Shoulder Pain Pump Injury Lawsuit - Class Action Suit Attorneys

Shoulder Damage Caused by Pain Pumps
Recent studies have identified intra-articular pain pumps as a likely cause of severe cartilage damage, primarily in the shoulder but possibly in other joints as well. In the shoulder, this condition is known as Postarthroscopic Glenohumeral Chrondrolysis (PAGCL). PAGCL is a loss of cartilage in the shoulder following shoulder surgery. Chondrolysis translates to cartilage cutting apart. The glenohumeral joint is composed of the ball at the end of the arm bone and the socket of the shoulder blade, joining the arm and shoulder. The head of the arm bone is covered in articular cartilage, allowing the shoulder joint to move smoothly and preventing grinding and pain. Glenohumeral chondrolysis is the breakdown and/or dissolution of the cartilage in the shoulder joint. Without this cartilage the shoulder cannot move smoothly and properly. The result is pain, stiffness and reduced range of motion. This condition is associated with the use of an intra-articular pain pump catheter (a tiny, flexible plastic tube) implanted in the shoulder joint by the surgeon during the shoulder surgery possibly because of the high concentration of the pain medication pumped directly into the surgery site. The pain pump stays in place for several days after surgery to deliver pain medication (such as Marcaine or Bupivacaine) to the shoulder joint.

Symptoms of PAGCL include:

Medical experts who understand PAGCL say that these symptoms generally occur between three months to a year after someone has had shoulder surgery and used a pain pump directly afterwards to manage the pain during recovery. This is a devastating condition that causes severe pain and the need for constant medication. The condition may ultimately require shoulder joint replacement surgery. There are many possible causes of PAGCL, however, the most notable cause is due to the use of a pain pump after someone has had shoulder surgery. Ask anyone whose undergone shoulder surgery and they’ll tell you that it can be very painful – especially in the recovery phase.

Doctors and patients generally have two ways to manage that pain – oral painkillers or a pain pump. While oral painkillers may work just as well as a pain pump, their use generally requires a nurse to administer the drugs which takes time. The pain pump is a small device that can be surgically implanted in the shoulder joint so that the painkiller medication can be delivered immediately.

It’s not surprising that, given those two options, many shoulder surgery patients have chosen the latter. However, medical experts have determined that use of the pump may cause permanent damage to the shoulder be eating away at the cartilage (a dense connective tissue that, among other things, allows movement in joints).

Recent studies
American Academy of Orthopedic Surgeons. According to a 2006 study by the American Academy of Orthopedic Surgeons, several shoulder surgery patients who developed PAGCL were studied and the one factor they had in common was that they all used a pain pump after their surgery.

American Journal of Sports Medicine. According to an October 2007 study published in the American Journal of Sports Medicine (AJSM), Dr. Charles Beck, an orthopedic surgeon and senior author of the study, stated that there is 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.”

“The complication, known as PAGCL, is permanent and can lead to extreme pain and lifelong suffering in 63 percent of the patients that use them. The medical records of numerous other patients suggest the complications may occur following open surgery as well.”

Lawsuits
There have been countless lawsuits filed against the makers of pain pumps, such as Stryker, DJO Inc., I-Flow, BREG Inc. and several others. Dr. Charles Beck alleges that the manufacturers knew about the problem years ago, but did nothing. According to Beck:
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.

The lawsuits allege the pain pump manufacturers failed to instruct or warn the U.S. medical community that the safety of using the pain pumps in the shoulder joint had not been established and that the continuous injection of commonly used anesthetics by these devices may cause permanent injury.

Pain pump manufacturers haven’t conducted any studies of their own which have been made public.

Only one manufacturer has posted ‘warning’
I-Flow seems to be the only company who has posted information about the problems with pain pumps and Postarthroscopic Glenohumeral Chondrolysis (PAGCL) on their website. However, even their bulletin downplays it and points at a list of other potential causes. From what we can tell, doctors and orthopedic surgeons around the country are continuing to use this pain pump and pointing the catheter into the joint space. They’re shocked when we show them the studies and share what we have learned.

Brand Names of Shoulder Pumps
These pumps can be found under brand names such as the Stryker Pain Pump, Accufuser Plus, Donjoy Pain Control Device in addition to the I-Flow On-Q Pump. These manufacturers are under heavy scrutiny from the medical world, as well as thousands of affected patients.

Donjoy Inc., a global medical technology firm headquartered in Vista California, is one of several companies that manufacture pain pumps – infusion devices that deliver controlled amounts of local anesthetics to patients in order to manage their pain after surgery. However, several studies have shown that pain pumps may cause a painful condition known as PAGCL (Postarthroscopic Glenohumeral Chondrolysis) – which can lead to a lifetime of suffering.

A closer look at Donjoy’s pain pumps
Donjoy markets two pain pumps, the Accufuser Plus and the Donjoy Pain Control Device. According to the company’s website (www.donjoy.com), the pain pumps provide continuous infusion of a local anesthetic directly to the surgical site alleviating moderate to severe pain patients experience following many operative procedures. Here’s a closer look at each product:

Accufuser Plus: Latex free and safe for use with patients who have latex allergies. The delivery of medication is administered and regulated by an elastomeric reservoir located in the pump and a flow restrictor in the catheter, providing extremely consistent flow rates. The device allows for bolus (extra) medication to be delivered when needed.

DonJoy Pain Control Device: Latex free and safe for use with patients who have latex allergies. The delivery of medication is administered and regulated by a spring mechanism located in with the pump and a flow restrictor in the catheter, providing extremely consistent flow rates.

I-Flow Inc., a medical technology firm with headquarters in Lake Forest California, is one of many firms that manufacture pain pumps – which are infusion devices that deliver controlled amounts of local anesthetics to patients in order to manage their pain after having surgery. Recent studies have linked pain pumps used after shoulder surgery to PAGCL (Postarthroscopic Glenohumeral Chondrolysis) – a very painful condition that can become permanent and inflict a lifetime of suffering without undergoing further surgery.

A closer look at I-Flow’s pain pump
I-Flow markets the ON-Q PainBuster pain pump. According to the company’s website (www.iflo.com), the device:
Provides continuous infusion of a local anesthetic directly into the patient’s surgical site for effective, non-narcotic post-operative pain relief for up to 5 days
Gets patients on their feet faster
Reduces patient need for narcotics and decreases potential of breakthrough pain
Is simple yet elegant and requires little to no management or intervention by the patient or caregiver
Is completely portable and can be carried in a pouch or attached to a patients’ clothing
I-Flow’s website contains FAQs and a technical bulletin regarding Chondrolysis which can be accessed at:
www.iflo.com/pdf/products/1302966E.pdf (FAQs)
www.iflo.com/pdfs/1303722e.pdf (Technical bulletin)
The company’s phone number is 1-800-448-3569
Stryker, a global medical technology firm headquartered in Kalamazoo Michigan, is one of several companies that manufacture pain pumps – infusion devices designed to deliver controlled amounts of local anesthetics to patients for post-operative pain management. However, studies have shown that using pain pumps after shoulder surgery are likely to cause PAGCL (Postarthroscopic Glenohumeral Chondrolysis) – a condition that can lead to extreme pain, lifelong suffering and can be permanent.

A closer look at Stryker’s pain pumps Stryker markets three different pain pumps, the ‘Pain Pump I’, the ‘Pain Pump 2’ and the ‘Pain Pump 2 BlockAid’. According to the company’s website (www.stryker.com), Stryker’s pain pumps deliver medication directly to the surgical wound site or in close proximity to the nerves associated with the surgical area. The pumps infuse medication at an hourly flow rate or combination of an hourly flow rate and controlled bolus (extra) doses. Here’s a closer look at each product:

PainPump I: A portable, single use, disposable pain management device that helps deliver a continuous, controlled infusion of local anesthetic to the surgical site.

PainPump 2: A programmable, portable, single use, disposable pain management system that provides a continuous, surgeon-controlled infusion of local anesthetics to the surgical site. Bolus feature helps patients take charge of their pain management.

PainPump 2 BlockAid: A programmable, portable, single use and disposable pain management device that continuously flows local anesthetic and narcotics in close proximity to nerves associated with the surgical area for postoperative regional anesthesia. This mode of pain management has been clinically proven to significantly reduce pain and length of stay in orthopedic surgery.
Additional information on Stryker’s pain pumps may be obtained from the company’s website, by contacting them at 1-877-848-5756 or by using the following links:
Pain pump I: Step by Step Guide:
www.stryker.com/stellent/groups/public/documents/web_prod/024307.pdf
Pain pump 2 FAQs:
www.stryker.com/stellent/groups/public/documents/web_prod/016681.pdf
Pain Pump 2 Blockade FAQs:
www.stryker.com/stellent/groups/public/documents/web_prod/024358.pdf
BREG Inc., a Vista California based medical technology firm, is one of several companies that manufacture devices known as pain pumps. These devices deliver controlled amounts of local anesthetics to patients in order to manage their pain after surgery. However, two recent studies have shown that the devices may be linked to a painful condition known as PAGCL (Postarthroscopic Glenohumeral Chondrolysis).

A closer look at BREG’s pain pumps
BREG markets several different types of pain pumps known as the e-Paincare System, the 2000 Series and the 3000 Series. According to the company’s website (www.breg.com), their infusion pumps are for local wound site infusion of non-narcotic anesthetic for the management of post-operative pain. Here’s a closer look at each series:

e-Paincare System: The e-PainCare System is an electronic, programmable, reusable, ambulatory infusion pump used to deliver local anesthetics to a post-operative wound site. The device provides an hourly bolus of non-narcotic pain reliever at a rate of 2 mL, 4 mL or 6 mL per hour.

PAIN CARE 2000, 2000L: The PAIN CARE 2000 series pumps provide a patient-controlled bolus (extra dose) of non-narcotic anesthetic directly to the post-operative wound site. The PAIN CARE 2000L provides a 30 minute “lock-out” between doses. The anesthetic is delivered through a radio-opaque, multi-port infusion catheter that can be trimmed to the desired length. These portable, lightweight and compact units are ideal for outpatient use. Two configurations are available to address clinical and patient preferences.

PAIN CARE 3000, 3200, 4200: The PAIN CARE 3000 series pumps (of which the 4200 seems to be included) combine a continuous drip of anesthetic to the post-operative wound site with a patient-controlled bolus. The anesthetic is delivered through a radio-opaque, multi-port infusion catheter, which can be easily trimmed to the desired length. These portable, lightweight and compact units make them ideal for outpatient use. Three configurations are available to address various clinical needs and requirements.

Additional information on the products can be obtained on the company’s website or by contacting them at 1-800-897-BREG (2734).

FDA approval never given
In 1998, a company called McKinley Medical was selling pain pumps and apparently sent a letter to the FDA asking for approval to promote the pain pump device to be pointed directly into the intra-articular space, or the synovial cavity. McKinley sought approval to promote it in such a fashion and the FDA told them to provide some safety and efficacy data. From what we can tell, that data was never provided to the FDA.
The FDA later approved some labeling indications for other uses, but not to point the catheter directly into the synovial cavity. So, it wasn’t as if they told the company to go and do studies and then never weighed in again. The FDA actually did come back, weigh in on use and they did not allow the company to promote the pumps for this use. No other FDA Approval for use of these pain pumps in this fashion was obtained.

Shoulder Pain Pump Lawsuit - Shoulder Pain Pump Lawyer