Comella et al v. Smith & Nephew, Inc.

Filing 42

MEMORANDUM Opinion and Order. Signed by the Honorable James B. Zagel on 12/11/2013. (ep, )

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION

BARBARA COMELLA and
FRANK COMELLA,

No. 13 C 1850
Judge James B. Zagel 

Plaintiffs,
v.

SMITH & NEPHEW, INC.,
Defendant. 

MEMORANDUM OPINION AND ORDER
Plaintiffs Barbara Comella (“Barbara”) and Frank Comella (“Frank”) have filed a
complaint against Defendant Smith & Nephew, Inc., manufacturer of the Birmingham Hip
Resurfacing System (“BHR System”), for strict products liability, negligence, and loss of
consortium. Currently before the court is Defendant’s motion to dismiss Plaintiffs’ complaint.
For the following reasons, Defendant’s motion is granted in part and denied in part.
I. BACKGROUND
On April 22, 2007, a BHR System, manufactured by Defendant Smith & Nephew and
consisting of two components, an acetabular cup and a femoral head, was implanted in Plaintiff
Barbara’s left hip. The FDA had granted premarket approval (“PMA”) for the device on May 9,
2006. Barbara asserts that, at the time of the procedure, her doctor was unaware of adverse
effects from the BHR System. Barbara first complained to her doctor, Dr. Sporer, about a
squeaking noise in her hip on September 11, 2009, and then, about a severe, sharp pain that
radiated throughout her left hip, groin, and buttocks on October 6, 2010. In March 2011, blood
serum metal ion tests were performed on Barbara that revealed highly elevated chromium and

cobalt levels. On March 10, 2011, Dr. Sporer performed Barbara’s left hip revision surgery and
removed the failed BHR System. A post-operative report further revealed corrosion on the
device at the modular junction and lab results consistent with metallosis.
As a result of the 2011 revision surgery, Barbara needed to be non-weight bearing for
approximately six weeks and required the use of a cane for approximately four additional weeks.
Further, Barbara needed multiple medications to manage pain and suffered intestinal problems
due to those medications. Despite undergoing two rounds of physical therapy and ongoing
treatment with a chiropractor, Barbara continues to suffer daily pain in her hip region and is
unable to walk easily for an extended amount of time.
On March 8, 2013, Plaintiffs Barbara and Frank filed a three-count complaint against
Defendant Smith & Nephew, and filed additional amended complaints on May 1, May 29, and
July 8, 2013. Plaintiffs base their state common-law claims on violations of 21 C.F.R. 820.30 et
seq., which describe the “current good manufacturing practices” (“CGMPs”) of the U.S. Food
and Drug Administration (“FDA”). Defendant filed a motion to dismiss the present case,
arguing that Plaintiffs’ claims are expressly and impliedly preempted and alternatively, that
Plaintiffs’ complaint is insufficient under Fed. R. Civ. P. 8. Currently before the court is
Defendant’s motion to dismiss Plaintiffs’ complaint.
II. DISCUSSION
Under the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic
Act (“the Act”), Class III devices, which include hip resurfacing systems, require PMA before
they can be made available to consumers. 21 U.S.C. § 360(e). Even after the product undergoes
the rigorous PMA review and is granted PMA, the FDA still requires medical device
manufacturers to comply with CGMPs “to ensure that finished [medical] devices will be safe and

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effective and otherwise in compliance with the [Act]”). 21 C.F.R. § 820.1; see generally 21
C.F.R. § 820 et seq.; Medtronic Inc. v. Lohr, 518 U.S. 470, 477 (1996). Plaintiffs’ strict products
liability, negligence, and loss of consortium claims are based on violations of the CGMPs,
including Defendant’s failure to comply with design controls under 21 C.F.R. § 820.30, failure to
comply with reporting requirements under 21 C.F.R. § 820.80, and failure to take appropriate
corrective and preventative actions under 21 C.F.R. § 820.100.
A.

Express Preemption
The central issue before the court is preemption. Under federal law, a product liability

claim may be preempted either expressly or impliedly. For a product liability claim to be
expressly preempted, Congress must make “clear and manifest” its purpose to supersede the
historic police powers of a state. Lohr, 518 U.S. at 485. In the Act, Congress expressly states its
intent to preempt any state requirement related to a products liability claim that is, (1) “different
from or in addition to” any requirement under the Act; and (2) related to the device’s safety or
effectiveness, or any other device requirement within the Act. 21 U.S.C. § 360k. A claim,
however, based on a state common law duty that is sufficiently parallel to the requirement under
the federal regulations, imposes no additional obligation and is not preempted. Lohr, 518 U.S. at
495 (“Nothing in § 360k denies Florida the right to provide a traditional damages remedy for
violations of common-law duties when those duties parallel federal requirements.”).
In their complaint, Plaintiffs allege that Defendant breached a common law duty by
failing to advise the FDA about dangers that became manifest after the product was put on the
market. In its motion to dismiss, Defendant contends that this state common-law duty to warn
imposes a requirement that is “in addition” to federal requirements and thus, expressly
preempted. Plaintiffs argue that their claim, based on the common law duty to warn, is

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sufficiently parallel to the requirement to make disclosures under the federal regulations so as not
to be preempted. I agree. Defendant was required under the Act and CGMPs to make certain
reports and disclosures to the FDA, and the state common law duty to warn creates no
requirement “different from, or in addition to” the requirements of the federal regulations. Lohr,
518 U.S. at 495; see Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008).
On the other hand, to the extent that the complaint alleges a breach of a duty to advise or
warn the public and medical community, it creates an additional requirement and is preempted.
While the federal requirement permits Defendants to provide interim supplemental warnings
pending approval by the FDA, it does not require it. Consequently, a common law duty to
provide a warning to the public and medical community imposes a requirement additional to the
federal regulations and is preempted. See McMullen v. Medtronic, Inc., 421 F.3d 482 (2005)
(“Because § 814.39 permits, but does not require, a manufacturer to provide interim
supplemental warnings pending approval by the FDA, a common-law duty to provide such a
warning imposes an additional obligation.”).
For the foregoing reasons, Defendant’s motion to dismiss under the express preemption
doctrine is granted in part, denied in part.
B.

Implied Preemption
A state law claim that conflicts with a federal agency’s regulatory regime may also be

found to be impliedly preempted. The entire relationship between the FDA and the entities it
regulates “originates from, is governed by, and terminates according to federal law.” Buckman
Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). Consequently, a private right of
action under the FDA could skew the “delicate balance of statutory objectives” addressed by the
federal regulations. Id. As such, a plaintiff generally has no private right of action under the Act

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to sue a manufacturer for “fraud-on-the-agency” or noncompliance with the FDA. Id. Tort
claims, however, are based on a state common law duty to warn and fall within the state’s
traditional role of protecting the health and safety of its citizens. Bausch v. Stryker Corp., 630
F.3d 546, 557 (2010). For this reason, tort claims are distinguishable from fraud claims and are
not impliedly preempted. Id.
Defendant argues that Plaintiffs’ claims are impliedly preempted because Plaintiffs do
not have a private right of action under the Act to sue a manufacturer for what are fundamentally
fraud allegations or noncompliance with the Act. Plaintiffs do not disagree that a fraud claim
would be impliedly preempted. Rather, Plaintiffs contend that their claim is not based on fraud,
but a breach of a state common law duty to warn based on failure to comply with disclosure and
reporting requirements. I agree. Although Plaintiffs’ claims are premised on alleged violations
of federal regulations, they are also capable of existing independent of these regulations as
failure of the duty to warn.
As in the Seventh Circuit’s holding in Bausch, Plaintiffs’ claims are tied directly to the
duty of manufacturers to avoid foreseeable dangers with their products by complying with
federal law. Bausch, 630 F.3d at 557 (violating a federal law “goes a long way toward showing
that the manufacturer breached a duty under state law”). As such, Plaintiffs’ claims are only
preempted to the extent intended by Congress—in this case, as directly stated under the express
preemption provision of the Act. Lohr, 518 U.S. at 485. Plaintiffs’ claims, then, are preempted
only to the extent that the duty to warn imposes an obligation on Defendant that is additional to
the federal requirements. Bausch, at 557 (finding “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”).

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For these reasons, Plaintiffs’ negligence and strict liability claims, based on the breach of
the duty to warn, are not impliedly preempted. See Bausch, 630 F.3d at 557-58; Lohr, 518 U.S.
at 495. Because Plaintiffs’ loss of consortium claim is contingent on the underlying negligence
and strict liability claims, it also is neither expressly nor impliedly preempted.
C.

Sufficiency of Plaintiff’s complaint
Defendant argues that Plaintiffs’ complaint is inadequate under Fed. R. Civ. P. 8 because

it fails to include relevant facts to support a failure to warn claim and deprives Defendant of
requisite notice. This argument, however, was not raised or developed until Defendant’s reply
brief and so, is waived. Coker v. Trans World Airlines, Inc., 165 F.3d 579, 586 (7th Cir. 1999)
(finding that failure to develop an argument until the reply, even if it is preserved, “is a day late
and a dollar short.”); see also Dobrzeniecki v. Salisbury, 2013 WL 500847, at *2 (N.D. Ill. Feb.
11, 2013) (“arguments developed for the first time in a reply brief are considered waived.”).
Nonetheless, even considering Defendant’s argument, I find Plaintiffs’ complaint sufficiently
pled.
Rule 8 requires that a complaint contain a “short and plain statement of the claim
showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8. Rule 8(a)(2). Notice pleading
remains the standard under Rule 8, and heightened fact pleading is not required to state a claim.
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). Notice pleading requires that a complaint
contain more than bare legal conclusions. While there must be a reasonable expectation that
discovery will reveal evidence to support the plaintiff’s allegations, a plaintiff’s pleading burden
corresponds to the amount of information available. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009);
see also Brooks v. Ross, 578 F.3d 574, 581 (7th Cir. 2009). In the case of Class III medical
devices, potentially valuable information related to PMA is kept confidential as a matter of

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federal law and formal discovery may be required before a plaintiff can fairly be expected to
identify specific defects. Bausch, 630 F.3d at 560.
Strict Liability
To state a claim for strict product liability, a plaintiff must show that the product was
“unreasonably dangerous” at the time it left the defendant’s control. Apperson v. E.I. du Pont de
Nemours & Co., 41 F.3d 1103, 1106 (7th Cir. 1994). Design or manufacturing defects, as well as
the failure to warn of a non-obvious risk, may cause a product to become unreasonably
dangerous. Id. Additionally, under both federal and Illinois law, a product that does not comply
with applicable federal standards may be considered unreasonably dangerous. Ross v. Black &
Decker, Inc., 977 F.2d 1178 (7th Cir. 1992).
Plaintiffs allege that the particular BHR System implanted in Barbara was defective and
unreasonably dangerous because Defendant failed to adhere to the approved design. Plaintiffs
point to high levels of chromium and cobalt found in Barbara’s blood as an indicator that the
BHR System was in an “unreasonably dangerous” condition at the time it left Defendant’s
control. Plaintiffs also offer Barbara’s eventual need for revision surgery and complete removal
of the BHR System as further evidence that the BHR System was defective. Bausch, at 558-59;
Elmore v. Smith & Nephew, 2013 WL 1707956, at 10 (N.D. Ill. Apr. 19, 2013) (“two revision
surgeries, coupled with increased chromium and cobalt levels in [plaintiff’s] blood, provide
sufficient factual grounding on which to base negligence and strict liability claims”).
Plaintiffs further allege that Defendant failed to advise the FDA about dangers that
became manifest after the product was put on the market, in violation of federal law. Plaintiffs
contend that this failure to comply with federal requirements set by government regulations
indicates that the BHR System was unreasonably dangerous.

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Plaintiffs’ complaint is plausible on its face. Accordingly, Plaintiffs have sufficiently
pled that the BHR System implanted in Barbara was “unreasonably dangerous” at the time it left
Defendant’s control to state a claim for strict product liability.
Negligence
To state a claim for negligence in Illinois that is based on a violation of a statute designed
to protect human life, a plaintiff must show that (1) the violation proximately caused his or her
injury; and (2) the statute was designed to protect a class of persons from injury to which the
plaintiff belongs. Kalata v. Anheuser-Busch Co., Inc., 581 N.E.2d 656, 661 (1991).
As a threshold matter, Defendant characterizes Plaintiffs’ allegations as failing to identify
a single breach of any federal regulation. Even assuming, arguendo, that Defendant is correct,
the Seventh Circuit held that the failure to specify which federal regulatory requirements were
allegedly violated did not amount to a failure to comply with Fed. R. Civ. P. 8 and could not
support a dismissal under Rule 12(b)(6). Bausch, 630 F.3d at 560.
Plaintiffs allege that Defendant violated the Act and CGMPs under various provisions of
21 C.F.R. § 820. Specifically, Plaintiffs claim that Defendant’s handling of over six hundred
Adverse Events Reports was significantly delayed and that Defendant failed to make complete
and accurate post-market reports. Plaintiffs also allege that Defendant did not adequately
conduct metal ion testing as expressly required under the PMA. Given the amount of
information to which they had access, Plaintiffs made plausible allegations and have sufficiently
pled a violation of a federal regulation by Defendant.
We now proceed to the question of whether the Act and CGMPs were designed to protect
a class of persons to which Plaintiffs belong from injury. Plaintiffs allege that the Act and
CGMPs were designed to protect consumers by continuing monitoring of medical devices.

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Plaintiffs also contend that Defendant’s failure to report and disclose dangers of the BHR System
to the FDA was the proximate cause of Plaintiffs’ injuries. Plaintiffs assert that, had Defendant
complied with the federal regulations, the dangers of the product would have been disseminated,
Plaintiff Barbara Comella’s doctor would not have recommended the BHR System to Plaintiff,
and Plaintiff would not have suffered the injuries caused by the BHR System.
As pled, Plaintiffs’ complaint is plausible on its face. Plaintiffs’ allegations provide
sufficient factual grounding on which to base negligence and strict liability claims. As the
Seventh Circuit has recognized, Plaintiffs’ alleging specific defects relating to Class III medical
devices face particular difficulty in pleading, and their burden is commensurate with the amount
of information they can access prior to discovery. Bausch, 630 F.3d at 561. Here, Plaintiffs
have assembled the minimum factual grounding necessary to meet the plausibility standard
required under Twombly and Iqbal. Consequently, the complaint complies with Fed. R. Civ. P.
8.
III. CONCLUSION
For the foregoing reasons, Defendant’s motion to dismiss is granted in part, denied in
part. Plaintiffs are ordered to strike the portion of their complaint seeking additional state
remedies. Defendant is directed to answer the complaint within 21 days.
DATE: December 11, 2013

ENTER:

James B. Zagel
United States District Judge

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