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Women sue pain pump manufacturer for dangerously defective device
April 24th, 2009 by Jennifer Walker-Journey
Attorney Frank Woodson with Beasley Allen Law Firm along with attorneys with partnering firms filed two separate lawsuits on April 8, 2009, alleging that pain pump devices implanted in the shoulder during and after surgery to repair shoulder injuries were unreasonably and dangerously defective beyond the extent contemplated by ordinary patients.
Plaintiffs are Laura E. and Jeffrey K. Ashworth and Sheri L. and Wade S. Patrick, all residents of Maricopa County, Arizona.
According to the complaints, Ms. Ashworth underwent an initial arthroscopic surgery on her right shoulder on March 29, 2006 at the Arizona Orthopedic Surgical Hospital in Chandler, Arizona. At the end of the procedure, the surgeon inserted a pain pump in the subachromial space, or the space above the shoulder joint, and not directly into the intra-articular joint space. Less than three months later, on June 12, 2006, she re-injured her right shoulder and underwent a second arthroscopic surgery a the same facility. The orthopedic surgeon implanted the catheter of an “On-Q PainBuster” pain pump, manufactured and marketed by I-Flow Corporation, directly into the intra-articular space of her right shoulder. The device injected pain relief medication directly into the plaintiff’s shoulder joint on a continuous basis for up to 72 hours following surgery.
Ms. Patrick underwent arthroscopic shoulder surgery on September 2, 2004, at Scottsdale Healthcare Shea-Piper Surgery Center in Scottsdale, Arizona. At the end of surgery, an I-Flow “On-Q PainBuster” pain pump was implanted into her left shoulder by her orthopedic surgeon. As in Ms. Ashworth’s situation, Ms. Patrick received continuous pain relief medications injected into her pain pump for up to 72 hours or more following surgery. She underwent a second arthroscopic surgery on January 16, 2007 at the Metro Surgery Center in Phoenix, Arizona and received another “On-Q PainBuster” pain pump on her left shoulder and, once again, received the continuous injections of pain killers through the device.
While the pain pumps are designed and intended to be used with commonly used anesthetics, the continuous injection into the shoulder joint of those medications at the doses prescribed over time can cause serious and permanent damage to the cartilage of the shoulder joint.
As a result of both Ms. Ashworth’s and Ms. Patrick’s pain pumps, which delivered dangerous doses of continuously injected medication into their shoulders, both women suffered narrowing of the joint space and/or chondrolysis, a condition in which the complete or nearly complete loss of cartilage in the shoulder joint. Chondrolysis is an irreversible, disabling and extremely painful condition.
A recent study published by The American Journal of Sports Medicine identified intra-articular pain pumps as the likely cause of chondrolysis.
The lawsuits allege that defendant I-Flow did not warn the plaintiffs or their surgeons, who used the devices as instructed and directed by the defendant, about the unreasonable risks and dangers of using the pain pump and anesthetic medications in this manner.
