Feds Turn Up Noses to $17 Million Shoulder Pain Pump Lawsuit

Washington, DCA $17 million shoulder pain pump lawsuit filed in January, 2011 under the False Claims Act was unsealed just before Christmas of last year after the federal government decided not to intervene. The lawsuit alleges that various manufacturers of shoulder pain pumps advocated uses for the device that were not approved by the US Food and Drug Administration (FDA).

One lawyer suggested the government’s disinterest could signal the case, in the government’s view, is not winnable and could be dismissed. To that end, opinion holds that the government’s position does not detract from the merits of the case, and the government has nonetheless signaled it wished to be kept apprised of any continuing developments in the case.

Let’s look at the merits of a case the government turned down…

The plaintiffs in the litigation--an orthopedic surgeon and a former consultant to three of the companies named as defendants, allege in their lawsuit that the defendants continued to promote the pain pumps for off-label uses even after the plaintiffs warned the respective companies they were operating outside of legal, moral and acceptable guidelines.

Shoulder pain pumps were approved by the FDA for use in the soft tissue surrounding the shoulder, but not in the shoulder joint itself. Delivering pain medication directly to the shoulder joint has been found to permanently break down the cartilage that cushions the shoulder joint. The condition is known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL), and has been an issue in both Canada and the US. The result has been intense pain and permanent mobility issues that can only be resolved with shoulder replacement surgery.

According to the Devices & Diagnostic Letter (12/24/12) the pain pumps were manufactured by Stryker, I-Flow, DJO and Orthofix (formerly Breg).

According to the shoulder pain pump lawsuit, Stryker was seen to be demonstrating to physicians the placement of Stryker pain pumps directly to the shoulder and knee joint without making any mention that the practice was an unapproved use of the product.

The plaintiff reportedly shared his observations with Stryker, but received no meaningful response. It was also reported the observations of Relator Lonnie Paulos were never reported to the FDA.

There were also, it was reported, concerns over the use of I-Flow pain pumps for use following orthopedic surgery, in the absence of proper clearance, approvals and protocols for that indication. I-Flow, it was alleged in the lawsuit, failed to evaluate the safety of its pain pumps even after receiving adverse event reports, and denied a Stanford researcher any assistance in conducting an animal study on the issue of intra-articular joint use. I-Flow is also accused, according to the lawsuit, of misleading the FDA with regard to use of pain pumps in joints.

As for Orthofix--formerly Breg--the company was noted to have conducted a clinical trial on pain pumps in joints but is alleged to have failed in properly monitoring the investigators, among other alleged failings. Alleged to have instructed its personnel to promote pain pumps for use in joints, Orthofix is also alleged to have waited three years from the time it knew about adverse events, to when it informed doctors of the hazards, or so it is alleged.

Pain pumps are often used following shoulder surgery to help manage pain. Shoulder surgery can be required for a variety of reasons??"injuries on the job, falls, and in the case of young athletes, a shoulder injury that occurs in the thrust of active play and competition.

For the young athlete, pain pump surgery can balloon to a serious, life-long problem if the shoulder pain pump is used to feed pain medication directly to the shoulder joint, rather than the soft tissue surrounding the shoulder in an indication for which the pain pumps carry FDA approval.

For the young athlete, shoulder repair surgery can save a promising career. However, the use of a shoulder pain pump incorrectly can not only cut a promising athletic career short, it can trigger a lifetime of future and costly surgical procedures to replace the shoulder, then maintain the artificial joints in good working order.

Little wonder many a shoulder pain pump lawsuit is filed by a young plaintiff in the prime of life, but also in the depths of despair for opportunity lost through no fault of their own.