Michael Johnson

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

Whitney Moore

The condition caused Moore pain and limited mobility in her shoulder, and left her little choice but to close her business. She even has to asks friends to do small chores for her, like cut the crust of a piece of pie. “Until this injury, I was in pretty prime physical condition,” Moore told the New York Times. “It’s a whole flip of my world.”

Moore is one of hundreds of victims of what a handful of studies say is a condition caused by the use of pain pumps. The devices look like balloons that are filled with anesthetic that sit outside the body. Attached to the pump are catheters that are placed in the wound site during surgery to drip painkillers in the shoulder during and after surgery. After 48-72 hours, the medication runs out and the patient simply pulls the catheter out.

Doctors were advised by pain pump manufacturers to place the catheters directly into the joint space, but what doctors later learned is that that use of pain pumps was not approved by the Food and Drug Administration (FDA), and was, in fact, turned down on more than one occasion for further safety studies.

Pain pump manufacturers now find themselves embroiled in a mass of lawsuits claiming they are responsible for the serious injuries, which in some cases requires total shoulder replacements and often a lifetime of pain.

SOURCE: Pain Pumps › Woman’s life turns topsy turvy after shoulder surgery

UCLA

Shoulder injuries among athletes is not uncommon and can bench a player for weeks or months. There was a time when such injuries that required surgery brought about career-ending fears, but technology over the years has made full recovery a more likely possibility. However, just a few years ago, surgery to repair the shoulder often was the cause of more serious injury.

A recent study published in The American Journal of Sports Medicine first brought to light the connection between chondrolysis, a condition in which the cartilage in the shoulder has been eroded away, and the use of pain pump devices during and following arthroscopic shoulder surgery. Pain pumps are balloon-like devices that hold local anesthetics. During surgery catheters that lead from the balloon area of the device are inserted into the surgical site. Pain medication is then administered for up to 72 hours following surgery. Once the medication has been used up, the patient simply pulls out the catheter.

Pain pumps are approved by the FDA with the catheter placed in the shoulder tissue. However, in the late 1990s, pain pump manufacturers began instructing surgeons to insert the catheter directly into the shoulder joint, allowing the medication to drip directly onto the cartilage, a use that was not FDA approved.

In the early 2000s, doctors became puzzled when more and more patients who had surgery to repair shoulder injuries – and who showed no signs of cartilage wear at the time of surgery – were suffering from pain and loss of motion, and were ultimately diagnosed with chondrolysis. It didn’t take long for doctors to make the connection between the debilitating chondrolysis and the use of pain pump devices.

Since the connection was made, the FDA and professional groups have instructed surgeons of the correct, FDA-approved use of shoulder pain pumps, making the surgery safer for patients. Meanwhile, the lawsuits against pain pump manufacturers are mounting.

SOURCE: Pain Pumps › UCLA’s Keefe benched due to shoulder injury, but recovery likely

Jean-Thenistor Pascal

Pascal said he dislocated his right shoulder three times during the fight and had to have his shoulder popped back into place at least once by one of his cornermen. Despite having to box stretches almost entirely with his left hand, and looking hurt and worn down in the last few rounds, Pascal prevailed, earning a unanimous victory from the judges.

“I know I have a lot of guts,” Pascal said after the fight. “I knew it and now I really know it. When it happened the first time I told myself I was finished, but I couldn’t pull out in front of these fans. No way was I going to quit.”

Pascal’s surgery involved the removal of a bone chip and repair to the shoulder labrum, according to a statement released by promoter Groupe Yvon Michel. Pascal has been ordered to rest his shoulder for three weeks followed by five or six weeks of rehabilitation before he will be allowed to resume normal training. Pascal is scheduled to meet the WBC interim champion Chad Dawson in 120 days, but he may need to postpone that meeting until his shoulder recuperates.

Shoulder repair surgeries are about 85-95 percent successful. But some patients have had lingering problems, including the developing of a painful and debilitation condition known as chondrolysis. It wasn’t until after 2000 that doctors began to make a connection between a type of chondrolysis known as Postarthroscopic Glenohumeral Chondrolysis and the use of intra-articular pain pumps used in surgery. Details of that discovery were later published by The American Journal of Sports Medicine, and numerous lawsuits from those who suffer from chondrolysis have since filed suit against the makers of pain pumps.

Source: Montreal Gazette

SOURCE: Pain Pumps › WBC boxing champ undergoes shoulder repair surgery

Pain pump manufacturers named in the lawsuit include Moog Inc., Stryker Corp., Orthofix Inc., Linvatee Corp, I-Flow Inc, Breg Inc., and DJO Inc.

A study published by The American Journal of Sports Medicine first brought to light the connection between PAGCL, a type of chondrolysis in the shoulder, and pain pumps used during shoulder repair surgery. As a result of that study, hundreds of lawsuits have been filed against manufacturers of pain pump devices and pharmaceutical companies as more and more victims begin to put the pieces together and realize they were unnecessarily harmed by the devices used to alleviate pain during shoulder surgery.

There is no cure for chrondrolysis. The condition causes continuous pain; weakness in the shoulder; clicking, popping or grinding in the shoulder; and/or decreased range of motion. Some who suffer from chondrolysis may require complete shoulder replacement.

Source: Buffalo Business Journal

SOURCE: Pain Pumps › More lawsuits filed against pain pump manufacturers

It is Dr. Carrese’s opinion that “to do otherwise would be a failure of expected ethical and professional conduct, and in turn a failure of good clinical practice.”

The opinion addresses the “ethical and professional obligations of orthopedic surgeons to patients who have had arthroscopic shoulder surgery in conjunction with postoperative use of a pain pump device that infuses medication continuously via a catheter directly into the shoulder joint and who are therefore at risk for developing severe pain and disability of the shoulder joint secondary to a condition known as chondrolysis.”

Dr. Carrese is an Associate Professor of Medicine and Director, Program on Ethics in Clinical Practice, at Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University.

This recommendation follows a report from the FDA distributed today to health care professionals following a review of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given “continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain.” According to the study, 97 percent of the reported cases of chondrolysis followed shoulder surgeries.

The FDA report says early adverse affects following pain pump use after surgery included joint pain, stiffness, and loss of motion, occurring as soon as two months after surgery. In half the reported cases, the FDA report notes, patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

A number of lawsuits have been filed on behalf of patients suffering from chondrolysis as a result of pain pumps being inserted directly into the cartilage rather than into the muscle tissue following surgery. The FDA only approved pain pump use as inserted in the muscle tissue, but the lawsuits allege pain pump manufacturers marketed the devices to physicians with instructions to insert the catheter into the joint for faster and more efficient pain relief.

However, studies show that introducing the anesthetic medications directly into the joint in this manner destroys the cartilege and results in chondrolysis.

Read the Ethics Recommendation Letter.

Read the FDA Report.

SOURCE: Pain Pumps › Doctors have obligation to tell former patients about pain pump risks

Plaintiff Martin R. Jaramillo, a citizen of Monterey County, California, has filed his complaint against DJO, LLC; DJO Inc.; FKA DJ Orthopedics Inc.; McKinley Medical, LLC, Moog, Inc., and Curlin Medical, Inc. He is represented by Frank Woodson of Beasley Allen Law Firm; Laura B. Kalur of Kalur Law Office; Michael L. Williams, Leslie O’Leary and Thomas B. Powers of Williams, Love, O’Leary & Powers; and C. Brooks Cutter with Kershaw, Cutter & Ratinoff.

Plaintiff Marilyn D. Reynolds of Idaho, has filed her complaint against the same businesses as Jaramillo. She is represented by Ted Meadows with Beasley Allen Law Firm and Yvonne M. Flaherty of Lockridge, Grindal, Nauen.

Plaintiff Gina K. Bass of Arkansas, has filed her complaint against DJO, LLC; DJO, Inc., and I-Flow Corporation. She is also represented by Ted Meadows with Beasley Allen Law Firm and Yvonne M. Flaherty of Lockridge, Grindal, Nauen.

All three complaints allege that the manufacturers of the pain pump devices caused the plaintiffs to suffer from the complete or nearly complete loss of cartilage in the shoulder joint, an injury that is irreversible, disabling and extremely painful. The lawsuits assert claims for negligence, strict product liability for design defect and strict product liability for failure to warn against defendants. The lawsuits seek compensatory and other damages.

Read the Jaramillo complaint.
Read the Reynolds complaint.
Read the Bass complaint.

SOURCE: Pain Pumps › Three new complaints filed against pain pump manufacturers

Lawsuits

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

Rotator cuff surgery

KFx Medical Corporation was awarded a patent this week by the U.S. Patent and Trademark office for knotless surgery tissue fixation. The key patent covers a broad range of methods used to perform surgical knotless tissue fixation, including the double row tissue repair technique used to restore the rotator cuff to its correct anatomic position.

The new knotless surgery tissue fixation is designed to eliminate knot tying and thus reduce the overall surgical time, which may aid in the healing process. Recovery from rotator cuff surgery is slow and can be painful. To help manage pain, surgeons often implant a pain pump into the shoulder tissue that delivers a steady amount of medication to the surgical site for up to 72 hours following surgery.

Pain pumps offer an alternative to narcotics and speed healing time, though they are not without fault. Shoulder pain pumps have been linked to a painful and debilitating shoulder condition known as chondrolysis in which the cartilage wears away leaving bone to rub against bone. As a result, manufacturers of shoulder pain pumps are facing hundreds of lawsuits filed by individuals injured by the pain pumps.

Sources: eHealthMD, Reuters

SOURCE: Pain Pumps › New rotator cuff surgery method can help reduce surgical time, effort

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

Chondrolysis is a rare condition in which the cartilage in a joint wears away causing bones to rub against bones. It was often seen in the hip where conditions such as birth defects caused the bones to rub against each other. This grinding of bones causes inflammation and pain and, eventually, destruction of the bones. It is painful and debilitating to those who suffer from this permanent condition.

In the 1990s, doctors began seeing chondrolysis in the shoulder, a place where it was rarely, if ever, seen before. As doctors began diagnosing more and more shoulder chondrolysis, also known as postarthroscopic glenohumeral chondrolysis (PAGCL), in patients who had previously had shoulder surgery, they began to make a connection between PAGCL and a new surgical use of pain pump devices used to manage pain following surgery.

That new use was to place the catheter of the pain pump directly into the shoulder joint rather than into the shoulder tissue. The constant drip of medication into the shoulder joint ate away at the cartilage in the shoulder.

It was the pain pump manufacturers who advised doctors to place the catheters directly into the joint space – a use that was not approved by the Food and Drug Administration. As a result, those manufacturers are facing hundreds of lawsuits against people who are suffering with PAGCL, a condition that is permanent and often requires shoulder replacement surgery.

SOURCE: Pain Pumps › Pain pumps blamed for painful chondrolysis in shoulder joints

Pain pumps

The devices take the place of narcotics, which carry a laundry list of side effects from nausea to vomiting to constipation and decreased sleep. They also require more monitoring and may require the patient to have a longer stay in the hospital.

“It may be $2,000 a day to have a patient stay in the hospital, so in this era of trying to reduce health care costs, if we can reduce their hospitalization from three days to one – or even better, to discharge them on the day of the surgery as an outpatient – we’ve dramatically changed the cost of that shoulder replacement or other major surgery,” said Randall Malchow, director of the Regional Anesthesia and Acute Pain Fellowship at Vanderbilt University. Dr. Malchow discussed the benefits of pain pumps for ABC 7 News.

The biggest risk these days with shoulder pain pumps is that in some cases, the pump does not work. That requires the patient to be admitted to the hospital and have pain medications administered by doctors and nurses. There is also a slight risk – about 1 percent – of infection. Pain pumps can be used for shoulder, elbow, wrist, knee and hip replacements.

The risks have recently improved since doctors began to make a connection between an alternative use of pain pumps and a painful and debilitating condition known as chondrolysis. Chondrolysis is when the cartilage in the joint has worn away and bone begins to rub against bone.

For years in the late 1990s and early 2000s, manufacturers of pain pumps began telling doctors to implant the pumps’ catheters directly into the shoulder joint rather than into the shoulder tissue. Inserting the catheter into the shoulder joint was not an FDA-approved use, as was placing the catheter in the shoulder tissue. By placing the catheters into the joint space, the medication dripped directly onto the cartilage and began eating away at it. The result? Pain, loss of motion, and limited use of the shoulder.

Today, doctors are using pain pumps as the FDA had intended – with the catheters placed in the shoulder tissue, with few risks. However, many of those who suffered because the pain pump manufacturers gave the surgeons ill advice have slapped the manufacturers with hundreds of lawsuits seeking justice.

SOURCE: Pain Pumps › Pain pumps less risky these days

The pain pumps eliminate the need for narcotics and costly hospital stays, and revolutionized pain management for procedures such as shoulder surgery. However, pain pumps didn’t always prove to be the best solution.

The pain pumps were first approved by the Food and Drug Administration (FDA) with the catheters feeding into the shoulder tissue. However, in the 1990s, the manufacturers of pain pumps asked the FDA to approve an alternative use – placing the catheters directly into the shoulder joint. The FDA required more testing before it would approve such a use. Rather than following proper protocol and running tests on the alternative use, the device manufacturers began advising surgeons to place the catheters in the shoulder joint.

Months and years later, doctors began noticing patients who had had shoulder surgery were beginning to suffer from a serious and debilitating condition known as chondrolysis in which the cartilage in the joint is worn away. Those doctors began to make the connection between patients with chondrolysis and the alternative use of the pain pumps.

Today, manufacturers of pain pumps are facing hundreds of lawsuits from people who have been injured by the devices. If you or a loved one has had shoulder surgery and now suffer from pain, weakness in the shoulder, decreased range of motion in the shoulder, or weakness in the shoulder, you may have a claim against the manufacturer.

Source: WCTV-TV

SOURCE: Pain Pumps › Shoulder pain pump makers face numerous lawsuits

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

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?

Pain pumps

“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

One of the complainants, Glen Gore, says a Stryker pain pump was implanted in his shoulder after repair surgery in December 2002. After using the pain pump, he was had lost almost all of the cartilage in his shoulder joint, is unable to raise his arm above shoulder level, and now needs replacement surgery.

Gore is among hundreds of patients who are suing the manufacturer of the pain pumps used in shoulder surgery after the pain pumps caused serious and likely permanent injury to their shoulders. The problem dates back to the early 2000s, when pain pump manufacturers began instructing doctors to place the catheter of the pain pump directly into the shoulder joint. The Food and Drug Administration (FDA) had previously approved its use with the catheter placed in the shoulder tissue but had rejected the manufacturers’ request to have the alternative catheter placement approved, citing the need for studies to ensure the safety.

Placed in the shoulder joint, the catheter dripped medicine that began eating away at the cartilage. Doctors soon began to make the connection between the pain pumps and a condition known as chondrolysis, or specifically Postarthroscopic Glenohumeral Chondrolysis. As a result, pain pump manufacturers like Stryker are facing numerous lawsuits from individuals who have been irreversibly harmed by their product.

Source: Boston.com

SOURCE: Pain Pumps › More lawsuits filed against maker of shoulder pain pumps

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

“When you lose someone like that,” Hillman said to The Kansas City Star, “it’s tough to replace. We tried to protect it, and we rested him a couple of times, but it’s just one of those things that needs to be repaired.”

The surgery will end the season prematurely for Crisp, but it shouldn’t hamper his chances for a full recovery. But for hundreds of individuals who had surgery for repairs like a torn labrum in the shoulder, the pain treatment turned out to be more painful and debilitating than the torn labrum itself.

The problem traced back to a pain pump device that is designed to deliver pain medication directly into the shoulder tissue for up to 72 hours following surgery. With the catheter placed in the shoulder tissue, the pumps were effective.

However, in the early 2000s, pain pump manufacturers advised surgeons to place the catheter in the shoulder joint. As the pain medication dripped into the joint rather than the tissue, it began eating away at the shoulder cartilage. The result was a painful condition known as chondrolysis, or specifically Postarthroscopic Glenohumeral Chondrolysis. The condition has caused greater disability and in some cases, shoulder replacement surgery was required.

Hundreds of lawsuits have since been filed against manufacturers of the pain pumps. Patients who have used a pain pump to regulate pain following shoulder, knee, hip, ankle or back surgery, should consult their doctor if they experience continued pain; weakness in the shoulder; clicking, popping or grinding in the shoulder; or a decreased range of motion. Individuals who have been injured by an intra-articular pain pump may have a claim against the manufacturers.

SOURCE: Pain Pumps › Coco Crisp to undergo season-ending shoulder surgery

Kansas City Royals

Crisp, who has not played since June 12, was put on the disabled list and restricted from all swinging and throwing activities. “Obviously, that’s not a good sign,” says general manager Dayton Moore.

Once thought of as a career-ending injury, torn labrums can be repaired and one’s throwing ability restored. Recovery usually takes several weeks. It also can be considered a safer procedure than in years past, when the device used to alleviate pain following surgery ended up causing more damage and, in many cases, rendering the shoulder useless.

Intra-articular pain pumps are devices that are approved by the Food and Drug Administration (FDA) to deliver medication through a catheter placed directly into the tissue near the wound site. In the early 2000s, pain pump manufacturers asked the FDA if the catheters could be placed directly into the shoulder joint rather than the tissue. The FDA said no; more testing would be required.

Instead of working the proper channels to get the alternative use approved, pain pump manufacturers began advising surgeons to place the catheters into the shoulder joint. As a result, patients began suffering from a condition known as chondrolysis. Chondrolysis is the disappearance of cartilage in the shoulder resulting in joint narrowing and stiffness. In some cases, shoulder replacement may be necessary.

The improper use of pain pumps has ceased, but those injured by the devices are just beginning to experience problems and as a result numerous lawsuits have been filed against the manufacturers of pain pumps.

SOURCE: Pain Pumps › Royals’ Crisp may need shoulder surgery

The labrum is a cartilage found in the shoulder’s ball-and-socket joint where the arm meets the body. It serves to deepen the socket so that the ball stays in place and helps stabilize the arm. When the labrum is torn due to injury, the ball may slide part or all of the way out of the socket. Symptoms of a labral tear depend on where the tear is located, and may include an aching sensation in the shoulder joint, catching of the shoulder when moved, and pain during physical activity.

Treatment for a torn labrum depends on the type of tear. They often do not require surgery; however, patients with persistent symptoms that do not respond to other therapies may need surgery. Recovery from surgery usually depends on where the tear occurred and how severe the tear was. Typically, it takes four to six weeks for the labrum to re-attach itself to the rim of the bone and another four to six weeks to strengthen and fully heal.

A majority of patients regain full functioning of their shoulder after labrum repair, but that was not always the case. Just a few years ago orthopedic surgeons began seeing more and more patients suffering from a painful and debilitating condition known as chondrolysis in patients who had had shoulder surgery. The condition was traced back to pain pumps used to deliver medication to the shoulder joint for up to 72 hours after surgery.

An investigation found that pain pump manufacturers were advising doctors to insert the pump catheters directly into the shoulder joint rather than the tissue, as was approved by the Food and Drug Administration (FDA). As a result, more than 140 lawsuits have been filed in state and federal court against manufacturers of pain pump devices.

Source: Johns Hopkins Medicine

SOURCE: Pain Pumps › Recovery more likely after shoulder surgery than in years past

Plaintiffs in each of the lawsuits, which were filed separately, are Robin and Craig Smith of Oakland County, Michigan; Davis Prickett of Lakeland, Florida; and Jessica Lee of Jacksonville, Florida. Partnering attorneys are Linda Miller Atkinson with Atkinson, Petruska, Kozma & Hart, and Michael Williams of Williams, Love, O’Leary & Powers; and C. Calvin Warriner and Brenda S.Fulmer with Searcy, Denney, Scarola, Barnhart & Shipley.

According to the complaints, Mrs. Smith’s surgeon implanted a Stryker pain pump into her left shoulder joint after each of two surgeries February 18, 2003 and August 13, 2003. Mr. Prickett was implanted with a Stryker pain pump following arthroscopic surgery on his right shoulder on June 3, 2003. Ms. Lee also used a Stryker pain pump after arthroscopic surgery on her right shoulder on May 13, 2005.

The Stryker pain pump is designed and intended to be used with anesthetics such as Marcaine (bupivacaine) with or without epinephrine for up to 72 hours. On all occasions, the plantiffs allege in their complaints that shoulder pain pumps delivered continuous doses of medication injected directly into the shoulder joint as designed and directed by the defendants, Stryker Corporation and Stryker Sales Corporation. However, usage of the pain pumps in the manner directed by the defendants can cause serious and permanent damage to the cartilage of the shoulder joint. This condition is known as chondrolysis. Chondrolysis is extraordinarily painful, causes narrowing of the joint space and eventually leads to partial or complete loss of cartilage around the joint. There is no known cure for chondrolysis and it will eventually require a total joint replacement.

The lawsuits allege that the defendants did not warn the plaintiffs or their surgeons who used the devices as instructed and directed by the defendants, about the unreasonable risks and dangers of using the pain pump and anesthetic medications in this manner.

Read the Smith complaint.

Read the Prickett complaint.

Read the Lee complaint.

SOURCE: Pain Pumps › Three lawsuits filed against Stryker pain pump manufacturer

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

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

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

However, in the 1990s and early 2000s, pain pump manufacturers began to market the product differently, according to Beasley Allen shareholder Frank Woodson. “The catheter was intended and approved by the FDA to be placed into the shoulder tissue. (But) with advice from manufacturers, the pain pump catheters were being placed in the joint space or intra-articular area, which allowed the pain medication into the joint space.”

By advising surgeons to use the pump in such a manner – one that had never been approved by the FDA – tragedy ensued. “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: Pain Pumps › Pain pump manufacturer’s bad advice leads to ‘tragedy’

Attorney Frank Woodson with Beasley Allen Law Firm along with attorneys with partnering firms filed two separate lawsuits on April 8, 2009, alleging that pain pump devices implanted in the shoulder during and after surgery to repair shoulder injuries were unreasonably and dangerously defective beyond the extent contemplated by ordinary patients.

Plaintiffs are Laura E. and Jeffrey K. Ashworth and Sheri L. and Wade S. Patrick, all residents of Maricopa County, Arizona.

According to the complaints, Ms. Ashworth underwent an initial arthroscopic surgery on her right shoulder on March 29, 2006 at the Arizona Orthopedic Surgical Hospital in Chandler, Arizona. At the end of the procedure, the surgeon inserted a pain pump in the subachromial space, or the space above the shoulder joint, and not directly into the intra-articular joint space. Less than three months later, on June 12, 2006, she re-injured her right shoulder and underwent a second arthroscopic surgery a the same facility. The orthopedic surgeon implanted the catheter of an “On-Q PainBuster” pain pump, manufactured and marketed by I-Flow Corporation, directly into the intra-articular space of her right shoulder. The device injected pain relief medication directly into the plaintiff’s shoulder joint on a continuous basis for up to 72 hours following surgery.

Ms. Patrick underwent arthroscopic shoulder surgery on September 2, 2004, at Scottsdale Healthcare Shea-Piper Surgery Center in Scottsdale, Arizona. At the end of surgery, an I-Flow “On-Q PainBuster” pain pump was implanted into her left shoulder by her orthopedic surgeon. As in Ms. Ashworth’s situation, Ms. Patrick received continuous pain relief medications injected into her pain pump for up to 72 hours or more following surgery. She underwent a second arthroscopic surgery on January 16, 2007 at the Metro Surgery Center in Phoenix, Arizona and received another “On-Q PainBuster” pain pump on her left shoulder and, once again, received the continuous injections of pain killers through the device.

While the pain pumps are designed and intended to be used with commonly used anesthetics, the continuous injection into the shoulder joint of those medications at the doses prescribed over time can cause serious and permanent damage to the cartilage of the shoulder joint.

As a result of both Ms. Ashworth’s and Ms. Patrick’s pain pumps, which delivered dangerous doses of continuously injected medication into their shoulders, both women suffered narrowing of the joint space and/or 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 intra-articular pain pumps as the likely cause of chondrolysis.

The lawsuits allege that defendant I-Flow did not warn the plaintiffs or their surgeons, who used the devices as instructed and directed by the defendant, about the unreasonable risks and dangers of using the pain pump and anesthetic medications in this manner.

Read the Ashworth complaint.

Read the Patrick complaint.

SOURCE: Pain Pumps › Women sue pain pump manufacturer for dangerously defective device

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