even if the Amended Complaint were fairly read to assert a claim of design defect based solely on the optional metal liner, any such claim would be preempted. That is because the optional metal liner received supplemental PMA approval in conjunction with the BHR System. As noted, design defect claims regarding a PMA-approved device are squarely preempted by the MDA.
There are no concrete factual allegations to support the claim that the R3 Acetabular System was defective as designed. To the extent that the Amended Complaint implies that the inclusion of an optional metal liner in that system rendered it defective, that claim is defeated by the fact that the R3 Acetabular System, as reviewed and approved by the FDA, did not contain any such liner.
Without concrete allegations tying Smith & Nephew to the decision to make such use of the optional metal liner component, however, this conduct does not state a claim for strict products liability, let alone on a design defect theory.
The Amended Complaint contains a long list of conclusory allegations as to the ways in which Smith & Nephew was purportedly negligent in designing the R3 Acetabular system. . . .But the Amended Complaint does not contain any concrete factual allegations to back up these legal conclusions. In short, there are not specific allegations plausibly indicating that the R3 Acetabular System was defective or that Smith & Nephew breached a duty of care; the Amended Complaint instead is limited to rote incantations of the elements of negligent manufacture.