Plaintiff Avoids Preemption and Twombly in Parallel
The Fifth Circuit has held in Bass v. Stryker that plaintiff's claim against the manufacturer of an allegedly defective hip replacement device is not preempted by the Medical Device Amendments of 1976 to the FDCA, and that his complaint satisfies Twombly. Because plaintiff's allegation "paralleled" an FDA manufacturing practice and asserted that the "good" practice was not followed, resulting in a device that did not work as contemplated causing his injuries, the lower court's dismissal of plaintiff's manufacturing defect, negligence and implied warranty claims was reversed.
The manufacturing practice at issue involved ensuring that the "final wash" was not contaminated so that the device would not become "adulterated". Were the wash to be so contaminated the microbes could set up shop on the device, in this case the ceramic shell, and prevent the bony ingrowth that would otherwise help secure the implant. Some months before this particular device was implanted the FDA had warned the manufacturer that it had not implemented necessary changes to the final wash portion of its manufacturing process and further had failed to verify that the wash met the standards for bioburden. Though Bass had not specifically plead that his device (which had been recalled) was contaminated, nor that doctors removing it had found evidence of an infectious process, the pleading was nevertheless sufficient to put Stryker on notice as to just what it was that plaintiff was claiming.
The bottom line is that if a plaintiff can find a way to turn a design defect into a manufacturing defect (e.g. claiming the device as manufactured was contaminated rather than claiming that the design failed to include an anti-bacterial agent) by finding a potential for variance in the manufacturing process, and then plead a plausible nexus between the resultant device and her injury, she ought at least be able to make it to the discovery stage.
