Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Michael Johnson says neither he nor his doctor would have agreed to have a pain pump devices implanted into his shoulder joint during two arthroscopic surgeries if he knew that by doing so it would result in a full shoulder joint replacement. Johnson contends that the manufacturers of the medical device knew that the pain pumps were unreasonably and dangerously defective, and yet they did nothing to warn him or his surgeon about the risks associated with using it. Furthermore, he claims, the Food and Drug Administration (FDA) specifically prohibited the marketing of pain pump devices with anesthetics to be placed in the joint cavity.

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Whitney Moore was in prime physical condition just a few years ago. She played junior varsity soccer at West Virginia University before opening a strength and conditioning business for young athletes. In 2004, she injured her shoulder playing soccer and had surgery to repair it. But the surgery only made her shoulder worse. Moore developed a once-rare condition known as chondrolysis, in which the cartilage in the joint wears away causing bone to rub against bone.

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UCLA forward James Keefe will miss two to three weeks with the team to recovery from a dislocated left shoulder. The senior was injured during the first half of UCLA’s game against New Mexico State on December 15th. The injury occurred on the same shoulder that required surgery for a torn labrum in 2007.

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Jean-Thenistor Pascal, the Haitian-Quebecker professional boxer and current WBC Light Heavyweight Champion, underwent arthroscopic surgery on his right shoulder this week and will be unable to train or fight for about nine weeks. The boxer hurt his shoulder while successfully defending his title against Adrian Diaconu last week.

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Five lawsuits against manufacturers of pain pumps and pharmaceutical companies on behalf of 28 people were filed in Los Angeles County Superior Court this month, alleging fraud, breach of warranty and products liability, saying the makers of the products continued to market the pain pumps as mitigation for shoulder joints despite the specific use of those products not being approved by the Food and Drug Administration (FDA). The lawsuits also allege that the pain pump devices caused a painful and debilitating condition known as postarthroscopic glenohumeral chondrolysis (PAGCL), in which the cartilage in the shoulder joint wears away causing bone to rub against bone.

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In light of a recent report released by the U. S. Food and Drug Administration that confirms the link between chondrolysis and pain pump use, Joseph A. Carrese, MD, MPH, an expert in bioethics, has issued an opinion stating that physicians have a responsiblity to inform former patients on whom they used the device of the possible risk.

It is Dr. Carrese’s opinion that “to do otherwise would be a failure of expected ethical and professional conduct, and in turn a failure of good clinical practice.”

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Attorneys with Beasley Allen Law Firm and attorneys with partnering firms have filed three separate lawsuits 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.

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Lawsuits against the manufacturers of shoulder pain pump devices have been filed in state and federal courts across the nation, and some have already been scheduled for trial beginning in 2010. What juries may be surprised to hear is how a device commonly used between 1999 and 2007 to relieve pain following shoulder surgery, has months later resulted in an irreversible, painful and debilitating condition known as chondrolysis.

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Rotator cuff surgery is considered one of the most painful sports-injuries surgeries to the shoulder. It involves the reattaching of the damaged tendon or tendons to the upper arm. In order to access the injured rotator cuff, the surgeon makes a two- to three-inch incision in the shoulder and cuts through the deltoid muscle. Scar tissue is removed and small holes are drilled through the bone allowing the surgeon to sew the tendon to the bone. The procedure can be difficult for sports medicine and orthopedic surgeons due to the multitude of knots that must be tied through a type of small tubing under arthroscopic viewing. But one corporation is making that procedure easier for surgeons.

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I-Flow Corp., the Irvine, Calif.-based device maker, exceeded expectations with its quarterly results and says it expects to see an operating profit for the year despite a sharp increase in the number of product liability lawsuits filed against the company in July 2009. The company, which makes devices that deliver targeted anesthesia as an alternative to narcotics known as pain pumps, has a market value of $175 million.

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