Attorney: Shoulder Pain Pump Manufacturers "Did Not Warn About the Risks"

October 25, 2010, 8:00AM. By Heidi Turner

Boston, MAFor patients dealing with post-operative shoulder surgery pain, the shoulder pain pump might have seemed like the answer to their prayers. The pain pump, used following surgery to repair a shoulder injury, was designed to apply medication directly to the area affected by pain. Unfortunately, some patients developed a serious condition following use of the pain pumps after shoulder surgery.

Pain pumps are medical devices designed to help people cope with chronic pain by administering medication into the affected areas. They can be used to treat many chronic conditions. Ben Stewart, attorney at Stewart Law P.L.L.C., says the problem is that pain pump manufacturers told doctors the pain pumps could be implanted inside the body to help treat post-surgery shoulder pain.

"The manufacturers failed to inform doctors in the hospital about the pain pump's side effects and the degrading quality of the medication on the joints," Stewart says. "Specifically, cartilage is lost by direct exposure to the medication. The FDA (Food and Drug Administration), which regulates the medical device and drug industry, did not approve these devices for use in the joints. The FDA has acknowledged that the device was only approved for use outside the joints but not inside the joints as was done following shoulder surgery."

Patients who were given the pain pumps following arthroscopic shoulder surgery could be at an increased risk of developing postarthroscopic glenohumeral chondrolysis (PAGCL). Once the cartilage is degraded, it does not regenerate, meaning the damage is permanent.

"It's been estimated by the American Journal of Sports Medicine that almost two-thirds of arthroscopic patients who received the pain pump will develop PAGCL," Stewart says. "Some people find that the pain and restriction of movement begin as soon as the drug is administered. Some, however, do not notice degradation until three to 12 months post-surgery. The only way to alleviate the symptoms once the damage has occurred is a shoulder replacement, which is a complicated and expensive surgery. The patients wouldn't have had to face this expense had they not used the pain pump."

Many patients who used pain pumps in their shoulder were high school- and college-aged athletes, recovering from rotator cuff injuries incurred during their sporting activities. They now face full shoulder replacement surgery, which can be painful and will likely put an end to their promising careers at the collegiate and professional levels. Even patients who were not athletic but had the pain pump used following car accidents and recreational sporting activities could face the daunting prospect of a full shoulder replacement surgery due to use of the pain pump.

Stewart says the use of the pain pump following shoulder surgery should not be blamed on the doctors.

"The doctors relied on the manufacturers for information," Stewart says. "This is the manufacturer trying to expand its sales by urging doctors to use their equipment for uses not approved by the FDA. The manufacturer did not warn about the risks of the pain pump coming into contact with the shoulder."

Patients who have had a pain pump implanted in their shoulder and experienced chronic pain, stiffness or lack of mobility that has not subsided with the removal of the pain pump should seek professional guidance to determine whether they were further injured by the use of the pain pump and whether this injury could have been avoided. They should not assume that pain is a natural course of the initial injury or surgery.

"As with all legal claims, they could lose their rights to recovery by waiting before contacting an attorney," Stewart says. "Too many clients wait to see if there is news about litigation, but by doing that they could miss their opportunity to file a claim. They should bring their claim now before legal finality has occurred in our court system. The clock is ticking."