Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Lane v. Boston Scientific Corp.

United States District Court, N.D. Indiana, South Bend Division

September 26, 2016




         This matter is before the court on defendant Boston Scientific Corporation's (hereinafter, “Boston Scientific”) motion to dismiss plaintiffs Allie and Florence Lane's (“the Lanes”) complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). The well-known legal standard applicable is that, with the complaint's factual allegations accepted as true, dismissal for failure to state a claim pursuant to Rule 12(b)(6) is appropriate when those facts are not enough to make a right to relief plausible, meaning more than speculative. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 556 (2007); Vinson v. Vermilion Cty., Illinois, 776 F.3d 924, 928 (7th Cir. 2015). To avoid dismissal. the well-pleaded factual content must allow the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. Iqbal, 556 U.S. at 678.

         The Lanes' amended complaint (DE # 11) pleads that plaintiff Allie Lane (“Allie”) had a medical device surgically implanted into his back called a Precision Plus ™ Implantable Pulse model #SC-1110-02, with serial #235086. The device was designed and manufactured by Boston Scientific, and intended to relieve back pain by providing electrical pulses. The device is what is known as a Class III Medical Device under the federal Food, Drug, and Cosmetic Act, about which a bit more will be said shortly.

         Not long after the operation Allie began experiencing severe shocks, which he understandably believed were being caused by some problem with the device, and he informed Boston Scientific of the issue. Approximately five months after the device was implanted, representatives of Boston Scientific determined that the battery in the device was discharging and depleting at a faster rate than expected, and that Boston Scientific would replace it under warranty. The surgeon who implanted the device indicated that it had malfunctioned and should be removed.[1]

         The essence of Boston Scientific's argument is that the Lanes' claims are preempted by federal law because plaintiffs have failed to plead enough facts to show that a plausible non-preempted claim exists. Because the heart of the parties' disagreement is limited to one issue, the court need not engage in a lengthy reiteration of Boston Scientific's entire argument or of the issue of federal preemption. It will suffice to say that Class III Medical Devices, because they are extremely important to human health but also have a high potential risk for causing illness or injury, are subject to extensive federal regulation including a premarket approval process. Once a device is approved, its manufacturer gains the benefit of an express preemption of liability claims:

[N]o 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 device under this chapter.

21 U.S.C. § 360k(a).

         This provision does not, however, preempt a so-called “parallel” claim, which is a state common-law claim based on a violation of the federal laws and regulations applicable to the medical device. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996); Bausch v. Stryker Corp., 630 F.3d 546, 552-53 (7th Cir. 2010). In Bausch, which involved a hip-replacement device, the plaintiff pleaded that the defendant had violated federal regulatory standards applicable to the device causing an unreasonably dangerous device to be implanted in plaintiff, and that prior to plaintiff's surgery the defendant knew or should have known the device was defective. Bausch, 630 F.3d at 558-59. The Seventh Circuit reversed the district court's dismissal of plaintiff's complaint, finding no “fatal defect in the original complaint that would have justified its dismissal.” Id. at 559.

         The Lanes argue that, just as in Bausch, they have adequately pleaded a parallel state claim. Their amended complaint alleges at paragraph 20 that the device implanted in Allie was “manufactured and distributed in violation of Federal law, ” more specifically:

17. That the actions of the defendant are violative of . . . Federal law particularly 21 U.S.C. §360 et. seq. as amended and the regulations set forth by the Federal Food and Drug Administration including but not limited to the Quality System Regulation and Current Good Manufacturing practices 21 C.F.R. §820.1(a)(1), and other mandates as set forth under Federal law;
18. That the defendant's failure to comply with the applicable provisions set forth above render the spinal cord stimulator adulterated as set forth under Section 501 (h) of the Act;
19. That the aforementioned product failed to comply with Section 820.90 and 21 C.F.R. Sections 820.72 - 820.90, and the product which had been implanted into Plaintiff Allie Lane failed to comply with product specifications as approved by the FDA through the pre-market approval process.

(DE # 11 at 3-4.)

         Boston Scientific argues that these allegations are nothing more than legal conclusions and fall short ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.