Those lawsuits might have a little more ammunition, now that several medical studies have drawn a connection between shoulder pain pump and the onset of chondrolysis.
There is no conclusive evidence as to what exactly causes chondrolysis. There are various hypotheses, not the least of which is the use of a shoulder pain pump to deliver pain medication directly to the shoulder joint following surgery.
The shoulder pain pump found favor with orthopedic surgeons in the 1990s. It would free up hospital beds more quickly, the manufacturers promised. Doctors could use a pain pump to deliver controlled doses of pain medication straight to the surgical site, rather than sending patients home with a bottle of pills.
It is alleged that the manufacturers actively promoted the application of their pain pumps directly to the shoulder joint. The US Food and Drug Administration (FDA) okayed the pain pump for use in muscle tissue surrounding the shoulder joint, but never approved the device for use in the shoulder itself.
Many in the medical community now say that pain medication serves as a toxin to cartilage. Exposing cartilage to local anesthetics for up to 72 hours causes the cartilage to start breaking down, resulting in pain and loss of mobility. Cartilage does not regenerate. Often additional surgery and/or complete shoulder replacement is required.
According to an article that appeared yesterday in the New York Times, surgeons began noticing an increase in chondrolysis cases in 2004. After various studies suggested that shoulder pain pumps could be to blame, manufacturer I-Flow Corporation altered its directions in package inserts, advising against the placement of pump catheters in joints. A bulletin was also posted on its website in June 2007.
I-Flow, the largest manufacturer of should pain pumps, reported in November that it has been named as a defendant in 191 chondrolysis cases involving 412 patients. AstraZeneca is a defendant in 68 active cases.
Sports careers over for young athletes
Marcus Suhn, a defensive end for South Dakota State University, returned to the field in the fall of 2006, his junior year, after a successful shoulder surgery in December 2005. Several months later, he noticed his shoulder worsening.
"I could make it through 15, 20 minutes of practice, and by that time, my arm was just dead," said Suhn, now 25. "I kept saying, 'Something's not right there.'"
His doctor found that his shoulder cartilage had deteriorated. Suhn, his football career now over, had to get his shoulder joint replaced in 2008. His pain has eased, but doctors still don't know the long-term outcome.
Another young patient, Whitney Moore, played junior varsity soccer at West Virginia University and later opened a strength and conditioning business for young athletes. After a 2004 shoulder injury, she had surgery and developed chondrolysis.
Unable to continue working, Moore had to close her business. On a recent night out, she had to ask a friend to help her cut the crust on her key lime pie.
Doctors say labels were too vague
In November the FDA issued a bulletin with regard to the pain pump issue, and reiterated that it had never approved use of shoulder pain pumps directly with joints—although doctors still have the legal and medical authority to use drugs and devices off-label to treat conditions for which they were not necessarily approved.
Some doctors now say that labels on pain pumps were too vague. "There was nothing on the package insert to say, 'Do not use in the joint,'" said Dr. David Bailie, an orthopedic surgeon from Scottsdale, Arizona, who has seen dozens of chondrolysis cases since 2005 and admits to losing some sleep over the issue. He published a case series on chondrolysis in 2009.
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More research is needed, says Dr. Constance R. Chu, an orthopedic surgeon and associate professor at the University of Pittsburgh who studies cartilage regeneration. "There's no study that I'm aware of that shows a direct cause," she says. Dr. Chu has completed several laboratory studies on the affect of local anesthetic on cartilage cells, which she says provide important information, "but it's a huge leap to say this is what's going on in the patient."
A federal judge in Florida dismissed a case in June against Breg over lack of scientific proof. However, another shoulder pain pump patient was recently awarded $5.5 million. It is not known whether I-Flow, the defendant in the case, will appeal the ruling.