The opinion of the court was delivered by: Judge Joy Flowers Conti
Magistrate Judge Maureen P. Kelly
This action was removed from the Court of Common Pleas of Allegheny County to this court on November 28, 2011. [ECF No. 1]. In the complaint, plaintiff Melinda Killen ("Plaintiff") asserts claims arising from the surgical implantation of the CerviCore Intervertebral Device ("Cervicore") and seeks damages for the injuries that she sustained as a result of the artificial disc implant. The case was referred to a United States Magistrate Judge for pretrial proceedings in accordance with the Magistrate Judges Act, 28 U.S.C. § 636(b)(1), and Local Rules of Court 72.C and 72.D.
Defendant Stryker Spine ("Defendant") filed a motion to dismiss. [ECF No. 3]. Plaintiff filed a response in opposition. [ECF No. 11]. A reply and sur-reply were also filed. [ECF Nos. 14, 20].
The magistrate judge's report and recommendation, filed on August 21, 2012, recommended that the motion to dismiss filed by Defendant, and premised upon federal preemption, be granted in part and denied in part [ECF No. 22]. Service of the Report and Recommendation was made upon all counsel of record. The parties were informed that in accordance with the Magistrate Judge's Act, 28 U.S.C. § 636(b)(1)(B) and (C), and Rule 72.D.2 of the Local Rules of Court, that they had fourteen days to file any objections. Defendant filed objections to the Report and Recommendations (the "objections") on September 7, 2012. [ECF No. 23]. Plaintiff filed a reply to the pobjections (the "reply") on September 21, 2012. [ECF No. 27].
Defendant asserts five specific objections upon which it argues that this court should reject the recommendations of the magistrate judge, grant the motion to dismiss, and dismiss Plaintiff's complaint in its entirety with prejudice. In her reply, Plaintiff requests that this court adopt the Report and Recommendation and deny the motion to dismiss.
After review of the complaint, the objections, the reply, the filings related to the motion to dismiss, applicable case law, and the Report and Recommendation, the court adopts the Report and Recommendation. Each of the five objections are addressed seriatim.
I. Objection that Plaintiff did not successfully pled parallel claims.
Defendant contends that Plaintiff did not successfully plead parallel claims on the ground that Current Good Manufacturing Practices ("CGMPs") are not applicable to investigational devices ("IDE devices") such as the CerviCore disc. Defendant is correct that CGMPs cannot serve as the basis for Plaintiff's state law claims because under 21 C.F.R. § 812.1, IDEs are exempt from CGMPs' requirements. See Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090, 1096 (6th Cir. 1997). If Plaintiff asserted her claims based on Defendant's violations of the CGMPs, those claims would be preempted because they would be different from or in addition to the requirements imposed by federal regulation. Id. at 1096. Plaintiff, however, does not rely on the CGMPs in the manner that Defendant suggests. Plaintiff alleges that Defendant violated the requirements imposed on Defendant by the FDA in the IDE approval process and relies on the CGMPs to set forth a plausible claim of what those requirements were. (ECF No. 28 at 4-5.) Plaintiff alleges that before discovery, she cannot determine what requirements the FDA actually imposed on defendant in the IDE approval process because that information is confidential. The court finds that state law claims asserting parallel violations of the requirements imposed by the FDA during the IDE approval process are not preempted because they are not different from or in addition to federal requirements or regulations. Plaintiff's claims, therefore, are not preempted to the extent that requirements imposed by the FDA on Defendant during the IDE approval process were the same as the requirements imposed by the CGMPs. To the extent the requirements imposed by the FDA in the IDE approval process are different from or in addition to the CGMP requirements, however, plaintiff's claims referring to those CGMP requirements will be preempted.
Defendant also argues that to the extent Plaintiff relies upon 21 C.F.R. § 812.5, the regulation is not device specific and Plaintiff's claim alleging the violation of § 812.5 is preempted. Defendant further contends that specific parallel claims must be asserted at this initial pleading stage. In response, Plaintiff argues that she sufficiently pled parallel claims to the best of her ability at this initial stage of the case. She further contends that prior to discovery it is impossible for her to access the device-specific requirements imposed by the Food and Drug Administration ("FDA"). Based on this sufficiency of pleading, Plaintiff argues that her negligence claims are not preempted. [ECF No. 28 at 2-5].
The court finds that the magistrate judge conducted a detailed and thorough review of this evolving area of the law relating to parallel claims and preemption, including the arguments raised again by Defendant in the objections. The magistrate judge also discussed the holding in Gross v. Stryker, Civil No. 11-1229, 2012 WL 876719 (W.D. Pa. Mar. 14, 2012). While agreeing in substance with the legal rationale in Gross, the magistrate judge correctly recognized that the facts of this case are distinguishable from the facts in Gross. Here, Plaintiff sufficiently pled parallel claims at this initial stage of the proceedings.
Plaintiff specifically avers in her complaint that Defendant: (1) was negligent in its record keeping and did not disclose manufacturing flaws that increased the risk of injury to patients receiving the implant and argues that this activity violated the manufacturer's duty to establish and maintain procedures for implementing corrective and preventative action -- which are alleged requirements of the IDE approval process that are the same as those imposed under 21 C.F.R. § 800.100(a)(6)(7); (2) was negligent in compromising the integrity of the CerviCore implant by utilizing titanium coating techniques -- which is a violation of the alleged requirements of the IDE approval process that are the same as those imposed under 21 C.F.R. § 820.70(e),(h)*fn1 ; and, (3) failed to provide proper warnings concerning defects in the device, including the use of nickel and the risks of metallosis, in violation of a manufacturer's duty outlined in 21 C.F.R. § 812.5(a) to describe "all relevant contradictions, hazards, adverse effects, interfering substances or devices, warnings and precautions." As recognized in the Report and Recommendation, Plaintiff, in her sur-reply, refers to the allegation in the complaint that Defendant was negligent in performing metal allergy testing prior to accepting patients into the clinical trial, but admits that, without discovery, Plaintiff cannot identify specific requirements imposing such testing.
The magistrate judge correctly found that these descriptions of purported regulatory violations go beyond the rote conclusory pleadings that the Gross court found insufficient to sustain parallel claim allegations.
As noted in the Report and Recommendation, it is disingenuous to identify the parallel claim exception to the Medical Device Act Amendments of 1976 ("MDA") exemption as articulated in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) , but foreclose a plaintiff any opportunity to prove the exception. As ...