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

In light of a recent report released by the U. S. Food and Drug Administration that confirms the link between chondrolysis and pain pump use, Joseph A. Carrese, MD, MPH, an expert in bioethics, has issued an opinion stating that physicians have a responsiblity to inform former patients on whom they used the device of the possible risk.

It is Dr. Carrese’s opinion that “to do otherwise would be a failure of expected ethical and professional conduct, and in turn a failure of good clinical practice.”

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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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Rotator cuff surgery is considered one of the most painful sports-injuries surgeries to the shoulder. It involves the reattaching of the damaged tendon or tendons to the upper arm. In order to access the injured rotator cuff, the surgeon makes a two- to three-inch incision in the shoulder and cuts through the deltoid muscle. Scar tissue is removed and small holes are drilled through the bone allowing the surgeon to sew the tendon to the bone. The procedure can be difficult for sports medicine and orthopedic surgeons due to the multitude of knots that must be tied through a type of small tubing under arthroscopic viewing. But one corporation is making that procedure easier for surgeons.

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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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The shoulder joint has the greatest range of motion of all our joints and allows us to use our arms for various tasks, from throwing pitches to supporting our bodies. When the shoulder is injured, surgery may be required to relieve pain and restore mobility. However, some individuals have found that surgery on their shoulder has made their condition worse.

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Pain pumps are devices used to deliver a steady amount of medication to a wound site for up to 72 hours following surgery. They are often used in shoulder surgery. The balloon-shaped part of the device rests outside the body and is attached to catheters that feed into the shoulder tissue. Once the medication has been used, patients are instructed to simply pull out the catheter.

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Three decades ago, Chuck Short dislocated his shoulder joint while pole-vaulting. The nagging pain and limited use eventually led his doctors to recommend a total shoulder replacement. Much had changed in the 30 years since Short originally injured his shoulder. Back then, he would nave needed to stay in the hospital for three to five days. But thanks to innovations in medical technology, Short was able to go home a mere two hours after surgery. The reason? A pain pump that rested outside his body but had a tiny catheter that fed into his wound site. The pump administered gradual doses of Novocaine into his shoulder for up to 72 hours.

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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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Pain pumps have been used for years by physicians to effectively deliver pain medication to surgical sites, for example, after shoulder surgery. So why are so many cases suddenly being filed against the manufacturers of pain pumps?

“I think what we’re seeing is that physicians are finally seeing the relationship between pain pumps and chondrolysis – especially since the first lawsuits were filed a couple years ago,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “In addition, literature is now being published about the connection between pain pumps and chondrolysis. The more information that becomes available, the more people are learning what may be causing their shoulder problems.”

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