by: Edward B. Mulligan V , Attorney
On Friday August 10, 2012, the United States Court of Appeals for the Sixth Circuit overturned a district court’s decision to dismiss the claims filed by Rachel Krumpelbeck in a product liability suit against Breg, Inc., a manufacturer of pain pumps and other medical devices.
Like hundreds of others in the pain pump litigation, Ms. Krumpelbeck’s claims arose out of her use of Breg pain pump following arthroscopic surgery. Ms. Krumpelbeck’s surgery occurred in March 2005, when she was just seventeen. Pain pumps were designed–as an alternative to conventional narcotics–to manage post-operative pain by continuously injecting local anesthetic directly into a patient’s shoulder joint. However, in the months following her successful surgery, Krumpelbeck began to experience extreme pain, worsening stiffness, clicking and popping in her shoulder joint. In December 2007, she was diagnosed with glenohumeral chondrolysis, a painful condition involving the permanent destruction of cartilage in the shoulder joint. As a result of her extensive cartilage loss, Ms. Krumpelbeck, now only 24 years old, will require multiple shoulder replacements during her lifetime.
Breg has faced hundreds of lawsuits premised upon both its failure to warn of the risks that its pain pumps pose to human cartilage as well as misrepresentations made to physicians regarding the safety of its pumps. Under the laws of most states, Breg was under a legal duty to warn physicians and their patients of all risks associated with its pumps about which it knew or should have known. In this case, as it has in many others, Breg argued that it was under no such duty because, at the time of the Plaintiff’s surgery in 2005, the association between chondrolysis and pain pumps was unknown to not only Breg, but the entire scientific community.
To counter Breg’s argument, the plaintiff merely needed to point to evidence suggesting that the facts–whether Breg knew or should have known of the risks of chondrolysis–were in dispute such that a jury trial would be required. Although Plaintiff presented a variety of evidence demonstrating that Breg did or should have had knowledge of the risks its pumps posed to cartilage, the district court agreed with Breg and dismissed all of Ms. Krumpelbeck’s claims.
On appeal, the Sixth Circuit panel reversed and remanded part of the district court’s dismissal of Ms. Krumpelbeck’s claims for “defective design and inadequate warning or instruction” for further proceedings and affirmed the remainder of the district court’s decision.
In overturning the lower court’s ruling as to Krumpelbeck’s defective design claim, the panel held the district court overlooked a key factor, the so-called “consumer expectation” test, which considers “[t]he extent to which [the product’s] design or formulation is more dangerous than a reasonably prudent consumer would expect when used in an intended or reasonably foreseeable manner.”
As to Krumpelbeck’s failure to warn claim, the panel determined that the evidence in the record was sufficient to create disputed issue of fact for trial. Specifically, the panel held that numerous articles and studies submitted by Krumpelbeck and published prior to her surgery had “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.” “A reasonable jury could conclude,” the panel wrote, that this information “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,” and “could be sufficient to put a reasonable manufacturer on notice of the need for testing to explore the potential risks inherent in such use.”
The panel also acknowledged the significance of evidence demonstrating
(1) that the FDA had repeatedly refused to clear Breg’s pain pumps for orthopedic and/or intra-articular use,
(2) that Breg had not tested the safety of these uses, and
(3) that Breg had promoted its pumps for those uses anyway. “Like the sufficiency of the medical literature,” the panel wrote, “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.”
While this decision is consistent with dozens of decisions issued by federal district courts around the country in the pain pump litigation, it is significant because it is the first federal appellate court decision to reverse one of only a few district court decisions that Breg and other pain pump manufacturers rely upon heavily in defending these cases. In this regard, it is an important victory for those who have been permanently injured by the wrongful conduct of pain pump manufacturers, including Breg. However, the significance of this ruling does not end there as the Sixth Circuit’s decision makes clear that a manufacturer can be found liable for failing to conduct adequate safety testing. Hopefully this aspect of the Sixth Circuit decision will encourage manufacturers, such as Breg, to more seriously engage in pre-market testing before selling its products for use on humans.