Opinion ID: 2671875
Heading Depth: 2
Heading Rank: 1

Heading: The Claims at Issue on Appeal

Text: The Appellants challenge only the judgment entered against them on their design-defect claims, which were held to be pre-empted. Before turning to the merits, we need to determine the scope of the claims before us, as some shapeshifting has been attempted. The parties, and particularly the Appellants, have been trying to catch up with precedential developments, most importantly the Supreme Court’s Bartlett decision. Consequently, as more fully described herein, the Appellants’ arguments have changed from their opening to their reply briefs. In their reply brief, the Appellants contend that they preserved their appeal on “all aspects of their design defect claims, including … those based on negligent design theories.” (Appellants’ Reply Br. at 3.) They assert that their negligence-based design-defect claims are grounded on the 11 The Appellants technically appealed the District Court’s order, signed on April 2, 2012, that granted in part and denied in part the plaintiffs’ motion for remand. In that order, the Court dismissed the claims against the Generic Defendants as pre-empted, “[t]o the extent” its previous judgment on the pleadings did not already reach all of the Generic Defendants. (J.A. Vol. 1 at 11.) The Appellants’ arguments focus on, and demonstrate an intention to appeal, only the portion of the order relating to the judgment on the pleadings. We review de novo an order granting judgment on the pleadings pursuant to Rule 12(c) of the Federal Rules of Civil Procedure. Rosenau v. Unifund Corp., 539 F.3d 218, 221 (3d Cir. 2008); Werwinski v. Ford Motor Co., 286 F.3d 661, 665 (3d Cir. 2002). 14 theory that the Generic Defendants were negligent “because of their failure to properly analyze Alendronate Sodium to discover the product’s defects and for negligently continuing to sell Alendronate Sodium after they were, or should have been aware, that it was defectively designed.” 12 (Id. at 13.) The Generic Defendants respond that the Appellants waived any arguments regarding negligence-based designdefect claims by raising them for the first time in their reply brief and that, instead, the only claims on appeal are the Appellants’ strict-liability design-defect claims. We agree. “We have consistently held that ‘[a]n issue is waived unless a party raises it in its opening brief, and for those purposes a passing reference to an issue … will not suffice to bring that issue before this court.’” Ethypharm S.A. France v. Abbott Labs., 707 F.3d 223, 231 n.13 (3d Cir. 2013) (alterations in original) (quoting Laborers’ Int’l Union of N. Am. v. Foster Wheeler Energy Corp., 26 F.3d 375, 398 (3d Cir. 1994)). The Appellants contend that they did raise the issue of negligence in their opening brief, and they point to their Statement of the Issues, which says: “The only issues for this Court’s determination are whether the district court erred when it granted the [G]eneric [Defendants’] motion to dismiss on the basis of federal preemption as to plaintiffs’ 12 The Appellants do not identify which count in their complaint allegedly constitutes their negligence-based designdefect claim, but Count XI, titled “NEGLIGENCE,” is the only one pled against the Generic Defendants that seems to fit that description. (J.A. Vol. 2 at 74.) 15 design defect claims.” 13 (Appellants’ Opening Br. at 2.) The idea, it seems, is that the words “design defect claims” are broad enough to encompass negligence-based design-defect claims. However, the Appellants’ Summary of the Argument in their opening brief states more specifically that “[t]he district court erred in dismissing appellants’ risk-utility based design defect claims.” (Id. at 9 (emphasis added).) Count IX, titled “STRICT LIABILITY – DEFECTIVE DESIGN,” is the only design-defect claim against the Generic Defendants brought under a risk-utility based theory, specifically that the “foreseeable risks exceeded the benefits associated with [alendronate sodium’s] design or formulation” and that alendronate sodium “lacked efficacy and/or posed a greater likelihood of injury than other osteoporosis treatments.” 14 13 The Appellants misidentify the motion for judgment on the pleadings as a motion to dismiss in that statement. 14 Count IX alleges, in part: 232. When placed into the stream of commerce, ALENDRONATE SODIUM was defective in its design or formulation and was unreasonably dangerous in that its foreseeable risks exceeded the benefits associated with its design or formulation. When placed into the stream of commerce, ALENDRONATE SODIUM was defective in design or formulation in that it lacked efficacy and/or posed a greater likelihood of injury than other osteoporosis treatments on the market and was more dangerous than ordinary consumers or their physicians could reasonably foresee or anticipate. 16 (J.A. Vol. 2 at 69-70.) It is also the only count from the Appellants’ complaint that they mention in their opening brief. Nowhere in the opening brief do they raise any arguments specific to a negligence-based design-defect claim or, for that matter, make any reference to such a claim at all. 15 233. Alternatively, when placed into the stream of commerce, ALENDRONATE SODIUM was defective in design and was unreasonably dangerous in that its label failed to warn physicians and patients of the dangers associated with long-term use of bisphosphonates, including, but not limited to the risk of severely suppressed bone turnover, brittle bones and a greater susceptibility to stress fractures or long bone fractures; and the label failed to instruct physicians and patients about the limited length of time ALENDRONATE SODIUM was actually effective in preventing fractures. (J.A. Vol. 2 at 69-71.) 15 The shift to negligence-based arguments in the Appellants’ reply brief is not surprising given that the Supreme Court’s Bartlett decision – which, as discussed below, addressed strict-liability design-defect claims – issued during the pendency of this appeal. According to the Generic Defendants, “[t]he bottom line … is that [the Appellants] placed their bets on the First Circuit’s Bartlett decision [that credited the theory embraced by the Appellants in their opening brief] … and they lost.” (Appellees’ Br. at 3.) After the Supreme Court overturned the First Circuit’s Bartlett 17 Therefore, fairly read, that brief is limited to the risk-utility based strict-liability design-defect claim set forth in Count