Why Have Shoulder Pain Pump Manufacturers Been Silent About Chondrolysis?
UPDATED: May 5, 2016
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Medical device companies that manufacture shoulder pain pumps are aware of their devices' link to chondrolysis, or PAGCL ( postarthroscopic glenohumeral chondrolysis). However, only one manufacturer has ever addressed the issue – and even its warning was insufficient. So, why have these companies been silent while so many people have been injured?
Lack of responsibility
Consumer advocate groups and legal experts have said that most manufacturers have not addressed the issue of how the unapproved, but popular, use of shoulder pain pumps in the shoulder cavity have caused chondrolysis, a condition where the cartilage disintegrates between the humeral head in the shoulder and the glenoid (ball and the socket).
Jeff Milman, a California attorney whose practice represents injured pain pump victims, told us that although manufacturers have not come to the table and accepted responsibility, his firm is seeing more and more of these cases:
Obviously, the word has been out since probably 2004 to a lot of the medical profession that this is not the best-indicated use of this. For example, in 2004, the American Journal of Sports Medicine reported three cases of this condition, this PAGCL, and after that the doctors became aware or it. More recently, the Academy of Orthopedics issued a position that these should not be used intra-articularly. So the issue is with patients who have had a shoulder surgery where a pain pump was used. Symptoms develop somewhere between three to 12 months after surgery. Some may take as long as a couple of years to show up on an X-ray, so there may be patients who had surgery in 2002 or 2003 who developed symptoms, but could never figure out why they were suffering. It’s not until recently that the nexus, the pain pumps, have been shown to be the cause.
I-Flow did issue a warning – but was it sufficient?
Milman answered that question quickly by saying, “Not at all.” He explained:
If you look at what the manufacturers knew, they knew or should have known that this was going on even before 2004. I-Flow added a warning to the On-Q pump label in late 2006, but they didn’t really go out of their way to alert the physicians. What they basically included in the same size language as other information they include is, “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 and the subsequent development of chondrolysis.”
So they did add the warning, but it failed to adequately warn of the danger. They didn’t tell the medical profession that the FDA had not approved the use of pain pumps to deliver anesthetic into the joint space, that there had never been any studies or tests that supported the use of pain pumps in this manner and that, in fact, the studies significantly connected the continuous infusion of these anesthetics into the joint space causing intra-articular chondrolysis. So, the warning was a little too little and a little too late.
If you've been injured due to a shoulder pain pump, contact an experienced products liability attorney to discuss your situation and evaluate your options. You may be entitled to compensation for your injuries.