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Patients who have had an orthopedic surgical procedure and received a prolonged infusion of a local anesthetic into the joint with a disposable elastomeric pump or any other infusion pump are urged by the Food and Drug Administration (FDA) to pay attention to symptoms of any joint pain, stiffness and decrease or loss of motion. If any of those symptoms persist, patients are advised to contact their health care professional.
UCLA forward James Keefe will miss two to three weeks with the team to recovery from a dislocated left shoulder. The senior was injured during the first half of UCLA’s game against New Mexico State on December 15th. The injury occurred on the same shoulder that required surgery for a torn labrum in 2007.
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.
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.
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.
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.
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.
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.”
Just five years ago, baseball writer, radio host and injury expert Will Carroll called torn shoulder labrums “baseball’s most fearsome injury,” adding “If pitchers with torn labrums were horses, they’d be destroyed.” However, thanks to improvements in surgery, baseball players no longer have to look at torn labrums as career-ending injuries.
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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