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Shoulder Pain Pump Patient Awarded $5.5 Million

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Portland, OROn January 22 a jury in Oregon awarded a chondrolysis patient nearly $5.5 million in compensation. At least a dozen more lawsuits alleging shoulder injury and debilitation due to improper use of shoulder pain pumps are expected to go to trial this year. They are part of more than 150 lawsuits currently making their way through the court system.

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.

Shoulder pain pump manufacturers deny that they marketed their products for off-label use, and note the lack of any scientific study that conclusively links chondrolysis onset to the use of a pain pump.

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.



Posted by

I had shoulder surgery on my right shoulder in 2004 where they used a pain pump the dr. told me "this is a slam dunk, 6 weeks & you'll be back to work" I did my therapy & was feeling pain during theropy, they told me I needed to push through the pain it also felt a bit gritty & made grinding sounds when I moved the joint. Later that year I after several times back complaining to the dr. about the pain I agreed to my 2nd surgery in 04. They found my "pushing through the pain" had torn my rotator cuff 90%. I was a bit ticked bout that news since I had been telling them during theropy it felt like something was tearing in my shoulder during range of motion exercises. Still I felt the grinding even worse after going back to the dr several more times complaining of pain & still not working as a plumber, the dr said "we can do a third surgery but it will be a hit & miss" I knew it was time to get a 2nd opinion cause the dr. had no idea what could be causing my now constant pain. Both the 1st & 2nd surgery were performed @ Willamette surgery center in salem oregon. So the salem dr referred me to specialist @ OHSU. The first thing they did there was take an x-ray & said "no wonder your in so much pain, your socket is wearing out" so their first surgery in 2006 was a clean up surgery scraping out the arthritis & checking everything in hopes of relieving the pain. I continued like before to do everything I was supposed to do to rehab my right shoulder. Still I felt constant pain with major sharp pains when I tried full range. My range of motion kept getting worse & worse. After a year of miserable pain I opted for the fourth surgery where they replaced my glenhumeral head in 2007. Both the 2006 & 2007 surgeries they used pain pumps. I hav been in constant pain & living a miserable life ever since the first surgery. Not one of the dr's even mentioned there could be some complications with the pain pump. Researching for the best dr. (Still unable to work) I found one of the best worked @ Washington state university in seattle wash. He was the first dr. to mention there was issues with the pain pump & he referred me to a lawyer who dealt with those cases. After months of looking at my case they told me I waited too long. I was & still am furious due to the fact I was never told about the potential problems with the use of the pain pump & feel I have a solid case that deserves compensation. I lost my life as I knew it due to the use of the pain pumps during my four surgeries. I am I n constant pain every minute of every hour of every day. I need help with the best lawyer so please if you are reading this & know someone who can help me

Posted by

I had shoulder surgery in july 2003 for possible torn labrum down time was a problem for me so the surgen debreid everything and i was set to come back in the fall to really have it fixed. A subacromial pain pump catheder was placed. There was a second subacromial pain pump catheder in the second surgery also. I was back October 2003 to repair the slap tear from 2:00 possition to nearly the 10:00 possition.After the first surgery I got about two weeks of pretty good pain relief. After the second surgery I seemed to progress somewhat better and then everything turned around,my pain went from good to bad in just a little while. I kept telling my surgen it felt like my bone was killing me.Needless to say I was soppose to be getting better but wasnt. It had my Doctor puzzled.I dealted with it till June 2004 and he went back in my shoulder.Then again in 2005, then again in Feb 2006. Still the same bone hurting stiff shoulder I had had since the second surgery as I remember right. My docter whom I still think a lot of sent me to a shoulder specialist and after two exploritory surgeries still no better. Fall 2006 and Feb 2008. I went back to him in mid 2009 to tell him to cut my shoulder off I couldnt stand any more and he recominded an MRI and nerve conduction study to see if there was any changes since the last surgery. And there was cartlage loss and tears due to the diagnoises of chondrolysis after arthroscopic shoulder surgery. Out come total shoulder replacement 2009. There is a problem with suacromial pain pumps too. My shoulder was worked on in the subacromial space and the glenohumeral joint at the same time - holes are holes and they leak no matter what. Thanks Big Daddy


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