IFLO I-Flow (MM)

Federal regulators are demanding changes to labels on devices that deliver pain killers directly to joints after surgery, in response to numerous reports of irreversible cartilage damage.

The U.S. Food and Drug Administration said between 2006 and 2008 it received 35 reports of severe cartilage damage in patients who were given pain-pumps after joint surgery. Nearly all of the reports involved patients who had shoulder surgery and more than half needed additional surgery, including joint replacement.

Companies making pain pumps include I-Flow Corp. (IFLO) and Stryker Corp. (SYK). Makers of the anesthetics used in pain pumps, such as APP Pharmaceuticals Inc. and Hospira Inc. (HSP), will also have to update their labels. The firms have 30 days to propose language to the FDA that includes a warning about the potential for cartilage destruction, according to an FDA spokeswoman.

"The significance of this injury to otherwise healthy young adults warrants notification to health care professionals," the FDA said in a notice to doctors and other health care professionals Nov. 13.

APP and Hospira declined to comment, citing ongoing litigation. Stryker has not yet responded to requests for comment.

Pain pumps are small plastic tubes that deliver and regulate pain medicine constantly, usually for two to three days. The anesthetics in the FDA's alert include bupivacaine, marketed as Sensorcaine or Marcaine, and lidocaine. These anesthetics, the FDA noted, have been used safely in single injections for many years without any reports of cartilage decay.

The new notice says the FDA did not clear pain pump infusion devices using the anesthetics for "intra-articular" or joint surgery. The pumps are approved to be used after abdominal and other surgeries, such as hysterectomies. They are considered a better way to deliver pain-relieving medications because they target specific areas and don't involve narcotics.

But reports about decaying cartilage after shoulder surgery began surfacing several years ago, followed by studies in medical journals on orthopedic surgery and sports medicine. In January, the Canadian government alerted surgeons about cartilage decay when the pain pumps are used for joint surgeries.

In a statement, I-Flow said its On-Q PainBuster has been used successfully for over ten years in two million patients in the U.S. The company said it couldn't comment further, citing ongoing litigation.

Kimberly-Clark Corp. (KMB) initiated a cash-tender offer on October 20 to buy all the outstanding shares of I-Flow.

But the pain pumps' effectiveness at delivering anesthetics is likely causing cartilage damage in people's shoulders, according to Dr. Constance Chu, who is director of a cartilage restoration center at the University of Pittsburgh and author of several medical papers on the topic. She said that the drugs were not intended for continuous use over two or more days.

She said when these pain pumps are used after shoulder surgeries, the tissue is getting blasted with so much anesthetic it almost can't survive. "If you don't give these tissues a break the toxicity is so high you can lose the tissue," she said.

The FDA's alert may be a boon to attorneys suing companies with patients who claim they have been injured by the pain pumps. Hundreds of cases are pending against companies such as Stryker, I-Flow and Moog Inc. (MOOG). Attorney Michael Williams of Portland, Ore., who has handled about 100 pain pump cases against device makers and distributors, says the FDA statement that it never approved the pain pumps for joint surgery "upends companies' defense that they were covered under the FDA's approval" for other kinds of surgery.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com

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