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