Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has released safety tips for nurses on elastomeric infusion devices, or pain pumps, used during and up to 72 hours after surgery to deliver a continuous amount of local anesthetic directly into the patient’s intra-articular space, or shoulder joint, for postoperative pain control. The FDA has received approximately 35 reports of chondrolysis in patients who received continuous intra-articular infusions with pain pump devices. This type of chondrolysis, called postarthroscopic glenhumeral chondrolysis (PAGCL), occurs when the shoulder cartilage is worn away, causing bone to rub against bone. It is a severe, life-altering complication that is usually irreversible. Many patients require a total shoulder replacement.

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Much has been reported lately about chondrolysis of the shoulder, or Postarthroscopic Glenohumeral Chondrolysis (PAGCL). So what is chondrolysis and why is it getting so much face time? Chondrolysis is the destruction of the cartilage in a joint. It is generally a rare condition anywhere in the body, but it has been most often heard of in hip joints most often from birth defects. Before the 1990s, chondrolysis in the shoulder was never seen.

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Patients who used pain pump devices to relieve pain from shoulder surgery are at risk for permanent joint damage, according to recent studies. Pain pumps are balloon-like devices that are filled with anesthetics that deliver medication directly into the surgical space via a catheter. The medication is slowly released into the joint space for up to 72 hours following surgery and then the catheter is removed by the patient.

While this use of pain pumps was a convenient way to relieve pain from surgery, it also resulted in a surprisingly high number of cases of a painful and debilitating deterioration of cartilage in the shoulder joint known as chondrolysis, specifically Postarthroscopic Glenhumeral Chondrolysis (PAGCL). The condition is permanent and many who suffer from it require shoulder replacement surgery.

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Just as the baseball season was getting underway, Tampa Bay Rays J.P. Howell had surgery on his left shoulder, ending his season prematurely. The left-handed reliever had to stop a simulated game last week just after starting because of discomfort in his shoulder. Two days later he was in surgery. Howell is expected to be recovered enough to play in the 2011 season.

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Five lawsuits against manufacturers of pain pumps and pharmaceutical companies on behalf of 28 people were filed in Los Angeles County Superior Court this month, alleging fraud, breach of warranty and products liability, saying the makers of the products continued to market the pain pumps as mitigation for shoulder joints despite the specific use of those products not being approved by the Food and Drug Administration (FDA). The lawsuits also allege that the pain pump devices caused a painful and debilitating condition known as postarthroscopic glenohumeral chondrolysis (PAGCL), in which the cartilage in the shoulder joint wears away causing bone to rub against bone.

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Lawsuits against the manufacturers of shoulder pain pump devices have been filed in state and federal courts across the nation, and some have already been scheduled for trial beginning in 2010. What juries may be surprised to hear is how a device commonly used between 1999 and 2007 to relieve pain following shoulder surgery, has months later resulted in an irreversible, painful and debilitating condition known as chondrolysis.

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I-Flow Corp., the Irvine, Calif.-based device maker, exceeded expectations with its quarterly results and says it expects to see an operating profit for the year despite a sharp increase in the number of product liability lawsuits filed against the company in July 2009. The company, which makes devices that deliver targeted anesthesia as an alternative to narcotics known as pain pumps, has a market value of $175 million.

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One of the three principal shoulder pain pump manufacturers facing lawsuits over serious injuries associated with the use of the pain pumps is no stranger to controversy. It was also engaged in an illegal scheme for which it was prosecuted for paying hundreds of thousands – and possibly millions – of dollars to physicians for using its hip and knee replacement products exclusively.

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Pain pumps are devices that are used to deliver medication to a surgical site. Medication is stored in a balloon that rests outside the body. A catheter is fed from the balloon and implanted into the surgical site, where it delivers medication for up to 72 hours. Once all the medication has been released, the patients simply pulls the catheter out.

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Four complaints have been filed in federal court in Philadelphia against Stryker Corp., maker of medical devices including postoperative pain pumps, for causing serious arthritis. The Kalamazoo, Michigan-based company is accused of actively concealing or misrepresenting information about the safety and efficacy of its pain pumps.

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