Bausch v. Stryker Corp.

In the

United States Court of Appeals
For the Seventh Circuit

No. 09-3434

M ARGARET J. B AUSCH,
Plaintiff-Appellant,
v.

S TRYKER C ORPORATION, et al.,
Defendants-Appellees.

Appeal from the United States District Court
for the Northern District of Illinois, Eastern Division.
No. 08 C 4248—Samuel Der-Yeghiayan, Judge.

A RGUED O CTOBER 21, 2010—D ECIDED D ECEMBER 23, 2010

Before E ASTERBROOK, Chief Judge, and M ANION and
H AMILTON, Circuit Judges.
H AMILTON, Circuit Judge. This diversity jurisdiction
case presents issues concerning federal preemption
and sufficient pleading of a plaintiff’s claim that she has
been injured by a medical device—a hip replacement—
allegedly manufactured in violation of federal law.
Plaintiff Margaret J. Bausch appeals the district court’s
dismissal of her case against defendants Stryker Corpora-
2 No. 09-3434

tion, HOC, and Stryker Ireland, Ltd. (collectively
“Stryker”), who have manufactured, distributed, and sold
the Trident-brand ceramic-on-ceramic hip replacement
system (“the Trident”) in the United States since 2003.
The Trident is a Class III medical device under federal
law, the class of devices that are most critical to human
health and subject to the most extensive federal regulation.
Bausch alleged that the defendants violated federal
law in manufacturing the Trident. The device was im-
planted in her body six days after the United States Food
and Drug Administration informed the defendants that
a component of the Trident hip system was “adulter-
ated” and that the companies’ manufacturing processes
failed to comply with federal standards. The Trident
implanted in Bausch failed, requiring surgical removal
and replacement of the product and leading to a host
of serious and painful medical problems. The defen-
dants later recalled a component of the Trident bearing
the same catalogue number as the one that had been
implanted in Bausch’s body. Bausch brought this suit
under Illinois common law for negligence and strict
liability for a defective product.
The district court granted defendants’ motion to
dismiss under Rule 12(b)(6) of the Federal Rules of Civil
Procedure, holding that Bausch’s common law claims
were preempted by federal law. In an unusual step,
the district court did not allow plaintiff a requested op-
portunity to amend her complaint, but immediately
entered final judgment dismissing the action with preju-
dice. The district court then denied Bausch’s motion to
No. 09-3434 3

vacate the judgment and for leave to file an amended
complaint.
We conclude that the district court erred. Bausch’s
claims that she was injured by defendants’ alleged viola-
tions of federal law are not preempted. Her original
complaint should not have been dismissed. Even if the
original complaint had been defective, the district court
abused its discretion by dismissing the action with preju-
dice and denying Bausch leave to file an amended com-
plaint. We address first the preemption issue and then
the pleading issues.

I. The Scope of Federal Preemption for Class III Medical
Devices
The central issue in this appeal is whether federal
law preempts product liability claims against manufac-
turers of Class III medical devices where a patient claims
that she was harmed by the manufacturer’s violation of
federal law. That statement of the issue may be a little
startling. 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. Nevertheless, manufac-
turers in this case and in others have asserted this
theory of defense. As we explain below, the manu-
facturer’s theory tries to stretch the Supreme Court’s
decisions in this field beyond the boundaries that were
made clear in those decisions. Medical device manu-
facturers who subject their Class III devices to the rigorous
premarket approval process are protected by federal
4 No. 09-3434

law from civil liability so long as they comply with
federal law. That protection does not apply where the
patient can prove that she was hurt by the manufac-
turer’s violation of federal law. We begin by analyzing
defendants’ asserted defense of express preemption and
then their defense of implied preemption.

A. Express Preemption—The Limited Scope of 21 U.S.C.
§ 360k
Defendants’ hip implants are so important to patients’
health that they are treated as “Class III Medical De-
vices” under the federal Food, Drug, and Cosmetic Act.
Class III medical devices are those used “in supporting
or sustaining human life or for a use which is of sub-
stantial importance in preventing impairment of human
health” and those that “present[ ] a potential unreasonable
risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(c). Under
the federal act, the Food and Drug Administration
(FDA) subjects new Class III medical devices to a
rigorous process of federal review for safety and effec-
tiveness called “premarket approval.” See 21 U.S.C. § 360e;
Riegel v. Medtronic, Inc., 552 U.S. 312, 317-20 (2008) (de-
scribing process and requirements).
The Medical Device Amendments of 1976 to the fed-
eral Food, Drug, and Cosmetic Act include an express,
but limited, preemption provision for product liability
claims against manufacturers of Class III medical devices:
[N]o State or political subdivision of a State may
establish or continue in effect with respect to a
No. 09-3434 5

device intended for human use any require-
ment—(1) which is different from, or in addition to,
any requirement applicable under this chapter to
the device, and (2) which relates to the safety or
effectiveness of the device or to any other matter
included in a requirement applicable to the device
under this chapter.
21 U.S.C. § 360k(a).
The Supreme Court has twice addressed the limited
scope of this preemption provision. Its decisions show
that plaintiff Bausch has stated a legally viable claim
based on alleged violations of federal law. First, in 1996,
the Supreme Court held that lawsuits brought under
state law against medical device manufacturers who
submit “premarket notification” to the FDA—a process
described below—are not preempted by 21 U.S.C.
§ 360k(a) when liability is premised on theories that
the device was defective and unreasonably dangerous
and that the manufacturer failed to use reasonable care
in the device’s design, manufacture, assembly, and sale.
Medtronic, Inc. v. Lohr, 518 U.S. 470, 481, 494-95 (1996). In
2008, the Supreme Court held that lawsuits brought
under state law against medical device manufacturers
who obtain the full federal “premarket approval” are
preempted by section 360k(a) when liability is premised
on violations of state law requirements that are in addi-
tion to or different from federal requirements reg-
ulating the devices. Riegel, 552 U.S. at 330. Neither case
held that state lawsuits premised on violations of federal
law are preempted under section 360k(a). In fact, the
6 No. 09-3434

Court’s opinions in Lohr and Riegel expressly left the
door open for state law claims based on violations of
federal law.
In Lohr, the Court rejected a preemption defense as
applied to another medical device (pacemaker leads)
where the plaintiff based her claims on allegations that
the manufacturer had violated federal regulations. The
Court explained that the federal preemption provision
allows claims under a state’s common law based on the
defendant’s violation of federal law:
Nothing in § 360k denies Florida the right to provide
a traditional damages remedy for violations of com-
mon-law duties when those duties parallel federal
requirements. Even if it may be necessary as a
matter of Florida law to prove that those viola-
tions were the result of negligent conduct, or that
they created an unreasonable hazard for users of the
product, such additional elements of the state-law
cause of action would make the state requirements
narrower, not broader, than the federal require-
ment. While such a narrower requirement might be
“different from” the federal rules in a literal sense,
such a difference would surely provide a strange
reason for finding pre-emption of a state rule insofar
as it duplicates the federal rule. The presence of a
damages remedy does not amount to the additional
or different “requirement” that is necessary under
the statute; rather, it merely provides another reason
for manufacturers to comply with identical existing
“requirements” under federal law.
Lohr, 518 U.S. at 495 (reversing dismissal of complaint).
No. 09-3434 7

The pacemaker leads at issue in Lohr had not been
approved through the FDA’s premarket approval pro-
cess. Instead, the FDA confirmed that the leads were
“substantially equivalent” to a device that was already
on the market through what is known as a “premarket
notification” or “§ 510(k) process.” Id. at 478-80. The
section 510(k) process is less rigorous than the pre-
market approval process, so much so that Lohr held
that such generally applicable standards are not “require-
ments” sufficient even to trigger preemption under
section 360k(a). Id. at 492-93. The Court went on to
explain that section 360k(a) does not preempt state rules
that merely duplicate federal requirements. Id. at 494-95.
Thus, the above quoted language in Lohr discussing
parallel claims also applies to products that have gone
through premarket approval.
Nothing in the more recent Riegel case calls into ques-
tion the ability of a patient to sue a Class III device manu-
facturer under state law for violations of federal law.
In fact, the Riegel Court went out of its way to explain
that such claims are not preempted. Because the case is
so central, we consider it in some detail.
In Riegel, the plaintiffs alleged that a medical device
that failed was designed, labeled, and manufactured in
breach of duties imposed by state common law, and that
the defects caused the plaintiffs to suffer severe and
permanent injury. Riegel, 552 U.S. at 320. The district
court held that section 360k preempted the plaintiffs’
claims of strict liability, breach of implied warranty, and
negligence in the design, testing, inspection, distribution,
8 No. 09-3434

labeling, marketing and sale of the device. Id. at 320-21.
The district court also held that section 360k preempted
the Riegels’ negligent manufacturing claim, but only to
the extent that the claim was not premised on the
theory that Medtronic had violated federal law. Id. at 321.
But the district court had allowed the Riegels to go
forward on claims that Medtronic was negligent in manu-
facturing by failing to comply with federal standards
and had breached an express warranty. Those claims
were not preempted by section 360k. The district court
later granted summary judgment on those claims, appar-
ently on the merits, and those claims, which were essen-
tially identical to plaintiff Bausch’s claims for these pur-
poses, were not before the Supreme Court. See id. at
321, n.2.
On review, the Supreme Court held that the premarket
approval process imposed federal “requirements” that
triggered the preemption clause of section 360k.
Id. at 322-23. The Court further held that the tort duties
implicit in a finding of liability under the common law
claims brought by the Riegels would also constitute
“requirements” under section 360k. Id. at 323-25. Ulti-
mately, the Court concluded that, to the extent the
state tort law underlying the Riegels’ claims would
require a manufacturer’s device to be safer (but perhaps
less effective) than the model device approved by the
FDA, those requirements would “disrupt[ ] the federal
scheme no less than state regulatory law to the same
effect.” Id. at 325. Thus, the Court found that the state
requirements implicit in the Riegels’ common law claims
No. 09-3434 9

were different from or in addition to the federal require-
ments and were preempted under section 360k.
The Riegel Court took care, however, to limit its
holding to claims that the device at issue “violated state
tort law notwithstanding compliance with the relevant
federal requirements.” 552 U.S. at 330 (emphasis added).
The Court gave lower courts clear instructions to allow
claims to proceed when they are based on claimed viola-
tions of federal law: Ҥ 360k does not prevent a State
from providing a damages remedy for claims premised
on a violation of FDA regulations; the state duties in
such a case ‘parallel,’ rather than add to, federal require-
ments.” Id. That passage in Riegel quoted the portion of
Lohr that we quoted above. See 518 U.S. at 495.
The Supreme Court thus 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. In
other words, where state law is parallel to federal
law, section 360k does not preempt the claim.
Consistent with Lohr, we held in McMullen v. Medtronic,
Inc., 421 F. 3d 482, 489 (7th Cir. 2005), quoting Bates v.
Dow Agrosciences LLC, 544 U.S. 431, 454 (2005), that state
requirements are not expressly preempted under § 360k
where the plaintiff can show that the requirements are
“genuinely equivalent.” We said that where there are
“both state and federal requirements to [the same] effect,
then the state requirements will not be different from, or
in addition to, the federal requirements.” Id. at 488; see also
10 No. 09-3434

Chambers v. Osteonics Corp., 109 F.3d 1243, 1248 (7th Cir.
1997) (Medical Device Amendments did not preempt
state law claim based on manufacturing defect resulting
from violation of FDA requirements); Mitchell v. Collagen
Corp., 126 F.3d 902, 913 n.6 (7th Cir. 1997) (negligence
claims not preempted if based on claims that manu-
facturer did not adhere to FDA standards in the
premarket approval process). Nothing in Riegel changes
our view that state law claims based on violations of
federal law are not expressly preempted by section 360k.
In this case, the district court erred by dismissing as
preempted plaintiff’s common law claims based upon
alleged violations of federal law. The district court
thought Riegel and Lohr would leave room for a claim
based on “a state regulatory enactment,” but that
common law claims would be different from or in addi-
tion to federal law and thus would be preempted. Bausch
v. Stryker Corp., 2008 WL 5157940, at *5 (N.D. Ill. Dec. 9,
2008). That analysis overlooked the Supreme Court’s
rejection in Lohr and Riegel of precisely that argument
against common law claims. As the passage quoted
above begins: “Nothing in § 360k denies Florida the
right to provide a traditional damages remedy for viola-
tions of common-law duties when those duties parallel
federal requirements.” 518 U.S. at 495.
Illinois treats a violation of a statute or ordinance de-
signed to protect human life or property as prima facie
evidence of negligence, though the violation may not
always be conclusive on the issue of negligence. See, e.g.,
Kalata v. Anheuser-Busch Companies, Inc., 581 N.E.2d 656,
No. 09-3434 11

661 (Ill. 1991) (violation of public safety ordinance reg-
ulating handrails is prima facie evidence of negligence);
Batteast v. Wyeth Laboratories, Inc., 560 N.E.2d 315, 323
(Ill. 1990) (violation of safety statute is prima facie
evidence of negligence if law designed to (1) protect
class to which plaintiff belongs and (2) injury has direct,
proximate connection with regulation); Barthel v. Illinois
Central Gulf Railroad Co., 384 N.E.2d 323, 326 (Ill. 1978),
citing Davis v. Marathon Oil Co., 356 N.E.2d 93 (Ill. 1976)
(a defendant’s violation of a statute designed to protect
human life or property is ordinarily prima facie evi-
dence of negligence); First National Bank in DeKalb v.
City of Aurora, 373 N.E.2d 1326, 1329-30 (Ill. 1978) (citing
violation of ordinances regulating street and sidewalk
safety was sufficient to state a cause of action); Hartje
v. Moxley, 85 N.E. 216, 217 (Ill. 1908) (driving at pro-
hibited rate of speed is prima facie evidence of negligence).
Section 360k provides immunity for manufacturers
of new Class III medical devices to the extent that they
comply with federal law, but it does not protect them
if they have violated federal law. Just as a plaintiff in
an auto accident may use the other driver’s speeding
violation as evidence of negligence, plaintiff Bausch
claims that she was injured by Stryker’s violations of
federal law in manufacturing the device implanted in
her hip. It remains to be seen whether she can prove
those allegations, including causation and damages. But
if she can prove those allegations of harm caused by
violations of federal law, her claims under state law
would not impose on defendants any requirement “dif-
12 No. 09-3434

ferent from, or in addition to, any requirement” imposed
by federal law. Her claims are not preempted.
Our conclusion that plaintiff Bausch’s claims for defec-
tive manufacture in violation of federal law are not ex-
pressly preempted by section 360k is consistent with
the Supreme Court’s decisions in Lohr and Riegel, and
also with numerous circuit and district court decisions
that have considered similar claims based on alleged
violations of federal law. See McMullen, 421 F.3d at 488-
89; Chambers, 109 F.3d at 1248; Mitchell, 126 F.3d at 913;
Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436 (6th
Cir. 2010) (unpublished opinion); Hofts v. Howmedica
Osteonics Corp., 597 F. Supp. 2d 830, 832 (S.D. Ind. 2009);
Prudhel v. Endologix, Inc., 2009 WL 2045559 (E.D. Cal. Jul. 9,
2009); Horowitz v. Stryker Corp., 613 F. Supp. 2d 271
(E.D.N.Y. 2009); Purcel v. Advanced Bionics Corp., 2008 WL
3874713 (N.D. Tex. Aug. 13, 2008); Rollins v. St. Jude Medi-
cal, 583 F. Supp. 2d 790 (W.D.La. 2008); Walker v. Medtronic,
Inc., 2008 WL 4186854 (S.D. W.Va. Sep. 9, 2008). We have
not been directed to any federal decisions, other than the
district court in this case, that adopted the broad view of
section 360k preemption argued by the defendants.
A few days before oral argument in this case, the Eighth
Circuit decided In re Medtronic, Inc., Sprint Fidelis Leads
Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010)
(“Medtronic Leads”), one of only two circuit court cases to
have applied Riegel to medical device preemption (the
other is Howard v. Sulzer Orthopedics, Inc.). A divided
panel of the Eighth Circuit affirmed dismissal of the
plaintiffs’ manufacturing defect claims on the basis of
No. 09-3434 13

express preemption. The majority properly left open
some possibility for parallel claims not preempted by
section 360k. The court noted, for instance, that there is
a “narrow gap through which a plaintiff’s state-law
claim must fit if it is to escape express or implied pre-
emption.” Medtronic Leads, 623 F.3d at 1204, quoting
Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D.
Minn. 2009). The majority affirmed dismissal of the manu-
facturing defect claims, however, because “as pleaded
and argued” to the district court, plaintiffs had failed
to identify specific violations of federal law but had
mounted instead a “frontal assault” on the FDA’s deci-
sion to approve the device. Id. at 1207. While the case
might well be distinguishable from our case based on
the Medtronic Leads’ plaintiffs’ deliberate decision not to
seek discovery and to assert claims for patients whose
devices had not failed, we essentially agree with
Judge Melloy’s dissent in Medtronic Leads. Judge Melloy
argued that the plaintiffs could not be expected to
plead their claims with greater specificity without dis-
covery to obtain access to confidential government and
company documents. 623 F.3d at 1209-14 (Melloy, J.,
dissenting).
Defendants argue in the alternative that if a common
law claim can survive their preemption defense, the
plaintiff must allege and prove a violation of a “concrete,
device-specific” federal regulation. The issue is im-
portant because manufacturers of Class III medical
devices are required by federal law to comply with
Quality System Regulations established by the FDA.
14 No. 09-3434

The Quality System Regulations also set forth Current
Good Manufacturing Practices. 21 C.F.R. § 820.1(a)(1).
(Many writers refer to these as QSRs and CGMPs. In
this already acronym-rich environment, we prefer not to
use the short versions.)
Defendants contend that the Quality System Regula-
tions and Current Good Manufacturing Practices are
too general to allow juries to enforce them. Some federal
courts have adopted this approach in the wake of
Riegel. See, e.g., Horowitz, 613 F. Supp. 2d at 284, quoting
In re Medtronic, Inc. Sprint Fidelis Leads Products Liability
Litig., 592 F. Supp. 2d 1147, 1157 (D. Minn. 2009), (plain-
tiff’s claims were “simply too generic, standing alone” to
serve as basis for manufacturing-defect claim), aff’d, 623
F.3d 1200 (8th Cir. 2010); Ilarraza v. Medtronic, Inc., 677
F. Supp. 2d 582, 588 (E.D.N.Y. 2009) (the “intentionally
vague and open-ended nature of the regulations relied
upon is the precise reason why they cannot serve as the
basis for a parallel claim”). The Sixth Circuit has
rejected this approach. See Howard, 382 Fed. Appx. at 440
(reversing summary judgment on preemption grounds,
concluding that the Current Good Manufacturing Prac-
tices are “not so vague as to be incapable of enforce-
ment.”).1

1
The Eighth Circuit panel majority opinion in Medtronic Leads
appears to have agreed that a plaintiff must allege and prove
violation of a device-specific requirement to avoid the preemp-
tion defense for a manufacturing defect claim. 623 F.3d at 1207
(“Plaintiffs simply failed to adequately plead that Medtronic
violated a federal requirement specific to the FDA’s PMA
(continued...)
No. 09-3434 15

Like the Sixth Circuit in Howard, we do not see a
sound legal basis for defendants’ proposal to distinguish
between general requirements and “concrete, device-
specific” requirements. Section 360k makes preemption
a defense if a state seeks to impose on a manufacturer
“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). We emphasize
the phrase “any requirement.” And federal law is clear:
for manufacturers of Class III medical devices, the

1
(...continued)
approval of this Class III device.”). The Medtronic Leads opinion
did not explain its apparent rejection of claims based on
violations of the Quality System Regulations or Current
Good Manufacturing Practices. In Howard v. Sulzer Orthopedics,
by contrast, all members of the Sixth Circuit panel appeared to
agree that a claim based on violations of the Quality System
Regulations or Current Good Manufacturing Practices could
avoid preemption, so that it was not necessary to show viola-
tion of a device-specific requirement. The point of disagree-
ment in Howard was in the interpretation of 21 C.F.R. § 820.70(h):
whether it required actual removal of manufacturing
materials (like lubricants) from the device, or whether only a
procedure to remove manufacturing materials was sufficient,
whether the procedure was successful or not. Compare 382
Fed. Appx. at 440-41 (majority concluding that actual removal
was required), with id. at 442-43 (Guy, J., dissenting) (having
a removal procedure is sufficient to comply with regulation,
whether successful or not).
16 No. 09-3434

Quality System Regulations and Current Good Manu-
facturing Practices adopted by the FDA under its
delegated regulatory authority are legally binding re-
quirements “under this chapter.” 21 C.F.R. § 820.1. “The
failure to comply with any applicable provision in this
part [of the regulations] renders a device adulterated
under section 501(h) of the act. Such a device, as well as
any person responsible for the failure to comply, is
subject to regulatory action.” 21 C.F.R. § 820.1(c).
Defendants’ proposed distinction between concrete,
product-specific requirements and more general require-
ments would also leave injured patients without
any remedy for a wide range of harmful violations of
federal law. The FDA regulations contain many require-
ments that are not concrete or product-specific, yet
which are obviously vital to producing safe and effective
medical devices. For example, the regulations require
each manufacturer to “establish and maintain pro-
cedures to prevent contamination of equipment or
product by substances that could reasonably be expected
to have an adverse effect on product quality,” 21 C.F.R.
§ 820.70(e), and to “establish and maintain procedures
for the use and removal” of manufacturing material
(such as lubricants or abrasives, or cleaning and disinfec-
tant agents) “to ensure that it is removed or limited to
an amount that does not adversely affect the device’s
quality.” 21 C.F.R. § 820.70(h). If a patient were harmed
by an implanted hip replacement system that was con-
taminated, for example, by a production worker’s blood
or mucus or by a lubricant or abrasive that caused an
infection after implantation, that contamination would
No. 09-3434 17

present a substantial claim for violating requirements
that are not “concrete” and “product-specific,” yet which
surely are essential for the manufacture of safe and effec-
tive medical devices for implantation in the human body.
See Howard, 382 Fed. Appx. at 442 (reversing summary
judgment for manufacturer when lubricant used in manu-
facturing had been left on knee replacement implanted
in plaintiff).
We also assume that manufacturing processes are not
perfect, despite what may be the best human efforts to
achieve perfection. Perhaps more to the point, the FDA
makes the same assumption, as is evident from its
Quality System Regulations and Current Good Manu-
facturing Process requirements. The FDA regulations
require each manufacturer to put in place processes to
test products for compliance with product specifica-
tions, to check and document compliance with product
specifications before products are accepted for sale and
use, and to identify and control nonconforming prod-
ucts. 21 C.F.R. §§ 820.72 to 820.90. Plaintiff Bausch’s
amended complaint alleges that the FDA found that the
defendants had failed to comply with section 820.90
regarding nonconforming products, and that the product
implanted in plaintiff Bausch failed to comply with
product specifications as approved by the FDA through
the premarket approval process.
We recognize the possibility that there may be some
room for interpretation of the applicable federal require-
ments, and it is at least conceivable that a jury deciding
a common law claim might apply those requirements
18 No. 09-3434

more stringently than the FDA intended. That danger is
defendants’ best argument in favor of their distinction
between general requirements and concrete, product-
specific requirements. We are not persuaded. First, the
meaning of the FDA’s requirements will present ques-
tions of law for the court to decide, not questions of fact
for a jury to decide. Second, those questions of law will
be questions of federal law, subject to the usual processes
for reconciling conflicting views. Third, the proposed
distinction between general requirements and con-
crete, product-specific requirements seems to us more
slippery and less workable than its proponents acknowl-
edge. And fourth, for the reasons we have explained
above, we believe the proposed distinction cannot be
derived from the language of the statutory preemption
provision or from its purpose, to provide preemption
for medical device manufacturers to the extent they
actually comply with stringent requirements of federal
law. Plaintiff Bausch’s claims are not expressly pre-
empted by federal law to the extent they are based on
defendants’ violations of federal law.

B. Implied Preemption
We turn now to the defendants’ argument on appeal
that Bausch’s amended complaint is not only expressly
preempted but impliedly preempted under Buckman Co.
v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). The
defendants argue specifically that implied preemption
is necessary to maintain the “statutory and regulatory
framework under which the FDA pursues difficult (and
No. 09-3434 19

often competing) objectives” for medical devices, such
as ensuring the safety and efficacy of the devices
while ensuring that the devices are available to those
who need them, and that Bausch’s claims are impliedly
preempted because they conflict with the FDA’s reg-
ulatory regime. Id. at 349. They extract language from
Buckman to conclude that Congress clearly provided
that the Food, Drug, and Cosmetic Act and the Medical
Device Amendments should be “enforced exclusively
by the Federal Government” and that only the FDA can
enforce the regulations on which Bausch’s claims are
based. See id. at 352. This argument is not convincing.
In Buckman, patients claimed to have suffered injuries
from implantation of orthopedic bone screws into
their spines. The patients brought suit alleging
that a regulatory consultant to the manufacturer made
fraudulent representations to the FDA in the course of
obtaining approval to market the screws. The Supreme
Court held that the Food, Drug, and Cosmetic Act as
amended by the Medical Devices Amendments
impliedly preempted the patients’ state law fraud claims
because the claims conflicted with federal law. The
Court concluded that the federal statute empowers the
FDA to deter and punish fraud and that the “balance
sought by the Administration can be skewed by
allowing fraud-on-the-FDA claims under state tort law.”
Id. at 348. But the Buckman court specifically dis-
tinguished such “fraud-on-the-agency” claims, i.e., claims
not related to a field of law that states had traditionally
occupied, from claims based on state law tort principles
such as in Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984),
20 No. 09-3434

and Lohr itself. “In contrast to situations implicating
‘federalism concerns and the historic primacy of state
regulation of matters of health and safety,’ as in Lohr,
518 U.S. at 485, no presumption against pre-emption
obtains in this case.” Id.
Bausch’s claims, like those in Lohr, and unlike those
in Buckman, are tort law claims based on manu-
facturing defects, not fraud on a federal agency. For
these claims, as both Buckman and Lohr make clear, we
“start with the assumption that the historic police
powers of the States were not to be superseded by the
Federal Act unless that was the clear and manifest
purpose of Congress.” Lohr, 518 U.S. at 485, quoting Rice v.
Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947). Here
we look to the express preemption provision, and we
find no indication that Congress intended preemption
of state claims based on violations of federal law,
beyond the limitations set forth in the express preemption
clause as discussed above. An express preemption provi-
sion does not “bar the ordinary working of conflict pre-
emption principles,” Geier v. American Honda Motor Co.,
529 U.S. 861, 869 (2000), but we see no way in which
Bausch’s claims conflict with the federal regulations,
and thus no reason for them to be impliedly preempted.
The defendants argue that Bausch’s claim that the
medical device was “adulterated” must be impliedly
preempted because there is simply no state tort duty
to manufacture a product that is not adulterated. We
disagree. The MDA defines an “adulterated” device as
a device “not in conformity with applicable requirements
No. 09-3434 21

or conditions.” 21 U.S.C. § 351(h). While there may not
be a “traditional state tort law” claim for an “adulter-
ated” product in so many words, the federal definition
of adulterated medical devices is tied directly to the
duty of manufacturers to avoid foreseeable dangers
with their products by complying with federal law.
The evidence showing a violation of federal law shows
that the device is adulterated and goes a long way
toward showing that the manufacturer breached a
duty under state law toward the patient.
Finally, the defendants point to the Eighth Circuit’s
opinion in Medtronic Leads, one of two cases from other
circuits that address the application of Riegel to claims
that medical device manufacturers violated federal law.
There the court upheld the district court’s dismissal of
all claims related to a Class III medical device on the
basis of express and implied preemption. The court
concluded that there is only a “narrow gap” through
which a plaintiff’s state law claim may fit to “escape
express or implied preemption.” Medtronic Leads, 623
F.3d at 1204, quoting Riley, 625 F. Supp. 2d at 777. “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).” Id. Regardless of how wide
or narrow the gap may seem, the Eighth Circuit’s com-
ment was reflecting the limits of both Buckman and Lohr.
The plaintiffs in Buckman who claimed that the manufac-
22 No. 09-3434

turer had defrauded the federal agency did not have an
implied right of action under federal law, and they were
not claiming the breach of a recognized state-law duty
for their benefit. Here, as in Lohr and as recognized in
Riegel, the plaintiff claims breach of a well-recognized
duty owed to her under state law—the duty of a manu-
facturer to use due care in manufacturing a medical
device. She may do so as long as she can show that she
was harmed by a violation of applicable federal law.
Her claim is not impliedly preempted by federal law.

II. Pleading “Parallel” Medical Device Claims
Beginning from the premise that federal law does not
preempt parallel claims under state law based on a
medical device manufacturer’s violation of federal law,
we turn to the problem of how difficult it is to plead
such a claim sufficiently to survive a motion to dismiss
for failure to state a claim under Rule 12(b)(6) of the
Federal Rules of Civil Procedure. There are no special
pleading requirements for product liability claims in
general, or for Class III medical device claims in particu-
lar. The federal standard of notice pleading applies, so
long as the plaintiff alleges facts sufficient to meet the
new “plausibility” standard applied in Iqbal and Twombly.
See Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009) (to
survive a motion to dismiss, the complaint “must
contain sufficient factual matter, accepted as true,
to ‘state a claim to relief that is plausible on its face’ . . . .
A claim has facial plausibility when the plaintiff
pleads factual content that allows the court to draw the
No. 09-3434 23

reasonable inference that the defendant is liable for the
misconduct alleged.”), quoting Bell Atlantic Corp. v.
Twombly, 550 U.S. 544, 556, 570 (2007).
In applying that standard to claims for defective manu-
facture of a medical device in violation of federal law,
moreover, district courts must keep in mind that much
of the product-specific information about manufacturing
needed to investigate such a claim fully is kept con-
fidential by federal law. Formal discovery is necessary
before a plaintiff can fairly be expected to provide a
detailed statement of the specific bases for her claim.
Accordingly, the district court erred in this case by dis-
missing plaintiff’s original complaint and by denying
her leave to amend her complaint.

A. The Original Complaint
Bausch’s original complaint asserted claims under
Illinois law for strict product liability and negligence.
Because the appeal is from the grant of a motion to
dismiss under Rule 12(b)(6), we must accept as true
Bausch’s allegations. See, e.g., Bonte v. U.S. Bank, N.A., 624
F.3d 461, 462 (7th Cir. 2010).
According to the original complaint, the defendants
manufacture the Trident brand ceramic-on-ceramic hip
replacement system. It is a Class III medical device
subject to the authority of the FDA. Plaintiff had right
total hip replacement surgery on March 21, 2007, in
which a Trident device was implanted. The original
complaint alleged that the Trident product was unrea-
sonably dangerous, causing plaintiff to suffer an
24 No. 09-3434

unstable right hip, pain, suffering, disability, and what
is euphemistically called “revision” surgery—in Bausch’s
case a second major operation in which the Trident
product was removed and replaced with a different
product.
The original complaint also alleged facts indicating
that defendants knew, or at least should have known,
before plaintiff’s original surgery that the Trident im-
planted in her was defective. According to the original
complaint, by early 2005, the defendants received com-
plaints that the Trident was failing after it was im-
planted. Defendants recalled a batch of Trident com-
ponents in March 2006 because of “dimensional anoma-
lies.” The FDA conducted an inspection at the defen-
dants’ Ireland manufacturing facility from October 31 to
November 3, 2006, and, following the inspection,
informed the defendants of “numerous deficiencies [in
the Trident] manufacturing and inspection processes.” Six
days before plaintiff Bausch’s surgery, “after several
months of inadequate response to the FDA findings by
the defendants,” the FDA issued a letter to defendants
on March 15, 2007 warning that the Trident was “adulter-
ated due to manufacturing methods . . . not in conformity
with industry and regulatory standards.” A device,
bearing the same catalogue number as the device
allegedly not in compliance with regulations, was then
implanted in Bausch’s body the next week. The device
in Bausch’s body failed and the same device was later
recalled.
The original complaint served the purposes of Rule 8 of
giving the defendants fair notice of the nature of the
No. 09-3434 25

claim against them and of stating a claim for relief that
was “plausible on its face” as required by Iqbal and
Twombly. In deciding whether a complaint can survive
a motion to dismiss, we have consistently said: “As a
general rule . . . notice pleading remains the standard.”
Windy City Metal Fabricators & Supply, Inc. v. CIT Tech.
Financial Services, 536 F.3d 663, 667 (7th Cir. 2008). Pursu-
ant to Rule 8, pleading is meant to “ ‘focus litigation on
the merits of a claim’ rather than on technicalities that
might keep plaintiffs out of court.” Brooks v. Ross, 578
F.3d 574, 580 (7th Cir. 2009), quoting Swierkiewicz v. Sorema
N.A., 534 U.S. 506, 514 (2002). We give the plaintiff “the
benefit of imagination, so long as the hypotheses are
consistent with the complaint.” Bissessur v. Indiana Univ.
Bd. of Trs., 581 F.3d 599, 603 (7th Cir. 2009), quoting
Sanjuan v. American Bd. of Psychiatry and Neurology, Inc., 40
F.3d 247, 251 (7th Cir. 1994). “Together, these rules
ensure that claims are determined on their merits rather
than on pleading technicalities.” Christensen v. County
of Boone, 483 F.3d 454, 458 (7th Cir. 2007).
We do not see a fatal defect in the original complaint
that would have justified its dismissal, let alone entry of
a final judgment dismissing the action with prejudice.
The only significant issue we see with the original com-
plaint is that it alleges not only violations of “regulatory”
standards, but also violations of “industry” standards.
To the extent that the claims are based upon violations
of “industry standards” that are different from or in
addition to the federal regulatory standards (which have
the force of law), those claims would be preempted
under section 360k. Yet complaints that combine legally
26 No. 09-3434

valid and invalid claims are common. When a com-
plaint asserts claims that are legally valid and those that
are not, the correct judicial response is not to dismiss
the complaint, let alone with prejudice. It’s not even
necessary to require a plaintiff to file a “cleaner” amended
complaint. The case may proceed under the original
complaint, with the understanding, provided by the
court if necessary, as to the proper scope of claims that
can survive the legal challenge.
Defendants object that the original complaint does not
specify the precise defect or the specific federal
regulatory requirements that were allegedly violated.
Although the complaint would be stronger with such
detail, we do not believe the absence of those details
shows a failure to comply with Rule 8 of the Federal
Rules of Civil Procedure or can support a dismissal
under Rule 12(b)(6). First, Rule 9(b) does not impose any
special requirement that such a claim be pled with par-
ticularity, as it does for fraud claims, for example.
Second, the victim of a genuinely defective product—for
example, an air bag that fails to inflate in a serious auto-
mobile collision, or an implantable cardiac defibrillator
that delivers powerful electric shocks to a heart that is
functioning normally—may not be able to determine
without discovery and further investigation whether
the problem is a design problem or a manufacturing
problem. It is common, for example, for injured plaintiffs
to plead both defective manufacture and defective design
and to pursue discovery on both theories, as occurred
in Riegel itself, for example. 552 U.S. at 320-21; accord, e.g.,
No. 09-3434 27

Gardner v. Tristar Sporting Arms, Ltd., 2010 WL 3724190
(S.D. Ind. Sept. 15, 2010) (granting summary judgment
for defendant on design defect claim but denying sum-
mary judgment on manufacturing defect claim); Show
v. Ford Motor Co., 697 F. Supp. 2d 975 (N.D. Ill. 2010)
(granting summary judgment for defendant on both
design defect and manufacturing defect claims); Gaskin
v. Sharp Electronics Corp., 2007 WL 2819660 (N.D. Ind.
Sept. 26, 2007) (granting summary judgment for
defendant on design defect claim but denying summary
judgment on manufacturing defect claim); In re Air
Crash Disaster at Sioux City, Iowa, 781 F. Supp. 1307 (N.D.
Ill. 1991) (in airliner crash case, denying motions for
summary judgment for defendants on plaintiffs’ claims
of manufacturing and design defects against different
defendants); see generally, e.g., Bennett v. Schmidt, 153
F.3d 516, 519 (7th Cir. 1998) (“Litigants are entitled to
discovery before being put to their proof”).
Third, in the context of Class III medical devices, much
of the critical information is kept confidential as a
matter of federal law. The specifications of the FDA’s
premarket approval documents, for example, are con-
fidential, and there is no public access to complete
versions of these documents. An injured patient cannot
gain access to that information without discovery. See
21 C.F.R. § 814.9; Medtronic Leads, 623 F.3d at 1211, n. 7
(Melloy, J., dissenting). If the problem turns out to be
a design feature that the FDA approved, section 360k
will protect the manufacturer. Riegel, 552 U.S. at 330. But
if the problem turns out to be a failure to comply with
the FDA’s legally enforceable conditions for approval
28 No. 09-3434

of the device, section 360k will not protect the manufac-
turer.
As noted earlier, one of the only two other circuits to
examine the application of Riegel to medical device pre-
emption is the Eighth Circuit in Medtronic Leads, where
the majority concluded that the plaintiffs had waived
discovery early in the proceedings. The majority up-
held the district court’s refusal to grant the plaintiffs
discovery to respond to the motion to dismiss. There
the court acknowledged the plaintiffs’ argument that the
district court held them to an “impossible pleading stan-
dard” because the FDA’s premarket approval applica-
tion was accessible only to the FDA and the manufac-
turer. The court found that “this argument—which
focuses on the timing of the preemption ruling—
would have considerable force in a case where a
specific defective Class III device injured a consumer,
and the plaintiff did not have access to the specific
federal requirements in the [premarket approval appli-
cation] prior to commencing the lawsuit.” Medtronic Leads,
623 F.3d at 1206. That is exactly the situation in this
case. Here, there has not yet been an opportunity for
discovery, and Bausch never waived discovery. For her to
plead with any more detail that her claims were “based
entirely on a specific defect in the Trident that existed
outside the knowledge and regulations of the FDA,” she
would need access to the confidential materials in the
premarket approval application setting forth the medical
device’s specifications. This is simply not possible without
discovery. It is also unreasonable to expect that Bausch
could have pled more specifically without access to the
No. 09-3434 29

failed Trident itself, but accessing the Trident outside of
a discovery process would risk charges of spoliation of
evidence, as Bausch’s counsel acknowledged at oral
argument. As Judge Melloy noted in Medtronic Leads: “If
plaintiffs must allege that the defendant violated a par-
ticular FDA-approved specification before discovery,
then it is difficult to appreciate how any plaintiff will
ever be able to defeat a Rule 12(b)(6) motion.” Id. at 1212
(Melloy, J., dissenting). We think Judge Melloy said it
well in suggesting that, in analyzing the sufficiency of
pleadings, “a plaintiff’s pleading burden should be com-
mensurate with the amount of information available to
them.” Id. Here, Bausch pled sufficiently given the
amount of information to which she had access.

B. The Proposed Amended Complaint
We turn to a final procedural problem with the
district court’s handling of this case. Plaintiff Bausch, in
her brief opposing dismissal of her original complaint,
asked the district court for an opportunity to file an
amended complaint in the event the court found a defi-
ciency in the original complaint. The district court granted
the defendants’ motion to dismiss under Rule 12(b)(6),
dismissed the original complaint with prejudice, and
entered a final judgment in favor of defendants. The
district court did not address the plaintiff’s request for
leave to file an amended complaint. Plaintiff then filed
a motion to alter the judgment under Rule 59 and sub-
mitted with the motion a proposed amended complaint.
The proposed amended complaint clarified (unneces-
30 No. 09-3434

sarily) that the plaintiff sought relief solely on a theory
that the defendants had violated federal law. The pro-
posed amended complaint also included additional
factual detail, particularly about the FDA’s notice to
defendants that their Trident products were adulterated
as a result of problems in the manufacturing process.
We review the district court’s denial of a request to
vacate the judgment and for leave to file an amended
complaint under an abuse of discretion standard. Foster
v. DeLuca, 545 F.3d 582, 583 (7th Cir. 2008).
The defendants led the district court into a procedural
sidetrack that began with defendants’ decision to move
for dismissal under Rule 12(b)(6) rather than filing
an answer to plead preemption as an affirmative
defense and moving for judgment on the pleadings
under Rule 12(c). Preemption is an affirmative defense,
e.g., Fifth Third Bank v. CSX Corp., 415 F.3d 741, 745 (7th Cir.
2005), and pleadings need not anticipate or attempt to
circumvent affirmative defenses. Gomez v. Toledo, 446 U.S.
635, 640 (1980) (concluding that there was no basis for
imposing on plaintiff the burden to anticipate an affirma-
tive defense); Doe v. GTE Corp., 347 F.3d 655, 657
(7th Cir. 2003) (“Affirmative defenses do not justify
dismissal under 12(b)(6)”); Fed. R. Civ. P. 8(c) (“in re-
sponding to a pleading, a party must affirmatively state
any avoidance or affirmative defense”). If the defense
had been properly presented under Rule 12(c), and if
the district court had adhered to its erroneous view of
preemption, then the proposed amended complaint
would have seemed futile, but, having been presented
with an affirmative defense, the plaintiff was entitled to
try to cure the problem through an amended complaint.
No. 09-3434 31

As the case was briefed, in any event, we find that the
denial of leave to amend the complaint was an abuse
of discretion for three reasons. First, for reasons ex-
plained above, the judge erred when he concluded that
the amended complaint was futile on the merits because
its claims would still be preempted. Second, the judge
concluded that Bausch had earlier failed to file a
formal motion for leave to amend, when she requested
leave to file an amended complaint in her response to
the defendants’ motion to dismiss. But a formal motion
for leave to amend was not necessary at the Rule 12(b)(6)
stage, and the plaintiff was entitled to wait and see
if any pleading problems the court might find could be
corrected. Finally, the judge concluded that Bausch’s
request was unduly delayed. We find no merit in the
undue-delay rationale. There was no new theory of
relief, but only a clarification that Bausch’s claims were
focused only on violations of federal law, and a showing
of additional factual details, especially related to the
FDA warning letter.
As a general matter, Rule 15 ordinarily requires that
leave to amend be granted at least once when there is a
potentially curable problem with the complaint or other
pleading. A plaintiff is entitled to amend the complaint
once as a matter of right, Fed. R. Civ. P. 15(a), and a
court should “freely give leave [for a party to file an
amended complaint] when justice so requires.” Fed. R.
Civ. P. 15(a)(2). A district court may deny leave to file
an amended complaint in the case of “undue delay,
bad faith or dilatory motive on the part of the movant,
repeated failure to cure deficiencies by amendments
32 No. 09-3434

previously allowed, undue prejudice to the opposing
party by virtue of allowance of the amendment, [and]
futility of amendment.” Airborn Beepers & Video, Inc.
v. AT&T Mobility LLC, 499 F.3d 663, 666 (7th Cir. 2007),
quoting Foman v. Davis, 371 U.S. 178, 182 (1962). However,
while a court may deny a motion for leave to file an
amended complaint, such denials are disfavored. As
we said in Foster, “[d]istrict courts routinely do not termi-
nate a case at the same time that they grant a defen-
dant’s motion to dismiss; rather, they generally dismiss
the plaintiff’s complaint without prejudice and give
the plaintiff at least one opportunity to amend her com-
plaint.” 545 F.3d at 584. Even if the Bausch court was
correct in dismissing with prejudice under James Cape &
Sons Co. v. PCC Const. Co., 453 F.3d 396, 400-01 (7th Cir.
2006) (affirming dismissal with prejudice where the
losing plaintiff failed to request leave to amend until it
was too late, and the district court had no way of
knowing what the proposed amended complaint en-
tailed), it was not correct in later refusing to vacate
the judgment to provide Bausch leave to amend when,
in the absence of undue delay or other fault on her
part, Bausch submitted a revised complaint that was not
futile.
One objective of Rule 8 is to decide cases fairly on their
merits, not to debate finer points of pleading where
opponents have fair notice of the claim or defense. See
Fed. R. Civ. P. 8(e) (“Pleadings must be construed so as
to do justice.”). Generally, if a district court dismisses
for failure to state a claim, the court should give the
party one opportunity to try to cure the problem, even
No. 09-3434 33

if the court is skeptical about the prospects for success.
See Foster, 545 F.3d at 584.

Conclusion
For the foregoing reasons, we R EVERSE the judgment
of the district court dismissing Bausch’s suit and denying
her the opportunity to file an amended complaint, and
we R EMAND for further proceedings consistent with
this opinion.

12-23-10