An Oregon jury has ordered I-Flow Corp. to pay $4.75 million in damages to a Portland couple who alleged that the company encouraged the off-label use of its pain pumps for shoulder-joint surgery patients. More than 100 similar suits against pain pump manufacturers have been filed nationwide.
The jury found I-Flow, now part of Kimberly-Clark, liable for the severe cartilage deterioration, called chondrolysis, that plaintiff Matthew Beale suffered after using an I-Flow pump to deliver pain medication directly into his shoulder joint after surgery.
A couple of studies showing a potential link between chondrolysis and pain pumps inserted in the joint were published in 2006. Since then, I-Flow has included instructions not to place catheters in joints in its package inserts and has posted a warning to patients on its Web site, reports the New York Times. But plaintiffs in the lawsuits against I-Flow and other pain pump manufacturers say the companies didn't warn doctors soon enough when evidence of the chondrolysis risk began to surface.
The FDA made it clear in a November 2009 safety warning that it "has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics" and that healthcare professionals shouldn't use pain pumps for this purpose after orthopedic surgery. The agency now requires the manufacturers of local anesthetics and pain pumps to include warnings of the potential for chondrolysis on their product labels.
"Local pumps should absolutely not be used in the joint at all," says Arizona-based orthopedic surgeon David S. Bailie, MD, who published a case series on severe chondrolysis after shoulder arthroscopy last year. "I would stay away from anything more than 10 to 20 cc in non-articular space only, and without epinephrine." Instead of pain pumps, physicians should use traditional pain medications and/or scalene blocks to treat joint pain after shoulder surgery, says Dr. Bailie.
Meanwhile, pain pump manufacturers and some medical experts point out that existing research does not conclusively prove the link between pain pumps and cartilage deterioration. "There's no study that I'm aware of that shows a direct cause," University of Pittsburgh researcher Constance R. Chu, MD, who's conducted several lab studies on the effects of local anesthetics on cartilage cells, tells the Times.
Irene Tsikitas
