Lawsuits allege use of device delivering local anesthetics in the shoulder joint causes permanent and painful damage.
Kalur Law Office filed six lawsuits on Jan. 8, 2009, in Arizona Federal Court on behalf of patients injured following the use of a medical device called a 'pain pump'. The lawsuits add to the growing number of cases across the country against some of the nation's largest pain pump manufacturers, including Stryker Corporation (NYSE: SYK), I-Flow Inc. (Nasdaq: IFLO), DJ Orthopedics Inc., Sorenson Medical, McKinley Medical, LLC, Moog, Inc. (NYSE: MOG.A), Curlin Medical, Inc. (a subsidiary of Moog), and Breg Inc. (a subsidiary of Orthofix International N.V. (Nasdaq: OFIX). The plaintiffs allege the products developed by these companies result in a lifelong and painfully debilitating injury to the shoulder.
According to the lawsuits, the injuries are a direct result of the pain pump delivering local anesthetics into the shoulder joint. Plaintiffs allege device manufacturers failed to warn the medical community that use of the pain pump directly in the shoulder joint could permanently damage the shoulder. Some pain pump manufacturers sought U.S. Food and Drug Administration (FDA) approval to use the pumps in the shoulder joint, but failed to disclose to doctors that the FDA denied clearance to market the device for this use on numerous occasions.
The lawsuits allege none of the device or drug companies conducted basic safety tests on animals or humans to see if use of the pain pump in the shoulder joint was safe and effective. The lawsuits also claim pain pump manufacturers withheld this information from orthopedic surgeons who used the pain pumps on patients following shoulder surgery.
Plaintiffs allege that after receiving the pain pump they developed a condition called chondrolysis, a permanent disability in the shoulder joint caused by the destruction of cartilage. Once cartilage in the shoulder is destroyed, it does not regenerate. This condition was rarely seen in post-operative shoulders prior to the use of pain pumps.
The pain pump devices, manufactured by named defendants, deliver high and continuous dosing of local anesthetic directly to the shoulder joint space. According to several medical experts, the continuous infusion of local anesthetic drugs delivered by the pain pump into the shoulder joint should be avoided, as studies show it causes permanent irreversible damage to the shoulder.
In June of 2008, the American Academy of Orthopaedic Surgeons (AAOS) issued a statement alerting surgeons of the risk posed to their patients by the use of post-operative pain pumps inside the joint space. The AAOS statement warns of the toxicity to articular cartilage of local anesthetics, such as bupivicane and lidocaine that are delivered by the pain pump.
In January 2009, Health Canada, the Canadian government counterpart to the FDA, published a "Canadian Adverse Reaction Newsletter," urging surgeons to refrain from using post-operative pain pumps for continuous infusion of the joint space with local anesthetics, and to follow the recently revised manufacturer's instructions to that effect.
"The support provided by the internationally recognized American Academy of Orthopaedic Surgeons (AAOS) as well as by the Canadian government is critically important for our clients and any future shoulder patients' safety," said Laura Kalur, one of the lead attorneys in these cases. "It helps assure injured patients nationwide and world-wide that they aren't alone in this fight."
Dr. Constance Chu, a leading researcher in cartilage injury, was recently interviewed in the November issue of Orthopedics Today about her series of research articles on the issue of the toxicity of continuous infusion of local anesthetics on cartilage. Dr. Chu recommends avoiding continuous use of local anesthetics through intra-articular infusion, as studies show it results in permanent damage.
In late 2007, Dr. Charles Beck, a well-respected orthopedic surgeon, published an article in The American Journal of Sports Medicine, demonstrating a strong association between the use of high volume pain pumps following shoulder surgery and the loss of hyaline cartilage in the shoulder joint. Dr. Beck's article was a retrospective study of patients who had received pain pumps in the shoulder joint space and showed an alarmingly high incidence of chondrolysis - 63 percent of patients who received intra-articular pain pumps suffered chondrolysis.
To date, more than 100 lawsuits are pending across the country, alleging similar claims against pain pump manufacturers.
Reference: To learn more about the devastating complications resulting from use of pain pumps after shoulder surgery or how to file your own claim against manufacturers, please call toll free (800) 898-2034 or visit www.painpump.net
Kalur Law represents individuals and families injured by defective products and medical devices, focusing on complex medical cases. Kalur has represented hundreds of injured and disabled clients. Learn more at www.kalurlaw.com