being approved by the Food and Drug Administration (FDA). The lawsuits also allege that the pain pump devices caused a painful and debilitating condition known as postarthroscopic glenohumeral chondrolysis (PAGCL), in which the cartilage in the shoulder joint wears away causing bone to rub against bone.
The Food and Drug Administration (FDA) is warning orthopedic and anesthesia health care providers and hospital risk managers not to continuously infuse local anesthetics directly into the intra-articular joint space because this use of anesthetics has led to a painful and debilitating condition known as chondrolysis, or the decaying and destruction of the cartilage.
Things were looking promising for Florida State University quarterback Christian Ponder, until last Saturday, when he separated his right shoulder making a tackle after throwing his fourth interception against Clemson. He now faces surgery to repair a Grade 3 AC separation, which will bench him for the rest of the season.
Lawsuits against the manufacturers of shoulder pain pump devices have been filed in state and federal courts across the nation, and some have already been scheduled for trial beginning in 2010. What juries may be surprised to hear is how a device commonly used between 1999 and 2007 to relieve pain following shoulder surgery, has months later resulted in an irreversible, painful and debilitating condition known as chondrolysis.
Pain pumps are devices used to deliver a steady amount of medication to a wound site for up to 72 hours following surgery. They are often used in shoulder surgery. The balloon-shaped part of the device rests outside the body and is attached to catheters that feed into the shoulder tissue. Once the medication has been used, patients are instructed to simply pull out the catheter.
One of the three principal shoulder pain pump manufacturers facing lawsuits over serious injuries associated with the use of the pain pumps is no stranger to controversy. It was also engaged in an illegal scheme for which it was prosecuted for paying hundreds of thousands – and possibly millions – of dollars to physicians for using its hip and knee replacement products exclusively.
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