By Rebecca Mayo, J.D.
An alternative product that performs all functions that an allegedly defective product was designed to do, but not quite as well, does not necessarily render the alternative an entirely different product, the U.S. Court of Appeals for the Fifth Circuit determined. The appellate panel rejected requests for judgments as a matter of law from hip replacement manufacturer DePuy Orthopaedics, Inc. and parent company Johnson & Johnson, finding that the patients at issue properly presented a safer alternative design to the allegedly defective hip replacement device (Christopher v. DePuy Orthopaedics, Inc, April 25, 2018, Smith, J.).
Five patients had DePuy’s Pinnacle Acetabular Cup System metal-on-metal (MoM) hip replacement implanted, suffered complications, and required revision surgery. The patients secured a half-billion-dollar jury verdict against DePuy. The device maker filed various post-trial motions that were denied except for a request that the exemplary-damages cap be applied to reduce the judgment amount. DePuy appealed the judgment and the patients cross-appealed the application of the cap.
Design defect. DePuy argued that metal-on-plastic (MoP) hip replacements are a different product from MoM hip replacements, not an alternative design of the same product. As such, DePuy argued that MoP hip devices should not be used to demonstrate a safer alternative design. However, the court found that DePuy’s own promotional materials characterized both products as "high stability, low wear" hip implants and never suggested that one material enabled the implant to perform discrete tasks otherwise impossible with the other. The fact that MoM is more durable was a distinction in degree rather than kind. Therefore, DePuy failed to show a sufficiently discrete functional advantage to prove MoP is fundamentally a different product.
Preemption. DePuy further argued that the design defect claims were preempted because they stood as an obstacle to the accomplishment and execution of the full purposes and objectives reflected in the MoM-related regulations of the Food and Drug Administration. The FDA had previously allowed MoMs to be brought to market through the 510(k) process of showing substantial equivalence to predicate devices. The FDA then issued an order requiring that all MoMs receive premarket approval. DePuy argued that because the FDA chose to allow MoMs the opportunity to get premarket approval instead of banning them, the MoMs could not be considered categorically defective and therefore DePuy’s MoM hip device could not be defective.
The court held that the FDA’s final rule that effectively withdrew all MoMs from the market and required premarket approval arguably demonstrated that the FDA likely contemplated the possibility that every MoM then on the market would (and perhaps should) fail premarket approval. Further, because premarket approval had not been granted to any MoM, DePuy could not prove that the patients’ theory of liability obstructed the FDA’s regulatory objectives.
The case is No. 16-11051.
Attorneys: W. Mark Lanier (Lanier Law Firm, PC) for Jay Christopher and Jacqueline Christopher. Paul D. Clement (Kirkland & Ellis, LLP) and John H. Beisner (Skadden, Arps, Slate, Meagher & Flom, LLP) for DePuy Orthopaedics, Inc. and Johnson & Johnson.
Companies: DePuy Orthopaedics, Inc.; Johnson & Johnson
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