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proximity between the knee injections she received and her injuries, which was insufficient to meet her obligation to plead the necessary causation element of her claims. Id. at *6.
While some members of the plaintiff’s bar may view the decision as a victory because the court did not hold plaintiffs to a heightened pleading standard in the context of medical devices, the decision cuts both ways. The court required the plaintiff to plead more than just mere temporal proximity between her knee injections and alleged injuries, which is often enough in product liability cases outside the context of medical devices. Moreover, the decision should be encouraging to the corporate defense bar because the court rejected plaintiff’s argument that she should be entitled to discovery in light of the disparity of information, which often presents a barrier in a medical device case.
Absent the benefit of discovery, or at least different, more compelling facts, it is difficult to conceive how the Dunn plaintiff could have plead sufficient facts to satisfy the causation element. Cf. Mink, 860 F.3d
at 1329 (hip replacement manufacturing defect claim properly pled where plaintiff alleged that he had “immediate and toxic levels of chromium and cobalt in his blood from the date of surgery.”). On the other hand, one might argue from a corporate perspective that had the court taken the path of least resistance, simply opening the door to burdensome and costly discovery on such bare allegations, the impact would have been a stifling of ingenuity and disincentive to the continued development of important, novel medical devices. In that way, Dunn strikes a fair balance between the interests at play in the MDA and Twombly.
Until there is a resolution by the United States Supreme Court of the split in authority in this important area of the law, the interplay between the MDA and Twombly will remain uncertain. In the meanwhile, Dunn represents a sensible approach for courts grappling with the difficult, unresolved issue of the level of specificity necessary to sufficiently plead a parallel claim in the context of product liability claims related to medical devices.
Peter M. Durney is an FDCC Defense Counsel Member at Cornell & Gollub in Boston, MA. He was assisted in writing this article by Christopher J. Hurst. Contact them at pdurney@cornellgollub.com and churst@cornellgollub.com.
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