[brief] THE TRIAL COURT COMMITTED A MISCARRIAGE OF JUSTICE IN ALLOWING PLAINTIFF’S MANUFACTURING-DEFECT CLAIM WITHOUT ANY PROOF THAT THE SPECIFIC PRODUCT AT ISSUE HAD THE ALLEGED DEFECT.  [ISSUE WAS RAISED (DA0785; DA0816; DA0846)]  “Courts must concern themselves with both weeding out frivolous claims and insuring that cases are sent to a jury where a reasonable man could find that a defect existed while the product was in the control of the manufacturer. ”  \textit{Scanlon v. General Motor Corp.}, 65 N.J. 582, 590 n.1 (1974).  Contrary to this Supreme Court directive, the Trial Court is allowing Plaintiff to proceed to trial without evidence that the product had a defect or the purported defect caused her harm.  New Jersey law requires expert proof on these essential elements, and Plaintiff’s experts wholly fail to supply it.  Using “recall” as a substitute for competent evidence of a manufacturing defect in Plaintiff’s Ozurdex® unit cannot fill this evidentiary void.  \textsuperscript{13}  Even if this claim was cognizable under the PLA and not preempted by federal law, the claim is still ripe for summary judgment because, as explained below, there is zero proof the product at issue had a defect that was capable of causing Plaintiff’s injuries.  As a matter of law, [...] had no duty to recall, recall sooner, or warn about a non-existent defect incapable of causing harm.  A.  Plaintiff Has the Burden to Prove Defect and Causation Through Qualified and Reliable Expert Testimony.  [ISSUE WAS RAISED (Da0785; Da0816; Da0846)]  To get past summary judgment on her PLA claim, Plaintiff must have evidence to prove (1) the product had a defect that (2) existed when it left the manufacturer’s control and (3) caused the plaintiff’s injuries.  *Myrlak v. Port Auth.*, 157 N.J. 84, 97 (1999).  Plaintiff alleges the Ozurdex® administered to her on November 6, 2018 had a manufacturing defect.  Accordingly, under the PLA, she must prove that specific Ozurdex® unit deviated “from [its] design specifications, formulae, or performance standards. ”  N.J.S.A. § 2A:58C-2a.  When a PLA claim concerns a complex product beyond jurors’ common knowledge, like a prescription drug or medical device, expert testimony is required to establish product defect and causation.  *Davis*, 219 N.J. at 407 (explaining that jurors impermissibly speculate without expert testimony where the subject matter is beyond their common knowledge); *Butler v. Acme Markets, Inc.*, 89 N.J.  279, 283 (1982) (stating expert testimony is necessary where the matter “is so esoteric that jurors of common judgment and experience cannot form a valid judgment”). --- 14 See also *Schweiger v. Standard Tile Supply, Co.*, 2019 WL 5783478, at *3 (N.J. Super. App. Ct. Nov. 6, 2019) (expert needed to prove complex product (ready-to-use plasma grout) was defective); *In re Phenylpropanolamine (PPA)*, 2003 WL 22417238, at *20 (N.J. Super. Ct. July 21, 2003) (expert required to show chemical ingestion caused harm); *McMillan v. Johnson & Johnson*, 2005 WL 20000203, at *3 (D.N.J. Aug. 19, 2005) (expert required for complex medical device); *In re Mirena IUD Prods. Liab. Litig.*, 202 F. Supp. 3d 304, 311 (S.D.N.Y. 2016) B. The Trial Court Wrongly Denied Summary Judgment Despite Plaintiff’s Complete Lack of Proof of a Manufacturing Defect.