## Facts

- In August 2002, Carol Mack underwent arthroscopic surgery on her left shoulder.
- Near the end of the procedure, her surgeon implanted a Stryker pain pump to infuse bupivacaine for post-operative pain control over roughly two days.
- The pump was configured to deliver anesthetic directly into the glenohumeral (intra-articular) joint space.
- Mack later developed glenohumeral chondrolysis, involving cartilage destruction that caused severe pain and loss of function.
- Mack alleged the intra-articular infusion of bupivacaine through Stryker’s pump caused her condition.
- Before 2002, the FDA had declined to clear Stryker’s pain pump for a specific intra-articular indication; Mack relied on those denials as evidence of notice of risk.
- Mack asserted negligence and strict products liability (design defect and failure to warn); Aaron Mack asserted a derivative loss-of-consortium claim.
- The district court granted summary judgment for Stryker, concluding the risk of chondrolysis from intra-articular use was not reasonably foreseeable in 2002 and therefore no duty to warn or redesign existed.

## Issues

1. Whether, based on medical and scientific knowledge available in 2002, it was reasonably foreseeable that continuous intra-articular infusion of bupivacaine via a pain pump could cause cartilage damage and chondrolysis, creating a duty to warn or design against the risk.
2. Whether FDA refusals to clear an intra-articular indication supported a finding that harm from intra-articular use was foreseeable to the manufacturer.
3. Whether the plaintiff’s expert evidence and cited literature created a genuine dispute of material fact on foreseeability sufficient to defeat summary judgment.

## Decision

- The Eighth Circuit reviewed the summary judgment ruling de novo and affirmed.
- The court held the evidence did not support a finding that, in 2002, the relevant risk of cartilage destruction from continuous intra-articular infusion was reasonably foreseeable to Stryker.
- Because foreseeability was not shown, Stryker owed no duty to warn or to design against the asserted risk, defeating negligence and strict-liability design-defect and failure-to-warn claims.
- The FDA’s denials of a specific intra-articular indication did not establish that the use was unsafe or that resulting harm was foreseeable.
- The court treated the dispute as one of evidentiary sufficiency, concluding the expert’s opinions and supporting studies did not create a triable issue on 2002 foreseeability.
- The derivative loss-of-consortium claim failed with the underlying claims.

## Legal Principles

- Foreseeability at the time of sale/use is central to duty analysis in negligence and informs product-liability duties to warn and to design safely.
- A manufacturer’s obligations are assessed using the state of scientific and medical knowledge at the relevant time, not later-developed literature linking a product to injury.
- Expert testimony must supply a sufficient basis for a reasonable jury to find foreseeability; conclusory opinions or literature not addressing the relevant use and risk may be insufficient to avoid summary judgment.
- FDA refusal to grant a specific indication, without more, is not equivalent to a determination that a use is unsafe and does not by itself establish foreseeability of harm.

## Conclusion

The Eighth Circuit affirmed summary judgment for Stryker because the record did not permit a reasonable finding that, in 2002, the risk of glenohumeral chondrolysis from continuous intra-articular anesthetic infusion using the pain pump was reasonably foreseeable; FDA non-clearance for an intra-articular indication did not change that result.


Mack v. Stryker Corp., 748 F.3d 845 (8th Cir. 2014)