Placement and Type of Shoulder Pain Pump Key Factors in Development of PAGCL
 
Since the early 1990s, surgeons have used external pain pumps to help shoulder surgery patients manage their pain once they return home after surgery. Pain pumps consist of a catheter that is inserted into a surgical site. Pain pumps are often inserted into a shoulder after rotator cuff and shoulder decompression procedures. The catheter administers a long-lasting local anesthetic for up to five days. The use of the pain pump reduces the amount of pain patients experience immediately following surgery without the inconvenience and affects of taking oral painkillers or using narcotics.

The following companies produce pain pumps: Stryker, DJO Inc., I-Flow, and BREG Inc. Pain pumps are marketed under the following brand names: Stryker Pain Pump, Accufuser Plus, Donjoy Pain Control Device, PainPump Blockaid, and I-Flow On-Q PainBuster Pump.

Postarthroscopic Glenohumeral Chrondrolysis (PAGCL) and Intra-articular Placement

A painful and permanent condition called Postarthroscopic Glenohumeral Chrondrolysis (PAGCL) occurs when the cartilage that protects parts of the shoulder joint permanently breaks down and deteriorates. As a result, bones rub against each other. This causes excruciating pain and inhibited movement. Symptoms of PAGCL include, but are not limited to the following:

• Constant shoulder pain
• Limited range of motion in the shoulder
• Shoulder weakness
• Shoulder stiffness
• Clicking, cracking, popping, or grinding of the shoulder

While there are many causes of PAGCL, orthopedic surgeons believe insertion of pain pump catheters in the shoulder joint space are the cause of an increasing number of new PAGCL cases.

Number of PAGCL Cases Has Increased

Initially, pain pump catheters were placed in the soft tissue around the joint on which the operation was performed, such as the muscle area surrounding the joint. This use typically does not cause negative side effects for the patients. In recent years, however, it has become increasingly common to place the catheter in the joint site, a technique known as intra-articular placement. Additionally, pain pumps have become higher capacity, delivering more medication to the patients. This shift to higher-capacity pain pumps combined with the placement of catheters directly in the joint space has coincided with a steep increase in the number of reported cases of PAGCL in the United States.

Studies Link Intra-articular Placement and PAGCL

As early as 2004, significant studies began appearing that suggested the use of high-capacity pain pumps placed into the shoulder joint space meant that a level of anesthetic concentrated in the joint space was being released that was permanently toxic to the cartilage. Orthopedic surgeons began closely examining their patients who had undergone shoulder surgery and later developed PAGCL. The conclusions of these early findings were that the common factor between the patients was that they had received pain pumps which were placed in the joint. These findings initiated widespread clinical research, the results of which are now becoming available. A 2006 study by the American Academy of Orthopedic Surgeons and an October 2007 study by the American Journal of Sports Medicine both suggest that a strong link exists between intra-articular pain pump placement in the shoulder and patients developing PAGCL.

In the American Academy of Orthopedic Surgeons study of 152 patients who underwent arthroscopic shoulder surgery, all ten of the patients who developed PAGCL had been treated with a higher-flow pain pump that was placed in their shoulder joint. Seven other patients who received a pain pump placed in the soft tissue surrounding the joint did not develop PAGCL. The intra-articular placement of the pain pump catheter was the only variable the ten PAGCL patients had in common.

The 2007 American Journal of Sports Medicine study suggested that when too much medication is dispensed into an area where there is cartilage, PAGCL might be caused. This study also suggested that as many as 63 percent of patients who receive intra-articular placement of a pain pump catheter are at risk of developing PAGCL.

Pain Pumps Not Approved For Use Directly In the Shoulder Joint

The Food and Drug Administration (FDA) has not approved the pumps for use in the actual shoulder joint. Since 1998, the pain pump manufacturers have applied to the FDA multiple times for approval to be able to include an indication for catheter placement in the shoulder joint. The FDA has denied the applications each time, which means that intra-articular placement of pain pump catheters is currently still an unapproved use.

Dr. Charles Beck, an orthopedic surgeon and senior author of the American Journal of Sports Medicine study, asserts that the pain pump manufacturers were informed about the potentially dangerous connection between intra-articular placement of higher-capacity pain pumps and the development of PAGCL. However, the manufacturers have thus far done very little to change the warnings inside the products or how they promote the pain pumps. Only one of the main pain pump manufacturers, I-Flow, has changed the warning it includes in the pain pump packaging to include the following:

"Avoid placing the catheter in joint spaces. Although there is no definitive established causal relationship, some literature has shown a possible association between continuous intra-articular infusions (particularly with bupivacaine) and the subsequent development of chondrolysis."

Despite the studies highlighting the dangers of intra-articular placement of shoulder pain pump catheters and the warnings given to the manufacturers, the unapproved use continued. The subsequent cases of PAGCL have resulted in the filing of more than 100 lawsuits across the United States. These suits accuse pain pump manufacturers of actively encouraging doctors to place the catheters in the shoulder joint, despite the FDA denying approval for such use. In May 2008, a petition was filed with the Judicial Panel on Multidistrict Litigation to consolidate all of the lawsuits pending in federal courts around the country regarding the intra-articular use of pain pumps. However, this petition was denied, which means that all of the potentially hundreds or thousands of claims will proceed individually. This has a significant impact on the lawsuits because the outcome of one lawsuit will not affect the outcome of all of the other lawsuits.

To determine whether potential liability exists in a products liability lawsuit against the pain pump manufacturer, it is critical to examine what the patient's surgeon wrote in the patient's medical records and post-operative report. Experienced attorneys such as those at Magaña, Cathcart & McCarthy can request these crucial medical and post-operative records to determine the type of pain pump used and if the pain pump catheter was placed in the shoulder joint.

If you or a loved one had a pain pump implanted after surgery and are experiencing continued shoulder pain or limited movement, you may be suffering from PAGCL. Seek the advice of experienced legal counsel to determine your options and to preserve your rights. Magaña, Cathcart & McCarthy is currently investigating potential claims involving pain pumps and representing clients in pain pump cases throughout the United States. For a free evaluation of your case by a nurse on staff, contact Magaña, Cathcart & McCarthy.