Penich Garross v. Medtronic Inc et al

Filing 30

DECISION AND ORDER signed by Judge Lynn Adelman on 1/21/15 granting in part and denying in part 15 Motion to Dismiss. The motion is GRANTED as to plaintiffs breach of express and implied warranty claims; the motion is DENIED as to all other claims. (cc: all counsel) (dm)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF WISCONSIN
_____________________________________________________________________
KATHLENE A. PENICH GARROSS,
Plaintiff,
v.

Case No. 14-cv-0134

MEDTRONIC, INC. and
MEDTRONIC SOFAMOR DANEK USA INC.,
Defendants.
_____________________________________________________________________
DECISION AND ORDER
Plaintiff, Kathlene Penich Garross, brings this diversity suit against defendants
(collectively “Medtronic”) alleging numerous tort claims stemming from her spinal surgery.
Specifically, plaintiff alleges that Medtronic violated state law by promoting an off-label use
of a Class III medical device regulated by the Food and Drug Administration (“FDA”).
Medtronic moves to dismiss the complaint on several grounds primarily that plaintiff’s
claims are expressly and impliedly preempted by federal law.
I. Background
The Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq.,
amended the Food, Drug and Cosmetic Act (“FDCA”), establishing several levels of federal
oversight of medical devices. Class III devices receive the most oversight and require
premarket approval by the FDA. Riegel v. Medtronic, Inc., 552 U.S. 312, 317–18 (2008).
Manufacturers must submit a multi-volume premarket approval application specifying,
among other things, the “intended use” of the device. 21 U.S.C. § 360e(c)(2)(A)(iv). The
FDA then determines the safety and effectiveness of the device based “on the conditions
of use included” in the application. § 360e(d)(1)(A). “Once a device has received premarket

approval, the MDA forbids the manufacturer to make, without FDA permission, changes
in design, specifications, manufacturing processes, labeling, or any other attribute, that
would affect safety or effectiveness.” Riegel, 552 U.S. at 319. Such changes require the
manufacturer to submit a supplemental application to the FDA, which is subject to the
same rigorous standards of review as an initial premarket approval application. Id.
In 2002, the FDA granted premarket approval for Medtronic’s Infuse bone graft/ltcage lumbar tapered fusion device (“combination device”), a Class III device designed to
treat degenerative disc disease which affects the spine. The device has two components:
(1) a spinal fusion cage and (2) a bone graft component, which includes a geneticallyengineered human protein and a sponge-like carrier or scaffold for the protein that is
placed inside the cage. The FDA’s premarket approval specified that the combination
device could be used in the lumbar spine (L4-S1) via an anterior, or abdominal, approach,
which was the intended use Medtronic supplied in its premarket approval application. The
FDA has never approved use of the combination device in other parts of the body or in any
other type of procedure. Further, it has never approved use of the bone graft component
separate from the cage component. In fact, the FDA-approved labeling states that “[t]hese
components must be used as a system. The InFUSE Bone Graft component must not be
used without the LT-Cage Lumbar Tapered Fusion Device component.” Defs.’ Br. in Supp.
Ex. 3, at 2 (ECF No. 16-3). The label goes on to explain that “[t]he safety and effectiveness
of the InFUSE Bone Graft component with other spinal implants, implanted at locations
other than the lower lumbar spine, or used in surgical techniques other than anterior open
or anterior laproscopic approaches have not been established. When degenerative disc
disease was treated by a posterior lumbar interbody fusion procedure with cylindrical
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threaded cages, posterior bone formation was observed in some instances.” Id. at 5.
In 2008, plaintiff had spinal surgery. Her surgeon implanted the Infuse bone graft
component without the cage component at the L1-L2 vertebrae using a posterior approach.
This was an “off-label” use of the device for several reasons: it involved only one
component rather than the combination device as a whole, it was implanted in the spine
at a different location than that approved, and it relied on a posterior rather than an anterior
approach. Since her 2008 surgery, plaintiff alleges that she has experienced “exuberant
bone growth,” causing pain and requiring additional surgeries, which she attributes to the
off-label surgery. Compl. at 4 (ECF No. 1).
Despite the label warnings and the limited nature of the premarket approval, plaintiff
alleges that Medtronic promoted the type of off-label use used in her surgery, namely use
of the bone graft component via a posterior approach, in violation of federal law.
Specifically, she alleges that Medtronic paid opinion leaders in the medical community to
promote riskier off-label uses of the bone graft component and to hide and downplay the
risks of these off-label uses, discouraged publication of adverse events resulting from
these off-label uses, and failed to report adverse events related to off-label uses to the
FDA. She further alleges that these violations of federal law caused her injuries and
constitute evidence of various state law torts such as fraudulent misrepresentation, fraud
in the inducement, constructive fraud, strict products liability – failure to warn, strict
products liability – design defect, breach of express and implied warranty, negligence, and
negligent misrepresentation.

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II. Discussion
A. Preemption
The FDCA expressly preempts any state or local requirement relating to medical
devices that is “different from, or in addition to” federal requirements and that “relates to
the safety or effectiveness of the device.” 21 U.S.C. § 360k(a); Riegel, 552 U.S. at 316. To
determine whether a federal law expressly preempts a state law claim, I first examine
whether there are federal “requirements” applicable to the medical device. Id. at 321–22.
If so, then I determine whether plaintiff’s state common law claims are “different from, or
in addition to” the federal requirements and related to the safety and effectiveness of the
device. Id.
“The Supreme Court . . . has made clear that section 360k protects a medical device
manufacturer from liability to the extent that it has complied with federal law, but it does not
extend protection from liability where the claim is based on a violation of federal law.”
Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010); see also Riegel, 552 U.S. at
330 (limiting its holding to claims that a device manufacturer “violated state tort law
notwithstanding compliance with the relevant federal requirements”); Medtronic, Inc. v.
Lohr, 518 U.S. 470, 513 (1996) (O’Connor, J., concurring in part and dissenting in part) (“I
also agree [with the Court] that the [plaintiff’s] claims are not pre-empted by § 360k to the
extent that they seek damages for Medtronic’s alleged violation of federal requirements.”).
This is so because a state law remedy for a violation of federal law does not impose a
requirement “different from, or in addition to” a federal requirement; it simply gives
manufacturers an additional reason to comply. Lohr, 518 U.S. at 513 (O’Connor, J.

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concurring in part and dissenting in part) (“Section 360k does not preclude States from
imposing different or additional remedies, but only different and additional requirements.”);
Bausch, 630 F.3d at 553 (“[I]f [plaintiff] can prove those allegations of harm caused by
violations of federal law, her claims under state law would not impose on defendants any
requirement ‘different from, or in addition to, any requirement’ imposed by federal law.”);
id. (“Just as a plaintiff in an auto accident may use the other driver’s speeding violation as
evidence of negligence, plaintiff . . . claims that she was injured by [defendant’s] violations
of federal law.”).
In addition to express preemption, plaintiff’s state law claims must survive implied
preemption, a doctrine under which state law claims arising “solely from the violation of
[federal] requirements” are impliedly preempted. Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341, 352–53 (2001) (finding that a state claim for “fraud on the FDA” was a claim
solely for violation of federal law impliedly preempted by 21 U.S.C. § 337(a)). Thus, there
is a gap through which plaintiff’s state law claims must fit if they are to escape express and
implied preemption: “The plaintiff must be suing for conduct that violates the Food, Drug,
and Cosmetic Act (or else his claim is expressly preempted by § 360k(a)), but the plaintiff
must not be suing because the conduct violates the Food, Drug, and Cosmetic Act (such
a claim would be impliedly preempted under Buckman).” Bausch, 630 F.3d at 557–58
(quoting In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204
(8th Cir. 2010)). In other words, a state law claim which alleges a violation of the FDCA but
which alleges that violation in the context of an independent, “well-recognized duty owed
to [plaintiff] under state law” can survive both express and implied preemption. Id. at 558.

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First, I consider whether federal requirements applicable to the device exist.
Premarket approval of Class III devices impose federal “requirements” within the meaning
of § 360k(a). Riegel, 552 U.S. at 322–23. These requirements are device-specific, not usespecific, Ramirez v. Medtronic, Inc., 961 F. Supp. 2d 977, 987–88 (D. Ariz. 2013), and thus
are still applicable to the device even for off-label uses. Thus, federal requirements
applicable to the Infuse combination device exist. Plaintiff contends, however, that no
federal requirements apply to the bone graft component itself because premarket approval
applied only to the use of the components together. I need not decide this issue because
even assuming federal requirements exist, the state law on which plaintiff’s claims rely do
not place different or added requirements on defendants and are thus not expressly
preempted.
Each of plaintiff’s claims is based on an alleged underlying violation of federal law.
First, her fraudulent misrepresentation and fraud in the inducement claims are based on
Medtronic’s alleged promotion of off-label uses of the bone graft component, including
misrepresenting the risks of such off-label uses to the medical community. While the FDCA
does not regulate a doctor’s off-label use of a device, see Buckman, 531 U.S. at 350–52,
the FDA prohibits device manufacturers from promoting off-label uses of their products,
see 21 U.S.C. § 331(a) (prohibiting manufacturers from misbranding medical devices); 21
C.F.R. § 814.80 (providing that a “device may not be . . . advertised in a manner that is
inconsistent with any conditions to approval specified in the PMA approval order for the
device”); Carson v. Depuy Spine, Inc., 365 Fed. Appx. 812, 815 (9th Cir. 2010) (“[W]hile
doctors may use a drug or device off-label, the marketing and promotion of a Class III

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device for an unapproved use violates Section 331 of the FDCA.”).1 Citing these alleged
violations of federal law as evidence of fraudulent misrepresentation and fraud in the
inducement thus does not impose requirements different from or in addition to federal
requirements; rather state law merely imposes a remedy for such violations.
Second, plaintiff’s negligence, negligent misrepresentation, strict liability – failure to
warn, fraud, and constructive fraud claims are based on Medtronic’s alleged failure to
report adverse events to the FDA and to submit a supplemental application seeking
approval of the off-label use it was promoting. Class III medical device manufacturers are
required to report adverse events to the FDA, 21 C.F.R. § 803.50, investigate serious
adverse events and submit follow-up reports, 21 C.F.R. § 803.56, and submit a
supplemental application for approval of additional uses of a medical device. 21 C.F.R. §
814.39 (listing “new indications for use of the device” as a change requiring supplemental
FDA approval). Plaintiff may rely on these alleged violations as evidence that Medtronic
violated a state common law duty to warn patients of the risks of the off-label use. Plaintiff
does not claim that state law imposes an additional requirement on Medtronic to warn
patients directly, but rather that a breach of these various federal requirements alone is

1

Medtronic cites U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012) to support the
assertion that “whether federal law prohibits off-label promotion remains a disputed
question.” Defs.’ Br. in Supp., at 15 n.14 (ECF No. 16). While Caronia “construe[d] the
FDCA as not criminalizing the simple promotion of a drug’s off-label use because such
a construction would raise First Amendment concerns,” Caronia, 703 F.3d at 160,
Medtronic has not raised First Amendment issues here, and I find those cases
interpreting the statutes and federal regulations as prohibiting off-label promotion
persuasive. See, e.g., Carson, 365 Fed. Appx. at 815, Houston v. Medtronic, Inc., 957
F. Supp. 2d 1166, 1179 (C.D. Cal. 2013); Ramirez, 961 F. Supp. 2d at 990 & n.8;
Hornbeck v. Medtronic, Inc., No. 13-C-7816, 2014 WL 2510817, at *4 (N.D. Ill. June 2,
2014).
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enough to establish liability under her various common law claims.
Third, plaintiff’s strict liability – design defect claim is based on Medtronic’s alleged
promotion of off-label use, failure to investigate and report adverse events, and failure to
seek supplemental FDA approval of that off-label use. Plaintiff argues that Medtronic’s
device was defectively designed for the use Medtronic promoted, and that Medtronic’s
alleged violations of federal law in failing to seek supplemental FDA approval and
promoting off-label use, despite knowledge of adverse effects, is evidence supporting her
design defect claim. Again, the state law on which plaintiff relies does not impose a
requirement different from or in addition to federal requirements; it merely creates a state
law remedy.
Thus, none of plaintiff’s state law claims are expressly preempted.
Nor are plaintiff’s claims impliedly preempted. This is so because none of them
arise solely from a violation of federal law; rather, each arises from an independent, wellrecognized duty owed under state law. See Buckman, 531 U.S. at 353 (distinguishing
between claims arising “from the manufacturer’s alleged failure to use reasonable care”
and claims arising “solely” from a violation of a federal requirement); Bausch, 630 F.3d at
558 (holding that claims which allege a “breach of a well-recognized duty owed to [plaintiff]
under state law” are not impliedly preempted).2
2

Medtronic’s alleged off-label promotion of its Infuse device has been the subject
of litigation throughout the country, and some courts have concluded that claims similar
to those asserted here are expressly and/or impliedly preempted. I do not find these
cases persuasive. Moreover, I am bound by Seventh Circuit case law stating that “[t]he
idea that Congress would have granted civil immunity to medical device manufacturers
for their violations of federal law that hurt patients is, to say the least, counter-intuitive.”
Bausch, 630 F.3d at 549; see also Hornbeck v. Medtronic, Inc., No. 13-C-7816, 2014
WL 2510817, at *4 (N.D. Ill. June 2, 2014) (noting that “Bausch makes clear that . . . a
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B. Other Arguments for Dismissal
Medtronic makes several additional arguments, first that plaintiff’s claims are timebarred by the applicable three year statute of limitations. See Wis. Stat. §§ 893.04, 892.54.
In Wisconsin, claims begin to accrue “once a person either discovers the injury or in the
exercise of reasonable diligence should have discovered the injury.” Claypool v. Levin, 209
Wis. 2d 284, 301 (1997). “[D]iscovery occurs when a potential plaintiff has information that
would give a reasonable person notice of her injury or its cause.” Id. at 300. When a
plaintiff should have reasonably discovered her injury is a fact issue. Hennekens v. Hoerl,
160 Wis. 2d 144, 172 (1991) (Abrahamson, J. dissenting); Carlson v. Pepin Cnty., 167
Wis. 2d 345, 349 (Ct. App. 1992).
Generally, a statute of limitations bar is an affirmative defense, and it is “irregular”
to dismiss a claim as untimely on a motion to dismiss. Hollander v. Brown, 457 F.3d 688,
691 n.1 (7th Cir. 2006) (quoting United State v. N. Trust Co., 372 F.3d 886, 888 (7th Cir.
2004)). Under Fed. R. Civ. P. 8, a complaint need not anticipate or overcome affirmative
defenses such as the statute of limitations. Xechem, Inc. v. Bristol-Myers Squibb Co., 372
F.3d 899, 901 (7th Cir. 2014). Dismissal based on a statute of limitations under Rule
12(b)(6) is only appropriate when the plaintiff effectively pleads herself out of court by
alleging facts that are sufficient to establish the defense. Hollander, 457 F.3d at 691 n.1.
Here, plaintiff’s complaint alleges that she “did not known[sic] and could not have
known by the exercise of reasonable diligence, until September 11, 2012" of her injuries.

medical device manufacturer receives no protection where a plaintiff can prove that the
manufacturer’s violation of federal law caused his or her injury compensable under
state law”).
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Compl., at 15 (ECF No. 1). This is enough to survive defendant’s motion to dismiss. When
plaintiff should have discovered her injuries is a fact question best determined after
discovery.
Second, Medtronic argues that plaintiff’s failure to warn and negligence claims fail
as a matter of law. It contends that under the learned intermediary doctrine, its duty to
warn runs to the surgeon and not the patient, and that under the sophisticated user
doctrine, it has “no duty to warn members of a trade or profession about dangers generally
known to the trade or profession.” Haase v. Badger Mining Corp., 266 Wis. 2d 970, 984
(Ct. App. 2003) (internal quotations omitted). Even assuming that the learned intermediary
doctrine applies in Wisconsin, which plaintiff contests, I decline to dismiss plaintiff’s failure
to warn claims at this time. Plaintiff alleges that Medtronic intentionally misrepresented and
misled the medical community about the risks associated with the promoted off-label use
of the Infuse bone graft component. These allegations raise a fact issue as to whether the
sophisticated user doctrine applies and precludes dismissal.
Third, Medtronic argues that plaintiff fails to adequately plead failure to warn,
negligence, design defect, and failure to report adverse events. To survive, plaintiff’s
complaint must “state a claim to relief that is plausible on its face,” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 570 (2007), and must give Medtronic fair notice of the nature of
her claims. Bausch, 630 F.3d at 559. Generally, “notice pleading remains the standard.”
Id. (internal quotations omitted).

Plaintiff’s claims are sufficiently pled to survive

Medtronic’s motion to dismiss. While Medtronic complains of an absence of detail, “much
of the product-specific information about manufacturing needed to investigate” claims such

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as plaintiff’s “is kept confidential by federal law.” Id. at 558. Thus, “[f]ormal discovery is
necessary before a plaintiff can fairly be expected to provide a detailed statement of the
specific bases for her claim.” Id.
Fourth, Medtronic argues that plaintiff fails to plead fraud with particularity as
required by Fed. R. Civ. P. 9(b). Rule 9(b) requires a plaintiff to plead “the who, what,
when, where, and how” of the allegedly fraudulent act. Wigod v. Wells Fargo Bank, N.A.,
673 F.3d 547, 569 (7th Cir. 2012) (internal quotations omitted). Plaintiff satisfies this
standard. Her complaint alleges the who (Medtronic in conjunction with various “opinion
leaders”), the what (promoting off-label use of the Infuse bone graft component and
causing plaintiff’s injury), the when (after premarket approval of the Infuse combination
device in 2002, continuing after a DOJ settlement in 2006, and through the time of
plaintiff’s surgery), the where (in various places, including editorials and industry-sponsored
articles), and the how (by paying “opinion leaders” to promote the off-label use and
manipulating medical literature). This is sufficient.
Finally, plaintiffs allege that Medtronic breached express and implied warranties,
and Medtronic moves to dismiss these claims on a variety of grounds. Plaintiff failed to
respond to Medtronic’s arguments. Failure to respond to an argument results in waiver.
Bonte v. U.S. Bank, N.A., 624 F.3d 461, 466 (7th Cir. 2010); Kirksey v. R.J. Reynolds
Tobacco Co., 168 F.3d 1039, 1041 (7th Cir. 1999) (“If [judges] are given plausible reasons
for dismissing a complaint, they are not going to do the plaintiff’s research and try to
discovery whether there might be something to say against the defendants’ reasoning.”).
Thus, I will dismiss plaintiff’s warranty claims.

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C. Request for Judicial Notice
Finally plaintiff requests that I take judicial notice of several medical journal articles,
a U.S. Senate staff report, hearing transcripts and filings from other cases, the FDAapproved labeling for the Infuse combination device, and letters from Senators to
Medtronic. Medtronic asks me to take judicial notice of the FDA-approved labeling but
objects to my taking judicial notice of the articles, staff report, and Senator letters and to
accepting the factual findings in any case materials. I may take judicial notice of publiclyavailable documents when the contents are “not subject to reasonable dispute” and are
“capable of accurate and ready determination by resort to sources whose accuracy cannot
reasonably be questioned.” Fed. R. Civ. P. 201(b). Neither party disputes the accuracy of
the FDA-approved labeling, and the document is publicly available on the FDA’s website.
See Funk v. Stryker Corp., 631 F.3d 777, 783 (5th Cir. 2011) (affirming the district court’s
decision to take judicial notice of the FDA’s premarket approval of a medical device). Thus,
I will take judicial notice of the FDA-approved labeling. I will deny plaintiff’s request for
judicial notice as to the rest of the documents because I did not rely on them in reaching
my decision.
III. Conclusion
THEREFORE, IT IS ORDERED that defendants’ motion to dismiss (ECF No. 15)
is GRANTED in part and DENIED in part.
(a)

The motion is GRANTED as to plaintiff’s breach of express and implied
warranty claims;

(b)

The motion is DENIED as to all other claims.

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Dated at Milwaukee, Wisconsin, this 21st day of January, 2015.

s/ Lynn Adelman
_____________________
LYNN ADELMAN
District Judge

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