Opinion ID: 181671
Heading Depth: 1
Heading Rank: 2

Heading: Pleading Parallel Medical Device Claims

Text: Beginning from the premise that federal law does not preempt parallel claims under state law based on a medical device manufacturer's violation of federal law, we turn to the problem of how difficult it is to plead such a claim sufficiently to survive a motion to dismiss for failure to state a claim under Rule 12(b)(6) of the Federal Rules of Civil Procedure. There are no special pleading requirements for product liability claims in general, or for Class III medical device claims in particular. The federal standard of notice pleading applies, so long as the plaintiff alleges facts sufficient to meet the new plausibility standard applied in Iqbal and Twombly. See Ashcroft v. Iqbal, ___ U.S. ___, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (to survive a motion to dismiss, the complaint must contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face'.... A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.), quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 556, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). In applying that standard to claims for defective manufacture of a medical device in violation of federal law, moreover, district courts must keep in mind that much of the product-specific information about manufacturing needed to investigate such a claim fully is kept confidential by federal law. Formal discovery is necessary before a plaintiff can fairly be expected to provide a detailed statement of the specific bases for her claim. Accordingly, the district court erred in this case by dismissing plaintiff's original complaint and by denying her leave to amend her complaint.
Bausch's original complaint asserted claims under Illinois law for strict product liability and negligence. Because the appeal is from the grant of a motion to dismiss under Rule 12(b)(6), we must accept as true Bausch's allegations. See, e.g., Bonte v. U.S. Bank, N.A., 624 F.3d 461, 462 (7th Cir.2010). According to the original complaint, the defendants manufacture the Trident brand ceramic-on-ceramic hip replacement system. It is a Class III medical device subject to the authority of the FDA. Plaintiff had right total hip replacement surgery on March 21, 2007, in which a Trident device was implanted. The original complaint alleged that the Trident product was unreasonably dangerous, causing plaintiff to suffer an unstable right hip, pain, suffering, disability, and what is euphemistically called revision surgery in Bausch's case a second major operation in which the Trident product was removed and replaced with a different product. The original complaint also alleged facts indicating that defendants knew, or at least should have known, before plaintiff's original surgery that the Trident implanted in her was defective. According to the original complaint, by early 2005, the defendants received complaints that the Trident was failing after it was implanted. Defendants recalled a batch of Trident components in March 2006 because of dimensional anomalies. The FDA conducted an inspection at the defendants' Ireland manufacturing facility from October 31 to November 3, 2006, and, following the inspection, informed the defendants of numerous deficiencies [in the Trident] manufacturing and inspection processes. Six days before plaintiff Bausch's surgery, after several months of inadequate response to the FDA findings by the defendants, the FDA issued a letter to defendants on March 15, 2007 warning that the Trident was adulterated due to manufacturing methods ... not in conformity with industry and regulatory standards. A device, bearing the same catalogue number as the device allegedly not in compliance with regulations, was then implanted in Bausch's body the next week. The device in Bausch's body failed and the same device was later recalled. The original complaint served the purposes of Rule 8 of giving the defendants fair notice of the nature of the claim against them and of stating a claim for relief that was plausible on its face as required by Iqbal and Twombly. In deciding whether a complaint can survive a motion to dismiss, we have consistently said: As a general rule ... notice pleading remains the standard. Windy City Metal Fabricators & Supply, Inc. v. CIT Tech. Financing Services, 536 F.3d 663, 667 (7th Cir.2008). Pursuant to Rule 8, pleading is meant to `focus litigation on the merits of a claim' rather than on technicalities that might keep plaintiffs out of court. Brooks v. Ross, 578 F.3d 574, 580 (7th Cir.2009), quoting Swierkiewicz v. Sorema N.A., 534 U.S. 506, 514, 122 S.Ct. 992, 152 L.Ed.2d 1 (2002). We give the plaintiff the benefit of imagination, so long as the hypotheses are consistent with the complaint. Bissessur v. Indiana Univ. Bd. of Trs., 581 F.3d 599, 603 (7th Cir.2009), quoting Sanjuan v. American Bd. of Psychiatry and Neurology, Inc., 40 F.3d 247, 251 (7th Cir.1994). Together, these rules ensure that claims are determined on their merits rather than on pleading technicalities. Christensen v. County of Boone, 483 F.3d 454, 458 (7th Cir.2007). We do not see a fatal defect in the original complaint that would have justified its dismissal, let alone entry of a final judgment dismissing the action with prejudice. The only significant issue we see with the original complaint is that it alleges not only violations of regulatory standards, but also violations of industry standards. To the extent that the claims are based upon violations of industry standards that are different from or in addition to the federal regulatory standards (which have the force of law), those claims would be preempted under section 360k. Yet complaints that combine legally valid and invalid claims are common. When a complaint asserts claims that are legally valid and those that are not, the correct judicial response is not to dismiss the complaint, let alone with prejudice. It's not even necessary to require a plaintiff to file a cleaner amended complaint. The case may proceed under the original complaint, with the understanding, provided by the court if necessary, as to the proper scope of claims that can survive the legal challenge. Defendants object that the original complaint does not specify the precise defect or the specific federal regulatory requirements that were allegedly violated. Although the complaint would be stronger with such detail, we do not believe the absence of those details shows a failure to comply with Rule 8 of the Federal Rules of Civil Procedure or can support a dismissal under Rule 12(b)(6). First, Rule 9(b) does not impose any special requirement that such a claim be pled with particularity, as it does for fraud claims, for example. Second, the victim of a genuinely defective productfor example, an air bag that fails to inflate in a serious automobile collision, or an implantable cardiac defibrillator that delivers powerful electric shocks to a heart that is functioning normallymay not be able to determine without discovery and further investigation whether the problem is a design problem or a manufacturing problem. It is common, for example, for injured plaintiffs to plead both defective manufacture and defective design and to pursue discovery on both theories, as occurred in Riegel itself, for example. 552 U.S. at 320-21, 128 S.Ct. 999; accord, e.g., Gardner v. Tristar Sporting Arms, Ltd., 2010 WL 3724190 (S.D.Ind. Sept. 15, 2010) (granting summary judgment for defendant on design defect claim but denying summary judgment on manufacturing defect claim); Show v. Ford Motor Co., 697 F.Supp.2d 975 (N.D.Ill.2010) (granting summary judgment for defendant on both design defect and manufacturing defect claims); Gaskin v. Sharp Electronics Corp., 2007 WL 2819660 (N.D.Ind. Sept. 26, 2007) (granting summary judgment for defendant on design defect claim but denying summary judgment on manufacturing defect claim); In re Air Crash Disaster at Sioux City, Iowa, 781 F.Supp. 1307 (N.D.Ill.1991) (in airliner crash case, denying motions for summary judgment for defendants on plaintiffs' claims of manufacturing and design defects against different defendants); see generally, e.g., Bennett v. Schmidt, 153 F.3d 516, 519 (7th Cir.1998) (Litigants are entitled to discovery before being put to their proof). Third, in the context of Class III medical devices, much of the critical information is kept confidential as a matter of federal law. The specifications of the FDA's premarket approval documents, for example, are confidential, and there is no public access to complete versions of these documents. An injured patient cannot gain access to that information without discovery. See 21 C.F.R. § 814.9; Medtronic Leads, 623 F.3d at 1211, n. 7 (Melloy, J., dissenting). If the problem turns out to be a design feature that the FDA approved, section 360k will protect the manufacturer. Riegel, 552 U.S. at 330, 128 S.Ct. 999. But if the problem turns out to be a failure to comply with the FDA's legally enforceable conditions for approval of the device, section 360k will not protect the manufacturer. As noted earlier, one of the only two other circuits to examine the application of Riegel to medical device preemption is the Eighth Circuit in Medtronic Leads, where the majority concluded that the plaintiffs had waived discovery early in the proceedings. The majority upheld the district court's refusal to grant the plaintiffs discovery to respond to the motion to dismiss. There the court acknowledged the plaintiffs' argument that the district court held them to an impossible pleading standard because the FDA's premarket approval application was accessible only to the FDA and the manufacturer. The court found that this argumentwhich focuses on the timing of the preemption rulingwould have considerable force in a case where a specific defective Class III device injured a consumer, and the plaintiff did not have access to the specific federal requirements in the [premarket approval application] prior to commencing the lawsuit. Medtronic Leads, 623 F.3d at 1206. That is exactly the situation in this case. Here, there has not yet been an opportunity for discovery, and Bausch never waived discovery. For her to plead with any more detail that her claims were based entirely on a specific defect in the Trident that existed outside the knowledge and regulations of the FDA, she would need access to the confidential materials in the premarket approval application setting forth the medical device's specifications. This is simply not possible without discovery. It is also unreasonable to expect that Bausch could have pled more specifically without access to the failed Trident itself, but accessing the Trident outside of a discovery process would risk charges of spoliation of evidence, as Bausch's counsel acknowledged at oral argument. As Judge Melloy noted in Medtronic Leads : If plaintiffs must allege that the defendant violated a particular FDA-approved specification before discovery, then it is difficult to appreciate how any plaintiff will ever be able to defeat a Rule 12(b)(6) motion. Id. at 1212 (Melloy, J., dissenting). We think Judge Melloy said it well in suggesting that, in analyzing the sufficiency of pleadings, a plaintiff's pleading burden should be commensurate with the amount of information available to them. Id. Here, Bausch pled sufficiently given the amount of information to which she had access.
We turn to a final procedural problem with the district court's handling of this case. Plaintiff Bausch, in her brief opposing dismissal of her original complaint, asked the district court for an opportunity to file an amended complaint in the event the court found a deficiency in the original complaint. The district court granted the defendants' motion to dismiss under Rule 12(b)(6), dismissed the original complaint with prejudice, and entered a final judgment in favor of defendants. The district court did not address the plaintiff's request for leave to file an amended complaint. Plaintiff then filed a motion to alter the judgment under Rule 59 and submitted with the motion a proposed amended complaint. The proposed amended complaint clarified (unnecessarily) that the plaintiff sought relief solely on a theory that the defendants had violated federal law. The proposed amended complaint also included additional factual detail, particularly about the FDA's notice to defendants that their Trident products were adulterated as a result of problems in the manufacturing process. We review the district court's denial of a request to vacate the judgment and for leave to file an amended complaint under an abuse of discretion standard. Foster v. DeLuca, 545 F.3d 582, 583 (7th Cir.2008). The defendants led the district court into a procedural sidetrack that began with defendants' decision to move for dismissal under Rule 12(b)(6) rather than filing an answer to plead preemption as an affirmative defense and moving for judgment on the pleadings under Rule 12(c). Preemption is an affirmative defense, e.g., Fifth Third Bank v. CSX Corp., 415 F.3d 741, 745 (7th Cir.2005), and pleadings need not anticipate or attempt to circumvent affirmative defenses. Gomez v. Toledo, 446 U.S. 635, 640, 100 S.Ct. 1920, 64 L.Ed.2d 572 (1980) (concluding that there was no basis for imposing on plaintiff the burden to anticipate an affirmative defense); Doe v. GTE Corp., 347 F.3d 655, 657 (7th Cir.2003) (Affirmative defenses do not justify dismissal under 12(b)(6)); Fed.R.Civ.P. 8(c) (in responding to a pleading, a party must affirmatively state any avoidance or affirmative defense). If the defense had been properly presented under Rule 12(c), and if the district court had adhered to its erroneous view of preemption, then the proposed amended complaint would have seemed futile, but, having been presented with an affirmative defense, the plaintiff was entitled to try to cure the problem through an amended complaint. As the case was briefed, in any event, we find that the denial of leave to amend the complaint was an abuse of discretion for three reasons. First, for reasons explained above, the judge erred when he concluded that the amended complaint was futile on the merits because its claims would still be preempted. Second, the judge concluded that Bausch had earlier failed to file a formal motion for leave to amend, when she requested leave to file an amended complaint in her response to the defendants' motion to dismiss. But a formal motion for leave to amend was not necessary at the Rule 12(b)(6) stage, and the plaintiff was entitled to wait and see if any pleading problems the court might find could be corrected. Finally, the judge concluded that Bausch's request was unduly delayed. We find no merit in the undue-delay rationale. There was no new theory of relief, but only a clarification that Bausch's claims were focused only on violations of federal law, and a showing of additional factual details, especially related to the FDA warning letter. As a general matter, Rule 15 ordinarily requires that leave to amend be granted at least once when there is a potentially curable problem with the complaint or other pleading. A plaintiff is entitled to amend the complaint once as a matter of right, Fed.R.Civ.P. 15(a), and a court should freely give leave [for a party to file an amended complaint] when justice so requires. Fed.R.Civ.P. 15(a)(2). A district court may deny leave to file an amended complaint in the case of undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party by virtue of allowance of the amendment, [and] futility of amendment. Airborne Beepers & Video, Inc. v. AT & T Mobility LLC, 499 F.3d 663, 666 (7th Cir. 2007), quoting Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962). However, while a court may deny a motion for leave to file an amended complaint, such denials are disfavored. As we said in Foster, [d]istrict courts routinely do not terminate a case at the same time that they grant a defendant's motion to dismiss; rather, they generally dismiss the plaintiff's complaint without prejudice and give the plaintiff at least one opportunity to amend her complaint. 545 F.3d at 584. Even if the Bausch court was correct in dismissing with prejudice under James Cape & Sons Co. v. PCC Const. Co., 453 F.3d 396, 400-01 (7th Cir.2006) (affirming dismissal with prejudice where the losing plaintiff failed to request leave to amend until it was too late, and the district court had no way of knowing what the proposed amended complaint entailed), it was not correct in later refusing to vacate the judgment to provide Bausch leave to amend when, in the absence of undue delay or other fault on her part, Bausch submitted a revised complaint that was not futile. One objective of Rule 8 is to decide cases fairly on their merits, not to debate finer points of pleading where opponents have fair notice of the claim or defense. See Fed.R.Civ.P. 8(e) (Pleadings must be construed so as to do justice.). Generally, if a district court dismisses for failure to state a claim, the court should give the party one opportunity to try to cure the problem, even if the court is skeptical about the prospects for success. See Foster, 545 F.3d at 584.