McCormick v. Medtronic, Inc. ( 2014 )

REPORTED
IN THE COURT OF SPECIAL APPEALS
OF MARYLAND
No. 670
September Term, 2013
STEVEN L. MCCORMICK, ET UX.
v.
MEDTRONIC, INC., ET AL.
Meredith,
Berger,
Arthur,
JJ.
Opinion by Arthur, J.
Filed: October 6, 2014
This case principally concerns the extent to which federal law expressly or
impliedly preempts state common-law and statutory claims for personal injuries that
resulted from the so-called “off-label” promotion of a medical device.
Relying on one of the first of what are now numerous federal district court
decisions concerning the specific device at issue in this case, the Circuit Court for
Montgomery County ruled that federal law preempted all of the plaintiffs’ claims, except
those for fraud. The court then ruled that the plaintiffs had failed to plead fraud with
particularity. Consequently, the court dismissed the claims against the manufacturer with
prejudice.
We shall hold that federal law does not expressly or impliedly preempt the
plaintiffs’ claims concerning misrepresentations or express warranties that the
manufacturer may have made in voluntary communications with the public or with
members of the medical profession. We shall also hold that the plaintiffs failed to plead
common-law fraud with particularity, but that the circuit court, on remand, should allow
them an opportunity to replead. We shall affirm the circuit court in all other respects.
Q UESTIONS P RESENTED
Appellants present two questions for our review, which we have rephrased as
follows:
I. Did the trial court err in holding that all of the
appellants’ causes of action (except those for fraud) are
expressly and impliedly preempted by federal law?
II. Did the trial court err in holding that appellants had
failed to plead fraud with particularity?
As stated above, we shall affirm in part and reverse in part on the preemption
issues. On the issue of pleading fraud with particularity, we shall affirm, but shall direct
the circuit court to afford leave to amend on remand.
F ACTUAL AND P ROCEDURAL H ISTORY
A. Introduction
This is one of numerous cases nationwide concerning the Infuse Bone Graft
device, a medical device that is manufactured and marketed by defendant Medtronic, Inc.
In 2007, plaintiff Steven McCormick underwent spinal-fusion surgery, in which
his surgeon, defendant Michael K. Rosner, M.D., implanted the Infuse device in an “off-
label” manner – i.e., in a manner other than the one “for which it has been approved by
the FDA.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001). Mr.
McCormick claims to have suffered serious complications, including excessive bone
growth, which allegedly necessitated a second surgery and has left him disabled. He
attributes his condition to what he characterizes as Medtronic’s “illegal” promotion of
off-label uses of the device, including alleged misrepresentations concerning the risks of
the off-label uses.
B. The Infuse Device
As approved by the FDA in 2002, the Infuse device consists of three components:
a genetically-engineered version of a naturally-occurring protein that stimulates bone
growth; a collagen sponge; and a cage or hollow cylinder that holds the vertebrae in place
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and directs the development of bone growth.
In surgery employing the device, the genetically-engineered protein is applied to
the sponge, which acts as a carrier and scaffold for the protein. The surgeon implants the
protein-infused sponge and the cage into the spine, where the protein evidently spurs the
bone growth necessary to achieve the fusion. The device thus appears to have been
intended to replace or supplant the conventional method of performing spinal-fusion
surgery, which involves harvesting bone (either from the patient’s hip or from a cadaver)
and implanting the harvested bone in the patient’s spine.
C. FDA Approval
The McCormicks allege that the majority of spinal-fusion procedures, including
those that are used to treat nerve compression, are performed by means of a “posterior
approach” through the back. The McCormicks further allege that even before the FDA
approved the Infuse device in 2002, Medtronic knew, from clinical trials, that when the
surgeons employed a posterior approach, the use of the genetically-engineered protein led
to undesired or “heterotopic” bone growth. According to the McCormicks, an FDA
advisory panel admonished Medtronic to guard against the use of the device in procedures
other than an “anterior approach,” by which the surgeon approaches the spine from the
front of the body, through an incision in the abdomen. One panel member allegedly
observed that because the cage is difficult to implant in a posterior approach, the use of
the cage would prevent most surgeons from employing the posterior approach.
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When the FDA approved the Infuse device, it required the labeling to warn that the
device may be used only via the anterior approach. In addition, the approved labeling
warns that the product “must not be used” without the cage.
D. Off-Label Marketing
The McCormicks’ complaint is replete with allegations that, after obtaining FDA
approval of the Infuse device, Medtronic engaged in an extensive and (they allege) illegal
effort to promote the off-label use of the device, apparently by means of a posterior
approach without the required cage. The McCormicks specifically allege that Medtronic
promoted the off-label use of the Infuse device by giving financial incentives to
physicians, by providing physicians with information from consultants and “key opinion
leaders” whom Medtronic had targeted and paid, and by placing Medtronic sales
representatives in operating rooms when surgeons were performing surgeries in which
they employed the off-label, anterior approach.1
The McCormicks allege that, as a result of Medtronic’s off-label promotion of the
Infuse device, sales of the device exceeded $900 million in 2010, of which more than 85
1
The McCormicks are not alone in making these allegations: “after a 16-month
investigation, the Senate Committee on Finance issued a 2,315-page report criticizing
Medtronic for its heavy involvement in ‘drafting, editing and shaping the content of
medical journal articles authored by its physician consultants who received significant
amounts of money through royalties and consulting fees from Medtronic.’” Schouest v.
Medtronic, Inc., ___ F. Supp. 2d ___, 2014 WL 1213243, at *2 (S.D. Tex. Mar. 24, 2014)
(quoting Staff of Sen. Comm. on Finance, 112th Cong., Staff Report on Medtronic’s
Influence on Infuse Clinical Studies 6 (Comm. Print 2012)).
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percent resulted from off-label procedures.
E. The Spine Journal
The McCormicks’ complaint prominently mentions the July 2011 edition of a
medical periodical, The Spine Journal, which, they say, devoted an entire issue to articles
concerning the Infuse device. The complaint alleges that the journal articles discussed
Medtronic’s failure to accurately report the adverse side-effects that occurred in the
clinical trials of the device; Medtronic’s failure to disclose that many of the authors who
studied and promoted the device had conflicts of interest because of their significant
financial ties to Medtronic (having received a median range of payments of between $12
million and $16 million per study); and Medtronic’s downplaying of the risks associated
with the device (including the stimulation of excessive bone growth) while
overemphasizing its advantages over conventional procedures (such as bone grafts).
F. The Disclosure of Increased Risks of Cancer
The McCormicks also allege that a November 2011 study showed that a high-
dosage use of the Infuse device, which, they say, occurs in some off-label procedures, can
result in a nearly four-fold increased risk of cancer. They go on to allege that, according
to the study’s lead researcher, the genetically-engineered protein in the Infuse device is a
cancer-promoting substance. The McCormicks claim that Medtronic knew of the alleged
risks of cancer, but failed to inform the public or the medical community of them.
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G. Mr. McCormick’s Unsuccessful Surgery
On July 27, 2007, well before the allegations about the Infuse device became
public, Mr. McCormick himself underwent spinal-fusion surgery to relieve his complaints
of persistent back pain. His surgeon, Dr. Rosner, took a posterior approach (rather than
the approved anterior approach), and he used a Medtronic cage that the FDA had not
approved for use with an Infuse bone graft. Additionally, the McCormicks appear to
allege that the surgeon used an inappropriate amount of the genetically-engineered protein
component of the device. According to the McCormicks’ complaint, at least one
Medtronic sales representative – defendant Vincent Profitt – was present in the operating
room during Mr. McCormick’s surgery.
The McCormicks allege that the surgery did not succeed in relieving Mr.
McCormick’s complaints. As a consequence, the McCormicks allege, Mr. McCormick
was unable to continue to work and was forced to go on permanent disability in October
2008. They claim that in the spring of 2010 Mr. McCormick’s physicians discovered that
he suffered from neural foraminal stenosis, or narrowing of the cervical disc space, at the
site where the Infuse device had been implanted. Eventually, in September 2010, Mr.
McCormick underwent revision surgery to remove the “bony overgrowth” and
inflammation that had allegedly resulted from the earlier surgery in 2007. The
McCormicks allege that in the revision surgery Mr. McCormick’s surgeon was forced to
chisel away the excess bone-growth that, they say, the Infuse product had caused.
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According to the McCormicks, Mr. McCormick learned in August 2011 that he
had two nodules in his lungs that he must monitor to ensure that they do not become
cancerous. The McCormicks contend that Mr. McCormick’s exposure to the Infuse
product significantly increases the risk that the nodules will become cancerous.
H. The Complaint
On the basis of these essential allegations, Mr. McCormick asserted a series of
claims against Medtronic, a Medtronic subsidiary, the Medtronic sales representative who
was in the operating room during his surgery (collectively, “Medtronic”), and Dr.
Rosner.2
As against Medtronic, Mr. McCormick asserted claims for negligence (Count II),
strict products liability (Count III), breach of warranty (Count IV), fraud (Count V),
negligence per se (Count VI), and violations of the Consumer Protection Act (Count VII).
As against the surgeon, Dr. Rosner, McCormick asserted a claim for failure to obtain
informed consent (Count VIII). Finally, Mr. McCormick and his wife asserted a joint
claim for loss of consortium (Count IX).3
2
The McCormicks originally filed suit in Minnesota state court, but dismissed
their claims before the court could rule on Medtronic’s motion to dismiss. They then
commenced this suit by filing a nearly-identical complaint in the Circuit Court for
Baltimore City. The Baltimore City court transferred the case to Montgomery County
because venue was improper in the City.
3
The complaint contains a Count I, but it consists solely of background allegations
and does not contain any request for relief under any specific legal theory.
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I. The Proceedings in the Circuit Court
Medtronic moved to dismiss the McCormicks’ complaint on several grounds,
including federal preemption and the failure to allege fraud with particularity. Dr. Rosner
also moved to dismiss the complaint, arguing that the McCormicks had failed to comply
with their obligation to submit their claim to the Health Care Alternative Dispute
Resolution Office before filing suit. See Md. Code (1974, 2013 Repl. Vol.) § 3-2A-
04(a)(1)(i) of the Courts and Judicial Proceedings Article. Meanwhile, Mr. McCormick
voluntarily dismissed the claim that alleged negligence per se.
After a hearing, the circuit court dismissed the claims against Medtronic, relying
exclusively on Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Ok. 2013), one
of the first reported cases to consider the extent to which federal law preempts state-law
claims concerning the Infuse device. Rather than dismiss the claims against Dr. Rosner,
however, the court stayed the proceedings to permit the McCormicks to file the claim in
the Health Care Alternative Dispute Resolution Office.
In response, the McCormicks initially asked the court to allow them to appeal the
order as to Dr. Rosner under the collateral order doctrine, “a very narrow exception to the
final judgment rule.” See, e.g., Nnoli v. Nnoli, 389 Md. 315, 329 (2011). After the court
complied with their request, however, the McCormicks dismissed the claims against Dr.
Rosner, without prejudice. Then they took this appeal.
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D ISCUSSION
I.
Before we discuss the substantive issues in this case, we first must address whether
there was a final judgment from which the McCormicks were entitled to appeal.
Although the circuit court granted Medtronic’s motion to dismiss, the court did not
adjudicate all of the claims against Medtronic’s co-defendant, Dr. Rosner. Because the
court, therefore, had “adjudicate[d] the rights and liabilities of fewer than all the parties to
the action,” its ruling was “not a final judgment.” Md. Rule 2-602(a)(1). Generally,
therefore, the McCormicks would have no right to appeal unless they could establish that
the ruling fell within one of the exceptions to the final judgment rule. See generally
Waterkeeper Alliance, Inc. v. Maryland Dep’t of Agriculture, 439 Md. 262, 286-89
(2014); Falik v. Hornage, 413 Md. 163, 175-76 (2010); St. Joseph Med. Ctr., Inc. v.
Cardiac Surgery Assocs., 392 Md. 75, 84 (2006).
The collateral order doctrine, which the McCormicks briefly invoked, would not
assist them. Even if the doctrine somehow applied,4 the court had permitted an appeal
only as to Dr. Rosner, not as to Medtronic – the party that the McCormicks most wanted
4
It did not. An appealable collateral order (1) conclusively determines the
disputed issue, (2) resolves an important issue, (3) resolves an issue that is completely
separate from the merits of the action, and (4) would be effectively unreviewable if the
appeal had to await the entry of a final judgment. See, e.g., Ehrlich v. Grove, 396 Md.
550, 563 (2007). Among other things, the order as to Dr. Rosner conclusively determined
nothing; it merely stayed the proceedings for a time. Nor would the temporary stay have
been unreviewable on appeal from a final judgment.
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to pursue.
The McCormicks did not solve the problem of Dr. Rosner’s continued presence by
dismissing all claims against him without prejudice: in Miller and Smith at Quercus LLC
v. Casey PMN, LLC, 412 Md. 230, 248-53 (2010), the Court of Appeals held that parties
cannot transform an otherwise interlocutory ruling into an appealable final judgment
through the voluntary dismissal, without prejudice, of the unadjudicated aspects of a case.
Thus, in light of Miller and Smith, we directed the parties, on our motion, to address
whether and how we could exercise appellate jurisdiction.
Having reviewed the parties’ submissions, we are convinced that we have the
power to decide the appeal under Md. Rule 8-602(e)(1). That rule provides as follows:
(e) Entry of judgment not directed under Rule 2-602. (1) If the
appellate court determines that the order from which the appeal is taken was
not a final judgment when the notice of appeal was filed but that the lower
court had discretion to direct the entry of a final judgment pursuant to Rule
2-602 (b), the appellate court may, as it finds appropriate, (A) dismiss the
appeal, (B) remand the case for the lower court to decide whether to direct
the entry of a final judgment, (C) enter a final judgment on its own initiative
or (D) if a final judgment was entered by the lower court after the notice of
appeal was filed, treat the notice of appeal as if filed on the same day as, but
after, the entry of the judgment.
(Emphasis added.)
In other words, if this Court confronts an improper, interlocutory appeal in a case
where the circuit court could have certified its ruling as final and appealable under Rule
2-602(b), then Rule 8-602(e) authorizes this Court, among other things, to “enter a final
judgment on its own initiative.” The question thus becomes whether the circuit court
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could have certified its ruling as final and appealable under Rule 2-602(b).
Rule 2-602(b) provides as follows:
(b) When allowed. If the court expressly determines in a written
order that there is no just reason for delay, it may direct in the order the
entry of a final judgment:
(1) as to one or more but fewer than all of the claims or parties; or
(2) pursuant to Rule 2-501(f)(3), for some but less than all of the
amount requested in a claim seeking money relief only.
(Emphasis added.)
In dismissing the claims against Medtronic but not against Dr. Rosner, the circuit
court disposed of all claims against one or more, but fewer than all, of the parties. If,
therefore, the circuit court had expressly determined in a written order that there was no
just reason to delay the entry of final judgment as to Medtronic, it would have had some
discretion to certify an immediate appeal of that ruling under Rule 2-602(b). See, e.g.,
Tharp v. Disabled American Veterans Dep’t of Maryland, Inc., 121 Md. App. 548, 562-
64 (1998); Allstate Ins. Co. v. Angeletti, 71 Md. App. 210, 215-17 (1987); Canterbury
Riding Condo. v. Chesapeake Investors, Inc., 66 Md. App. 635, 646 (1986); see also USA
Cartage Leasing, LLC v. Baer, 202 Md. App. 138, 169-70 (2011), aff’d, 429 Md. 199(2012).
While the circuit court’s exercise of discretion under Rule 2-602(b) would have
been subject to appellate scrutiny to ensure that it did not conflict with Maryland’s strong
policy against piecemeal appeals (see, e.g., Tharp, 121 Md. App. at 562-64), the Court of
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Appeals recently approved the exercise of discretion in a similar case, where the circuit
court had disposed of all claims against the central defendant, leaving only the claims
against a minor defendant who may have been insolvent. Barclay v. Briscoe, 427 Md.
270, 278 n.6 (2012). In reaching that decision, the Court of Appeals specifically noted
the “financial hardship” that the injured plaintiffs would face were they forced to incur
the time and expense of litigating the case to a conclusion before they could appeal. Id.;
compare Waterkeeper Alliance, 439 Md. at 289 (declining to exercise authority under
Rule 8-602(e) because there was a significant reason to delay the entry of judgment).
Under Barclay, the circuit court could properly have exercised its discretion to
certify its ruling as to Medtronic as an appealable final judgment under Rule 2-602(b).
Not only is this case almost entirely about Medtronic, but the McCormicks have told us
that Dr. Rosner has no liability insurance and that they now regard the Medtronic
defendants as the only culpable parties. In fact, after we directed the parties to address
the issue of appellate jurisdiction, the McCormicks corroborated their assertions by
dismissing their claims against Dr. Rosner with prejudice.
An appellate court “should be reluctant” to enter judgment on its own initiative
under Rule 8-602(e) when no party asked the circuit court to exercise its authority under
Rule 2-602(b). Smith v. Lead Indus. Ass’n, Inc., 386 Md. 12, 26 (2005). In fact, the
appellate court may not exercise that authority at all if the circuit court was asked to
certify the judgment under Rule 2-602(b), but exercised its discretion not to do so.
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Addison v. Lochearn Nursing Home, LLC, 411 Md. 251, 263 (2009); Brown &
Williamson Tobacco Corp. v. Gress, 378 Md. 667, 682 (2003).
In this case, however, it seems clear that the circuit court would have exercised its
authority under Rule 2-602(b) had the McCormicks asked it to employ that specific tool.
After dismissing the claims against the Medtronic defendants, the court and counsel
engaged in a discussion about facilitating an appeal. As a result of that discussion, the
court signed the order that made its ruling as to Dr. Rosner immediately appealable under
the collateral order doctrine. Although that order had no effect on the McCormicks’
ability to appeal the decision in favor of Medtronic, it strongly suggests that the court
intended to permit an immediate appeal, but used the wrong rule.
In these specific circumstances, it would make little sense not to permit the appeal
to proceed. If we were to dismiss the appeal because of a “technical” problem (Smith,
386 Md. at 26) resulting from the decision to stay rather than dismiss the claims against
Dr. Rosner, we would only prolong the litigation and increase the financial hardship that
the plaintiffs face. Thus, because the circuit court could have certified its ruling as final
under Rule 2-602(b), we have the power, under Rule 8-602(e)(1)(C), to enter a final
judgment on our own initiative, which we hereby do.5
5
Alternatively, because the circuit court’s order effectively became final when the
McCormicks dismissed their claims against Dr. Rosner with prejudice, we may treat their
“notice of appeal as if filed on the same day as, but after, the entry of the judgment.” Md.
Rule 8-602(e)(1)(D). In either case, the appeal is properly before us.
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II.
The McCormicks’ claims arise against the backdrop of a highly-detailed scheme of
federal regulation. To evaluate the extent to which federal law preempts the
McCormicks’ claims, we must examine that scheme at some length.
A. The FDCA and the MDA
In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (the
“FDCA”), 21 U.S.C. § 301 et seq., which generally required the Food and Drug
Administration (the “FDA”) to approve the introduction of new drugs onto the market.
Until the 1970s, however, “the introduction of new medical devices was left largely for
the States to supervise as they saw fit.” Riegel v. Medtronic, Inc., 552 U.S. 312, 315
(2008) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-76 (1996)).
In the 1970s, in the aftermath of the failure of some complex devices, particularly
the Dalkon Shield,6 several states adopted regulatory measures, including measures
requiring premarket approval of new devices. Id. In an effort to standardize the
regulatory environment, Congress responded by passing the Medical Device Amendments
of 1976 (the “MDA”), 21 U.S.C. § 360c et seq., which “swept back some state
obligations and imposed a regime of detailed federal oversight.” Riegel, 552 U.S. at 316.
The MDA contains an express preemption provision, which provides, in pertinent
6
“[T]he Dalkon Shield intrauterine device, introduced in 1970, was linked to
serious infections and several deaths[.]” Riegel, 552 U.S. at 315.
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part, as follows:
[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).7
The MDA established three levels of oversight of medical devices: Class I, Class
II, and Class III. Class I, which includes devices such as elastic bandages and
examination gloves, is subject to the lowest level of oversight, consisting of “general
controls,” such as labeling requirements. Riegel, 552 U.S. at 316 (citing 21 U.S.C. §
360c(a)(1)(A)). “Class II, which includes such devices as powered wheelchairs and
surgical drapes, . . . is subject to ‘special controls’ such as performance standards and
postmarket surveillance measures.” Id. at 316-17 (citing 21 U.S.C. § 360c(a)(1)(B)).
Lastly, Class III devices, “which include replacement heart valves, implanted cerebella
stimulators, and pacemaker pulse generators,” receive “the most federal oversight.” Id. at
317.
A device is classified as Class III if “it cannot be established that a less stringent
7
The preemption provision contains an exception that allows the FDA to exempt
some requirements from preemption (see 21 U.S.C. § 360k(b)), but neither party contends
that the exception applies in this case.
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classification would provide reasonable assurance of safety and effectiveness, and the
device is ‘purported or represented to be for a use in supporting or sustaining human life
or for a use which is of substantial importance in preventing impairment of human
health,’ or ‘presents a potential unreasonable risk of illness or injury.’” Id. at 317
(quoting 21 U.S.C. § 360c(a)(1)(C)(ii)). Medtronic’s Infuse device is a Class III medical
device under the MDA.
Unless the FDA deems a new Class III device to be “substantially equivalent” to a
device that was on the market in 1976, the device must go through a “rigorous regime of
premarket approval.” Riegel, 552 U.S. at 317. To begin that process, the manufacturer
must submit what is typically a multi-volume application, which includes:
full reports of all studies and investigations of the device’s safety and
effectiveness that have been published or should reasonably be known to
the applicant; a “full statement” of the device’s “components, ingredients,
and properties and of the principle or principles of operation”; “a full
description of the methods used in, and the facilities and controls used for,
the manufacture, processing, and, when relevant, packing and installation
of, such device”; samples or device components required by the FDA; and a
specimen of the proposed labeling.
Id. at 318 (quoting 21 U.S.C. § 360e(c)(1)).
“Before deciding whether to approve the application, the agency may refer it to a
panel of outside experts, . . . and may request additional data from the manufacturer.” Id.
(citing 21 C.F.R. § 814.44(a); 21 U.S.C. § 360e(c)(1)(G)). “The FDA spends an average
of 1,200 hours reviewing each application.” Id. (citing Lohr, 518 U.S. at 477).
The FDA “grants premarket approval only if it finds there is a ‘reasonable
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assurance’ of the device’s ‘safety and effectiveness.’” Riegel, 552 U.S. at 318 (quoting
21 U.S.C. § 360e(d)). In making that finding, the FDA must “‘weig[h] any probable
benefit to health from the use of the device against any probable risk of injury or illness
from such use.’” Id. (quoting 21 U.S.C. § 360c(a)(2)(C)). The agency “may thus approve
devices that present great risks if they nonetheless offer great benefits in light of available
alternatives.” Id.
“The premarket approval process includes review of the device’s proposed
labeling.” Id. “The FDA evaluates safety and effectiveness under the conditions of use
set forth on the label . . . and must determine that the proposed labeling is neither false
nor misleading.” Id. (citing 21 U.S.C. § 360c(a)(2)(B); 21 U.S.C. § 360e(d)(1)(A)).
Premarket approval “incorporates an FDA finding that a device is safe and effective
under the conditions of use included on the label and that the label is not false or
misleading.” Cornett v. Johnson & Johnson, 211 N.J. 362, 381 (2012) (citing 21 U.S.C. §
360e(d)(1)(A), (d)(2)).
After the FDA has granted premarket approval, the MDA imposes further
restrictions. For instance, without FDA permission, the manufacturer may not make any
“changes in design specifications, manufacturing processes, labeling, or any other
attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319 (citing 21
U.S.C. § 360e(d)(6)(A)(i)). Furthermore, if the manufacturer wishes to make such a
change, “it must submit, and the FDA must approve, an application for supplemental
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premarket approval,” which is “evaluated under largely the same criteria as an initial
application.” Id. (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39(c)).
B. Express Preemption Under the MDA
As stated above, the MDA expressly preempts certain state-law “requirement[s]”
“with respect to” federally-regulated medical devices – specifically, requirements that
“relate[] to the safety or effectiveness of the device” and are “different from, or in
addition to, any requirement applicable” under the MDA itself. 21 U.S.C. § 360k(a).
In Riegel, 552 U.S. at 323-24, the Supreme Court held that common-law causes of
action for negligence and strict liability impose “requirements,” within the meaning of the
MDA’s express preemption provision in § 360k(a).8 In addition, the Court held that the
state-law duties underlying negligence, strict liability, and implied-warranty claims
impose requirements “with respect to” devices, within the meaning of § 360k(a). Id. at
327-30. Thus, because the Riegel plaintiffs contended that a Class III medical device (a
heart catheter) was defective under state law notwithstanding the manufacturer’s full
compliance with all of the requirements that the FDA had imposed, the Supreme Court
held that the MDA expressly preempted their claims (id. at 323-30): the plaintiffs had
improperly attempted to impose state-law requirements that were “different from, or in
addition to,” the requirements for safety and effectiveness that the FDA itself had
8
A majority of the members of the Court had previously endorsed that conclusion
in various concurring and dissenting opinions. See Lohr, 518 U.S. at 512 (O’Connor, J.,
dissenting); id. at 503-05 (Breyer, J., concurring in part and concurring in the judgment).
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imposed. See 21 U.S.C. § 360k(a).
In reaching its decision, the Court nonetheless recognized that “[s]tate
requirements are pre-empted under the MDA only to the extent that they are ‘different
from, or in addition to,’ the requirements imposed by federal law.” Riegel, 552 U.S. at
330 (quoting 21 U.S.C. § 360k(a)(1)) (emphasis added). “Thus,” the Court continued, the
express preemption provision in § 360k(a) “does not prevent a State from providing a
damages remedy for claims premised on a violation of FDA regulations[.]” Riegel, 552
U.S. at 330 (emphasis added). “[T]he state duties in such a case,” the Court explained,
would “‘parallel,’ rather than add to, federal requirements.” Id. (citing Lohr, 518 U.S. at
495).9
Since the Riegel decision in 2008, numerous courts have recognized that the MDA
expressly preempts state-law claims only when a manufacturer has complied with federal
law, and not when the manufacturer has in some way violated federal law. See, e.g.,
Hughes v. Boston Scientific Corp., 631 F.3d 762, 769 (5th Cir. 2011); Bausch v. Stryker
Corp., 630 F.3d 546, 549-50 (7th Cir. 2010), cert. denied, ___ U.S. ___, 132 S. Ct. 498(2011); see also Stengel v. Medtronic Inc., 704 F.3d 1224, 1232-33 (9th Cir. 2013) (en
9
Indeed, in Riegel itself, the district court had held that the MDA did not
expressly preempt the plaintiffs’ claims that the manufacturer had breached an express
warranty and had negligently failed to manufacture the device in compliance with federal
standards. Riegel, 552 U.S. at 321 n.2. Those claims did not reach the Supreme Court,
because the district court disposed of them on summary judgment when the plaintiffs
failed to adduce sufficient factual support for them. See id.-19-
banc) (holding that the MDA did not expressly preempt a parallel state-law claim based
on violations of FDA regulations regarding reporting of adverse events). As the Seventh
Circuit stated: “The 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.
C. Implied Preemption Under Buckman
Nonetheless, even though a state-law claim may survive express preemption if it is
based on a violation of federal law, it may be impliedly preempted if it is based solely on
a violation of federal law or if the claim would not exist but for federal law. Buckman
Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352-53 (2001). Buckman specifically
prohibits an attempt to bring a putative state-law claim alleging that a manufacturer
defrauded the FDA in obtaining approval for its device. More generally, Buckman
prohibits the private enforcement of the statutes and regulations that the FDA alone is
empowered to enforce.
In Buckman, 531 U.S. at 343-46, the device-manufacturer allegedly obtained FDA
approval by making fraudulent representations to the FDA about the intended use of the
device (bone screws). The manufacturer had unsuccessfully applied for approval for the
use of the device in spinal surgery. After the FDA rejected the initial application, the
manufacturer revised the application to specify a different use (“long bone surgery”). The
FDA approved the revised application for that purpose, but physicians later used the
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device for the so-called “off-label” purpose of spinal surgery. The plaintiffs, who were
injured because of the off-label use of the device in spinal surgery, claimed that they
would not have suffered damages but for the alleged misrepresentations to the FDA. See
id. at 346-47.10
The district court dismissed the case, characterizing it as a claim of “fraud-on-the-
FDA.” Id. at 347. The Supreme Court affirmed, stating that “state-law fraud-on-the-
FDA claims conflict with, and are therefore impliedly pre-empted by, federal law.” Id. at
348.
In reaching its decision, the Court explained that the FDA must achieve a “delicate
balance of statutory objectives” (id.), and it expressed its concern that the balance could
be “skewed by allowing fraud-on-the-FDA claims under state tort law.” Id. In this
regard, the Court specifically observed that under federal law the FDA may respond to
fraud by instigating both civil and criminal proceedings. Id. at 349 (citing 21 U.S.C. §
332; 21 U.S.C. § 333(f)(1)(A); 21 U.S.C. § 334(a)(2)(D); 21 U.S.C. § 333(a)). Indeed,
10
The manufacturer had not submitted the device for premarket approval. Rather,
because the manufacturer contended that the device was substantially equivalent to a
device that had been on the market at the time of the adoption of the MDA in 1976, it was
able to take advantage of the less rigorous approval process under 21 U.S.C. § 510(k).
The FDA had refused to approve the device on the ground that it was not the substantial
equivalent of an earlier device that had been used in spinal surgery. The manufacturer
had obtained approval by recharacterizing the device as the substantial equivalent of an
earlier device that had been used in long bone surgery. The plaintiffs evidently alleged
that, despite the recharacterization of the intended use, the manufacturer had intended all
along for the device to be used in spinal surgery. See Buckman, 531 U.S. at 346-47.
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the FDA alone is authorized to enforce the FDCA or to restrain violations of it. Id. at 349
n.4 (citing 21 U.S.C. § 337(a)).
Because Buckman involved the off-label use of an FDA-approved device, the
Court took pains to remark that off-label usage “is an accepted and necessary corollary of
the FDA’s mission to regulate in this area without directly interfering with the practice of
medicine.” Id. at 350. The Court worried that fraud-on-the-FDA claims could deter off-
label use even though “the FDCA expressly disclaims any intent to directly regulate the
practice of medicine, . . . and even though off-label use is generally accepted.” Id. at 350-
51 (citing 21 U.S.C. § 396).
Finally, the Court rejected the plaintiffs’ effort to characterize their fraud-on-the-
FDA claim as a parallel, state-law claim that would survive express preemption under the
MDA. The Court explained that, unlike (for example) a claim concerning the failure to
use reasonable care in manufacturing a device, the claims in Buckman “exist[ed] solely by
virtue of the FDCA disclosure requirements.” Id. at 352-53. The plaintiffs, thus, were
not “relying on traditional state tort law which had predated the federal enactments in
question.” Id. at 353. Accordingly, their claims were impliedly preempted. See id.
D. The Scylla and Charybdis of Express and Implied Preemption
In light of Riegel and Buckman, a plaintiff can survive a preemption challenge to a
state-law tort claim concerning an allegedly defective medical device only by steering
between the Scylla of express preemption under § 360k(a) and the Charybdis of the
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implied Buckman preemption of claims that exist solely by virtue of the FDCA. It is a
challenge to avoid one obstacle without colliding with the other, because the plaintiffs
must show that a manufacturer has violated federal law if they are to defeat express
preemption, but the plaintiffs must also show that their legal theories predated the federal
enactment or would exist independently of federal law if they are to defeat implied
preemption.
In other words, “the conduct on which the plaintiff’s claim is premised must
violate the FDCA if the claim is to escape express preemption,” but the conduct must also
be “the type of conduct that would traditionally give rise to liability under state law – and
that would give rise to liability under state law even if the FDCA had never been
enacted.” Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009) (emphasis in
original). To put it another way, “[t]he 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).” Id. (emphasis in original).
E. The Legality of Off-Label Promotion
A central feature of the McCormicks’ complaint is their repeated allegation that
Medtronic has engaged in what they call illegal, off-label promotion of the Infuse device.
The legality of off-label promotion is important to this case because the McCormicks can
avoid express preemption only if their claims are based on some violation of federal law.
-23-
See Riegel, 552 U.S. at 330; Bausch, 630 F.3d at 549.11
To understand the legality of off-label promotion, it is necessary, first, to
distinguish between off-label uses by healthcare practitioners and the promotion of off-
label uses by manufacturers. Off-label use by members of the medical profession “is
permissible under the terms of the MDA.” Cornett, 211 N.J. at 380; see Buckman, 531
U.S. at 351 n.4. In fact, Congress has specifically denied the FDA any power “to limit or
interfere with the authority of a health care practitioner to prescribe or administer any
legally marketed device to a patient for any condition or disease within a legitimate health
care practitioner-patient relationship.” 21 U.S.C. § 396; see Buckman, 531 U.S. at 350;
Cornett, 211 N.J. at 382.
Off-label promotion by a manufacturer, however, stands on different footing from
off-label use by a healthcare practitioner, because off-label promotion may constitute
“misbranding,” a criminal violation of the FDCA.
Although “[f]ederal law does not expressly define, or ban, off-label promotion[,] . .
. the FDCA prohibits ‘the adulteration or misbranding of any food, drug, device, tobacco
product, or cosmetic in interstate commerce.’” Schouest v. Medtronic, Inc., ___ F. Supp.
2d ___, 2014 WL 1213243, at *6 (S.D. Tex. Mar. 24, 2014) (quoting 21 U.S.C. § 331(b))
(emphasis added). “Class III devices may be misbranded if their ‘labeling is false or
11
Of course, the McCormicks may nonetheless be blocked by implied preemption
if their claims are based solely on a violation of federal law. See Buckman, 531 U.S. at
352-53.
-24-
misleading in any particular,’ 21 U.S.C. § 352(a), or if they use ‘false or misleading
advertising,’ [21 U.S.C.] § 352(q).” Schouest, 2014 WL 1213243, at *6. “Devices can
also be misbranded if their labeling does not bear ‘adequate directions for use,’ [21
U.S.C.] § 352(f),” which is “defined by the FDA as ‘directions under which the layman
can use a device safely and for the purposes for which it is intended.’” Schouest, 2014
WL 1213243, at *6 (quoting 21 C.F.R. § 801.5). “A device’s intended use is determined
by ‘the objective intent of the persons legally responsible for the labeling of devices’” –
i.e., by the objective intent of the manufacturer. Id. (quoting 21 C.F.R. § 801.4). In
addition, the intended use “can be demonstrated by ‘oral written statements’” by the
manufacturer or its representatives. Id. (quoting 21 C.F.R. § 801.4).
On the basis of this web of statutes and regulations, the FDA takes the position
that off-label promotion can constitute misbranding in violation of the FDCA. See
Schouest, 2014 WL 1213243, at *6. “Based on this view, the FDA has recovered
millions of dollars in settlements from drug manufacturers that have engaged in off-label
promotion.” Id.The FDA has, however, recognized a safe harbor that allows manufacturers of
Class III devices to provide members of the medical profession with peer-reviewed
articles or reference publications concerning the safety, effectiveness, or benefit of the
off-label uses of the device. See Riley, 625 F. Supp. 2d at 781-82; Cornett, 211 N.J. at
-25-
382 (citing 21 U.S.C. §§ 360aaa, 360aaa-1).12
Furthermore, one federal appellate court has held, by a 2-1 margin, that the First
Amendment prohibits the United States from prosecuting a person for misbranding if he
or she has merely engaged in off-label promotion that does not involve untruthful or
misleading statements. United States v. Caronia, 703 F.3d 149, 168-69 (2d Cir. 2012)
(the FDCA does not prohibit the “truthful off-label promotion of FDA-approved
prescription drugs”). In that case, however, the government had not argued “that the
promotion in question was false or misleading.” Id. at 165 n.10. Indeed, the court
observed that “off-label promotion that is false or misleading is not entitled to First
Amendment protection.” Id. The court also observed that “[p]hysicians and
pharmaceutical manufacturers can be held accountable for off-label drug use through
medical malpractice and negligence theories of liability.” Id. at 168 n.11.
“Out of this muddy statutory and regulatory framework,” Schouest, 2014 WL
1213243, at *7, a growing number of courts have begun to conclude that “federal law
bars off-label promotion when it is false or misleading.” Id. (citing Houston v.
12
The safe harbor is based on a statute that expired on September 30, 2006, but the
FDA has announced that it continues to take a position consistent with the statute. FDA,
Guidance for Industry – Good Reprint Practices for the Distribution of Medical Journal
Articles and Medical or Scientific Reference Publications on Unapproved New Uses of
Approved Drugs and Approved or Cleared Medical Devices (Jan. 2009), available at
http://www.fda.gov/regulatoryinformation/guidances/ucm125126.htm (last visited Aug.
13, 2014); see Riley, 625 F. Supp. 2d at 782 n.7; Cornett, 211 N.J. at 382 n.7.
-26-
Medtronic., Inc., 957 F. Supp. 2d 1166, 1179 & n.8 (C.D. Cal. 2013); see also Martin v.
Medtronic, Inc., ___ F. Supp. 2d ___, 2014 WL 3635292, at *7 (D. Ariz. July 23, 2014)
(“The FDCA does prohibit untruthful off-label promotion”); Beavers-Gabriel v.
Medtronic, Inc., ___ F. Supp. 2d ___, 2014 WL 1396582, at *9 (D. Haw. Apr. 10, 2014)
(“[T]he FDCA prohibits “misbranding” of medical devices, which includes either
misleading labeling or misleading advertising of the medical device”);
Brady v. Medtronic, Inc., ___ F. Supp. 2d ___, 2014 WL 1377830, at *7 (S.D. Fla. Apr.
8, 2014) (claim based on affirmed misrepresentations in off-label promotion was not
preempted); Riley, 625 F. Supp. 2d at 783 (failure to warn claim could escape express
preemption if plaintiff alleged that manufacturer affirmatively promoted off-label use in a
manner that violated federal law); Cornett, 211 N.J. at 390-91 (failure to warn claim,
based on misrepresentations in off-label promotion outside of safe harbor, was not
expressly preempted).
Accordingly, we hold that the MDA does not expressly preempt state-law claims
that are based on a violation of the federal prohibition of false or misleading off-label
promotion.13
13
One federal judge has held that the concept of express preemption does not
apply at all when a plaintiff’s state-law claims arise out of an off-label use “that has not
been reviewed by the FDA but has been promoted by the manufacturer.” Ramirez v.
Medtronic Inc., 961 F. Supp. 2d 977, 991 (D. Ariz. 2013). Ramirez reasoned that federal
law imposes no device-specific “requirements” as to an off-label use and, thus, that state
law could not impose requirements that were “different from, or in addition to,” those
(continued...)
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F. Which Claims Are Preempted?
We turn now to the specific allegations of the McCormicks’ complaint, to
determine which, if any, are expressly or impliedly preempted.
1. The Misrepresentation-Based Claims. The McCormicks’
complaint contains a series of counts that are based on misrepresentations, intentional or
otherwise: Count V alleges common-law fraud; Count II alleges negligence and includes
allegations of negligent misrepresentation; and Count VII alleges violations of the
Consumer Protection Act, Md. Code (1975, 2013 Repl. Vol.) § 13-301 of the Commercial
Law Article, which prohibits various forms of “unfair or deceptive trade practices,”
including fraud, false or misleading representations that have the capacity, tendency, or
effect of deceiving or misleading consumers, and the failure to state a material fact if the
failure deceives or tends to deceive.
These claims are preempted insofar as they attack the accuracy or adequacy of the
13
(...continued)
under federal law. Id. at 992-93. Although one Maryland circuit court case has followed
Ramirez, Ramirez has been almost universally rejected elsewhere. The courts that have
rejected Ramirez correctly point out that federal law does impose requirements regarding
off-label use and promotion of devices. See, e.g., Martin, 2014 WL 3635292, at *6;
Beavers-Gabriel, 2014 WL 1396582, at *10; Brady, 2014 WL 1377830, at *5; see also
Hawkins v. Medtronic, Inc., ___ F. Supp. 2d ___, 2014 WL 346622, at *5-6 (E.D. Cal.
Jan. 30, 2014); Gavin v. Medtronic, Inc., ___ F. Supp. 2d ___, 2013 WL 3791612, at *11
(E.D. La. July 19, 2013); Houston, 957 F. Supp. 2d at 1176 (“even though Plaintiff was
not implanted with the Infuse Device in an approved manner, her state claims are oriented
‘with respect to’ the off-label promotion and use of a device that is covered by federal
requirements”). We join the many courts that have rejected Ramirez’s holding that
concepts of express preemption do not apply in a case involving off-label uses.
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statements that Medtronic made in the FDA-mandated and FDA-approved labeling. See,
e.g., Hughes, 631 F.3d at 769; Martin, 2014 WL 3635292, at *8; Beavers-Gabriel, 2014
WL 1396582, at *10; Gavin v. Medtronic, Inc., ___ F. Supp. 2d ___, 2013 WL 3791612,
at *12 (E.D. La. July 19, 2013). To fault Medtronic for making the statements that the
FDA required it to make, or to impose liability on Medtronic for not making statements
that the FDA required it not to make, would be to impose state-law requirements that are
“different from, or in addition to,” those imposed by the FDCA. See Martin, 2014 WL
3635292, at *8; Beavers-Gabriel, 2014 WL 1396582, at *10. Section 360k(a) prohibits
state courts from entertaining such claims.
Section 360k(a) does not, however, preempt claims concerning the
misrepresentations that Medtronic allegedly made in voluntary communications with the
medical profession or the public, Houston, 957 F. Supp. 2d at 1179-80; Schouest, 2014
WL 1213243, at *8-10; Martin, 2014 WL 3635292, at *9; outside the scope of the safe
harbor. Cornett, 211 N.J. at 390-91; Riley, 625 F. Supp. 2d at 783. Indeed, those claims
would survive preemption even under the case on which the circuit court relied.
Caplinger, 921 F. Supp. 2d at 1220. Insofar as Medtronic’s alleged misrepresentations
consist of false statements of material fact in the context of off-label promotion, outside
the scope of the safe harbor, a state-law misrepresentation claim would parallel the FDCA
prohibitions on off-label marketing. To that extent, therefore, a state-law
misrepresentation claim would not impose any requirements different from or in addition
-29-
to those imposed under federal law. See, e.g., Beavers-Gabriel, 2014 WL 1396582, at *9;
Brady, 2014 WL 1377830, at *7; Schouest, 2014 WL 1213243, at *8; Eidson v.
Medtronic, Inc., 981 F. Supp. 2d 868, 884-85 (N.D. Cal. 2013); Houston, 957 F. Supp. 2d
at 1179-80.
Furthermore, because those misrepresentation claims predate the FDCA and would
continue to exist even if the FDCA were repealed, they do not depend on the FDCA for
their existence. See, e.g., Houston, 957 F. Supp. 2d at 1179 (“fraudulent advertising
claims are not impliedly preempted under Buckman because they are moored in
traditional state common law that exists independently from the FDCA”);
Arthur v. Medtronic, Inc., ___ F. Supp. 2d ___, 2014 WL 3894365, at *7 (E.D. Mo. Aug.
11, 2014) (same); Blankenship v. Medtronic, Inc., ___ F. Supp. 2d ___, 2014 WL
1226491, at *10 (E.D. Mo. Mar. 25, 2014); Schouest, 2014 WL 1213243, at *9 (fraud is
“a venerable common law claim[]”); Martin, 2014 WL 3635292, at *8 (“there is a state
law duty to refrain from making misrepresentations, and this duty or requirement predates
the FDCA”). Therefore, to the extent that the complaint concerns false statements of
material fact that Medtronic allegedly made in voluntary communications constituting
off-label marketing of the Infuse product, outside the scope of the safe harbor, the
McCormicks’ claims are neither impliedly preempted under Buckman nor expressly
preempted under § 360k(a).
Our ruling applies not only to the common-law claims for fraud and negligent
-30-
misrepresentation (which is embodied in the generic negligence claim), but also to the
separate statutory claim for unfair and deceptive trade practices under the Consumer
Protection Act. See Schouest, 2014 WL 1213243, at *12 (“a deceptive act in the
promotion of the Infuse device would survive a preemption challenge for the same
reasons that [the plaintiff]’s fraud and negligent misrepresentations claim [sic] would”).14
2. Negligence. Count II of the McCormicks’ complaint asserts a claim
for negligence. As the court in Riley said of the complaint in that case, the allegations
here are both “prolix and uninformative,” Riley, 625 F. Supp. 2d at 780 n.5, in that they
attack a wide variety of conduct. Some of the allegations are preempted; some are not.
Count II refers to an array of misrepresentations in the context of off-label
promotion; the negligent failure to disclose material facts concerning the Infuse device
and to “fully disclose” the results of testing on the device; and the failure to “adequately
warn” the medical community, the public, and Mr. McCormick concerning the dangers
14
At least one court has relied on a distinction between claims based on false
statements of material fact and claims based on the omission to state material facts.
Schouest, 2014 WL 1213243, at *5. In the view of that court, omission claims are
preempted, but claims based on affirmative misstatements are not. Id. The distinction is
immaterial in Maryland, because Maryland’s common law authorizes a misrepresentation
claim for the concealment of material facts only when the defendant has an affirmative
disclosure obligation to the plaintiff (as, for example, when the defendant stands in a
fiduciary relationship to the plaintiff). See, e.g., Green v. H&R Block, 355 Md. 488, 525
(1999). As Medtronic is not alleged to have had any such affirmative disclosure
obligation to the McCormicks, it could be liable for fraudulent or negligent
misrepresentation under Maryland common law only if it affirmatively made a false
statement of material fact or uttered a half-truth (i.e., failed to disclose material facts that
were necessary to make its other statements not misleading).
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and side-effects of the device. The count also refers to the allegedly negligent failure to
disclose Medtronic’s employment of consultants, such as Mr. McCormick’s surgeon, Dr.
Rosner; the negligent failure to inform the public about the identity of the surgeons with
whom Medtronic had financial relations; and the negligent failure to act as a “reasonably
prudent drug manufacturer, promoter and distributor.”
We have already held that federal law neither expressly nor impliedly preempts the
allegations of negligent misrepresentations in the context of off-label promotion outside
the scope of the safe harbor. For similar reasons, federal law does not preempt the
allegations concerning the failure to disclose material facts concerning the device and the
failure to “fully disclose” the results of testing on the device, provided that those
omissions occurred in the context of off-label promotion and that the omitted facts were
necessary to make Medtronic’s other statements not misleading.
Nonetheless, the negligence claim is expressly preempted to the extent that the
McCormicks intend to challenge the adequacy of the FDA-approved warnings on the
labeling: if such a claim were allowed to proceed, Medtronic would face liability under
state law even though it had fully complied with federal law. See Martin, 2014 WL
3635292, at *14; Beavers-Gabriel, 2014 WL 1396582, at *15; Hawkins v. Medtronic,
Inc., ___ F. Supp. 2d ___, 2014 WL 346622, at *9 (E.D. Cal. Jan. 30, 2014). Riegel
prohibits such a result. See Houston, 957 F. Supp. 2d at 1180 (a state claim is parallel to
federal law, and thus not expressly preempted, only if there is no likelihood that the
-32-
defendant could be held liable under state law without also having violated federal law).15
Furthermore, to the extent that the McCormicks’ allegations solely concern a
failure to disclose material facts or test results to the FDA in the premarket approval
process, they are impliedly preempted under Buckman, because they would amount to
allegations of fraud on the FDA, which the FDA alone may pursue. See Cornett, 211 N.J.
at 389 (to the extent that claim was “based solely on a contention that defendants obtained
FDA approval for the device only after submitting fraudulent representations to or
withholding material information from the FDA, this claim falls squarely within the
Buckman implied preemption rule”) (emphasis in original).
The claims are also impliedly preempted to the extent that they may concern the
act of off-label promotion itself, divorced from any misrepresentations that Medtronic
may have made in the course of off-label promotion. Such a claim exists solely by virtue
of the federal statutes and regulations that concern misbranding, and the claim has no
independent existence in Maryland law. See Houston, 957 F. Supp. 2d at 1178.
“Permitting this claim to proceed would essentially allow a private litigant to attempt to
enforce the FDCA,” id., which the statute itself expressly prohibits. 21 U.S.C. § 337(a)
(providing that, in general, “all such proceedings for the enforcement, or to restrain
15
The McCormicks do not appear to allege that the warning labels failed to
comply with FDA requirements. If that were the case, a state-law claim for failure to
warn would not be expressly preempted, because it would parallel the manufacturer’s
failure to comply with federal law. See Alton v. Medtronic, Inc., 970 F. Supp. 2d 1069,
1101 (D. Or. 2013).
-33-
violations, of this chapter shall be by and in the name of the United States”).
Courts have divided on the question of whether a negligent failure to warn claim is
expressly preempted. Some would allow such claims to proceed, at least insofar as they
are “founded on” the promotion of off-label uses beyond the safe harbor recognized by
the FDA. Cornett, 211 N.J. at 391 (citing Riley, 625 F. Supp. 2d at 781-82). Other
courts, by contrast, hold that the claims are expressly preempted because they would
require “warnings beyond those in the FDA-approved label for the Infuse Device.”
Houston, 957 F. Supp. 2d at 1177; accord Schouest, 2014 WL 1213243, at *7; Martin,
2014 WL 3635292, at *11.
We agree that federal law would preempt any effort to impose an amorphous duty
to warn that required Medtronic to give warnings “different from, or in addition to,” those
in the FDA-approved labeling: under federal law, Medtronic cannot deviate from the
FDA-prescribed labeling without the FDA’s permission. See Schouest, 2014 WL
1213243, at *7. However, to the extent that the failure to warn claim simply restates the
McCormicks’ claim for the failure to disclose material facts that were necessary to make
Medtronic’s other statements not misleading in the context of off-label promotion, it may
proceed for the same reason that the misrepresentation-based claims may proceed.16
16
Some courts have observed that a plaintiff might avoid preemption by alleging a
failure-to-warn claim that is based on the manufacturer’s failure to comply with the
FDCA’s requirement that it submit reports of adverse events to the FDA. Stengel, 704
F.3d at 1233; Martin, 2014 WL at 3635292, at *12; Eidson v. Medtronic, Inc., ___ F.
(continued...)
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3. Strict Products Liability. Count III of the complaint purports to
state a claim for strict products liability, but it is unclear what particular theory the
McCormicks intend to pursue. For example, they do not specifically allege that the Infuse
product was somehow defective or unreasonably dangerous. Instead, they allege that the
off-label use of the product in the posterior approach was “defective, unsafe, and
ineffective.” Elsewhere, they make allegations that sound in fraud or negligent
misrepresentation as they reiterate their many complaints about off-label promotion. In
addition, they invoke the risk-utility test, claiming that the risk of off-label uses outweighs
the benefits. Similarly, they invoke the consumer-expectation test, alleging that the
product, when used in an off-label manner, did not perform as a reasonable consumer
would expect it to perform.
To the extent that the complaint would impose liability on the basis of the risk-
utility or consumer-expectation tests, it is expressly preempted under § 360k(a). The
FDA has approved the Infuse product, and the agency neither has prohibited nor can
prohibit its off-label use by members of the medical profession. Because Maryland
cannot impose different or additional requirements, the risk-utility and consumer-
expectation allegations fail to state a claim.
16
(...continued)
Supp. 2d ___, 2014 WL 1996024, at *20 (N.D. Cal. May 13, 2014); Gale v. Smith &
Nephew, Inc., 989 F. Supp. 2d 243, 251 (S.D.N.Y. 2013). No such allegation, however,
appears in the McCormicks’ complaint.
-35-
The complaint also fails to state a claim insofar as it attempts to premise a products
liability claim on off-label use: products liability law concerns products, not the uses of
products. In any event, to the extent that the McCormicks’ products liability claim is a
stand-in for a complaint about the off-label use of the Infuse product, it is impliedly
preempted under Buckman, because the concept of illegal off-label use or promotion of a
medical device would not exist but for the FDCA. See Cornett, 211 N.J. at 389.
Finally, to the extent that the products liability claim repeats the allegations of
misrepresentation and failure to warn, we reiterate our prior conclusions: federal law
neither expressly nor impliedly preempts claims of misrepresentation in the context of
off-label marketing outside of the safe harbor, but it does expressly preempt any
challenge to the adequacy of the warranty or disclosures in the FDA-approved labeling
for the Infuse device. Furthermore, federal law impliedly preempts any attempt to
recover damages on the basis of a contention that Medtronic obtained FDA approval for
the device only after submitting fraudulent representations to or withholding material
information from the FDA.17
4. Breach of Warranty. Count IV of the McCormicks’ complaint
17
The McCormicks do not appear to have asserted any claim alleging the defective
design of the product. Had they done so, however, federal law would have expressly
preempted the claim, as the FDA has carried out the only permissible risk-benefit analysis
as to the appropriate product design. See, e.g., Houston, 957 F. Supp. 2d at 1177-78. A
state cannot impose design requirements that are “different from, or in addition to,” those
mandated by the FDA. Id.
-36-
alleges a claim for breach of warranty. The complaint mentions express warranties to
physicians and members of the public, as well as the implied warranties of
merchantability and fitness for a particular purpose under the Uniform Commercial Code.
See Md. Code (1975, 2013 Repl. Vol.) §§ 2-314, 2-315 of the Commercial Law Article.
To the extent that the McCormicks allege the breach of the implied warranties of
merchantability or fitness for a particular purpose, their claims are expressly preempted:
to impose additional warranties by operation of law would be to impose requirements that
are “different from, or in addition to,” the specific warranties or representations that the
FDA required Medtronic to make in the packaging and labeling that accompanies the
product. See Schouest, 2014 WL 1213243, at *11. Therefore, the circuit court correctly
concluded that the McCormicks failed to state a claim for breach of implied warranty.
Similarly, to the extent that the breach of express warranty claim is based solely on
alleged warranties in the FDA-approved labeling, the claim is expressly preempted: to
hold otherwise would be to hold that a manufacturer could face liability under state law
even though it had done exactly what it is required to do under federal law. See Riley,
625 F. Supp. 2d at 787, 788; see also Cornett, 211 N.J. at 392. Because a state-law claim
is “parallel” (and thus not expressly preempted) only if there is no likelihood that the
manufacturer could be held liable under state law unless it had also violated federal law
(Houston, 957 F. Supp. 2d at 1180), the express warranty claim cannot survive insofar as
it is based on the FDA-approved labeling itself.
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On the other hand, to the extent that the McCormicks contend that Medtronic
breached express warranties that it made in voluntary communications with the medical
profession or the public, the FDCA does not expressly preempt those claims. See, e.g.,
Schouest, 2014 WL 1213243, at *11; Houston, 957 F. Supp. 2d at 1180-81; Martin, 2014
WL 3635292, at *15; Riley, 625 F. Supp. 2d at 788; Alton v. Medtronic, Inc., 970 F.
Supp. 2d 1069, 1104 (D. Or. 2013); Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 165
(S.D.N.Y. 2011); Cornett, 211 N.J. at 392, 393. Because federal law already prohibits
false or misleading off-label promotion outside the safe harbor, a state would not impose
any requirements that are “different from, or in addition to,” those under federal law if it
held a manufacturer liable for making misleading warranties outside the label. Schouest,
2014 WL 1213243, at *11; Houston, 957 F. Supp. 2d at 1180-81; Martin, 2014 WL
3635292, at *15; Beavers-Gabriel, 2014 WL 1396582, at *16-17; Riley, 625 F. Supp. 2d
at 788. The manufacturer “need only to refrain from making misleading warranties,
which adds no burden beyond what federal law already imposes.” Houston, 957 F. Supp.
2d at 1181. To that extent, therefore, the express warranty claim survives express
preemption.18
18
In Caplinger, the case on which the circuit court relied, the federal judge
concluded that an express warranty claim would be expressly preempted even if it related
to the warranties that the manufacturer made in voluntary communications with the
public. See Caplinger, 921 F. Supp. 2d at 1222-23. At least one court has criticized the
superficial analysis that led the Caplinger court to that conclusion. Alton, 970 F. Supp.
2d at 1090.
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Nor would such a claim be impliedly preempted under Buckman. The claim for
breach of express warranty has a long and venerable history in Maryland (see, e.g., Schley
v. Zalis, 172 Md. 336 (1937)), and elsewhere. Houston, 957 F. Supp. 2d at 1181; Martin,
2014 WL 3635292, at *15. It predated the FDCA, and it would continue to exist if the
FDCA were repealed in its entirety. Therefore, to the extent that the breach of warranty
claim addresses warranties that Medtronic voluntarily made to the medical profession or
the public outside of the context of the FDA-approved and FDA-mandated labeling, the
McCormicks have stated a claim.19
G. Failure to Plead Fraud With Particularity
As an alternative ground for a part of its decision, the circuit court, like the
Caplinger court on which it relied, ruled that the plaintiffs had not pleaded fraud with the
requisite degree of particularity. We agree.
Although Rule 2-305 generally requires that a complaint contain only “a clear
statement of the facts necessary to constitute a cause of action,” Maryland courts have
long required parties to plead fraud with particularity. See, e.g., Lloyd v. General Motors
Corp., 397 Md. 108, 153-54 (2007); Edison Realty Co. v. Bauernschub, 191 Md. 451,
461 (1948); Tucker v. Woolery, 99 Md. App. 295, 304 (1994), abrogated on other
grounds, D’Aoust v. Diamond, 424 Md. 549 (2012); Sims v. Ryland Group, Inc., 37 Md.
19Because the loss of consortium claim is derivative of Mr. McCormick’s claims
(see, e.g., Proctor v. Washington Metro. Area Transit Auth., 412 Md. 691, 727-28
(2010)), it survives to the extent that the other claims survive.
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App. 470, 473 (1977); see also Thomas v. Nadel, 427 Md. 441, 453 (2012) (quoting
Spangler v. Sprosty Bag Co., 183 Md. 166, 173 (1944)) (“‘It is the settled rule that [one]
seeking any relief on the ground of fraud must distinctly state the particular facts and
circumstances constituting the fraud and the facts so stated must be sufficient in
themselves to show that the conduct complained of was fraudulent’”); Antigua Condo.
Ass’n v. Melba Investors Atl., Inc., 307 Md. 700, 735 (1986) (“[a] plaintiff must allege
facts which indicate fraud or from which fraud is necessarily implied”); John B. Parsons
Home, LLC v. John B. Parsons Found., 217 Md. App. 39, 68 (2014) (affirming dismissal
of complaint because of failure to plead constructive fraud with particularity). Because
the courts have continued to adhere to this principle even after the adoption of the
Maryland Rules in 1984, the requirement of particularity must be seen as a kind of judge-
made gloss on the general rules of pleading.
The requirement of particularity ordinarily means that a plaintiff must identify who
made what false statement, when, and in what manner (i.e., orally, in writing, etc.); why
the statement is false; and why a finder of fact would have reason to conclude that the
defendant acted with scienter (i.e., that the defendant either knew that the statement was
false or acted with reckless disregard for its truth) and with the intention to persuade
others to rely on the false statement. See, e.g., Spaulding v. Wells Fargo Bank, N.A., 714
F.3d 769, 781 (4th Cir. 2013) (Davis, J.) (concerning the analogous federal rule).
In this case, the McCormicks’ complaint satisfactorily alleges that the Medtronic
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defendants knew that the off-label use of the Infuse product could lead to many, serious
side-effects, including the side-effects that Mr. McCormick claims to have suffered.
Similarly, the complaint satisfactorily alleges that the Medtronic defendants intended to
induce physicians, including Mr. McCormick’s physician, to rely on the alleged
misrepresentations and to use the Infuse product in the allegedly dangerous, off-label
procedures. The complaint, however, lacks specificity in alleging when and how the
Medtronic defendants made the false statements of material fact (or failed to disclose
material facts that were necessary to make other statements not misleading). Instead, the
complaint repeatedly makes vague references to Medtronic’s failure to accurately report
the side-effects from its clinical trials and to its failure to report that many of the authors
who studied and promoted the Infuse product had significant financial ties to Medtronic.
Because these vague allegations fail to meet the standard of particularity, the circuit court
correctly dismissed the fraud claim.
Ordinarily, however, when a circuit court dismisses a complaint for a pleading
defect, it should afford the plaintiff an opportunity to amend the complaint and to correct
the defect. See Thomas v. Ford Motor Co., 48 Md. App. 617, 631-32 (1981). Perhaps
because the circuit court believed that the vast majority of the complaint was preempted,
it failed to afford the McCormicks the opportunity to correct the defects in their fraud
claim. Thus, because the case must return to the circuit court for consideration of the
claims that in our view are not preempted (including the claims based on negligent
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misrepresentation and the misrepresentation-based Consumer Protection Act claims), the
circuit court, on remand, should allow the McCormicks a reasonable opportunity to
amend their complaint and to plead fraud with greater particularity.
H. Failure to Plead Consumer Protection Violations with Particularity
Citing Lloyd v. General Motors Corp., 397 Md. 108 (2007), Medtronic argues that
the McCormicks’ Consumer Protection Act claim is premised on fraud and, thus, must be
pleaded with particularity. Medtronic is correct in part and incorrect in part.
Under the Consumer Protection Act, an “unfair and deceptive trade practice”
replicates common-law fraud insofar as it includes “[d]eception, fraud, false pretense,
false premise, misrepresentation, or knowing concealment, suppression, or omission of
any material fact with the intent that a consumer rely on the same in connection with . . .
[t]he promotion or sale of any consumer goods . . . .” Md. Code (1975, 2013 Repl. Vol.)
§ 13-301(9) of the Commercial Law Article. Accordingly, if a party alleges an “unfair or
deceptive trade practice” under that specific subsection, he or she must allege fraud with
particularity, as the Lloyd plaintiffs successfully did. Lloyd, 397 Md. at 154.
Under other provisions of the act, however, a party can allege an “unfair and
deceptive trade practice” without replicating a claim for common-law fraud. For
example, an “unfair or deceptive trade practice” may include a “[f]alse, falsely
disparaging, or misleading oral or written statement, visual description, or other
representation of any kind which has the capacity, tendency, or effect of deceiving or
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misleading consumers” (Md. Code (1975, 2013 Repl. Vol.) § 13-301(1) of the
Commercial Law Article), or the “[f]ailure to state a material fact if the failure deceives
or tends to deceive.” Id. § 13-301(3). To prove those violations, it is unnecessary to
prove scienter. Consumer Prot. Div. v. Morgan, 387 Md. 125, 211 (2005); Golt v.
Phillips, 308 Md. 1, 10-11 (1986). It is, therefore, unnecessary to allege those violations
with particularity.20
C ONCLUSION
In summary, we reverse the circuit court’s conclusion that federal law preempts
the claims for fraud, negligent misrepresentation, and violations of the Consumer
Protection Act insofar as those claims are based on false statements of material fact that
Medtronic may allegedly have made in voluntary communications with the public or
members of the medical professions, in the context of off-label promotion of the Infuse
device, and outside of the safe-harbor that permits the distribution of peer-reviewed
articles or reference publications concerning the safety, effectiveness, or benefit of the
off-label uses of the device. We also reverse the circuit court’s conclusion that federal
20
Medtronic makes a number of miscellaneous arguments that the circuit court did
not consider. These include arguments that Mr. McCormick has not satisfactorily alleged
a demonstrable fear of cancer, that Maryland does not permit strict liability or breach of
warranty claims against device manufacturers, and that Medtronic disclaimed all
warranties. Although we may consider these arguments in reviewing the grant of a
motion to dismiss (see, e.g., Lizzi v. Washington Metro. Area Transit Auth., 156 Md. App.
1, 7, aff’d, 384 Md. 199 (2004)), we decline to do so in view of the circuit court’s failure
to consider them and the lack of emphasis on them in the parties’ briefs. Medtronic is
free to reassert the arguments on remand.
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law preeempts the claims for the breach of any express warranties that Medtronic may
have made in voluntary communications with the public or members of the medical
professions outside of the context of the FDA-mandated and FDA-approved labeling for
the device. We affirm the circuit court in all other respects, including in its conclusion
that the McCormicks failed to plead fraud with particularity, but we direct the circuit
court to afford them an opportunity to attempt to satisfy that pleading requirement on
remand.
JUDGMENTS REVERSED AND
REMANDED TO THE CIRCUIT
COURT FOR MONTGOMERY
COUNTY FOR FURTHER
PROCEEDINGS NOT
INCONSISTENT WITH THIS
OPINION; COSTS TO BE PAID
ONE-HALF BY APPELLANT AND
ONE-HALF BY APPELLEE.
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