Marcum v. Depuy Orthopedics, Inc.
| Decision Date | 02 May 2013 |
| Docket Number | Case No. 1:12-cv-834 |
| Parties | CHRISTIAN MARCUM, Plaintiff, v. DEPUY ORTHOPEDICS, INC., Defendant. |
| Court | U.S. District Court — Southern District of Ohio |
This civil action is before the Court on Defendant's motion to dismiss (Docs. 7, 8) and the parties' responsive memoranda. (Docs. 12, 13). This prescription medical device case arises from a ceramic femoral head component that broke four years after Plaintiff's total hip replacement surgery. Plaintiff has asserted claims for strict liability (defective manufacturing, defective design, and nonconformance with representations), common law negligence, breach of express warranty, breach of implied warranty, and negligent misrepresentation, and Plaintiff seeks punitive damages in her prayer for relief. (Doc. 1 at ¶¶ 13-21).
For purposes of this motion to dismiss, the Court must: (1) view the complaint in the light most favorable to Plaintiff; and (2) take all well-pleaded factual allegations as true. Tackett v. M&G Polymers, 561 F.3d 478, 488 (6th Cir. 2009).
Defendant is responsible for the design, manufacturing, marketing, distribution, and sale of the DePuy Duraloc Option cup and DePuy Articul/EZE ceramic femoral head. (Doc. 1 at ¶ 4). Defendant represents on its website that the femoral head is "comprised of high-purity aluminum oxide ceramic to provide high hardness for extreme wear." (Id. at ¶ 23). Defendant states that the product allows for "precise polishing to provide exceptionally smooth articulating surfaces for optimum wear resistance." (Id.) Defendant notes that these characteristics are important because "[l]ong term resistance to wear is a critical component of successful THA [total hip arthroplasty]." (Id.)
Defendant's Articul/EZE ceramic femoral head is considered a Class II medical device under 21 CFR §§ 860 and 888.3353. (Id. at ¶ 16). In May 1995, Defendant submitted a § 510(k) premarket notification approval for its Articul/EZE ceramic femoral head to the FDA and was granted market approval on June 30, 1995 (Id. at ¶ 17-18). However, Plaintiff alleges that Defendant failed to establish and maintain current good manufacturing practices with respect to quality audits, quality testing, and process validation for its Articul/EZE product. (Id. at ¶ 53-57).
On November 12, 2007, Plaintiff underwent a total hip replacement using Defendant's components. (Doc. 1 at ¶ 7). Plaintiff's left hip socket was replaced by a Duraloc Option acetabular cup and a Duraloc Option ceramic insert and the top of her femur was replaced by an Articul/EZE ceramic femoral head. Id. Plaintiff and/or her physician relied on Defendant's representations concerning the wear characteristics of itsproduct to select the DePuy Articul/EZE ceramic femoral head for implantation. (Id. at ¶¶ 73, 95). Approximately four years later, Plaintiff went to the emergency room complaining of popping and grinding in her left hip and an inability to bear weight on that leg. (Id. at ¶ 9). Although hip replacements are designed to last approximately 15 years, an x-ray revealed that the ceramic femoral head was broken and Plaintiff underwent revision surgery during which the ceramic cup liner and femoral head were replaced by new components. (Id. at ¶ 9-11). Plaintiff's surgeon confirmed that Defendant's product had fractured and noted that ceramic fragments had to be removed from Plaintiff's body. (Id. at ¶ 10).
A motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) operates to test the sufficiency of the complaint and permits dismissal of a complaint for "failure to state a claim upon which relief can be granted." To show grounds for relief, Fed. R. Civ. P. 8(a) requires that the complaint contain a "short and plain statement of the claim showing that the pleader is entitled to relief."
While Fed. R. Civ. P. 8 "does not require 'detailed factual allegations,' . . . it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949 (2009) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007)). Pleadings offering mere "'labels and conclusions' or 'a formulaic recitation of the elements of a cause of action will not do." Id. (citingTwombly, 550 U.S. at 555). In fact, in determining a motion to dismiss, "courts 'are not bound to accept as true a legal conclusion couched as a factual allegation[.]" Twombly, 550 U.S. at 555 (citing Papasan v. Allain, 478 U.S. 265 (1986). Further, "[f]actual allegations must be enough to raise a right to relief above the speculative level[.]" Id.
Accordingly, "[t]o 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.'" Iqbal, 129 S.Ct. at 1949. A claim is plausible where "plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. Plausibility "is not akin to a 'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully." Id. "[W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged—but it has not 'show[n]'—'that the pleader is entitled to relief,'" and dismissal is warranted. Id. (citing Fed. R. Civ. P. 8(a)(2)),
Plaintiff does not contest that Count IV (Negligence), Count V (Breach of Express Warranty), and Count VI (Breach of Implied Warranty) are abrogated by the Ohio Product Liability Act (OPLA) and as such does not oppose Defendant's motion to dismissthese claims. Counts IV, V, and VI of the Complaint are therefore appropriately dismissed. (Doc. 1 at 17-20).
The OPLA broadly defines "product liability claim" to include "[a]ny warning or instruction, or lack of warning or instruction, associated with that product. O.R.C. § 2307.71(A)(13)(b). This broad definition demonstrates a legislative intent that all claims arising from the manufacturing, marketing, warning, warranty, or representation of a product are claims exclusively defined, remedied, and governed by the OPLA. Jones v. Walker Mfg. Co., No. 97301, 2012-Ohio-1546 (Ohio Ct. App. April 5, 2012); Luthman v. Minister Supply Co., No. 2-06-43, 2008-Ohio-165, ¶ 13 (Ohio Ct. App. Jan 22, 2008).
Although this Court has found that claims for fraud or negligent misrepresentation may fall outside the scope of the OPLA's abrogation, such an exception only applies when the claims in question are grounded in the Uniform Commercial Code or "implicate the more general duty not to deceive, rather than a duty to warn." CCB Ohio LLC v. Chemque, Inc., 649 F. Supp. 2d. 757, 764-65 (S.D. Ohio 2009); Piskura v. Taser Int'l, No. 1:10-cv-248, 2012 WL 5378805, at *19 (S.D. Ohio Oct. 29, 2012); Stratford v. Smithkline Beecham Corp., No. 2:07-cv-639, 2008 U.S. Dist. LEXIS 84826 at *23 (S.D. Ohio June 17, 2008). Courts in the Sixth Circuit have largely found that the OPLAabrogates negligent misrepresentation claims.1
The 2005 and 2007 amendments to the OPLA "specify that the legislature's intent in enacting the OPLA was 'to abrogate all common law product liability cases of action.'" Piskura, 2012 WL 5378805, at *19 (citing Wimbush v. Wyeth, 619 F.3d 632, 637 (6th Cir. 2010). Although Plaintiff suggests that her negligent misrepresentation claim is not abrogated because it implicates a more general duty not to deceive rather than a duty to warn, in reality Plaintiff's claim is not based on Defendant's alleged active deception, but on Plaintiff's allegation that in the exercise of reasonable care, Defendant should have known of the condition of its product. This is functionally an alleged failure to warn, and Plaintiff's negligent misrepresentation claim is abrogated.
Furthermore, even if fraud were implicated in Plaintiff's claim, Fed. R. Civ. P. 9(b) requires that the circumstances constituting fraud must be stated with particularity. As the Sixth Circuit instructs, this requires "the plaintiff, at a minimum, to 'allege the time, place, and content of the alleged misrepresentation on which he or she relied; the fraudulent scheme; [and] the fraudulent intent of defendant[.]" Stratford, 2008 WL2491965 at * 8 (citing Yuhasz v. Brush Wellman, Inc., 181 F. Supp. 2d 785, 788 (N.D. Ohio 2001) (citing Coffey v. Foamex, L.P., 2 F.3d 157 (6th Cir. 1993)). Plaintiff has alleged none of the above and therefore her negligent misrepresentation claim is appropriately dismissed even if not preempted by the OPLA.
The ceramic femoral head is a Class II medical device. (Doc. 1 at ¶ 16). "Class II devices are those possessing a greater potential dangerousness and thus warranting more stringent controls." Buckman v. Plaintiff's Legal Committee, 531 U.S. 341, 344 (2001); 21 U.S.C. § 360(c)(a)(1)(C)(ii)(II). Class II devices reach the market through the 510(k) process. (Doc. 1 at ¶ 16). In the course of this process, a manufacturer must provide "proposed labels, labeling and advertisements sufficient to describe the device, its intended use, and directions for use," and show that "the device is similar to and/or different from other products of comparable type in commercial distribution." Buckman, 531 U.S. at 345 (quoting 21 C.F.R. § 807.87(e) & (f)). However, no private right of action exists for violations of federal regulations such as this. Id. at 349 n.4; see 21 U.S.C. § 337(a) ().
Plaintiff's strict liability claims are not, at base, claims for violation of federal law, however. Althoug...
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