The US Food and Drug Administration (FDA) approved the shoulder pain pump for the delivery of pain medication to the soft tissue surround the shoulder joint—in other words, the surrounding muscle—following shoulder surgery. However, the device was never given the FDA's blessing to administer pain medication to the joint itself.
Various plaintiffs have claimed in lawsuits that pain medication fed directly to the shoulder joint adversely affected the delicate cartilage—which does not regenerate—within the joint, resulting in further shoulder injury and in many cases complete incapacitation of the shoulder.
Lawsuits have claimed that not only did these pain pumps ruin many a shoulder, but that doctors were not apprised by the manufacturer of the risk to shoulder cartilage, and that some pain pump manufacturers actively promoted their use inherent to an indication for which the devices do not carry FDA approval.
As articulated in Lawyers Weekly USA (5/23/12), the plaintiff in Rodriquez v. Stryker Corp. claimed that a pain pump used on his injured shoulder following arthroscopic surgery in 2004 decimated the cartilage in his shoulder joint, causing chondrolysis. Four years later, the plaintiff launched a shoulder pain pump lawsuit against Stryker Corp., the manufacturer of the pain pump, for failure to warn under Tennessee product liability law.
The defendant argued that it could not have reasonably known about the risk of chondrolysis—the breaking down of shoulder cartilage—in 2004 and thus, did not have a duty to warn.
In this particular case, a jury in US Court of Appeals for the 6th Circuit found for the defendant, noting that the plaintiff's medical evidence failed to establish a duty to warn.
It is not known in this shoulder pain pump lawsuit if the plaintiff will appeal the finding to a higher court. However, it should be noted that other pain pump surgery victims have sued various manufacturers involved in delivering pain medication such as bupivicaine to the shoulder joint, with some success.
READ MORE PAIN PUMP LEGAL NEWS
The misguided and unapproved use of shoulder pain pumps to deliver pain medication directly to the shoulder joint has cost many a young athlete a promising career following a shoulder injury and shoulder repair surgery. Once shoulder cartilage gas been destroyed there is no way to replace it. A patient's only option is to either live with limited and painful mobility, or opt for expensive shoulder replacement surgery. For a young person, the latter may have to be performed several times over the course of a lifetime.
All because some manufacturers of pain pumps 'neglected' to advise doctors that their products were not properly approved for direct application to the shoulder joint.