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 pumps

Pain pumps are often used in shoulder surgery and work effectively when used as approved by the Food and Drug Administration (FDA), with the catheter implanted in the shoulder tissue. However, in the early 2000s, pain pump manufacturers began advising physicians to insert the catheter directly into the shoulder joint, a method not approved by the FDA. When pain pumps were used in this manner, medication dripped directly into the shoulder joint, slowly eating away at the cartilage. Patients began experiencing a painful and debilitating condition known as chondrolysis.

As a result, numerous lawsuits have been filed against the manufacturers of pain pumps by individuals injured by the devices. But aren’t the companies that supplied the drugs used in the pain pumps also liable?

“They are, when you can find them,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “One of the issues that I think that the attorneys representing pain pump victims are seeing is that is that the hospitals and/or surgical centers, wherever you had the surgery performed, sometimes do not do the best jobs of tracking what medications they placed into the pumps. I can tell you for a fact from the medical and billing records that sometimes it is impossible to determine who manufactured the medicine.”

If the manufacturer can be determined, “It is likely they are going to be added as a defendant because they knew from the medical literature that their medicine was toxic to cartilage,” Woodson says. “If they knew that their medicine was going to be used in pain pumps that were being placed intra-articularly into that joint space, then they’re just as liable as the pain pump manufacturers.”

SOURCE: Pain Pumps › Are drug companies to blame for shoulder pain pump injuries?

“I think what we’re seeing is that physicians are finally seeing the relationship between pain pumps and chondrolysis – especially since the first lawsuits were filed a couple years ago,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “In addition, literature is now being published about the connection between pain pumps and chondrolysis. The more information that becomes available, the more people are learning what may be causing their shoulder problems.”
Chondrolysis is a condition in which the cartilage in the joint wears away, resulting in loss of mobility and pain. Over the past few years, surgeons began seeing several patients who have had shoulder repair surgery contract chondrolysis. It didn’t take long for doctors to discover what was causing the painful condition.

“This goes all the way back to about the year 2000. People who had surgery seven or eight years ago who thought they had recovered are now seeing that they’re losing their cartilage and they don’t know why,” Woodson says. “For a long period of time, physicians didn’t know why either. However, now that the literature is expanding and more and more doctors are finding out about this, they’re telling patients to contact attorneys to get advice on what recourse they may have.”

Several cases are set for trial this year. “I think you’re going to see juries return verdicts against these defendants and then others will start to file lawsuits as well,” Woodson says.

SOURCE: Pain Pumps › Why are there so many lawsuits against pain pump manufacturers?

Intra-articular pain pumps

Intra-articular pain pumps are medical devices that hold pain medication. The devices have a tube with a catheter attached to them and that catheter is approved by the Food and Drug Administration (FDA) to be placed in the shoulder tissue for pain relief. The catheter is sort of like a garden hose with holes in it that you place in a flowerbed. Just as water would pass through the garden hose to water plants in the bed, medication is pumped through the catheter of the pain pumps into the shoulder tissue gradually over a 48- to 73-hour period. Once the pain medication has been completely used, the patient is instructed to simply pull the catheter out of his shoulder.

Before pain pumps became available for use, patients were given medication either orally or by injection and would have to be monitored by medical staff. The use of pain pumps allowed patients to go home earlier and require less medical attention post surgery. Used properly, risks associated with pain pumps are minimal and most patients have a relatively good recovery after physical therapy. But then tragedy struck.

“With advice from manufacturers, the pain pump catheters were being placed in the joint space or intra-articular area (as opposed to the joint tissue, as was approved by the FDA) which allowed the pain medication into the joint space,” says Frank Woodson, shareholder with Beasley Allen Law Firm. As a result, “doctors began to see patients suffer severe damage to their shoulder cartilage that we’ve rarely seen before.”

The condition, called chondrolysis, is the loss of cartilage in the joint space and causes extreme pain, loss of motion and in many cases, shoulder replacement. Those who relied on their shoulder strength, found themselves suffering from career-ending injuries.

Approximately 140 lawsuits against manufacturers of pain pumps are currently filed by individuals injured by those pumps. “As patients and physicians learn more about the link between pain pumps and chrondrolysis, I think you’ll see more people come forward,” Woodson says.

SOURCE: Pain Pumps › Pain pump manufacturers knowingly put patients at risk

The culprit was not the surgery itself but the device used to deliver pain medication to the wound site. Used properly, as approved by the Food and Drug Administration (FDA), the pain pumps were hardly dangerous. But pain pump manufacturers began advising surgeons to use the pain pumps differently, by inserting the catheter directly into the shoulder joint space. Over time, the pain medication was toxic to the cartilage, resulting in chondrolysis.

In 2008, a petition was filed for a multidistrict litigation (MDL) to consolidated the lawsuits pending against the manufacturers of pain pumps. MDLs help coordinate the litigation that is pending in federal courts across the country involving the same allegations or same parties. The Judicial Panel on Multidistrict Litigation decides whether cases should be consolidated under MDL and where to transfer the cases. The judicial panel denied the initial petition requesting an MDL. Many more lawsuits have been filed in federal courts across the country and the panel may revisit its initial decision.

“Denial of the MDL  may be a good thing for patients and consumers because there are already cases that are going to trial,” Woodson says. Several of those cases were settled right before or after the opening statement and others were resolved on a confidential basis in early 2009.

“These are substantial injury cases. This is a very severe injury that should not have occurred,” Woodson says. “Most of these people did not know what occurred to them until they started seeing advertisements from lawyers for these cases. So, that’s the first time that they had any inkling in their mind that there could have been a connection between the use of a pain pump and what’s ultimately happened to their shoulder.

“I’d advise (individuals who believe they may have been injured by the pain pump) that people  see an attorney as soon as possible. ”

SOURCE: Pain Pumps › Pain pump makers may be liable for injury after shoulder surgery

Labrum repair surgery requires months to heal because the fibrocartilage has a poor blood supply. During surgery, the labrum is stitched together and anchored to the bone. It generally takes about six months for the tissue to heal. Typically, surgeons perform authroscopic surgery to repair shoulder injuries in patients and often use pain pumps to help alleviate pain for up to 72 hours following surgery. Pain pumps offer an alternative to narcotics and pain killers; however, misinformation about how the pain pumps should be used provided by pain pump manufacturers years ago have resulted in debilitating – and for some athletes, career-ending – injury to the shoulder joint.

The injuries stem from a change in the way pain pump manufacturers began to market the devices to surgeons, according to Frank Woodson, shareholder for Beasley Allen Law Firm. When the pain pumps were originally approved by the Food and Drug Administration (FDA), the pump’s catheter was to be placed in the shoulder tissue. However, in the 1990s and early 2000s, pain pump manufacturers began advising surgeons to place the pain pump catheters in the joint space, or intra-articular area, allowing pain medication to go directly into the joint space. This use had not been approved by the FDA. Shortly after the pumps were used in the inappropriate manner, per the advice of the pain pump manufacturers, “doctors began to see patients suffer severe damage to their shoulder cartilage that we’ve rarely seen before,” Woodson said.

What resulted was the loss of cartilage, or joint space, commonly called chondrolysis. It leads to severe pain because the cartilage in the shoulder space is gone, causing bones to rub together. As the condition progresses, patients may require shoulder replacement and it makes normal daily activities painful and difficult.

There are approximately 140 lawsuits filed by people who have been injured by misuse of these pain pumps. All are pending in state and federal courts throughout the country. “There are many more cases under review across the country and there will likely be many more filed,” Woodson said. “As patients and physicians learn more about the link between pain pumps and chrondrolysis, I think you’ll see many more people come forward.”

Source: Google: AFP

SOURCE: Pain Pumps › Magic’s Nelson plays just months after shoulder surgery

The nine are among a growing number of lawsuits filed against the makers of shoulder pain pumps that were used in patients following shoulder surgery. The devices have a catheter that is implanted into the surgical site and delivers regular does of anesthetics to the wound for up to 72 hours. Doctors soon began to see a connection between the use of the devices and a painful and debilitating condition known as chondrolysis.

The pain pumps were approved by the Food and Drug Administration (FDA) with the catheters placed in the shoulder tissue, but in the 1990s pain pump manufacturers sought approval from the FDA to have the catheters placed directly in the shoulder joint.

“To the FDA’s credit, they said no,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “The FDA said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.”

When the catheters were placed in the shoulder joint instead of the tissue, the medication began to eat away at the cartilage in the joint, causing the painful condition known as chondrolysis.

As a result, more than 140 lawsuits have been filed in state and federal courts against manufacturers of pain pump devices. “I hope this litigation will continue to educate the medical community to use pain pumps in a proper manner because if it is done in that way, then we should stop seeing these injuries occur,” Woodson said.

SOURCE: Pain Pumps › Lawsuits seek more than $68 million from pain pump manufacturers

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

Pain pumps are devices that hold pain medication that is gradually released into the shoulder tissue through a catheter implanted in the surgical site. Once the pain medication has been released into the joint, the catheter is removed by the patient. When used properly, pain pumps offer a convenient alternative to oral or intravenous painkillers for those undergoing shoulder surgery. And most patients can expect a good recovery following physical therapy.

However, in the late 1990s manufacturers of pain pumps sought FDA approval to have the catheters placed directly in the joint area, rather than the shoulder tissue. “To the FDA’s credit, they said no,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “The FDA said, ‘If you want permission to do that, you’re going to have to do safety studies to determine whether or not that is a safe practice or a safe method to use your product.’ The companies did not do that and just went ahead and started advising physicians to place the pain pump catheter in the joint space.

“They never studied it and they never obtained FDA approval,” he says. As a result, physicians began seeing their patients with a debilitating condition called chondrolysis, or a narrowing of the cartilage. As the cartilage begins to wear away, bone rubs against bone causing pain and disability. In many cases, shoulder replacement is required.

Approximately 140 lawsuits have been filed in state and federal courts against manufacturers of pain pump devices and several cases are set for trial in 2009. “I hope this litigation will continue to educate the medical community to use pain pumps in a proper manner because if it is done in that way, then we should stop seeing these injuries occur,” Woodson said.

SOURCE: Pain Pumps › FDA told pain pump manufacturers ‘no,’ but they refused to listen

“I think what we’re seeing is that physicians are finally seeing the relationship between pain pumps and chondrolysis – especially since the first lawsuits were filed a couple years ago,” he says. “In addition, literature is now being published about the connection between the pumps and chondrolysis. So, the more information that becomes available, the more people are learning what may be causing their shoulder problems.”

The problem traces back to about the year 2000, when pain pump manufacturers began advising physicians to place the device’s catheter into the joint space, or intra-articular area. The catheters were intended and approved by the Food and Drug Administration (FDA) to be placed into the shoulder tissue, and not the joint space. As a result, medicine was feeding directly into the joint space causing the cartilage to gradually wear away. This narrowing of the cartilage, called chondrolysis, causes severe pain and disability. There is no cure for the condition and many individuals are faced with lifelong disability as a result.

Recently, a study published by The American Journal of Sports Medicine identified intra-articular pain pumps as the likely cause of chondrolysis.

“People who had surgery seven or eight years ago who thought they had recovered are now seeing that they’re losing their cartilage and they don’t know why,” Woodson says, adding that several cases are set for trial in 2009. “I think that you’re going to see juries return verdicts against these defendants and then others will start to file lawsuits as well.”

SOURCE: Pain Pumps › More lawsuits filed as link made between pain pumps, chondrolysis