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Cavender v. Medtronic, Inc.

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

November 8, 2016

MEDTRONIC, INC., Defendant.


          William C. Lee, Judge

         This matter is before the court on the motion to dismiss and memorandum in support filed by Defendant Medtronic, Inc. (docket entries 9 and 10). Plaintiff Miriam Cavender filed a response in opposition (DE 15) and Medtronic filed a reply (DE 18). For the reasons discussed in this order, the court holds as follows:

1) Plaintiff Miriam Cavender's common law negligence claim is DISMISSED WITH PREJUDICE;
2) Plaintiffs 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 regulation). Medtronic is directed to file an answer to plaintiffs 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.


         Miriam Cavender had health problems that required surgical implant of a cardiac defibrillator. On March 16, 2015, doctors implanted a Viva XT CRT-D Defibrillator, which was manufactured by Medtronics. Cavender alleges 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." Complaint (DE 4), p. 2. She filed this lawsuit on March 24, 2016, apparently asserting product liability, breach of warranty, and negligence claims against Medtronic. Id.[1] In Count I of her Complaint, Cavender alleges that Medtronic "is strictly liable to . . . Cavender[] for designing, manufacturing and placing into the stream of commerce the said implant-able [sic] defibrillator which was unreasonably dangerous for its reasonably foreseeable uses." Id. She contends that "[a]s a direct and proximate result of the strict liability, breach of duties . . . [of] strict liability and breach of warranty . . . [Cavender] sustained personal injuries . . . ." Id., p. 3. Also in Count I, Cavender contends that Medtronic is liable "with respect to its failure to warn or adequately warn or instruct in the safe use of said implant-able [sic] defibrillator." Id. In Count II of her Complaint, Cavender asserts a state law negligence claim against Medtronic. Id., pp. 3-4.

         Medtronic contends that Cavender's claims must be dismissed under Fed.R.Civ.P. 12(b)(6) for failure to state a claim. Motion to Dismiss, p. 1. More specifically, Medtronic states that Cavender's claims should be dismissed "in whole or in part, under the Indiana Product Liability Act ('IPLA')[, ]" that her complaint fails to state any valid breach of warranty claim, and that her "tort claims are preempted under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. . . 21 U.S.C. § 360k(a)." Defendant's Memorandum, pp.7-8.[2]


         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, 127 S.Ct. 1955, 167 L.Ed.2d 929 (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, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (citing Twombly, 550 U.S. at 556).


         There are two things about the pending motion to dismiss that are obvious from the outset. First, Cavender's complaint is woefully insufficient under the Rule 12(b)(6) pleading standard and dismissal is warranted. That said, Medtronic's motion jumps the gun a bit given that it raises substantive legal defensives (some possibly dispositive) to claims that may not even exist in Cavender's complaint. Some of the issues raised by Medtronic are better suited for presentation in a motion for summary judgment, but that can't happen until Cavender cleans up her complaint enough that the precise causes of action she is asserting-and the facts on which those claims are based-are clear. The court cannot resolve many of the substantive defenses raised by Medtronic at this point since Cavender's complaint, as it stands now, fails to state a valid claim in the first place. The path forward for this case is for Cavender's claims to be dismissed, for her to file an amended complaint, and for Medtronic to be in a position to file an answer to the complaint. All of that said, the court will 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.

         Medtronic's arguments for dismissal are summarized in a few paragraphs in its memorandum. Medtronic begins by attacking the factual sufficiency of Cavender's complaint:

Plaintiffs complaint is only three pages and consists of two counts. Within the two counts, the complaint asserts a scattershot of common law causes of action, including strict liability based on a manufacturing defect, a design defect, and a failure to warn; breach of express and implied warranties; and negligence based on a manufacturing defect, a design defect, and a failure to warn. Despite these many causes of action, the complaint contains few if any factual allegations. There are, indeed, only three facts alleged in the entire complaint: (1) Medtronic designed, manufactured, and put the Defibrillator into the stream of commerce; (2) the Defibrillator supposedly "malfunctioned" in an unspecified way; [and] (3) . . . the Defibrillator "[severely] injured Plaintiff in some unspecified way.

Id., p. 7. Medtronic then argues that Cavender's claims "should be dismissed with prejudice . . . for three reasons. First, Indiana law (which governs this case) does not provide for any common law causes of action in personal injury product liability cases. Rather, Plaintiffs only right to relief would be under the [IPLA], which Plaintiff has failed to cite or use as the basis for her Complaint. . . . Second, Plaintiff has failed to plead facts to support any theories of liability whether under common law or under the IPLA. . . . Third, all of Plaintiff s tort claims are preempted under the [MDA]." Id., pp. 7-8.

         Cavender's argument in opposition to the motion is stated even more succinctly. She argues that this court should "deny the motion to dismiss on all bases under the guidance of the recent Seventh Circuit case Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), which addresses all the arguments posed by Medtronic." Plaintiffs Response, p. 1. That sentence is very intriguing, given that it implies that one case will inform the resolution of the present motion; and it turns out that the Bausch case is indeed applicable and helpful in many respects, although resolution of the issues presented in Medtronic's motion is not as simple as applying the holding of Bausch, which Medtronic claims Cavender misapplies anyway.

         I. Indiana Product Liability Act preemption.

         Medtronic argues that "the Court should dismiss the entire complaint because it is not brought pursuant to the IPLA, or alternatively, dismiss all claims not predicated on a manufacturing defect, design defect, or failure to warn." Defendant's Memorandum, p. 10. 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. That language is pretty darn clear and would seem to be the end of the inquiry here since, as Medtronic points out, Cavender's complaint does not so much as mention the IPLA. Medtronic's characterization of Cavender's complaint as "a scattershot of. . . causes of action" is accurate. Cavender includes in almost every paragraph of her complaint phrases like "stream of commerce, " "defective product, " "use and purpose intended, " "inherently and unreasonably dangerous, " "express and implied warranties, " "reasonably foreseeable uses, " "failure to warn, " "strict liability, " and "negligence." Complaint, pp. 1-4. These terms, most of which are commonly associated with product liability actions, pop up like weeds throughout Cavender's complaint but lack any factual context. Put another way, Cavender uses language in her complaint that implies (or from which the court and Medtronic infer) she is asserting several different product liability claims (defective design, failure to warn, and so forth), some type of breach of warranty claim, and a common law negligence claim, but her complaint states her causes of action in a very vague and cursory manner. In fact, near the end of her complaint Cavender summarizes her claims by stating that "[a]s a direct and proximate result of the negligence and breach of duties of [Medtronic], including but not limited to negligence, . . . Cavender[] sustained personal injuries . . . ." (Complaint, p. 4), an awkward and open-ended sentence that adds to the confusing presentation of her claims. It's not that Cavender's complaint is insufficient just because it lacks express reference to the IPLA or the MDA or some common law liability theory. Rather, as Medtronic insists, it is insufficient because it lacks context from which the Defendant and the court can ascertain the precise nature-or more specifically the precise legal and factual bases-of Cavender's claims. Medtronic emphasizes that "there are no common law product liability claims for personal injuries under Indiana law[, ]" since '"the IPLA provides for a single cause of action, regardless of the plaintiffs substantive legal theories[.]'" Defendant's Memorandum, p. 11 (citations omitted). Therefore, argues Medtronic, Cavender's "complaint is thus without a valid legal basis and . . . should be dismissed." Id. (citation omitted). Medtronic then sharpens its point a bit by stating that "[i]f the Court excuses [Cavender's] failure to offer the proper statutory basis [for her claims], the Court must still dismiss all of the personal injury claims not based on a manufacturing defect, design defect, or failure to warn. The IPLA recognizes only those three possible theories of recovery." Id. (citations omitted).

         As stated, Cavender claims in her response brief that the Bausch case precludes dismissal of her complaint and that it "addresses all the arguments posed by Medtronic." Cavender insists that her complaint "adequately recites the theories of recovery under the Indiana Product Liability Act." Plaintiffs Response, p. 2 (italics added). She also argues that her complaint "employs the language of Chapter 2 of the IPLA[.]" Id., p. 3 (italics added). Cavender concludes this argument by proclaiming that "[s]ubstantively, the Complaint properly allege[s] facts to bring a product liability claim under the IPLA." Id., p. 4 (citing Bausch, 630 F.3d at 562) (italics added). So, Cavender's argument in opposition to the motion to dismiss is this: her complaint states valid product liability claims under the IPLA even though it doesn't cite the IPLA as the legal basis for those claims, and the Bausch case supports her position. (She presents a second argument-related to her breach of warranty claims, which she says have an independent legal basis in the UCC-that the court will address below.)

         In Bausch, the plaintiff brought suit against Stryker Corporation, the manufacturer of a hip replacement device that was implanted in Ms. Bausch, asserting common law negligence claims (under Illinois state law) and product liability claims. Stryker moved to dismiss Bausch's complaint under Rule 12(b)(6), arguing that her common law claims were preempted by federal law (i.e., the MDA) and that her complaint failed to meet the Rule 12(b)(6) pleading threshold (or the Iqbal/Twombly threshold, if one prefers) since she failed to allege sufficient facts to support any claim against Stryker. The district court granted Stryker's motion to dismiss (and also denied Bausch's request for leave to amend her complaint, but more on that point later) but the Seventh Circuit reversed, concluding that while Bausch's complaint was admittedly thin on factual allegations, the facts pled were sufficient to meet the pleading standard under Rule 12(b)(6). The facts contained in the complaint included the following:

1) Stryker Corporation manufactured the hip replacement product that was implanted in Bausch;
2) the device was "a Class III medical device subject to the authority of the ...

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