United States District Court, E.D. Kentucky, Northern Division, Ashland
MEMORANDUM OPINION AND ORDER
HENRY R. WILHOIT, Jr., District Judge.
This matter is before the Court upon the Defendants' Motion to Dismiss Plaintiff s Amended Complaint [Docket No. 24]. The motion has been fully briefed by the parties [Docket Nos. 25 and 26]. For the reasons stated herein, the Court finds that Plaintiff has not stated a claim upon which relief can be granted and, thus, dismissal is warranted.
I. FACTUAL AND PROCEDURAL BACKGROUND
The relevant factual allegations are as follows:
On October 25, 2010, Ms. Kitchen underwent an Oxford medial compartment replacement of the left knee at King's Daughters Medical Center in Ashland, Kentucky. Ms. Kitchen's implant consisted of a Biomet Oxford knee size small femur, size A tibial component and size 8 poly component. On February 9, 2012, Ms. Kitchen was sitting in a chair at work when she twisted her knee slightly, felt a pop, and experienced severe pain. She was taken to the emergency room of King's Daughters Medical Center in Ashland, Kentucky, where she was discovered to have a failure of the left knee implant with acute dislocation of the poly component and a partial tear of the MCL. On February 9, 2012, Ms. Kitchen underwent a total knee revision of the left knee at King's Daughters Medical Center in Ashland, Kentucky.
[Amended Complaint, Docket No. 23, ¶¶ 10-14].
As a result of the failure of her Oxford partial knee implant, Ms. Kitchen experienced great pain and suffering and emotional distress, underwent replacement surgery, incurred expenses for medical care and treatment including physical therapy, missed work.
Id. at ¶ 15.
In her Complaint, Plaintiff asserted negligence, strict liability and breach of warranty claims. She contends that the Partial Knee System suffered from defects that caused her pain and ultimately required her to have the device removed. [Docket No. 1, Complaint, ¶¶ 12-15]. She claims that the Partial Knee System is "defective and unreasonably dangerous" because it (I) failed prematurely, (ii) failed with acute dislocation of poly component; and (iii) the component parts failed to remain properly aligned, affixed to each other, and/or affixed to Plaintiffs body. Id. at ¶¶ 17-18. She further alleges that Biomet "designed, manufactured, assembled, tested, inspected, provided with warnings and instructions, marketed, and distributed" the Partial Knee System "in an unreasonably dangerous and inherently defective condition" and "expressly and impliedly warranted" that the Partial Knee System was "of merchantable quality" and fit for its "usual and intended purpose." Id. at ¶¶ 20, 24)
Defendants sought dismissal of Plaintiff's Complaint, arguing that her claims were preempted by federal law [Docket No. 12]. In response to Defendants' motion, Plaintiff sought leave to file an Amended Complaint [Docket No. 19]. The parties agreed to pennit the filing of the Amended Complaint [Docket No. 22] and it was entered on September 26, 2013 [Docket No. 23].
The Amended Complaint asserts no new factual allegations or causes of action. Indeed, the Amended Complaint is virtually identical to the original Complaint with the addition of three allegations:
18. The Oxford partial knee implant was defective in one or more of the following respects:
(f) failure to comply with Quality System Regulations and Current Manufacturing Practices required by the FDA in 21 C.F.R. § 820.72 to 820.90. Among other things, these regulations require manufacturers to put in place suitable processes to test products for compliance with product specifications, to check and document compliance with product specifications before products are accepted for sale and use, and to identify and control nonconforming products;
19. Because of these effects, the knee implant failed to comply and operate within the terms of its Pre-Market Approval from The Food and Drug Administration.
29. In the approval letter dated April 21, 2004 for the FDA Center for Devices and Radiological Health to Biomet, Inc., the FDA specifically states that: "CDRH doesnot evaluate information related to contract liability warranties, however, you should be aware that any such warranty statements must be truthful, accurate, ...