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.

Cavender v. Medtronic, Inc.

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

April 14, 2017

MEDTRONIC, INC., Defendant.


          William C. Lee, Judge United States District Court Northern District of Indiana

         This matter is before the Court on the motion to dismiss and memorandum in support filed by Defendant Medtronic, Inc. (docket entries 21 and 22). Plaintiff Miriam Cavender filed a response in opposition (DE 23) and Medtronic filed a reply (DE 26). For the reasons discussed in this order, the motion is DENIED. The Plaintiff's claims for negligence, negligence per se, and breach of express and implied warranties are SUBSUMED by the Indiana Product Liability Act claim and merged into a cause of action under that statute for manufacturing defect, design defect and failure to warn; the motion is DENIED as to the issue of federal preemption. This case will proceed on Plaintiff Miriam Cavender's cause of action under the IPLA.


         Plaintiff Miriam Cavender had health problems that required surgical implant of a cardiac defibrillator. Her doctors implanted a defibrillator that was manufactured by Medtronic. Cavender alleged that the product “malfunctioned causing . . . Cavender to become [severely] injured as a direct and proximate result of the defective product and hazardous condition of said product.” Original Complaint (DE 4), p. 2.[1] She filed this lawsuit on March 24, 2016, asserting strict product liability, breach of warranty, and negligence claims against Medtronic. Id. Medtronic filed a motion to dismiss Cavender's original Complaint in its entirety on May 31, 2016 (DE 9). The Court issued an Opinion and Order (DE 19), Cavender v. Medtronic, Inc., 2016 WL 6599744 (N.D.Ind. Nov. 8, 2016), concluding that “Cavender's complaint is woefully insufficient under the Rule 12(b)(6) pleading standard and dismissal is warranted[.]” (id., p. 4) but that Cavender should be afforded the opportunity to file an amended complaint “in which she shall plead her product liability claims pursuant to the IPLA (to include only claims for manufacturing defect, design defect, or failure to warn) and present facts and clearly articulated legal theories to support any additional claims she contends are valid (be they breach of warranty or violation of FDA or other federal regulation).” Id., p. 23. The Court then ruled as follows:

1) Plaintiff Miriam Cavender's common law negligence claim is DISMISSED WITH PREJUDICE;
2) Plaintiff's product liability claims and UCC breach of warranty claims are DISMISSED WITHOUT PREJUDICE; and
3) Plaintiff is ordered to file an amended complaint within 30 days of the date of this Opinion and Order, in which she shall plead her product liability claims pursuant to the Indiana Product Liability Act (“IPLA”) (to include only claims for manufacturing defect, design defect, or failure to warn), and present facts and clearly articulated legal theories to support any additional claims she contends are valid (be they breach of warranty or violation of FDA regulations). Medtronic is directed to file an answer to plaintiff's amended complaint (or a second motion to dismiss should Defendant conclude that one is necessary) within 30 days from the date of the filing of Plaintiff's amended complaint.

Court's Opinion and Order (DE 19); Cavender, 2016 WL 6599744. Cavender filed her Amended Complaint on December 7, 2016 (DE 20). The Amended Complaint, according to Cavender, presents her claims properly and corrects the defects in her original Complaint that the Court identified in its previous order. Not so, contends Medtronic, which filed its renewed motion to dismiss the Amended Complaint. Medtronic contends that the arguments it presented in favor of dismissal the first time are still valid and that Cavender's Amended Complaint, like her original one, fails to state a valid claim and must be dismissed pursuant to Fed.R.Civ.P. 12(b)(6). Medtronic states that “[t]his Court's dismissal order gave Plaintiff a clear manDated: present plausible facts and clearly articulated legal theories. The Amended Complaint . . . does neither.” Defendant's Memorandum in Support of Motion to Dismiss (DE 22), p. 1.


         Rule 12(b)(6) allows a defendant to move to dismiss a complaint that has fails to “state a claim upon which relief can be granted.” Fed.R.Civ.P. 12(b)(6). When deciding a motion to dismiss under Rule 12(b)(6), the court accepts as true all factual allegations in the complaint and draws all inferences in favor of the plaintiff. Bielanski v. County of Kane, 550 F.3d 632, 633 (7th Cir. 2008). The complaint must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). In Bell Atlantic Corp. v. Twombly, the Supreme Court explained that the complaint must allege facts that are “enough to raise a right to relief above the speculative level.” Twombly, 550 U.S. 544, 555 (2007). Stated differently, the complaint must include “enough facts to state a claim to relief that is plausible on its face.” Hecker v. Deere & Co., 556 F.3d 575, 580 (7th Cir. 2009) (internal citation and quotation marks omitted). To be facially plausible, the complaint must allow “the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 556).


         Even though the Court determined that it could not resolve the issues raised in Medtronic's first motion to dismiss since Cavender's original Complaint was too vague, the Court proceeded to “address the legal arguments presented in the motion to dismiss, even though most of them cannot be resolved at this point, in order to provide what the Court hopes will be a framework for streamlining the presentation of Cavender's claims, whatever they may be, and Medtronic's defenses.” Cavender, 2017 WL 6599744 at * 2. In response to that order, Cavender filed a 31-page Amended Complaint (her original Complaint consisted of four pages) in which she asserts four claims against Medtronic. Cavender's first claim, which she titled “First Claim for Relief (Product Liability), ” seeks relief under the Indiana Products Liability Act, based on allegations of strict liability, manufacturing defect, design defect, and failure to warn. Amended Complaint, pp. 23-25. Her “Second Claim for Relief (Breach of Implied and Express Warranties)” asserts claims under the Uniform Commercial Code. Id., pp. 25-27. Her “Third Claim for Relief (Negligence)” asserts an Indiana common law negligence claim (id., pp. 27-28). And her “Fourth Claim for Relief (Negligence per se)” includes a claim for negligence per se that she contends is distinct from her traditional negligence claim because it is based on alleged violations of federal regulations (id., pp. 28-29).

         Medtronic's present motion to dismiss raises exactly the same issues and incorporates the same arguments as its original motion, and Cavender's Amended Complaint and her brief in opposition to the motion do likewise. The only thing that has changed is that Cavender filed a much longer, more detailed complaint the second time around. The Amended Complaint still includes all the same claims Cavender attempted to present in her original Complaint, although they are dressed in much more elaborate apparel (as Medtronic is quick to point out). In its original motion to dismiss, Medtronic characterized Cavender's original Complaint as “a scattershot” of claims-a characterization this Court concluded was accurate. Cavender, 2017 WL 6599744 at *3. Cavender's Amended Complaint does not take a similar scattershot approach, seeing as it organizes her claims neatly and provides an abundance of specific factual allegations that were conspicuously (even fatally) absent from her first attempt. That said, the Amended Complaint still takes the proverbial “kitchen sink” or “throw it all against the wall” approach. This is evidenced by the fact that the Amended Complaint still includes claims that this Court already dismissed the first time around, as well as claims with doubtful legal foundation (as in her breach of warranty claims), all of which were discussed at some length in the Court's previous order. On the other hand, Cavender's Amended Complaint sets forth her claims with much more specificity, both in terms of factual assertions and legal theories, which is a huge improvement over her original Complaint, and so the Court can turn to assessing the sufficiency of those claims in light of the motion to dismiss.

         Before turning to the dispositive issues the Court must clear away some dust. In its memorandum in support of its motion, Medtronic begins by attacking Cavender's Amended Complaint for two reasons: first, because it “now alleges that a different Medtronic device, the Sprint Fidelis 6949 Lead, injured her[, ]” whereas her original Complaint stated that her injuries were caused by a Medtronic “Viva XT CRT-D Defibrillator[, ]” (Defendant's Memorandum, pp. 2-3); and second, because it “mirrors the Master Consolidated Complaint relating to the Leads that has already been fully litigated and dismissed-with prejudice at the pleading stage.” Id., p. 4 (citing In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F.Supp.2d 1147 (D.Minn. 2009))[2] (emphasis in original). Medtronic attached to its memorandum a copy of the Master Complaint filed in the multidistrict Medtronic Leads litigation (more on that below) and notes that Cavender's Amended Complaint is a “copy and paste” version of it. See, e.g., Defendant's Memorandum, pp. 4-5 (comparing language in Master Complaint to language in Cavender's Amended Complaint). Both of Medtronic's contentions are correct but ultimately not relevant. They are included for the purpose of casting aspersions on Cavender's Amended Complaint by drawing attention to what this Court has already referred to as Cavender's elaborate window dressing of her claims. In other words, while the claims contained in her original Complaint were barely discernible, they now jump vividly off the page in full regalia, all because they are clothed in language taken-largely verbatim-from another complaint filed against Medtronic that was summarily dismissed by another district court eight years ago. Cavender responds to these contentions by arguing “so what?” She explains that she now alleges that her injuries were caused by a different Medtronic device simply because she “found that the product alleged in the Original Complaint, the Viva XT CRT-D Defibrillator, was in error because it did not encompass the Leads (the wires that are part of the defibrillator) and Plaintiff's claims relate more specifically to the Leads.” Plaintiff's Response, p. 3. Cavender states that she “amended her Complaint to allege the specific product[, ]” that “[b]ecause the statute of limitation has not run, the correction does not prejudice Medtronic[, ]” and “because Plaintiff was not part of the MDL actions, the Eighth Circuit decisions do not prevent Plaintiff from bringing her claims.” Id. Cavender admits that her Amended Complaint names a different (or at least more specific) Medtronic product and that it mirrors the Master Complaint from the Medtronic Leads litigation. It does the latter, Cavender maintains, because “many of the same factual assertions [in] the MDL Complaint . . . apply to Plaintiff's case and claims.” Id.[3] But these arguments about the language in Cavender's Amended Complaint threaten to distract from the overarching issue here, which is the sufficiency of Cavender's allegations, as presented in her Amended Complaint (even if it is not an entirely original piece of prose), under the prevailing Rule 12(b)(6) standard of review. Medtronic continues to insist that the emperor has no clothes and that all of Cavender's claims, notwithstanding their new attire, should be dismissed for the same reasons presented in the company's original motion. Those reasons, again, are that Cavender's negligence claims are not cognizable, her breach of warranty claims “still sound in tort[]” and “are therefore still subsumed by the IPLA[, ]” her claims “are based on nothing more than generic allegations . . ., ” and that all her claims are preempted by the federal Medical Device Amendments. Defendant's Reply, pp. 1-2.

         I. Applicable law.

         Resolution of the issues raised by Medtronic's motion to dismiss requires application of state and federal statutes and an understanding of the interplay between them. Those statutes, of course, are the Indiana Product Liability Act, I.C. § 34-20-1-1, et seq., and the Medical Device Amendments to the Food, Drug and Cosmetics Act, 21 U.S.C. § 360c et seq.

         A. IPLA subsumption.

         The IPLA expressly states that “[t]his [Act] governs all actions that are: (1) brought by a user or consumer; (2) against a manufacturer or seller; and (3) for physical harm caused by a product; regardless of the substantive legal theory or theories upon which the action is brought.” Ind. Code § 34-20-1-1. This means that the “IPLA subsumes both strict liability and negligence actions[.]” Lyons v. Leatt Corp., 2015 WL 7016469, at *2-3 (N.D.Ind. Nov. 10, 2015) (citing Gardner v. Tristar Sporting Arms, Ltd., 2010 WL 3724190, at *2 (S.D.Ind. Sept. 15, 2010)). A plaintiff who alleges that a product was defective due to a manufacturing defect, design defect, or failure to warn, states claims “that are all recognized under IPLA.” Id. (citing In re Lawrence W. Inlow Accident Litig., 2002 WL 970403, at *12 (S.D.Ind. Apr.16, 2002)) (stating that IPLA governs all actions “for physical harm brought by a consumer against a manufacturer or seller of a product, regardless of the substantive legal theory”). Id. “A product may be defective within the meaning of IPLA because of a manufacturing flaw, a design defect, or a failure to warn of the dangers associated with the product's use.” Id. (citing Cook v. Ford Motor Co., 913 N.E.2d 311, 319 (Ind.Ct.App. 2009)). “Under the IPLA, a strict liability standard applies to manufacturing defect claims . . . whereas a negligence standard applies to design defect and failure to warn claims.” Gardner, 2010 WL 3724190, at *2 (citing Myers v. Briggs & Stratton Corp., 2010 WL 1579676, at *3 (S.D.Ind. April 16, 2010); Burt v. Makita USA, Inc., 212 F.Supp.2d 893, 897 (N.D.Ind. 2002)).

         In Lyons, the plaintiff brought a product liability action and included in his complaint claims for negligence, gross negligence, strict liability, and breach of warranty. This Court (Judge Springmann) held as follows:

While the Defendant is correct that IPLA subsumes both strict liability and negligence actions, see Gardner . . . , 2010 WL 3724190, at *2 . . ., dismissal is improper here. First, when viewing the allegations in a light most favorable to the non-movant, the Plaintiff has satisfied the general pleading standards by stating a plausible claim for relief-namely, that he suffered physical harm due to the Defendant's defective product. Accordingly, the Plaintiff's strict liability and negligence claims are properly treated as merged claims under IPLA.

Lyons, 2015 WL 7016469, at *2-3 (citing Atkinson v. P & G-Clairol, Inc., 813 F.Supp.2d 1021, 1024 (N.D.Ind. 2011); Cincinnati Ins. Cos. v. Hamilton Beach/Proctor-Silex, Inc., 2006 WL 299064, at *3 (N.D.Ind. Feb.7, 2006); Bourne v. Marty Gilman, Inc., 2005 WL 1703201, at *3 n. 2 (S.D.Ind. July 20, 2005)). Medtronic argues that the law is clear and well established, and that Cavender's claims-whether based on a negligence theory, strict liability theory, or breach of warranty theory-are all subsumed by the IPLA, which is her only vehicle for bringing a claim for personal injuries caused by an allegedly defective product. As this Court noted in Atkinson, “it is . . . proper for [plaintiff's] claims of strict liability and negligence to be merged into one claim under the IPLA. . . . Therefore, [plaintiff's] claims of negligence and strict liability . . . will be incorporated to form one products liability claim under the IPLA.” Atkinson, 813 F.Supp.2d at 1024 (citing Am. Int'l Ins. Co. v. Gastite, 2009 WL 1383277 at *4 (S.D.Ind. May 14, 2009); Bourne, 2005 WL 1703201 *3 at n. 2; Henderson v. Freightliner, LLC, 2005 WL 775929, at *3 (S.D.Ind. Mar. 24, 2005); Tungate v. Bridgestone Corp., 2004 WL 771191, at *6 (S.D.Ind. Mar. 26, 2004)).

         In the present case, Cavender has unquestionably alleged that she suffered personal injuries proximately caused by Medtronic's allegedly defective product. She was admonished by the Court in its previous order for not presenting these claims as an action under the IPLA. In her Amended Complaint she pleads exactly such an action, but also includes a negligence claim and attempts to add a negligence per se claim, apparently as independent creatures separate from her IPLA claim. But the law regarding IPLA subsumption is clear and Cavender's claims for personal injury, whether based on a theory of strict liability, negligence, or negligence per se, (or even breach of warranty, as discussed below) are subsumed by the IPLA and merged into an action for damages pursuant to that statute.

         1. Common law negligence claim.

         Cavender's claims for negligence and negligence per se should not have been included in her Amended Complaint. Cavender concedes that her “third claim for relief, ” i.e., her common law negligence claim, “was mistakenly included in Cavender's Amended Complaint.” Plaintiff's Response, p. 4. Cavender admits that “this Court stated in its prior Order [that the] IPLA subsumes negligence claims made under state law and this Court's prior dismissal with prejudice applies to Count III of the Amended Complaint.” Id. Indeed, the Court dismissed this claim in its previous order. While it is difficult to discern any practical difference between dismissal of this claim and its merger or subsumption into the IPLA, courts in this circuit have held routinely that merging claims into a single IPLA action (whether it is based on theories of manufacturing defect, design defect, failure to warn, or a combination thereof) is preferable and more proper than outright dismissal. “Plaintiffs' common law claims and breach of implied warranty claims are in effect superseded by or merged into their statutory product liability claims, so the case will proceed on only the statutory claims.” Lyons, 2015 WL 7016469, at *3. “Because Counts I-IV of the Plaintiff's Complaint are properly treated as merged under IPLA, the Defendant's request to dismiss such counts is denied.” Henderson, 2005 WL 775929, at *1. “[The] motions for summary judgment are denied with the qualification that plaintiff's common law and breach of implied warranty claims are superseded by their statutory claims. The case will proceed to trial on the statutory product liability claims only.” Id. at * 18. This Court, then, will follow suit and hold that Cavender's common law negligence claim is subsumed and merged into her cause of action under the IPLA (notwithstanding the fact that a negligence claim, in and of itself, is not cognizable under that statute).

         2. Negligence per se claim.

         While Cavender concedes that she cannot assert a common law negligence claim, she does not offer the same concession as to her claim for negligence per se, arguing that it is a valid claim because it “alleges negligence per se for violations of the Federal laws and regulations applicable to the [defibrillator].” Plaintiff's Response, p. 3. She further claims that Medtronic's alleged “violations of the Federal requirements remove any immunity granted to Medtronic.” Id. In other words, Cavender claims that her common law claim for negligence per se is somehow transformed into a claim that escapes IPLA subsumption because it is founded on allegations that Medtronic violated federal regulations. Medtronic argues that “[t]he fact that Plaintiff asserts her claim here is based on federal law violations does not mean negligence per se is not a common law negligence theory. . . . Negligence-per se or otherwise-is not a federal tort claim, but rather a common law negligence claim.” Defendant's Reply, p.1. Cavender's argument that such a claim is valid because it is based on violations of federal regulations “creates a false distinction[]” between a common law negligence claim and a federal tort claim. Id., p. 3 (citing Moore v. Hamilton Se. Sch. Dist., 2013 WL 4607228, at *10 (S.D.Ind. Aug. 29, 2013)) (“Negligence per se under state tort law can be premised on the violation of a federal statute, with the statute providing the standard of conduct and state common law furnishing the other elements of the tort.”) (italics added). Stated differently, Medtronic is arguing that Cavender is trying to mask a state law negligence claim as something else-a sort of hybrid state law/federal law claim that is not subsumed by the IPLA (which she concedes does subsume her other negligence claim). Medtronic says it must be dismissed because Cavender's new negligence per se claim is just another way of alleging any common law negligence claim, and because this Court, in its prior Opinion and Order, held that “‘[o]n this issue Medtronic is correct-the IPLA subsumes Cavender's common law negligence claim. For this reason, any common law negligence claim Cavender includes in her complaint must be, and is hereby dismissed with prejudice.'” Defendant's Memorandum in Support, p. 6 (quoting this Court's Opinion and Order (DE 19), p. 14) (boldface and italics in memorandum).[4] Just because Cavender claims she is basing her negligence per se claim on alleged violations of federal regulations does not magically transform a common law negligence ...

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.