About Elastomeric Infusion Devices

Numerous state and federal lawsuits have been filed against pain pump manufacturers. The reason? Those medical devices have been associated with permanent and crippling cartilage damage. The pumps can effectively deliver pain medication following arthroscopic shoulder surgery, but their use in unapproved ways has been linked to Postarthroscopic Glenohumeral Chondrolysis, or PAGCL.

PAGCL is an extremely painful condition involving the deterioration of shoulder cartilage. There is no cure and many individuals who suffer PAGCL require a complete shoulder replacement. If you have been diagnosed with Postarthroscopic Glenohumeral Chondrolysis (PAGCL) following the use of a pain pump, you need legal help -- and you need it now. The MedLaw Legal Team of Janet, Jenner & Suggs, LLC is investigating PAGCL claims nationwide and currently accepting new shoulder pain pump cases.

Fill out our online contact form or call us at 1-888-4-MED-LAW for an evaluation of your case.

An intra-articular elastomeric infusion pain pump is typically used for about 48-72 hours after shoulder surgery to bathe the joint with a local anesthetic. Companies that manufacture, market or distribute pain pumps include Stryker, DJO Inc., I-Flow Inc., BREG Inc. and others.

The pain pump consists of a highly flexible reservoir that is enclosed in a protective shell and a flow restrictor system. The pain medication is infused directly into the shoulder through a catheter. The most common pain medication used with a pain pump is bupivacaine with epinephrine (Marcaine). The drug is contained in the reservoir and its release rate is determined by the pressure in the reservoir, the flow control tubing, and the flow restrictor.

Elastomeric infusion devices are widely used to deliver drugs for chemotherapy, pain management, and antibiotic treatment. These devices offer several advantages over standard infusion devices due to their weight, size, decreased interference with daily activities, and user friendliness.

Pain pumps were originally placed in the muscle or outside the shoulder joint and caused few complications. However, the development of high-volume pumps led the manufacturers to advise physicians to insert the catheter directly into the joint space, or intra-articular area.

Neither the local anesthetics, including bupivacaine, nor the elastomeric infusion devices have been approved or cleared by the Food and Drug Administration (FDA) for this off-label use. In fact, the FDA denied an application by the pain pump makers to use the devices intra-articularly. In November 2009, the FDA explicitly reiterated its position that it had "not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics."

Lawsuits filed by patients with PAGCL alleged the manufacturers ignored the FDA denial of their application and instead told health care providers that the pain pumps could be safely used in the joint space. That unapproved use has been associated with at least 35 case of PAGCL, according to the FDA, which states that "the infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of [PAGCL]."

If you or someone you love has developed PAGCL following joint surgery, you may have valuable legal rights that we can help you protect. Please contact the MedLaw Legal Team of Janet, Jenner & Suggs, LLC by filling out our online contact form or calling us at 1-888-4-MED-LAW.

Janet, Jenner & Suggs, LLC

Cohen & Malad, LLP