Janus et al v. Wright Medical Technology, Inc. et al
Filing
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OPINION by U.S. Magistrate Judge Byron Cudmore: Plaintiffs' Motion for Leave to File Amended Complaint 9 ALLOWED in part and DENIED in part. See written order. (LB, ilcd)
E-FILED
Tuesday, 20 December, 2011 02:09:36 PM
Clerk, U.S. District Court, ILCD
IN THE UNITED STATES DISTRICT COURT
FOR THE CENTRAL DISTRICT OF ILLINOIS, PEORIA DIVISION
CHESTER JANUS, and
CATHERINE ANN JANUS,
Plaintiffs,
v.
WRIGHT MEDICAL
TECHNOLOGY, INC., and
WRIGHT MEDICAL GROUP, INC. ,
Defendants.
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No. 11-CV-1183
OPINION
BYRON G. CUDMORE, U.S. MAGISTRATE JUDGE:
This matter comes before the Court on Plaintiffs Chester and
Catherine Ann Janus’ Motion for Leave to File Amended Complaint
(d/e 9) (Motion).1 The Plaintiffs bring claims against Defendants Wright
Medical Technology, Inc., and Wright Medical Group, Inc. (collectively
Wright Medical) for injuries arising from an allegedly defective hip
replacement medical device implanted into Chester Janus. Notice of
Removal, Exhibit A, Tazewell County, Illinois Circuit Court Pleadings, at
26 Complaint at Law.2 The Plaintiffs seek to file an Amended Complaint
1
Plaintiffs’ Reply (d/e 18) is ordered stricken as it was filed in violation of Local
Rule 7.1(B). The court has not considered reply (d/e 18) in rendering this Opinion.
2
The Court refers to the pagination placed on the document by the Court’s
CMECF filing system.
Page 1 of 13
alleging ten claims by Chester Janus and one claim for loss of consortium
by Catherine Ann Janus. Motion, Exhibit A, Amended Complaint and Jury
Demand (Amended Complaint). Wright Medical opposes the Motion
because it argues that filing several of the claims would be futile. For
reasons set forth below, the Motion is ALLOWED in part and DENIED in
part. The Court also gives the Plaintiffs leave to replead.
Leave to amend pleadings is to be freely given when justice so
requires. Fed. R. Civ. P. 15(a)(2). The Court may deny leave to file an
amendment to a complaint when the amendment would be futile.
Foman v. Davis, 371 U.S. 178, 182 (1962). Wright Medical argues that
filing the proposed Amended Complaint would be futile because several
counts would fail to state a claim. In considering such an objection, the test
is whether the proposed Amended Complaint states a claim under Federal
Rule of Civil Procedure 12(b)(6). See Smart v. Local 702 International
Brotherhood of Electrical Workers, 562 F.3d 798, 811 n.15 (7th Cir. 2009).
Rule 12(b)(6) requires only “a short and plain statement of the claim
showing that the pleader is entitled to relief,” and allegations must be
“simple, concise, and direct.” Fed. R. Civ. P. 8(a)(2) & (d)(1). The Court
must accept as true all well-pleaded factual allegations and draw all
inferences in the light most favorable to pleader. Hager v. City of West
Peoria, 84 F.3d 865, 868-69 (7th Cir. 1996); Covington Court, Ltd. v. Village
Page 2 of 13
of Oak Brook, 77 F.3d 177, 178 (7th Cir. 1996). While a complaint need not
contain detailed, specific factual allegations, it must contain sufficient facts
to “state a claim to relief that is plausible on its face.” Bell Atlantic Corp. v.
Twombly, 550 U.S. 544, 570 (2007). A claim is plausible if the plaintiff
“pleads factual content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct alleged.”
Ashcroft v. Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 1949 (2009). A claim is
plausible on its face if it provides the defendant fair notice of what the claim
is and the grounds upon which it rests. George v. Smith, 507 F.3d 605,
608 (7th Cir. 2007). Dismissal under Rule 12(b)(6) is appropriate when
“the factual detail in a complaint [is] so sketchy that the complaint does not
provide the type of notice of the claim to which the defendant is entitled
under Rule 8.” Airborne Beepers & Video, Inc. v. AT & T Mobility, LLC,
499 F.3d 663, 667 (7th Cir. 2007).
In analyzing a complaint under Rule 12(b)(6), the Court does not
consider matters outside the pleadings. See Rule 12(d). The Court,
therefore, excludes from consideration the material outside the Amended
Complaint that have been submitted by the parties.
STATEMENT OF FACTS
The proposed Amended Complaint alleges that Wright Medical
designed, manufactured, imported and distributed the Wright Medical
Page 3 of 13
Profemur Hip System (System). The System is a permanent medical
device designed to be implanted into a person as a hip replacement. The
System was implanted into Plaintiff Chester Janus on his right side as a hip
replacement on November 3, 2003. The Plaintiffs allege the System
implanted into Chester Janus’s right side catastrophically failed while being
used in a normal and expected manner. A portion of the System identified
as a modular neck fractured while in normal use. The Plaintiffs allege that
Chester Janus had the defective System surgically removed on November
17, 2008.
The Plaintiffs allege that the System implanted into Chester Janus
was in the same condition in all relevant respects when it left Wright
Medical’s control. The Plaintiffs allege that the System was unreasonably
dangerous for its intended and/or reasonably foreseeable uses. The
Plaintiffs allege that the modular necks in the System were known by
Wright Medical to fail from fatigue fractures prior to the date the System
was implanted into Chester Janus, and Wright Medical did not warn
patients or surgeons of these known failures at the time. Amended
Complaint ¶¶ 23(A)(10) and (11) and 23(B)(6) and (7). The Plaintiffs
further allege that Wright Medical violated federal statutes and regulations
governing the manufacture and distribution of medical devices such as the
System, specifically 21 U.S.C. § 351 and 360j, and 21 C.F.R. §§ 820.1,
Page 4 of 13
820.22, 820.30, 820.70, 820.75, and 820.90. Amended Complaint ¶¶
36-68. The Plaintiffs allege that Wright Medical misrepresented in its
marketing, advertising, promotions and labeling that the System was safe
and met all applicable design and manufacturing requirements. Id.
¶¶ 117-18.
Based on these allegations, the Plaintiff Chester Janus alleges
products liability claims for defective manufacturing (First Cause of
Action),design defect (Second Cause of Action), nonconformance with
representations (Third Cause of Action), and failure to warn and instruct
(Fourth Cause of Action); negligence (Fifth Cause of Action); breach of
express warranty (Sixth Cause of Action); breach of implied warranty
(Seventh Cause of Action); negligent misrepresentation (Eighth Cause of
Action); negligence per se (Ninth Cause of Action); and punitive damages
for fraud, malice or willful and wanton conduct (Eleventh Cause of Action).
Plaintiff Catherine Ann Janus alleges a claim for loss of consortium
(Twelfth Cause of Action).3 Wright Medical argues that filing the proposed
Amended Complaint would be futile because the Third, Eighth, Ninth, and
Eleventh Causes of Actions fail to state a claim, and the Twelfth Cause of
Action improperly refers to the Illinois Consumer Protection Act in the
prayer. The Court will address each disputed Cause of Action in order.
3
There is no Tenth Cause of Action.
Page 5 of 13
Third Cause of Action
The Plaintiffs allege that when the System left Wright Medical, it did
not conform to Wright Medical’s representations about the System and/or
applicable federal regulations. The Plaintiffs allege that Chester Janus’
surgeon relied on Wright Medical’s representations about the System. The
Plaintiffs allege that Chester Janus suffered injuries as a result of this
reliance on Wright Medical’s representations about the System and/or
Wright Medical’s failure to comply with applicable federal regulations.
Amended Complaint ¶¶ 79-83.
Wright Medical argues that Illinois does not recognize any products
liability claim for a product’s nonconformance to representations or
regulations. Wright Medical cites authority that a products liability claim
has four elements: (1) the plaintiff’s injury resulted from the condition of a
product; (2) the condition of the product was unreasonably dangerous;
(3) the unreasonably dangerous condition existed when the product left the
defendant’s control; and (4) the dangerous condition was the proximate
cause of the injury. Wright Medical’s Response to Plaintiffs’ Motion for
Leave to File Amended Complaint (d/e 17) (Response), at 7 (citing Bilski v.
Scientific Atlanta, 964 F.2d 697, 699 (7th Cir. 1992). Wright Medical argues
that the allegations in the Third Cause of Action do not state these four
elements.
Page 6 of 13
The Court agrees that the Third Cause of Action does not state a
product liability claim for defective manufacture or design. The Third
Cause of Action, however, states a claim under a representational theory of
products liability. The representational theory focuses on the
manufacturer’s representations about a products safety and efficacy for a
particular use:
In those cases in which a manufacturer explicitly or implicitly
represents that its product possesses certain characteristics
that it does not actually possess, the representational theory
would impose liability on the manufacturer for the resulting
injury that reasonable use of the product causes.
Smith v. American Motors Sales Corp., 215 Ill.App.3d 951, 576 N.E.2d 146,
152 (Ill. App. 5th Dist. 1991) and authorities cited therein; see Restatement
Second of Torts, § 402B. The Plaintiffs’ allegations about the alleged
misrepresentations are sufficient to give Wright Medical notice of the basis
for the claim. The Court, therefore, finds that filing the Third Cause of
Action would not be futile.
Eighth Cause of Action
The Eighth Cause of Action alleges that Wright Medical in the
exercise of reasonable care should have known that the System “failed to
comply with federal requirements for safe design and manufacture and/or
was in other ways out of specification, yet Wright Medical negligently
misrepresented to Plaintiff Chester Janus . . . that its device was safe and
Page 7 of 13
met all applicable design and manufacturing requirements.” Amended
Complaint ¶ 117. The Plaintiffs further allege that Wright Medical made
these misrepresentations “in their marketing, advertisements, promotions
and labeling concerning these products for use in patients such as plaintiff
Chester Janus.” Id. ¶ 118. The Plaintiffs allege that Chester Janus and his
surgeon relied on these misrepresentations, and that the
misrepresentations proximately caused Chester Janus’ injuries from the
defective System implanted in his body. Id. ¶¶ 119-122.
Wright Medical argues that the Eighth Cause of Action fails to state a
claim because the Plaintiffs do not allege that Wright Medical intended to
induce Plaintiffs to act on its misrepresentations. Response, at 9. The
elements of negligent misrepresentations are: (1) misstatement of material
fact; (2) the defendant’s negligence in ascertaining the truth concerning the
misstatement; (3) the defendant’s intent to induce the plaintiff to rely on the
misrepresentation; (4) justifiable reliance; and (5) damages. See Sassak v.
City of Park Ridge, 431 F.Supp.2d 810, 818 (N.D. Ill. 2006). Wright
Medical argues that the Amended Complaint fails to allege the element of
intent. The Court disagrees. The Plaintiffs allege that Wright Medical
made these misrepresentations in its marketing, advertising, promotional
material, and product labeling. This allegation is sufficient to put Wright
Medical on notice that the Plaintiffs allege that Wright Medical made these
Page 8 of 13
representations with the intent to induce potential patients and physicians
to select the System for use as an implant for hip replacement. The
function of advertising, marketing, and promotional material is to induce
consumers to select and purchase a product. Filing the Eighth Cause of
Action, therefore, would not be futile.
Ninth Cause of Action
The Ninth Cause of Action alleges that: (1) Wright Medical violated
applicable federal statutes and regulations governing the manufacture and
distribution of medical devices such as the System; (2) these statutes and
regulations were intended to protect individuals such as Chester Janus
from the type of injury he suffered from the defective System that was
implanted into his body; and (3) Wright Medical’s violations of the
applicable statutes and regulations proximately caused Chester Janus’
injuries. These allegations are sufficient to state a claim in Illinois for
negligence per se. See Heisner ex rel Heisner v. Genzyme Corp., 2008
WL 2940811, *6 (N.D. Ill. 2008).
Wright Medical argues that the Plaintiffs must give Wright Medical
notice of the statutes and regulations that it allegedly violated. The
Plaintiffs have done so. The Plaintiffs allege that Wright Medical violated
21 U.S.C. § 351 and 360j, and 21 C.F.R. §§ 820.1, 820.22, 820.30, 820.70,
820.75, and 820.90. Amended Complaint ¶¶ 36-68. This is sufficient
Page 9 of 13
notice. Wright Medical relies on Heisner to support its argument of
insufficient notice. In Heisner, the plaintiffs failed to state a claim because
they alleged the wrong regulations in their complaint. Heisner, 2008 WL
2940811 at *6. That did not occur here. Filing the Ninth Cause of Action
would not be futile.
Eleventh Cause of Action
The Plaintiffs allege that Wright Medical acted with fraud, malice or in
a wilful and wanton manner when it committed the allegedly wrongful
conduct that forms the basis of Chester Janus’ claims in the First through
Ninth Causes of Actions. Based on these allegations, the Plaintiffs ask for
punitive damages. These allegations state a claim for punitive damages.
Punitive damages are allowed in Illinois for wrongful conduct done
maliciously or in a wilful and wanton manner. Kelsay v. Motorola, Inc.,
74 Ill.2d 172, 186, 384 N.E.2d 353, 360 (Ill. 1978).
Wright Medical argues that the Eleventh Cause of Action fails to state
a claim for punitive damages because fraud must be pled with particularity.
Wright Medical correctly states the requirements for pleading fraud;
however, malice may be pled generally. Fed. R. Civ. P. 9(b). Thus, filing
the Eleventh Cause of Action would be futile to the extent that the Plaintiffs
attempt to allege fraud, but the Eleventh Cause of Action states a claim for
punitive damages based on malice. The Court therefore denies the Motion
Page 10 of 13
with respect to the Eleventh Cause of Action, but gives the Plaintiffs leave
to replead the Eleventh Cause of Action without the reference to fraud.
Wright Medical also argues that Rule 11 requires the Plaintiffs to
prove allegations of fraud and malice in order to secure leave to amend the
Complaint to add a claim for punitive damages. Response, at 5-6. Wright
Medical is incorrect. Rule 15 governs amendments to pleadings. Rule 15
does not require evidence in order to secure leave to amend. Leave to
amend is to be freely given when justice so requires. Fed. R. Civ. P.
15(a)(2). Wright Medical has argued that the amendment would be futile
for failure to state a claim. See Foman, 371 U.S. at 182; Smart, 562 F.3d
798, 811 n.15. In determining whether a proposed amendment would be
futile for failure to state a claim, the Court assumes the allegations are true;
the Court does not consider evidence outside the pleadings. Fed. R. Civ.
P. 12(d); Hager, 84 F.3d at 868-69; Covington Court, Ltd., 77 F.3d at 178.
Thus, the Plaintiffs are not required to prove their allegations at this stage
in the proceedings.
Furthermore, Rule 11 does not require a party to present evidence
before filing a pleading. Rather, Rule 11 states that the person signing a
pleading certifies the propriety of the pleading. In this case, Plaintiffs’
counsel has certified by signing and filing the Motion that, after reasonable
inquiry under the circumstances: (1) the Motion was not presented for an
Page 11 of 13
improper purpose; (2) the claims set forth in the proposed Amended
Complaint are warranted under existing law or by nonfrivolous arguments
for extending or modifying existing law; and (3) the factual allegations in the
proposed Amended Complaint will likely have evidentiary support after a
reasonable opportunity for further investigation or discovery. Fed. R. Civ.
P. 11(b) (1), (2) and (3). The Court sees no basis to doubt counsel’s
certification.
If Wright Medical believes the Plaintiffs’ counsel violated Rule 11, it
must file a separate motion for sanctions in accordance with the
procedures set forth in Rule 11(c)(2). Wright Medical has not done so.
Rule 11, therefore, is not at issue at this time. Rather, as explained above,
the Plaintiffs have been granted leave to replead the Eleventh Cause of
Action without the reference to fraud.
Twelfth Cause of Action
Wright Medical complains that the Twelfth Cause of Action improperly
refers to the Illinois Consumer Protection Act. The Court agrees. The
Twelfth Cause of Action is a loss of consortium claim. The claim is based
on the allegedly tortious acts committed against Catherine Ann Janus’
husband Chester. Amended Complaint ¶¶ 136-137. Plaintiff Chester
Janus does not allege any violation of any Illinois consumer protection
Page 12 of 13
statute; thus Catherine Ann Janus’ injuries are not derived from any such
violation.
Filing the Twelfth Cause of Action would be futile to the extent that
Catherine Ann Janus asks for relief under any Illinois consumer protection
statute. The Court, therefore, denies the Motion with respect to the Twelfth
Cause of Action, but grants Plaintiffs leave to replead the Twelfth Cause of
Action without the reference to the Illinois Consumer Protection Act.
WHEREFORE, Plaintiffs Chester and Catherine Ann Janus’ Motion
for Leave to File Amended Complaint (d/e 9) is ALLOWED in part and
DENIED in part. The Court denies Plaintiffs’ request to amend its
Complaint to add the proposed Eleventh and Twelfth Causes of Action set
forth in the proposed Amended Complaint attached to the Motion, but
grants the Plaintiffs leave to replead those two causes of action in
accordance with this Opinion and to file a Second Amended Complaint.
The Plaintiffs are directed to file the Second Amended Complaint, if any, by
January 6, 2012. The Defendants are directed to file their response by
January 27, 2012.
ENTER: December 20, 2011
s/ Byron G. Cudmore
BYRON G. CUDMORE
UNITED STATES MAGISTRATE JUDGE
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