Coblin v DePuy Orthopaedics Inc et al

Filing 226

MEMORANDUM OPINION & ORDER: 1. Request 84 to dismiss claims for manufacturing defect, fraudulent misrepresentation, and fraudulent concealment is DENIED; and 2. The remainder Motion 84 is DENIED AS MOOT. Signed by Judge Gregory F. Van Tatenhove on 3/22/2024.(CBD)cc: COR

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF KENTUCKY
CENTRAL DIVISION
FRANKFORT
WILLIAM GRANVILLE COBLIN, JR., as
Executor of the Estate of Pollyann Coblin,
Plaintiff,
v.
DEPUY ORTHOPAEDICS, INC., et al.,
Defendants.

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Civil No. 3:22-cv-00075-GFVT-MAS
MEMORANDUM OPINION
&
ORDER

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This matter is before the Court on Defendants’ Motion to Dismiss. [R. 84.] Pollyann
Coblin suffered injury and death allegedly caused by Defendants’ hip replacement device. Now,
Defendants move to dismiss portions of Ms. Coblin’s Complaint for failure to state a claim. For
the following reasons, the Defendants’ Motion [R. 84] is DENIED.
I
On September 8, 2009, Pollyann Coblin arrived at St. Joseph Hospital in Lexington,
Kentucky for a hip surgery. 1 [R. 87 at 6.] Ms. Coblin received a Pinnacle metal-on-metal hip
implant manufactured, designed, and marketed by Defendants. Id.
In the ensuing years, Ms. Coblin experienced a litany of complications. Id. First, she
noticed “right anterior thigh pain and swelling, numbness and tingling along the right lateral and
medial thigh.” Id. Then, she developed “foot drop.” Id. In 2017, she was diagnosed with a
pseudotumor in her right hip, “a result of metal-on-metal articulation.” Id. Ms. Coblin

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The facts stated herein are taken from Ms. Coblin’s Third Amended Complaint. [R. 87.]

subsequently underwent a “right total hip arthroplasty” revision surgery because of “failure of
total hip arthroplasty,” “neuropathy of the right sciatic nerve,” and “metallosis.” Id.
What befell her next was a series of additional surgeries and treatments. Id. In spite of
these procedures, she continued to “suffer significant pain” and ultimately lost the use of her leg.
Id. Finally, during the pendency of this litigation, Ms. Coblin passed away. [R. 87-1.] Her
estate alleges that her death was caused by complications from the implant. [R. 87 at 7.]
Specifically, the metal-on-metal implant was allegedly defective and dangerous because it
released metal ions into Ms. Coblin’s body, resulting in serious illness and death. Id. at 6, 11.
William Coblin, the executor of Ms. Coblin’s estate, brings this action against Johnson &
Johnson, Johnson & Johnson International, Johnson & Johnson Services, DePuy Orthopeadics,
DePuy Products, DePuy International, and DePuy Synthes. Id. at 1. Johnson & Johnson is the
parent company of subsidiaries Johnson & Johnson Services, Johnson & Johnson International,
DePuy Products, and DePuy Synthes. Id. at 4. This lawsuit was initially filed in 2018 as part of
a multi-district litigation (MDL) action in the United States District Court for the Northern
District of Texas. [R. 1.] Based on the complexities of the MDL, the District Court for the
Northen District of Texas appointed a Special Master. [R. 29.] Upon review, the Special Master
recommended Ms. Coblin’s case be transferred to the Eastern District of Kentucky. [R. 49.]
Accordingly, Ms. Coblin’s case was transferred from the Northern District of Texas to the
undersigned in December 2022. [R. 50; R. 51.]
Defendants’ Motion to Dismiss was initially directed at Plaintiff’s Second Amended
Complaint. [R. 84.] After that Motion was filed, Plaintiff Coblin filed her Third Amended
Complaint. [R. 87.] The Third Amended Complaint asserts negligent misrepresentation,
negligence, gross negligence, fraudulent concealment, fraudulent misrepresentation, wrongful
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death, and several strict liability claims. Id. Defendants moved to strike the Third Amended
Complaint for failure to comply with Federal Rule of Civil Procedure 15. [R. 96.] This Court
denied the Motion to Strike, permitting the Third Amended Complaint to serve as Plaintiff
Coblin’s operative pleading. [R. 166.] In their pending Motion, Defendants move to dismiss
Plaintiff’s claims for manufacturing defect, fraudulent concealment, and fraudulent
misrepresentation. 2 [R. 84.]
II
A motion to dismiss pursuant to Rule 12(b)(6) tests the sufficiency of a plaintiff’s
complaint. Fed. R. Civ. P. 12(b)(6). In reviewing a Rule 12(b)(6) motion, a court must
“construe the complaint in the light most favorable to the plaintiff, accept its allegations as true,
and draw all reasonable inferences in favor of the plaintiff.” Directv, Inc. v. Treesh, 487 F.3d
471, 476 (6th Cir. 2007). However, a court “‘need not accept as true legal conclusions or
unwarranted factual inferences.’” Id. (quoting Gregory v. Shelby Cnty., 220 F.3d 433, 446 (6th
Cir. 2000)). “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) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). In other
words, “[t]he factual allegations, assumed to be true, must do more than create speculation or
suspicion of a legally cognizable cause of action; they must show entitlement to relief.” League
of United Latin Am. Citizens v. Bredesen, 500 F.3d 523, 527 (6th Cir. 2007) (emphasis in
original) (citing Twombly, 550 U.S. at 555).

In her Third Amended Complaint, Plaintiff Coblin voluntarily dismissed some of the causes of action challenged
by Defendants in their Motion. Because those claims have been removed in the Third Amended Complaint, any
request to dismiss those claims is now moot. The Court focuses only on those challenged claims included in the
Third Amended Complaint.
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A
First, Johnson & Johnson and DePuy seek dismissal of the manufacturing defect claim,
arguing that Plaintiff Coblin fails to identify any defect in the implant. [R. 84 at 5.] Plaintiff
responds by asserting that her Amended Complaint solves this problem. [R. 88 at 2.]
Plaintiff Coblin is correct. Under Kentucky law, a strict liability manufacturing defect
plaintiff must show that the product left “the hands of the manufacturer in a defective condition
because it was not manufactured or assembled in accordance with its specifications.” Greene v.
B.F. Goodrich Avionics Sys., Inc., 409 F.3d 784, 788 (6th Cir. 2005). The burden is on the
plaintiff to show an “identifiable, unreasonably dangerous defect.” Hurst v. Dixie Truss, Inc.,
No. 2020-CA-0816-MR, 2021 WL 1826881, at *4 (Ky. Ct. App. May 7, 2021) (internal citation
omitted).
The Third Amended Complaint satisfies this burden at the 12(b)(6) stage. Ms. Coblin
first alleges that the Defendants manufactured the implant using a “citric acid passivation
process” to passivate the device’s components. [R. 87 at 9.] Because of this allegedly improper
process, the implant released far more metal ions into Ms. Coblin’s body than it should have. Id.
Second, Plaintiff avers that the manufacturer’s cooling process was faulty. Id. at 10.
Specifically, the flawed cooling process caused the metal liner in the implant to become either
too big or too small. Id. at 11. The metal liner’s improper size allegedly allowed heightened
levels of metal ions to be released within Ms. Coblin’s body. Id.
These allegations identify two specific manufacturing defects. Accordingly, Defendants’
request to dismiss the strict liability manufacturing defect claim is denied.

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B
Next, Defendants ask the Court to dismiss the Plaintiff’s claims for fraudulent
concealment and fraudulent misrepresentation. [R. 84 at 8–10.]
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Defendants correctly indicate that both claims are subject to Federal Rule of Civil
Procedure 9(b)’s heightened pleading standard for fraud claims. [R. 84 at 8]; Fed. R. Civ. P.
9(b).
Ordinarily, claims challenged under 12(b)(6) must satisfy the familiar “plausibility”
standard. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). But the pleading standard for a fraud
plaintiff is heightened. Specifically, the fraud plaintiff “must state with particularity the
circumstances constituting fraud[.]” Fed. R. Civ. P. 9(b) (emphasis added). To plead with
particularity, the plaintiff must provide “the time, place, and content of the alleged
misrepresentation on which he or she relied; the fraudulent scheme; the fraudulent intent of the
defendants; and the injury resulting from the fraud.” Coffey v. Foamex L.P., 2 F.3d 157, 161–62
(6th Cir. 1993) (internal citation omitted). “When the complaint involves multiple defendants,
then ‘each defendant’s role must be particularized with respect to their alleged involvement in
the fraud.’” Anderson v. Pine S. Cap., L.L.C., 177 F. Supp. 2d 591, 596–97 (W.D. Ky. 2001)
(internal citation omitted). The purpose of this requirement is to “place[] the defendant on
‘sufficient notice of the misrepresentation’” so that the defendant may respond in an “informed”
fashion. Coffey, 2 F.3d at 162 (quoting Brewer v. Monsanto Corp., 644 F. Supp. 1267, 1273
(M.D. Tenn. 1986)).

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In Kentucky, “a fraud claim requires that a plaintiff establish six elements by clear and
convincing evidence: (1) a material misrepresentation, (2) which is false, (3) known to be false
or made recklessly, (4) made with inducement to be acted upon, (5) acted in reliance thereon,
and (6) causing injury.” Derby City Cap., L.L.C. v. Trinity HR Servs., 949 F. Supp. 2d 712, 726
(W.D. Ky. 2013); see generally Erie R. Co. v. Tompkins, 304 U.S. 64 (1938) (federal courts
sitting in diversity apply state substantive law and federal procedural law).
2
Plaintiff’s allegations meet the pleading requirement for fraud. Ms. Coblin’s Complaint
claims that before her surgery in September 2009, Johnson & Johnson and DePuy’s
representative (Bill Martin) provided false literature about the implant’s safety to Dr. Ellingsen
(Ms. Coblin’s doctor). [R. 87 at 17.] Mr. Martin’s literature represented that the implant has
been used in Europe “long before it was released in the United States and had good results
statistically.” Id. Ms. Coblin states that Mr. Martin knew this to be false. Id. He allegedly
knew as much because a very similar hip implant sold by Defendants was “removed from the
European market [in 2004] because of extremely high rates of revisions of over 15% at 5 years.”
Id. A 2004 report issued by European authorities identified heightened metal ion release as a key
problem with the discontinued product. Id. at 18–19. In September 2009, Ms. Coblin and Dr.
Ellingsen allegedly decided to use the Defendants’ hip implant in reliance on Mr. Martin’s false
representations. Id.
At various points, Defendants allegedly targeted doctors with marketing materials stating
that Ms. Coblin’s implant had “the lowest published ion levels in the industry.” Id. at 19–20.
DePuy also at some point advertised to physicians that Ms. Coblin’s implant “has a 99.9%
survivorship at five years.” Id. at 21. Then, when the implant was discontinued, Defendants
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published a statement on their website that “[t]he decision to discontinue [the implant] is not
related to safety or efficacy . . . [the products] are backed by clinical data showing they are safe
and effective . . . .” Id. at 22.
Ms. Coblin alleges that Defendants had knowledge of the implant’s problems when the
false statements were made. Id. at 17–26. DePuy executive, Paul Berman (director of hip
marketing), stated in an 2008 email that “[w]e continue to hear growing concerns over [metalon-metal] hips. . . . The team at the mayo clinic have warned us that metal will take a significant
hit over the next few months based on papers and presentations at and prior to aaos [American
Academy of Orthopedic Surgeons].” Id. at 19. In September 2008, after attending a hip society
meeting, Michael Rhee wrote in an email to Mr. Berman that the surgeons attending the meeting
had “serious concern[s]” about metal-on-metal implants. 3 Id. at 22. Rhee continued that “80%
of the [surgeon] attendees had seen [a] tissue reaction” from a metal-on metal device. Id. These
reactions, according to Rhee, looked “bad,” “alarming[,] and concerning.” Id. After receiving
this warning, Mr. Berman allegedly instructed his subordinates in a 2008 email to “keep quiet for
now.” Id. at 22–23. Additionally, Ms. Coblin states, DePuy knew of the dangerous heightened
metal particle release prior to 2009 through internal simulator testing of the implant. 4 Id. at 19–
21.
Ms. Coblin pleads her fraud claims with particularity. First, she states a claim for fraud
under Kentucky law. The Complaint alleges several material misrepresentations. Plaintiff
provides evidence of the falsehood of these statements; she also cites internal emails, studies, and
tests indicating the Defendants knew of the falsity of these statements. Further, the glowing

Plaintiff does not clarify who Michael Rhee is.
Ms. Coblin suggests that Defendants may have known of the implant’s problems as early as 2001, when a DePuy
employee published a paper concluding that metal-on-metal implants generate a heightened number of metal
particles compared to a non-metal-on-metal implant. Id. at 20.
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literature allegedly provided to Dr. Ellingsen was made to induce reliance; Dr. Ellingsen
indicates that he did in fact rely on these statements when he decided to use the implant in Ms.
Coblin’s case. Further, Defendants’ various advertisements and marketing materials were
allegedly intended to induce reliance. Finally, Ms. Coblin states she was injured as a
consequence of the misrepresentations. Thus, Ms. Coblin has alleged a fraud claim under
Kentucky law.
Further, Ms. Coblin satisfies Rule 9(b)’s particularity requirement. Plaintiff Coblin
identifies the source of the representations (website statements, advertising materials, and
representations to Dr. Ellingsen). And Ms. Coblin identifies the role of the particular corporate
Defendants in the fraud. She indicates that Bill Martin, a representative of DePuy and Johnson
& Johnson made false claims. She further states that Defendant DePuy made false statements in
its advertisements to doctors and on its website. See Newberry v. Serv. Experts Heating & Air
Conditioning, L.L.C., 806 F. App’x 348, 362 (6th Cir. 2020) (“[A] complaint that identifies a
particular corporate defendant as well as the ‘time, place, and content of the alleged
misrepresentation’ need not also identify the corporation’s individual employee who made the
alleged fraudulent misrepresentation.”) (internal citation omitted). Finally, she alleges that
Johnson & Johnson and DePuy intentionally concealed their knowledge of the implant’s dangers.
And although Ms. Coblin does not provide specific dates for every single instance of
misrepresentation or concealment, “[c]ourts [assessing 9(b) particularity] are [] more lenient
when the alleged wrong did not occur at a discrete time and place and instead ‘the transactions
involved are complex or cover a long period of time.’” Pascarella v. Swift Transp. Co., 694 F.
Supp. 2d 933, 941 (W.D. Tenn. 2010) (internal citation omitted). The allegations are sufficient

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to put the Defendants on notice. The Court declines to dismiss the fraudulent concealment and
fraudulent misrepresentation claims.
III
Accordingly, and the Court being otherwise sufficiently advised, it is hereby ORDERED
as follows:
1. Defendants’ request to dismiss Plaintiff’s claims for manufacturing defect, fraudulent
misrepresentation, and fraudulent concealment [R. 84] is DENIED; and
2. The remainder of Defendants’ Motion [R. 84] is DENIED AS MOOT.

This the 22nd day of March, 2024.

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