Pain Pump Catheter Lawsuit Information
Two of the body's largest joints, the shoulder and the knee, are vulnerable to relatively minor injuries that can lead to painful, debilitating instability.
The shoulder is a highly complex joint, based on its anatomical construction and biomechanics, and has a large range of motion. Even a minor shoulder injury can cause damaging instability. Similarly, the knee has a complex structure that, in supporting the body's weight, sustains massive stress from the force of walking.
Like the shoulder, the knee is susceptible to injuries that can have devastating consequences.
When surgery is performed to repair the damage or alleviate the pain of shoulder or knee injury, anesthetic infusion devices, commonly referred to as "pain pumps," are often used to manage post-surgery pain. One reason is that pain pumps can provide excellent post-operative pain relief with a reduced dosage of narcotics. They are often used in combination with anesthetics such as bupivacaine (Marcaine, Sensorcaine), lidocaine, or ropivacaine, either with or without epinephrine.
Surgeons typically implant a pain pump after joint surgery to facilitate continuous delivery of pain relief through a catheter. Health care providers in the operating room will select the specific anesthetic and program delivery settings immediately after surgery.
This pain relief delivery system may operate for several hours or a few days. The catheter is removed and discarded when the pain pump is no longer necessary.
Unfortunately, pain pump catheters have been linked to permanent pain and other serious side effects. Victims may be entitled to file a pain pump lawsuit for their pain and suffering.
An Unapproved Procedure Causes Cartilage Loss, Permanent Pain
Up until a few years ago, physicians inserted pain pump catheters directly into the joint's muscle tissue after surgery. But beginning in 2000, at the suggestion of some pump manufacturers, many surgeons began inserting the catheters into the joint space (synovial space) and/or the rotator cuff or subacromial areas instead of into muscle tissue. Unfortunately, this use had never been cleared or approved by the Food and Drug Administration.
As a result of this non-standard procedure, post-surgery patients began experiencing a problem called glenohumeral chondrolysis; painful cartilage disintegration that resulted in excruciating pain and more surgery or even complete replacement of the joint.
In a nutshell, chondrolysis is a condition characterized by lost or deteriorated cartilage that can cause severe pain whether the joint is in motion or not. Chondrocytes are the cells found in cartilage which, when they die, do not regenerate. When chondrocytes are gone, loss of cartilage is pervasive, and within just a few months, permanent. Common symptoms of chondrolysis are stiffness of the joint, reduction in strength, and a significant decrease in the range of motion.
A layman with little medical knowledge can readily see the cartilage deterioration resulting from direct insertion of a pain pump catheter into joint space.
Bupivacaine and Epinephrine Linked to Post-Surgery Chondrolysis
As direct infusion of pain medication into joint space became more common, medical journals began to report cases of post-surgery chondrolysis, and new research surfaced linking this to bupivacaine, the drug used most often in pain pumps. It was previously known that bupivacaine destroyed bovine cartilage, but subsequent research with rabbits indicated that, in simulating conditions and dosages consistent with human use of pain pumps, continuous infusion of bupivacaine seriously impaired or eradicated the cartilage cells.
At an annual meeting of the American Academy of Orthopaedic Surgeons in March 2006, Drs. Brent Hanson and Charles Beck presented data that supported the likely link between intra-articular pain pumps and bupivacaine and epinephrine. The following year, they published a study of a dozen of their own patients who between August 2003 and March 2005 had received pain pumps with infusions of bupivacaine and epinephrine directly into the joint.
Up until this period, the physicians had never seen chondrolysis as an outcome of joint repair procedures. But in this study, 63 percent of patients had developed chondrolysis labeled by Hanson and Beck a "strong association" warranting further investigation. They recommended suspension of the use of intra-articular pain pump catheters in combination with these two drugs.
Pain Pump Manufacturers Profit at the Expense of Patient Safety
The three major manufacturers of anesthetic pain control infusion devices appear to have many things in common in addition to their devices. Their history is checkered with inadequate research, financial relationships with doctors promoting their devices, and failure to warn surgeons and their patients about the dangers of these products.
Stryker Corporation is a multinational publicly-traded corporate giant, self-described as a "global leader in medical technology that consistently delivers exceptional results." With 15,000 employees, it claims to be one of the largest players in the orthopedic market. Yet the story of the acquisition and marketing of its pain pump products would seem inconsistent with the Code of Conduct Stryker proudly posts on its web site: a commitment to safety and effectiveness, complying with or exceeding regulations of the Food and Drug Administration and laws and regulations of countries of origin.
When in 2000 Stryker acquired exclusive rights to market McKinley Medical's pain pump products in the US, Canada, and Mexico, McKinley's Outbound Pain Pump, and equivalent products, were not approved by the FDA for use in infusing medication into the synovial cavity or intra-articular joint space. These products were approved only for insertion of medications intravenously, intra-arterially, subcutaneously, and epidurally into the muscle, skin, or nerve tissue.
As a matter of fact, two years before licensing its pain pumps to Stryker, McKinley had applied for FDA approval to market them for infusion directly into joint spaces, asserting that no harm would ensue. The FDA requested safety and efficacy studies, and then later required labeling that the pumps were to be used for infusion directly into the intra-operative site, not into the synovial cavity.
So, when it purchased rights to the McKinley pain pumps, Stryker knew not only that there were no adequate studies to back up direct infusion of bupivacaine directly into the joint space, they knew that the FDA had already rejected this use.
Compounding Stryker's apparent disregard of patient safety, the company has been prosecuted for paying millions of dollars to orthopedic specialists for using its products exclusively. This raises critical questions about the marketing and promotion of direct-infusion pain pump catheters in a vacuum of scientific evidence, and has become the basis for much of the litigation against Stryker.
For the last several years, I-Flow Corporation's pain relief products have been commonly used for regional anesthesia, intravenous infusion therapy, and oncology infusion services. Two smaller sizes of I-Flow's SoakerTM Catheters were approved by the FDA in 1999 and 2000 for pain management of large surgical incisions, and in 2005, the FDA granted I-Flow approval if its one-inch and ten-inch Soaker Catheters. Other products in I-Flow acute pain kit line are the ON-Q® PainBuster® Post Operative Pain Relief System, for which it has exclusive US distribution rights, and the C-BlocTM Continuous Nerve Block System.
Pressured by increasing questions about direct infusion pain pump products, in August 2007 I-Flow issued a "technical bulletin" on its website, downplaying the mounting evidence linking pain pumps and chondrolysis. The bulletin, directed at physicians, listed some alternative causes for chondrolysis. But there is no evidence that I-Flow sent warning letters to surgeons, or that I-Flow's sales team told doctors not to insert pain pumps delivering bupivacaine directly into the joint space.
Most important, here are some points that I-Flow's weak warnings did not disclose:
- That direct infusion of medication by pain pumps into joint spaces was never approved by the FDA.
- That the safety of direct infusion by these pain pumps has never been adequately studied.
- That studies of bupivacaine and epinephrine have demonstrated damage to, and destruction of, cartilage cells.
- That the FDA specifically rejected the marketing of pain pumps that injected these drugs directly into the synovial cavity.
The maker of a product called the DonJoy® Pain Control Device is DJO, a Delaware corporation operating out of California which boasts that it is a global provider of rehabilitation and regeneration products for the non-operative orthopedic, spine, and vascular markets. While DJO's history is less well-documented than that of Stryker and I- Flow, what is known is that the company has assets of nearly two hundred million and reports healthy revenues each quarter.
Several Defense Excuses Can Be Anticipated from Pain Pump Makers
It is likely that these giant corporate manufacturers will defend aggressively the devices that are making them millions of dollars while leaving patients racked with pain and disability. Here are some of the defenses we might anticipate, based on the companies' literature and our prior experience.
Claims Subject to Preemption
Preemption is a legal theory that argues in favor of immunity for the pain pump manufacturers because of alleged "FDA approval."
The Court addressed whether 21 U.S.C. & 360k(a) preempts state tort law claims against the manufacturers of medical devices that have received pre-market approval (PMA) review under the Medical Device Amendments Act (MDA). The Supreme Court held in a 7-1 decision that the MDA's preemption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received pre-market approval from the FDA.
The above-cited case evaluated heart devices, which are Class III medical devices approved through the PMA process. Pain pumps are Class II medical devices that have been in use for more than 25 years, which means that they did not undergo the more recent rigorous FDA PMA process requiring substantial safety and efficacy data. Pain pump manufacturers marketed their products without extensive FDA oversight and approval, and, in fact, promoted use of products which they knew were not approved by the FDA. So we believe that it would be inappropriate to preempt on this basis claims against pain pumps used for direct infusion into joint spaces.
Using this argument, pain pump device manufacturers may seek to hide behind another entity, arguing that it is orthopedic surgeons and other health professionals who should be blamed for using the pain pumps in a way that would cause harm. At Gordon & Partners, we also find this argument without merit. Until surgeons were warned, they had no way of knowing that this new use of delivering pain medication would be dangerous. Surgeons and other health care providers were not only denied critical information, they were encouraged—and in some cases, paid—to use the devices by the very companies who now seek to impose blame.
When pain pump manufacturers learned of the adverse results of using their devices to deliver medication directly into joint spaces, they should have sounded the alarm immediately. Instead of sending "Dear Doctor" letters and publicizing the dangers, they recklessly continued to expand their marketing and promotion. In fact, many surgeons are unknowingly using these pumps today, inadvertently putting their patients in danger because pain pump manufacturers failed to issue appropriate alerts.
Blame the Patient
Blaming the patient is an old trick, and we expect it to surface as litigation progresses against pain pump manufacturers. This argument asserts that the damage is actually caused by the patient's pre-existing condition, and that the use of a pain pump made little or no difference in the ultimate outcome. A corollary to this argument is that injured patients failed to follow proper instructions.
In their desperate search for a scapegoat, the makers of health care products can be counted on to draw upon their multi-million dollar profits and deploy their powerful attorneys to blame those whose lives have been ruined. Nonetheless, the attorneys at Gordon & Partners are committed to seeking justice for victims and their families.
We are prepared to help you discuss and evaluate claims related to damage caused by direct infusion pain pumps used after joint surgery. Victims may be entitled to file a pain pump lawsuit for their pain and suffering.
Please fill out our contact form, or call us at 1 (855) 722-2552 to arrange a confidential and free consultation.