Pain Pump Manufacturer Should Have Disclosed the Risks of Their Product

A U.S. district court precluded summary judgment due to questions of fact, regarding whether a manufacturer of a pain pump knew, or should have known, of the risks involved in using its product directly into the shoulder joint, in a lawsuit against the manufacturer.

Shoulder pain pumps are usually used following arthroscopic shoulder surgery, and have become quite popular in order to help manage pain following surgery, without the use of narcotics. The shoulder pumps are also used to help reduce recovery time by limiting the amount of breakthrough pain a patient experiences. Unfortunately, intra-articular pain pumps are now linked to serious, debilitating, and long-term shoulder damage, particularly those which administer epinephrine and bupivacaine.

In 2004, after a surgeon placed a Stryker pain pump directly into the joint space to deliver pain after a patient’s arthroscopic surgery, there was no FDA approval for this device. After the patient subsequently developed glenohumeral chondrolysis, he sued Stryker, alleging they were aware that use of the pump in the joint space could cause injury, but continued marketing it for that use and failed to warn physicians that it had not been approved for such use.

The court cited a declaration that the medical and scientific communities knew before 2000, that “continuous exposure to foreign solutions could be harmful” to joint cartilage. The plaintiff also presented internal Stryker documents, referencing the lack of FDA approval for “inter-articular injection” of a particular pain medication and referencing anesthetic “toxicity” concerns related to the pain pump use.

New research has established a connection between the use of intra-articular shoulder pain pumps and the patient’s development of postarthroscopic glenohumeral chondrolysis (PAGCL). The shoulder pain pump (such as Stryker) is used to deliver medication directly to the site of surgery, through a catheter, which is inserted directly into the shoulder joint. Medication is infused for several days until no longer needed, at which time the disposable pump is removed.

Shoulder pain management pumps have been linked to PAGCL, which is a rare condition that results in the deterioration of cartilage in the shoulder joint. This results in permanent shoulder pain, and significant limitation in the use of the shoulder. There is currently no successful treatment for this condition.

In 2006, a paper was presented at the American Academy of Orthopedic Surgeons’ conference, showing evidence that the use of intra-articular pain pumps could be responsible for this painful condition.

According to a study published in the October, 2007 issue of The American Journal of Sports Medicine, as much as 63 percent of patients who use shoulder pain pumps, like Stryker pain pumps, are at risk of developing PAGCL.

PAGCL is an extremely painful, life-changing condition. Symptoms of PAGCL include pain in the shoulder when in motion or at rest; increased shoulder stiffness; popping or grinding when the shoulder is in motion; decrease in the range of motion; and a loss of strength in the joint. Treatment for this condition is usually an additional surgery. Many patients never fully regain complete use of their shoulder.

There are several lawsuits being filed against Stryker for their promotion of unapproved uses of their products. Many plaintiffs agree that Stryker should have known that its pain pumps, when used with anesthetic medications in the joint space, could be toxic to shoulder cartilage, causing permanent injury. Lawsuits also allege that the manufacturers of shoulder pain pumps failed to instruct or warn the U.S. medical community that the safety of using the pain pumps directly into the shoulder joint had not yet been established. Is this justice?

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