Jones v. Coloplast Corp. (In re Coloplast Corp. Pelvic Support Sys. Prods. Liab. Litig.)
| Citation | 220 F.Supp.3d 731 |
| Decision Date | 09 December 2016 |
| Docket Number | Civil Action No. 2:14–cv–11148,MDL NO. 2387 |
| Court | U.S. District Court — Southern District of West Virginia |
| Parties | IN RE: COLOPLAST CORP. PELVIC SUPPORT SYSTEMS PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO: Jane Jones v. Coloplast Corp. |
Pending before the court is Coloplast Corp.'s Motion to Dismiss on the Pleadings [ECF No. 16]. The plaintiff responded [ECF No. 18] and Coloplast Corp. replied [ECF No. 19] making the Motion ripe for adjudication. For the reasons set forth below, the Motion is GRANTED in part and DENIED in part .
This case resides in one of seven MDLs assigned to me by the Judicial Panel on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse ("POP") and stress urinary incontinence ("SUI"). In the seven MDLs, there are more than 58,000 cases currently pending, approximately 500 of which are in the Coloplast Corp. ("Coloplast") MDL, MDL 2387.
On May 26, 2010, Ms. Jones was surgically implanted with Coloplast's Suspend–Tutoplast Processed Fascia Lata ("Fascia Lata"), a device manufactured by Coloplast to treat SUI and to reconstruct the pelvic floor. Short Form Compl. ¶¶ 9–10 [ECF No. 1]. Ms. Jones' surgery occurred at Tuomey Healthcare System in Sumter, South Carolina. Id. ¶ 11. Ms. Jones claims that as a result of implantation of the Fascia Lata, she has experienced multiple complications. She adopts the following counts as alleged in the First Amended Master Long Form Complaint and Jury Demand ("Master Complaint"): I—negligence, II—strict liability design defect, III—strict liability manufacturing defect, IV—strict liability failure to warn, V—strict liability defective product, VI—breach of express warranty, VII—breach of implied warranty, VIII—fraudulent concealment, IX—constructive fraud, X—discovery rule and tolling, XI—negligent misrepresentation, XII—negligent infliction of emotional distress, XIII—violation of consumer protection laws, XIV—gross negligence, XV—unjust enrichment, and XVII—punitive damages. Id. ¶ 13.
According to the Master Complaint, Coloplast "designed, patented, manufactured, packaged, labeled, marketed, sold, and distributed a line of pelvic mesh products," one of which was an allograft, the Fascia Lata. First Am. Master Compl. ¶¶ 22–23 [ECF No. 49, MDL 2387]. Coloplast admits in its Joint Master Long Form Answer and Affirmative Defenses to Plaintiffs' First Amended Master Long Form Complaint and Jury Demand ("Master Answer") that it "generally packaged, labeled, marketed, sold[,] and distributed" such pelvic mesh devices. Master Answer ¶ 22 [ECF No. 62, MDL 2387]. The Fascia Lata device is "dehydrated, ... processed fascia lata from donated human tissue." See Def.'s Mot. Dismiss on the Pleadings Ex. B, at 1 [ECF No. 16–2] ("Package Insert"). The Fascia Lata is preserved such that it "retains the three-dimensional collagen structure responsible for the unidirectional, mechanical properties of the original fascia lata tissue." Id.
"[T]he Rule 12(c) judgment on the pleadings procedure primarily is addressed to ... dispos[e] of cases on the basis of the underlying substantive merits of the parties' claims and defenses as they are revealed in the formal pleadings." 5C Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 1367 (3d ed. 2004). A motion under 12(c) is useful when only questions of law remain. Id.
[A] Rule 12(c) motion is designed to provide a means of disposing of cases when the material facts are not in dispute ... and a judgment on the merits can be achieved by focusing on the content of the competing pleadings, exhibits thereto, matters incorporated by reference in the pleadings, [and] whatever is central or integral to the claim for relief or defense ....
Id. Rule 12(h)(2) provides that the defense of failure to state a claim upon which relief can be granted may be raised in a motion for judgment on the pleadings. Fed. R. Civ. P. 12(h)(2). If this is asserted in a Rule 12(c) motion, the district court will apply the same standards for granting the appropriate relief or denying the motion as it would have employed had the motion been brought prior to the defendant's answer under 12(b)(6). Wright & Miller, supra , § 1367 ; see Exec. Risk Indem., Inc. v. Charleston Area Med. Ctr., Inc. , 681 F.Supp.2d 694, 706 n.17 (S.D. W. Va. 2009) ().
A motion to dismiss filed under Rule 12(b)(6) tests the legal sufficiency of a complaint or pleading. Giarratano v. Johnson , 521 F.3d 298, 302 (4th Cir. 2008). A pleading must contain a "short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). This standard "does not require ‘detailed factual allegations,’ but it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). "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.’ " Id. (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ). To achieve facial plausibility, the plaintiffs must plead facts allowing the court to draw the reasonable inference that the defendant is liable, moving the claim beyond the realm of mere possibility. Id. Mere "labels and conclusions" or "formulaic recitation[s] of the elements of a cause of action" are insufficient. Twombly , 550 U.S. at 555, 127 S.Ct. 1955.
The plaintiff asserts that Coloplast's Rule 12(c) Motion to Dismiss on the Pleadings is truly a Rule 56 Summary Judgment Motion because Coloplast has attached exhibits for the court's consideration. However, when deciding a 12(c) motion, the court may consider "the content of the competing pleadings, exhibits thereto, matters incorporated by reference in the pleadings, [and] whatever is central or integral to the claim for relief or defense." Wright & Miller, supra , § 1367. Of Coloplast's attached documents and the plaintiff's referenced evidence in their Response, the court will only consider the package insert marked as Exhibit B to Coloplast's Motion because it is integral to the claim for relief and defense. See Package Insert. The package insert offers a product description and a warranty statement which are pertinent to the claims at hand—specifically the breach of warranty claims. Seeid. at 1; Short Form Compl. ¶ 13. The evidence the plaintiff put forward in her Response, the content from Coloplast's website, is not part of the content of the pleadings, an exhibit thereto, incorporated by reference in the pleadings, or central or integral to the claims. Therefore, it will not be considered. Further, Coloplast attached the Short Form Complaint as Exhibit A to its Motion. See Def.'s Mot. Dismiss on the Pleadings Ex. A [ECF No. 16–1]. This is a pleading and must be considered by the court, and accordingly has no transformative power. Thus, Coloplast's Motion is not a Rule 56 Summary Judgment Motion.
Next, this court applies the substantive tort law of the state where the plaintiff's implantation occurred—in this case, South Carolina. In re: Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig. , No. 2:12–cv–760, 2016 WL 3067752, at *2 ; Short Form Compl. ¶ 11. The claims are addressed below.
Coloplast argues that it is immune from the plaintiff's strict liability and warranty claims alleged in Counts II–VII by virtue of South Carolina's blood and human tissue shield statute which states:
The implied warranties of merchantability and fitness are not applicable to a contract for the sale, procurement, processing, distribution, or use of human tissues including, but not limited to, corneas, bones or organs, whole blood, plasma, blood products, or blood derivatives. Human tissue, whole blood, plasma, blood products, and blood derivatives must not be considered commodities subject to sale or barter, and the transplanting, injection, transfusion, or other transfer of these substances into the human body are considered a medical service.
S.C. Code Ann. § 44–43–10. Here, the statute plainly exempts the distribution of human tissue from the implied warranties of merchantability and fitness. Further, it explicitly delineates that human tissue is not considered a "product" subject to sale. Id. ; see also Samson v. Greenville Hosp. Sys. , 297 S.C. 409, 377 S.E.2d 311, 312 (1989) ().
Where there is no sale of a product, products liability (which includes strict liability and breach of warranty claims) cannot apply. See 63 Am. Jur. 2d Products Liability § 625 (2010) (). South Carolina courts have fallen into step with many other jurisdictions in refusing to apply strict liability to human tissue, stating simply that "blood is not a product for purposes of strict liability in tort." Samson , 377 S.E.2d at 312. Moreover, the statute clearly pulls the distribution of human tissue out of the realm of the implied warranties. S.C. Code Ann. § 44–43–10 ; see Samson v. Greenville Hosp. Sys. , 295 S.C. 359, 368 S.E.2d 665, 666, 669 (1988) (...
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