Promotion of Off-Label Use May Make Medical Device Manufacturer Liable

A seventeen-year-old girl underwent arthroscopic surgery on her shoulder. The surgeon installed a pain pump device, manufactured by the defendant, to administer a local anesthetic to the patient’s shoulder for four days following her surgery. The device’s catheter was installed directly into the patient’s shoulder joint. Subsequently, the girl experienced extreme pain, and worsening stiffness, clicking, and popping in her shoulder joint. She was diagnosed with glenohumeral chondrolysis, a painful condition involving the permanent destruction of articular cartilage in the shoulder joint. Her prognosis is poor, and she will likely require several complete shoulder replacements during her lifetime.


The patient sued the manufacturer of the pain pump device raising a number of common law claims as well as statutory claims that hold manufacturers strictly liable for defective design and inadequate warning or instruction. The defendant argued that at the time of the patient’s surgery, neither they nor the treating physician had knowledge of any risk associated with the continuous intra-articular infusion of anesthetic and, more specifically, any link to chondrolysis. The district court granted the defendant’s motion for summary judgment.


The Sixth Circuit Court of Appeals affirmed the trial court’s dismissal of the plaintiff’s common law claims, but reversed and remanded regarding her statutory claims for defective design and inadequate warning or instruction.


A product is defective in design or formulation if the foreseeable risks associated with its design or formulation exceed the benefits. The foreseeable risks associated with a product's design are determined by considering factors, including, but not limited to, the likely awareness of product users of the risk of harm; the likelihood of the design or formulation to cause harm in light of the product's intended or reasonably foreseeable uses; and the extent to which the design or formulation is more dangerous than a reasonably prudent consumer would expect when used in an intended or reasonably foreseeable manner. A product is defective due to inadequate warning or instruction if the manufacturer knew, or in the exercise of reasonable care, should have known about a risk that is associated with the product and the manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided concerning that risk.


The court reasoned that the medical literature available at the time of the plaintiff’s surgery was sufficient to put the manufacturer on notice of the risk of damage and destruction of cartilage related to the infusion of chemicals into the joint space, even if there was insufficient medical literature finding a connection between this use of this device and chondrolysis. The literature available at the time could be sufficient to put a reasonable manufacturer on notice of the need for testing to explore the potential risks inherent in such use.


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.


The court held that, 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. The FDA rejected the pump for orthopedic and intra-articular use due to the absence of any studies or data affirmatively establishing the safety of such use. Nonetheless, the defendant actively marketed the pump for off-label intra-articular use without conducting safety studies. The court reasoned that, together, these allegations would allow a jury to infer that the defendant was on notice of the need to conduct testing of the pumps to establish their safety for orthopedic and intra-articular use.


The court remanded the action as it found there are genuine disputes of fact that could allow a reasonable jury to find in her favor on her statutory claims of defective design and inadequate warning or instruction.


See: Krumpelbeck v. Breg, Inc., 2012 WL 3241587 (C.A.6 (Ohio), August 10, 2012) (not designated for publication).