Anastasi v. Wright Medical Technology, Inc. et al

Filing 15

MEMORANDUM AND ORDER - IT IS HEREBY ORDERED that Defendants Wright Medical Technology, Inc. and Wright Medical Group, Inc.s Motion to Dismiss Counts I, VI, VII, and VIII of Plaintiffs Complaint [ECF No. 5] is GRANTED in part and DENIED in part. Coun ts VII and VIII are DISMISSED with prejudice. Plaintiff will be given the opportunity to replead her fraudulent misrepresentation claim (Count VI). Plaintiffs amended complaint shall be filed within thirty (30) days of entry of this Order. In all other respects, Defendants Motion is denied. Signed by District Judge E. Richard Webber on April 28, 2014. (MCB)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION

LOIS ANNETTE ANASTASI,
Plaintiff,
vs.
WRIGHT MEDICAL TECHNOLOGY, INC.,
and WRIGHT MEDICAL GROUP, INC.,
Defendants.

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Case No. 4:14CV00053 ERW

MEMORANDUM AND ORDER
This matter comes before the Court on “Defendants Wright Medical Technology, Inc. and
Wright Medical Group, Inc.’s Motion to Dismiss Counts I, VI, VII, and VIII of Plaintiff’s
Complaint” [ECF No. 5].
I.

BACKGROUND
On January 13, 2014, Plaintiff Lois Annette Anastasi, pursuant to 28 U.S.C. § 1332(a)(1),

filed a Complaint against Defendants Wright Medical Technology, Inc., and Wright Medical
Group, Inc. (collectively referred to as “Defendants”), alleging injuries related to medical
devices, known as the Wright Medical Hip Implant and Conserve Cup, implanted in her hip
[ECF No. 1]. Plaintiff’s Complaint asserts eight counts: I) strict liability (design defect); II) strict
liability (manufacturing defect); III) strict liability (failure to warn); IV) negligence; V) negligent
misrepresentation; VI) fraudulent misrepresentation; VII) breach of express warranty; and VIII)
breach of implied warranty.
Defendants filed their Motion to Dismiss Counts I, VI, VII, and VIII of Plaintiff’s
Complaint on March 14, 2014 [ECF No. 5]. Plaintiff filed a Memorandum in Opposition [ECF
No. 11]. As an initial matter, the Court notes Plaintiff concedes the dismissal of Counts VII and

VIII from her Complaint. Accordingly, the Court shall dismiss those two counts, in their
entirety; and its analysis of Defendants’ Motion to Dismiss shall be limited to a discussion of
their arguments regarding Counts I and VI.
II.

LEGAL STANDARD
A party may move under Rule 12(b)(6) to dismiss a complaint for “fail[ing] to state a

claim upon which relief may be granted.” Fed. R. Civ. P. 12(b)(6). The purpose of a motion to
dismiss is to test “the sufficiency of a complaint[.]” M.M. Silta, Inc. v. Cleveland Cliffs, Inc.,
616 F.3d 872, 876 (8th Cir. 2010).
“To survive a motion to dismiss, a complaint must contain sufficient factual matter,
accepted as true, to state a claim to relief that is plausible on its face.” Ashcroft v. Iqbal, 556
U.S. 662, 678 (2009) (internal quotations and citation omitted). “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.” Id. Ordinarily, only the facts alleged in
the complaint are considered for purposes of a motion to dismiss; however, materials attached to
the complaint may also be considered in construing its sufficiency. Reynolds v. Dormire, 636
F.3d 976, 979 (8th Cir. 2011).
When ruling on a motion to dismiss, a court “must liberally construe a complaint in favor
of the plaintiff[.]” Huggins v. FedEx Ground Package Sys., Inc., 592 F.3d 853, 862 (8th Cir.
2010). However, if a claim fails to allege one of the elements necessary to recovery on a legal
theory, that claim must be dismissed for failure to state a claim upon which relief can be granted.
Crest Constr. II, Inc. v. Doe, 660 F.3d 346, 355 (8th Cir. 2011). “Threadbare recitals of a cause
of action, supported by mere conclusory statements, do not suffice.” Iqbal, 556 U.S. at 678; Bell
Atlantic v. Twombly, 550 U.S. 544, 555 (2007). Although courts must accept all factual

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allegations as true, they are not bound to take as true “a legal conclusion couched as a factual
allegation.” Twombly, 550 U.S. at 555 (internal quotations and citation omitted); Iqbal, 556 U.S.
at 677-78.
III.

STATEMENT OF FACTS
For purposes of this Motion to Dismiss, the following pertinent facts, as alleged in

Plaintiffs Amended Complaint and contained in exhibits incorporated therein, are accepted as
true.
At all relevant times, Defendants were engaged in the business of designing, licensing,
manufacturing, distributing, selling, marketing, or introducing into interstate commerce, either
directly or indirectly through third parties or related entities, the metal-on-metal Wright Hip
Implant including the Conserve Cup.
The hip joint, where the femur connects to the pelvis, is made up of the femoral head and
acetabulum (a cup-like structure at the bottom of the pelvis). The femoral head, a ball-like
structure at the top of the femur, rotates within the acetabulum. A total hip replacement replaces
the body’s natural hip joint with an artificial one, usually made out of metal and plastic. A
typical total hip replacement system consists of four separate components: a femoral stem; a
femoral head; a liner; and an acetabular shell. After the surgeon hollows out a patient’s femur
bone, the femoral stem is implanted. The femoral head is a metal ball that is fixed on top of the
femoral stem. The femoral head forms the hip joint when it is placed inside the liner and
acetabular shell. These conventional hip replacement implants typically last 15 to 20 years.
The Wright Conserve Cup has a different design, one that puts the metal femoral ball
directly in contact with a metal acetabular cup; most other hip replacements use a polyethylene or
plastic acetabular cup. By using a metal acetabular cup and a metal femoral ball, the Wright

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Conserve Cup forces metal to rub against metal with the full weight and pressure of the human
body.
On or about January 11, 2012, Plaintiff underwent a right total hip replacement at St.
David’s Georgetown Hospital in Georgetown, Texas. Dr. Clifton O’Meara performed the
procedure. During that procedure, the following hip implant components manufactured and
marketed by Defendants were implanted into Plaintiff’s body: Wright Medical Total A-Class
Head (Size 38 mm, Ref. No. 38AM-3804, Lot No. 03010738491401); Wright Medical Profemur
Plasma Z Stem (size 3, Ref. No. PHA-00264, Lot No. 0511349140); Wright Medical Profemur
Modular Neck (Size 8, Ref. No. PHAC-1252, Lot No. 0211188740); and Wright Dynasty CoCr
Liner (Size 38mm, Ref. No. DLCOGD38, Lot No. 019752153). The Wright Medical Hip
Implant with the Conserve Cup that were implanted into Plaintiff had not been materially altered
or modified prior to the implantation of the devices.
Subsequently, Plaintiff experienced severe and debilitating pain, discomfort, and
inflammation in her right thigh and right hip area; severe infection in her hip caused by
metallosis; and loosening of the Wright Medical Hip Implant and Conserve Cup. On or about
May 1, 2013, Plaintiff had the Wright Medical Device on her right hip explanted at St. David’s
Georgetown Hospital in Georgetown, Texas. Dr. O’Meara performed the procedure. Because of
Defendants’ defective design for the Wright Conserve Cup, hundreds of patients, including
Plaintiff, have been forced to undergo surgeries to replace the failed hip implants within only a
few years after being implanted with the defective Wright Medical Hip Implant.
The design of the Wright Medical Hip Implant, including the Conserve Cup, was not
sufficiently tested by Defendants, and the Conserve Cup was never approved by the FDA as
being safe or effective for the product’s intended purpose.

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The Conserve Cup is a class III medical device. Class III devices are those devices that
operate to sustain human life, or are for a use substantially important in preventing impairment of
human health, or pose potentially unreasonable risks to patients. The Medical Device
Amendments to the Food, Drug and Cosmetics Act of 1938 (“MDA”) require Class III medical
devices, including the Wright Medical Hip Implant and the Conserve Cup, to undergo premarket
approval by the Food and Drug Administration (“FDA”), a process that obligates the
manufacturer to design and implement a clinical investigation and to submit the results of that
investigation to the FDA as part of obtaining approval to sell the device.
Premarket approval is a rigorous process, requiring manufacturers to submit a multivolume application that includes, among other things: full reports of all studies and
investigations of the device’s safety and effectiveness that have been published or reasonably
should be known to the applicant; a full statement of the device’s components, ingredients, and
properties or principle of operation; a listing of the facilities used in, and a full description of the
methods and controls used for the manufacture, processing, and, when relevant, packing
installation of such device; samples of device components as required by the FDA; and a
specimen of the proposed labeling. The FDA may grant premarket approval only if it finds there
is reasonable assurance that a particular medical device is safe and effective, and the FDA must
weigh any probable benefit to health stemming from use of the device against any probable risk
of injury or illness emanating from such use.
A medical device that was on the market prior to the effective date of the MDA (i.e., a
device that was approved prior to May 28, 1976), referred to as “grandfathered” device, was not
required to undergo premarket approval. In addition, a medical device marketed after the MDA’s
effective date may bypass the rigorous premarket approval process if the device is “substantially

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equivalent” to a grandfathered pre-MDA device. This exception to premarket approval is known
as the “510(k)” process and simply requires a manufacturer to notify the FDA, under section
510(k) of the MDA, of that manufacturer’s intent to market a new device at least 90 days prior to
the device’s introduction to the market and to explain how the new device is “substantially
equivalent” to a pre-MDA predicate device. The FDA may then approve the new devise for sale
in the United States. Most new Class III devices in the market go through the 510(k) process.
Instead of ensuring the safety of the Conserve Cup and the Wright Medical Hip Implant
through clinical trials, Defendants sought to market their Wright Medical Hip Implant, including
the Conserve Cup, without conducting any clinical trials, by obtaining FDA approval under
section 510(k). By telling the FDA that the Conserve Cup’s design was substantially equivalent
to other hip products on the market, Defendants were able to avoid the safety reviews, including
clinical trials, required for pre-market approval under FDA regulations.
The FDA ultimately approved the marketing of the Wright Medical Hip Implant,
including the Conserve Cup, based upon the abbreviated 510(k) process. The FDA approval,
through the 510(k) process, means only that the device was substantially equivalent to another
product on the market and does not mean the FDA has found the device to be safe and effective
for its intended use in patients, including Plaintiff.
Under section 510(h) of 21 U.S.C. § 351, Defendants’ Wright Medical Hip Implant and
Conserve Cup are adulterated devices, because, among other things, the products fail to meet
established performance standards, in that the products caused severe injuries to recipients of the
Wright Hip Implant, and other conditions that often require premature, painful revision surgery
and make future revision surgeries less likely to be successful. In addition, Defendants’ Wright
Medical Hip Implant and Conserve Cup are misbranded, because, among other things, they cause

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severe injuries to the device recipients when they are used in the manner prescribed,
recommended, or suggested in their labeling.
Implantation of Defendants’ Wright Medical Hip Implant, including the Conserve Cup,
results in the release of high levels of toxic metal ions into every hip implant patient’s tissue and
blood stream. Particles released by friction of the metal-on-metal surfaces also result in
metallosis, tissue death, and tumor growth. This friction wear, commonly referred to as “edge
wear” or “edge loading,” is especially pronounced in the early “wear in” period, especially on the
leading edge of the metal acetabular cup of the Wright Medical Hip Implant. Once the body is
exposed to the Wright Medical Hip Implant and absorbs the toxic metallic ions and particular
debris created by friction of the metal-on-metal implant surfaces, inflammation occurs, which
leads to severe pain, infection, death of the surrounding tissue, bone loss, and the potential for
tumors to develop.
Defendants’ Wright Medical Hip Implant is also defective in that, as a result of the
product’s defective design, proper and successful surgical placement is exceedingly difficult for
even experienced and competent surgeons to accomplish in implanting the devices in patients.
It is estimated that perhaps only 5% of Class III medical device failures are ever reported to the
FDA. Despite this fact, the FDA has received adverse event reports from patients, surgeons, and
device manufacturers documenting hundreds of patient injuries attributable to metal-on-metal hip
implants, including the Wright Medical Hip Implant with the Conserve Cup. These adverse
event reports include a number of patient injuries, such as metallosis, premature device failure,
dislocation, disarticulation, disassembly, pseudo-tumor formation, elevated cobalt and chromium
levels in serum, and heavy metal toxicity. Leading orthopedic surgeons in the United States have
virtually stopped using metal-on-metal hip implants, because a significant number of patients

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who receive these implants suffer early failure of the implants, dislocations, and disarticulations.
Many patients also suffer severe tissue loss, infection, and irreversible bone damage caused by
the failure of the metal-on-metal hip implants, metallosis, presence of metallic debris in the joint
space, and heavy toxicity.
In a press release issued on August 25, 2005, and published on Defendants’ website,
Defendants noted:
Wright Medical Group, Inc. (NASDAZ: WMGI), a global orthopedic medical
device company, today announced the launch of its wear-reducing A-ClassTM
Advanced Metal for use with the Company’s BFH® hip technology featuring
large femoral heads for increased range of motion and a lowered potential for
dislocation. The new A-ClassTM Advanced Metal is the result of a patent-pending
process developed to reduce the creation of material debris in metal-on-metal total
hip arthroplasty, significantly enhancing the cutting-edge design features of
Wright’s total hip systems that feature BFH® technology. Metal-on-metal
articulation in hip systems for its high level of durability through reduced wear.
A-ClassTM Advanced Metal focuses on further minimizing wear debris, thereby
potentially reducing the creation of metal ions. Wright’s A-ClassTM Advanced
Metal minimizes wear to optimize durability, reducing the surface run-in wear to
one-tenth the rate experienced by conventional total hip systems with BFH®
Technology, while reducing cumulative lifetime wear by more than two-thirds.
Since 2006, Defendants have had actual knowledge that the Wright Medical Hip Implant,
including the Conserve Cup, could fail early due to metal debris, thereby giving rise to
unnecessary pain and suffering, debilitation, and the need for revision surgery to replace the
defective implants with the attendant risk of complications and death from such further implant
revision surgery in patients, including Plaintiff. In May of 2011, the FDA demanded that
medical device companies who manufactured and delivered metal-on-metal hip implants conduct
post-marketing studies regarding the safety of metal-on-metal implants and concerns about heavy
metal poisoning in implanted patients.
Defendants have known for years that implantation of their Wright Medical Hip Implants
including the Conserve Cup, results in metallosis, biological toxicity, and an increased risk for
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early and excessive premature failures of the implanted devices. Defendants failed to disclose
this fact to consumers, including Plaintiff. Instead, Defendants took affirmative steps to prevent
physicians and consumers from learning of this fact, while aggressively marketing the Wright
Medical Hip Implant and Conserve Cup as being safe and effective for use in hip replacement
surgeries. This concealment was done by Defendants with the intent to induce Plaintiff, as well
as other patients, and physicians, to purchase the Wright Medical Hip Implant and the Conserve
Cup, and to prevent patients from discovering they had been implanted with a defective Wright
Medical Hip Implant and from filing lawsuits seeking damages.
As early as March of 2006, Defendants advertised on their website and in their product
brochures distributed to physicians and patients, that Defendants’ Wright Medical Implant and
Conserve Cup were designed to be an improvement over the metal-on-polyethylene implants,
because the metal-on-metal design would reduce the amount of wear particles. In particular,
Defendants’ advertisements and representations included this statement: “Despite improvements
in the manufacturing, processing, and sterilization of polyethylene, wear related problems still
exist in modern Total Hip Arthroplasty. To address problem, the CONSERVE Total Hip System
has eliminated polyethylene from the design altogether. The result is a one-piece, highly super
finished metal-on-metal design, which provides significantly less wear particles than the
conventional total hip replacement.”
Defendants’ advertisements and representations also included information that would
lead patients and their surgeons to believe there would be only a minimal amount of wear debris
generated from the Wright Medical Hip Implants and Conserve Cup, and the amount of wear
debris would be substantially less than that associated with ceramic-on-polyethylene or cobalt
chrome-on-polyethylene implant designs.

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Plaintiff’s physicians communicated Defendants’ representations to the Plaintiff. These
representations about the extended durability of the Wright Medical Hip Implant and Conserve
Cup led Plaintiff and her surgeons to believe the Wright Medical Hip Implant and Conserve Cup
would last longer than the approximate 15 to 20 years that a conventional hip implant would last.
Defendants made representations, affirmations of fact, or promises through Defendants’
advertisements, labeling, detailing, marketing, and promotion of the Wright Medical Hip Implant
and Conserve Cup to healthcare professionals, the FDA. Plaintiff, and the public, by representing
the Wright Medical Implant and Conserve Cup were safe, effective, and fit and proper for their
intended uses, in order to induce patients and surgeons to purchase or use the Wright Medical
Hip Implant and Conserve Cup. These representations, affirmations, or promises regarding the
Wright Medical Hip Implants were false. Plaintiff, in privity with Defendants through her
surgeon acting as an agent, relied on Defendants’ representations in choosing to purchase the
Wright Medical Hip Implant and Conserve Cup.
Plaintiff and her physicians might have been able to discover the cause of Plaintiff’s pain
and disability, or defects in the Wright Medical Hip Implant earlier, but for the Defendants’
active concealment of these facts from physicians, patients, and Plaintiff, which led to a delay in
discovery and unnecessary suffering for Plaintiff.
In reliance on Defendants’ concealment, Plaintiff purchased the Wright Medical Hip
Implant so that her physician could surgically implant the device into Plaintiff. Had Plaintiff
known the Wright Medical Hip Implant with the Conserve Cup could fail early, thereby giving
rise to unnecessary physical injury, pain and suffering, debilitation, and the need for revision
surgery with attendant risks of complications and death, Plaintiff would not have purchased the
Wright Medical Hip Implant with the Conserve Cup.

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IV.

DISCUSSION
Plaintiff is a citizen and resident of Texas, and the relevant events underlying Plaintiffs’

claims, including her original hip replacement and revision surgeries, occurred in Texas. Both
parties agree that Texas law applies to the substantive issues in this dispute.
As relevant to this discussion, Defendants, pursuant to Federal Rule of Civil Procedure
12(b)(6), move the Court to dismiss Counts I and VI of Plaintiffs’ Complaint, for failure to state
a claim upon which relief may be granted [ECF Nos. 5, 6].
A.

Count I – Strict Liability (Design Defect)

Defendants contend Plaintiffs’ claim for design defect (Count I) should be dismissed
because it is barred by Comment k to Section 402A of the Restatement (Second) of Torts.
Comment k defines “unavoidably unsafe products,” and reads, in pertinent part:
There are some products which, in the present state of human knowledge, are
quite incapable of being made safe for their intended and ordinary use. These are
especially common in the field of drugs . . .. Such a product, properly prepared,
and accompanied by proper directions and warning, is not defective, nor is it
unreasonably dangerous. The same is true of many other drugs, vaccines, and the
like, many of which for this very reason cannot legally be sold except to
physicians, or under the prescription of a physician . . .. The seller of such
products, again with the qualification that they are properly prepared and
marketed, and proper warning is given, where the situation calls for it, is not to be
held to strict liability for unfortunate consequences attending to their use, merely
because he has undertaken to supply the public with an apparently useful and
desirable product, attended with a known but apparently reasonable risk.
Comment k to § 402A Rest. (2d) Torts. Defendants acknowledge that Texas courts have applied
Comment k to prescription drugs, but not to medical devices. However, they contend courts
nationwide have adopted Comment k’s reasoning regarding the field of prescription drugs and
applied Comment k to bar liability in medical device design claims. Defendants assert Comment
k applies here, because the hip implant components are medical devices prescribed and
implanted by a physician with the intention of correcting Plaintiff’s improperly functioning right
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hip. They argue, to hold them strictly liable for any alleged design defect of such components,
would contradict the strong public policy encouraging developments in medical treatment.
In her Memorandum in Opposition to Defendants’ Motion to Dismiss, Plaintiff notes
Defendants’ challenge is not to the sufficiency of the Complaint’s strict-liability, design-defect
pleading generally, but rather, is an assertion Plaintiff cannot, as a matter of law, state such a
claim for the hip implant components pursuant to Comment k [ECF No. 11]. Plaintiff first
points to the lack of Texas precedent applying Comment k to medical devices. Plaintiff also
contends Defendants’ Comment k argument is inapplicable, at least at this juncture of the
proceeding. She argues that Comment k is generally recognized as an affirmative defense, which
would require Defendants to present proof the product was incapable of being made safer at the
time of manufacture and distribution, and she contends their burden of proof is not excused by
the FDA approval process that enabled them to introduce the device into commerce. Plaintiff
claims the FDA approval process for a prescription drug is drastically different than the FDA’s
“Section 510(k)” (referring to the corresponding section of the original MDA) approval for
“Class III”1 medical devices such as the hip implant at issue. Section 510(k) approval refers to a
limited form of review, imposed on medical device manufacturers intending to market a new
device, that requires the manufacturers to submit a pre-market notification to the FDA for Class
III medical devices that are the substantial equivalent of products available prior to the effective
date of the MDA. Plaintiff contends, “Given the Section 510(k) approval at issue, there is no

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In accordance with 21 U.S.C. § 360(k), the FDA requires medical device manufacturers
to submit a report before marketing a new product, indicating the class in which the device is
classified under 21 U.S.C. § 360c, i.e., Class I, Class II, or Class III. Class III devices are those
for which insufficient information exists to determine the adequacy of general controls, and those
“purported or represented to be for a use in supporting or sustaining human life or for a use
which is of substantial importance in preventing impairment of human health,” or presenting “a
potential unreasonable risk or illness or injury.” 21 U.S.C. § 360c(a)(1)(C).
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basis for any type of judicial finding that, as a matter of law at the pleading stage, the product
was ‘unavoidably unsafe,’” and again, she emphasizes the lack of Texas law supporting such a
result.
The duty of a federal court exercising diversity jurisdiction, when the state courts have
not supplied an answer to the specific issue presented, is to apply the rule it believes would be
applied by the highest court of the state if the specific question were presented to it. Cont’l Cas.
Co. v. Advance Terrazzo & Tile Co., Inc., 462 F.3d 1002, 1007 (8th Cir. 2006). Texas has
approved the theory of strict products liability set forth in Section 402A of the Restatement
(Second) of Torts. Reyes v. Wyeth Labs., 498 F.2d 1264, 1271-72 (5th Cir. 1974). Although the
Fifth Circuit and the Texas Supreme Court have not ruled on this issue, both parties agree Texas
courts have applied Comment k to exempt prescription drugs from strict liability under a design
defect theory. See e.g., Hackett v. G.D. Searle & Co., 246 F.Supp.2d 591, 595 (W.D. Tex. 2002)
(granting summary judgment to defendants on plaintiff’s design defect claim in context of
prescription drugs; holding under Texas law and Comment k defendants can only be held strictly
liable if drug not properly prepared or marketed, or accompanied by proper warnings).
Accepting the Complaint’s well-pleaded allegations as true, and liberally construing it in
Plaintiff’s favor, the Court finds Plaintiff’s Complaint contains sufficient factual matter to state a
facially plausible strict-liability-design-defect claim. See Iqbal, 556 U.S. at 678 (standard of
review); Reyes, 498 F.2d 1264, 1272-74 (plaintiff must prove: 1) product was defective; 2) the
defect existed when the product left defendant’s hands; 3) due to the defect, the product was
unreasonably dangerous to the user (plaintiff); 4) plaintiff suffered injury; and 5) the defect was
proximate cause of plaintiff’s injuries). Indeed, as noted by Plaintiff, Defendants have not

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asserted the Complaint’s allegations insufficiently plead the requisite elements; but instead assert
the claim is barred by Comment k.
The Court finds Defendants’ Comment k argument is prematurely brought in their
Motion to Dismiss. “Basically, Section 402A subjects to liability the seller or manufacturer of a
product sold ‘in a defective condition unreasonably dangerous’ to an ultimate user or consumer
whose person or property is physically harmed by the product.” Reyes, 498 F.2d at 1272. The
design defect claim’s “unreasonably dangerous” inquiry involves a two-step analysis to evaluate
the possible liability of a manufacturer for injuries caused by its inevitably hazardous product: 1)
whether the product is so unsafe that marketing at all is “unreasonably dangerous per se”; and 2)
if not, whether the product has been introduced into the stream of commerce with insufficient
safeguards and is thereby “unreasonably dangerous as marketed.” Id. at 1273. The first prong of
the inquiry involves a balancing process in which the product’s utility is weighed against the
potential harmful effects caused by its introduction into commerce. Id. Only if the product is
determined not “unreasonably dangerous per se” does the analysis proceed to the “unreasonably
dangerous as marketed” inquiry, at which point Comment k becomes applicable. Id. at 1273-75.
See also Gerber v. Hoffman-La Roche, Inc., 392 F.Supp.2d 907, 922 (S.D. Tex. 2005) (“Under
Comment K, a prescription drug is unreasonably dangerous in design if it is not ‘accompanied by
proper directions and warning.’”). Because the prerequisite “unreasonable dangerous”
determination involves weighing of evidence, consideration of the applicability of Comment k’s
bar to Plaintiff’s strict liability design defect claim is not appropriate in a motion to dismiss. The
Court will deny Defendants’ motion to dismiss Count I – Strict Liability (Design Defect).

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B.

Count VI – Fraudulent Misrepresentation

Defendants argue that Plaintiff’s fraud claim must be dismissed with prejudice, because
its allegations do not satisfy the heightened pleading standard imposed by Federal Rule of Civil
Procedure 9(b). They contend Count VI is “wholly insufficient as it does nothing more than
generally allege that Wright Medical engaged in ‘misrepresentations and concealment’ to the
public with the intent to defraud.” Defendants claim the Complaint does not provide any details
regarding the content of the alleged misstatements or omissions; specify when or where they
were made; or identify the individuals responsible for making them.
Claims alleging fraudulent representations are subject to Rule 9(b)’s heightened pleading
standard, which requires they be alleged “with particularity.” Fed. R. Civ. P. 9(b). Rule 9(b)
usually requires the plaintiff to identify “the who, what, when, where, and how of the alleged
fraud.” Schouest v. Medtronic, Inc., 2014 WL 1213243 at *13 (S.D. Tex. March 24, 2014)
(internal quotations and citation omitted); see also Crest Constr. II, Inc., 660 F.3d at 353.
Under Texas law, the elements of fraud are: 1) a material representation was made; 2) the
representation was false; 3) when made, the speaker knew the representation was false, or made
it recklessly without any knowledge of the truth and as a positive assertion; 4) the speaker
intended the other party should act upon the representation; 5) the other party acted in reliance on
the representation; and 6) the other party was injured as a result. Aquaplex, Inc. v. Rancho La
Valencia, Inc., 297 S.W.3d 768, 774 (Tex. 2009). This is a case in which the alleged fraudulent
misrepresentations were not made directly to Plaintiff, but to Plaintiff’s physicians, who relied on
the representations, and who communicated the allegedly false information to Plaintiff. Thus,
the Complaint’s fraud allegations are based on an “intermediary theory,” which imposes liability
upon companies when treating physicians rely on positive and specific false representations that

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the companies’ products are safe and harm results. See Schouest, 2014 WL 1213243 at *13;
Crocker v. Winthrop Lab., Div. of Sterling Drug, Inc., 514 S.W.2d 429, 433 (Tex. 1974).
Count VI of Plaintiff’s Complaint alleges Defendants had actual knowledge the Wright
Medical Hip Implant and Conserve Cup were defective in that the device created an
unreasonably high risk of serious injury and complications when implanted and used as directed.
Count VI further alleges that, despite Defendant’s actual knowledge of complaints and adverse
event reports received concerning the device, Defendants “knowingly and intentionally”
continued to market, promote and sell their implant with no warning concerning the known high
risk of serious injury and complications, so as to maximize their sales and profits at the expense
of the health and safety of the public and Plaintiff. In its “General Allegations Common to All
Counts,” the Complaint alleges Defendants made false representations, affirmations of fact, or
promises through their advertisements, labeling, detailing, marketing, and promotion of the
device to healthcare professionals, the FDA, Plaintiff, and the public by representing it to be safe,
effective, and fit and proper for its intended uses. Additionally, Count VI alleges all of the
misrepresentations and concealment by Defendants were intentional acts specifically directed to
keep safety concerns about the device from decreasing the sales of the device and were
undertaken with the intent that Plaintiff and her physicians would rely upon them; and with the
intent of defrauding and deceiving Plaintiff, to induce and encourage the sale of the device.
Plaintiff’s Complaint further alleges that Plaintiff relied upon, and was induced by Defendants’
misrepresentations, omissions, and active concealment of the danger of serious and permanent
the Wright Medical Hip Implant and Conserve Cup, and that she suffered personal injuries,
economic and non-economic damages, including pain and suffering, as a result of Defendants’
fraudulent misrepresentations and omissions concerning the dangers of the device.

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Plaintiff asserts the Complaint’s fraudulent misrepresentation allegations satisfy all element of
fraud, as it alleges Defendants: 1) advertised and sold the Wright Medical Hip Implant with the
implication it could be implanted in patients, including Plaintiff; 2) acted with gross negligence
and willful and wanton disregard for the safety of the general public and Plaintiff; 3) had actual
knowledge the device was defective, in that it created an unreasonably high risk of serious injury
and complications when implanted and used as directed; and 4) despite having actual knowledge
of the implant’s potential problems, still proceeded to knowingly and intentionally market,
promote, and sell the implant so as to maximize their sales and profits at the expense of the
public’s and Plaintiff’s health and safety. In the event the Court should find Plaintiff’s
Complaint insufficiently pleads the fraudulent misrepresentation claim, however, Plaintiff seeks
leave to amend her pleading to add additional facts or allegations.
When faced with a similar Rule 9 challenge to a Texas state law fraudulent
misrepresentation claim, a district court in the Southern District of Texas determined the efficient
course was to allow the plaintiff one opportunity to amend her complaint. Schoest, 2014 WL
1213243 at *14. “Judicial economy would be ill-served if the Court were to engage in the laborintensive process of scrutinizing the specific allegations at this point, find them insufficient, and
then follow the usual pattern of allowing the plaintiff at least one opportunity to replead.” Id.
The Court will give Plaintiff the opportunity to replead her fraud claim (Count VI) before
engaging in a Rule 9(b) analysis. Should Wright Medical Group thereafter believe the amended
complaint’s fraudulent misrepresentation claim still is insufficiently pled, they may file another
Rule 12 motion.
V.

CONCLUSION
Accordingly,

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IT IS HEREBY ORDERED that “Defendants Wright Medical Technology, Inc. and
Wright Medical Group, Inc.’s Motion to Dismiss Counts I, VI, VII, and VIII of Plaintiff’s
Complaint” [ECF No. 5] is GRANTED in part and DENIED in part. Counts VII and VIII are
DISMISSED with prejudice. Plaintiff will be given the opportunity to replead her fraudulent
misrepresentation claim (Count VI). Plaintiff’s amended complaint shall be filed within thirty
(30) days of entry of this Order. In all other respects, Defendants’ Motion is denied.
Dated this

28th

day of April, 2014.

E. RICHARD WEBBER
SENIOR UNITED STATES DISTRICT JUDGE

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