In Re Medtronic, Inc., Sprint Fidelis Leads

United States Court of Appeals
FOR THE EIGHTH CIRCUIT
___________

No. 09-2290
___________

In re: Medtronic, Inc., Sprint Fidelis *
Leads Products Liability Litigation, *
------------------------------------------------ *
Anna Bryant, et al., *
*
Plaintiff - Appellant, *
* Appeal from the United States
v. * District Court for the
* District of Minnesota.
Medtronic, Inc., et al., *
*
Defendant - Appellee. *
------------------------------------------------ *
Product Liability Advisory Council, *
*
Amicus on Behalf of Appellee. *
___________

Submitted: April 12, 2010
Filed: October 15, 2010
___________

Before LOKEN, MELLOY, and SHEPHERD, Circuit Judges.
___________

LOKEN, Circuit Judge.

Defendant Medtronic, Inc., designed, manufactured, and sold the Sprint Fidelis
Lead, a wire that delivers signals that allow an implantable cardiac defibrillator to
detect an abnormal heart rhythm and deliver a shock to help the heart return to an
appropriate rhythm. After Medtronic recalled the product in October 2007, Anna
Bryant and other patients with implanted Sprint Fidelis Leads filed suits across the
country against Medtronic and its affiliates (collectively, Medtronic) asserting tort and
breach of warranty claims for injuries allegedly caused by the defective leads. The
cases were transferred to the District of Minnesota for pretrial proceedings by the
Judicial Panel on Multidistrict Litigation.

Plaintiffs filed a Master Consolidated Complaint seeking damages and equitable
relief on behalf of “all Plaintiffs who had Sprint Fidelis Leads implanted,” asserting
some twenty distinct state law causes of action including failure to warn, defective
design and manufacturing, breach of express warranty, and fraud. Applying the
preemption principles of Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and the
pleading principles of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), the
district court1 granted Medtronic’s motion to dismiss and denied Plaintiffs’ post-
judgment motions for recusal and for leave to file an amended complaint. Plaintiffs
appeal these rulings. We affirm.

I. Background

In the Medical Device Amendments to the Federal Food, Drug and Cosmetic
Act (“MDA”), Congress authorized the Food and Drug Administration (“FDA”) to
regulate the safety and effectiveness of medical devices. The Sprint Fidelis Lead was
a Class III device, one that presents a potentially unreasonable risk of injuring patients
or that is used to sustain life. See 21 U.S.C. § 360c(a)(1)(C); Medtronic, Inc. v. Lohr,
518 U.S. 470, 477 (1996). Before a new Class III device may be marketed, the
manufacturer must assure the FDA through a rigorous Pre-Market Approval (“PMA”)
process that the device is safe and effective. Once the product is approved, the
manufacturer may not change its design, manufacturing process, labeling, or other

1
The HONORABLE RICHARD H. KYLE, United States District Judge for the
District of Minnesota.

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attributes that would affect safety or effectiveness without filing a PMA Supplement.
21 C.F.R. § 814.39(a). The PMA Supplement is reviewed using the same standard as
the original PMA. See generally Riegel, 552 U.S. at 315-19.

In December 1993, the FDA granted Medtronic premarket approval for the
Transvene Lead System. Progressively smaller leads, such as the Sprint Quattro, were
later approved in a series of PMA Supplements. In June 2004, the FDA approved a
PMA Supplement for the Sprint Fidelis Lead. Patients with implanted Sprint Fidelis
Leads began suffering unnecessary shocks. Dr. Robert G. Hauser of the Minneapolis
Heart Institute and his colleagues investigated patient complaints, published a report
finding that the Sprint Fidelis Lead was more likely to fracture than other types of
leads, met with Medtronic to voice their concerns, and advised the FDA of those
concerns. Despite knowing the leads were unsafe, Plaintiffs allege,2 Medtronic
undertook a vigorous defense of its product that included sending a “Dear Doctor”
letter to practitioners asserting that failures may be the result of improper surgical
technique and assuring doctors that the Sprint Fidelis Leads performed as well as other
Medtronic leads.

In May 2007, Medtronic applied for a PMA Supplement approving design and
manufacturing changes to the Sprint Fidelis Leads without, Plaintiffs allege, advising
FDA of the high rate of failures. A PMA Supplement was approved in July.
Medtronic continued to sell previously manufactured Sprint Fidelis Leads, “finally”
filed 120 adverse event reports in September, and suspended sales in early October,
but doctors continued to implant Sprint Fidelis Leads. Not until October 15, 2007, did
Medtronic announce a world-wide recall of the Sprint Fidelis Lead. Soon after, the
FDA announced a Class I recall, the most serious type of medical device recall. These
product liability lawsuits followed.

2
For purposes of reviewing Medtronic’s motion to dismiss, we assume that facts
pleaded in Plaintiffs’ Master Consolidated Complaint are true. Zutz v. Nelson, 601
F.3d 842, 846 (8th Cir. 2010).

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 The MDA contains an express preemption provision: no State “may establish
or continue in effect with respect to a device . . . 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.” 21 U.S.C. § 360k(a).3 In
Riegel, the Court held that, for § 360k(a) preemption purposes, (i) FDA pre-market
approval is “federal safety review” that results in federal “requirements” specific to
the approved device, and (ii) common law product liability claims result in “state
requirements” that are preempted to the extent they relate to the safety and
effectiveness of the device and are “different from, or in addition to,” the federal
requirements established by PMA approval. 552 U.S. at 322-24. However, the Court
noted, § 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.

The MDA also provides that all actions to enforce FDA requirements “shall be
by and in the name of the United States,” 21 U.S.C. § 337(a). In Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001), the Court construed § 337(a)
as barring suits by private litigants “for noncompliance with the medical device
provisions.” Read together -

Riegel and Buckman create a narrow gap through which a plaintiff’s
state-law claim must fit if it is to escape express or implied preemption.
The 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).

3
The term “relates to” reflects Congress’s “intent to pre-empt a large area of
state law.” Altria Group, Inc. v. Good, 129 S. Ct. 538, 548 (2008).

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Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009). The contours of the
parallel claim exception were not addressed in Riegel and are as-yet ill-defined.

Medtronic moved to dismiss the Master Consolidated Complaint, arguing that
the claims were preempted by § 360k(a). The district court granted the motion,
holding all claims preempted. In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab.
Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009) (“Medtronic Leads”). Plaintiffs’
product liability claims (design defect, manufacturing defect, failure to warn, breach
of warranty, and fraud, among others) unquestionably relate to the safety or
effectiveness of the Sprint Fidelis Lead. Thus, the crucial question on appeal is
whether these claims are parallel claims that avoid preemption because they would not
impose state requirements “different from or in addition to” the federal requirements
established by PMA approval of the Sprint Fidelis Lead.4

II. Parallel Claim Issues

A. Failure to Warn and Related Claims. In the Master Consolidated
Complaint, Plaintiffs alleged that Medtronic failed to adequately warn consumers of
“known defects” and that the Sprint Fidelis Leads presented an unreasonably
dangerous risk beyond what the ordinary consumer would reasonably expect. These
claims are preempted by § 360k. The FDA’s PMA approval includes specific
language for Class III device labels and warnings. Plaintiffs did not allege that
Medtronic modified or failed to include FDA-approved warnings. Rather, they
alleged that, by reason of state law, Medtronic was required to give additional

4
In opposing Medtronic’s motion to dismiss in the district court, Plaintiffs’ lead
argument was that Medtronic lost its federal preemption defense when the Sprint
Fidelis Leads were recalled. Plaintiffs briefed this issue on appeal but did not press
it at oral argument. We reject the contention for the reasons stated by the district
court. Medtronic Leads, 592 F. Supp. 2d at 1155-56.

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warnings, precisely the type of state requirement that is “different from or in addition
to” the federal requirement and therefore preempted. See Riegel, 552 U.S. at 330.

Even if federal law allowed Medtronic to provide additional warnings, as
Plaintiffs alleged, any state law imposing an additional requirement is preempted by
§ 360k. “Where a federal requirement permits a course of conduct and the state makes
it obligatory, the state’s requirement is in addition to the federal requirement and thus
is preempted.” McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005), cert.
denied, 547 U.S. 1003 (2006). Plaintiffs’ reliance on Wyeth v. Levine, 129 S. Ct.
1187 (2009), for a contrary rule is unavailing. Wyeth turned on implied conflict
preemption, not express preemption, because Congress did not extend the express
preemption for medical devices in § 360k to prescription drugs. Id. at 1200.

Plaintiffs further alleged that Medtronic was negligent in continuing to sell the
original version of the Sprint Fidelis Lead after it had received FDA approval to sell
a modified version. However, as the FDA did not prohibit Medtronic from continuing
to sell the unmodified lead, a state requirement to that effect would be “different from
or in addition to” the federal requirement and preempted under § 360k. Finally,
Plaintiffs alleged that Medtronic failed to provide the FDA with sufficient information
and did not timely file adverse event reports, as required by federal regulations. As
the district court concluded, 592 F. Supp. 2d at 1161, these claims are simply an
attempt by private parties to enforce the MDA, claims foreclosed by § 337(a) as
construed in Buckman, 531 U.S. at 349, 353. See Hughes v. Boston Scientific Corp.,
669 F. Supp. 2d 701, 710-12 (S.D. Miss. 2009).

B. Design Defect Claims. The Master Consolidated Complaint alleged that
Medtronic designed the Sprint Fidelis Leads “in a dangerous and defective condition”
and “in a manner violative of the [MDA].” Absent concrete allegations that the
product sold by Medtronic was not the product design approved in the PMA
Supplement, these are not parallel claims. Rather, they are attacks on the risk/benefit

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analysis that led the FDA to approve an inherently dangerous Class III device. Such
claims are expressly preempted by § 360k. See Mitchell v. Collagen Corp., 126 F.3d
902, 913-14 (7th Cir. 1997), cert. denied, 523 U.S. 1020 (1998). “State tort law that
requires a manufacturer’s [Class III device] to be safer, but hence less effective, than
the model the FDA has approved disrupts the federal scheme.” Riegel, 552 U.S. at
325.

C. Manufacturing Defect Claims. Plaintiffs assert that the Sprint Fidelis
Leads were defectively manufactured because Medtronic used unreliable direct
resistence spot welding to affix the device’s cables to electrodes. Count II of the
Master Consolidated Complaint further alleged that “facilities or controls used by
[Medtronic] in the manufacture, packing, storage, or installation of the Sprint Fidelis
Leads were not in conformity with applicable requirements” of the MDA. In
opposing Medtronic’s motion to dismiss, Plaintiffs explained to the district court that
the referenced “applicable requirements” were FDA Current Good Manufacturing
Practices (“CGMPs”) found in the Quality System Regulations applicable to all
medical devices. See 21 C.F.R. Part 820.

The district court concluded that Plaintiffs’ general allegations of failure to
comply with CGMPs -- practices that FDA has described as “an umbrella quality
system” providing “general objectives” for all device manufacturers -- do not save
these claims from preemption under § 360k because Plaintiffs failed to identify any
specific federal requirement in the PMA approval for the Sprint Fidelis Leads that
forms the basis for an unpreempted parallel claim. By contrast, the court noted, the
plaintiff in Rollins v. St. Jude Medical, 583 F. Supp. 2d 790, 799-800 (W.D. La.
2008), alleged that the Class III device manufacturer failed to comply with the
device’s specific PMA requirements. As a result, the court concluded, 592 F. Supp.
2d at 1157-59, Plaintiffs failed to allege a parallel manufacturing defect claim with the
detail required by Twombly, 550 U.S. at 555 (“[A] plaintiff’s obligation to provide
the ‘grounds’ of his ‘entitle[ment] to relief’ requires more than labels and conclusions,

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and a formulaic recitation of the elements of a cause of action will not do.”). Accord
Ashcroft v. Iqbal, 129 S. Ct. 1937, 1951 (2009).

On appeal, Plaintiffs primarily argue that the district court’s application of
Twombly in this case held them to an impossible pleading standard because the
FDA’s specific federal manufacturing requirements are set forth in the agency’s PMA
approval files that are accessible, without discovery, only to Medtronic and to the
FDA. This argument -- which focuses on the timing of the preemption ruling -- would
have considerable force in a case where a specific defective Class III device injured
a consumer, and the plaintiff did not have access to the specific federal requirements
in the PMA prior to commencing the lawsuit. Compare Braden v. Wal-Mart Stores,
Inc., 588 F.3d 585, 598 (8th Cir. 2009) (while plaintiffs “must offer sufficient factual
allegations to show that he or she is not merely engaged in a fishing expedition or
strike suit, we must also take account of their limited access to crucial information.”).5

But that is not the case Plaintiffs presented to the district court. Plaintiffs
alleged that state law entitles every person who has an implanted Sprint Fidelis Lead
to damages (for emotional distress) and to equitable relief (monitoring or implanting
of a replacement device) because all Sprint Fidelis Leads have an unreasonably high
risk of fracture failure. In the district court, Plaintiffs conceded that the PMA
Supplement doubtless authorized the use of spot welding, and they specifically
disclaimed the need for discovery in opposing Medtronic’s motion to dismiss. Thus,

5
At oral argument, Medtronic argued Plaintiffs’ claims fail because the FDA did
not find any violation of federal requirements. Without question, a prior FDA
enforcement action is relevant to whether a plaintiff has adequately pleaded a parallel
claim against a Class III device manufacturer. See Purcel v. Advanced Bionics Corp.,
2008 WL 3874713 at *2 (N.D. Tex. Aug. 13, 2008). But the absence of FDA
enforcement does not preclude the assertion of parallel claims and therefore is relevant
only at the summary judgment stage or at trial.

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as pleaded and argued, the manufacturing defect claims are not parallel, they are a
frontal assault on the FDA’s decision to approve a PMA Supplement after weighing
the product’s benefits against its inherent risks. On this record, the district court
properly concluded these claims are preempted.

At oral argument, Plaintiffs posited a hypothetical case in which the plaintiffs
could not know without discovery that every Class III device was defectively
manufactured because the PMA approval required 400 degree welds but the
manufacturer used a 300 degree welding process. This hypothetical well illustrates
the care that courts must exercise in applying Riegel’s parallel claim principle at the
pleading stage, particularly to manufacturing defect claims. But here, Plaintiffs
simply failed to adequately plead that Medtronic violated a federal requirement
specific to the FDA’s PMA approval of this Class III device. The district court did
not abuse its discretion in denying Plaintiffs’ motion to reconsider the dismissal order
and grant their belated request for discovery to see if they could find such a
requirement. Medtronic Leads, 2009 WL 294353 at *3 (D. Minn. Feb. 5, 2009).

III. Breach of Express Warranty Claims

In the Master Consolidated Complaint, Plaintiffs alleged the breach of express
warranties that Sprint Fidelis Leads “were safe, effective, fit and proper for their
intended use.” The district court concluded that these claims are preempted because
“the safety and effectiveness of the leads are matters solely for the FDA, and because
the FDA determined that the leads were safe and effective.” Medtronic Leads, 592
F. Supp. 2d at 1164. On appeal, Plaintiffs argue that express warranties are not state
“requirements” preempted by § 360k because “the ‘requirement[s]’ imposed by an
express warranty claim are not ‘imposed under State law,’ but by the warrantor.”
Cipollone v. Liggett Group, Inc., 505 U.S. 504, 525 (1992) (plurality opinion)
(emphasis in original).

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 Though Cipollone construed a different, narrower express preemption
provision, the opinion suggests that breach of express warranty claims are not
expressly preempted by § 360k. See In re Medtronic, Inc. Implantable Defibrillators
Litig., 465 F. Supp. 2d 886, 898 (D. Minn. 2006); contra Parker v. Stryker Corp., 584
F. Supp. 2d 1298, 1303 (D. Colo. 2008). However, we need not decide that issue. To
succeed on the express warranty claim asserted in this case, Plaintiffs must persuade
a jury that Sprint Fidelis Leads were not safe and effective, a finding that would be
contrary to the FDA’s approval of the PMA Supplement. A state common law claim
is preempted if it “actually conflicts with the federal requirement -- either because
compliance with both is impossible, or because the state requirement stands as an
obstacle to the accomplishment and execution of the full purposes and objectives of
Congress.” Lohr, 518 U.S. at 507 (Breyer, J., concurring) (quotations and citations
omitted). The MDA in § 360k expressly prohibits States from imposing requirements
“in addition to” federal requirements. The district court correctly concluded that this
express warranty claim interferes with the FDA’s regulation of Class III medical
devices and is therefore conflict preempted. See Gomez v. St. Jude Medical Daig
Div., Inc., 442 F.3d 919, 932 (5th Cir. 2006); cf. Pet Quarters, Inc. v. Depository Trust
& Clearing Corp., 559 F.3d 772, 780-81 (8th Cir. 2009).

IV. Denial of Leave to Amend

Following the district court’s dismissal of their claims and denial of their
motion to reconsider, Plaintiffs moved for leave to file an 85-page Revised Amended
Master Consolidated Complaint. The district court denied the motion because (i)
Plaintiffs did not seek leave to amend before the adverse dismissal ruling, (ii) many
of the allegedly newly-discovered facts were available before they filed the Master
Consolidated Complaint, and (iii) “even if not untimely the Court would deny
Plaintiffs’ Motion because the proposed amendments would be futile.” Medtronic
Leads, 2009 WL 1361313 at *1-2 (D. Minn. May 12, 2009). Plaintiffs appeal that
ruling. We review denial of leave to amend for an abuse of discretion, but the legal

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conclusions underlying a determination of futility are reviewed de novo. In re NVE
Corp. Sec. Litig., 527 F.3d 749, 752 (8th Cir. 2008).

Post-dismissal motions to amend are disfavored. United States ex rel Roop v.
Hypoguard USA, Inc., 559 F.3d 818, 824 (8th Cir. 2009). The untimeliness factor is
particularly acute in this case because Plaintiffs did not seek leave to amend until after
they failed to persuade the district court to reconsider its dismissal order. On the
merits of their motion, though the proposed amended complaint added more factual
details, it again alleged no violation of a specific federal requirement. The amended
complaint continued to allege that every person with an implanted Sprint Fidelis Lead
is entitled to damages and equitable relief, the frontal assault on the FDA’s PMA
approval that resulted in the district court’s dismissal. After careful review of the
proposed amended complaint, we agree with the district court’s futility ruling; the
court did not abuse its discretion in denying the post-judgment motion to amend. See
Briehl v. General Motors Corp., 172 F.3d 623, 629-30 (8th Cir. 1999).

V. The Recusal issue

More than one year after the Judicial Panel on Multidistrict Litigation
consolidated and transferred what became hundreds of cases to Judge Kyle for pretrial
purposes, two months after Judge Kyle dismissed the Master Consolidated Complaint,
and one month after he denied the motion to reconsider, Plaintiffs filed a Motion for
Recusal based upon the fact that Judge Kyle’s son, Richard Kyle, Jr., is a shareholder
at Fredrikson & Byron, a Minneapolis law firm that represents Medtronic in other
matters. Fredrikson & Byron did not represent Medtronic in any matter relating to the
Sprint Fidelis Leads. Mr. Kyle Jr. has a criminal defense practice and has never
worked on a case on behalf of Medtronic. Judge Kyle denied the motion after
thoroughly reviewing the governing law, the facts relevant to the recusal issue, and
the “prudential considerations” militating against recusal. Medtronic Leads, 601 F.
Supp. 2d 1120 (D. Minn. 2009). Plaintiffs appeal that ruling.

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 Plaintiffs knew, or with due diligence could have known, that Medtronic is a
significant client of Fredrikson & Byron, and that Judge Kyle’s son is a shareholder
of the firm, before the Judicial Panel transferred this litigation to Judge Kyle. Thus,
the recusal motion was untimely. It was also a device “interposed for suspect tactical
and strategic reasons” following the district court’s adverse rulings. In re Kansas
Public Employees Retirement System, 85 F.3d 1353, 1360 (8th Cir. 1996). As the
grant of such a belated motion would have serious adverse effects on the efficient use
of judicial resources and the administration of justice, “on this basis alone, the district
court’s . . . denial of the recusal motion is affirmed.” Tri-State Fin., LLC v. Lovald,
525 F.3d 649, 654 (8th Cir.), cert. denied, 129 S. Ct. 630 (2008). We reject,
summarily, Plaintiffs’ additional contention that Judge Kyle’s response to press
inquiries concerning the recusal motion would cause a reasonable person to question
his impartiality in these proceedings. See 28 U.S.C. § 455(a). Cf. White v. Nat’l
Football League, 585 F.3d 1129, 1138-41 (8th Cir. 2009); United States v. Fortier,
242 F.3d 1224, 1229-30 (10th Cir.), cert. denied, 534 U.S. 979 (2001).

The judgment of the district court is affirmed. Medtronic’s motion to file an
oversized 28(j) letter is granted.

MELLOY, Circuit Judge, Concurring in Part and Dissenting in Part.

I.

I concur with the majority except as to the dismissal of the manufacturing-
defect claim and the related issues of the denial of the plaintiff's discovery request and
motion to amend. On these issues, I would reverse and remand for limited discovery
and the opportunity to amend the master consolidated complaint.

I would hold the specificity requirements of Twombly must be applied in a
practical manner that recognizes the parties' relative access to information necessary

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to articulate claims with specificity. Here, as described by the majority and
determined by the district court, the parallel state claim that may escape preclusion
under § 360k requires the plaintiffs to prove Medtronic failed to manufacture the
Sprint Fidelis Leads in compliance with the requirements set forth in the confidential
PMA and supplemental PMAs. To apply Twombly rigidly without permitting
discovery as to these documents effectively creates an impossible-to-achieve
specificity requirement. I do not believe the Court intended Twombly to create this
type of insurmountable hurdle. Rather, I believe the application of Twombly must be
pragmatic. Here, that means requiring only a degree of specificity that may be
achieved without use of the confidential documents. After discovery—an interrelated
issue discussed below—a court reasonably and consistently with Twombly may
demand more from plaintiffs in the articulation of their claims.

Regarding the discovery request and the motion to amend, I would hold, in the
context of the present case, that it was an abuse of discretion to deny the request and
motion. I emphasize that the requested discovery would be quite limited and impose
virtually no burden on the defendants. What the plaintiffs seek, in fact, they already
possess in redacted form: the PMA and supplemental PMAs. What they require is an
unredacted copy of these clearly identified documents that undisputedly rest in the
possession of the FDA and Medtronic. This case does not raise the specter of
burdensome and speculative discovery proceedings as referenced in Twombly and
bears no resemblance to the discovery-related parade of horribles described with
rhetorical flare in the defendant's brief. The plaintiffs here do not seek a fishing
expedition in order to discover possible claims, and they have not asked for anything
resembling a protracted and expensive discovery process.

The defendants argue the plaintiffs did not ask for discovery until after the
district court's initial grant of the motion to dismiss. The majority states the plaintiffs
disclaimed the need for discovery and concludes with no discussion that the district
court did not abuse its discretion "in denying . . . [the plaintiff's] belated request for

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discovery." I disagree. Early in this matter, at least one attorney had strongly urged
the court to allow discovery. Later, the plaintiffs represented in a status conference
that discovery would not be needed unless the motion rested on information outside
the pleadings. By applying Twombly in a manner that requires the plaintiffs to first
obtain PMAs and specifically articulate claims through reference to deviations from
manufacturing requirements as set forth in the PMAs, the district court necessarily
brought the PMAs into the case. Doing so advanced the motion to dismiss beyond the
mere pleadings. Accordingly, I view the record as showing that the plaintiffs had
indicated discovery would be needed in this exact situation.

Unfortunately, the plaintiffs did not know until after the district court dismissed
their complaint that the viability of their manufacturing-defect claims at the pleading
stage would rest wholly upon the contents of the PMAs. When this disputed legal
issue was clarified through the district court's application of Twombly in its
preemption decision, plaintiffs sought the opportunity to review the documents that
were made outcome determinative by the district court's dismissal order. Only review
of these documents could empower the plaintiffs to amend their pleadings in a manner
consistent with the district court's interpretation of the preemption/parallel claim
doctrine.

The combination of the rigid application of Twombly and the now-articulated
parallel claim exception to § 360k preemption have, in these cases, led to the dismissal
of over two hundred potentially meritorious lawsuits on a technicality. I view this as
unjust in this evolving and complex area of the law. It is particularly inappropriate
where all that is required to avoid this result is the grant of a request for focused
discovery that will involve truly de minimis costs. In some case, concerns for
efficient case administration may dictate a result like that reached today. Efficiency
cannot rule the day, however, when plaintiffs seek only the disclosure of clearly
identified documents undisputedly held by the defendants.

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 II.

Supplemental PMAs impose requirements specific to individual devices based
on manufacturers’ submissions to the FDA. Riegel, 552 U.S. at 323. “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
effectiveness.” Id. (internal quotations and citation omitted); see also 21 C.F.R.
§ 814.80 ("A device may not be manufactured, packaged, stored, labeled, distributed,
or advertised in a manner that is inconsistent with any conditions to approval specified
in the PMA approval order for the device."); id. § 820.70(a) ("Each manufacturer shall
develop, conduct, control, and monitor production processes to ensure that a device
conforms to its specifications.").

The plaintiffs allege (mostly in their amended master complaint) that they were
injured because the Sprint Fidelis Leads failed to conform to the device's
specifications. At a general level, this is a classic example of a "parallel" state-law
claim because the plaintiffs' claim does not seek relief based on some duty or
requirement specific to the Sprint Fidelis Leads beyond what is imposed by federal
law. The district court recognized this type of claim as a "back door for plaintiffs"
that was left open by Riegel. See generally Miller v. DuPuy Spine, Inc., 638 F. Supp.
2d 1226, 1230 (D. Nev. 2009) ("Only a departure from such FDA-approved
specifications could conceivably escape preemption. . . ."). In general, plaintiffs
attempting to the fit into this narrow category nearly always rely on the
manufacturer’s submissions to the FDA.6

6
The Sixth Circuit, pre-Twombly, explained that a manufacturer’s submissions
to the FDA are critical to discerning what requirements are applicable to a medical
device:

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 The present plaintiffs do not allege how the Sprint Fidelis Leads failed to
conform to FDA-approved specifications. Instead, they assert that they "cannot
specify the requirements because filings with the FDA are confidential."7 Thus, the
discovery issue on appeal is intertwined with the question of the sufficiency of the
pleadings. The question with regard to the motion to dismiss, therefore, is whether
the plaintiffs must allege that the Sprint Fidelis Leads violated a particular and
confidential FDA-approved specification.

The district court held that the plaintiffs' "conclusory allegation" about FDA-
approved specifications "fails to pass muster." I view this holding as failing to take
into account the practical difficulties inherent in situations, like this, where the
"crucial information . . . tend[s] systematically to be in the sole possession of the

It is true that in granting approval for a Class III device, the FDA does
not set forth the reasons justifying its decision. Impliedly, however, the
FDA has relied upon both the PMA submission approved for the original
Class III device and the PMA Supplement providing specific information
on the proposed modification in question. These specific submissions
form the basis of the FDA’s approval of the PMA Supplement. Thus, we
conclude the specific requirements applicable to the Model 4004M
include the entire relevant PMA and accompanying PMA Supplement,
rather than certain portions thereof. In the case of the Model 4004M,
then, the information submitted to and approved by the FDA in both the
Model 4003 PMA and as modified by the Model 4004M PMA
Supplement comprise the specific federal requirements applicable to
Medtronic’s Model 4004M pacemaker lead.

Kemp v. Medtronic, Inc., 231 F.3d 216, 228 (6th Cir. 2000).
7
Federal regulations provide that the information about a PMA applicant’s
"[m]anufacturing methods or processes, including quality control procedures"
generally are not available for public disclosure unless that information has been
previously disclosed to the public. 21 C.F.R. § 814.9(h)(1).

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defendants . . . ." Braden v. Wal-Mart Stores, Inc., 588 F.3d 585, 598 (8th Cir. 2009)
(describing a similar information imbalance in certain ERISA actions). In Braden, our
court reversed a dismissal on the pleadings and called for "careful and holistic
evaluation of . . . factual allegations" where defendants were in sole possession of
facts necessary to state claims with particularity. In my view, this "careful and holistic
evaluation" should accommodate the possibility of limited discovery when the subject
matter at hand makes clear that the discovery burden will be slight.

In Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830, 838 (S.D. Ind.
2009), for example, the court refused to use Twombly to cut off manufacturing-defect
claims articulated in a manner almost identical to those in the present case. There, in
fact, the court commented on the district court's order from the present case,
suggesting that it is "an unusually stringent application of Twombly and Rule 8 of the
Federal Rules of Civil Procedure at the motion to dismiss stage." Id. The court
explained:

Manufacturing defect claims are not subject, for example, to the
"particularity" pleading requirements of Rule 9. By way of comparison,
in Lohr, the Supreme Court reversed dismissal of similar claims, even
though “the precise contours of their theory of recovery have not yet
been defined,” because it was clear that the plaintiffs allegations "may
include claims that Medtronic has, to the extent that they exist, violated
FDA regulations." 518 U.S. at 495.

Id. In Hofts, the plaintiff “brought claims premised on Howmedica’s alleged failure
to manufacture the [device] in accordance with the PMA issued by the FDA." Id.
Ultimately, that court held the allegations—virtually identical to the present
allegations—sufficient to state a claim.

I agree with the court in Hofts because its pragmatic approach does not turn
Twombly into an insurmountable hurdle for plaintiffs. Importantly, submissions to

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the FDA for PMAs and supplemental PMAs are confidential, and, as in the present
case, redacted copies obtained through Freedom of Information Act requests are not
always adequate to supply plaintiffs with the manufacturing requirements critical to
articulate a non-preempted claim. 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. In
essence, application of Twombly in this manner eliminates the remaining exception
to § 360k preemption.

The basic principle I would apply recognizes, simply and fairly, that a plaintiff's
pleading burden should be commensurate with the amount of information available
to them. This is not an unorthodox approach. See Michaels Bldg. Co. v. Ameritrust
Co., N.A., 848 F.2d 674, 680 (6th Cir. 1988) ("Courts have held that the [Rule 9(b)
particularity requirement] may be relaxed where information is only within the
opposing party's knowledge. Especially in a case in which there has been no
discovery, courts have been reluctant to dismiss the action where the facts underlying
the claims are within the defendant's control.") (internal citations omitted). Most of
the arguments that would militate against this approach rely upon the risk that
discovery will create unnecessary burdens for defendants and permit unworthy
plaintiffs to file frivolous suits merely to fish for possible claims. See, e.g., United
States ex rel. Joshi v. St. Luke's Hosp., Inc., 441 F.3d 552, 559 (8th Cir. 2006)
(rejecting a request for discovery in the context of a qui tam action and rejecting a
request to relax Rule 9(b)'s heightened particularity requirements for pleading fraud
claims, noting, "The reluctance of courts to permit qui tam relators to use discovery
to meet the requirements of Rule 9(b) reflects, in part, a concern that a qui tam
plaintiff, who has suffered no injury in fact, may be particularly likely to file suit as
a pretext to uncover unknown wrongs." (quoting United States ex rel. Karvelas v.
Melrose-Wakefield Hosp., 360 F.3d 220, 231 (1st Cir. 2004)) (emphasis added)). I
fail to appreciate how these concerns relate in any manner to the present case, where
all that is needed through discovery is an unredacted copy of the PMAs, where at least

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some of the plaintiffs have suffered actual and serious injuries, and where other
plaintiffs are at heightened risk for future medical intervention.

Regarding the district court's discovery ruling in particular, some additional
facts are helpful to provide the full context for this matter. The defendants argue that
the plaintiffs shifted positions following the district court's initial dismissal of their
claims and now seek discovery after having expressly disavowed any need for
discovery. I view this as an inaccurate description of the case. The plaintiffs had
sought the PMA documents through FOIA requests, but according to them, "the
documents the FDA produced were too heavily redacted to provide the specifications
that the district court required." The plaintiffs moved to compel production of
unredacted documents or to amend the protective order to allow the FDA to produce
the documents without redaction. A magistrate judge denied the plaintiffs' motion.
One day later, the district court issued its order dismissing all claims with prejudice
and staying all proceedings pending appeal. The plaintiffs filed a letter asking the
district court "to clarify that their time to object to [the magistrate judge's] Order is
stayed along with the rest of this case." The district court ordered that the stay of
proceedings includes the time for the plaintiffs to object to the magistrate judge's order
on compelling unredaction of the FDA documents. Thus, the magistrate judge's
discovery order is not ripe for appeal.

During a status conference on January 28, 2009, plaintiffs' counsel indicated
that they intended to seek leave to file a motion to amend the master consolidated
complaint. According to the district court, "Plaintiffs argued strenuously that they are
entitled to discovery before moving to amend . . . ." The district court denied
discovery. The district court, in denying leave to amend and pursue discovery,
suggested that the plaintiffs were unclear about the scope of discovery and how they
believed the material will help them. However, the order itself demonstrates that the
court was aware that the plaintiffs specifically sought to discover the specifications
contained in the Sprint Fidelis Leads' PMAs. Indeed, the plaintiffs have sufficiently

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alleged that the Leads were defective, they have discovered violations of other FDA
requirements, but they cannot allege a violation of an FDA-approved specification
without access to Medtronic’s submissions. This is far from"play[ing] Court-
sanctioned roulette, hoping that they will hit the discovery 'jackpot' and uncover facts
to support their claims," as suggested by the district court and as echoed by the
defendants.

The defendants note that the district court stated "Plaintiffs' lead counsel made
clear from the outset of this case that no discovery was necessary in order to resolve
the preemption issue." The majority also makes this point. In fact, the district court
rejected the plaintiffs' attempt to explain the statement in an earlier status conference
stating "counsel is attempting to engage in revisionist history by suggesting that he left
open the door for discovery at the initial status conference."

Discussing the motion to dismiss, however, counsel did not disavow the need
for discovery if the motion was "going to be some sort of broader motion that pulls
in information outside of the pleadings." The attorney who made this statement was
subsequently appointed lead attorney, but he was not lead attorney at the time he made
the statement. Another attorney at the same conference suggested, presciently, that
discovery was necessary on the manufacturing-defect issues in order to establish an
exception to Riegel—and he even said that he could be sued for legal malpractice for
failing to request such discovery. All of these circumstances lead me to believe that
Plaintiffs’ account of the scheduling conference was not so “revisionist,” and also that
it was improper for the district court to rely on this exchange to deprive Plaintiffs of
discovery that is seemingly necessary for them to state a claim that will avoid federal
preemption.

Finally, regarding the motion for leave to amend, I do not present an exhaustive
analysis. I note only that I can find no suggestion of bad faith by the plaintiffs or
prejudice to the defendants associated with granting leave to amend. Accordingly, for

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the reasons set forth above, I would hold denial of the motion for leave to amend and
the request for discovery was an abuse of discretion.
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