Pain Pumps

Do Pain Pumps Cause the Deterioration of Cartilage in the Shoulder? Litigation Argues the Science While Former Patients Suffer.

By Michael Ramsey

As previously reported on Pain.com, there is some serious issues in regards to intra-articular pain pumps. The issues in question is whether these pumps should have ever been inserted into a joint, does the science prove that the pump insertion did in fact cause the development of chondrolysis, and was the cause due to over-dosage and not the unit/procedure itself, and could the manufacturers have provided better warning to surgeons regarding risks.

Science

November 2009: The Food and Drug Administration (FDA) has been tracking reports from people using pain pumps and discovered that 35 people had damage to their cartilage in the joint after using the pain pump post surgery. The report says most of the 35 people had shoulder surgery, and more than half of them required additional surgery, including joint replacement. (1)

In a September 2009 study by the American Academy of Orthopedic Surgeons, "it's time to stop using pain pumps." (2) The pumps when inserted into the joint after arthroscopic surgery have been linked to a debilitating condition called postarthroscopic glenohumeral chondrolysis (PAGCL). It turns out that this condition can be far worse than the original condition itself the surgery was performed to repair. Opponents of the procedure say it leaves the patient with destroyed cartilage. During the study, 152 patients who had undergone arthroscopic shoulder surgeries were studied. Twelve of the patients developed PAGCL, and all of them had received pain pumps during their surgeries. The use of the intra-articular pain pump was the only factor that the PAGCL patients had in common. (3)

Without doubt, PAGCL destroys the cartilage in the shoulder. However, it is not only present when the pump is used. There have multiple studies linking PAGCL and the use of pain pumps. "Several basic science studies have confirmed the chondrotoxicity of both bupivacaine and epinephrine. [The medications typically delivered by the pumps.] The effects of bupivacaine have been shown to be time- and dose-dependent."

Symptoms of PAGCL Include: 

• Clicking, popping or grinding (Crepitus) in the shoulder
• Decrease in range of motion in the shoulder
• Joint space narrowing as shown on an x-ray
• Loss of strength
• Increased pain in the shoulder at rest and with motion
• Increased stiffness in the shoulder

The New York Times reports that Dr. David S. Bailie, an orthopedic surgeon in Scottsdale, Ariz., said he had seen dozens of cases of chondrolysis since 2005. “There’s nothing worse than a surgeon doing something that causes a problem, not fixes a problem.” (4)

Litigation

On January 22, 2010 a Portland Oregon jury awarded a single chondrolysis patient nearly $5.5 million for debilitation resulting from the use of shoulder pain pumps. Some 28 different corporations were named as defendants in over 300 personal injury pain pump related lawsuits. The primary manufacturer of shoulder pain pumps, I-Flow "reported in November that it has been named as a defendant in 191 cases involving 412 patients. AstraZeneca is a defendant in 68 active cases." In May 2008, several litigation teams filed for class action status with the case but were denied on the grounds that "consolidation would not serve the convenience of the parties or further the interest of the judicial economy." (5)

The lawsuits allege, in part, the following:(2)

• The pain pump manufacturer/defendants knew or should have known,prior to placing the product on the market, that continuous intra-articular infusion of local anesthetics such as lidocaine and bupivacaine, with or without epinephrine, for extended periods of time, results in chondrocyte death and thus, chondrolysis in shoulder surgery patients.
• The defendants failed to adequately warn the orthopaedic community of the danger posed by intra-articular placement of pain pump catheters.
• The defendants failed to adequately warn—through labeling or educatation of their sales force—the orthopaedic community that such a use had been specifically denied multiple times by the U.S. Food and Drug Administration (FDA).

Conclusions

Busfield feels that "orthopaedic surgeons who have used intra-articular pain pumps in patients in the past should immediately contact those patients and tell them to seek a follow-up visit immediately and should immediately discontinue use of intra-articular pain pumps in joints following surgery." Initial short-term studies associated with subacromial pain pumps demonstrates the pumps to be safe and effective, but more long term studies are needed. (2)

Note: The information contained in this article is intended for general information purposes and should not be considered legal advice. Individuals who need legal advice should contact a duly licensed professional.

References:

1. Pumping Pain Relief. Pain.com. 11/23/2009. Accessed 1/28/2010 http://www.pain.com/go/default/practitioner/medical-library/news-for-the-medical-practitioner/pumping-pain-relief/

2.Busfield,  Benjamin T. MD, Kalur, Laura B. Esq. Safety and litigation update for shoulder pain pumps. AAOS Now. September 2009 Issue.  http://www.aaos.org/news/aaosnow/sep09/clinical8.asp. Accessed online: 1/28/2010

3. Defective Pain Pump Shoulder Injury. www.LawyersandSettlements.com. 12/19/2009 http://www.lawyersandsettlements.com/case/defective-shoulder-pain-pump.html?ref=article13500 Accessed online 1/28/2010.

4. Thomas, Kate. Studies Link Rare Ailment to Pain Pumps. New York Times. 1/26/2010. Accessed online 1/28/2010. http://www.nytimes.com/2010/01/27/sports/27painpump.html?pagewanted=1&sq=pain%20medicine%20pumps&st=cse&scp=1

5. Gibb, Gordon.Shoulder Pain Pump Patient Awarded $5.5 Million. www.LawyersandSettlements.com. 1/27/2010.
http://www.lawyersandsettlements.com/articles/13500/shoulder-pain-pump-chondrolysis.html Accessed online: 1/28/2010