Cramer v. Ethicon, Inc.

UNITED STATES DISTRICT COURT

WESTERN DISTRICT OF NORTH CAROLINA

ASHEVILLE DIVISION

1:20-cv-95-MOC-WCM

FLORENCE CRAMER, )

)

Plaintiff, )

)

vs. ) ORDER

)

ETHICON, INC., ET AL., )

)

)

Defendants. )

___________________________________ )

THIS MATTER comes before the Court on a Motion to Dismiss the Original

Complaint, filed by Defendants Ethicon, Inc. and Johnson & Johnson, (Doc. No. 8), and on a

Motion to Dismiss the Amended Complaint, filed by Defendants Ethicon, Inc. and Johnson &

Johnson, (Doc. No. 14).

I. BACKGROUND

Plaintiff Florence Cramer brings a product liability action against Defendants Ethicon,

Inc. and Johnson & Johnson (collectively, “Defendants” or “Ethicon”). Plaintiff’s Amended

Complaint alleges that she has suffered damages as a result of having been implanted on April 2,

2007, with Ethicon, Inc.’s TVT-O prescription pelvic mesh medical device to treat her urinary

incontinence. Specifically, Plaintiff asserts the following causes of action: failure to warn

(Count I), negligence (Count II), design defect (Count III), manufacturing defect (Count IV),

breach of implied warranty (Count V), violation of North Carolina Consumer Protection and

Deceptive Business Practices Act (Count VI), and punitive damages (Count VII).

At all times relevant to the matters asserted in this action, Plaintiff Florence Cramer was a

resident citizen of North Carolina. Plaintiff suffered from urinary incontinence (“UI”). On

April 2, 2007, Plaintiff underwent surgery to have Ethicon, Inc.’s TVT-O implanted at Margaret

R. Pardee Memorial Hospital in Hendersonville, North Carolina. On April 25, 2017, Plaintiff

underwent a surgical revision of the TVT-O at Park Ridge Health in Hendersonville, North

Carolina. Plaintiff alleges that her TVT-O implant has caused her to suffer physical, mental,

financial, and/or economic injury and/or loss.

On April 20, 2020, Plaintiff filed this product liability action, asserting claims for failure

to warn (Count I), negligence (Count II), negligent misrepresentation (Count III), design defect

(Count IV), manufacturing defect (Count V), breach of express warranty (Count VI), breach of

implied warranty (Count VII), violation of North Carolina Consumer Protection and Deceptive

Business Practices Act (Count VIII), fraud (Count IX), fraud by concealment (Count X), and

punitive damages (Count XI).

On July 20, 2020, Defendants moved to dismiss Plaintiff’s Complaint on the ground that

her claims were barred by the statute of repose. (Doc. No. 8). On August 21, 2020, this Court

issued an Order granting Plaintiff leave to amend her Complaint to add allegations relating to the

application of the statute of repose. (Doc. No. 12). On September 10, 2020, Plaintiff filed her

Amended Complaint, asserting claims for failure to warn (Count I), negligence (Count II), design

defect (Count III), manufacturing defect (Count IV), breach of implied warranty (Count V),

violation of the North Carolina Consumer Protection and Deceptive Business Practices Act

(Count VI), and punitive damages (Count VII). (Doc. No. 13). The Amended Complaint

abandoned the claims for negligent misrepresentation, breach of express warranty, fraud, and

fraud by concealment that Plaintiff had asserted in her original Complaint.

With respect to the statute of repose issue, Plaintiff added two new factual allegations to

the Amended Complaint: (1) that “[b]etween 2011 and 2017, Plaintiff suffered from persistent

and/or chronic urinary tract and bladder infections, but did not associate these problems with

Defendants’ Pelvic Mesh product,” and (2) that “Plaintiff did not know until 2017 that her

chronic urinary tract and bladder infections were caused by Defendants’ Pelvic Mesh product.”

(Id. at ¶¶ 23, 24).

Defendants filed their second motion to dismiss on September 24, 2020. Defendants

move for dismissal of Plaintiff’s Amended Complaint as barred by North Carolina’s statute of

repose for product liability actions. Defendants contend that, regardless of whether the Court

applies the six-year statute of repose in effect at the time of Plaintiff’s implant or the twelve-year

statute of repose adopted in 2009, it is undisputed that Plaintiff did not file this action until more

than 13 years after her TVT-O implant. Defendants further contend that the “disease exception”

to the statute of repose does not apply in this case because Plaintiff has not alleged that she was

diagnosed with any disease as a result of her implant. Alternatively, Defendants request that this

Court dismiss Plaintiff’s claims for manufacturing defect and breach of implied warranty as

insufficiently pleaded or otherwise precluded as a matter of law. Plaintiff filed a response on

October 8, 2020. On October 13, 2020, Defendant informed the Court that it did not intend to

file a Reply. Thus, this matter is ripe for disposition.

II. STANDARD OF REVIEW

Federal Rule of Civil Procedure 12(b)(6) provides that a motion may be dismissed for

failure to state a claim upon which relief can be granted. A motion to dismiss pursuant to Rule

12(b)(6) tests the sufficiency of the complaint without resolving contests of fact or the merits of a

claim. Republican Party of N.C. v. Martin, 980 F.2d 943, 952 (4th Cir. 1992), cert. denied, 510

U.S. 828 (1993). Thus, the Rule 12(b)(6) inquiry is limited to determining if the allegations

constitute “a short and plain statement of the claim showing the pleader is entitled to relief”

pursuant to Federal Rule of Civil Procedure 8(a)(2). To survive a defendant’s motion to dismiss,

factual allegations in the complaint must be sufficient to “raise a right to relief above a

speculative level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). Thus, a complaint

will survive if it contains “enough facts to state a claim to relief that is plausible on its face.”

Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly, 550 U.S. at 570).

For the purposes of a Rule 12(b)(6) analysis, 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. (quoting Twombly, 550 U.S. at 556). The

Court must draw all reasonable factual inferences in favor of the plaintiff. Priority Auto Grp.,

Inc. v. Ford Motor Co., 757 F.3d 137, 139 (4th Cir. 2014). In a Rule 12(b)(6) analysis, the Court

must separate facts from legal conclusions, as mere conclusions are not entitled to a presumption

of truth. Iqbal, 556 U.S. at 678. Importantly, “[t]hreadbare recitals of the elements of a cause of

action, supported by mere conclusory statements, do not suffice.” Id. However, well-pleaded

factual allegations are entitled to a presumption of truth, and the court should determine whether

the allegations plausibly give rise to an entitlement to relief. Id. at 679.

III. DISCUSSION

A. Applicable State Law

When, as here, a federal court sits in diversity, it applies the choice of law rules of the

forum state. Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496 (1941). North Carolina

courts use two different choice-of-law approaches, both of which support the application of

North Carolina substantive law to Plaintiff’s claims in this case. For tort claims, North Carolina

applies the “lex loci delicti” approach. Harco Nat’l Ins. Co. v. Grant Thornton LLP, 698 S.E.2d

719, 722–23 (N.C. App. 2010).

This approach provides that “the state where the injury occurred is considered the situs of

the claim.” Id. at 722 (quoting Boudreau v. Baughman, 368 S.E.2d 849, 853–54 (N.C. 1988)).

The alleged injury for a prescription medical device occurs in the state of the implant. See

Simmons v. Boston Sci. Corp., No. 2:12-cv-07398, 2015 WL 2137145, at *2–3 (S.D. W. Va.

May 7, 2015). For warranty claims, North Carolina applies the “most significant relationship”

approach, which “requires the forum to determine which state has the most significant

relationship to the case.” 698 S.E.2d at 723. North Carolina courts have found that “the place of

sale, distribution, delivery, and use of the product, as well as the place of the injury—to be the

state with the most significant relationship to the warranty claims.” Boudreau, 368 S.E.2d at

855–56.

Here, Plaintiff is seeking damages for alleged injuries that occurred in North Carolina,

where Plaintiff was implanted with the allegedly defective device. In addition, Plaintiff is a

resident citizen of North Carolina, and all relevant medical care and treatment took place in

North Carolina. As such, North Carolina is the place of the alleged injury and the state with the

most significant relationship to Plaintiff’s claims. Accordingly, North Carolina substantive law

applies to Plaintiff’s claims.

B. North Carolina Statute of Repose

North Carolina has a statute of repose for all “action[s] for the recovery of damages for

personal injury, death, or damage to property based upon or arising out of any alleged defect or

any failure in relation to a product.” N.C. GEN. STAT. § 1-46.1(1). All product liability claims,

regardless of their nature, are subject to a statute of repose. Nat’l Property Investors, VIII v.

Shell Oil Co., 950 F. Supp. 710, 713 (E.D.N.C. 1996); Colony Hill Condo. I Ass'n v. Colony

Co., 320 S.E.2d 273 (N.C. Ct. App. 1984). The plaintiff’s knowledge of an alleged injury is not

relevant for the purposes of the statute of repose:

Unlike an ordinary statute of limitations which begins running upon accrual of the

claim . . . the period contained in the statute of repose begins when a specific

event occurs, regardless of whether a cause of action has accrued or whether any

injury has resulted. . . . Thus, the repose serves as an unyielding and absolute

barrier that prevents a plaintiff’s right of action even before his cause of action

may accrue, which is generally recognized as the point in time when the elements

necessary for a legal wrong coalesce.

Black v. Littlejohn, 325 S.E.2d 469, 474–75 (N.C. 1985) (citations omitted); see also Bryant v.

Don Galloway Homes, Inc., 556 S.E.2d 597, 600 (N.C. Ct. App. 2001) (noting that a statute of

repose begins to run when the statutory triggering event occurs, “regardless of whether or not

there has been an injury”). Moreover, “[w]hile equitable doctrines may toll statutes of limitation,

they do not toll substantive rights created by statutes of repose.” Monson v. Paramount Homes,

Inc., 515 S.E.2d 445, 449 (N.C. Ct. App. 1999).

In product liability actions, the statute of repose begins to run on “the date of initial

purchase for use or consumption.” N.C. GEN. STAT. § 1-46.1(1). Before 2009, North Carolina

law provided that no personal injury claims “based upon or arising out of any alleged defect or

any failure in relation to a product shall be brought more than six years after the date of initial

purchase for use or consumption.” N.C. GEN. STAT. § 1-50(a)(6) (1995). On October 1, 2009,

the North Carolina legislature repealed N.C. GEN. STAT. § 1-50(a)(6) and enacted a new, twelve-

year statute of repose. See N.C. GEN. STAT. § 1-46.1(1). However, this new statute applies only

“to causes of action that accrue on or after” the effective date of the statute, October 1, 2009.

See 2009 N.C. Sess. Laws 2009-420 § 3.

As such, courts applying North Carolina law have consistently applied N.C. GEN. STAT. §

1-50(a)(6)’s six-year statute of repose in cases where the product in question was first purchased

or delivered, as here, before October 1, 2009. See, e.g., Robinson v. Bridgestone/Firestone N.

Am. Tire, LLC, 703 S.E.2d 883, 886–87 (N.C. Ct. App. 2011) (applying six-year statute of

repose in product liability action involving allegedly defective tires purchased in 1995 or 1996,

and declining to apply N.C. GEN. STAT. § 1-46.1(1)); Lackey v. DePuy Orthopaedics, Inc., No.

5:10cv30, 2011 WL 2791264, at *3 (W.D.N.C. July 14, 2011) (holding that “the applicable

statute of repose is N.C. GEN. STAT. § 150(a)(6), which was in effect at the time Plaintiff

purchased the allegedly defective product”); Ferro v. Vol Vo Penta of the Americas, LLC, No.

5:17cv194, 2017 WL 3710071, at *3 (E.D.N.C. Aug. 28, 2017) (finding that plaintiff’s claims

involving products purchased before October 1, 2009, where governed by six-year statute of

repose, while claims involving products purchased after that date were governed by twelve-year

statute of repose); In re: Elk Cross Timbers Decking Mktg., No. 15cv18, 2015 WL 6467730, at

*11 (D.N.J. Oct. 26, 2015) (applying North Carolina law) (“Plaintiff Shepherd alleges that he

‘purchased and installed Decking on his home in 2007.’ (OAC ¶ 32.) Therefore, § 1-50(a)(6), the

statute in effect at the time of his purchase, applies.”).

The Court finds that Plaintiff’s claims are governed by the six-year statute of repose in

N.C. GEN. STAT. § 1-50(a)(6), because the latest date on which her TVT-O could have been

purchased for use or consumption was the date of her implantation surgery, April 2, 2007, two

years before the effective date of N.C. GEN. STAT. § 1-46.1(1). See In re Mentor Corp. ObTape

Transobturator Sling Prods. Liab. Litig., 4:08-MD-2004, 2016 WL 873854, at *3 (M.D. Ga. Mar.

4, 2016) (applying North Carolina law) (finding that N.C. GEN. STAT. § 1-50(a)(6) applied to

plaintiff’s claims involving pelvic mesh device implanted in 2005). However, even applying

N.C. GEN. STAT. § 1-46.1(1)’s twelve-year statute of repose, Plaintiff’s claims are barred as a

matter of law. Plaintiff was implanted with the TVT-O on April 2, 2007, but she did not file suit

until April 20, 2020, more than thirteen years later. Accordingly, Plaintiff’s claims were

extinguished by the statute of repose before she filed suit, and the Complaint must be dismissed

with prejudice.

In response to the motion to dismiss, Plaintiff argues that a “disease exception” to the

statute of repose applies to her claims and renders this lawsuit timely. However, this exception

does not apply under the facts alleged in the Amended Complaint because Plaintiff does not

allege that she suffers from a disease within the meaning of the exception. The “disease

exception” to the statute of repose was first recognized in Wilder v. Amatex Corp., 336 S.E.2d

66 (N.C. 1985), a case involving a plaintiff who had developed asbestosis as a result of his

prolonged exposure to the defendant’s chemicals. At issue in Wilder was whether the plaintiff’s

personal injury claims were barred by N.C. GEN. STAT. ANN. § 1-15(b), which imposed a 10-year

statute of repose for latent personal injury claims. Id. at 69. After reviewing the state of the law

at the time the statute was enacted and the statute’s legislative history, which revealed that the

term “disease” had been deliberately removed during the legislative process, the Wilder Court

concluded that the statute of repose was not intended to apply to claims arising out of a latent

disease that manifests itself over a long period of time. Id. at 72–73. The Court explained that

such “[a] disease presents an intrinsically different kind of claim” than a “situation[] in which it

was possible to identify a single point in time when plaintiff was first injured”:

Diseases such as asbestosis, silicosis, and chronic obstructive lung disease

normally develop over long periods of time after multiple exposures to offending

substances which are thought to be causative agents. It is impossible to identify

any particular exposure as the “first injury.” Indeed, one or even multiple

exposures to an offending substance in these kinds of diseases may not constitute

an injury. The first identifiable injury occurs when the disease is diagnosed as

such, and at that time it is no longer latent.

Id. at 71. The Fourth Circuit has followed the reasoning of Wilder to apply a latent disease

exception to N.C. GEN. STAT. ANN. § 1-50(a)(6). See Hyer v. Pittsburgh Corning Corp., 790

F.2d 30, 33–34 (4th Cir. 1986).

Here, Plaintiff’s alleged urinary tract and bladder infections do not fit Wilder’s definition

of a disease for purposes of the statute of repose. A true latent disease, such as the asbestosis at

issue in Wilder, or the plaintiff’s leukemia associated with exposure to toxic discharges over

many years in Stahle v. CTS Corp., 817 F.3d 96, 98 (4th Cir. 2016), develops within the body

over an extended time period before manifesting any symptoms. Consequently, it is difficult, if

not impossible, to determine the first point at which the plaintiff was first “injured.” Here, on the

other hand, Plaintiff’s alleged urinary tract and bladder infections are discrete medical events that

occurred at readily identifiable points in time. Because Plaintiff can pinpoint the times at which

she was “injured” by a urinary tract or bladder infection, those injuries do not qualify as a latent

disease. See Douglas v. Sandoz Pharms. Corp., No. 1:98cv911, 2000 WL 33342286, at *5

(M.D.N.C. July 18, 2000) (finding that the plaintiff’s stroke was not a “disease” because the

point at which she suffered the stroke was readily identifiable, even if the exact series of events

leading up to the stroke could not be easily established).

Additionally, the Wilder Court reasoned that diseases, unlike other injuries, typically

develop after multiple exposures to a harmful substance and that one particular exposure cannot

be identified as the “injury-causing” event. Wilder, 336 S.E.2d at 70. Plaintiff’s alleged urinary

tract and bladder infections do not fit within this narrow category of latent diseases. Taking the

allegations of the Amended Complaint as true, all of Plaintiff’s alleged injuries are attributable to

a single event: Plaintiff’s implantation with the TVT-O. As such, the Wilder Court’s reasons for

distinguishing latent diseases from other injuries in the statute-of-repose context do not apply.

Finally, the categories of injuries alleged in the Amended Complaint go well beyond the

Wilder Court’s narrow definition of “disease” and make clear that this is not a disease case. In

Paragraph 25 of the Amended Complaint, Plaintiff alleges that, as a result of her implantation

with the TVT-O, she has suffered “significant mental and physical pain and suffering, has

sustained permanent injury and permanent and substantial physical deformity and has suffered

financial or economic loss, including, but not limited to, obligations for medical services and

expenses.” (Doc. No. 13, ¶ 23). In Paragraph 37, she alleges a laundry list of potential

complications allegedly attributable to TVT-O, including mesh contraction, scar tissue

formation, dyspareunia (pain with sexual intercourse), pelvic pain, nerve damage and pain,

pelvic organ prolapse, and the need for additional corrective surgeries. (Id. at ¶ 35). Plaintiff’s

allegations clearly focus on the bodily injuries she allegedly has sustained and do not mention

any actual “disease.”

Another federal district court applying North Carolina law has addressed similar factual

allegations and rejected the contention that the disease exception should apply in a case

involving an implantable pelvic mesh device. In In re Mentor Corp., No. 4:13cv301, 2016 WL

4385846, at *2 (M.D. Ga. Aug. 15, 2016), a multi-district litigation case involving a pelvic

device called the “Obtape Transobturator Tape,” the plaintiff argued that North Carolina’s statute

of repose did not bar her product liability claims arising out of her implantation with the

defendant’s pelvic mesh device because her case qualified as a “disease case.” Reviewing the

Fourth Circuit’s decisions addressing North Carolina’s statute of repose as interpreted by the

North Carolina Supreme Court in Wilder, the federal district court for the Middle District of

Georgia found that “cases fall within the ‘disease exception’ if (1) the plaintiff's injury is a

disease, (2) it is difficult to establish the exact time of injury (when the disease process started)

and (3) it is difficult to establish that the disease was caused by the product.” Id.

Following the Fourth Circuit’s interpretation of Wilder, the In re Mentor Corp. court

determined that the disease exception in the North Carolina repose statute does not apply “in

situations where it is possible to identify a single point in time when the plaintiff was first

injured.” Id. at *2. Because the plaintiff’s complications were directly attributable to the

defendant’s pelvic mesh device and the plaintiff could not point to any evidence that she was

diagnosed with a disease caused by the device, the In re Mentor Corp. court concluded that the

disease exception did not apply. Id. at *3 (explaining that the plaintiff “experienced symptoms

when her medical device eroded through her bodily tissues. And while pelvic inflammatory

disease can occur due to a variety of reasons other than an intrauterine device, the types of

complications [the plaintiff] suffered–like erosion of her ObTape–were directly attributable to

ObTape when they happened. Thus, the rationale behind the disease exception does not apply

here.”); see also In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., No.

4:12cv335, 2016 WL 873854, at *2 (M.D. Ga. Mar. 4, 2016) (finding that the disease exception

did not apply and reasoning, “Mrs. Wallace's claim is not a claim arising from disease that

developed over many years after multiple exposures to a toxic substance; it is a claim arising

from complications she contends were caused by a medical device that was implanted in her

body”).

Here, similar to the plaintiff in In re Mentor Corp., Plaintiff seeks damages for personal

injuries that she attributes to a specific event, the implantation of a pelvic mesh device, and

nowhere in the Amended Complaint does she allege that she developed a latent disease as a

result of her implantation with the mesh. Because she filed her Complaint more than 13 years

after her implantation, her claims are barred under either the 6-year or 12-year version of North

Carolina’s statute of repose, and the Complaint will be dismissed with prejudice.'

IV. CONCLUSION

For the reasons set forth above, this action is dismissed with prejudice.

IT IS THEREFORE ORDERED that:

(1) Defendants’ Motion to Dismiss, (Doc. No. 8), is TERMINATED as moot.

(2) Defendants’ Motion to Dismiss, (Doc. No. 14), is GRANTED.

(3) This action is dismissed with prejudice.

Signed: January 25, 2021

Biever SS

Max O. Cogburn i )

United States District Judge ttget

'l Because the statute of repose bars Plaintiff's claims, the Court does not address Defendants’

alternative ground for dismissal.

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