The law firm of Schachter, Hendy & Johnson has won a tremendous victory at the Court of Appeals in pain pump litigation against Breg, Inc. The firm has successfully represented more than 100 people who have been injured by pain pumps that destroyed the cartilage in their shoulder and knee joints. We have recovered millions of dollars for these injured persons. The one glaring discrepancy was the case of Rachel Krumpelbeck, where a district court judge dismissed the case on December 27, 2010. Today, Ms. Krumpelbeck has been vindicated by the Court of Appeals for the 6th Circuit. That Court reversed the lower court judge and reinstated her case against Breg. Ms. Krumpelbeck will now be allowed to present her case to a jury in Cincinnati, Ohio. The Court of Appeals noted the following important points regarding pain pump litigation:
"Moreover, we find that the district court’s order frames the issue too narrowly. While the medical literature as of March 2005 was insufficient to put Breg on notice of the risk of chondrolysis specifically, Krumpelbeck pointed to numerous articles and published studies prior to that time that found a link between infusion of chemicals into the joint space and harm of the same general nature as that Krumpelbeck suffered—damage and destruction of the cartilage. The district court correctly noted that this literature does not establish that Breg had actual notice of the risk of chondrolysis prior to her surgery. A reasonable jury could conclude, however, that it was sufficient to put Breg on notice of the risk of harm to the cartilage generally when its device was used to inject anesthetics directly in the joint space. Similarly, the literature could be sufficient to put a reasonable manufacturer on notice of the need for testing to explore the potential risks inherent in such use."
- "In rejecting this evidence, the district court made an impermissible factual determination that the evidence was not sufficient, stating that it was “particularly troubled by [Krumpelbeck’s] failure to provide any expert testimony supporting counsel’s bald conclusion that there was relevant literature available prior to March 2005.” It is unclear why—at least, at the summary judgment stage—the court would require Krumpelbeck to produce an expert to testify that there was relevant literature when Krumpelbeck produced, instead, the literature itself. While a trial expert will almost certainly be required to explain the significance of the literature to a jury, the literature itself is evidence, more than a mere scintilla, sufficient to establish an issue for trial."
- "However, whether the FDA’s rejection did or should have put Breg on notice of the need to conduct testing of its pumps to establish their safety for orthopedic and intra-articular use is another question entirely. Had Breg elected to promote and market its pain pump only for those uses cleared by the FDA, perhaps Breg would have no duty to conduct such testing. But there is evidence in the record from which a jury could conclude that Breg actively marketed its products for off-label orthopedic and/or intra-articular use without conducting any relevant safety studies."
- "For instance, Plaintiff’s Exhibit 57, submitted in support of Krumpelbeck’s opposition to the motion for summary judgment, is a New Product Release for Breg’s Pain Care 4200 pump, dated September 2002. This is an internal document, apparently directed to Breg’s sales force, which describes the various components, features, benefits, and specifications of the 4200 pain pump. The indications clearly list orthopedic procedures, a use that the FDA expressly informed Breg it would not approve due to Breg’s lack of data supporting the safety of such use. A jury could conclude that a reasonable manufacturer would not market a product for a particular off- label use without first conducting tests to establish the safety of such use. There is also Plaintiff’s Exhibit 54, another of Breg’s internal documents submitted in support of Krumpelbeck’s opposition to Breg’s motion. The relevant portion of this document describes placement of the pain pump catheter and indicates that it should be placed at the origin of the pain, including around the joint and/or directly into the joint cavity. (Sealed App. at 140.) This is further evidence from which a jury could find that Breg actively promoted the use of its pain pumps for off-label use directly in the joint space. Finally, Krumpelbeck’s surgeon, Dr. Paul Favorito testified that “BREG did promote the use of intra-articular pain catheters. They never promoted them that I remember directly in the shoulder, but I know they promoted them in the knee.”
- "While promoting an off-label use does not necessarily give rise to liability in itself, promoting a use for which the safety and long-term effects have never been tested or established might give rise to liability. Like the sufficiency of the medical literature, it is for a jury to decide whether a reasonable manufacturer in Breg’s position would have conducted such testing prior to promoting an off-label use of its product."
The lawyers of Schachter, Hendy & Johnson look forward to being able to present Rachel Krumpelbeck's case at trial.