Mullins et al v. Johnson & Johnson et al

Filing 1881

MEMORANDUM OPINION AND ORDER It is ORDERED that 1) The plaintiffs in this consolidated trial may present evidence of one or more products liability theories available under West Virginia law, but only the theories sufficiently supported by the e vidence admitted at trial may be submitted to the jury, 2) Evidence that an alternative surgical procedure should have been used in place of the TVT device is not an alternative, feasible design as a matter of law, 3) A polypropylene suture is not an alternative, feasible design for the TVT device as a matter of law, 4) Once the court determines that the plaintiffs have provided sufficient evidence to identify a comparable product or design concept, whether the design features of the comp arable product or the design concept existing at the time of the TVT's manufacture is an alternative, feasible design for the TVT is a factual question left to the jury, 5) Under West Virginia law, the plaintiffs are not required to provide e vidence of an alternative, feasible design under a negligence theory of products liability, 6) The plaintiffs may proceed under the malfunction theory of strict products liability, and 7) Under West Virginia law, the plaintiffs are not required to produce evidence of an alternative, feasible design under the malfunction theory. Signed by Judge Joseph R. Goodwin on 2/23/2017. (cc: counsel of record; any unrepresented party) (ts)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
TERRESKI MULLINS, et al.,
Plaintiffs,
v.

CIVIL ACTION NO. 2:12-cv-02952

JOHNSON & JOHNSON, et al.
Defendants.

MEMORANDUM OPINION AND ORDER
On February 14, 2017, I directed the parties to submit simultaneous briefing
regarding the contours of what an alternative, feasible design can be under West
Virginia law. I asked the parties to cover this issue as broadly as possible, taking into
consideration the multiple tort theories available to a plaintiff under West Virginia
law. On February 20, 2017, the parties filed their respective briefs [ECF Nos. 1867 &
1868]. On February 21, 2017, the parties filed their respective responses [ECF Nos.
1872 & 1873]. This Order will discuss many of the legal arguments made by the
parties in their briefing and at the February 22, 2017, final pretrial conference.
I.

Multiple Products Liability Theories
West Virginia law permits plaintiffs to submit multiple products liability

theories to the jury. The Supreme Court of Appeals of West Virginia has determined
the following:

Product liability actions may be premised on three independent
theories—strict liability, negligence, and warranty. Each theory
contains different elements which plaintiffs must prove in order to
recover. No rational reason exists to require plaintiffs in product
liability actions to elect which theory to submit to the jury after the
evidence has been presented when they may elect to bring suit on one or
all of the theories.
Syl. pt. 6, Ilosky v. Michelin Tire Corp., 307 S.E.2d 603, 605 (W. Va. 1983) (emphasis
added). Additionally, the West Virginia Pattern Jury Instructions (“PJI”), § 401,
enumerates the three separate theories available to a plaintiff in a products liability
case. Further, the PJI establishes different elements for each products liability
theory. See generally W. Va. P.J.I. § 401, et seq. Accordingly, I FIND that the
plaintiffs in this consolidated trial may present evidence on one or more products
liability theories available under West Virginia law, but only the theories sufficiently
supported by the evidence admitted at trial may be submitted to the jury.1

I note that West Virginia law on this point is inconsistent with the Restatement (Third) Torts:
Products Liability § 2. See Restatement (Third) of Torts: Products Liability § 2 cmt. n (Am. Law Inst.
1998) (“[T]wo or more factually identical defective-design claims or two or more factually identical
failure-to-warn claims should not be submitted to the trier of fact in the same case under different
doctrinal labels. Regardless of the doctrinal label attached to a particular claim, design and warning
claims rest on a risk-utility assessment. To allow two or more factually identical risk-utility claims to
go to a jury under different labels, whether ‘strict liability,’ ‘negligence,’ or ‘implied warranty of
merchantability,’ would generate confusion and may well result in inconsistent verdicts. In
proceedings in which multiple theories are alleged, the Restatement leaves to local law the question
of the procedural stage in a tort action at which plaintiff must decide under which theory to pursue
the case.”). This inconsistency exists because West Virginia, unlike the Restatement (Third), applies
different elements of proof to different products liability theories. Syl. pt. 6, Ilosky, 307 S.E.2d at 605;
see also Restatement (Third) of Torts: Products Liability § 2 cmt. n (“The rules are stated functionally
rather than in terms of traditional doctrinal categories. . . . As long as these requisites are met,
doctrinal tort categories such as negligence or strict liability may be utilized in bringing the claim.”).
1

2

II.

Alternative, Feasible Design
I am convinced that an alternative, feasible design must be examined in the

context of products—not surgeries or procedures. The Fourth Circuit, in applying
Virginia law, has addressed this issue squarely. In Talley v. Danek Med., Inc., 179
F.3d 154 (4th Cir. 1999), the Court evaluated an expert’s theory that spinal fixation
screws were defective because spinal fusion procedures with the screws were not more
successful than spinal fusion procedures without the screws. The Court ruled as
follows:
This testimony, however, did not indicate any design flaw in the DynaLok Device. Rather, it questioned the medical judgment of doctors who
use spinal fixation devices in surgery. While such an opinion might be
relevant in a malpractice suit against a doctor, it is irrelevant in a suit
against the product manufacturer. Thus, the district court did not abuse
its discretion in refusing to consider this evidence in a suit against the
manufacturer of a spinal fixation device. In summary, we agree with the
district court’s conclusion that Talley has failed to come forth with
admissible evidence which would permit a jury to conclude that the
Dyna-Lok Device was defectively designed.

Talley, 179 F.3d at 162. I am persuaded by the reasoning in Talley.2
Evidence that a surgical procedure should have been used in place of a device
is not an alternative, feasible design in relation to the TVT. Whether an alternative
procedure could have been preformed without the use of the TVT does nothing to

The Fifth Circuit has reached the same conclusion. See Theriot v. Danek Med., Inc., 168 F.3d 253,
255 (5th Cir. 1999) (“Theriot therefore argues that other products that do not use pedicle screws should
be considered as alternative designs, such as external neck braces or internal systems that use hooks
or wires. Underlying this argument is the assumption that all pedicle screws are defective and there
can be no system using pedicle screws that would be an acceptable product. The problem with this
argument is that it really takes issue with the choice of treatment made by Theriot’s physician, not
with a specific fault of the pedicle screw sold by Danek.”).
2

3

inform the jury on the issue of an alternative, feasible design for the TVT. Instead,
alternative surgeries or procedures raise issues wholly within the context of what a
treating physician has recommended for patients based on the individual needs and
risk factors associated with individual patients. In other words, alternative surgeries
or procedures concern the medical judgment of the doctors who use TVT devices to
treat stress urinary incontinence (“SUI”); other surgeries or procedures do not inform
the jury on how the TVT’s design could have feasibly been made safer to eliminate
the risks that caused the plaintiffs’ injuries. See Talley, 179 F.3d at 162; W. Va. P.J.I.
§ 411.
The plaintiffs have also argued that polypropylene sutures should be
considered an alternative, feasible design for the TVT. The basis of their argument is
that the TVT device is essentially made up of woven-together sutures, forming a midurethral sling. I am not persuaded by this argument. In fact, Ethicon has made the
exact argument in order to invoke relevant federal preemption doctrines, and I have
previously found that Ethicon’s argument lacks merit:
Ethicon’s argument ignores the fact that the Prolene suture and the TVT
are two entirely different medical devices that went through different
FDA processes. Although Ethicon represents that the products are
primarily composed of the same material, it does not automatically
follow that the material is safe in both devices. The Prolene suture is a
nonabsorbable surgical suture; the TVT is a form of transvaginal mesh.
The Prolene suture consists of a single filament of polypropylene; the
TVT is a mesh woven from knitted Prolene filaments. The average
Prolene suture is a few inches long; the TVT measures one-half inches
by sixteen inches, and contains many times the amount of polypropylene
material. The Prolene suture is not intended to adhere to human tissue;
the TVT is designed to adhere to human tissue. The Prolene suture is
4

designed to be easily pulled out of the body; the TVT cannot be removed
without invasive surgery.

Huskey v. Ethicon, Inc., 29 F. Supp. 3d 736, 747 (S.D. W. Va. 2014) (quoting Lewis v.
Johnson & Johnson, 991 F. Supp. 2d 748, 757–59 (S.D. W. Va. 2014)). Thus, I have
previously ruled that a polypropylene suture and the TVT device are entirely
different products, performing different functions. Accordingly, I FIND that a
polypropylene suture is not an alternative, feasible design for the TVT device as a
matter of law.
I further FIND that the plaintiffs must provide evidence of an alternative,
feasible design for the product at issue—in this case, the TVT. Once the court
determines that the plaintiffs have provided sufficient evidence to identify a
comparable product or design concept, whether the design features of the comparable
product or the design concept existing at the time of the TVT’s manufacture is an
alternative, feasible design for the TVT is a factual question left to the jury.
III.

Negligence
The defendants argue that an alternative, feasible design is required for

proving the plaintiffs’ cases under both strict liability and negligence. The defendants’
primary argument is that because both theories apply the risk/utility test, both must
require evidence of an alternative, feasible design. As I have already pointed out, the
West Virginia Supreme Court has held that negligence and strict liability claims have
different elements. Syl. pt. 6, Ilosky, 307 S.E.2d at 605. Moreover, the PJI even
separates the products liability instructions based on negligence, strict liability, and
5

breach of warranty theories, establishing different elements of proof for each.
Sections 424 and 425 of the PJI state the applicable standards for negligence in a
products liability case, and absent from these instructions is any element of proof
regarding an alternative, feasible design. See W. Va. P.J.I. §§ 424, 425. Unlike in
strict liability, where the defective condition of the product is the principal basis of
liability, negligence focuses on the conduct of the manufacturer. See Syl. pt. 3,

Morningstar v. Black & Decker Mfg. Co., 253 S.E.2d 666, 667 (W. Va. 1979) (“The
cause of action covered by the term ‘strict liability in tort’ is designed to relieve the
plaintiff from proving that the manufacturer was negligent in some particular fashion
during the manufacturing process and to permit proof of the defective condition of the
product as the principal basis of liability.”); see also 63 Am. Jur. 2d Products Lability
§ 519 (“Strict liability looks at the product itself and determines if it is defective,
whereas negligence looks at the act of the manufacturer and the court determines if
the manufacturer exercised ordinary care in design and production.”) Certainly, the
existence of an alternative, feasible design is relevant to the manufacturer’s conduct,
but a requirement to establish an alternative, feasible design is simply not among the
requisite elements under a negligence products liability theory.
Accordingly, I FIND that under West Virginia law, the plaintiffs are not
required to provide evidence of an alternative, feasible design under a negligence
theory of products liability.

6

IV.

Malfunction Theory
The malfunction theory is available to the plaintiffs in this case. West Virginia

case law and the PJI allow a plaintiff to prove his or her design defect strict liability
case with circumstantial evidence. Specifically, the West Virginia Supreme Court has
determined the following:
Circumstantial evidence may be sufficient to make a prima facie case in
a strict liability action, even though the precise nature of the defect
cannot be identified, so long as the evidence shows that a malfunction
in the product occurred that would not ordinarily happen in the absence
of a defect. Moreover, the plaintiff must show there was neither
abnormal use of the product nor a reasonable secondary cause for the
malfunction.
Syl. pt. 3, Anderson v. Chrysler Corp. 403 S.E.2d 189, 190 (W. Va. 1991); see also

Bennett v. ASCO Servs., Inc., 621 S.E.2d 710, 717 (W. Va. 2005) (referring to
Anderson’s “malfunction theory”). Additionally, § 407 of the PJI provides an
instruction on the malfunction theory under a strict liability framework, which is
nearly identical to § 3 of the Restatement (Third) of Torts: Products Liability.
I am not persuaded by the defendants’ argument that the plaintiffs are not
permitted to advance a malfunction theory simply because they have identified
alleged specific design flaws in the TVT. From the cases I have reviewed, nothing
indicates that a plaintiff is barred from advancing the malfunction theory just
because the plaintiff also has identified a possible design flaw. See Bennett, 621
S.E.2d at 718 (“We must therefore consider whether the Bennetts offered sufficient
evidence—circumstantial or otherwise—to create a triable issue of fact regarding
7

whether the alarm system components were not reasonably safe for their intended
use.” (emphasis added)). Instead, allowing the plaintiffs to advance the malfunction
theory alongside a more traditional strict liability theory (that is, one where direct
evidence of a design flaw is offered along with an alternative, feasible design) is
consistent with Ilosky, which allows multiple theories to go to the jury. Syl. pt. 6,

Ilosky, 307 S.E.2d at 605. Accordingly, I FIND that the plaintiffs may proceed under
the malfunction theory of strict products liability.
The parties have also raised the issue of whether an alternative, feasible
design is a required element of proof under the malfunction theory. I have found no
such requirement under West Virginia law. First, neither Anderson nor Bennett
requires evidence of an alternative, feasible design. See generally Anderson, 403
S.E.2d at 190; Bennett, 621 S.E.2d at 712–13. Second, § 407 of the PJI—the
instruction applicable to the malfunction theory—does not mention an alternative,
feasible design in its enumerated elements of proof. Finally, § 3 of the Restatement
(Third) offers highly persuasive commentary, stating that an alternative, feasible
design is not a required element of proof under the malfunction theory. Restatement
(Third) of Torts: Products Liability § 3 reporters’ note 1 (concluding that under § 3,
“[t]he plaintiff need not prove that . . . a reasonable alternative design could have
been adopted”); see also Aaron D. Twerski & James A. Henderson Jr., Manufacturers’

Liability for Defective Product Designs: The Triumph of Risk-Utility, 74 Brook. L.
Rev. 1061, 1108 (2009) (“Indeed, section 3 of the Products Liability Restatement
8

enthusiastically supports the principle that there is no need to prove a reasonable
alternative design when a product fails to perform its manifestly intended function.”).
The Supreme Court of Appeals of West Virginia appears to have essentially
adopted the elements of proof discussed in § 3 of the Restatement (Third). See W. Va.
P.J.I. § 407; syl. pt. 3, Anderson, 403 S.E.2d at 190. Additionally, the applicable case
law and PJI sections do not indicate that an alternative, feasible design is a required
element under a malfunction theory. Accordingly, I FIND that the plaintiffs in this
case are not required to produce evidence of an alternative, feasible design to
establish a prima facie case under the malfunction theory adopted in Anderson.3
V.

Conclusion
For the reasons discussed above, the court ORDERS as follows:
(1) The plaintiffs in this consolidated trial may present evidence of one
or more products liability theories available under West Virginia

It appears at first blush that a plaintiff who can readily identify a purported design defect has a
more difficult journey to proving her direct evidence strict liability case than a plaintiff advancing a
circumstantial evidence strict liability case. I can only reconcile these differing elements by taking
stock of the different, but considerable, burden a plaintiff must actually overcome under the
malfunction theory. In Bennett, the West Virginia Supreme Court held that “while a defect in a
product cannot be presumed solely from the fact that an accident occurred, proof that a product
malfunctioned—that is, failed to function as it was intended and typically would in normal usage—is
circumstantial proof of its defective condition.” Bennett, 621 S.E.2d at 717; see also Restatement
(Third) of Torts: Products Liability § 3 cmt. b (“Section 3 claims are limited to situations in which a
product fails to perform its manifestly intended function, thus supporting the conclusion that a defect
of some kind is the most probable explanation.”); id. at reporters’ note 2 (“The inference of defect may
not be drawn, however, from the mere fact of a product-related accident.”). Thus, under the
malfunction theory, the plaintiffs in this consolidated trial must first meet the burden of showing that
the TVT device failed to perform its intended function, which is the treatment of SUI. Accordingly,
both the direct evidence and the circumstantial evidence theories of strict products liability under
West Virginia law pose their own individual challenges.
3

9

law, but only the theories sufficiently supported by the evidence
admitted at trial may be submitted to the jury.
(2) Evidence that an alternative surgical procedure should have been
used in place of the TVT device is not an alternative, feasible design
as a matter of law.
(3) A polypropylene suture is not an alternative, feasible design for the
TVT device as a matter of law.
(4) Once the court determines that the plaintiffs have provided sufficient
evidence to identify a comparable product or design concept, whether
the design features of the comparable product or the design concept
existing at the time of the TVT’s manufacture is an alternative,
feasible design for the TVT is a factual question left to the jury.
(5) Under West Virginia law, the plaintiffs are not required to provide
evidence of an alternative, feasible design under a negligence theory
of products liability.
(6) The plaintiffs may proceed under the malfunction theory of strict
products liability.
(7) Under West Virginia law, the plaintiffs are not required to produce
evidence of an alternative, feasible design under the malfunction
theory.

10

The court DIRECTS the Clerk to send a copy of this Order to counsel of record
and any unrepresented party.
ENTER:

11

February 23, 2017