Silver v. Medtronic, Inc.

236 F. Supp. 3d 889, 2017 WL 676015, 2017 U.S. Dist. LEXIS 24313
CourtDistrict Court, M.D. Pennsylvania
DecidedFebruary 21, 2017
Docket1:16-cv-1682
StatusPublished
Cited by10 cases

This text of 236 F. Supp. 3d 889 (Silver v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering District Court, M.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Silver v. Medtronic, Inc., 236 F. Supp. 3d 889, 2017 WL 676015, 2017 U.S. Dist. LEXIS 24313 (M.D. Pa. 2017).

Opinion

MEMORANDUM & ORDER

John E. Jones III, United States District Judge

Presently pending before the Court is a motion to dismiss (the “Motion”) filed by Defendants Medtronic, Inc. Medtronic Puerto Rico Operations, Co, and Medtronic Logistics, LLC.1 (collectively “Medtronic”) (Doc. 9), Plaintiff Jason Silver .brings seven counts against Medtronic arising out of the alleged malfunction of a Medtronic device, the SynchroMed II.2 (Doc. 1). The Motion has been fully briefed (Docs. 11,14, 15) and is therefore ripe for our review. For the reasons that follow, the Motion shall be granted in part and denied in part.

I. BACKGROUND

Plaintiff Jason Silver filed a Complaint against Medtronic on August 12, > 2016. (Doc. 1). Plaintiff brings the following causes of action arising out of the alleged malfunction of Medtronic’s product, the SynchroMed II Device (the ' “Device”): manufacturing defect, failure to warn, negligence, breach of express' warranty, [893]*893breach of implied warranties, negligent misrepresentation, and violation of Pennsylvania’s unfair trade practices and consumer protection law.

In accordance with the standard of review applicable to a motion- to dismiss, the following facts are derived from Plaintiff’s Complaint. (Doc. 1).

Plaintiff is a fifty-two year old man with diagnosed cervical radiculopathy and cervi-calgia, (Id., at ¶¶ 10, 12). On December 7, 2012, Plaintiff had the Device, comprised of a pump and an intrathecal catheter, implanted in his abdomen. (Id., at ¶ 13). The Device is a programmable drug infusion system that delivers medication into the intrathecal space of the patient’s spine. (Id., at ¶¶22, 25). It is implanted and remains under the skin. (Id., at ¶ 25).

For several months after the Device was implanted, Plaintiffs pain improved. (Id., at ¶ 14). However, in the summer of 2014, the Device overdelivered pain medication and caused Plaintiff severe, pain, nausea, and lack of mobility. (Id.). On August 12, 2014, Plaintiff underwent a procedure to remove the Device due to its malfunction. (Id., at ¶ 15).

The Device is a Class III medical device approved by the Food and Drug Administration (“FDA”) through the Pre-Market Approval (“PMA”) process in 1988. (M, at ¶ 23), PMA is the FDA’s process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. (Id., at ¶29).' The applicant must supply information to the FDA in a PMA application, (Id., at ¶ 30). The information includes: “a) device description, b) clinical safety trials, c) methods of its product testing, d) design of the ■ device and specific manufacturing controls, e) outcome evaluation, and f) proposed labeling.” (Id.). Medtronic submitted a PMA application and the Device was approved under PMA 860004. (Id., at ¶ 23). Since the original approval, the FDA has approved many changes to the Device. (Id.). Following PMA approval, the holder must comply with certain FDA requirements and federal regulations, including those set out in 21 C.F.R. § 801, et seq., 21- C.F.R, § 803, et seq.,- 21 C.F.R. § 814, et seq., 21 C.F.R. § 806, et seq., 21 C.F.R.- § 820, et seq., and 21 U.S.C. §§ 351-52. (Id., at ¶¶31, 66). The holder must also comply with specifications imposed during the PMA process for the Device. (Id., at ¶ 66).

Starting in 2006, the FDA issued Med-tronic a series of warning letters -identifying federal manufacturing and quality control violations at their -manufacturing plants. (Id., at ¶ 32). On April 27, 2015, the U.S. Department of Justice and ,U.S. Department of Health and Human Services filed a complaint requesting a permanent injunction, leading to a court ordered consent decree “imposing a moratorium on the manufacture, sale, and distribution” of the Device. (Id.).-

The warning letters issued by the FDA identified “Significant Deviations” from Current Good Manufacturing Practices (CGMPs), codified at 21 C.F.R. 820, committed by Medtronic while manufacturing the Device. (Id., at ¶ 36). The letters outlined specific CGMPs that Medtronic failed to follow. (Id.). Due to these deviations, the Device was found to be “adulterated” or “misbranded.” (Id., at ¶¶36, 37, 39)( The FDA also notified Medtronic on multiple occasions of several manufacturing defects in the Device. (Id., at ¶¶41, 46). Since 2008, the FDA has issued nineteen Class I recall actions for the Device to address federal violations. (Id., at ¶ 48).

In addition to manufacturing issues and violations of CGMPs, the FDA notified Medtronic of the following failure to follow their PMA: •

[894]*894“Regulatory approval was received for Supplement 136 to. PMA P860004 on December 15, 2011 to change the design of SC Catheter models 8709 SC, 8731 SC, 8596 SC, and Revision Kit model 8578 to mitigate a known field, issue associated with, CAPA 1507-SC Catheter Occlusion. This design change was implemented via ECO 12-00985, date March 6, 2012, and the new revisions of Catheter models were released to the field in September 2012. However, the previous SC catheter models which do not conform to the current design have continued to be distributed and have been attributed to 60 complaints of catheter 'occlusion since September 2012.” (Id, at ¶ 47).

On April 27, 2015, the United States Department of Justice and the United States Department of Health and Human Services filed a complaint for a permanent injunction against Medtronic with respect to manufacture of the Device. (Id., at ¶ 52). The complaint alleges that Medtronic is well aware that their practices violate the Act, presumably referring to the CGMPs. (Id., at ¶ 53). The complaint alleged that Medtronic continued to violate 21 U.S.C. §§ 331(a) and (k) by introducing adulterated devices into commerce. (Id., at ¶ 56). On April 27, 2015, the Court signed a consent decree of permanent injunction preventing the manufacture and distribution of the Device. (Id., at ¶ 58). According to Plaintiff, Medtronic continues to produce, distribute, and sell the Device in violation of the.consent decree. (Id., at ¶ 60).

II. STANDARD OF REVIEW

In considering a motion to dismiss pursuant to Rule 12(b)(6), courts “accept all factual allegations as true, construe the complaint in the light most favorable to the plaintiff, and determine whether, under any reasonable reading of the. complaint, the plaintiff may be entitled to relief.” Phillips v. Cty. of Allegheny, 515 F.3d 224, 231 (3d Cir. 2008) (quoting Pinker v. Roche Holdings, Ltd.,

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Bluebook (online)
236 F. Supp. 3d 889, 2017 WL 676015, 2017 U.S. Dist. LEXIS 24313, Counsel Stack Legal Research, https://law.counselstack.com/opinion/silver-v-medtronic-inc-pamd-2017.