Harrison v. Medtronic

Case: 22-10201 Document: 00516568526 Page: 1 Date Filed: 12/06/2022
United States Court of Appeals
for the Fifth Circuit United States Court of Appeals
Fifth Circuit
FILED
December 6, 2022
No. 22-10201 Lyle W. Cayce
Clerk
Dennis Harrison; Susan Harrison,
Plaintiffs—Appellants,
versus
Medtronic, Incorporated,
Defendant—Appellee.
Appeal from the United States District Court
for the Northern District of Texas
USDC No. 3:20-CV-1407
Before Higginbotham, Duncan, and Engelhardt.
Per Curiam:*
When a pacemaker allegedly malfunctioned and caused the plaintiff’s
cardiac arrest, he sued the manufacturer on various products liability and
implied warranty claims. The district court dismissed all the plaintiff’s
claims, concluding the allegations in his third amended complaint were
insufficient. We agree with the district court that the plaintiff failed to plead
valid manufacturing and marketing defect claims under Texas law. But we
*
This opinion is not designated for publication. See 5th Cir. R. 47.5.
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disagree with respect to the plaintiff’s design defect claim and his implied
warranty claim, which the plaintiff supported with adequately specific
allegations. Accordingly, we affirm in part and reverse and remand in part.
I.
In August 2017, Plaintiff Dennis Harrison underwent heart surgery, in
which doctors implanted an external pulse generator (“EPG”), a type of
pacemaker manufactured by Defendant Medtronic. A day after the surgery,
Harrison went into cardiac arrest, requiring medical staff to resuscitate him
by performing CPR and shocking him. Although medical staff saved his life,
Harrison alleges the cardiac arrest has left him with permanent injuries,
including chest pains and neurological deficits.
Harrison and his wife Susan (we refer to them together as
“Harrison”) sued Medtronic, claiming the company’s EPG caused the
cardiac arrest by firing a mistimed electrical pulse in between Harrison’s
heartbeats. Harrison claims this malfunction was caused by the EPG’s loose
battery or a corroded lead-connector. He therefore brought products liability
claims, under both strict liability and negligence, for manufacturing,
marketing, and design defects, and a separate claim for breach of the implied
warranty of merchantability.
After Harrison served his second amended complaint, Medtronic
moved to dismiss for failure to state a claim. The district court granted the
motion, with its order identifying the pleading’s factual deficiencies. By leave
of court, Harrison was then allowed to file a third amended complaint.
The district court found the third amended complaint substantially
similar to the second, with the only difference being two new factual
allegations concerning the EPG’s allegedly defective design. The new
allegations are that (1) the EPG’s battery should have been secured by a clip
or phalange to prevent power malfunctions, and (2) the EPG’s lead
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connector should have been made from a non-corrosive metal. The court
found that these new allegations were conclusory and insufficiently specific,
and consequently that the third amended complaint also failed to plead all
essential elements of Harrison’s claims. The court thus dismissed the
complaint, this time with prejudice. Harrison timely appealed.
II.
We review de novo the grant of a motion to dismiss under Rule
12(b)(6), accepting all well-pleaded facts as true and viewing them in the light
most favorable to the plaintiff. Retana v. Twitter, Inc., 1 F.4th 378, 380 (5th
Cir. 2021). To survive such a motion, a plaintiff’s “[f]actual allegations must
be enough to raise a right to relief above the speculative level . . . on the
assumption that all the allegations in the complaint are true (even if doubtful
in fact)[.]” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citation
omitted). Although a complaint need not allege facts in minute detail, it must
allege “‘more than labels and conclusions,’ as ‘a formulaic recitation of the
elements of a cause action will not do.’” Heinze v. Tesco Corp., 971 F.3d 475,
479 (5th Cir. 2020) (quoting Twombly, 550 U.S. at 555)). Finally, while our
review is generally limited to allegations on the face of the pleadings, we
“may consider documents attached to or incorporated in the complaint.”
United States ex. rel. Willard v. Humana Health Plan Tex. Inc., 336 F.3d 375,
379 (5th Cir. 2003).
III.
Harrison brings products liability claims for manufacturing,
marketing, and design defects (both of the strict liability and negligence
varieties). He also brings a claim for breach of the implied warranty of
merchantability. We address those two groups of claims separately.
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A.
We turn first to Harrison’s strict products liability claims. To prevail
on such claims under Texas law, a plaintiff must show: (1) a defective product
that (2) was unreasonably dangerous, (3) did not substantially change from
its original condition when it reached the consumer, and (4) caused the
plaintiff’s injuries. Syrie v. Knoll Int’l, 748 F.2d 304, 306 (5th Cir. 1984); see
Am. Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420, 426 (Tex. 1997).1 Texas
recognizes three types of product defects: “marketing, design, and
manufacturing.” Cooper Tire & Rubber Co. v. Mendez, 204 S.W.3d 797, 800
(Tex. 2006). Harrison alleges that Medtronic’s EPG suffers from all three
kinds of defects. We agree with the district court that Harrison failed to plead
viable manufacturing or marketing claims, but we disagree with respect to his
design claim.
1.
To allege a manufacturing defect, a plaintiff must plead that a
“product deviates, in its construction or quality, from the specifications or
planned output in a manner that renders it unreasonably dangerous.” Casey
v. Toyota Motor Eng’g & Mfg. N. Am., Inc., 770 F.3d 322, 326 (5th Cir. 2014).
The “touchstone” of such a claim “is proof that the allegedly defective
product differs from other products in the same product line.” Id. at 329.
Harrison concedes he failed to allege a specific manufacturing defect. That is
for good reason: his third amended complaint claims only that the EPG “may
1
By contrast, a claim of negligent products liability requires only that we “look[] at
the act of the manufacturer and determine[] if it exercised ordinary care.” Garrett v.
Hamilton Standard Controls, Inc., 850 F.2d 253, 256 (5th Cir. 1988) (quoting Syrie, 748 F.2d
at 307). Despite these different showings, a negligence claim still presupposes a
“defective” product. Id. at 257. Consequently, our conclusion with respect to the strict
liability claims—which turns on whether Harrison adequately pleaded a particular defect—
controls our disposition of the negligence claims. See infra p. 4–9.
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have contained a manufacturing defect,” without identifying anything
specific or even alleging the device deviated from Medtronic’s specifications.
Pleading the “mere possibility of misconduct” does not suffice. Ashcroft v.
Iqbal, 556 U.S. 662, 679 (2009).
Harrison instead argues res ipsa loquitur (“the thing speaks for itself”),
an evidentiary rule that allows a factfinder to infer a defendant’s negligence
from the “circumstances surrounding the accident.” Haddock v. Arnspiger,
793 S.W.2d 948, 950 (Tex. 1990). But our court has explained that merely
“rel[ying] on res ipsa loquitur” is not a valid substitute for shouldering the
burden of specifying a manufacturing defect. See Funk v. Stryker Corp., 631
F.3d 777, 782 (5th Cir. 2011). That is because “Texas law does not generally
recognize a product failure or malfunction, standing alone, as sufficient proof
of a product defect.” Casey, 770 F.3d at 326; see Cooper Tire, 204 S.W.3d at
807 (“The mere fact that the [product] failed would amount to evidence of a
manufacturing defect so slight as to make any inference a guess and is in legal
effect no evidence.”) (cleaned up).2 The district court thus correctly found
that Harrison failed to allege a manufacturing defect.
2.
Harrison’s marketing defect claim fails for similar reasons. A
marketing defect exists “when a defendant knows or should know of a
potential risk of harm presented by a product” but fails to adequately warn
buyers. Wright v. Ford Motor Co., 508 F.3d 263, 274 (5th Cir. 2007) (citation
2
Res ipsa loquitur is also a poor fit here because it only applies when the product is
in the “control of the defendant.” Pearson v. BP Prods. N. Am., Inc., 449 F. App’x 389, 391
(5th Cir. 2011). Harrison pleads that his doctor, not Medtronic, inserted the pacemaker,
conceding the device was outside Medtronic’s control when it allegedly malfunctioned.
See also, e.g., Tyre v. Excel Indus., Inc., No. 4:19-CV-951-A, 2020 WL 791052, at *5 (N.D.
Tex. Feb. 14, 2020) (holding that res ipsa loquitur is inapplicable in a products-liability claim
when the product was in the user’s possession, not the defendant’s).
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omitted); see Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 382 (Tex. 1995). The
hallmark of this claim is that the “lack of adequate warnings or instructions
renders an otherwise adequate product unreasonably dangerous.” Smith v.
Robin Am., Inc., 484 F. App’x 908, 912 (5th Cir. 2012) (quoting Ranger
Conveying & Supply Co. v. Davis, 254 S.W.3d 471, 480 (Tex. App.—Houston
[1st Dist.] 2007, pet. denied)). Usually, the adequacy of a defendant’s
warning is a question of fact, but “if a warning specifically mentions the
circumstances complained of, then the warning is adequate as a matter of
law.” Hale v. Metrex Rsch. Corp, 963 F.3d 424, 428 (5th Cir. 2020) (quoting
Seifried v. Hygenic Corp., 410 S.W.3d 427, 433 (Tex. App.—Houston [1st
Dist.] 2013, no pet.)).
Harrison’s complaint mostly parrots the legal elements of a marketing
defect claim, without identifying which of Medtronic’s warnings were
allegedly defective. General allegations—such as that the “warnings failed to
inform the user of the nature of the danger”—do not meet the pleading
standard. See, e.g., Fearrington v. Bos. Sci. Corp., 410 F. Supp. 3d 794, 802
(S.D. Tex. 2019) (dismissing complaint because it only “allege[d] generally”
that defendant failed to provide adequate warnings). Harrison’s only specific
allegations are really design-defect claims in disguise. For instance, he claims
Medtronic should have warned doctors that the device’s lead connector
could result in malfunction. But this allegation does not claim the warning, or
lack thereof, renders this “otherwise adequate [pacemaker] unreasonably
dangerous.” Smith, 484 F. App’x at 912 (quotation omitted). The claim is
rather that Medtronic’s design using lead, instead of a less-corrosive metal,
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rendered the pacemaker inherently dangerous.3 That is a design claim, not a
marketing claim.
3.
Harrison’s complaint does sufficiently plead a design defect claim,
however. Such a claim requires allegations that: (1) the product’s defective
design made it unreasonably dangerous; (2) a safer alternative design existed;
and (3) the defect caused the alleged injury. Casey, 770 F.3d at 330 (citing
Goodner v. Hyundai Motor Co., 650 F.3d 1034, 1040 (5th Cir. 2011)). To
overcome a 12(b)(6) motion to dismiss, a plaintiff need not provide “detailed
factual allegations” proving each element, but only enough “‘to raise a
reasonable expectation that discovery will reveal evidence of’ the necessary
claims or evidence.” In re S. Scrap Material Co., 541 F.3d 584, 587 (5th Cir.
2008) (quoting Twombly, 550 U.S. at 556).
The third amended complaint satisfies that standard. Harrison
pleaded the EPG was defectively designed because (1) its battery did not
maintain constant connection with the battery drawer, and (2) its lead
connector had a propensity to, and did, corrode. These defects, he alleged,
caused the EPG to fire a mistimed electrical impulse in between his
heartbeats which caused his cardiac arrest. Harrison also alleged that the
3
The district court alternatively concluded that Medtronic’s warnings were
adequate as matter of law since its product manual explicitly warned of the EPG’s battery
failure and potential lead-connector problems. Since Harrison referenced the EPG’s
warnings in his complaint and Medtronic attached the technical manual containing the
warnings to its motion to dismiss, the district court can properly review the manual. See
Sullivan v. Leor Energy, LLC, 600 F.3d 542, 546 (5th Cir. 2010) (“[T]he court may consider
documents attached to a motion to dismiss that ‘are referred to in the plaintiff’s complaint
and are central to the plaintiff’s claim.’” (quoting Scanlan v. Tex. A&M Univ., 343 F.3d
533, 536 (5th Cir. 2003))). Harrison fails to challenge on appeal the district court’s
conclusion that Medtronic’s warnings were legally sufficient, so he has forfeited the issue.
See Rollins v. Home Depot¸8 F.4th 393, 397–98 & n.1 (5th Cir. 2021).
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EPG was unreasonably dangerous because Medtronic could have mitigated
this risk either by inserting a clip to hold the battery or by using a silver or
copper connector less prone to corrosion. Those allegations sufficiently plead
a design defect claim by alleging how the product’s design caused it to fail,
how the failure caused his injury, and how Medtronic could have designed a
safer product.4 In response, Medtronic contends that Harrison’s allegations
are mere “speculation” thrown against the wall “in the hope one theory
might stick.” We disagree. At this stage, we must take Harrison’s claims as
true, and, viewing them as such, they sufficiently allege a design defect claim
under Texas law.
The district court rejected Harrison’s design defect claims because his
complaint did not include a “substantive evaluation” of the EPG’s risks
versus benefits, nor specifically allege safer alternative designs that are
economically and technically feasible. We disagree. Harrison’s complaint
specified alternative designs that he claimed are both safer and feasible and
that, by not using them, the EPG was unreasonably dangerous. That is
enough at the pleading stage. Harrison’s complaint did not need to include
additional specificity with respect to proposed alternative designs.5 Those
“very detailed and specific allegations” can wait until Harrison has an
“opportunity for discovery.” Flagg, 647 F. App’x at 318; cf. Casey, 770 F.3d
4See, e.g., Flagg v. Stryker Corp., 647 F. App’x 314, 318 (5th Cir. 2016) (under a
similar Louisiana law, finding validly pleaded design defect where the complaint alleged
manufacturer could have used a different metal alloy); Ardoin v. Stryker Corp., 2019 WL
4933600, at *2 (S.D Tex. Oct. 7, 2019) (finding validly pleaded design defect where
complaint alleged bone screws were designed with defects in their metallurgical integrity).
5
See, e.g., Ardoin, 2019 WL 4933600, at *3 (holding “[p]laintiff’s allegations that
the components could have been alternatively designed in a safer manner such that they
did not contain discrepancies or metallurgical weaknesses must be accepted as true” on a
12(b)(6) motion).
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at 330–336 (balancing the tradeoffs of an alternative design at summary
judgment after discovery).
We therefore reverse the district court’s dismissal of Harrison’s
design-defect claim.6
B.
Finally, we turn to Harrison’s claim for breach of implied warranty of
merchantability, which the district court also dismissed. Under Texas law,
merchants implicitly warrant that their goods are not defective. See Gen.
Motors Corp. v. Brewer, 966 S.W.2d 56, 57 (Tex. 1998). To recover on such a
claim, a buyer must notify the seller “within a reasonable time after he
discovers or should have discovered” any defect. McKay v. Novartis Pharm.
Corp., 751 F.3d 694, 705 (5th Cir. 2014) (quoting Tex. Bus. & Com.
Code § 2.607(c)(1)). The reasonableness of notice “is ordinarily a question
of fact,” but notice can be unreasonable as a matter of law if no reasonable
mind could disagree that the notice was untimely. Ameristar Jet Charter, Inc.
v. Signal Composites, Inc., 271 F.3d 624, 628 (5th Cir. 2001).
The district court found that Harrison’s implied warranty claim failed
for two independent reasons. First, the court concluded Harrison’s failure to
plead a defect was also fatal to his implied warranty claim. But, as discussed,
Harrison did sufficiently plead a design defect, so his implied warranty claim
cannot be dismissed on this basis.
6
As explained supra note 1, Harrison’s negligence-based products liability claims
also depend on adequately alleging one of the three kinds of product defects. Garrett, 850
F.2d at 257. Given our conclusion that Harrison properly alleged only a design defect claim,
we reverse the district court’s judgment as to that negligence claim only. We affirm as to
Harrison’s negligence claims based on alleged manufacturing and marketing defects.
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Separately, the court found that Harrison’s notice to Medtronic was
so untimely that his warranty claim failed as a matter of law. We disagree
because the court based its ruling on assumptions not warranted on a motion
to dismiss. It found that Harrison informed Medtronic of the alleged defect
in a July 2019 letter. Because Harrison plead the EPG was the only
explainable cause for his cardiac arrest, the court assumed he must have
known the device was defective when it malfunctioned in August 2017. But
Harrison alleges he realized the EPG was defective only based on his
cardiologist’s testimony, which occurred sometime after the malfunction.
We must accept that plausible allegation as true at this stage. See Masel v.
Villarreal, 924 F.3d 734, 743 (5th Cir. 2019). Furthermore, even assuming
Harrison should have known the EPG was defective at the time of his cardiac
arrest, Medtronic does not explain why a delay of less than two years is so
unreasonable that the question must be removed from the factfinder. By
failing to establish when Harrison “discovered the breach” and “why the
period between [Harrison’s] discovery of the breach and his giving notice was
unreasonable,” we cannot conclude Harrison’s notice was so unreasonable
it fails as a matter of matter of law. Ketter v. ESC Med. Sys. Inc., 169 S.W.3d
791, 799–800 (Tex. App.—Dallas 2005, no pet.) (concluding a two year and
seven-month delay from plaintiff’s receipt of the product to when notice was
provided was not unreasonable as a matter of law).
Ultimately, of course, Harrison still bears the burden to show he did
not unreasonably delay notice to Medtronic. See McKay, 751 F.3d at 705. But
viewing the facts in his favor, as we must do at this stage, we conclude that
Harrison alleged a valid implied warranty claim.
IV.
Medtronic separately argues that we should affirm the district court’s
judgment on alternative grounds because Harrison failed to disclose experts
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by the district court’s deadline, and, without experts, he cannot prove his
claims. But our “powers are limited to reviewing issues raised in, and decided
by, the [district] court.” Companion Prop. & Cas. Ins. Co. v. Palermo, 723 F.3d
557, 561 (5th Cir. 2017) (alteration and emphasis in original) (citation
omitted). Whether Harrison has run out of time to designate experts is a
question better addressed by the district court in the first instance. Harrison
previously moved to extend the expert-designation deadline, but the district
court dismissed his case before deciding whether good cause warranted an
extension. We therefore remand the case to the district court to consider that
question and any other questions the court and the parties deem pertinent.
V.
For the foregoing reasons, the district court’s judgment is
AFFIRMED IN PART, REVERSED IN PART, and REMANDED
for further proceedings consistent with this opinion.
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