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`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF LOUISIANA
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`JESSIE SIMMONS
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`VERSUS
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`CARDINAL HEALTH, INC., et al
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`CIVIL ACTION
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`NO: 20-2174
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`SECTION: “J”(2)
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`ORDER AND REASONS
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`Before the Court is a Motion to Dismiss (Rec. Doc. 9) filed by Defendants,
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`Cardinal Health 200, LLC and Cardinal Health, Inc (collectively “Cardinal Health”).
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`Plaintiff, Jessie Simmons, opposes the motion. (Rec. Doc. 15). Defendants filed a reply
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`(Rec. Doc. 22). Having considered the motion and legal memoranda, the record, and
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`the applicable law, the Court finds that the motion should be GRANTED in part
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`and DENIED in part.
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`FACTS AND PROCEDURAL HISTORY
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`Defendants in this case designed, manufactured, tested, marketed, promoted,
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`and sold a high viscosity bone cement known as Cardinal Health Arthroplasty Bone
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`Cement (hereinafter “Cardinal HV”), which was intended to be used in total knee
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`arthroplasties. The bone cement is used to attach artificial knee joints to the femur
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`and tibia. Bone cement may be low, medium, or high viscosity, but all three types of
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`bone cements have the same intended use and are used interchangeably.
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`On February 28, 2018, Plaintiff received a total knee arthroplasty in which
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`Cardinal HV was used. Plaintiff alleges that he was forced to undergo a revision
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 2 of 10
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`surgery on August 7, 2019 due to the defectiveness of Defendants’ Cardinal HV.
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`Specifically, Plaintiff alleges that Defendants’ Cardinal HV failed due to mechanical
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`loosening. Plaintiff also alleges that high viscosity bone cements, such as Cardinal
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`HV, have been proven worse than lower viscosity bone cements because they fail more
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`often and have an increased risk of mechanical loosing.
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`On August 4, 2020, Plaintiff filed the present action against Defendants,
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`primarily alleging that Defendants violated the Louisiana Products Liability Act
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`(“LPLA”) due to a design defect, construction or composition defect, and breach of
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`express warranty. Plaintiff also alleges that Defendants breached the warranty
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`against redhibitory defects. In response, Defendants filed the instant motion to
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`dismiss.
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`LEGAL STANDARD
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`Under the Federal Rules of Civil Procedure, a complaint must contain “a short
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`and plain statement of the claim showing that the pleader is entitled to relief.” Fed.
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`R. Civ. P. 8(a)(2). The complaint must “give the defendant fair notice of what the
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`claim is and the grounds upon which it rests.” Dura Pharm., Inc. v. Broudo, 544 U.S.
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`336, 346 (2005) (internal citations omitted). The allegations “must be simple, concise,
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`and direct.” Fed. R. Civ. P. 8(d)(1).
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`“Under Rule 12(b)(6), a claim may be dismissed when a plaintiff fails to allege
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`any set of facts in support of his claim which would entitle him to relief.” Taylor v.
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`Books A Million, Inc., 296 F.3d 376, 378 (5th Cir. 2002) (citing McConathy v. Dr.
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`Pepper/Seven Up Corp., 131 F.3d 558, 561 (5th Cir. 1998)). To survive a Rule 12(b)(6)
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 3 of 10
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`motion to dismiss, the plaintiff must plead enough facts to “state a claim to relief that
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`is plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl.
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`Corp. v. Twombly, 550 U.S. 544, 570 (2007)). A claim is facially plausible when the
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`plaintiff pleads facts that allow the court to “draw the reasonable inference that the
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`defendant is liable for the misconduct alleged.” Id. A court must accept all well-
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`pleaded facts as true and must draw all reasonable inferences in favor of the plaintiff.
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`Lormand v. U.S. Unwired, Inc., 565 F.3d 228, 232 (5th Cir. 2009); Baker v. Putnal,
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`75 F.3d 190, 196 (5th Cir. 1996). The court is not, however, bound to accept as true
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`legal conclusions couched as factual allegations. Iqbal, 556 U.S. at 678. “[C]onclusory
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`allegations or legal conclusions masquerading as factual conclusions will not suffice
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`to prevent a motion to dismiss.” Taylor, 296 F.3d at 378.
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`I.
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`DESIGN DEFECT
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`DISCUSSION
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`First, Defendants argue that Plaintiff failed to state a design defect claim
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`because Plaintiff did not allege the existence of an alternative design. After
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`establishing that a product caused damage through a reasonably anticipated use, a
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`plaintiff alleging a design defect must prove: “(1) there existed an alternative design
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`that was capable of preventing the claimant's damage, and (2) the risk avoided by the
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`alternative design outweighed the burden of its adoption by the manufacturer and
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`any adverse effect the alternative design would have on the product's utility.”
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`Marable v. Empire Truck Sales of Louisiana, LLC, 2016-0876 (La. App. 4 Cir.
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`6/23/17), 221 So. 3d 880, 895 (citing LA. REV. STAT. § 9:2800.56).
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`3
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 4 of 10
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`In this case, Plaintiff alleges that a low or medium viscosity bone cement is a
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`safer reasonable alternative design to high viscosity bone cement. (Rec. Doc. 1, at
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`¶26-29). Specifically, Plaintiff alleges that lower viscosity bone cement designs are
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`safer than Cardinal HV because Cardinal HV suffers from “significantly increased
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`variations in application and setting times.” (Rec. Doc. 1, at ¶37). In support of
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`Plaintiff’s allegations, Plaintiff argues that the Orthopaedic Research Society and
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`Journal of Arthroplasty have published research showing that high viscosity bone
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`cement is less effective than lower viscosity bone cement, due to increased risk of
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`failure. (Rec. Doc. 1, at ¶¶ 26-27). In their motion to dismiss, Defendants argue that
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`low or medium viscosity bone cements are not an alternative design to high viscosity
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`bone cements, but instead, they are an entirely different product. (Rec. Doc. 9, at p.
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`5). Thus, this argument turns on where the line is drawn between an alternative
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`design of a product and an entirely different product.
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`In support of their argument, Defendants cite Theriot v. Danek Medical, Inc.,
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`where the Fifth Circuit Court of Appeals examined this issue with regards to the use
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`of pedicle screws for biomechanical stability. 168 F.3d 253, 255 (5th Cir. 1999). In
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`that case, the plaintiff raised two separate arguments. Id. at 255-56. First, the
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`plaintiff argued that all pedicle screws were an alternative design to other classes of
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`product that provide biomechanical stability, “such as external neck braces or
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`internal systems that use hooks or wires.” Id. at 255. The Fifth Circuit rejected this
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`argument, holding that this was an issue with the physician’s choice of treatment,
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`rather than the design of the product. Id. In the alternative, the plaintiff also argued
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 5 of 10
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`that there were alternative pedicle screw designs that would have prevented his
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`injury. Id. Although the Fifth Circuit rejected this argument because it had not been
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`raised to the district court, the Fifth Circuit noted that an alternative pedicle screw
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`design may have existed that supported the plaintiff’s claim. Id. In summary, the
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`Fifth Circuit in Theriot held that different types of products that perform the same
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`function are not alternative designs, but instead, alternative designs are variations
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`in the characteristics of a single type of product. Id. at 255-56.
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`In this case, Plaintiff does not allege that alternatives with the same function
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`could have achieved the same result as bone cements. Instead, Plaintiff argues that
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`a bone cement with a less viscous design would have prevented his injury, which is a
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`characteristic of the bone cement, not an entirely different product. Thus, Plaintiff
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`has sufficiently alleged that lower viscosity bone cements are an alternative design
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`to high viscosity bone cements. Since Plaintiff alleges that lower viscosity designs are
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`a reasonable alternative design with lower risk of mechanical loosening, the Court
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`finds the Complaint plausibly states a design defect claim under the LPLA.
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`II.
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`CONSTRUCTION OR COMPOSITION DEFECT
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`Next, Defendants argue that Plaintiff’s construction or composition defect
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`claim should be dismissed. To survive this motion, Plaintiff must have plausibly
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`alleged Defendants’ specification or performance standards for Cardinal HV and “how
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`the product in question materially deviated from those standards so as to render it
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`unreasonably dangerous.” Lyles v. Medtronic Sofamor Danek, USA, Inc., 871 F.3d
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`305, 311 (5th Cir. 2013). The Complaint asserts that Cardinal HV has “significantly
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`5
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 6 of 10
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`increased variations in application and setting times,” which Plaintiff submits should
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`be sufficient to state a claim for a construction or composition defect. (Rec. Doc. 1, at
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`¶37). However, this quote is prefaced by a comparison to the design used for a
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`competing bone cement known as Palacos, which tends to prove Defendants’ assertion
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`that this quote was in reference to a potential design defect, not a construction or
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`composition defect. (Rec. Doc. 1, at ¶37). In addition, this conclusory reference does
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`not specify the specifications or performance standard of Cardinal HV, nor does it
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`establish how or why the product deviated from those standards. Thus, the Court
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`finds that Plaintiff did not adequately plead a construction or composition defect
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`claim.
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`However, courts in this circuit are “mindful that much of the evidence in
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`pharmaceutical products liability cases may be in the defendant's possession, and
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`thus, without the benefit of discovery, stating more specific allegations may be nearly
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`impossible at this stage.” Lahaye v. AstraZeneca Pharm. LP, No. CIV.A. 14-00111,
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`2015 WL 1935947, at *5 (M.D. La. Apr. 28, 2015). The Court agrees with Plaintiff
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`that it would be nearly impossible to adequately plead a construction or composition
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`defect claim in this case without first conducting discovery regarding the
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`specifications and performance standards of Cardinal HV. Therefore, the Court finds
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`that Plaintiff’s construction or composition defect claim should be dismissed without
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`prejudice, so it may be realleged if new evidence supporting this claim is found during
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`discovery.
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`III. BREACH OF EXPRESS WARRANTY
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 7 of 10
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`Third, Defendants argue that Plaintiff’s breach of express warranty claim
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`should be dismissed. To state a claim for breach of express warranty under the LPLA,
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`a plaintiff must plead that: “(1) there was an express warranty made by the
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`manufacturer about the product; (2) the express warranty induced the plaintiff to use
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`the product; and (3) the plaintiff’s damage was proximately caused because the
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`express warranty was untrue.” Parra v. Coloplast Corp., No. 16-14696, 2017 WL
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`24794, at *4 (E.D. La. Jan. 3, 2017) (citing LA. REV. STAT. § 2:2800.58).
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`Plaintiff alleges that the following representations by Cardinal Health are
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`express warranties:
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`(1) that the Cardinal HV Bone Cements are a safe and effective bone
`cement, with safety and efficiency features similar to other bone
`cements (Rec. Doc. 1, at ¶ 104);
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`(2) that Cardinal HV “provides the mechanical and fatigue strength to
`meet surgeons’ needs. A short waiting time and a long working time
`offer surgeons flexibility during introduction and positioning of the
`implant” (Rec. Doc. 1, at ¶ 35);
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`(3) that Cardinal HV is similar to Palacos, another HV cement, and has
`“[s]imilar handling properties to Palacos® R and Palacos® R+G.”
`(Rec. Doc. 1, at ¶ 36);
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`(4) that Cardinal HV provides the speed and rapid mixing times of high-
`viscosity cement, while also marketing, promoting, and representing
`that Cardinal HV was as strong, safe, and effective as Palacos or non-
`HV cements (Rec. Doc. 1, at ¶ 38).
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`However, “[a] general opinion about or general praise of a product” is not an express
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`warranty. LA. REV. STAT. § 9:2800.53(6). Further, a representation that a product is
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`“safe” is considered general praise of a product, and thus, is not an express warranty.
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`Pierre v. Medtronic, Inc., No. CV 17-12196, 2018 WL 1911829, at *5 (E.D. La. Apr.
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 8 of 10
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`23, 2018) (citing Doe v. AstraZeneca Pharm. LP, No. 15-438, 2015 WL 4661814, at *4
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`(E.D. La. Aug. 5, 2015); Corley v. Stryker Corp., No. 13-2571, 2014 WL 3375596, at *5
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`(W.D. La. May 27, 2014)). In addition, representations made to market a product are
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`not generally considered express warranties. Robertson v. AstraZeneca
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`Pharmeceuticals, LP, No. CIV.A. 15-438, 2015 WL 5823326, at *5 (E.D. La. Oct. 6,
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`2015) (citing Becnel v. Mercedes–Benz USA, LLC, No. 14–0003, 2014 WL 4450431, at
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`*4 (E.D. La. Sept. 10, 2014).
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`The Court agrees with Defendants that representations (1) and (4) are general
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`opinions regarding the safety of the product due to their lack of specificity. Thus,
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`these two representations are not express warranties. On the other hand,
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`representation (2) is not a general opinion; rather, it contains specific descriptions of
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`the products qualities, such as the product’s “mechanical and fatigue strength.”
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`Similarly, representation (3) is also not a general opinion because it specifically
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`describes the handling properties of Cardinal HV by comparing it to the handling
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`properties of Palacos bone cements. However, the Complaint does not specifically
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`allege whether Plaintiff or Plaintiff’s physician heard these representations prior to
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`Plaintiff’s surgery, nor does it allege that they were induced into using Cardinal HV
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`by these representations. Therefore, Plaintiff has failed to state a claim for breach of
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`express warranty, and this claim should be dismissed.
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`IV. MISCELLANEOUS RELIEF
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`Finally, Defendants seek to dismiss: (1) any claims preempted by the LPLA;
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`(2) any claims for personal injury damages under Plaintiff’s claim for breach of the
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 9 of 10
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`warranty against redhibitory defects; (3) any claims for attorney’s fees outside of
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`those permitted to recover pure economic loss in redhibition; and (4) any claims for
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`punitive damages. Plaintiff responds by asserting that the Complaint does not list
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`any claims preempted by the LPLA or any personal injury claims outside of those
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`allowed under the LPLA. Plaintiff also does not oppose the dismissal of any claims
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`for punitive damages or attorney’s fees outside of those allowed under the claim for
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`breach of the warranty against redhibitory defects.
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`The Court agrees that the Complaint does not include any claims preempted
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`by the LPLA or any personal injury claims outside of those allowed under the LPLA.
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`The Court also agrees that Plaintiff’s request for punitive damages and attorney’s
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`fees outside of those permitted under Plaintiff’s claim for breach of the warranty
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`against redhibitory defects should be dismissed.
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`Accordingly,
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`CONCLUSION
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`IT IS ORDERED that Defendants’ Motion to Dismiss (Rec. Doc. 9) is
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`GRANTED in part and DENIED in part.
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`IT IS FURTHER ORDERED that Defendants’ Motion to Dismiss (Rec. Doc.
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`9) is GRANTED as to Plaintiff’s construction or composition defect and breach of
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`express warranty claims. Plaintiffs’ claims alleged in Count III and Count IV of the
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`Complaint are DISMISSED without prejudice.
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`IT IS FURTHER ORDERED that Defendants’ Motion to Dismiss (Rec. Doc.
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`9) is GRANTED as to Plaintiff’s claims for punitive damages and attorney’s fees.
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`9
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`Case 2:20-cv-02174-CJB-DPC Document 23 Filed 11/20/20 Page 10 of 10
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`Plaintiff’s claims for punitive damages and attorney’s fees, except those permitted
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`under Plaintiff’s claim for breach of the warranty against redhibitory defects, are
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`DISMISSED with prejudice.
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`IT IS FURTHER ORDERED that Defendants’ Motion to Dismiss (Rec. Doc.
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`9) is DENIED as to Plaintiff’s design defect claim.
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`New Orleans, Louisiana, this 20th day of November, 2020.
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`CARL J. BARBIER
`UNITED STATES DISTRICT JUDGE
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