Stryker Corporation, a multinational, publicly traded corporation, sells McKinley Medical pain products in the U.S., Canada and Mexico. Pain pumps are devices that deliver pain medication directly into the surgery site for up to 72 hours. The pumps were approved by the Food and Drug Administration (FDA) for use with the catheters inserted into the shoulder tissue; however, pain pump manufacturers, like Stryker, began advising doctors to place the catheters directly into the shoulder joint, which was not approved by the FDA.

When the pain medication dripped directly into the shoulder joint – where it was not FDA-approved to do – the medication ate away at the shoulder cartilage, resulting in a painful and debilitating condition known as chondrolysis. Soon physicians began making the connection between this use of pain pumps and chondrolysis. As a result, Stryker and other pain pump manufacturers are now facing hundreds of lawsuits from individuals injured by the devices.

During the same time that pain pump manufacturers were telling doctors to place the catheters of the devices into the joint space, it also began paying orthopedic surgeons for using the Stryker hip and knee replacement products, which is illegal. Questions still remain about whether doctors were also paid by Stryker to encourage other doctors to use Stryker products.

SOURCE: Pain Pumps › Pain pump manufacturer no stranger to controversy

Pain pumps

PAGCL is a painful and debilitating condition that occurs when the cartilage in the shoulder joint wears away, causing the bones to rub together. There is no cure for PAGCL. Some patients my require shoulder replacement surgery.

There are three medical device manufacturers at the crux of the shoulder pain pump controversy – Stryker Corporation, I-Flow Corporation, and DJO Incorporated. Stryker is a multinational, publicly traded corporation that sells the McKinley Medical LLP pain pump products in the U.S., Canada and Mexico. In 2006, the company reported net sales of almost $5.5 billion.

I-Flow’s family of products focuses on Regional Anesthesia, Intravenous (IV) Infusion Therapy, and Oncology Infusion Services. It’s acute pain management product line includes the ON-Q PainBuster Post-Op Pain Relief Sustem, The Soaker Catheter, and the C-bloc Continuous Nerve Block System. I-Flow has exclusive rights in the U.S. to distribute the On-Q PainBuster. In 2007, company recorded assets exceeding $81 million.

DJO is a global provider of solutions for musculosketal and vascular health that specializes in rehabilitation and regeneration products for the non-operative orthopedic, spine and vascular markets. The company manufactures and/or distributes the DonJoy Pain Control Device. In 2007, the company reported net assets of more than $173 million.

Allegations against the manufacturers include negligence, strict liability, warranty, and failure to warn physicians and patients of the risk of chondrolysis with use of the shoulder pain pumps. Those who have been injured by shoulder pain pumps are advised to seek legal counsel, as they may have a case against the manufacturer.

SOURCE: Pain Pumps › Three pain pump manufacturers at crux of controversy

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

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