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

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