In Krumpelbeck v. Breg, Inc. (Case No. 11-3726), the Sixth Circuit ruled that a plaintiff’s claims for defective design and failure to warn regarding a pain pump manufactured by Breg, Inc. could go to a jury.  Interestingly, the court permitted the claims to continue based on literature regarding harm of the same general nature as plaintiff’s injury, even though the parties agreed that there was no literature at the time of the procedure linking the pump to the plaintiff’s specific type of injury.  Furthermore, the court concluded that FDA denials for lack of safety data could be considered by a jury to put Breg on notice of a need to conduct safety studies if it promoted the pain pump for off-label uses. 

In moving for summary judgment before the trial court, Breg relied on the undisputed fact was that there was no literature at the time of the incident connecting use of its pain pump to the type of cartilage injury suffered by the plaintiff.  The court reversed summary judgment in Breg’s favor because the district court did not analyze the defective design claim using the “consumer expectation” test and because the court found two pieces of evidence it considered sufficient to send the claims to the jury.

First, there was literature that “found a link” between infusion of chemicals into the joint and “harm of the same general nature as that Krumpelbeck suffered.”  The court acknowledged that the literature would not have placed Breg on notice of “the risk of chondrolysis specifically.”  But, it still concluded that a jury might find that the pump the literature put Breg “on notice of the risk of harm to the cartilage generally” and that the literature might put “a reasonable manufacturer on notice of the need for testing to explore the potential risks inherent in such use.”

Second, the court focused on the FDA’s rejection of Breg’s application for approval of the pump for orthopedic or intra-articular uses because Breg did not submit any safety information regarding orthopedic uses.  The denials were not enough to put Breg on actual notice regarding any safety issues.  However, because Breg apparently promoted its pump for the rejected uses, the court found that a jury could conclude that a reasonable manufacturer in Breg’s position would have conducted safety studies before promoting such off-label uses.

The court affirmed summary judgment in the manufacturer’s favor with regard to the plaintiff’s other statutory and common law claims regarding alleged misrepresentation of the pump’s safety, because there was no evidence of actual representations by Breg regarding the safety of the device for use directly in the joint cavity or FDA approval for orthopedic and intra-articular uses.  The statement by the plaintiff’s physician that no Breg representative warned him that the pump was not FDA-approved for such uses, despite the physician’s belief that it was so approved, was not sufficient.

As reported by Law360 (subscription), Breg’s counsel states that Breg ”believes the opinion contains a number of significant factual inaccuracies, and Breg is evaluating its options.”