Washington, DCThere are certain things that just don't mix—oil and water, the sleep habits of teenagers and their parents. Or shoulder cartilage and bupivacaine mixed with epinephrine. The latter are pain medications that have found their way directly to the irreplaceable shoulder cartilage by way of a shoulder pain pump.
Many shoulder injury patients have seen their shoulders negatively impacted by this condition, known as postarthroscopic glenohumeral chondrolysis (PAGCL). The latter is characterized by the onset of debilitating pain and a diminution in range of motion of the shoulder regardless of a patient's age. As damaged cartilage does not regenerate, complete joint replacement is often the only option.
For a young patient having undergone shoulder surgery and stricken with PAGCL, numerous shoulder replacement procedures may be required over the course of his or her lifetime.
At issue is the use of pain pumps to deliver pain medication directly to the shoulder, and the fact that the US Food and Drug Administration (FDA) never approved the use of the shoulder pain pump for delivery of pain medication directly to the shoulder joint—but rather, into the soft tissue surrounding the shoulder.
The controversy—and the foundation of numerous pain pump surgery lawsuits—surrounds whether or not pain pump manufacturers promoted the use of the pain pump for an indication that might prove unsafe, was untested and did not carry FDA approval. While doctors have always possessed the authority to use medications and devices off-label, it is illegal for manufacturers to promote their use for off-label indications.
Doctors and health care professionals have since suggested that had there been any doubt about the safety and effectiveness of the shoulder pain pump to infuse pain medication directly to the shoulder, they would certainly have spared their patient that risk.
Meanwhile, the talking heads on the FDA Patient Safety News segment dated February 2010 noted that the actual cause of PAGCL is not known. Shoulder pain pumps infuse pain medication at a pre-determined rate for a period of 48 to 72 hours continuously. FDA Patient Safety News notes that single (not continuous) intra articular infusions of pain medication have been carried out in orthopedic procedures in the past with no reports of complication.
Thus, with the shoulder pain pump, is it the pain medication, the materials in the infusion device itself or a combination thereof?
While lawsuits filed by shoulder repair surgery patients continue to wind their way through the courts, the FDA asked the manufacturers of pain medication to update the warning labels on their products, with regard to the shoulder pain pump dilemma.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a defective products lawyer who may evaluate your Pain Pump claim at no cost or obligation.