O'Shea v. Zimmer Biomet Holdings, Inc.
342 F.Supp.3d 1354 (2018)
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Rule of Law:
A manufacturing defect claim for a complex medical device may survive summary judgment without expert testimony if the plaintiff presents sufficient circumstantial evidence, such as the manufacturer's own internal documents, admitting the device failed to perform as intended and that no other contributing factors caused the failure.
Facts:
- Patrick O'Shea suffered from a deformed left leg due to a prior gunshot wound, which caused his leg to be shorter, bowed, and externally rotated, resulting in an abnormal gait.
- O'Shea was also obese at the time of his surgery.
- In June 2007, surgeon Dr. Diehl implanted a Zimmer Biomet NexGen replacement knee system in O'Shea's left leg.
- The knee implant functioned without issue for seven years.
- In 2014, O'Shea's knee pain returned, and a subsequent surgery revealed that the polyethylene tibial post of the Zimmer implant had fractured.
- The broken component was not preserved after the surgery.
- An internal Zimmer Biomet complaint-handling form, completed by a company employee, answered 'Yes' to the question of whether the device failed to perform as intended and 'No' to whether there were any contributing conditions such as patient anatomy.
Procedural Posture:
- Plaintiff Patrick O'Shea filed a products liability action against Defendants Zimmer Biomet Holdings, Inc. and its related entities in the U.S. District Court for the Northern District of Georgia.
- O'Shea's complaint asserted claims for manufacturing defect, design defect, and failure to warn under both strict liability and negligence theories.
- Following the discovery phase, Defendants filed a Motion for Summary Judgment seeking dismissal of all claims.
- Plaintiff O'Shea subsequently filed a Motion to Amend his Complaint to withdraw the design defect claim.
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Issue:
Does a plaintiff's manufacturing defect claim for a complex medical device survive summary judgment without expert testimony when the primary evidence of the defect is an internal company document in which an employee admits the device malfunctioned and that no other conditions contributed to the failure?
Opinions:
Majority - Judge Michael L. Brown
Yes. A plaintiff's manufacturing defect claim for a complex medical device can survive summary judgment without expert testimony if the plaintiff provides circumstantial evidence that creates a genuine issue of material fact. Here, the defendant's internal complaint-handling form, which admits the device failed to perform as intended and denies the existence of other contributing factors, is sufficient. Under Georgia law, expert testimony is required when evaluating an alleged defect is beyond the 'common experience of a jury,' which is true for a complex medical device like a knee implant that failed after seven years in a patient with complicating anatomical factors. However, the defendant's own internal document serves as an admission that the device malfunctioned and eliminates other plausible causes for the failure, such as the plaintiff's weight or gait. This admission accomplishes what the plaintiffs in precedent cases like Mast Biosurgery failed to do: it provides evidence from which a jury could infer that a manufacturing defect was the most likely cause of the injury, thus precluding summary judgment.
Analysis:
This case clarifies the evidentiary threshold for manufacturing defect claims involving complex products under Georgia law. It establishes that a defendant's internal admission can be a powerful substitute for expert testimony, which is often costly and difficult for plaintiffs to obtain. The decision signals that courts may allow cases to proceed to a jury based on strong circumstantial evidence found during discovery, even when the product's mechanics are beyond a layperson's understanding. This may encourage plaintiffs to pursue discovery of internal company investigations and quality control documents as a primary strategy in products liability litigation.
