UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF INDIANA

SOUTH BEND DIVISION

ALLIE LANE and FLORENCE LANE, )

)

Plaintiffs )

)

v. ) 3:14 CV 1982

)

BOSTON SCIENTIFIC CORPORATION, )

)

Defendant )

ORDER and OPINION

This matter is before the court on defendant Boston Scientific Corporation’s

(hereinafter, “Boston Scientific”) motion to dismiss plaintiffs Allie and Florence Lane’s

(“the Lanes”) complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). The wellknown legal standard applicable is that, with the complaint’s factual allegations

accepted as true, dismissal for failure to state a claim pursuant to Rule 12(b)(6) is

appropriate when those facts are not enough to make a right to relief plausible, meaning

more than speculative. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Bell Atlantic Corp. v.

Twombly, 550 U.S. 544, 556 (2007); Vinson v. Vermilion Cty., Illinois, 776 F.3d 924, 928 (7th

Cir. 2015). To avoid dismissal. the well-pleaded factual content must allow the court to

draw the reasonable inference that the defendant is liable for the misconduct alleged.

Iqbal, 556 U.S. at 678.

The Lanes’ amended complaint (DE # 11) pleads that plaintiff Allie Lane

(“Allie”) had a medical device surgically implanted into his back called a Precision Plus

TM Implantable Pulse model #SC-1110-02, with serial #235086. The device was designed
and manufactured by Boston Scientific, and intended to relieve back pain by providing

electrical pulses. The device is what is known as a Class III Medical Device under the

federal Food, Drug, and Cosmetic Act, about which a bit more will be said shortly. 

Not long after the operation Allie began experiencing severe shocks, which he

understandably believed were being caused by some problem with the device, and he

informed Boston Scientific of the issue. Approximately five months after the device was

implanted, representatives of Boston Scientific determined that the battery in the device

was discharging and depleting at a faster rate than expected, and that Boston Scientific

would replace it under warranty. The surgeon who implanted the device indicated that

it had malfunctioned and should be removed.1

 The essence of Boston Scientific’s argument is that the Lanes’ claims are

preempted by federal law because plaintiffs have failed to plead enough facts to show

that a plausible non-preempted claim exists. Because the heart of the parties’

disagreement is limited to one issue, the court need not engage in a lengthy reiteration

of Boston Scientific’s entire argument or of the issue of federal preemption. It will

suffice to say that Class III Medical Devices, because they are extremely important to

human health but also have a high potential risk for causing illness or injury, are subject

to extensive federal regulation including a premarket approval process. Once a device is

1

 It apparently was later removed, but this is not alleged in the complaint. (DE

# 16, Exhibit A at ¶ 14.)

2
approved, its manufacturer gains the benefit of an express preemption of liability

claims:

[N]o State or political subdivision of a State may establish or continue in

effect with respect to a device intended for human use any

requirement—(1) which is different from, or in addition to, any

requirement applicable under this chapter to the device, and (2) which

relates to the safety or effectiveness of the device or to any other matter

included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a). 

This provision does not, however, preempt a so-called “parallel” claim, which is

a state common-law claim based on a violation of the federal laws and regulations

applicable to the medical device. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996); Bausch

v. Stryker Corp., 630 F.3d 546, 552-53 (7th Cir. 2010). In Bausch, which involved a hipreplacement device, the plaintiff pleaded that the defendant had violated federal

regulatory standards applicable to the device causing an unreasonably dangerous

device to be implanted in plaintiff, and that prior to plaintiff’s surgery the defendant

knew or should have known the device was defective. Bausch, 630 F.3d at 558-59. The

Seventh Circuit reversed the district court’s dismissal of plaintiff’s complaint, finding

no “fatal defect in the original complaint that would have justified its dismissal.” Id. at

559.

The Lanes argue that, just as in Bausch, they have adequately pleaded a parallel

state claim. Their amended complaint alleges at paragraph 20 that the device implanted

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in Allie was “manufactured and distributed in violation of Federal law,” more

specifically:

17. That the actions of the defendant are violative of . . . Federal law

particularly 21 U.S.C. §360 et. seq. as amended and the regulations set

forth by the Federal Food and Drug Administration including but not

limited to the Quality System Regulation and Current Good

Manufacturing practices 21 C.F.R. §820.1(a)(1), and other mandates as set

forth under Federal law;

18. That the defendant’s failure to comply with the applicable provisions

set forth above render the spinal cord stimulator adulterated as set forth

under Section 501 (h) of the Act;

19. That the aforementioned product failed to comply with Section 820.90

and 21 C.F.R. Sections 820.72 – 820.90, and the product which had been

implanted into Plaintiff Allie Lane failed to comply with product

specifications as approved by the FDA through the pre-market approval

process.

(DE # 11 at 3-4.) 

Boston Scientific argues that these allegations are nothing more than legal

conclusions and fall short of establishing a plausible claim: 

Plaintiffs’ reliance on Bausch is misplaced because the Bausch plaintiff pled

several key facts linked to specific regulatory violations that plausibly

supported a parallel claim that would survive preemption. In contrast,

Plaintiffs here have pled nothing more than legal conclusions of

unspecified federal regulations with no underlying supporting facts to

connect them to Plaintiffs’ alleged injuries.

(DE # 17 at 1.) The key facts Boston Scientific is talking about that were available to the

Bausch plaintiffs were that complaints had been received almost two years prior to the

implantation of the hip-replacement device; that defendant had previously recalled

components of the device; and that prior to its implantation in plaintiff, and the FDA

4
had warned the defendant about deficiencies in the manufacturing process. Bausch, 630

F.3d at 559.

The Lanes have alleged no such facts,2 and Boston Scientific argues that without

them the Lanes “cannot unlock the doors to discovery.” (DE # 17 at 2.) Boston Scientific

has cited a number of cases stating that the sole fact that a Class III Medical Device

malfunctions is not indicative that it was manufactured in violation of federal law

because of the numerous other reasons why such a device could fail, for example, poor

surgical technique. See, e.g., Clark v. Medtronic, 572 F. Supp. 2d 1090, 1094 (D. Minn.

2008); Cafferty v. Cayuga Med. Ctr., No. 5:08-CV-0179 NPM/ATB, 2011 WL 541809

(N.D.N.Y. Feb. 8, 2011); Funk v. Stryker Corp., 673 F. Supp. 2d 522, 531-32 (S.D. Tex.

2009); Williams v. Cyberonics, Inc., 654 F. Supp. 2d 301, 308 (E.D. Pa. 2009); Davenport v.

Medtronic, Inc., 302 F. Supp. 2d 419, 438 (E.D. Pa. 2004); Enlow v. St. Jude Med., Inc., 327 F.

Supp. 2d 738, 743 (W.D. Ky. 2003) (listed in same order as cited by Boston Scientific, DE

# 17 at 7-8).

However, the fact that a device can fail for many reasons does not by itself make

failure because of a defect violating a regulation applicable to the device implausible.

Manufacturing processes “are not perfect” and were a patient harmed because a

“production worker’s blood or mucus . . . caused an infection after implantation, that

2

 According to Boston Scientific, this is because no such facts exist. That does not

necessarily rule out the possibility that this case could be the first example of problems

to come, or of an isolated manufacturing defect that would nevertheless violate federal

law applicable to the device.

5
contamination would present a substantial claim for violating [federal] requirements.”

Bausch, 630 F.3d at 555. More to the point, none of this precedent Boston Scientific cites

is from the Seventh Circuit, and its argument echoes one the Seventh Circuit considered

and rejected in Bausch. Discussing In re Medtronic, Inc., Sprint Fidelis Leads Products

Liability Litigation, 623 F.3d 1200 (8th Cir.2010), where the court had affirmed dismissal

of a complaint that “failed to identify specific violations of federal law,” Bausch, 630 F.3d

at 554, the Seventh Circuit stated that it “essentially agree[d]” with the dissenting

opinion in Medtronic that plaintiffs can “not be expected to plead their claims with

greater specificity without discovery to obtain access to confidential government and

company documents.” Id. 

In short, the court believes that under the applicable precedent in this circuit, the

Lanes’ amended complaint is sufficient to state a plausible claim. As the Seventh Circuit

stated in Bausch, in applying the Twombly/Iqbal plausibility standard to complaints

involving Class III Medical Devices, district judges:

[M]ust keep in mind that much of the product-specific information about

manufacturing needed to investigate such a claim fully is kept

confidential by federal law. Formal discovery is necessary before a

plaintiff can fairly be expected to provide a detailed statement of the

specific bases for her claim.

Id. at 558. In Bausch the Seventh Circuit went on to explain that while the defendants

therein, like here, “object[ed] that the original complaint does not specify the precise

defect or the specific federal regulatory requirements that were allegedly violated,”the

Court of Appeals did “not believe the absence of those details shows a failure to comply

6
with Rule 8 of the Federal Rules of Civil Procedure or can support a dismissal under

Rule 12(b)(6).” Id. at 560. The reasons for this were fourfold.

First, “Rule 9(b) does not impose any special requirement that such a claim be

pled with particularity, as it does for fraud claims, for example.” Id. Second, “the victim

of a genuinely defective product—for example, . . . an implantable cardiac defibrillator

that delivers powerful electric shocks to a heart that is functioning normally—may not

be able to determine without discovery and further investigation whether the problem

is a design problem or a manufacturing problem.” Id.

Third, in the context of Class III medical devices, much of the critical

information is kept confidential as a matter of federal law. The

specifications of the FDA’s premarket approval documents, for example,

are confidential, and there is no public access to complete versions of these

documents. An injured patient cannot gain access to that information

without discovery.

Id. Fourth and last:

It is also unreasonable to expect . . . [a complaint to be] pled more

specifically without access to the failed Trident [medical device] itself, but

accessing the Trident outside of a discovery process would risk charges of

spoliation of evidence[.] . . . As Judge Melloy noted in Medtronic Leads: “If

plaintiffs must allege that the defendant violated a particular

FDA-approved specification before discovery, then it is difficult to

appreciate how any plaintiff will ever be able to defeat a Rule 12(b)(6)

motion.” Id. [623 F.3d] at 1212 (Melloy, J., dissenting). 

Id. at 561. 

The Lanes have pleaded that Allie Lane received powerful and painful shocks

from Boston Scientific’s Precision Plus medical device, that the device’s battery was

discharging too quickly, and that both Boston Scientific and the surgeon who implanted

7
the device indicated that it should be replaced. That is enough to plead a plausible

parallel state claim based on possible violation(s) of federal standards. Accordingly,

Boston Scientific’s motion to dismiss (DE # 13) is DENIED. The Lanes’ motion for a

pretrial conference (DE # 18) is GRANTED, and Magistrate Judge Gotsch will hold a

conference at his and the parties’ earliest convenience.

SO ORDERED.

Date: September 26, 2016

 s/James T. Moody 

JUDGE JAMES T. MOODY

UNITED STATES DISTRICT COURT