Defective Pain Pump Shoulder Injury

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Shoulder surgery can be painful and pain management is usually required post-surgery. Oral painkillers are often prescribed but to better manage post-surgical pain of arthroscopic shoulder surgery, a disposable small and flexible plastic tube, called an intra-articular pain pump catheter, is surgically implanted in the shoulder joint and left for a few days after surgery to deliver pain medication to that area.

The pump delivers relief but evidence has revealed that it cause severe and irreparable damage. The shoulder pain pump has been associated with Postarthroscopic glenohumeral chondrolysis or PAGCL, an extremely painful condition that can cause life-long disability. PAGCL is one of the most common complications following shoulder surgeries but physicians were unable to determine a cause until a study was published in 2006.

The study, conducted by the American Academy of Orthopedic Surgeons, reported that the use of shoulder pain pumps may be associated with PAGCL. Medical charts of 152 patients who had undergone arthroscopic shoulder surgeries were studied. Twelve of the patients developed PAGCL, and all of them had received pain pumps during their surgeries. The use of the intra-articular pain pump was the only factor that the PAGCL patients had in common.

PAGCL is a progressive loss of cartilage of the glenohumeral joint--the joint that joins the arm and shoulder. The head of the arm bone, which connects to the joint, is covered in articular cartilage, which allows the shoulder joint to move smoothly. If this cartilage is damaged or destroyed the shoulder cannot move easily. It will cause significant pain and reduced range of motion.

Shoulder pain pumps did not cause any adverse side effects when the tip of the catheter insert stopped at soft tissue. But pain pump manufacturers allegedly wanted to expand the use—and thus, their market for the units by introducing pain medication directly to the shoulder joint.

According to sources, the manufacturer sought approval from the FDA for expanded use on numerous occasions, asking the FDA to approve the device for inter-articular placement. This additional use was turned down by the FDA but the manufacturer assured the medical community that shoulder pain pumps were safe to use for placement in the joint space.

PAGCL Symptoms

• Increased pain in the shoulder at rest and with motion
• Increased stiffness in the shoulder
• Clicking, popping or grinding (Crepitus) in the shoulder
• Decrease in range of motion in the shoulder
• Loss of strength
• Joint space narrowing as shown on an x-ray

PAGCL Lawsuits

More than 30 lawsuits have been filed nationwide against the manufacturers of shoulder pain pumps, alleging that the devices caused the development of a painful and debilitating condition where the cartilage in the shoulder is destroyed.

In May, 2008 several attorneys filed a petition to consolidate all federal lawsuits filed on behalf of individuals who developed shoulder chondrolysis after using a pain pump following arthroscopic shoulder surgery. But in August, 2009 the United States Judicial Panel on MDL denied the petition. The panel determined that a MDL was not appropriate in shoulder pain pump litigation, mainly because an indeterminate number of different pain pumps made by different manufacturers are at issue, and consolidation would not serve the convenience of the parties and witnesses or further the interests of judicial economy.

About 28 different corporations and medical providers filed in federal court are named as defendants in the various shoulder pain pump lawsuits, including Stryker Corp., I-Flow Corp., Smith & Nephew, Inc., DePuy, Inc., DJO, Inc., Breg, Inc. and AstraZeneca PLC. All of the defendants opposed the consolidation.

What Can You Do?

PAGCL is usually diagnosed with an x-ray showing the narrowing of the shoulder joint space. Treatment for this condition is further surgery; however, many patients never regain full use of their shoulder joint.

If you'­ve had arthroscopic shoulder surgery and were given a shoulder pain pump, and are experiencing any of the above symptoms you should contact your doctor immediately. And you may want to seek legal help.