Cincinatti, OHIt's been a long road so far for plaintiff Rachael Krumpelbeck, an alleged shoulder pain pump victim who sustained permanent injury to her shoulder, allegedly through the inter-articular use of a pain pump, in 2005. However, following the granting of summary judgment for the defendant and a subsequent appeal by Krumpelbeck, the young woman from Ohio can proceed with claims of defective design and inadequate warning.
An analysis of shoulder pain pump lawsuit Rachel Krumpelbeck v. Breg Inc., et al., No. 11-3726, United States Court of Appeals, Sixth Circuit shows that it all started for the young woman at age 17. On March 3, 2005 Krumpelbeck was fitted with a shoulder pain pump following arthroscopic surgery. According to the lawsuit her surgeon used a Breg pain pump to deliver local anesthetic to the plaintiff's shoulder for a period of four days.
According to the lawsuit, in the months following shoulder surgery Krumpelbeck began experiencing extreme pain and worsening stiffness in the affected shoulder, which had also begun to 'pop' and 'click' in an abnormal fashion.
By December, 2007—a little under two years following her initial shoulder pain surgery—Krumpelbeck was diagnosed with glenohumeral chondrolysis, referenced in layman's terms as the complete and permanent breakdown and destruction of the articular cartilage in the shoulder joint.
It has since been hypothesized that the delivery of pain medication directly to the shoulder joint reacts in a negative fashion with shoulder cartilage, which cannot heal or regenerate. According to Krumpelbeck's shoulder pain pump lawsuit, her prognosis is poor and the plaintiff will likely require "several" complete shoulder replacements during her lifetime, as articulated in the Sixth Circuit Court's summary of Krumpelbeck's case, and its subsequent decision.
Krumpelbeck initially filed a seven-count shoulder pain pump lawsuit against manufacturer Breg, together with Breg parent Orthofix International NV and Advanced Technology, a wholesale distributer of medical equipment. The complaint alleged strict liability for defective design, inadequate warnings, and failure of the pump to conform to representations together with claims for negligence, breach of express and implied warranty, negligent misrepresentation, and fraud.
Breg filed—and was granted—a motion for summary judgment based on the assertion that neither Breg, nor the plaintiff's treating physician was aware of the risks associated with the potential for chondrolysis. Krumpelbeck appealed, noting in part that repeated refusals on the part of the US Food and Drug Administration (FDA) to approve the use of shoulder pain pumps for intra-articular use should have been sufficient to alert the manufacturer as to potential concerns for that indication.
The appellate court noted that the repeated denials on the part of the FDA were due to a lack of documentation making the case for that particular indication, and that use of pain pumps directly to the shoulder were deemed to be safe.
While the defendant(s) asserted, in requesting summary judgment and defending same, that it had no reasonable knowledge that use of a pain pump directly to the shoulder joint could cause harm, The Court nonetheless gave a nod to the plaintiff's assertion that there was a reasonable collection of medical literature and published articles prior to 2005 that pointed to the possibility of shoulder injury from intra-articular pain pump use.
Additionally, "there is evidence in the record from which a jury could conclude that Breg actively promoted its device for use directly in the joint space," the Sixth Circuit Court ruled. "What the record lacks, however, is evidence that Breg's representatives made any express representations to Krumpelbeck—either directly or through Dr. [Paul] Favorito [the plaintiff's surgeon]—regarding the safety, efficacy, or FDA approval of such use."
Favorito testified that he recalled Breg promoting the intra-articular use of pain pumps, specifically to the knee, although he could not recall if Breg representatives expressly referenced the shoulder.
In the end, the appellate court upheld the district court's grant of summary judgment to the defendant as to the plaintiff's claims of nonconformance with representations, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation and fraud.
However, when considering the shoulder pain pump lawsuit the appellate court remanded the plaintiff's statutory claims for defective design and inadequate warning or instruction. Many plaintiffs have filed shoulder pain pump lawsuits in the US and Canada, alleging grievous injury.
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