Lawsuits Claim Makers Ignored FDA in Promoting Shoulder Pain Pump Use

By Jim Greene

Published on December 30, 2009

Five lawsuits have been filed in Los Angeles County Superior Court accusing makers of post-surgical pain pumps of promoting the devices for shoulder surgery patients without U.S. Food and Drug Administration (FDA) approval, resulting in irreversible cartilage damage. The suits claim some patients suffered damage severe enough to require joint replacement.

Attorneys with Houston-based Arnold & Itkin LLP are representing 28 plaintiffs in the shoulder pain pump suits announced Nov. 11.

Pain pumps are designed to deliver a continuous dosage of pain medication directly to the surgery site during the first few days of recovery. To do so, a small tube is left implanted in the site.

The FDA has said it cleared pain pumps only for use after abdominal surgery, not joint surgery. The agency said that, while the anesthetics delivered by the devices have been used in single-injection treatment for years without cartilage damage, a steady stream of drugs may be harmful. Bupivacaine, marketed as Marcaine® or Sensorcaine®, is often used, as is lidocaine.

Defendants named in the suits include pump makers Stryker Corp., Orthofix, Inc., I-Flow, Inc., Moog, Inc., Sgarlato R.P., Inc., Breg, Inc., Linvatec Corp., and DJO, Inc. Also named are anesthetic makers AstraZeneca, Abbott Laboratories, APP Pharmaceuticals, and Hospira Worldwide.

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