Lewis et al v. Johnson & Johnson et al
MEMORANDUM OPINION AND ORDER (Motion in Limine No. 1, Summary Judgment Motions on 510(k) Issue) for reasons set forth herein, the 124 MOTION by Carolyn Lewis, Kenneth Lewis in Limine No. 1 - 510(k) Clearance of the Ethicon Mesh Products by the Unit ed States Food and Drug Administration or Lack of FDA Enforcement Action is GRANTED; the 128 MOTION by Ethicon, Inc., Johnson & Johnson for Partial Summary Judgment Based on Preemption of Certain Claims is DENIED; the 150 MOTION by Carolyn Lewis, Kenneth Lewis for Partial Summary Judgment is GRANTED. Signed by Judge Joseph R. Goodwin on 1/15/2014. The Clerk is directed to post a copy of this published opinion on the court's website, www.wvsd.uscourts.gov. (cc: attys; any unrepresented party) (skh)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CAROLYN LEWIS, et al.,
CIVIL ACTION NO. 2:12-cv-04301
JOHNSON & JOHNSON, et al.,
MEMORANDUM OPINION AND ORDER
(Motion in Limine No. 1, Summary Judgment Motions on 510(k) Issue)
Pending are Plaintiffs’ Motion in Limine No. 1 – 510(k) Clearance of the Ethicon Mesh
Products by the United State Food and Drug Administration (“FDA”), or Lack of FDA
Enforcement Action [Docket 124], Defendants’ Motion for Partial Summary Judgment Based on
Preemption of Certain Claims [Docket 128], and Plaintiffs’ Motion for Partial Summary Judgment
[Docket 150]. The motions are ripe for review. For the reasons set forth below, Plaintiffs’ Motion
in Limine No. 1 [Docket 124] is GRANTED, Defendants’ Motion for Partial Summary Judgment
Based on Preemption of Certain Claims [Docket 128] is DENIED, and Plaintiffs’ Motion for
Partial Summary Judgment [Docket 150] is GRANTED.
A. Factual and Procedural History
This multidistrict litigation involves surgical mesh products manufactured and sold by the
defendants, Ethicon, Inc. and Johnson & Johnson, Inc. (collectively “Ethicon”) to treat pelvic
organ prolapse and stress urinary incontinence. One of the devices produced by Ethicon is the
Gynecare TVT (“TVT”), which was implanted in the plaintiff, Ms. Lewis. The instant case is the
first bellwether trial scheduled in this MDL, and trial is set to begin on February 10, 2014.
There are three motions currently before the court. The first is Plaintiffs’ Motion in Limine
No. 1 – 510(k) Clearance of the Ethicon Mesh Products by the United State Food and Drug
Administration, or Lack of FDA Enforcement Action [Docket 124]. In it, the plaintiffs argue that
evidence related to FDA clearance and regulation of the TVT should be excluded under Federal
Rules of Evidence 402 and 403. The plaintiffs contend that because the FDA’s 510(k) clearance
process is not related to safety and efficacy, evidence of the clearance is irrelevant and misleading
to the jury. The defendants respond that compliance with FDA regulations is relevant and
admissible, that the TVT’s clearance is relevant to its safety and effectiveness, and that
post-clearance FDA regulation also relates to safety and effectiveness.
The second motion is Defendants’ Motion for Partial Summary Judgment Based on
Preemption of Certain Claims (“Defs.’ Mot. for Summ. J.”) [Docket 128]. The defendants
primarily argue that because the TVT is made with the same material that is in another device
approved through the FDA’s premarket approval process, state law tort claims related to the TVT
are preempted. The plaintiffs contend that Ethicon’s discussion of the premarket approval of other
medical devices is irrelevant to the TVT and the case at hand.
The third motion is Plaintiffs’ Motion for Partial Summary Judgment [Docket 150]. In it,
the plaintiffs argue that three affirmative defenses provided for by Texas law do not apply to
Ethicon. The plaintiffs state that two of the defenses fail because they speak only to products that
have been approved by the FDA, and the TVT was not approved by the FDA. They also argue that
a third affirmative defense does not apply because it relates only to mandatory safety regulations,
and no such regulations exist in this case.
B. The FDA 510(k) Approval Process
The TVT is a Class II medical device regulated by the FDA. In order to market and sell the
TVT, Ethicon went through the FDA’s 510(k) clearance process. See 21 C.F.R. § 807.87, 807.92,
807.93 (2012) (describing the requirements for 510(k) clearance). The 510(k) clearance process
“imposes a limited form of review” on manufacturers of qualifying devices. Medtronic, Inc. v.
Lohr, 518 U.S. 470, 478 (1996). “If the FDA concludes on the basis of the § 510(k) notification
that the device is ‘substantially equivalent’ to a pre-existing device, it can be marketed without
further regulatory analysis[.]” Id. This is an easier bar to pass than the FDA’s rigorous premarket
approval process, under which “[m]anufacturers must submit detailed information regarding the
safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200
hours on each submission.” Id. at 477; see also id. at 478-79 (“The § 510(k) notification process is
by no means comparable to the [premarket approval] process; in contrast to the 1,200 hours
necessary to complete a [premarket approval] review, the § 510(k) review is completed in an
average of only 20 hours. As one commentator noted: ‘The attraction of substantial equivalence to
manufacturers is clear. Section 510(k) notification requires little information, rarely elicits a
negative response from the FDA, and gets processed very quickly.’”) (internal citations omitted);
Horn v. Thoratec Corp., 376 F.3d 163, 167 (3d Cir. 2004) (“A manufacturer can obtain an FDA
finding of ‘substantial equivalence’ by submitting a pre-market notification to the agency in
accordance with Section 510(k) of the [Federal Food, Drug and Cosmetic] Act. A device found to
be ‘substantially equivalent’ to a predicate device is said to be ‘cleared’ by FDA (as opposed to
‘approved’ by the agency under a [premarket approval]). A pre-market notification submitted
under Section 510(k) is thus entirely different from a [premarket approval], which must include
data sufficient to demonstrate to FDA that the device is safe and effective.”) (quoting Amicus
Curiae Letter Brief to the Court, filed by the FDA) (internal citations omitted) (emphasis in
The Supreme Court has determined that the 510(k) process is focused on equivalence with
a preexisting device rather than safety, while the premarket approval process is focused on safety
and efficacy. Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008); Lohr, 518 U.S. at 478-79, 493.
Because of the differences in these processes, tort claims regarding medical devices cleared
through the 510(k) process are not preempted by federal law, while tort claims regarding medical
devices approved through the premarket approval process generally are preempted. Riegel, 552
U.S. at 321-23; Lohr, 552 U.S. at 501-02.1
A. Choice of Law
Under 28 U.S.C. § 1407, this court has authority to rule on pre-trial motions. In
multidistrict litigation cases such as this, the choice-of-law for these pre-trial motions depends on
whether they involve federal or state law. “When analyzing questions of federal law, the transferee
court should apply the law of the circuit in which it is located.” In re Temporomandibular Joint
(TMJ) Implants Prods. Liab. Litig., 97 F.3d 1050, 1055 (8th Cir. 1996) (internal citations omitted);
see also 15 Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 3866 (3d
Not all tort claims regarding medical devices that have gone through premarket approval are preempted. However,
“because of the congressional balance reflected in the [Medical Device Amendments to the Federal Food, Drug and
Cosmetic Act], a plaintiff’s state law cause of action based on injuries caused by a Class III medical device could only
survive if the alleged malfunction also violated a federal requirement.” Walker v. Medtronic, Inc., 670 F.3d 569, 579
(4th Cir. 2012).
ed. 2009). This is in accordance with the law in this circuit. See Bradley v. United States, 161 F.3d
777, 782 n.4 (4th Cir. 1998) (“[T]his court cannot and does not apply the law of another circuit
simply because the case was transferred from the other circuit.”).
The Honorable Shira A. Scheindlin has made a similar observation that the law of the
transferee circuit applies:
[C]ourts have held that the law of the transferee circuit controls
pretrial issues such as whether the court has subject matter or
personal jurisdiction over the action, or whether the cases should be
remanded to state court because the cases were not properly
In re Methyl Tertiary Butyl Ether (“MTBE”) Prods. Liab. Litig., 241 F.R.D. 435, 439 (S.D.N.Y.
2007) (footnote omitted). Judge Scheindlin’s observation, as noted in her opinion, reflects the
general approach. See, e.g., In re Linerboard Antitrust Litig., No. 04 Civ. 4001, MDL 1261, 2005
WL 1625040, at *4 (E.D. Pa. July 11, 2005) (applying the law of the Third Circuit on a motion to
dismiss for lack of subject matter jurisdiction); In re Bridgestone/Firestone, Inc., Tires Prods.
Liab. Litig., 256 F. Supp. 2d 884, 888 (S.D. Ind. 2003) (applying the law of the Seventh Circuit on
a motion for remand to state court). Pursuant to this doctrine and this court’s Order on summary
judgment motions, Texas substantive law will apply to the plaintiffs’ tort claims, New Jersey law
will apply to the plaintiffs’ punitive damages claims, and the law of the Fourth Circuit will apply to
issues of federal law.
B. Summary Judgment
To obtain summary judgment, the moving party must show that there is no genuine issue as
to any material fact and that the moving party is entitled to judgment as a matter of law. Fed. R.
Civ. P. 56(a). In considering a motion for summary judgment, the court will not “weigh the
evidence and determine the truth of the matter.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
249 (1986). Instead, the court will draw any permissible inference from the underlying facts in the
light most favorable to the nonmoving party. Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio
Corp., 475 U.S. 574, 587-88 (1986).
Although the court will view all underlying facts and inferences in the light most favorable
to the nonmoving party, the nonmoving party nonetheless must offer some “concrete evidence
from which a reasonable juror could return a verdict in his [or her] favor[.]” Anderson, 477 U.S. at
256. Summary judgment is appropriate when the nonmoving party has the burden of proof on an
essential element of his or her case and does not make, after adequate time for discovery, a
showing sufficient to establish that element. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23
(1986). The nonmoving party must satisfy this burden of proof by offering more than a mere
“scintilla of evidence” in support of his or her position. Anderson, 477 U.S. at 252. Likewise,
conclusory allegations or unsupported speculation, without more, are insufficient to preclude the
granting of a summary judgment motion. See Felty v. Graves Humphreys Co., 818 F.2d 1126,
1128 (4th Cir. 1987); Ross v. Comm’ns Satellite Corp., 759 F.2d 355, 365 (4th Cir. 1985),
abrogated on other grounds, Price Waterhouse v. Hopkins, 490 U.S. 228 (1989).
Federal preemption originates from the Constitution’s Supremacy Clause. See U.S. Const.
art. VI, cl. 2.2 In addressing a preemption issue, the court’s first task is to determine whether
Congress intended to preempt. See California Fed. Savings & Loan Ass’n v. Guerra, 479 U.S. 272,
280-81 (1978). Intent to preempt can manifest itself in three forms: field preemption, express
“This Constitution, and the Laws of the United States which shall be made in Pursuance thereof . . . shall be the
supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.”
U.S. Const. art. VI, cl. 2.
preemption, and conflict preemption. See H&R Block E. Enters., v. Raskin, 591 F.3d 718, 722 (4th
Cir. 2010). Field preemption occurs when the “federal scheme of regulation of a defined field is so
pervasive that Congress must have intended to leave no room for the states to supplement it[.]”
City of Charleston, S.C., v. A Fisherman’s Best, Inc., 310 F.3d 155, 169 (4th Cir. 2002). Express
preemption arises when “Congress expressly declares its intent to preempt state law.” Pinney v.
Nokia, Inc., 402 F.3d 430, 453 (4th Cir. 2005). Finally, conflict preemption occurs when “state law
stands as an obstacle to the accomplishment and execution of the full purposes and objectives of
Congress.” Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985)
(internal quotation omitted). Conflict preemption can also arise when “compliance with both
federal and state regulations is a physical impossibility[.]” Id. (internal quotation omitted).
Once Congress’s intent to preempt is determined, the focus turns to the scope of that
preemption. See Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324, 328 (4th Cir. 1996). Two
presumptions guide this inquiry. See id. First, “‘the purpose of Congress is the ultimate
touchstone’ in every pre-emption case.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)
(quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)). Second, a court starts “with the
basic assumption that Congress did not intend to displace state law.” Maryland v. Louisiana, 451
U.S. 725, 746 (1981). “This presumption is strongest when Congress legislates ‘in a field which
the States have traditionally occupied.’” S. Blasting Servs., Inc. v. Wilkes Cnty., N.C., 288 F.3d
584, 590 (4th Cir. 2002) (quoting Lohr, 518 U.S. at 485).
A. Plaintiffs’ Motion in Limine No. 1 – 510(k) Clearance of the Ethicon
Mesh Products by the FDA, or Lack of FDA Enforcement Action
The plaintiffs argue that any evidence of FDA clearance of Ethicon’s mesh products or
FDA enforcement actions should be excluded because the 510(k) process does not relate to the
safety or efficacy of the product. Therefore, evidence of FDA clearance should be excluded as
irrelevant under Federal Rule of Evidence 402 and misleading under Rule 403. Ethicon argues that
such evidence is relevant and admissible. I FIND that evidence of FDA clearance and enforcement
should be excluded under Federal Rules of Evidence 402 and 403.
Rule 403 provides that even relevant evidence may be excluded “if its probative value is
substantially outweighed by a danger of one or more of the following: unfair prejudice, confusing
the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative
evidence.” Evidence regarding the 510(k) process poses a substantial risk of misleading the jury
and confusing the issues. That a device has been given clearance through the FDA’s 510(k)
process is not relevant to state tort law. Admission of any evidence regarding the 510(k) process
runs the risk of misleading the jury to believe that FDA 510(k) clearance might be dispositive of
the plaintiffs’ state law claims.. The prejudicial value of evidence regarding the 510(k) process far
outweighs its probative value.
Both parties cite to the Third Restatement of Torts to support their position. The
Restatement states that “a product’s compliance with an applicable product safety statute or
administrative regulation is properly considered in determining whether the product is
defective[.]” (emphasis added). Restatement (Third) of Torts: Products Liability § 4 (1998). The
comments to this section specifically explain that the phrase “safety statute or administrative
regulation” is meant to encompass regulations “that establish binding safety standards for the
design and marketing of products.” Id. § 4 cmt. a. Similarly, “the safety statute or administrative
regulation must be such that compliance reduces the risk that caused the plaintiff’s harm.” Id. § 4
The 510(k) process is not a safety statute or administrative regulation. The Supreme Court
has determined that “the 510(k) process is focused on equivalence, not safety.” Lohr, 518 U.S. at
493 (internal quotation omitted); see also Riegel, 552 U.S. at 323 (“While § 510(k) is focused on
equivalence, not safety, premarket approval is focused on safety, not equivalence.”) (internal
quotation omitted).3 FDA regulations also note that 510(k) clearance “does not in any way denote
official approval of the device.” 21 C.F.R. § 807.97 (2012). The FDA thus prohibits manufacturers
of devices cleared through the 510(k) process from making any representations that their devices
have been approved by the FDA. See id. (“Any representation that creates an impression of official
approval of a device because of complying with the premarket notification regulations is
misleading and constitutes misbranding.”). Because the FDA’s 510(k) clearance of the TVT does
not speak to its safety or efficacy, it is irrelevant to this case and inadmissible under Rule 402.
Ethicon argues that even if 510(k) clearance does not relate to safety and efficacy, the
subsequent FDA regulation of a Class II medical device does relate to its safety and efficacy.
However, admission of evidence regarding FDA enforcement actions against Ethicon (or the lack
thereof) runs the same risk of misleading the jury as the 510(k) clearance process. Jurors are likely
Other courts interpreted Lohr as holding that the 510(k) process does not go to whether a product is safe and
effective, and that the 510(k) process does not impose any requirements on its own. See, e.g., Martin v. Am. Med. Sys.,
Inc., 116 F.3d 102, 104 (4th Cir. 1997); Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir. 2012); Brooks v.
Howmedica, Inc., 273 F.3d 785, 794 (8th Cir. 2001); Mack v. Stryker Corp., 893 F. Supp. 2d 976, 985 (D. Minn.
2012); Soufflas v. Zimmer, Inc., 474 F. Supp. 2d 737, 747 n.6 (E.D. Pa. 2007); Nicoll v. I-Flow, LLC, No. 12-1593,
2013 WL 2477032, at *3 (E.D. La. June 7, 2013).
to believe that FDA enforcement relates to the validity of the plaintiffs’ state law tort claims,
which it does not. As the plaintiffs note, Ethicon itself has argued in at least one other case that
evidence related to FDA regulation is misleading and irrelevant. (See Pls.’ Reply in Supp. of Mot.
in Limine No. 1 – 510(k) Clearance of the Ethicon Mesh Prods. by the FDA, or Lack of FDA
Enforcement Action (“Pls.’ Reply”) [Docket 167], at 1-2; Pls.’ Reply Ex. 1 [Docket 167-1]). In
that case, Ethicon argued that “the jury may attach undue significance” to an FDA determination,
and that “alleged shortcomings in FDA procedures are not probative to a state law products
liability claim[.]” (Pls.’ Reply Ex. 1 [Docket 167-1], at 6). I agree with this reasoning.
Ethicon also contends that the TVT’s clearance is relevant to its safety and efficacy,
because the TVT was cleared “with reference” to a product that had gone through the premarket
approval process. This, too, is irrelevant to the case at hand. The product that went through the
premarket approval process is not the TVT. It is a different medical device that was approved for a
different purpose. I will discuss the differences between these devices further in the preemption
In sum, the parties may not present evidence regarding the 510(k) clearance process or
subsequent FDA enforcement actions. This is consistent with prior rulings by this court. See, e.g.,
Cisson v. C.R. Bard, Inc., No. 2:11-cv-00195, 2013 U.S. Dist. LEXIS 102699, at *22 (S.D. W. Va.
July 23, 2013) (“The FDA 510(k) process does not go to safety and effectiveness and does not
provide any requirements on its own. Basically, it has no operative interaction with state tort
laws.”) (internal reference omitted); Order, Cisson v. C.R. Bard, Inc., No. 2:11-cv-00195 (S.D. W.
Va. July 1, 2013), [Docket 309], at 3-4 (“Under United States Supreme Court precedent, the FDA
510(k) process does not go to whether the product is safe and effective . . . . Because the FDA
510(k) process does not go to whether the [mesh] products are safe and effective and the 510(k)
process does not impose any requirements on its own, the 510(k) process is inapplicable to this
case. This evidence is excluded under Federal Rule of Evidence 402 as irrelevant, and under Rule
403 for the reasons previously stated, including the very substantial dangers of misleading the jury
and confusing the issues.”); Mem. Op. & Order, Cisson v. C.R. Bard, Inc., No. 2:11-cv-00195
(S.D. W. Va. June 27, 2013) [Docket 302], at 3-4 (holding that evidence regarding the 510(k)
process and enforcement should be excluded under Rule 403).
B. Defendants’ Motion for Partial Summary Judgment Based on
Preemption of Certain Claims
The Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act
(“FDCA”) contain an express preemption provision. The provision provides that, with respect to
medical devices, state law may not impose any requirement “which is different from, or in addition
to” the requirements of the FDCA, or any requirement “which relates to the safety or effectiveness
of the device or to any other matter included in a requirement applicable to the device under [the
FDCA].” 21 U.S.C. § 360k(a) (2012).
The Supreme Court has determined that the FDCA’s preemption provision does not apply
to products liability claims regarding medical devices that underwent 510(k) clearance rather than
the premarket approval process. Lohr, 518 U.S. at 501-02. In Lohr, the Court found that because
the 510(k) requirements did not relate to the safety or efficacy of the device, they did not preempt
state tort claims. Id. As the Court noted,
The generality of [the 510(k)] requirements make this quite unlike a case in which
the Federal Government has weighed the competing interests relevant to the
particular requirement in question, reached an unambiguous conclusion about how
those competing considerations should be resolved in a particular case or set of
cases, and implemented that conclusion via a specific mandate on manufacturers or
producers. Rather, the federal requirements reflect important but entirely generic
concerns about device regulation generally, not the sort of concerns regarding a
specific device or field of device regulation that the statute or regulations were
designed to protect from potentially contradictory state requirements.
Id. at 501. Because of this, the Court reasoned, the FDCA’s preemption provision does not apply to
products that received clearance through the 510(k) process.
The FDCA’s preemption provision does apply, however, to medical devices approved
through the premarket approval process. Riegel, 552 U.S. at 322-23. The Supreme Court explained
While § 510(k) is focused on equivalence, not safety, premarket approval is
focused on safety, not equivalence. While devices that enter the market through §
510(k) have never been formally reviewed under the MDA for safety or efficacy,
the FDA may grant premarket approval only after it determines that a device offers
a reasonable assurance of safety and effectiveness. And while the FDA does not
require that a device allowed to enter the market as a substantial equivalent take any
particular form for any particular reason, the FDA requires a device that has
received premarket approval to be made with almost no deviations from the
specifications in its approval application, for the reason that the FDA has
determined that the approved form provides a reasonable assurance of safety and
Id. at 323. “In sum, the Supreme Court held that the terms of a . . . device’s premarket approval
constitute federal requirements and that a common law tort claim premised on different or
additional requirements is preempted by the MDA.” Walker v. Medtronic, Inc., 670 F.3d 569, 577
(4th Cir. 2012).
Ethicon argues that the plaintiffs’ claims are preempted to the extent that they relate to the
use of Prolene polypropylene filaments in the TVT. This argument is related to the components of
the TVT mesh rather than the 510(k) clearance process that the TVT went through. Ethicon
represents that the “TVT is made of PROLENE mesh . . . . PROLENE mesh in turn consists of
knitted PROLENE filaments, which are composed of the same material as PROLENE suture. That
material is polypropylene to which proprietary ingredients have been added.” (Mem. in Supp. of
Mot. for Partial Summ. J. Based on Preemption of Certain Claims (“Mem. in Supp.”) [Docket
129], at 2). Unlike the TVT, which went through the 510(k) clearance process, the Prolene suture
went through the more rigorous premarket approval process.4 Thus, Ethicon argues, any argument
by the plaintiffs that the Prolene filaments are defective is preempted by federal law.
Ethicon’s argument in support of preemption is premised on the FDA’s premarket
approval of the Prolene suture, not the 510(k) clearance of the TVT. Essentially, Ethicon argues
that because the FDA confirmed the safety and effectiveness of the Prolene suture, and the TVT is
composed of the same material as the Prolene suture, the plaintiffs should be barred from arguing
that the Prolene material is defective. At first glance, this argument appears to have some
merit—after all, the FDA gave the Prolene suture its stamp of approval and confirmed its safety
and efficacy. However, 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.5 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
The Prolene suture went through the FDA’s new drug approval process rather than today’s medical device
premarket approval process because it was produced prior to the 1976 MDA. However, after the MDA was passed,
Prolene was subject to premarket approval, supplemented its premarket approval application several times, and was
regulated as a Class III medical device. It has since been reclassified as a Class II medical device. (See generally Decl.
of Reynaldo Librojo in Supp. of Mot. for Summ. J [Docket 128-1]).
Notably, the TVT did not even gain its 510(k) clearance due to its equivalence to the Prolene suture—it gained its
clearance due to its equivalence to the Boston Scientific Protegen. (Pls.’ Resp. Ex.1 (Cecchini Dep.) [Docket 174-1],
sixteen inches, and contains many times the amount of polypropylene material.6 The Prolene
suture is not intended to adhere to human tissue; the TVT is designed to adhere to human tissue.7
The Prolene suture is designed to be easily pulled out of the body; the TVT cannot be removed
without invasive surgery.8
The FDA’s approval of the Prolene suture necessarily related to its use as a suture; it did
not categorically approve Prolene filament for use in medical devices. When the FDA approved
the Prolene suture, it stated that it had concluded the Prolene suture was “safe and effective for use
as recommended in the submitted labeling.” (Defs.’ Mot. for Summ. J. Ex. 4 (FDA Approval
Letter) [Docket 128-5], at 1) (emphasis added)). The FDA did not examine whether that same
material was safe when woven together to create a transvaginal mesh product. Ethicon would like
the court to determine that because the FDA found polypropylene is safe to use as a suture, it is
automatically safe to use in transvaginal mesh. Although purportedly constructed of the same
material, it is a different product, used in a different manner, for a different purpose. The plaintiffs
have presented evidence demonstrating the difference in risk profiles between the Prolene suture
and TVT, (see Pls.’ Resp. in Opp’n Ex. 5 (Dep. of Ethicon Vice President of Clinical Development
and Medical Affairs Jim Hart) [Docket 174-5], at 3-4), and evidence that the process of weaving
the filaments creates different surface characteristics in the mesh (see Pls.’ Resp. in Opp’n Ex. 6
(Report Investigating Mesh Erosion in Pelvic Floor) [Docket 174-6], at 37 (“The knitting process
produces a mesh with a ‘technical front’ and ‘technical back’; these have different surface
Defs.’ Mot. for Summ. J. Ex. 18 (TVT 510(k) Notification) [Docket 128-19], at 11; Pls.’ Resp. in Opp’n [Docket
Pls.’ Resp. in Opp’n [Docket 174], at 5 (quoting Ethicon’s website).
characteristics (‘roughness’) owing to the mesh construction.”)). If a specific type of metal were
approved for use in a bone screw via the premarket approval process, it would not follow that that
same type of metal was safe in all medical devices, no matter what their function in the human
body. The same is true for Prolene filament. It does not follow that the same Prolene filament that
is safe for use as a suture is automatically safe for use in transvaginal mesh.
Furthermore, the TVT is a Class II medical device consisting of several components.
Prolene filament is merely one component of the TVT. Although Ethicon focuses on the Prolene
filament for the purposes of this motion, even they admit that the filament is not the only part of the
TVT. (See Mem. in Supp. [Docket 129], at 9 (stating that the Prolene polypropylene is the
“principal component” of the TVT)). The TVT—that is, the regulated medical device at issue in
this case—consists of more than just Prolene filament. The TVT is “a sterile single-use device
consisting of one piece of undyed PROLENE* polypropylene Mesh (tape) approximately ½ by 16
inches (1.1 x 40 cm), covered by a plastic sheath cut in the middle, and held between two stainless
steel needles bonded to the mesh and sheath with plastic collars.” (Defs.’ Mot. for Summ. J. Ex. 18
(TVT 510(k) Notification) [Docket 128-19], at 11). Ethicon has pointed out the difference between
the mesh itself and the final medical device in another case in this MDL:
Plaintiffs’ Motion to Remand rests in its entirety on the erroneous proposition that
“the mesh is the device.” This erroneous assertion is made with a total disregard for
the FDA’s classification and regulation of the Ethicon Products as Class II Medical
Devices governed by the Federal Food and Drug Cosmetic Act, 21 U.S.C. § 301 et
seq., and 21 C.F.R. §§ 800-98 . . . To accept Plaintiffs’ argument that “the mesh is
the device” would require the Court to ignore what the FDA classifies as the Class
II medical device that is the subject of its regulatory authority and to accept that the
individually cut mesh pieces, . . . which are only a part of the kit that makes up each
Class II medical device, are somehow the same as the rolls of mesh that leave [the
control of Ethicon’s mesh producer].
(Defs. Ethicon, Inc., Gynecare, and Johnson & Johnson’s Opp’n to Pls.’ Mot. to Remand,
Musewicz v. Ethicon, Inc., No. 2:13-cv-26024 [Docket 16], at 4-5). Ethicon noted in that case that
“the FDA does not classify or regulate the rolls of mesh; it classifies and regulates the final product
manufactured by Ethicon, Inc., as a Class II medical device.” (Id. at 4-5). Ethicon also described
the process it goes through after it receives the woven rolls of mesh, stating it must “convert the
knitted rolls of mesh into the finished . . . Ethicon Products, which includes cutting the large mesh
rolls into individual units of implantable mesh, assembling these units with other component parts,
such as the surgical tools, which are part of the Class II medical device, and sterilizing these
different items.” (Id. at 5).
“Persuasive authority from other district courts . . . indicates that the preemption analysis
is not applied differently to the component parts of a medical device and the medical device
itself[.]” Gavin v. Medtronic, Inc., CIV.A. 12-0851, 2013 WL 3791612, at *11 (E.D. La. July 19,
2013). Interestingly, the shoe is normally on the other foot—the defendant is arguing that a cause
of action is preempted because a device underwent premarket approval, while the plaintiff is
arguing there is no preemption because a component part of the device underwent 510(k)
clearance. Courts addressing this issue have determined that a device should not be broken into its
component parts in order to apply a preemption analysis. See Smith v. Depuy Orthopaedics, Inc.,
CIV.A. 11-4139 JAP, 2013 WL 1108555, at *12 (D.N.J. Mar. 18, 2013) (finding plaintiff’s claim
was preempted where component parts of a device went through the 510(k) process but the device
itself went through the premarket approval process); Duggan v. Medtronic, Inc., 840 F. Supp. 2d
466, 471 (D. Mass. 2012) (“Many courts have held that once premarket approval is granted, all
claims relating to all components of the device are preempted . . . . This analysis applies even
where a component of a [premarket]-approved device had previously been approved through the §
510(k) process.”); Gross v. Stryker Corp., 858 F. Supp. 2d 466, 487 (W.D. Pa. 2012) (“[A] device
receiving premarket approval cannot be separated into its component parts to avoid application of
express preemption.”); Bentzley v. Medtronic, Inc., 827 F. Supp. 2d 443, 452 (E.D. Pa. 2011)
(“Plaintiff’s contention that, in considering a preemption issue, the Court must break a medical
device into its component parts, is without legal support. In fact, courts that have dealt with this
issue have done just the opposite.”); Lewkut v. Stryker Corp., 724 F. Supp. 2d 648, 656 (S.D. Tex.
2010) (stating other courts have “found, in the context of other medical devices, that attempting to
separate the component parts of a medical device for purposes of preemption is not appropriate”);
Phillips v. Stryker Corp., 3:09-CV-488, 2010 WL 2270683 at *5, n.4 (E.D. Tenn. June 3, 2010)
(“The Court notes the serious practical difficulties associated with plaintiff’s divisibility argument,
even were the Court inclined to accept it.”); Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D.
Minn. 2009) (refusing to “pick apart the components of a medical device and apply different
preemption analyses to different components”). The same reasoning used in those cases is
applicable here: analyzing the component parts of a device separately from the device itself simply
does not make sense.
“To require that a distinction be drawn between the approval process of the individual
components of a system and the system itself, would, it seems, add a level of complication to the
medical device approval process not anticipated by Congress, the FDA, or medical device
manufacturers.” Lewkut, 724 F. Supp. 2d at 656. “It makes no sense—indeed, it would probably be
impossible—to pick apart the components of a medical device and apply different preemption
analyses to different components.” Riley, 625 F. Supp. 2d at 780. Determining preemption based
upon the component parts of a device, rather than the device as a whole, would create a legal
quagmire whereby tort claims against one part of a device are preempted while tort claims against
another part of a device are not. Indeed, this is exactly what Ethicon would like the court to
declare—as Ethicon noted, its “motion addresses only the use of PROLENE filaments and does
not address other alleged defects, such as mesh pore size.” (Defs.’ Mot. for Summ. J. [Docket
128], at 1).
Analyzing each component of a medical device separately to determine whether claims are
preempted would create a doctrine that forces courts to dissect every medical device. In that world,
a different preemption analysis would apply to each part of the device, rather than the device as a
whole. See Phillips, 2010 WL 2270683, at *5 n.4 (noting the “serious practical difficulties” with
separating the device from its component parts to determine preemption). Particularly in complex
litigation such as this, bright line rules are important to create clarity for all parties involved. The
doctrine Ethicon asks this court to accept would only serve to create chaos in a field that is already
difficult to navigate. Each involved party should be able to determine whether tort claims
regarding a medical device are preempted based upon the review process the device actually went
through. If the TVT had gone through the premarket approval process while the polypropylene
filament had gone through the 510(k) process, I cannot imagine that Ethicon would think the
component parts of a device should be analyzed separately from the device itself. As discussed
above, Ethicon itself has recognized the importance of viewing the TVT as a whole, rather than
just its component parts. Just as “a device receiving premarket approval cannot be separated into
its component parts to avoid application of express preemption,” Gross, 858 F. Supp. 2d at 487, a
device receiving 510(k) approval cannot be separated into its component parts to create express
Based upon the foregoing, I FIND that the plaintiffs’ claims regarding the use of
polypropylene are not preempted by federal law.
C. Plaintiffs’ Motion for Partial Summary Judgment
In their motion for partial summary judgment, the plaintiffs argue that three affirmative
defenses Ethicon plans to assert are inapplicable to this case. These affirmative defenses, found in
Sections 82.007 and 82.008 of the Texas Civil Practice and Remedies Code, provide products
liability defendants with rebuttable presumptions of adequate warnings and non-liability in certain
1. Section 82.007
Section 82.007 of the Texas Civil Practice and Remedies Code (“Section 82.007”) is only
applicable to “products liability action[s] alleging that an injury was caused by a failure to provide
adequate warnings or information with regard to a pharmaceutical product.” Tex. Civ. Prac. &
Rem. Code § 82.007(a) (2013). The failure to warn and breach of express and implied warranty
claims have been dismissed from this action. Therefore, I FIND that Section 82.007 does not apply
to this case.
2. Section 80.008(a)
Section 82.008(a) of the Texas Civil Practice and Remedies Code (“Section 82.008(a)”)
In a products liability action brought against a product manufacturer or seller, there
is a rebuttable presumption that the product manufacturer or seller is not liable for
any injury to a claimant caused by some aspect of the formulation, labeling, or
design of a product if the product manufacturer or seller establishes that the
product's formula, labeling, or design complied with mandatory safety standards or
regulations adopted and promulgated by the federal government, or an agency of
the federal government, that were applicable to the product at the time of
manufacture and that governed the product risk that allegedly caused harm.
Tex. Civ. Prac. & Rem. Code § 82.008(a) (2013) (emphasis added). As discussed above, the
TVT’s 510(k) clearance does not relate to its safety or efficacy. Furthermore, Ethicon has not
provided the court with any mandatory safety standards or regulations with which the TVT
complied. Therefore, I FIND that Section 82.008(a) in inapplicable in this case.
3. Section 82.008(c)
Section 82.008(c) of the Texas Civil Practice and Remedies Code (“Section 82.008(c)”)
provides as follows:
In a products liability action brought against a product manufacturer or seller, there
is a rebuttable presumption that the product manufacturer or seller is not liable for
any injury to a claimant allegedly caused by some aspect of the formulation,
labeling, or design of a product if the product manufacturer or seller establishes that
the product was subject to pre-market licensing or approval by the federal
government, or an agency of the federal government, that the manufacturer
complied with all of the government’s or agency’s procedures and requirements
with respect to pre-market licensing or approval, and that after full consideration of
the product’s risks and benefits the product was approved or licensed for sale by
the government or agency.
Tex. Civ. Prac. & Rem. Code § 82.008(c) (2013) (emphasis added). The FDA conducts a full
analysis of the product’s risks and benefits when a product goes through the premarket approval
process, not the 510(k) clearance process. As discussed above, the 510(k) process relates to a
medical device’s equivalence to a pre-existing device; it does not require “full consideration of the
product’s risks and benefits[.]” Clearance through 510(k) notification also does not constitute
FDA “approval” of the device. Therefore, I FIND that Section 82.008(c) does not apply to Ethicon
in this case.
Based upon the foregoing, Plaintiffs’ Motion in Limine No. 1 [Docket 124] is GRANTED,
Defendants’ Motion for Partial Summary Judgment Based on Preemption of Certain Claims
[Docket 128] is DENIED, and Plaintiffs’ Motion for Partial Summary Judgment [Docket 150] is
The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party. The court further DIRECTS the Clerk to post a copy of this published
opinion on the court’s website, www.wvsd.uscourts.gov.
January 15, 2014
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