Thompson v. Depuy Orthopaedics, Inc. et al

Filing 15

ORDER denying 5 Motion to Dismiss for Failure to State a Claim; any motions to amend the current calendar shall be filed within 20 days of this Order. Signed by Judge Michael R. Barrett on 6/23/14. (ba1)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF OHIO
WESTERN DIVISION
MYRTLE THOMPSON,

CASE NO.: 1:13-CV-00602

Plaintiff,

Judge Michael R. Barrett

v.
DEPUY ORTHOPAEDICS, INC., et al.,
Defendants.
OPINION AND ORDER
This matter is before the Court on the Motion to Dismiss of Defendants DePuy
Orthopaedics, Inc. and Johnson & Johnson. (Doc. 5). Plaintiff Myrtle Thompson has filed a
response in opposition (Doc. 8), and Defendants have filed a reply (Doc. 9). This matter is now
ripe for review.
I.

FACTUAL AND PROCEDURAL OVERVIEW
A.

Factual Background

The basic facts construed in the light most favorable to Plaintiff are as follow.
DePuy International, Ltd., a subsidiary of Defendant Johnson & Johnson, manufactures
bone cement that is used in knee replacement surgeries. (Doc. 1, ¶¶ 8-9). The bone cement is
considered a Class II medical device. (Id. ¶ 21). That bone cement is distributed in the United
States by Defendant DePuy Orthopeadics, Inc. ("DePuy") under the trade name DePuy CMW 1
Gentamicin bone cement. (Id. ¶ 9).
The DePuy CMW 1 Gentamicin bone cement has been approved by the Food and Drug
Administration ("FDA") through the 510(k) premarket notification process.

As alleged by

Plaintiff, DePuy submitted a 510(k) premarket notification for its DePuy 1 Gentamicin bone

1

cement on or about June 30, 2003. (Id. ¶ 24). The 510(k) submission indicates that "DePuy 1
Gentamicin Bone Cement is a self curing cement, to which one gram of Gentamicin is added in
40 grams of PMMA (Polymethyl methacrylate) cement for allowing the seating and securing of a
metal or plastic prosthesis to living bone." (Id.) On or about September 29, 2003, the FDA
granted marketing approval for the DePuy 1 Gentamicin Bone Cement as substantially
equivalent to legally marketed predicate devices. (Id. ¶ 25).
On or about June 17, 2004, DePuy submitted a new 510(k) premarket notification for its
DePuy 1 Gentamicin Bone Cement. (Id. ¶ 26). It did so because "[t]he Gentamicin Sulphate
used in the cements is to be changed from micronised particles to non-micronised particles."
(Id.) The 510(k) submission further indicates that "[b]ased on similarities in design, material,
manufacturing method and intended use, DePuy believes that the DePuy 1 Gentamicin . . .
manufactured with non-micronised are substantially equivalent to the previously cleared
antibiotic bone cements manufactured with micronised Gentamicin." (Id.) On or about July 1,
2004, the FDA granted marketing approval for the DePuy 1 Gentamicin Bone Cement as
amended with non-micronized antibiotic particles as substantially equivalent to legally marketed
predicate devices. (Id. ¶ 27).
On or about October 24, 2005, DePuy submitted another new 510(k) premarket
notification for its DePuy 1 Gentamicin Bone Cement. (Id. ¶ 28). This time, the 510(k)
submission listed the DePuy 1 Gentamicin as being branded as DePuy CMW 1 Gentamicin Bone
Cement and as a substantially equivalent device. (Id. ¶ 29). The 510(k) submission also
described the DePuy CMW 1 Gentamicin Bone Cement as a "self curing cement" that "allows
the seating and securing of a metal or plastic prosthesis to living bone." (Id.) It further identified
the following modifications: "DePuy CMW 1 Gentamicin will be made available in a 20 gram

2

presentation in addition to the previously cleared 40 gram presentation. Changes are being made
to the formulation of the bone cement liquid component." (Id.) On November 22, 2005, the
FDA granted marketing approval for the DePuy CMW 1 Gentamicin Bone Cement as a
substantially equivalent device. (Id. ¶ 30).
On January 22, 2009, Plaintiff Myrtle Thompson underwent left knee replacement
surgery. (Id. ¶ 8). Plaintiff's surgeon used DePuy CMW 1 Gentamicin Bone Cement for that
knee replacement surgery. (Id.)
Around late 2011, Plaintiff began complaining to her physician of aching and throbbing
pain in her left knee. (Id. ¶¶ 10-11). In April 2012, a bone scan showed a loosening of the tibial
component of the knee replacement for which her physician recommended knee revision
surgery. (Id. ¶ 12). On May 24, 2012, Plaintiff underwent a total revision knee surgery. (Id. ¶
13). Notes from her surgery indicate that tibial component was grossly loose and could be lifted
up off the tibial cement. (Id. ¶ 13). Plaintiff's physician confirmed that the tibial component had
loosened from the bone due to the failure of the bone cement to properly adhere to the surface.
(Id.)
B.

Procedural Background

Based upon those facts, Plaintiff alleged five causes of action against Defendants DePuy
and Johnson & Johnson for: (1) strict products liability for defective manufacturing under Ohio
Rev. Code § 2307.74; (2) strict products liability for design defects under Ohio Rev. Code §
2307.75; (3) strict products liability for defect due to inadequate warning under Ohio Rev. Code
§ 2307.76; (4) strict products liability for defect due to nonconformance with representations
under Ohio Rev. Code § 2307.77; and (5) fraudulent and negligent misrepresentation. Plaintiff
also sought punitive damages against Defendants. Subsequently, the parties stipulated to the

3

voluntary dismissal of Johnson & Johnson, and Plaintiff abandoned her claims for fraudulent and
negligent misrepresentation. (Doc. 12; Doc. 8, p. 19). Accordingly, Plaintiff now proceeds
against only DePuy on the four claims for strict products liability brought under Ohio Rev. Code
§ 2307 and on the request for punitive damages.
DePuy has moved to dismiss all remaining claims asserted against it in the Complaint on
two grounds. (Doc. 5). First, DePuy contends that the strict products liability claims fail to state
a plausible claim for relief under the pleading standards of Ashcroft v. Iqbal, 556 U.S. 662 (2009)
and Bell Atlantic Corporation v. Twombly, 550 U.S. 544 (2007). Second, DePuy contends that
the request for punitive damages is barred as a matter of law because the bone cement at issue is
a medical device subject to the regulatory jurisdiction of the FDA.
II.

LEGAL STANDARD
To survive a motion to dismiss under Fed. R. Civ. P. 12(b)(6), a complaint "must contain

(1) 'enough facts to state a claim to relief that is plausible,' (2) more than 'a formulaic recitation
of a cause of action's elements,' and (3) allegations that suggest a 'right to relief above a
speculative level.'" Tackett v. M&G Polymers, USA, LLC, 561 F.3d 478, 488 (6th Cir. 2009)
(quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S. Ct. 1955 (2007)). "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." Ashcroft v. Iqbal,
556 U.S. 662, 678, 129 S. Ct. 1937, 1949 (2009). 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, 550 U.S. at 556). In determining
whether the plausibility standard is satisfied, the Court must "'construe the complaint in the light
most favorable to the plaintiff, accept its allegations as true, and draw all reasonable inferences

4

in favor of the plaintiff.'" Bassett v. NCAA, 528 F.3d 426, 430 (6th Cir. 2008) (quoting Directv,
Inc. v. Treesh, 487 F.3d 471, 476 (6th Cir. 2007)). Nevertheless, a court need not "accept as true
a legal conclusion couched as a factual allegation." Twombly, 550 U.S. at 555. A pleading that
offers "labels and conclusions" or a "formulaic recitation of the elements of a cause of action will
not do." Twombly, 550 U.S. at 555.
III.

STRICT LIABILITY CLAIMS
To bring a claim under the Ohio Product Liability Act ("OPLA"), the plaintiff must

establish that (1) the product was defective; (2) the defect was the proximate cause of the
plaintiff's harm; and (3) the manufacturer designed, formulated, produced, constructed, created,
assembled, or rebuilt the actual product that was the cause of harm for which the plaintiff seeks
to recover. Ohio Rev. Code § 2307.73. With respect to the first element, the defect may be one
relating to the manufacture or construction, the design or formulation, a warning or instruction,
or the lack of conformance to a representation. Id. A plaintiff may prove a defect by direct or
circumstantial evidence. Id.
A. Manufacturing Defect Claim (Count One)
Plaintiff brings the claim for strict products liability for defective manufacturing under
Ohio Rev. Code 2307.74. Section 2307.74 provides:
A product is defective in manufacture or construction if, when it left the
control of its manufacturer, it deviated in a material way from the design
specifications, formula, or performance standards of the manufacturer, or
from otherwise identical units manufactured to the same design
specifications, formula, or performance standards. A product may be
defective in manufacture or construction as described in this section even
though its manufacturer exercised all possible care in its manufacture or
construction.
Ohio Rev. Code § 2307.74.

5

DePuy seeks to dismiss the manufacturing defect claim on the bases that Plaintiff has not
plausibly alleged (1) a material deviation or the nature of the defect; (2) that the bone cement
reached her in substantially the same condition; (3) that the tibial component loosened because of
the bone cement; and (4) that other alternative causes could be ruled out.
Within the Sixth Circuit, multiple courts have considered when a defect claim has been
plausibly pled. Generally, defect claims based on manufacture have been dismissed where the
plaintiff identifies the problems experienced after using a particular product but fails to identify
the nature of the alleged defect. See Frey v. Novartis Pharmaceuticals Corp., 642 F. Supp. 2d
787, 795 (S.D. Ohio 2009). Manufacturing defect claims have survived, however, in various
circumstances. At a minimum, the district courts have required allegations that the defendant
manufactured the product, that the product was used by the plaintiff, that the product failed while
being used by the plaintiff, and that the portion of the product that failed could be identified and
is so identified in the complaint. See Marcum v. DePuy Orthopedics, Inc., No.: 1:12-cv-834,
2013 U.S. Dist. LEXIS 62875, at *13-15 (S.D. Ohio May 2, 2013) (holding that allegations that
plaintiff had defendant's hip replacement parts surgically implanted, the hip replacement parts
broke while implanted, that defendant's products can be identified, and that defendant was
required to maintain good manufacturing practices were sufficient to allege claims for
manufacturing and design defect); Clark v. Wright Med. Tech., Inc., No. 3:11-cv-162, 2011 U.S.
Dist. LEXIS 74248 (S.D. Ohio July 11, 2011) (alleging that defendant's product used in hip
replacement, that hip failed and revision surgery was necessary, and that medical tests showed
that components manufactured by defendant had fractured); Friedman v. Intervet Inc., No. 3:09cv-2945, 2010 U.S. Dist. LEXIS 71718 (S.D. Ohio July 16, 2010) (holding a plausible product
liability claim had been pled where allegations detailed the specific problem with the product,

6

the consequences of that problem, that plaintiff used the product, and that those consequences
occurred); Foust v. Stryker Corp., No. 2:10-cv-00005, 2010 U.S. Dist. LEXIS 69771, at *10-12
(S.D. Ohio June 22, 2010) (holding a plausible product liability claim had been pled where the
plaintiff alleged that the product was manufactured by the defendant, that the product was used
by the plaintiff, that the product broke while implanted in the plaintiff, and that the defendant's
products that allegedly failed could be identified in two parts by specific part number); Redinger
v. Stryker Corp., No. 10-cv-104, 2010 U.S. Dist. LEXIS 49465 (N.D. Ohio May 19, 2010)
(holding product liability claims were sufficiently pled where the plaintiff alleged that a part
related to the implant device was recalled and that the actual device broke in the plaintiff's leg).
Some courts also have expressly considered the fact that the plaintiff pled specific and detailed
facts from which the requisite material deviation could be inferred. See Friedman, 2010 U.S.
Dist. LEXIS 71718; Redinger, 2010 U.S. Dist. LEXIS 49465; Stratford v. SmithKline Beechmam
Corp., No. 2:07-cv-639, 2008 U.S. Dist. LEXIS 84826, at *21 (S.D. Ohio June 17, 2008).
Here, Plaintiff's Complaint adequately pleads facts to make her manufacturing defect
claim plausible. Plaintiff specifically pleads that DePuy obtained approval from the FDA for
marketing the bone cement under "the trade name DePuy CMW 1 Gentamicin bone cement" and
that DePuy "distributed" the bone cement in the United States "under the trade name DePuy
CMW 1 Gentamicin bone cement." (Doc. 1, ¶¶ 9, 22-30). 1 Plaintiff further alleges that the
product was defective when it left the hands of the manufacturer, and that it reached Plaintiff on
January 22, 2009 when it was used for her left knee replacement surgery. (Id. ¶¶ 8, 9, 45).
1

"Suppliers" may be liable under the OPLA, as if they were a manufacturer, under certain circumstances. As is
relevant here, a supplier may be liable as if it were the manufacturer of the product when "[t]he supplier in question
marketed that product under its own label or trade name." Ohio Rev. Code § 2307.78(B)(7). A supplier is defined
as a "person that, in the course of a business conducted for the purpose, sells, distributes, leases, prepares, blends,
packages, labels, or otherwise participates in the placing of the product in the stream of commerce." Ohio Rev.
Code § 2307.71(15)(a)(i). Plaintiff's allegations make it plausible that DePuy was a supplier that marketed the bone
cement under its own label or trade name.

7

Moreover, Plaintiff identifies the previously implanted tibial component as the component that
loosened from the bone, and identifies the DePuy cement, and in particular, the use of nonmicronized particles, the change in the liquid component and the failure to adequately test the
results of those changes, as the reasons for that failure. (Id. ¶¶ 13, 47-49). She further alleges
that her physician noted the failure, and that operative reports noted that the tibial component
"could be lifted up off the tibial cement." (Id.) She alleges that she learned that the component
had loosened from the bone after her complaints of persistent aching and throbbing in her left
knee, after an x-ray showed her knee replacement device was in good position, and after
subsequently undergoing a bone scan that showed the loosening. (Id. ¶¶ 11-12). As a result of
the loosening, she underwent total revision knee surgery. (Id. ¶ 13).

Plaintiff alleges that the

loosening was unexpected and premature, and caused her permanent damage and weakness. (Id.
¶ 17). She also pleads and references good manufacturing practices that are to be maintained.
(Id. ¶¶ 35-36). These facts are incorporated into each of Plaintiff's counts and go beyond a mere
recitation of the cause of actions elements that have been found insufficient to state a claim for
relief.
DePuy's assertion that Plaintiff had to, but did not, allege facts sufficient to show the
product reached her in substantially the same condition is not well taken. Not only does DePuy
attempt to introduce, without explanation, facts not contained within the Complaint, but DePuy
also fails to cite any authority that indicates the combination of the liquid and powder
components means that the product could never reach the patient in substantially the same
condition. While courts have held that a "'substantial alteration subsequent to the manufacture
and sale of the product will relieve the defendant-manufacturer from liability[,]'" they have
defined substantial alteration as a change that "'increases the likelihood of malfunction,'" "'is the

8

proximate cause of the harm complained of'" and is "'independent of the expected and intended
use to which the product is put.'" Aldridge v. Reckart Equip. Co., No. 04CA17, 2006 Ohio App.
LEXIS 4904, at *21 (4th App. Dist. Sept. 19, 2006) (quoting Cox v. Oliver Machinery Co., 41
Ohio App. 3d 28, 30-31 (12th App. Dist. 1987); Kobza v. General Motors Corp., 63 Ohio App.
3d 742, 745 (8th App. Dist. 1989)); see also Marcum, 2013 U.S. Dist. LEXIS 62875, at *14-15
(citing Alridge, 2006 Ohio App. LEXIS 4904, at *21). Here, even if the product required a
combination of a powder and liquid component, the mere use of the product after combining
those components does not make the change independent of the expected and intended use.
Although it is possible that the evidence may eventually show that a substantial alteration existed
that created the alleged problem, Plaintiff does not need to set forth specific facts beyond her
current allegations to disprove a substantial alteration and to avoid a Rule 12(b)(6) dismissal.
See Foust, 2010 U.S. Dist. LEXIS 69771, at *11-12 (citing Redinger, 2010 U.S. Dist. LEXIS
49465) (holding that the fact that the plaintiff's hip replacement parts may have failed for
multiple reasons was relevant to proving claims but not to determining whether the claim was
plausible at the motion to dismiss stage).
Similarly, DePuy's argument that Plaintiff has not alleged facts that rule out alternative
causes does not require dismissal of Plaintiff's defective manufacturing claim. See Foust, 2010
U.S. Dist. LEXIS 69771, at *11-12 (citing Redinger, 2010 U.S. Dist. LEXIS 49465). While
DePuy points out that the same lot of bone cement was used for all components of the total knee
replacement but only the tibial component failed, DePuy's argument improperly places upon
Plaintiff the burden of pleading a probable rather than a plausible claim. 2 Considering that facts

2

Although DePuy also argues that the change to the non-micronised particles cannot be the basis for the claim
because a change in antibiotic powder particle size affects the release of the drug and not the adherence, those
statements are unsupported evidence outside of the Complaint. (Doc. 9, p. 6). Those statements thus are not
properly considered in ruling on a motion to dismiss.

9

may exist that explain why the bone cement, although purportedly defective, did not fail to
adhere to other components and that Plaintiff has set forth more than a bare recitation of the
cause of actions elements, the Court concludes that Plaintiff has set forth a plausible claim based
upon a manufacturing defect.
B. Defective Design (Count Two)
Plaintiff brings the claim for strict products liability for defective design under Ohio Rev.
Code § 2307.75. Section 2307.75 provides, in pertinent part:
[A] product is defective in design or formulation if, at the time it left the
control of its manufacturer, the foreseeable risks associated with its design
or formulation . . . exceeded the benefits associated with that design or
formulation . . . .
Ohio Rev. Code § 2307.75(A). That section further sets forth factors to be considered in
balancing the foreseeable risks and the benefits associated with the design or formulation. Ohio
Rev. Code § 2307.75(B)-(C). Yet, a product cannot be defective in design or formulation under
that section "if that harm . . . was caused by an inherent characteristic of the product which is a
generic aspect of the product that cannot be eliminated without substantially compromising the
product's usefulness or desirability and which is recognized by the ordinary person with the
ordinary knowledge common to the community." Ohio Rev. Code § 2307.75(E). A product also
cannot be defective in design or formulation when "at the time the product left the control of its
manufacturer, a practical and technically feasible alternative design or formulation was not
available that would have prevented the harm for which the claimant seeks to recover . . . without
substantially impairing the usefulness or intended purposes of the product." Ohio Rev. Code §
2307.75(F).
DePuy seeks to dismiss the design defect claim on the bases that Plaintiff has not
plausibly alleged (1) the requisite elements of the claim or the nature of the defect; (2) that the
10

bone cement reached her in substantially the same condition; (3) that the tibial component
loosened because of the bone cement; (4) the inherent characteristics and other alternative causes
could be ruled out; and (4) there existed other feasible alternative designs.
Similar to the manufacturing defects, courts in the Sixth Circuit generally have dismissed
design defect claims where the plaintiff merely sets forth the elements of the claim without
specific allegations as to the alleged defect. See, e.g., Liming v. Stryker Corp., No. 1:11-cv-788,
2012 U.S. Dist. LEXIS 75509, at *13 (S.D. Ohio May 31, 2012) (dismissing design defective
claim because the complaint "merely regurgitates, nearly verbatim, the elements of a defective
design claim . . . [and] contains no substantive, specific factual allegations with respect to the
design of the pain pump from which the Court could plausibly infer a strict liability design defect
cause of action"); Frey, 642 F. Supp. 2d at 795 (dismissing the plaintiff's design defect claim
"because plaintiffs have once again simply provided a formulaic recitation of the elements" and
have not "alleged any facts that would permit the Court to conclude that there was a defect in the
design or formulation"). Design defect claims have survived, however, in various circumstances.
At a minimum, the district courts have required allegations that the defendant manufactured or
designed the product, that the product was used by the plaintiff, that the product failed while
being used by the plaintiff, and that the portion of the product that failed could be identified and
is so identified in the complaint. See Marcum, 2013 U.S. Dist. LEXIS 62875, at *15; Clark,
2011 U.S. Dist. LEXIS 74248, at *5-6; Foust, 2010 U.S. Dist. LEXIS 69771, at *10-12. Some
district courts have relied on the fact that the product at issue had been recalled when
determining that the plaintiff had raised a plausible inference that the foreseeable risks associated
with the design or formulation of the product outweighed the benefits. Friedman, 2010 U.S.
Dist. LEXIS 71718, at *12-13; Redinger, 2010 U.S. Dist. LEXIS 49465, at *7. Nevertheless, a

11

plaintiff is not required to set forth specific facts addressing the multi-factor balancing test set
forth in Ohio Rev. Code § 2307.75 to survive a motion to dismiss. Boroff v. Alza Corp., 685 F.
Supp. 2d 704, 709 (N.D. Ohio 2010); see also Alridge, 2006 Ohio App. LEXIS 4904, at *32
("Foreseeable uses of a product, foreseeable risks associated with a product, benefits associated
with a product, and consumer expectations regarding a product's uses and risks are ordinarily all
factual questions" and a "determination whether a design defect exists involves a balancing of
these factual issues.").
For many of the same reasons set forth above with respect to the manufacturing defect
claim, the Court concludes that Plaintiff has sufficiently pled a claim for design defect. As
explained previously, Plaintiff has alleged supplier liability as well as multiple specific facts that
identify the problems she experienced and why she contends the bone cement was the root of
those problems. Plaintiff's factual allegations in the Complaint also sufficiently put DePuy on
notice that the safety risks at issue are the failure of the bone cement to properly adhere to the
bone or prosthetic device and the premature loosening of the bone cement as a result of changes
made to the bone cement, which cause further permanent impairments and weaknesses, and
require the patient to undergo premature revision surgery. The extent to which those risks are
foreseeable and outweigh the benefits associated therewith requires the Court to make factspecific inquiries that are not appropriate at this stage of the litigation.
With respect to the substantially same condition argument and causation arguments that
were addressed in regards to the manufacturing defect claim, the Court incorporates its above
analysis here.
DePuy's final arguments specific to the design defect claim are that Plaintiff did not
sufficiently plead facts that plausibly eliminate the inherent characteristics of the product as the

12

cause or that plausibly show that an alternative design or formulation was not available. The
Court, however, disagrees.

Plaintiff has alleged that DePuy changed the design from the

micronized particles to the non-micronized particles and made a change to the liquid component,
and that those changes made the product defective. Those allegations, construed in favor of
Plaintiff, raise the reasonable inference that her injuries were caused a change in design, not by
an inherent characteristic of the product, and that a practical and feasible alternative design exists
(i.e., the bone cement with the micronised particles and without the change to the liquid
component) that may prevent the harm. Accordingly, Plaintiff has sufficiently pled a plausible
claim based upon design defect.
C. Inadequate Warning (Claim Three)
Plaintiff brings the claim for strict products liability based upon inadequate warnings
under Ohio Rev. Code § 2307.76. Section 2307.76 provides, in pertinent part:
[A] product is defective due to inadequate warning or instruction if either of
the following applies:
(a) The manufacturer knew or, in the exercise of reasonable care, should
have known about a risk that is associated with the product and that
allegedly caused harm for which the claimant seeks to recover
compensatory damages;
(b) The manufacturer failed to provide the warning or instruction that a
manufacturer exercising reasonable care would have provided concerning
that risk, in light of the likelihood that the product would cause harm of the
type for which the claimant seeks to recover compensatory damages and in
light of the likely seriousness of that harm.
Ohio Rev. Code § 2307.76.
DePuy contends that Plaintiff's inadequate warning claim should be dismissed because
the learned intermediary doctrine is applicable, and Plaintiff did not allege a single warning that
DePuy should have provided the surgeon that would have persuaded him to choose a different
bone cement. The Court disagrees.
13

The learned intermediary doctrine does not automatically "'relieve the manufacturer of
liability to the ultimate user for an inadequate or misleading warning.'" Vaccariello v. Smith &
Nephew Richards, Inc., 94 Ohio St. 3d 380, 384 (2002) (quoting Tracy v. Merrell Dow
Pharmaceuticals, Inc., 58 Ohio St. 3d 147, 149-50 (1991)). It "'only provides that the warning
reaches the ultimate user through the learned intermediary.'" Vaccariello, 94 Ohio St. 3d at 384
(quoting Tracy, 58 Ohio St. 3d at 150). Only when the manufacturer provides the learned
intermediary with an adequate warning will the manufacturer's duty be discharged. DeGidio v.
Centocor Ortho Biotech, Inc., No. 3:09-cv-721, 2010 U.S. Dist. LEXIS 118406, at *14 (N.D.
Ohio Nov. 5, 2010).
Here, the issue raised is whether Plaintiff's allegations plausibly show that the
information at issue did not reach her or her physician. 3 The Court finds that her allegations
adequately make that showing. Plaintiff alleges that DePuy knew or should have known about
the risk that the bone cement would not adhere to the bone or prosthetic device and knew or
should have known that the failure to adhere would cause injury and require revision surgery.
(Doc. 1, ¶¶ 67-68). She further alleges that no warnings were provided by DePuy about those
risks. (Id.) Construing those allegations in Plaintiff's favor, the alleged lack of any warning
plausibly shows that the warning did not reach the physician or the patient as is necessary for the
learned intermediary doctrine to be applicable. Whether the physician would have changed his
prescribing conduct goes to the issue of proximate cause, which is not properly decided on a
motion to dismiss where, as here, the allegations give rise to at least a plausible inference that the
physician may have changed course upon receiving the requisite warnings. See DeGidio, 2010

3

DePuy does not set forth any specific argument as to why the warnings given were adequate and were not
misleading.

14

U.S. Dist. LEXIS 118406, at *14. Accordingly, Plaintiff has sufficiently alleged a claim based
upon inadequate warning. Liming, 2012 U.S. Dist. LEXIS 75509, at *13. 4
D. Non-Conformance with Representations (Claim Four)
Plaintiff brings the claim for strict products liability based upon non-conformance with
representations under Ohio Rev. Code § 2307.77. Section 2307.77 provides:
A product is defective if it did not conform, when it left the control of its
manufacturer, to a representation made by that manufacturer. A product
may be defective because it did not conform to a representation even though
its manufacturer did not act fraudulently, recklessly, or negligently in
making the representation.
Ohio Rev. Code § 2307.77. To recover under this section, a plaintiff must prove that: (1) the
defendant made a representation as to material fact concerning the character or quality of the
product; (2) the product failed to conform to that representation; (3) the plaintiff and/or her
physician justifiably relied on that representation; and (4) the reliance by plaintiff and/or her
physician on the defendant's representations was the direct and proximate cause of the plaintiff's
injuries. Cervelli v. Thompson/Center Arms, 183 F. Supp. 2d 1032, 1045 (S.D. Ohio 2002).
Where the plaintiff fails to identify a representation made about the product, the claim for nonconformance with the representation must fail. Id.
DePuy contends that Plaintiff's claim for non-conformance with representations should
be dismissed on the bases that Plaintiff has not plausibly alleged (1) any of the requisite elements
of the claim; (2) that the bone cement reached her in substantially the same condition; (3) that the
tibial component loosened because of the bone cement; and (4) how a different representation
would have persuaded her surgeon to choose a different bone cement. The Court disagrees.

4

To the extent DePuy intended to raise with respect to this claim any of the arguments addressed in regards to other
claims, the Court incorporates its analyses of those arguments here.

15

Plaintiff's Complaint adequately pleads facts that state a plausible claim based upon nonconformance with representations. The representations relied upon by Plaintiff are more than an
affirmation of the value of goods, the seller's opinion, or a commendation of the goods that is not
actionable. See Jordan v. Paccar, Inc., 37 F.3d 1181, 1185 (6th Cir. 1994) (quoting Ohio Rev.
Code Ann. § 1302.26(B)). Plaintiff instead relies on a representation made by DePuy that the
bone cement was "safe for use in knee replacement surgery" despite the allegedly known harm of
injury, pain, and revision surgery resulting from the failure of the bone cement to properly
adhere to the bone or prosthetic device and the premature loosening of the cement as a result of
changes made thereto. See Liming, 2012 U.S. Dist. LEXIS 75509, at *12-13 (allegations that the
defendant represented to the plaintiff's surgeon that the product was safe for use in the joint
space and that it was actually unsafe was sufficient to survive a motion to dismiss); Gawloski v.
Miller Brewing Co., 96 Ohio App. 3d 160, 167-168 (9th App. Dist. 1994) (indicating it would be
sufficient for the plaintiff to allege the defendant made a representation that the product was safe
even though there are risks associated with the normal use that are not generally known and
recognized). 5 Plaintiff also describes DePuy's representations as to the characteristics of its
products as "self-curing cement," as allowing the "seating and securing of a metal or plastic
prosthesis to living bone," and as being "substantially equivalent to the previously cleared
antibiotic bone cements manufactured with micronised Gentamicin." (Doc. 1, ¶¶ 26, 28). Even
though Plaintiff does not utilize the exact language of DePuy's representations, her allegations
permit the plausible inference that a representation was made and the bone cement did not
conform to that representation. Liming, 2012 U.S. Dist. LEXIS 75509, at *12; see also Lefker v.
I-Flow Corp., No. 1:10-cv-350, 2010 U.S. Dist. LEXIS 121624, at *10-11 (S.D. Ohio Nov. 17,
5

Whether the harm alleged is generally known and recognized is an issue that is not raised here and thus is not
appropriate for resolution on the motion to dismiss. See Gawloski, 96 Ohio App. 3d at 167.

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2010). 6 Moreover, Plaintiff alleges that she and/or her physician justifiably relied upon the
representations in choosing DePuy's product for use in her original knee replacement surgery and
that the representations were false because the bone cement did not sufficiently adhere to the
bone and prematurely loosened on the tibial component, which led to her having the total
revision surgery.
The Court is not persuaded by DePuy's argument that Plaintiff insufficiently pled that her
surgeon would have chosen a different bone cement if those representations had not been made.
As courts in this circuit have recognized, a "'plaintiff will not be thrown out of court for failing to
plead facts in support of every arcane element of his claim'" but she must include facts that if
existed would "'clearly dominate the case.'" Lefker, 2010 U.S. Dist. LEXIS 121624, at *9
(quoting Scheid v. Fanny Farmer Candy Shops, Inc., 859 F.2d 434, 437 (6th Cir. 1988)). This is
not such an issue that would plainly dominate the case.

In any event, Plaintiff's factual

allegations as to the representations made by DePuy, the use of the DePuy bone cement for her
surgery, and the lack of conformance with the representations raise at least a plausible inference
that the surgeon would have made a different decision if DePuy had not made those
representations.
As for the substantially same condition argument and the causation arguments that were
addressed with respect to the manufacturing defect claim, the Court incorporates its above
analysis here. Accordingly, Plaintiff has sufficiently pled a plausible claim for strict liability
based upon the non-conformance with representations.
IV.

PUNITIVE DAMAGES

6

DePuy's reliance on Liming, 2012 U.S. Dist. LEXIS 75509, at *10, is misplaced. The quotation upon which it
relies (Doc. 9, p. 11) to support its argument that Plaintiff did not allege sufficient factual detail to survive dismissal,
was made in the context of the plaintiff's fraud claim, and not the strict liability claim based upon non-conformance
with representations. Indeed, in contrast to the fraud claim, the Liming court determined that claim for nonconformance with representations survived dismissal. See Liming, 2012 U.S. Dist. LEXIS 75509, at *12.

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Plaintiff requests punitive damages on all of her strict liability claims. (Doc. 1, ¶¶ 52, 64,
70, 76). DePuy contends that the request is barred under Ohio law that precludes an award of
punitive damages in connection with a product liability claim when the product allegedly causing
the harm "was manufactured and labeled in relevant and material respects in accordance with the
terms of an approval or license issued by the federal food and drug administration under the
'Federal Food, Drug, and Cosmetic Act[.]" Ohio Rev. Code § 2307.80(C)(1).
While there is no question that DePuy received the requisite 510(k) approval for the bone
cement, the facts alleged by Plaintiff are sufficient to show a plausible lack of compliance with
the manufacturing and labeling requirements. As explained previously, Plaintiff pleads that,
contrary to the requirements of the 510(k) approval process, the bone cement was adulterated
because the product deviated from performance standards, that DePuy failed to establish and
maintain good manufacturing practices, and that as a result of DePuy's failure to maintain such
standards and practices, the bone cement failed and caused Plaintiff harm. Construing the
allegations in the Complaint in light most favorable to Plaintiff, those allegations are sufficient to
plead a plausible claim for punitive damages.
V.

CONCLUSION
For the foregoing reasons, Depuy's Motion to Dismiss (Doc. 5) is DENIED. The case

shall proceed as scheduled against DePuy. If the parties desire to amend the calendar, a motion
to amend the current calendar order containing new proposed deadlines shall be submitted to the
Court within twenty (20) days of this Opinion and Order.
IT IS SO ORDERED.
s/Michael R. Barrett
Michael R. Barrett, Judge
United States District Court

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