Shoulder Pain Pump Litigation

A pain pump consists of a container of anesthetic which is taped to the patient's shoulder following surgery to repair a torn labrum, repair a rotator cuff injury, perform a shoulder decompression surgery, or other arthroscopic shoulder procedure. The container of medicine is attached to a catheter which is inserted into the shoulder near the surgery site, providing a continuous flow of anesthetic. This procedure provides pain relief in the days immediately following the surgery, when post-procedure pain is at its highest. The shoulder pain pump delivers its dose for up to five days, or sooner if the patient chooses to discontinue its use. The advantages of the shoulder pain pump over traditional painkillers is the avoidance of habit-forming narcotics or the stomach complications and other adverse aside effects that can occur with oral analgesics.

Where the Problem Lies
Originally, the catheter was inserted into soft tissue, such as the muscle near the surgery site. However, next generation pain pumps were capable of higher flow, delivering more anesthetic to the site, and are inserted into the intra-articular space between the shoulder joint.

The shoulder joint is what is known as a ball and socket joint. A layer of cartilage lies between the "ball" of the humerus, or arm bone, and the "socket" of the scapula, or shoulder bone. A condition known as chondrolysis occurs when this cartilage breaks down, causing the bones in the joint to scrape and grind against each other. Chondrolysis is extremely painful and greatly restricts arm movement. Chondrolysis requires constant treatment and medication, and in many cases a joint replacement surgery is required. Unfortunately, artificial joints are not permanent solutions, and a young chondrolysis patient may require several joint replacement surgeries over a lifetime, each one accompanied by a lengthy, painful recovery process. Since shoulder injuries are common among athletic injuries, a large population of chondrolysis sufferers are young, often in high school or college at the onset of the condition.

Chondrolysis, specifically Post-Arthroscopic Glenohumeral Chondrolysis (PAGCL), has been linked to the intra-articular placement of the pain pump catheter. It is felt that the continuous exposure to the cartilage of the anesthetic is toxic to the cartilage, causing its deterioration.

Ten Years Later, FDA Takes Action
The U.S. Food and Drug Administration (FDA), the government agency responsible for ensuring that drugs marketed to consumers are safe and effective, has been under pressure since 1998 from pain pump manufacturers who want to market their products for use in the intra-articular joint space. The FDA has steadfastly refused, citing a lack of evidence that such use would be safe. However, up until very recently it did nothing to discourage such use either.

In November of 2009, the FDA finally issued a warning to consumers about the possible danger of having a pain pump catheter inserted into the joint space. The FDA further ordered the pump manufacturers to change their packaging labels so as to specifically discourage such use.

Manufacturer's Products Liability
Did the pain pump manufacturers promote the use of their product for insertion into the joint space? While the packaging and product literature may not specifically recommend this type of usage, we know for a fact that the manufacturers have been trying to get the FDA to approve the pain pump for use in the joint space since 1998. We also know that drug companies and product manufacturers hire salespeople called "detailers" who make the rounds to doctors' offices bearing gifts and free samples and encouraging doctors to prescribe their products. These detailers are also known to promote "off-label" uses of drugs in higher dosages or for different treatments than were ever approved by the FDA. Insertion of the catheter into the joint space as opposed to soft tissue is a prime example of an off-label use of a product.

Many manufacturers openly question the link between chondrolysis and the use of their product. Despite the numerous studies and the weight of the evidence, they still claim that a causal link has not been established. Prior to the FDA warning, only one manufacturer (I-Flow) had changed its packaging to discourage intra-articular use of its product. Of the 150 or so lawsuits currently pending in state and federal courts, most cases are still in the discovery phase, during which time evidence is gathered and depositions are taken as to what company executives knew or should have known about pain pump risks.

Products Liability-Failure to Warn
Given the weight of the evidence establishing a link, many lawsuits are proceeding under a products liability theory that the manufacturers breached a duty to warn the users of the product about its safe use and any dangers associated with other reasonably foreseeable uses. Usually a products liability case proceeds on the theory that a product is either defectively designed or defectively manufactured, so as to make it unsafe for its intended use and other reasonably foreseeable uses. A failure to warn or failure to include adequate instructions is another way in which a product can be rendered dangerously unsafe. When an unsafe product enters the stream of commerce, and an end-user is harmed by its use, the manufacturer may be held liable without the plaintiff having to prove negligence or fault on the part of the manufacturer. The fact that a product left the manufacturer's control in an unsafe condition is enough to impose liability.

$5.5 Million Verdict in Pain Pump Case
On February 12th, an Oregon jury awarded $5.5 million in a state-based lawsuit against pain pump manufacturer I-Flow, in what is the first of probably many verdicts to come in this area of law. In the meantime, pain pumps continue to be marketed as a solution to post-surgery pain management. In mid-February of 2010, ContourMD introduced the SmartInfuser PainPump, adding to the many pain pumps already on the market, including Stryker, Donjoy, Accufuser Plus, and I-Flow's On-Q PainBuster.

Given the multitude of manufacturers, products and painkillers used, The United States Panel on Multi-District Litigation (MDL) has so far decided not to consolidate all of the claims into an MDL class action. At this point, each lawsuit is proceeding individually. Since each plaintiff will have to go up individually against the pharmaceutical giants and large corporations with their in-house legal departments and vast financial resources, it is important for plaintiffs to choose an experienced trial lawyer attorney who is experienced in products liability law. Leandros A. Vrionedes has that experience. If you reside in the New York City area and believe you developed chondrolysis after using a shoulder pain pump inserted into the joint space, contact Leandros A. Vrionedes P.C. for professional legal advice and aggressive, effective representation.