United States District Court, E.D. Missouri, Eastern Division
JUDITH A. REDD, Plaintiff,
DePUY ORTHOPAEDICS, INC., Defendant
For Judith A. Redd, Plaintiff: Daniel A. Raniere, AUBUCHON AND RANIERE, St. Louis, MO.
For DePuy Orthopaedics, Inc., Defendant: Dan H. Ball, LEAD ATTORNEY, Randy J. Soriano, BRYAN CAVE LLP, St. Louis, MO; Jan Marie Carroll, LEAD ATTORNEY, BARNES AND THORNBURG, Indianapolis, IN.
MEMORANDUM AND ORDER
CATHERINE D. PERRY, UNITED STATES DISTRICT JUDGE.
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.
I. Motion to Dismiss Standard
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. 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.
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.
III. The Medical Device Amendments
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) (MDA was enacted in " response to mounting consumer and regulatory concern" ).
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 (noting that it takes the FDA an average of 1,200 hours to review an application for premarket approval). 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, 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 (noting that a § 510(k) review takes an average of 20 hours). 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.
The MDA also expressly preempts certain state laws. Subject to some unrelated exceptions, " no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the ...