Welz v. Boston Scientific Corporation

UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF MISSOURI

EASTERN DIVISION

DANIEL WELZ, )

)

Plaintiff, )

)

vs. ) Case No. 4:24 CV 820 CDP

)

BOSTON SCIENTIFIC CORP., )

)

Defendants. )

MEMORANDUM AND ORDER

Plaintiff Daniel Welz was implanted with a Boston Scientific A219 MRI

compatible subcutaneous cardioverter defibrillator pulse generator (hereafter, ICD)

at a Missouri hospital in October 2020. He immediately began experiencing

complications related to his device, including the failure to provide a shock when

necessary, failure to transmit, and frequent errors lights. As a result of the

complications, the ICD was removed and replaced with a different device. The

ICD was later recalled. Welz alleges that the ICD’s failure to work properly was

caused by manufacturing defects and brings Missouri state law claims for strict

liability, negligence, and failure to warn.1

1 The Amended Complaint brings the following four claims under Missouri common law: Strict

Liability—Defective Product (Count I); Strict Liability—Failure to Warn (Count II);

Negligence—Defective Product (Count III); and Negligence—Failure to Warn (Count IV).

Before me now is Boston Scientific’s Rule 12(b)(6) motion to dismiss.

Boston Scientific argues that Welz’s claims are preempted by the 1976 Medical

Device Amendments to the Food, Drug and Cosmetic Act. Because I find that

Welz’s claims rooted in manufacturing defects are not preempted, I will deny

Boston Scientific’s motion as to those claims. However, the motion is granted to

the extent the Amended Complaint alleges design defects and failures to warn.

Motion to Dismiss Standard

The purpose of a motion to dismiss under Rule 12(b)(6) is to test the legal

sufficiency of the complaint. When considering a 12(b)(6) motion, the court

assumes the factual allegations of a complaint are true and construes them in favor

of the plaintiff. Neitzke v. Williams, 490 U.S. 319, 326–27 (1989). Rule 8(a)(2),

Fed. R. Civ. P., provides that a complaint must contain “a short and plain statement

of the claim showing that the pleader is entitled to relief.” In Bell Atlantic Corp. v.

Twombly, the Supreme Court clarified that Rule 8(a)(2) requires complaints to

contain “more than labels and conclusions, and a formulaic recitation of the

elements of a cause of action.” 550 U.S. 544, 555 (2007); accord Ashcroft v. Iqbal,

556 U.S. 662, 678–79 (2009). Specifically, to survive a motion to dismiss, a

complaint must contain enough factual allegations, accepted as true, to state a

claim for relief “that is plausible on its face.” Twombly, 550 U.S. at 570. The

issue in considering such a motion is not whether the plaintiff will ultimately

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prevail, but whether the plaintiff is entitled to present evidence in support of the

claim. See Neitzke, 490 U.S. at 327.

The Medical Device Amendments

In 1976, Congress passed the Medical Device Amendments (MDA) to the

Food, Drug and Cosmetic Act (FDCA). See 21 U.S.C. § 360c et seq. The

amendments authorized the FDA to “regulate the safety and effectiveness of

medical devices.” In re Medtronic, Inc., 623 F.3d 1200, 1203 (8th Cir. 2010).

Through the amendments, which were a response to proliferation (and frequent

failure) of medical devices entering the market, Congress “swept back some state

obligations and imposed a regime of detailed federal oversight.” Riegel v.

Medtronic, Inc., 552 U.S. 312, 316 (2008); see also Medtronic, Inc. v. Lohr, 518

U.S. 470, 476 (1996) (MDA was enacted in “response to the mounting consumer

and regulatory concern”).

The MDA classifies medical devices into three groups (Classes I, II, and III)

based on the degree of risk they pose. In general, Class III devices—as the most

dangerous—are subject to the highest level of scrutiny by the FDA. This manifests

in a rigorous, comprehensive inquiry called “premarket approval,” or PMA. See

Lohr, 518 U.S. at 477 (noting that it takes the FDA an average of 1,200 hours to

review an application for PMA). An applicant seeking PMA for a Class III device

must supply information to the FDA, including a description of the device, clinical

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safety trials, methods of product testing, design of the device and manufacturing

controls, outcome evaluation, and proposed labeling. Sullivan v. Medtronic, Inc.,

498 F. Supp. 3d 1106, 1110 (E.D. Mo. 2020). The FDA does not conduct

independent testing on a medical device in a PMA application. Id. Following

PMA, an applicant must comply with certain FDA requirements and federal

regulations, including those set out in 21 C.F.R. Pt. 803, 21 C.F.R. Pt. 820, and 21

U.S.C. §§ 351–52. Id. The holder must also comply with specifications imposed

during the PMA process for the device. Id.

ICD’s PMA and Recall

Although not pleaded in the Amended Complaint, it is a matter of public

record (and not disputed by Welz) that the ICD is a Class III device approved by

the FDA through the supplemental PMA process. See 78 Fed. Reg. 17415–16

(Mar. 21, 2013) (listing the original September 28, 2012 PMA approval for the

Subcutaneous Implantable Defibrillator (S-ICD) System, PMA No. P110042).2

This Court may take judicial notice of the PMA and PMA Supplement approvals

because they can be accurately and readily determined from sources whose

accuracy cannot reasonably be questioned. See Fed. R. Evid. 201(b)(2); see also

2 See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110042 (last

reviewed August 12, 2024) (providing links to the original PMA approval letter and all

applicable supplements, including Supplement No. S058, which lists the August 8, 2016

supplemental PMA approval for the Boston Scientific Model A219 EMBLEM MRI S-ICD).

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Antonacci v. Allergan USA, Inc., Case No. 4:20CV1841 AGF, 2021 WL 3404024,

at *1 n.2 (E.D. Mo. Aug. 4, 2021) (taking judicial notice of a breast implant PMA

and noting that “[t]he Court may take judicial notice of public records and consider

them on a motion to dismiss”) (citing Stahlv. U.S. Dep’t of Agric., 327 F.3d 697,

700 (8th Cir. 2003)); Arthur v. Medtronic, Inc., Case No. 4:14CV52 CEJ, 2014

WL 3894365, at *1 n.1 (E.D. Mo. Aug. 11, 2014) (taking judicial notice of PMA

approval). A PMA and PMA Supplement are both subject to the same rigorous

standards of review. Riegel, 552 U.S. at 319 (citing 21 C.F.R. § 814.39(c)). The

original and supplemental PMAs remain in effect for the ICD, and have never been

suspended or revoked.

The Amended Complaint alleges that on or about December 2, 2020, Boston

Scientific issued a recall of the ICD “due to a manufacturing defect wherein a

potential short-circuit that could cause significant complications, including, but not

limited to, patients experiencing less shock than intended or no shock at all.” ECF

14 at ¶ 9. Welz further alleges that in a December 2020 Medical Device Advisory,

Boston Scientific stated that “variations in header assembly allowed a very small

pathway for moisture ingress enabling a shorting condition to occur during

delivery of high voltage therapy” and that “a header assembly subprocess was

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found to be subject to process variations directly contributing to this behavior.”

ECF 14 at ¶ 10.3

The MDA and Federal Preemption

The MDA expressly preempts certain state laws. Subject to some unrelated

exceptions, “no 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). The United States Supreme Court has articulated a two-part

test for applying the express preemption principles codified in Section 360k of the

MDA. See Riegel, 552 U.S. at 321–22. The test requires the court to examine the

particular federal laws and regulations applicable to the device in question and

compare them to the state claims the plaintiff wishes to bring. First, a court must

determine whether “the Federal Government has established requirements”

applicable to a particular device. Second, the court must determine whether a

plaintiff’s claims “are based upon [state] requirements with respect to the device

3 Because these allegations appear in the Amended Complaint, I need not, and therefore do not,

consider the documents attached to plaintiff’s opposition to the motion to dismiss.

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that are different from, or in addition to the federal ones, and that relate to safety

and effectiveness.” Id. If the Court answers both questions in the affirmative, the

state laws are expressly preempted by the MDA. Id. at 321-23. However, Ҥ 360k

does not prevent a State from providing a damages remedy for claims premised on

a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than

add to, federal requirements.” Id. at 330.

Premarket approval is a federal “requirement” that meets the first prong of

the test for Section 360k preemption. Riegel, 552 U.S. at 322–23 (PMA was

“specific to individual devices” and “focused on safety, not equivalence.”). As for

the second prong of the Section 360k preemption test, included in the meaning of

“state requirements” subject to federal preemption are common law causes of

action, such as negligence and strict liability. Id. at 323-244.

In Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the

Supreme Court construed § 337(a) of the MDA—which provides that all actions to

enforce FDA requirements “shall be by and in the name of the United States”—“as

barring suits by private litigants ‘for noncompliance with the medical device

provisions.’” In re Medtronic, 623 F.3d at 1204 (quoting Buckman, 531 U.S. at

349 n. 4). The Eighth Circuit Court of Appeals has read Buckman and Riegel

together to create only a “narrow gap through which a plaintiff’s state-law claim

must fit if it is to escape express or implied preemption.” Id. (quoting Riley v.

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Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009)). As such, a plaintiff

“must be suing for conduct that violates the FDCA (or else his claim is expressly

preempted by § 360k(a)), but the plaintiff must not be suing because the conduct

violates the FDCA (such a claim would be impliedly preempted under Buckman).”

In re Medtronic, 623 F.3d at 1204 (quoting Riley, 625 F. Supp. 2d at 777) (italics

in original).

Here, Boston Scientific argues that Welz’s claims are expressly preempted

by the MDA. The parties do not dispute that the first prong of the Riegel test is

satisfied, as the ICD was subjected to PMA and is thus governed by the specific

requirements set forth in the PMA Supplement.

Boston Scientific argues that “plaintiff’s Amended Complaint is devoid of

any allegations to substantiate a viable design defect and/or failure to warn claim.

Nowhere in the amended pleading does Plaintiff attempt to plead violations of

federal requirements related to the FDA-approved design or warnings associated

with the device at issue.” ECF 16 at 16. Boston Scientific attempts to

characterize the Amended Complaint as pleading only design defects, and in doing

so ignores the fact that plaintiff alleges manufacturing defects, which survive

preemption. In opposition to dismissal, plaintiff argues that he only pleads claims

for manufacturing defects, and in doing so ignores the fact that the Amended

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Complaint also alleges (albeit in conclusory fashion) design defects, as well as

claims for failure to warn. See ECF 14 at ¶¶ 11-28 and 43-44.

State law claims based on allegations of a manufacturer’s failure to comply

with device-specific PMA specifications survive preemption. See Sullivan, 498 F.

Supp. 3d at 1114-15; Edwards, Trustee for Herrman v. Thoratec LLC, 532 F.

Supp. 3d 786, 792 (D. Minn. 2021); Silver v. Medtronic, Inc., 236 F. Supp. 3d 889,

898-99 (M .D. Pa. 2017) (claim that device was manufactured out of specification

not preempted); In re Medtronic Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592

F. Supp. 2d 1147, 1161 n.17 (D. Minn. 2009) (“[A]n adequately pleaded claim that

a specific device was not manufactured in accordance with its PMA specifications

can survive preemption.”); Warren v. Howmedica Osteonics Corp., Case No.

4:10CV1346 DDN, 2011 WL 1226975, at *5 (E.D. Mo. Mar. 29, 2011)

(“[B]ecause plaintiffs allege that defendants violated a federal requirement specific

to the FDA’s PMA approval of [the device], plaintiffs’ claims survive

preemption.”) (internal quotation marks and citation omitted).

Welz clearly pleads manufacturing defects, and in opposition to dismissal

insists that he only pleads manufacturing defects as a basis for his strict liability

and negligence claims. To the extent his conclusory references to design defects,

as recited above, amount to an attempt to plead claims for strict liability and

negligence based on design defects, those claims are preempted and dismissed.

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See In re Medtronic, 623 F.3d at 1206 (design defect claims are “attacks on the

risk/benefit analysis that led the FDA to approve an inherently dangerous Class III

device. Such claims are expressly preempted.”) (cleaned up). However, the

claims stated in Counts I and III of the Amended Complaint are not preempted to

the extent they allege that Boston Scientific’s failures to manufacture the ICD in

accordance with the PMA and PMA Supplement violate Missouri law.

Although Boston Scientific complains that Welz’s Amended Complaint is

not specific enough as to how his ICD was not manufactured in compliance with

the PMA, the Eighth Circuit has recognized “the care that courts must exercise in

applying Riegel’s parallel claim principle at the pleading stage, particularly to

manufacturing defect claims.” In re Medtronic, 623 F.3d at 1207. The Court

must be mindful not to hold Welz “to an impossible pleading standard.” Id. at

1206. Here, Welz has done more than simply allege that Boston Scientific has

violated unspecified or generic federal regulations; he has set out how the ICD was

manufactured outside the specifications of the PMA and alleged the ways that

those defects caused his device to fail and injure him. As such, he is entitled to

conduct discovery to support his claims. I thus conclude that Counts I and III of

Welz’s Amended Complaint sufficiently allege a specific federal violation for

claims rooted in manufacturing defects.

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However, the same cannot be said of the failure to warn claims alleged in

Counts II and IV of the Amended Complaint. Welz omits any reference to, or

discussion of, these claims in opposition to dismissal, prompting Boston Scientific

to argue in its reply brief that Welz has abandoned these claims and/or concedes

that they should be dismissed. Given Welz’s failure to address these claims in

opposition to dismissal and his repeated insistence that he only brings claims for

manufacturing defects, in the absence of any allegations that Boston Scientific

modified or failed to include FDA-approved warnings about the ICD the Court

concludes that Welz’s failure to warn claims alleged in Counts II and IV of the

Amended Complaint are preempted. In re Medtronic, 623 F.3d at 1205 (failure to

warn claims alleging that state law requires a device manufacturer to give

additional warnings about Class III devices are “different from or in addition to”

federal requirements and therefore preempted); see also Williams v. Bayer Corp.,

541 S.W.3d 594, 609 (Mo. Ct. App. 2017) (under Missouri law, claim based on

failure to warn of problems with Class III implanted device was expressly

preempted under MDA). Counts II and IV are accordingly dismissed.

The next issue is whether Welz’s state law claims for manufacturing defects

are “different from, or in addition to” federal requirements and, if not, whether

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such claims would give rise to liability under state law even if the FDCA had never

been enacted.4 Riegel, 552 U.S. at 321-23; Buckman, 531 U.S. at 353.

Count I of Welz’s Amended Complaint alleges a claim of strict liability for

manufacturing defects under Missouri law. To make a submissible case, Welz has

to prove:

(1) the defendant sold a product in the course of its business; (2) the product

was then in a defective condition, unreasonably dangerous when put to a

reasonably anticipated use; (3) the product was used in a manner reasonably

anticipated; and (4) the plaintiff was damaged as a direct result of such

defective condition as existed when the product was sold.

Coterel v. Dorel Juvenile Group, Inc., 827 F.3d 804, 808 (8th Cir. 2016) (quoting

Columbia Mut. Ins. Co. v. Epstein, 239 S.W.3d 667, 671 (Mo. Ct. App. 2007)).

In Missouri, a manufacturing defect occurs when something goes wrong in the

manufacturing process and the product deviates from its intended condition.

Gillan v. Wright Med. Tech. Inc., 396 F. Supp. 3d 844, 848 (E.D. Mo. 2019) (citing

Smith v. Brown & Williamson Tobacco Corp., 275 S.W.3d 748, 791 (Mo. Ct. App.

2008)).

In support of this claim, Welz alleges that: the ICD implanted into him was

manufactured in deviation of the manufacturing specifications set out in the PMA;

these manufacturing defects rendered the ICD defective and unreasonably

4 There is no dispute that the claims brought by Welz “relate to the safety or effectiveness” of the

device.

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dangerous when put to its reasonably anticipated use; the ICD was defective

because it allowed moisture ingress into the device enabling a shorting condition to

occur, causing the device to fail to deliver shocks, deliver less shock than intended,

fail to respond to a device check-in, and fail to issue appropriate battery alerts; and

that as direct result of the ICD’s manufacturing defects, he was injured.

In support of his claim of negligent manufacturing defects5 in Count III of

his Amended Complaint, Welz alleges: the ICD implanted in him was

manufactured in violation of the PMA specifications as described in Count I;

Boston Scientific owed him a duty under Missouri law to use reasonable care to

manufacture the ICD to be reasonably safe; Boston Scientific was negligent in

failing to use reasonable care in manufacturing the ICD and manufactured the

device in a way that did not comply with the PMA requirements; and as a direct

result of Boston Scientific’s negligence, he was injured.

These claims as pleaded by Welz in Counts I and III of the Amended

Complaint do not attempt to impose responsibilities on Boston Scientific that are

5 Under Missouri law, “in an action for negligence, generally, a plaintiff must allege ultimate

facts which if proven, show: (1) the existence of a duty on the part of the defendant to protect the

plaintiff from injury; (2) failure of the defendant to perform that duty; and (3) injury to the

plaintiff resulting from such failure.” Redd v. DePuy Orthopaedics, Inc., 48 F. Supp. 3d 1261,

1270 (E.D. Mo. 2014). “Thus, in order to recover on a claim for negligent manufacture, a

plaintiff must establish that the defendant failed to use ordinary case to manufacture the product

to be reasonably safe.” Id. (cleaned up).

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different from, or in addition to, the federal requirements, and sufficiently plead

violations of parallel Missouri law such that they are not preempted.

Accordingly,

IT IS HEREBY ORDERED that defendant’s motion to dismiss [15] is

granted as to Counts II and IV of the Amended Complaint, and to Counts I and II

only to the extent that Counts I and II plead design defects as a basis for the strict

liability and negligence claims; in all other respects, the motion to dismiss 1s

denied as to Counts I and III.

This case will be set for a Rule 16 scheduling conference by separate Order.

CATHERINE D.PERRY //

UNITED STATES DISTRICT JUDGE

Dated this 20th day of September, 2024.

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