Tice et al v. Zimmer Holdings, Inc. et al
Filing
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OPINION ; signed by Judge Robert Holmes Bell (Judge Robert Holmes Bell, kcb)
UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF MICHIGAN
SOUTHERN DIVISION
RICHARD E. TICE,
SANDRA TICE,
Plaintiffs,
File No. 1:15-cv-134
v.
HON. ROBERT HOLMES BELL
ZIMMER HOLDINGS, INC. et al.,
Defendants.
/
OPINION
This is an action brought by Plaintiff Richard E. Tice and his wife, Sandra Tice,
against Zimmer Holdings, Inc. and its subsidiaries Zimmer, Inc. and Zimmer US, Inc.
(collectively, “Zimmer”). Plaintiffs claim that Mr. Tice was injured by Zimmer’s product,
a hip implant containing components known as the “Zimmer Trilogy Acetabular System
Longevity Crosslinked Polyethylene Liner, Zimmer Versys Hip System Femoral Stem, and
Zimmer Versys Hip System Femoral Head” (collectively, the “Devices”). (Am. Compl. ¶ 1,
ECF No. 17.) On July 15, 2015, the Court issued an opinion and order partially granting
Zimmer’s motion to dismiss. The fraud and negligent misrepresentation claims in Count V
were dismissed for failure to meet the pleading requirements in Rule 9 of the Federal Rules
of Civil Procedure, but the Court gave Plaintiffs an opportunity to file an amended complaint.
Before the Court is Zimmer’s motion to dismiss Counts I and V of the amended complaint
pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. Zimmer asserts that the
claim in Count I is based on a theory of strict liability which is not recognized in Michigan.
Zimmer also contends that the amended claim in Count V fails to state a claim of fraud or
negligent misrepresentation. Zimmer also seeks dismissal of the loss-of-consortium claim
in Count VI, to the extent that it is derivative of Counts I and V. The motion will be granted
in part and denied in part.
I.
A complaint may be dismissed for failure to state a claim if “‘it fails to give the
defendant fair notice of what the . . . claim is and the grounds upon which it rests.’” Bell
Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting Conley v. Gibson, 355 U.S.
41, 45-46 (1957)). While a complaint need not contain detailed factual allegations, a
plaintiff’s allegations must include more than labels and conclusions. Twombly, 550 U.S. at
555; Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“Threadbare recitals of the elements of a
cause of action, supported by mere conclusory statements, do not suffice.”). The Court must
determine whether the complaint contains “enough facts to state a claim to relief that is
plausible on its face.” Twombly, 550 U.S. at 570. “A claim has facial plausibility when the
plaintiff pleads factual content that allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 679. Although the
plausibility standard is not equivalent to a “‘probability requirement,’ . . . it asks for more
than a sheer possibility that a defendant has acted unlawfully.” Id. at 678 (quoting Twombly,
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550 U.S. at 556). “[W]here the well-pleaded facts do not permit the court to infer more than
the mere possibility of misconduct, the complaint has alleged – but it has not ‘show[n]’ – that
the pleader is entitled to relief.” Id. at 679 (quoting Fed. R. Civ. P. 8(a)(2)).
II.
A. Count I: Strict Liability
Zimmer contends that Count I of the amended complaint should be dismissed because
it relies on a theory of strict liability, which is not recognized in Michigan. “In Michigan,
two theories of recovery are recognized in product liability cases; negligence and implied
warranty. Strict liability has not been recognized as a third theory of recovery.” Johnson v.
Chrysler Corp., 254 N.W.2d 569, 571 (Mich. Ct. App. 1977); see also Rodger v. Ford Motor
Co., No. 275578, 2008 WL 4646140, at *6 (Mich. Ct. App. Oct. 21, 2008) (“Michigan does
not recognize strict liability as a theory of recovery in product liability actions.”).
Count I alleges that Zimmer is liable for Mr. Tice’s injuries because the Devices
“were designed, manufactured, promoted, distributed, marketed, and sold by the Defendants
in a defective and unreasonably dangerous condition at the time they were placed in the
stream of commerce.” (Am. Compl. ¶ 30, ECF No. 17.) In particular, Plaintiffs allege that
the Devices contained manufacturing defects and design defects, the Devices were not
adequately tested, they were not accompanied by adequate instructions or warnings regarding
the risks associated with their use, and Defendants failed to provide adequate warnings about
known failures and defects. (Id.) Count I further alleges that Zimmer knew of the dangers
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and defects in the Devices but it continued to sell them, that a “practical and technically
feasible alternative production practice” was available to Zimmer, and that Zimmer knew or
should have known of the manufacturing defects and the risk of injury associated with the
Devices.
In contrast, Count II asserts that Zimmer owed Mr. Tice a duty of reasonable care to
provide a safe product, and that Zimmer breached this duty of care by “defectively designing,
manufacturing, and/or negligently failing to warn of these defects in the Devices[.]” (Id. at
¶ 42.) In addition, Count III asserts that Zimmer “impliedly warranted that the Devices . . .
were merchantable, fit and safe for [their] ordinary and intended use.” (Id. at ¶ 45.)
Based on the foregoing, it appears that Counts II and III are expressly based on
theories of negligence and implied warranty, respectively, which are the only two theories
of recovery recognized in Michigan for a product liability claim. Johnson, 254 N.W.2d at
571. Thus, the Court agrees with Zimmer that, to the extent that Count I relies on a different
theory (i.e. strict liability), it does not state a claim.
On the other hand, Plaintiffs assert that Count I does not “sound” in strict liability and
that it “contains the elements required by the statute governing product liability cases such
as this one.” (Pls.’ Resp. to Mot. to Dismiss 3, ECF No. 22.) Plaintiffs cite Mich. Comp.
Laws § 600.2946(2), which provides:
In a product liability action brought against a manufacturer or seller for harm
allegedly caused by a production defect, the manufacturer or seller is not liable
unless the plaintiff establishes that the product was not reasonably safe at the
time the specific unit of the product left the control of the manufacturer or
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seller and that, according to generally accepted production practices at the time
the specific unit of the product left the control of the manufacturer or seller,
a practical and technically feasible alternative production practice was
available that would have prevented the harm without significantly impairing
the usefulness or desirability of the product to users and without creating equal
or greater risk of harm to others.
Mich. Comp. Laws § 600.2946(2). The foregoing statute sets forth certain requirements for
a product liability claim against a seller or manufacturer for a production (or design) defect.
See id. § 600.2945(i) (defining production to include design). Among other things, a plaintiff
must show that a “practical and technically feasible alternative production practice was
available” that would have prevented the harm. Id. § 600.2946(2). In Count I, but not in
Counts II or III, Plaintiffs allege that a feasible alternative production practice was available
to Zimmer. Thus, Count I contains unique allegations that may be necessary to establish
liability on Plaintiffs’ product liability claim.
In its prior opinion, the Court characterized Count I as a strict liability claim to
distinguish it from Counts II and III. But it does not necessarily follow that, because Counts
II and III rely on other theories of liability, Count I relies solely on a theory of strict liability.
Indeed, Plaintiffs’ contention in Count I that Zimmer designed defective devices could be
construed as relying on a theory of negligence, a theory of implied warranty, or both. See
Prentis v. Yale Mfg. Co., 365 N.W.2d 176, 187 (Mich. 1984) (noting that in defective design
cases, “the standards of liability under the theories of implied warranty and negligence [are]
indistinguishable”). Although Count I appears to be duplicative of Counts II and III in many
respects, the Court will not dismiss it for failure to state a claim at this stage of the
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proceedings. Instead, the Court will make clear that Plaintiffs may obtain relief on their
product liability claims only under a theory of negligence or implied warranty. To the extent
that Count I relies on another theory of liability, such as strict liability, it does not state a
claim.
B. Count V: Fraud/Negligent Misrepresentation
Plaintiffs claim that Zimmer is liable for negligent misrepresentation because it had
“actual knowledge of serious risks and danger” associated with the use of the Devices, but
it failed to disclose these risks when it had a duty to do so. (Am. Compl. ¶ 57.) Specifically,
Plaintiffs refer to a recall notice for the Versys Hip System femoral stem, which indicates that
the “femoral heads will not seat onto the taper of the hip stem[.]” (Ex. 1 to Am. Compl.,
ECF No. 17-1.)
Plaintiffs also allege that Zimmer willfully or negligently supplied false information
to Plaintiffs and the public about the safety, quality, and effectiveness of the Devices, and
that Mr. Tice and his physician relied on this information to purchase and use them.
Plaintiffs refer to statements in pamphlets for “Zimmer’s Total Revision Ability,” including
statements in the following exhibits to the amended complaint:
Exhibit 2:
Through our skilled hands and because of the innovative solutions you can
create in response to each situation, patient quality of life is enhanced and
restored. Zimmer makes your innovative solutions possible with products
designed in partnership with you and in collaboration with the world’s finest
surgeons and top designers. Because of our dedication to developing and
producing the highest-quality orthopaedic products, you can repair, replace,
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and regenerate with confidence. To be the best and to respond to every unique
need. You make that pledge to each patient. We make that pledge to you.
Exhibit 3:
You’re committed to helping patients return to active lives, and Zimmer is
committed to bringing you our best products and techniques to make this
happen.
Exhibit 4:
Created by the world’s finest surgeons and designers, Zimmer’s hip revision
products offer complete solutions for needs, expected or unexpected.
Exhibit 5:
Zimmer acetabular liners provide configurations that address joint
reconstruction and stability. Longevity Highly Crosslinked Polyethylene Liners
provide for true alternative bearing solutions.
Exhibit 6:
Construction. Supporting solutions – From greater trochanteric to pelvic and
femoral reconstruction. Zimmer has the solutions to support complex hip
revision surgery.
(Am. Compl. 11-12, ECF No. 17.)
Plaintiffs also cite statements about the “Trilogy Acetabular System” from an
archived version of Zimmer’s website.
Exhibit 7:
. . . Zimmer has a documented history of more than 20 years of clinical success
with compression-molded polyethylene. . . . It addresses the five key factors
that impact polyethylene performance: material, processing, design,
sterilization, and packaging.
. . . Modular liners are designed to minimize wear by achieving maximum
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congruency and optimum polyethylene thickness without compromising range
of motion and metal shell thickness.
Proven design features. Supported by long-term clinical experience.
(1) propriety locking mechanism helps prevent dislocation of the liner from the
shell, yet provides easy disassembly, if necessary. (2) Full congruency between
the liner and shell inhibits micromotion as the liner maintains integrity under
load and stress. (3) Anti-rotational tabs secure the liner firmly in place.
(4) Bottoming-out feature prevents rim loading and helps to distribute stresses
evenly by ensuring uniform metal shell support of the polyethylene liner.
(5) Polar boss minimizes transverse forces and helps prevent micromotion by
providing an additional stabilization point.
Results of long-term clinic studies show that Zimmer fiber metal cups
achieved extremely high success rates in the acetabulum. A review of 14
studies revealed a success rate of over 98 percent when considering failure of
any kind, including radiographic loosening. . . . Trilogy Shells continue to
utilize this extremely well-performing ingrowth material.
(Id. at 13-14.)
In addition, Plaintiffs refer to statements in an article from an archived version of
Zimmer’s website from the fall of 2003.
Exhibit 8:
Improvements are continually being made in materials used for hip
replacements. For instance:
- Polyethylene durability has been improved through ‘crosslinking.’
- Highly crosslinked polyethylene, advancement in this material, is
highly wear-resistant.
- Today’s ceramic implants generally resist chipping and breaking
better than the early versions.
- Second generation metal-on-metal products are designed to address
loosening that sometimes occurred in first generation metal-on-metal.
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Clinical studies have shown that, generally, the higher the level of
crosslinking, the greater the improvement in wear resistance. Zimmer’s highly
crosslinked polyethylene is produced using harmless high-dose electron beam
radiation, which further links together the molecular structure of the
polyethylene. Laboratory testing has shown that in crosslinking, a new
three-dimensional structure is created that results in a polymer more resistant
to wear.
(Id. at 14-15.)
Also, Plaintiffs refer to statements in an another article from an archived version of
Zimmer’s website from the fall of 2004.
Exhibit 9:
Hip Replacement Considerations - Stability
Zimmer hip implant designs are the result of detailed analyses of hundreds of
patients x-rays for maximum stability and optimal bone/implant fit. The goal
is to maximize the patient’s range of motion while at the same time
minimizing the possibility for dislocation.
(Id. at 15.)
In addition, Zimmer allegedly made the following statements from an archived article
on Zimmer’s website dated 2004:
Exhibit 10:
Metasul® - The Strength of Metal-on-Metal
In the Metasul implant, the conventional plastic polyethylene insert [has a]
cobalt-chrome, metal inlay. This helps minimize wear over time, potentially
increasing the longevity of the implant. . . . Metasul offers the promise of
greater longevity than traditional hip implants.
(Id.)
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Also, Plaintiffs cite these statements from a version of Zimmer’s website archived in
2010:
Exhibit 11:
Hip Products Zimmer – By collaborating with innovating hip surgeons
worldwide, Zimmer strives to improve patient quality of life with Zimmer®
Minimally Invasive Solutions Procedures and leading-edge implant technology
that continually raise the standard of care and give surgeons confidence they’re
providing the best patient solutions.
(Id. at 15-16.)
Finally, Plaintiffs quote a caption from Zimmer’s website, a copy of which is attached
in Exhibit 12: “Enhancing quality of life for patients worldwide.” (Id. at 16.)
Zimmer contends that the aforementioned statements do not state a claim for fraud or
negligent misrepresentation because they amount to puffery, or they are irrelevant to the
Devices or to Mr. Tice’s decision to use them. Zimmer also contends that Plaintiffs’
allegations fail to satisfy the pleading requirements in Rule 9(b) of the Federal Rules of Civil
Procedure. See Smith v. Bank of Am. Corp, 485 F. App’x 749, 752 (6th Cir. 2012) (requiring
claims of fraud and negligent misrepresentation under Michigan law to be pleaded with
particularity in accordance with Fed. R. Civ. P. 9(b), where both claims rely on the same
course of conduct).
In Michigan, claims of fraud and negligent misrepresentation both require a showing
that the defendant made a statement with the knowledge or intention that the plaintiff would
rely on it, and that the statement was false when made. See Hi–Way Motor Co. v. Int’l
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Harvester Co., 247 N.W.2d 813, 816 (Mich. 1976) (elements for fraud); Law Offices of
Lawrence J. Stockler, P.C. v. Rose, 436 N.W.2d 70, 82 (Mich. Ct. App. 1989) (elements for
negligent misrepresentation). The expression of an opinion, or “puffing,” is not actionable
as fraud. Van Tassel v. McDonald Corp., 407 N.W.2d 6, 8 (Mich. Ct. App. 1987). Puffing
is “a salesman’s praise of his own property, involving matters of estimate or judgment upon
which reasonable men may differ.” Hayes Constr. Co. v. Silverthorn, 72 N.W.2d 190, 192
(Mich. 1955). “[I]t is within normal expectations of commercial dealing for salesmen to
‘hype’ their products beyond objective proof.” Van Tassel, 407 N.W.2d at 8. “An action for
fraudulent misrepresentation must be predicated on a statement relating to a past or an
existing fact.” Eerdmans v. Maki, 573 N.W.2d 329, 333 (Mich. Ct. App. 1997). “Future
promises are contractual and do not constitute fraud.” Hi-Way Motor Co., 247 N.W.2d at
816; accord Forge v. Smith, 580 N.W.2d 876, 884 (Mich. 1998) (negligent
misrepresentation).
The Court agrees with Zimmer that Plaintiffs’ allegations do not state a claim because
the allegedly false statements described in the complaint appear to be either irrelevant to the
Devices or not actionable because they amount to puffing or statements about future
performance.
Exhibit 1
Exhibit 1 contains information indicating that a particular size of femoral head of a
Versys implant was recalled because the head will not seat properly on the femoral stem.
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Plaintiffs ostensibly claim that Zimmer was aware of this defect and should have disclosed
it; however, Plaintiffs’ complaint contains no allegations from which to infer that Mr. Tice’s
implant was subject to the recall or that the failure of his implant was in any way related to
an inability of the femoral head to sit on the stem. Instead, the claimed defect in the Devices
is that they failed due to “corrosion and deterioration . . . after a period of time following
implanting that caused friction resulting in metal-on-metal contact.” (Am. Compl. ¶ 57
(emphasis added).) Consequently, Plaintiffs’ reliance on Exhibit 1 is not sufficient to state
a plausible claim.
As for the statements in Exhibits 2 through 12, the Court agrees that these statements
fail to satisfy the pleading requirements of Rule 9(b) because none of Plaintiffs’ allegations
explain why they are false. See Smith, 485 F. App’x at 752 (requiring that the allegations
“explain why the statements were fraudulent”). Plaintiffs contend that the Court should not
apply the heightened pleading requirements of Rule 9(b) because those requirements are
flexible and are to be read in accordance with the purpose of the Rules, which is to provide
notice of the plaintiff’s claims sufficient to prepare a defense. See U.S. ex rel. Folliard v.
CDW Tech. Servs., Inc., 722 F. Supp. 2d 20, 25 (D.D.C. 2010). Plaintiffs contend that this
is not the sort of case where heightened pleading requirements need to be applied because
Defendants have defended many identical claims across the country and the nature of these
claims has been known to them for many years.
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Plaintiffs provide no factual support for their contention that Defendants have
defended similar claims, and no legal support for their contention that the requirements for
pleading a claim can be satisfied by allegations raised in a different case. Moreover,
Plaintiffs’ allegations do not provide adequate notice of the allegedly false statements that
Plaintiffs or their physicians relied upon when choosing to purchase and implant the Devices.
Plaintiffs have provided a list of publicly-disseminated statements without facts indicating
that any of the statements were actually relied upon by Plaintiffs or their physicians.
Moreover, without allegations indicating why any of these statements were false, it is not
clear how Zimmer could be expected to respond to Plaintiffs’ allegations. Thus, Plaintiffs’
argument for not applying pleading requirements of Rule 9(b) is not persuasive.
Even assuming that Plaintiffs’ allegations satisfy Rule 9, the statements in Exhibits
2 through 12 do not give rise to a claim because they are irrelevant or are not actionable
under state law.
Exhibits 2-6
The statements in Exhibits 2 to 6, which refer to Zimmer’s “highest quality” products,
Zimmer’s commitment to providing the “best” products created by the “finest” designers, and
the fact that Zimmer “has solutions” to address hip revision and “configurations” to address
“stability,” amount to puffing. Cf. Hayes Constr. Co., 72 N.W.2d at 192 (holding that
defendant’s assertions as to the merits of a Coleman furnace, “that it would do the job, that
it was miserly in its consumption of fuel, and the maintenance nil” were puffing).
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Exhibit 7
Exhibit 7 concerns Zimmer’s design of the acetabular liner, which sits between the
ball of the hip joint and the shell or cup. (See Exs. 7, 8 to Am. Compl., ECF Nos. 17-7, 178.) The statements in this exhibit are also puffing. Even assuming that the alleged defect in
the Devices is related to the acetabular liner, such a defect would not render false Zimmer’s
vague assertions that it “designed” its devices to minimize wear and prevent dislocation of
the liner, or that it had achieved “success” with a polyethylene liner.
Exhibit 8
Exhibit 8 provides general statements about “improvements” in Zimmer’s products
and the fact that its polyethylene liner is “highly wear-resistant.” There is no basis on which
a fact-finder could find that such statements are false. Assuming that Mr. Tice’s implant
prematurely failed as a result of wear and tear in the liner (which Plaintiffs have not
specifically alleged), that fact alone would not render false Zimmer’s assertion that its
polyethylene material is “wear resistant.”
Exhibit 9
Exhibit 9 provides a general statement about the stability of the Devices and Zimmer’s
goal to maximize the patient’s range of motion. Zimmer’s goals are not at issue in this case,
and there is no allegation that the defect experienced by Mr. Tice is at all related to the
stability of the Devices.
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Exhibit 10
Exhibit 10 concerns the properties of the metal-on-metal Metasul system. Plaintiffs
do not indicate how Zimmer’s statements about this system has any relevance to Plaintiff’s
implant, which ostensibly used a polyethylene liner between metal components.
Exhibits 11, 12
Exhibits 11 and 12 provide general statements about Zimmer’s intent to improve
patient quality of life and its “leading-edge” implant technology. These are further examples
of puffing that are not actionable as misrepresentations of fact.
For all the foregoing reasons, therefore, Count V will be dismissed for failure to state
a claim.
C. Count VI: Loss of Consortium
Zimmer seeks dismissal of Mr. Tice’s claim for loss of consortium to the extent that
it relies upon the theory of strict liability in Count I and the fraud claim in Count V. Such
a request is not necessary. The loss-of-consortium claim is necessarily contingent upon, and
limited by, Mr. Tice’s ability to recover for his injuries. Several claims regarding those
injuries are still pending. If Mr. Tice cannot recover under those other claims, then the lossof-consortium claim will fail as a matter of law. Otherwise, Count VI will remain viable.
Zimmer need not seek partial dismissal of the loss-of-consortium claim whenever some, but
not all, of Mr. Tice’s claims are resolved against him.
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III.
In summary, Count I will be dismissed to the extent that it relies on a theory of strict
liability. Count V will be dismissed for failure to state a claim. An order will be entered that
is consistent with this Opinion.
Dated: October 30, 2015
/s/ Robert Holmes Bell
ROBERT HOLMES BELL
UNITED STATES DISTRICT JUDGE
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