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Smith v. Howmedica Osteonics Corp, et al., 17-1174 (E.D. Pa. April 27, 2017) Beetlestone, J. This Court predicts that the Pennsylvania Supreme Court would not bar strict liability claims asserting a manufacturing defect against medical device manufacturers under Comment k. of Restatement 402A and Tincher.

Here, Plaintiffs have plausibly alleged a manufacturing defect strict liability claim. The existence of a manufacturing defect is satisfied by the allegation that the Stryker Gamma 3 Nail System broke down after it was implanted into Mr. Smith, where it was subjected to normal and anticipated use, and that there were no reasonable secondary causes. That it existed at the time it left Defendants’ control is plausibly suggested by the allegation that the product was manufactured and shipped by Defendants to Grand View Hospital, where it was ultimately 11 implanted into Mr. Smith. And causation follows from the allegation that the failure of the Stryker Gamma 3 Nail System necessitated a subsequent surgery to remove it, as well as a total hip replacement, which gave rise to a secondary infection. Therefore, the motion to dismiss the strict liability claim insofar as it asserts a manufacturing defect will be denied.

A close analysis of the Complaint reveals that Plaintiffs have failed to allege facts plausibly giving rise to a negligence claim. First with respect to negligent manufacturing, it is necessary to allege some facts that would plausibly suggest that the manufacturer failed to exercise reasonable care during the “manufacturing process.” Restatement (Second) of Torts § 395. Here, there are no factual allegations that address the manufacturing process. There is only the conclusory allegation that the manufacture of the Stryker Gamma 3 Nail System was negligent, which is precisely the type of merely conclusory statement not entitled to a presumption of truth on a motion to dismiss. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). While Plaintiffs do incorporate the factual allegations made in support of the manufacturing defect strict liability claim – that the product broke following implantation under normal and anticipated use and in the absence of any secondary causes – these are insufficient to state a claim for negligent manufacturing under Pennsylvania law because they solely address the product, and not the Defendants’ conduct. Without any factual allegation as to the nature of what went wrong during the manufacturing process, there is no plausible road to recovery for negligent manufacturing.

Next, with respect to the alleged negligent design of the Stryker Gamma 3 Nail System, the factual allegations are similarly insufficient to survive a motion to dismiss. The only explicit reference to the product’s design is the conclusory allegation that Defendants were negligent in such design. Setting this conclusory statement aside, the remaining factual allegations do not 14 address the design of the Stryker Gamma 3 Nail System in any level of meaningful detail. All that can be gleaned from the Complaint is that the product is a type of “prosthetic implant system” that is implanted into a patient’s leg and hip. From this information, even accepting as true Plaintiffs’ allegation that the product broke after implantation, it cannot be plausibly inferred that Defendants failed “to exercise reasonable care in the adoption of a safe . . . design” as required by Restatement of Torts Section 398. Finally, the Complaint is equally lacking in any factual specificity with regard to the allegation that Defendants were negligent in their failure to warn or to recall.

Having concluded that Plaintiffs’ design defect strict liability claim is not cognizable under Comment k, Defendants’ motion to dismiss will be granted to the extent that the claim for breach of the implied warranty of merchantability asserts a design defect. But having predicted that the Pennsylvania Supreme Court would recognize Plaintiffs’ manufacturing defect strict liability claim, and having concluded that Plaintiffs have pled sufficient facts to support it, the motion to dismiss Count Three will be denied insofar as the breach of the implied warranty of merchantability claim asserts a manufacturing defect.