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

Matthew was a physically active individual who suffered a minor tear in his right bicep tendon his while throwing a football. Following surgery to repair the tear, Matthew’s condition worsened. Matthew’s surgeon had implanted a pain pump device to deliver pain medication directly into the shoulder joint for up to 72 hours following surgery, following a method that was instructed to surgeons by pain pump manufacturers.

However, the constant drip of anesthetic into the shoulder joint was found to wear down the cartilage in the shoulder joint, resulting in a painful and debilitating condition known as chondrolysis. In November 2009, as more cases of chondrolysis in shoulder joints surfaced, the Food and Drug Administration (FDA) issued a warning to health care professionals that it had never approved such use of pain pumps in shoulder surgeries.

Jurors awarded Beale $1.275 million in economic damages and $3 million in non-economic damages. His wife, Krista Beale, was awarded $1.2 million in loss of consortium damages.

Source: The Medical News

SOURCE: Pain Pumps › Oregon appeals court denies I-Flow request for retrial

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.

Beale’s doctor had no idea that the pain pump he had prescribed Beale was not approved by the Food and Drug Administration (FDA). He later discovered that 49 patients he had treated with the I-Flow pain pump had similar complications following surgery.

Last week, an Oregon jury awarded Beale $5.5 million for damages caused by the pain pump device that was not approved by the FDA. Attorneys representing Beale and his wife, Krista, said that I-Flow knowingly marketed its On-Q Painbuster device to orthopedic surgeons even though the FDA had repeatedly rejected the device for lack of safety data. Beale’s award includes $1.75 million in damages to Krista Beale.

The Beales were represented by Paulson Coletti law firm and Williams, Love, O’Leary & Powers, P.C. Attorneys with Beasley Allen Law Firm are working with Williams, Love, O’Leary & Powers, P.C. on all pain pump cases. Currently, Beasley Allen and the Williams firm have the largest number of pain pump clients, with approximately 60 cases filed, and intention to file additional cases.

In November 2009, the FDA issued a warning to doctors that it had never approved such use of pain pumps during shoulder surgery. But some worry that there are many more people suffering from similar debilitating injuries caused by pain pump devices, who may not even realize the pain pump is to blame. Getting the message out to physicians and patients is key to helping victims get the justice they deserve.

SOURCE: Pain Pumps › Jury awards man $5.5 million for shoulder injury caused by pain pump

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

The company’s Regional Anesthesia sales, which includes the company’s flagship On-Q product lines, also increased 9 percent during the same quarter, according to the report.

There are approximately 140 lawsuits against manufacturers of pain pumps, including I-Flow Corporation, currently pending in state and federal courts throughout the country, says Frank Woodson, shareholder with Beasley Allen Law Firm. That number has jumped considerably since the summer of 2008, as more and more evidence began to link pain pumps to a serious and debilitating shoulder injury known as chondrolysis.

Pain pumps are commonly used by surgeons when performing shoulder surgeries. The pump, which sits outside the body but is attached to a catheter that is implanted into the surgical site, delivers medication for up to 72 hours. Once all the medication has been injected, the catheter is gently pulled out by the patient.

Pain pump manufacturers were given Food and Drug Administration (FDA) approval to market the devices with the catheter in the shoulder tissue. In early 2000, manufacturers sought to have FDA approval to put the catheters directly into the shoulder joint but the FDA rejected the request. However, pain pump manufacturers went ahead and instructed physicians to implant the catheter in the shoulder joint. The medicine that dripped into the shoulder joint area ate away the cartilage in the shoulder joint causing the painful and debilitating condition known as chondrolysis. There is no cure for the condition and in some cases, more surgery may be required.

SOURCE: Pain Pumps › Pain pump manufacturer enjoys gains despite mounting lawsuits

But during a game in October 2006, McKeown’s left shoulder was injured while trying to recover a fumble. Doctors implanted the catheter of a On-Q PainBuster pain pump manufactured by I-Flow into his shoulder joint. For up to 72 hours, medication gradually dripped into his shoulder and slowly began eating away at the cartilage.

But McKeown was tough. He rehabbed quickly and bulked up to 300 pounds. He lead the team in weightlifting statistics, bench pressing a maximum of 460 pounds. His chances at making to the NFL one day seemed promising.

Even as he worked out, he ignored the burning pain in his shoulder, refusing to admit to anyone how badly it hurt. And then he injured his shoulder again. Once again, he was put on an I-Flow pain pump that dripped medication into his shoulder joint. A follow up MRI revealed a horrible mess. The promising athlete’s shoulder cartilage had been worn down so badly that repairing it was impossible. McKeown’s hopes for a professional football career were ruined.

McKeown is now suing I-Flow, the manufacturer of the pain pump, after he and his doctor learned that a 2006 study had revealed that by inserting the pain pump’s catheter in McKeown’s shoulder joint instead of the muscle tissue, the medicine essentially destroyed his shoulder. The Food and Drug Administration (FDA) had granted approval to have the pain pump’s catheters inserted into the muscle tissue, but denied manufacturers’ request to instruct surgeons to place the catheters in the shoulder joint. As a result, countless patients have suffered similar fates as McKeown.

Source:
Cincinnati.com

SOURCE: Pain Pumps › Athlete’s hopes of playing pro ball dashed by shoulder pain pump

The On-Q PainBuster pain pump offers an alternative to traditional intravenous and oral painkillers, which can leave patients feeling groggy. The pain pump uses a small balloon that holds a local anesthetic that is fed through a thin antimicrobial catheter that is inserted into the surgical site. The device injects the pain relief medication directly to the surgical site on a continuous basis for up to 72 hours following surgery. Following surgery, the patient goes home with the implanted device and after two or three days, the patient gently pushes out the catheter and discards the device.

Doctors who have used the pain pumps for hysterectomies and C-sections say the device helps women get up and about faster than using more traditional pain meds.

The I-Flow On Q PainBuster pain pumps have been a popular choice for orthopedic surgeons performing knee and shoulder surgeries. The pain pumps are designed and intended to be used with anesthetics that are administered continuously over time.

However, in shoulder surgeries in particular, the medication delivered directly to the surgery site has caused serious and permanent damage to the cartilage of the shoulder joint. This narrowing of the joint space is known as chondrolysis, a condition in which the complete or nearly complete loss of cartilage in the shoulder joint. Chondrolysis is an irreversible disabling and extremely painful condition.

A recent study published by The American Journal of Sports Medicine identified these intra-articular pain pumps as the likely cause of chondrolysis in shoulders.

There do not appear to be any reported problems with pain pump use following C-sections and hysterectomies at this time.

SOURCE: Pain Pumps › Pain pumps used following C-sections, hysterectomies

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