News Tagged ‘FDA

Jury awards man $5.5 million for shoulder injury caused by pain pump

Matthew Beale of Portland, Oregon, routinely participated in football, racquetball and golf, and he enjoyed coaching his son’s baseball teams. But a minor tear in his bicep tendon caused by throwing a football benched the 38-year-old father of four. His doctor recommended routine during which he was prescribed an I-Flow pain pump to deliver pain medication directly to the wound site for up to 72 hours.

However, the anesthetic that dripped from the pain pump into Beale’s shoulder joint killed the cells that create cartilage. Within months, Beale’s cartilage was completely destroyed, causing him so much pain he couldn’t shake his clients’ hands or even pick up his baby without a shockwave of pain. He now faces a complete shoulder replacement that doctors say will likely not permanently resolve his chronic pain or enable him to regain his active lifestyle.

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Surgeons discuss characteristics of chondrolysis caused by pain pumps

Characteristics of chondrolysis associated with intra-articular pain pumps after shoulder surgery was among the topics at the 2009 Annual Meeting of the American Academy of Orthopaedic Surgeons/ the American Association of Orthopaedic Surgeons. The discussion included Drs. Peter Thomas Scheffel, Jeremiah Clinton, Joseph Lynch, Winston J. Warme, and Frederick A. Matsen III, and was moderated by Drs. Carl J. Basamania and Guido Marra. The message centered on the need for surgeons and patients to be aware of chondrolysis as a potential complication of the infusion of local anesthetic after shoulder arthroscopy.

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Doctors have obligation to tell former patients about pain pump risks

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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More lawsuits filed against maker of shoulder pain pumps

Four complaints have been filed in federal court in Philadelphia against Stryker Corp., maker of medical devices including postoperative pain pumps, for causing serious arthritis. The Kalamazoo, Michigan-based company is accused of actively concealing or misrepresenting information about the safety and efficacy of its pain pumps.

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Pain pump makers may be liable for injury after shoulder surgery

For a long time, physicians didn’t know why patients who had shoulder surgery began suffering from a painful condition known as chondrolysis, in which the patient loses the cartilage in the shoulder. “This goes all the way back to about the year 2000. People who had surgery seven or eight years ago who thought they would recover are now seeing that they have lost their cartilage and they don’t know why,” says Frank Woodson, shareholder with Beasley Allen . “However, now that the literature is expanding and more and more doctors are finding out about this and they’re telling patients to contact attorneys to get advice on what recourse they may have.”

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Royals’ Crisp may need shoulder surgery

Kansas City Royals outfielder Coco Crisp could be out for the rest of the season if the injury to his right shoulder turns out to be a torn labrum. He is getting second opinion from the renowned surgeon Dr. James Andrews. If it is torn, Crisp will have to decide whether to undergo immediate season-ending surgery or to put off surgery in hopes he can play again this season, according to The Kansas City Star.

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Recovery more likely after shoulder surgery than in years past

Many athletes who rely on their throwing motion for their livelihood consider the torn shoulder labrum one of the most fearsome injuries. In many cases, it can ruin a career or at the very least, leave them benched for weeks if not months.

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Magic’s Nelson plays just months after shoulder surgery

Last February, experts thought Orlando Magic point guard Jameer Nelson was done for the season when he underwent surgery to repair a torn labrum in his right shoulder. Recovery usually takes about six months, and over the past four months the Magic began inching toward the Finals. Now it seems, just four months post surgery, Nelson has stepped back into the game to help his team fight for the title against the Los Angeles Lakers.

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Lawsuits seek more than $68 million from pain pump manufacturers

Nine people in Arizona who claim they were permanently injured by a medical device designed to deliver pain medication to the shoulder joint, are suing the makers of the device for more than $68 million, according to the Phoenix Business Journal.

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I-Flow pain pump manufacturers face more lawsuits

Postoperative pain pump marketer I-Flow Corporation is facing more , this time from a pain pump competitor over the package inserts I-Flow distributes about its pain pump. Zone Medical LLC claims I-Flow is misrepresenting latex exposure risks and putting patients and health care professionals at risk in order to gain commercial advantages.

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