I-Flow had tried to prevent evidence from being included in the trial that would have been used to form the basis of punitive damage claims. That evidence allegedly included information that I-Flow’s chief executive officer was advised, prior to the plaintiffs’ injuries, to issue a warning that the pumps should not be used for shoulder surgery. Instead, I-Flow continued to instruct surgeons to use the pain pumps with local anesthetics for shoulder surgery, a use that was never approved by the Food and Drug Administration (FDA).

In November 2009, the FDA required manufacturers of pain pumps as well as the makers of local anesthetics used in the devices to add new warnings about the risk of chondrolysis. The warnings also alerted health care professionals not to use the pumps with local anesthetics.

There are at least 150 shoulder pain pump lawsuits pending against I-Flow and other manufacturers of pain pump devices from plaintiffs who allege that the devices caused them to develop chondrolysis of the shoulder. All lawsuits claim the manufacturers failed to warn patients and their doctors of the risk of chondrolysis.

SOURCE: Pain Pumps › I-Flow settles lawsuits from plaintiffs injured by shoulder pain pumps

Johnson is suing Moog Inc., Stryker Corp. and Stryker Sales Corp., McKinley Medical, Curlin Medical and Linvatec Corp. for economic, non-economic and punitive damages resulting from use of his pain pump.

Pain pumps are balloon-like medical devices filled with medication that rest outside the body. The device has a catheter that is placed into the shoulder area and feeds medication to the surgery site for up to 72 hours. When all the medication has been used, patients simply pull the catheter out of the body. While the pain pumps have reduced hospital stays and provided relief immediately following shoulder repair surgeries, the long-term effects can be dangerous. The anesthetic used in the pain pumps eats away at the cartilage in the shoulder joint, leading to a debilitating condition known as chondrolysis.

Chondrolysis occurs when cartilage in the shoulder joint wears away causing bone to rub against bone. Those with chondrolysis have pain in the shoulder joint and limited mobility. Many require shoulder joint replacements.

Several people treated with pain pump devices following shoulder surgery have developed this once-rare condition, and many are joining Johnson in the fight against pain pump manufacturers for justice.

Source: The Southeast Texas Record

SOURCE: Pain Pumps › Another lawsuit filed against pain pump manufacturers

Pain pump manufacturers, such as I-Flow, Don Joy, Stryker, Moog, and Breg, to name a few, dismiss the claims that their products have caused numerous people harm. But by 2006, physicians and scientists clearly began to see the connection between the shoulder pain pumps and chondrolysis.

At issue was the placement of the pain pump’s catheter directly into the joint space, a use that was promoted by the devices’ manufacturers but not approved by the Food and Drug Administration (FDA). The constant and steady dripping of anesthetic drugs such as Marcaine, bupivacaine and ropivacaine into the shoulder joint for up to 72 hours after surgery gradually ate away at the cartilage. In most cases, it was months or years before patients began experiencing the serious symptoms of chondrolysis.

There is no cure for chondrolysis, and in some cases shoulder replacement surgery is required. Yet pain pump manufacturers say they are not liable despite aggressively promoting the devices for joint surgeries of the shoulder as well as the knee, ankle and foot.

No lawsuits have yet gone to verdict. Some have reached confidential settlements. But plaintiff victims are focused on 2010 as the year when justice is served.

SOURCE: Pain Pumps › Pain pump victims seek justice against manufacturers

I-Flow Corp

I-Flow currently faces 212 lawsuits from people who claimed they were harmed by the company’s ON-Q pain pumps used for shoulder surgery, yet the company says it is optimistic that it can skirt the claims made against it. The most damning evidence includes a recent study published by The American Journal of Sports Medicine that identified intra-articular pain pumps as the likely cause of a condition known as chondrolysis. Postarthroscopic Glenohumeral Chondrolysis (PAGCL) is a specific type of chondrolysis associated with shoulder pain pumps.

PAGCL is a painful and debilitating condition in which the cartilage in the shoulder wears away causing bone to rub against bone. It can greatly decrease range of motion and cause weakness in the shoulder. There is no cure for PAGCL, and in severe cases, shoulder replacement surgery is required.

I-Flow’s total revenue for the first six months of 2009 increased 7 percent to $68 million, up $4.3 million over the first six months of 2008. First six month sales of the company’s On-Q product lines increased 5 percent, or $2.2 million, compared to the first six months of 2008. I-Flow projects a yearly revenue of $139.7 million to $146 million, over analysts’ average expectation of $138 million.

Sources:
Fox Business
Orange County Business Journal

SOURCE: Pain Pumps › I-Flow enjoys profits amid spike in product liability lawsuits

Zone maintains that the cover of I-Flow’s On-Q pain pump contains holes that allow latex to come in contact with patients and health care professionals. The company contends that individuals who come in contact with the pump and suffer a latex reaction may not be properly treated based on the assumption that the I-Flow product does not pose a latex risk. Zone is the worldwide distributor for the Solace pain pump, which has a latex-free design.

I-Flow may want to take a closer look at patient safety. The company is one of several pain pump manufacturers – a list that also includes Stryker Corporation, DJ Orthopedics Inc., and Breg Inc. – facing lawsuits from plaintiffs that allege the pumps have caused lifelong and painfully debilitating shoulder injury. Lawsuits contend that manufacturers of pain pumps instructed physicians to use the pumps in a manner that was not approved by the FDA for shoulder surgery.

Instead of implanting the catheter of the pain pumps into the shoulder tissue as was FDA approved, surgeons were instructed to place the catheters into the shoulder joint area. Doing so allowed medication to drip into the shoulder joint and essentially eat away the cartilage, causing bone to rub against bone and resulting in a serious, irreversible condition known as chondrolysis.

Source: PR Web

SOURCE: Pain Pumps › I-Flow pain pump manufacturers face more lawsuits

Post-operative pain pumps are a pain-management system that deliver medication directly to the surgical wound. The pumps came under fire recently after The American Journal of Sports Medicine linked intra-articular (or post-operative) pain pumps to cases of Postarthroscopic Glenohumeral Chondrolysis, a progressive degeneration of the cartilage in the shoulder resulting in pain and loss of motion. Chondrolysis is a chronic condition that often requires surgery.

Until the 1990s, the pumps delivered medication at a limited flow rate. In the late 1990s, manufacturers increased the amount of anesthetic used in the pain pumps. The lawsuit contends that continuous injection of the high-volume anesthetics into the shoulder can cause serious and permanent damage to the joint cartilage in the shoulder. The lawsuit also claims the pumps were marketed without first doing studies to determine the safety of the high-volume pain pumps or what damage could have occurred, instead encouraging use of both the pain pumps with the high doses of anesthetics.

“The plaintiffs are demanding compensatory damages for fraudulent misrepresentation, negligent misrepresentation negligence, strict liability, and breach of warranty,” according to the report.

SOURCE: Pain Pumps › Pain pump manufacturers named in lawsuit

These devices have been used on thousands of patients nationwide, and based on our findings, hundreds appear to be at risk for this complication which results in severe pain, debilitating stiffness and eventual joint replacement surgery for many of those affected. We sent the results of our study to the manufacturers more than two years ago, but their response has so far been minimal to non-existent. It is time to get the word out and stop these devices from ruining any more lives.
Dr. Beck’s warning comes at an appropriate time now that football season is in full swing. Manufacturers report that the number of orthopedic surgeries rise sin the fourth quarter of each year tied to increased sports activity, particularly football and skiing. It appears that patients may tend to defer elective surgeries until the fourth quarter after annual insurance deductibles are satisfied.

The article, published in the October 2007 issue of The American Journal of Sports Medicine, demonstrates a strong association between the intra-articular (inside the joint space) use of high volume pain pumps following arthroscopic shoulder surgery and an otherwise unexplainable loss of hyaline cartilage in the shoulder joint. Dr. Brent Hansen, an orthopedic surgeon, was the senior author of the study. The complication discussed in the article, known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL), is permanent and can lead to extreme pain and lifelong suffering in 63% of the patients that use the pain pumps. It is suggested that the complications may occur following open surgery as well.

Numerous lawsuits are pending against the companies that manufacture, market, or distribute the pain pumps, including Stryker, DJO Inc., I-Flow Inc., BREG Inc. and others. Included among the many claims in the lawsuits are the allegations that the manufacturers failed to instruct or warn the U.S. medical community that the safety of using the pain pumps in the shoulder joint space had not been established or that the continuous injections of commonly used anesthetics may cause permanent injury.

Our firm is looking into a number of claims from people across the country whose lives have been devastated by these pain pumps. These are supposed to be routine outpatient procedures, but the patients often endure several more surgeries, and most will eventually need complete shoulder replacement. We expect hundreds of individuals across the country to come forward with their own stories of ongoing pain and suffering they have experienced after using one of these devices. Frank Woodson, who is in our Mass Torts Section, is heading up a team that is investigating cases that include the use of pain pumps, not only in the shoulder, but in the knee, ankle and hip. If you need additional information relating to this matter, you can contact Frank at (334) 269-2343.

Source: Associated Press

November 15th, 2007

SOURCE: Pain Pumps › Pain pumps can cause cartilage damage