November 18, 2009 by Robert Tharp at 11:47:46 am
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Arnold & Itkin attorneys representing 28 who used controversial pain pumps following shoulder surgery
Interesting article in yesterday's Wall Street Journal highlights the FDA's increasing concern regarding so-called "pain pumps" that deliver pain killers directly to joints after surgery. Mounting complaints that these pain pumps are to blame for severe and often irreversible cartilage damage led the FDA last week to order the manufacturers to change warning labels on the devices.
Writes the WSJ: The Food and Drug Administration said from 2006 to 2008 it received 35 reports of severe cartilage damage in patients who were given pain pumps after joint surgery. Nearly all the reports involved patients who had shoulder surgery; more than half needed additional surgery, including joint replacement.
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.
Attorneys at the Houston trial law firm, Arnold & Itkin LLP, have filed five lawsuits on behalf of individuals injured using pain pumps following shoulder surgery. "The dangers of these pumps have been known for years, and even the FDA knew it was a bad idea to use them in shoulder joints," says Arnold & Itkin attorney Mike Pierce, who represents the plaintiffs. "Many of our clients have undergone multiple surgeries, all trying to fix a problem caused by these faulty pumps."
Named as defendants are several pain pump manufacturers, including Portage, Mich.-based Stryker Corp. (NYSE: SYK), London-based Orthofix Inc. (Nasdaq: OFIX), Lake Forest, Calif.-based I-Flow Inc. (Nasdaq: IFLO), East Aurora, N.Y.-based Moog Inc. (NYSE: MOG.A), San Jose, Calif.-based Sgarlato R.P. Inc., Vista-Calif.-based Breg Inc., Largo, Fla.-based Linvatec Corp., and Vista-Calif.-based DJO Inc. The lawsuits also name several leading pharmaceutical companies, including London-based AstraZeneca (NYSE:AZN), Abbott Park, Ill.-based Abbott Laboratories (NYSE:ABT), Schaumburg, Ill.-based APP Pharmaceuticals and Lake Forest, Ill.-based Hospira Worldwide (NYSE:HSP).
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