Cline v. Advanced Neuromodulation System, Inc.Cline v. Advanced Neuromodulation System, Inc.
ORDER
This matter is before the Court on Plaintiffs Motion for Leave to File Second Amended Complaint [Doc. 33] and Motion to Lift Stay of Discovery [Doc. 39].
I. Background
This case arises from the surgical implantation of a medical device and the injuries sustained from its failure and removal. In an attempt to relieve her chronic back and lower body pain, Plaintiff Sheryl D. Cline had a medical device surgically inserted in her back on December 24, 2009. (Am. Compl. ¶ 5.) This device, called an implantable pulse generator (“IPG”), is designed to relieve pain through electric stimulation of nerves. (Id. at ¶¶ 4, 5.) The IPG implanted in the Plaintiff was an Eon Mini Model 3788 Spinal Cord Stimulator (“Model 3788”), which Defendant designed, manufactured, marketed, and sold. (Id.)
The Model 3788 relieved Plaintiffs pain initially, but in June 2010, the device stopped working. (Id. at ¶ 6.) Plaintiff underwent surgery to extract the Model 3788 on October 20, 2010, and the device was sent to Defendant for analysis. (Id. at ¶ 7.) After examination of the device, Defendant wrote Plaintiffs physician on February 15, 2011, explaining that the device failed as “the result of a defective IPG battery.” (Id. at ¶ 8, Ex. A.)
Plaintiff filed her Complaint for Damages in the State Court of Fulton County, Georgia, on October 24, 2011. On November 23, 2011, Defendants St. Jude Medical, Inc., and St. Jude Medical S.C., Inc., removed the case to this Court based on diversity jurisdiction.
Defendants
On January 23, 2012, Defendant filed a Motion to Dismiss Plaintiffs Amended Complaint under Federal Rule of Civil
On June 15, 2012,
As to count II (“Violation of FDA Regulations”), Plaintiff argued that it was a non-preempted “parallel claim.” A “parallel claim” is a state claim based on a violation of the FDA regulations and is not preempted under the MDA. Riegel v. Medtronic,
Plaintiff now requests leave to amend her complaint a second time, arguing that this amendment will cure the deficiencies as to count II. (Doc. 33.) Should the Court deny Plaintiffs request, she then requests that the Court lift the stay of discovery to allow for limited discovery regarding premarket and supplemental premarket approvals by the FDA concerning the manufacture of Defendant’s Eon Mini Model 3788 IPG (the medical device at issue in this case). (See Doc. 39.)
II. Motion for Leave to Amend Complaint
A. Legal Standard
Rule 15(a) of the Federal Rules of Civil Procedure provides that a party may amend her complaint after the filing of the answer “only by leave- of court or by written consent of the adverse party.” Fed. R.Civ.P. 15(a)(2). “The court should freely give leave when justice so requires.” Id.; accord Foman v. Davis,
B. Analysis
Defendant asserts that undue delay, undue prejudice, a repeated failure to cure deficiencies, and futility exist here warranting the denial of Plaintiffs request to amend her complaint. Defendant’s first three assertions are without merit.
First, though Plaintiffs motion to amend her complaint delays the resolu
Thus, futility remains the only basis for Defendant’s opposition to Plaintiffs motion for leave to amend her complaint. Defendant argues that Plaintiffs claim in count II, as alleged in her Second Amended Complaint, is (1) impliedly preempted by the Food, Drug & Cosmetic Act (“FDCA”), 21 U.S.C. § 337(a) and (2) not a sufficiently pled parallel claim to avoid preemption under the MDA. Thus, Defendant contends that granting Plaintiff leave to amend her complaint would be futile.
1. Whether Count II is Impliedly Preempted
Defendant argues that Plaintiffs allegations in count II amount to an attempt to bring a prohibited private action for violations of the Food, Drug & Cosmetic Act (“FDCA”), 21 U.S.C. § 337(a). The FDCA provides that “all such proceedings for the enforcement, or to restrain violations, of [the FDCA, 21 U.S.C. § 301 et seq.,] shall be by and in the name of the United States.” The Supreme Court has held that this provision impliedly preempts state law claims alleging fraud on the FDA. Buckman Co. v. Plaintiffs’ Legal Committee,
In Buckman, the plaintiff alleged that the manufacturer made fraudulent representations to the FDA about the intended use of a component part of its device. Id. Upon this misrepresentation, as the plaintiff alleged, the FDA cleared the device for sale, and this device was subsequently used to plaintiffs detriment. Id. The Supreme Court reasoned that allowing this fraud-on-the-FDA claim would skew the “delicate balance” of statutory objectives
In count II of Plaintiffs Second Amended Complaint, she alleges a common law negligence claim, not one asserting fraud-on-the-FDA. Thus, this claim is not impliedly preempted by § 337(a). The elements of negligence in Georgia are: “the’ existence of a legal duty; breach of .that duty; a causal connection between the defendant’s conduct and the plaintiffs, injury; and damages.” Seymour Electrical & Air Conditioning v. Statom,
2. Whether Count II Sufficiently Pleads a Parallel Claim
Defendant next argues that count II in Plaintiffs Second ’ Amended Complaint fails to satisfy the pleading requirements for a parallel claim based on a violation of FDA requirements. In Riegel v. Medtronic, the Supreme Court introduced the concept of “parallel claims,” which provide a narrow exception to MDA preemption. Riegel v. Medtronic, Inc.,
The Eleventh Circuit has since specifically addressed the pleading requirements for parallel claims. WolickiGables v. Arrow Int’l, Inc.,
In count II of her Second Amended Complaint, Plaintiff alleges a parallel claim based on two interrelated violations of federal regulations. First, she alleges violations of unspecified Pre Market Approval requirements (“PMAs”).
However, Plaintiff also directs the Court to violations of the FDA’s Current General Manufacturing Practices (CGMPs) relating to the device at issue. (Second Am. Compl. ¶¶ 23, 35-36, Ex. D.) Generally, violations of the CGMPs alone are insufficient to state a parallel claim. This is because CGMPs apply to many different types of devices and are thus not specific to any one device. 62 Fed. Reg. 52601-52654, 52603. CGMPs require manufacturers of medical devices to put in place “quality system[s] ... to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act.” 21 C.F.R. § 820.1(a). The FDA embraces an “ ‘umbrella’ approach ... providing] the framework that all manufacturers must follow” and then requiring manufacturers to “fill in the details that are appropriate to a given device.” Id. As the CGMPs are general by design, assertions of general CGMP violations, alone, are often insufficient to state a parallel claim, which requires a violation of a device-specific regulation. Ilarraza v. Medtronic,
In Ilarraza, for example, the plaintiff tried to make out a parallel claim merely by providing a list of CGMPs the defendant allegedly violated. Ilarraza,
In contrast, in Purcel, the plaintiff alleged CGMP violations specifically focused on moisture problems in the device at issue, a cochlear implant. Purcel,
Here, in Plaintiffs Second Amended Complaint, she provides more than conclusory assertions of CGMP violations. She also alleges specific facts about when and how these violations occurred in the manufacture of the specific device at issue. According to Plaintiff, on June 29, 2009, the FDA sent Defendant a warning letter regarding numerous, specific CGMP violations in the manufacture of its IPG devices. (Second Am. Compl. ¶ 36 and Ex. D.) These CGMP violations include:
• 21 C.F.R. § 820.100(b) (failing to establish and maintain adequate procedures for implementing corrective and preventive actions in violation);
• 21 C.F.R. § 820.100(a)(2) (failing to investigate the cause of non-conformities related to the product);
• 21 C.F.R. § 820.30(g) (failing to establish and maintain adequate procedures for validating device design in order to ensure that the devices conform to define user needs and intended uses);
• 21 C.F.R. §§ 820.80(d) and 820.80(e) (failure to establish adequate procedures for finished device acceptance); and
• 21 C.F.R. § 820.198 (failure to establish and maintain complaint handling procedures).
(Second Am. Compl. ¶ 36.)
Plaintiff next alleges that based on these CGMP violations, the FDA determined that the Defendant’s IPG’s were “adulterated within the meaning of § 501(h) of the Act, 21 U.S.C. § 351(h).” (Second Am. Compl, ¶ 36 (quoting Ex. D).) Thus, the FDA stated that it would not provide market approval for the devices related to Defendant’s specific CGMP violations until Defendant corrected each violation. (Id.)
Plaintiffs. specific allegations are sufficient to state a plausible parallel claim at this early stage of litigation. C.f. WolickiGables,
III. Motion to Lift Stay
As the Court has granted Plaintiffs request to amend her complaint, the Court DENIES AS MOOT Plaintiffs Motion to Lift Stay of Discovery. [Doc. 39].
IV. Conclusion
Plaintiffs Motion for Leave to File Second Amended Complaint [Doe. 33] is GRANTED and her Motion to Lift Stay of Discovery [Doc. 39] is DENIED AS MOOT. Pursuant to the Court’s August 14, 2012 Order (Doc. 25), discovery as to count I SHALL COMMENCE immediately. The Court ORDERS limited discovery as to count II, DIRECTING Defendant to produce:
(1) the Pre Market Approval (“PMA”) specifications and supplemental specifications related to Defendant’s manufacture and/or assembly of implantable pulse generators (“IPGs”) including the Eon Mini Model 3788 Spinal Cord Stimulator;
(2) any communications between Defendant and the FDA regarding the PMA specifications and supplemental specifications identified in (1) above; and
(3) any materials contained in the PMA file (as defined in 21 C.F.R. § 814.9) related to Defendant’s manufacture and/or assembly of the battery and printed circuit board in any IPG including the Eon Mini Model 3788 Spinal Cord Stimulator.
The limited discovery period provided for count II SHALL CONCLUDE 75 days from the date of the approval of the confidentiality consent order. Plaintiff shall file a Third Amended Complaint alleging facts in connection with count II no later than February 5, 2013. Failure to do so will indicate Plaintiffs desire to abandon her parallel claim in count II.
The Clerk is DIRECTED to resubmit this matter to the undersigned upon the filing of Plaintiffs Third Amended Complaint or the expiration of the aforementioned time period.
Notes
. The Court derives the factual background primarily from Plaintiff's first Amended Complaint. This background is meant only to provide context and does not constitute actual findings of fact.
. On December 8, 2011, the Court entered a Consent Order to Substitute Parties substituting Advanced Neuromodulation Systems, Inc., d/b/a St. Jude Medical Neuromodulation Division for the original named defendants St. Jude Medical, Inc. and St. Jude Medical S.C., Inc. [Doc. 8].
. Defendant’s only support for this contention is that it "ha[s] to address these frivolous motions” and there will be "more undue prejudice if this motion is granted.” (Doc. 38 at 21.) These assertions do not allege an "undue prejudice.” See Loggerhead Turtle,
. Of course, a properly pled parallel claim is a state law claim. Defendant argues that Plaintiff failed to allege a. state law claim. However, in count II, Plaintiff asserts the elements of common law negligence in Georgia: "the existence of a legal duty; breach of that duty; a causal connection between the defendant’s conduct and the plaintiff's injury; and damages.” Seymour Electrical & Air Conditioning v. Statom,
. In fact, for this reason, the Seventh and Fifth Circuits have abandoned this heightened pleading standard in favor of notice pleading for parallel claims. Bausch v. Stryker Corp.,
. For a discussion of the PMA process, see the Court’s June 15, 2012 Order in this case. (Doc. 25,
. In Medtronic, the Eighth Circuit adopted the rigid pleading requirement urged by Defendant here. Medtronic,
. Defendant notes that the specific model of IPG is not mentioned in the FDA warning letter upon which Plaintiff relies to support her allegations. (Def’s Resp. at 14-15.) Even so, the FDA letter indicates that the IPG devices manufactured at Defendant’s facility in Plano, Texas were adulterated, and Plaintiff further alleges that the very IPG model at issue here was manufactured at that facility. (Second Am. Compl. V 36, Ex. D.) These allegations are sufficient to warrant limited dis
. In the Court's prior Order (Doc. 37) granting the parties' Consent Motion to Stay and Extend Discovery (Doc. 36), the Court established that, upon the Court’s ruling on Plaintiff's Motion for Leave to File Second Amended Complaint, discovery shall recommence.
. Upon Plaintiff's filing of her Third Amended Complaint, the Court shall consider authorizing broader discovery on count II and an extended discovery period. A status conference will be held with the parties as appropriate.