Redd v. DePuy Orthopaedics, Inc.
| Decision Date | 08 September 2014 |
| Docket Number | Case No. 4:13CV2228 CDP. |
| Citation | 48 F.Supp.3d 1261 |
| Court | U.S. District Court — Eastern District of Missouri |
| Parties | Judith A. REDD, Plaintiff, v. DePUY ORTHOPAEDICS, INC., Defendant. |
Daniel A. Raniere, Aubuchon and Raniere, St. Louis, MO, for Plaintiff.
Dan H. Ball, Randy J. Soriano, Bryan Cave LLP, St. Louis, MO, Jan Marie Carroll, Barnes and Thornburg, Indianapolis, IN, for Defendant.
Plaintiff Judith Redd underwent a hip replacement using a prosthesis manufactured by defendant DePuy Orthopaedics, Inc. Approximately four years later, the replacement failed and Redd was diagnosed with a broken femoral component (stem) of her prosthesis. Redd has sued DePuy, alleging that the failure was caused by the prosthesis's defects and DePuy's failure to warn of the risks. She brings four state common law claims under negligence and strict liability theories.
This action is now before me on DePuy's Rule 12(b)(6) motion to dismiss. DePuy argues that Redd's claims are preempted by the 1976 Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. It also argues that even if the claims are not preempted, Redd has failed to state a plausible claim for relief. Because I find that the claims are not preempted and that they meet federal pleading requirements, I will deny DePuy's motion.
The purpose of a motion to dismiss under Rule 12(b)(6) is to test the legal sufficiency of the complaint. When considering a 12(b)(6) motion, the court assumes the factual allegations of a complaint are true and construes them in favor of the plaintiff. Neitzke v. Williams, 490 U.S. 319, 326–27, 109 S.Ct. 1827, 104 L.Ed.2d 338 (1989).
Rule 8(a)(2), Fed.R.Civ.P., provides that a complaint must contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” In Bell Atlantic Corp. v. Twombly, the Supreme Court clarified that Rule 8(a)(2) requires complaints to contain “more than labels and conclusions, and a formulaic recitation of the elements of a cause of action.”
550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ; accord Ashcroft v. Iqbal, 556 U.S. 662, 678–79, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Specifically, to survive a motion to dismiss, a complaint must contain enough factual allegations, accepted as true, to state a claim for relief “that is plausible on its face.” Twombly, 550 U.S. at 570, 127 S.Ct. 1955. The issue in considering such a motion is not whether the plaintiff will ultimately prevail, but whether the plaintiff is entitled to present evidence in support of the claim. See Neitzke, 490 U.S. at 327, 109 S.Ct. 1827.
DePuy designed, manufactured, and sold the AML Total Hip System, including the AML Small Stature stem. Redd's left hip was replaced with the System in April 2008. Approximately four years later, she was diagnosed with a broken stem, which had caused her hip replacement to fail. She claims that the stem was subject to premature and sudden fatigue fracture
because the alloy used had inadequately low fatigue strength and limited ductility and because the manufacturing process did not adequately anneal the alloy. She brings the following four claims under Missouri common law: Strict Liability—Product Defect; Strict Liability—Failure to Warn; Negligence—Product Defect; and Negligence—Failure to Warn.2
In 1976, Congress passed the Medical Device Amendments to the Food, Drug and Cosmetic Act. See 21 U.S.C. § 360c et seq. The amendments authorized the FDA to “regulate the safety and effectiveness of medical devices.” In re Medtronic, Inc., 623 F.3d 1200, 1203 (8th Cir.2010). Through the amendments, which were a response to proliferation (and frequent failure) of medical devices entering the market, Congress “swept back some state obligations and imposed a regime of detailed federal oversight.” Riegel v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) ; see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ().
The MDA classifies medical devices into three groups (Classes I, II, and III) based on the degree of risk they pose. In general, Class III devices—as the most dangerous—are subject to the highest level of scrutiny by the FDA. This manifests in a rigorous, comprehensive inquiry called “premarket approval.” See Lohr, 518 U.S. at 477, 116 S.Ct. 2240 (). However, through the MDA, Congress also provided an alternative route to market for all medical devices, including Class III devices. If the FDA deems a medical device to be “substantially equivalent” to a device already on the market,3 the FDA may approve its sale through a process known as “premarket notification” or the “§ 510(k) process.” See Lohr, 518 U.S. at 478–80, 116 S.Ct. 2240 (). Most Class III devices now being sold have entered the market through the abbreviated § 510(k) process rather than the more demanding premarket approval process. Id. at 479, 116 S.Ct. 2240.
21 U.S.C. § 360k(a).
The Supreme Court has articulated a two-part test for applying the express preemption principles codified in Section 360k of the MDA. See Riegel, 552 U.S. at 321–22, 128 S.Ct. 999. The test requires the court to examine the particular federal laws and regulations applicable to the device in question and compare them to the state claims the plaintiff wishes to bring. First, a court must determine whether “the Federal Government has established requirements” applicable to a particular device. Second, the court must determine whether a plaintiff's claims “are based upon [state] requirements with respect to the device that are different from, or in addition to the federal ones, and that relate to safety and effectiveness.” Id.
The contours of this test are further illuminated by the Supreme Court's holdings in Lohr and Riegel. In Lohr, a divided Supreme Court held that the petitioner's state common law claims concerning a device brought to market through the § 510(k) process were not preempted under Section 360k. Id. at 481, 494–95, 116 S.Ct. 2240. Although the device at issue—a pacemaker lead
—was categorized as Class III, it was subject only to the FDA's “general controls,” the lowest and least specific of the three levels of oversight. The Court held that neither the § 510(k) process nor the continuing “general controls” were a device-specific federal “requirement” that could trigger Section 360k preemption. Id. at 493–94, 116 S.Ct. 2240 ; see also Riegel, 552 U.S. at 322, 128 S.Ct. 999. However, five justices did find that common law claims for negligence and strict liability imposed state “requirements” and would therefore be preempted had there been federal requirements to override them. See id. at 512, 116 S.Ct. 2240 (opinion of O'Connor, J., joined by Rehnquist, C. J., and Scalia and Thomas, JJ.); id. at 503–05, 116 S.Ct. 2240 ().
In Riegel, the Court held that similar state common law claims were preempted when they involved devices that had undergone the rigorous premarket approval process. 552 U.S. at 322–25, 128 S.Ct. 999. Unlike the brief § 510(k) process, premarket approval was “specific to individual devices” and “focused on safety, not equivalence.” Id. at 323, 128 S.Ct. 999. Therefore, premarket approval was a federal “requirement” that met the first prong of the test for Section 360k preemption. Turning to the second prong of the Section 360k preemption test, the Riegel Court held—like the Lohr majority—that “[a]bsent other indication, reference to a State's ‘requirements' includes its common-law duties.” Id. at 324, 128 S.Ct. 999. Addressing the Section 360k language that only state requirements “with respect to devices” are preempted, the Riegel Court held that nothing in the MDA “suggests that the preempted state requirement must apply only to the relevant device, or only to medical devices and not to all products and all actions in general.”Id. at 328, 128 S.Ct. 999.
In addition to its holdings in Lohr and Riegel, the United States Supreme Court weighed in on the preemptive effects of the MDA a third time in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). In that case, the Court construed § 337(a) of the MDA—which provides that all actions to enforce FDA requirements “shall be by and in the name of the United States”—“as barring suits by private litigants ‘for noncompliance with the medical device provisions.’ ” In re Medtronic, 623 F.3d at 1204 (quoting Buckman, 531 U.S. at 349 n. 4, 121 S.Ct. 1012 ). The Eighth Circuit has read Buckman and Riegel together to create only a “narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption.” Id. As such, a plaintiff “must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a) ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman ).” Id. (quoting Riley v. Cordis Corp., 625 F.Supp.2d 769, 777 (D.Minn.2009) ).
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