Prudhel et al v. Endologix, Inc., No. 2:2009cv00661 - Document 28 (E.D. Cal. 2009)

Court Description: ORDER granting in part and denying in part 15 Motion to Dismiss for Lack of Jurisdiction signed by Senior Judge Lawrence K. Karlton on 7/8/09. (Kaminski, H)

Download PDF

Prudhel et al v. Endologix, Inc. Doc. 28 1 2 3 4 5 6 7 UNITED STATES DISTRICT COURT 8 FOR THE EASTERN DISTRICT OF CALIFORNIA 9 10 11 MARLENE PRUDHEL, RANDALL S. PRUDHEL, BRADLEY K. PRUDHEL, RYAN K. PRUDHEL, and SHAYNE R. PRUDHEL, 12 NO. CIV. S-09-0661 LKK/KJM Plaintiffs, 13 v. 14 15 O R D E R ENDOLOGIX, INC., and DOES 1 through 50, inclusive, 16 Defendants. 17 / 18 19 Plaintiffs bring various state-law claims arguing that a 20 medical device designed and manufactured by defendant caused the 21 death of Edwin Prudhel. 22 that plaintiffs’ claims are expressly preempted by federal law. 23 24 Defendants move to dismiss on the ground I. BACKGROUND Decedent underwent an aortic stent graft repair. 25 Amended Complaint (“FAC”) ¶¶ 19, 20. 26 treating physician attempted to use a Powerlink stent. First During this procedure, the FAC ¶ 21. 1 Dockets.Justia.com 1 The operation was unsuccessful, and decedent suffered fatal 2 injuries, which plaintiffs attribute to malfunction of the stent. 3 FAC ¶¶ 9, 24-25. 4 and sold by defendant Endologix. FAC ¶¶ 7, 12-13, 26. Defendant’s 5 argument for dismissal turns on the Food and Drug Administration’s 6 (“FDA”) regulation of medical devices. 7 regulatory framework before returning to plaintiffs’ particular 8 claims. 9 A. The Powerlink stent is designed, manufactured, The court reviews this Federal Regulation of Medical Devices 10 The Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, 11 21 U.S.C. § 301 et seq., requires FDA approval prior to the 12 introduction 13 Medtronic, Inc., ___ U.S. ___, 128 S.Ct. 999, 1002 (2008). 14 1976, Congress passed the Medical Device Amendments to this Act, 15 21 U.S.C. § 360c et seq. (“MDA”). 16 include medical devices. 17 levels of regulation, Class III of which is relevant here. 18 U.S.C. § 360c(a)(1).1 19 of new drugs into the market. See Riegel v. In The MDA broadened the Act to These devices are divided into three 21 Class III devices are subject to a premarket approval process 20 which the Supreme Court has described as “rigorous.” Medtronic, 21 Inc. v. Lohr, 518 U.S. 470, 477 (1996). 22 provide the FDA with a ‘reasonable assurance’ that the device is 23 both safe and effective.” 24 An applicant must submit, inter alia, “[T]he manufacturer must Id. (quoting 21 U.S.C. § 360e(d)(2)). 25 1 26 Unqualified § 360 et seq. numbers hereinafter refer to sections of 21 U.S.C. 2 1 full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a “full statement” of the device’s “components, ingredients, and properties and of the principle or principles of operation”; “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device”; samples or device components required by the FDA; and a specimen of the proposed labeling. 2 3 4 5 6 7 8 Riegel, 128 S.Ct. at 1004 (quoting 21 U.S.C. § 360e(c)(1)). 9 determining whether this evidence demonstrates that approval is 10 warranted, the FDA “weigh[s] any probable benefit to health from 11 the use of the device against any probable risk of injury or 12 illness from such use.” § 360c(a)(2)(C). 13 presents great risks may be approved if it also provides great 14 benefits. Riegel, 128 S.Ct. at 1004. After completing review, the 15 FDA may grant or deny approval outright, or it may grant an 16 approval conditioned on adherence to various requirements. See 21 17 U.S.C. §§ 360e(d), 360j(e)(1). 18 send 19 conditions could render the device approvable. 20 814.44(e), (f). 21 a letter to the In Thus, a device that The FDA may also deny approval but applicant indicating what changes or 21 C.F.R. §§ The MDA imposes further requirements after devices have been 22 approved. After approval, “the MDA forbids the manufacturer to 23 make, without FDA permission, changes in design specifications, 24 manufacturing processes, labeling, or any other attribute, that 25 would affect safety or effectiveness.” 26 (citing § 360e(d)(6)(A)(i)). Riegel, 128 S. Ct. at 1005 Approved devices are also subject to 3 1 ongoing reporting requirements related to the device’s health and 2 safety. 3 B. 4 § 360i. Factual Background and Plaintiffs' Claims Defendant received premarket approval for the Powerlink stent 5 in October 2004. 6 decedent on April 3, 2008. 7 the tip and/or cap of the stent’s delivery device (a component 8 included in the premarket approval) allegedly “disengaged,” a 9 malfunction. 10 A Powerlink stent was used in an operation on FAC decedent’s injuries. 11 ¶ FAC ¶¶ 19-20. 24. This During the procedure, malfunction allegedly caused FAC ¶ 25. Plaintiffs attribute this malfunction to manufacturing and/or 12 design defects. 13 allegedly violated the FDA’s manufacturing requirements imposed by 14 the premarket approval and 21 C.F.R. § 820, resulting in “an 15 impurity, imperfection, and/or other product defect” in the stent 16 and components. 17 allege 18 “unreasonably dangerous,” FAC ¶ 65, and that it was neither as safe 19 nor as adequately tested as defendant represented to the FDA. 20 ¶ 67. Plaintiffs generally allege that defendant violated numerous 21 federal regulations, including medical device reporting procedures, 22 21 23 procedures, § 820, recall and notification procedures, § 806, and 24 provision of instructions for use, § 814. FAC ¶¶ 45-47, 49. 25 26 that C.F.R. the § As to manufacturing, the stent’s manufacture FAC ¶¶ 50, 52, 55. stent 803k, suffered failure As to design, plaintiffs design analysis defects and rendering quality it FAC assurance Plaintiffs’ general allegations also claim that defendant had previously recalled several batches of Powerlink stents. 4 FAC ¶¶ 1 27-30. Some batches were recalled because “the tip may separate 2 from the catheter sheath inner core during insertion of the graft,” 3 causing the delivery catheters to be recalled. 4 batches were recalled because of separation problems with the 5 delivery catheter which prevented deployment of the graft. 6 29.2 7 scope of the recalls, FAC ¶ 30, although plaintiffs do not allege 8 that the particular stent used on decedent was subject to the above 9 recalls, nor do plaintiffs specifically allege that the stent used 10 should have been recalled. Although plaintiffs do not specifically 11 connect these recall allegations to any claim for relief, these 12 allegations provide some indication of the type of defects alleged 13 to exist. 14 benefit of all reasonable inferences (see §II, infra), it is not 15 unreasonable to infer that plaintiffs' claims are based on these 16 alleged faults. FAC ¶ 27. Other FAC ¶ Plaintiffs contend that defendant should have expanded the Under the court's obligation to give the pleader the 17 Based on the above, plaintiffs enumerate four causes of 18 action: a strict liability claim for a manufacturing defect, a 19 strict liability claim for a design defect, negligence, and breach 20 of both express and implied warranty. 21 all claims as explicitly preempted by the MDA. 22 23 Defendant moves to dismiss II. STANDARD FOR A FED. R. CIV. P. 12(B)(6) MOTION TO DISMISS In order to survive a motion to dismiss for failure to state 24 2 25 26 Specifically, plaintiffs allege that “The stated reason for [the second] recalls was that the front sheath of the delivery catheter separation, [sic] preventing deployment of the stent graft.” FAC ¶ 29. 5 1 a claim, plaintiffs must allege "enough facts to state a claim to 2 relief that is plausible on its face." 3 Twombly, 550 U.S. 544, 569 (2007). 4 plead "detailed factual allegations," the factual allegations it 5 does include "must be enough to raise a right to relief above the 6 speculative level." Bell Atlantic Corp. v. While a complaint need not Id. at 555. 7 The Supreme Court recently held that Federal Rule of Civil 8 Procedure 8(a)(2) requires a "showing" that the plaintiff is 9 entitled to relief, “rather than a blanket assertion” of 10 entitlement to relief. Id. at 555 n.3. Though such assertions may 11 provide a defendant with the requisite "fair notice" of the nature 12 of 13 allegations can clarify the "grounds" on which that claim rests. 14 Id. 15 statement of facts that merely creates a suspicion [of] a legally 16 cognizable right of action." 17 Miller, Federal Practice and Procedure, § 1216, pp. 235-36 (3d ed. 18 2004).3 19 a plaintiff's claim, the Court opined that only factual "The pleading must contain something more. . . than . . . a Id. at 555, quoting 5 C. Wright & A. On a motion to dismiss, the allegations of the complaint must 20 be accepted as true. 21 The court is bound to give the plaintiff the benefit of every 22 reasonable inference See Cruz v. Beto, 405 U.S. 319, 322 (1972). to be drawn from the "well-pleaded" 23 3 24 25 26 The holding in Twombly explicitly abrogates the well established holding in Conley v. Gibson that, "a complaint should not be dismissed for failure to state a claim unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief." 355 U.S. 41, 45-46 (1957); Twombly, 550 U.S. at 560. 6 1 allegations of the complaint. 2 Schermerhorn, 373 U.S. 746, 753 n.6 (1963). 3 complaint is construed favorably to the pleader. 4 Rhodes, 416 U.S. 232, 236 (1974), overruled on other grounds by 5 Harlow v. Fitzgerald, 457 U.S. 800 (1982). Nevertheless, the court 6 does not accept as true unreasonable inferences or conclusory legal 7 allegations cast in the form of factual allegations. 8 Council v. Watt, 643 F.2d 618, 624 (9th Cir. 1981). 11 In general, the See Scheuer v. W. Mining III. ANALYSIS 9 10 See Retail Clerks Int’l Ass'n v. A. The MDA’s Preemption of State Law Defendant moves to dismiss all of plaintiffs’ claims on the 12 ground that these claims are preempted by the MDA. 13 explicitly preempts any state requirement “‘which is different 14 from, or in addition to, any requirement applicable . . . to the 15 device’ under federal law.” 16 U.S.C. § 360k(a)(1)). Thus, for state law to be preempted, federal 17 law must impose requirements on a device, and state law must impose 18 additional requirements. 19 disputed 20 preemption when there is a requirement specific to a particular 21 device, premarket approval of the Powerlink under the MDA is such 22 a specific requirement. 23 at 1007. 24 requirements on the Powerlink that exceed those imposed by the FDA. 25 Id. at 1007. 26 here. The MDA Riegel, 128 S.Ct. at 1006 (quoting 21 The first step of this analysis is not Although federal requirements only trigger Id. (citing Lohr, 518 U.S. at 495), id. State law is therefore preempted insofar as it imposes In Riegel and Lohr, the Supreme Court concluded that state 7 1 common law duties impose “requirements” within the meaning of the 2 MDA’s preemption clause. Riegel, 128 S.Ct. at 1008; Lohr, 518 U.S. 3 at 512 (opinion of O’Connor, J., joined by Rehnquist, C.J., and 4 Scalia and Thomas, JJ.), 503-05 (opinion of Breyer, J.).4 5 tort law that requires a manufacturer’s catheters to be safer, but 6 hence less effective, than the model the FDA has approved disrupts 7 the federal scheme no less than state regulatory law to the same 8 effect.” 9 noted that juries applying state common law may focus on the risks 10 demonstrated by a single case rather than the benefits realized by 11 the device’s other users. Riegel, 128 S.Ct. at 1008. “State In particular, the court Id. 12 However, state common law duties are not preempted entirely. 13 Instead, “§ 360k does not prevent a State from providing a damages 14 remedy for claims premised on a violation of FDA regulations; the 15 state duties in such a case ‘parallel,’ rather than add to, federal 16 requirements.” 17 parallel claims were permitted, Riegel did not discuss parallel 18 claims. 19 Id. at 1011. Other than to hold generally that The present case raises at least three questions regarding 20 Riegel and the MDA’s preemption provision. 21 MDA’s preemption provision applies to all claims, what types of 22 claims 23 successfully plead a parallel claim. are parallel, and what a These are whether the plaintiff must allege to 24 4 25 26 Lohr was, prior to Riegel, the primary Supreme Court opinion interpreting the MDA’s preemption provision. Lohr produced a divided opinion, in which Justice Breyer’s concurring opinion is controlling. 8 1 No decision of the Ninth Circuit directly speaks to any of 2 these three questions. Nor has any other Circuit addressed these 3 issues since Riegel was decided. 4 independently analyze the issues, but in doing so, can draw on the 5 decisions of other district courts.5 6 B. Accordingly, this court must Scope of the MDA’s Preemption Provision, 21 U.S.C. § 360k 7 Plaintiffs first argue that under Riegel, the MDA’s preemption 8 clause, § 360k, does not apply to claims for breach of express 9 warranty--i.e., that a claim for breach of express warranty may 10 proceed regardless of whether it parallels federal requirements.6 11 The FAC alleges that defendant “provided express warranties that 12 the Powerlink was safe for intended and foreseeable use,” and that 13 defendant made “representations . . . on the product label, in 14 other promotional and sales materials and otherwise.” 15 68. 16 of these representations. Defendant has not responded to, or even 17 acknowledged, plaintiffs' argument that the express warranty claim 18 is not subject to preemption under the MDA. 19 silence may constitute an admission, the court nonetheless examines FAC ¶¶ 87, Plaintiffs have not otherwise alleged the content or details Although defendants' 20 21 22 5 Curiously, as far as this court can determine, no district court within this Circuit has directly addressed the problem. 6 23 24 25 26 Plaintiffs also argue that Riegel does not apply to claims for manufacturing defects. Plaintiffs misinterpret the authorities upon which they rely. The cases have held, as Riegel obviously requires, that manufacturing defects claims are preempted to the extent that they impose additional state law requirements, but that such claims may be the type that permissibly enforces parallel duties. The question of whether plaintiffs’ manufacturing defect claim is parallel is discussed in the following section. 9 1 2 the issue. The MDA preempts requirements imposed by states that exceed 3 federal requirements. 4 observed that in general, state law claims for breach of express 5 warranty sound in contract, rather than tort. Cipollone v. Liggett 6 Group, Inc., 505 U.S. 504, 526 (1992) (Stevens, J., for the 7 plurality). 8 contractual obligations are voluntarily assumed by the parties, and 9 such obligations may therefore fall outside preemption clauses. 10 For example, the Supreme Court has held that a breach of express 11 warranty 12 Fungicide, and Rodenticide Act’s preemption of state imposition of 13 different or additional labeling packaging requirements. Bates v. 14 Dow Agrosciences L.L.C., 544 U.S. 431, 444-45 (2005) (discussing 15 7 U.S.C. § 136v(b)). 16 claim While is 21 U.S.C. § 360k. tort not duties preempted are by The Supreme Court has imposed the by Federal the state, Insecticide, The court explained that 21 a cause of action on an express warranty asks only that a manufacturer make good on the contractual commitment that it voluntarily undertook by placing that warranty on its product. Because this common-law rule does not require the manufacturer to make an express warranty, or in the event that the manufacturer elects to do so, to say anything in particular in that warranty, the rule does not impose a requirement for labeling or packaging. 22 Id. (internal quotation omitted); see also Cipollone, 505 U.S. at 23 525-26 (express warranty claim similarly not preempted by the 24 Public Health Cigarette Smoking Act). 25 express warranty law follows this general pattern, in that a 26 California claim for breach of express warranty is based on a 17 18 19 20 10 California’s breach of 1 violation of a voluntary representation made by defendant. See 2 Krieger v. Nick Alexander Imports, Inc., 234 Cal. App. 3d 205, 212 3 (1991) (citing Cal. Uniform Comm. Code § 2313 and Cal. Civ. Code 4 § 1791.2). 5 Following Cipollone, several courts have held that a claim for 6 breach of express warranty lies outside the scope of the MDA’s 7 preemption clause. 8 is Mitchell v. Collagen Corp., 126 F.3d 902, 915 (7th Cir. 1997). 9 In Mitchell, the Seventh Circuit held that because a claim for 10 breach of express warranty is contractual, it “does not necessarily 11 interfere with the operation of the [pre-market approval], and 12 therefore we cannot say that such a cause of action is preempted.” 13 Id. at 915.7 The case most often cited for this proposition 14 Other courts have held that the MDA preemption analysis turns 15 on whether the language purportedly giving rise to an express 16 warranty was compelled by the FDA, approved by the FDA, or 17 extraneous to FDA approval. 18 contain certain information. 19 labels must by approved by the FDA. 20 determines that the labels are neither false nor misleading. 21 360e(d)(1)(A). The parties have not identified any FDA involvement The FDA may require product labels to Other representations on product In approving labels, the FDA § 22 23 24 25 26 7 In the initial district court opinion in Riegel, the district court followed Mitchell to conclude that an express warranty claim was not preempted by the MDA. Riegel v. Medtronic, Inc., 2002 WL 34234093, *9 (N.D.N.Y. 2002). This claim was otherwise resolved before the case was heard by the Supreme Court, and neither the Second Circuit nor the Supreme Court addressed this claim on appeal. 11 1 in 2 devices. 3 other (i.e., non-label) communications regarding medical Mitchell did not address this point, instead granting summary 4 judgment to defendant 5 identified 6 communicated. 7 communications, the Fifth Circuit has taken the most restrictive 8 approach, concluding that express warranty claims are preempted 9 whenever they are based on language approved by the FDA. any on evidence Id. the that Among ground an that express courts plaintiff warranty looking at had had not been particular Gomez v. 10 St. Jude Med. Daig Div., Inc., 442 F.3d 919, 932 (5th Cir. 2006); 11 accord Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1303 (D. 12 Colo. 2008), Horowitz v. Stryker Corp., 2009 WL 436406 (E.D.N.Y. 13 2009); see also Carter, 582 F. Supp. 2d at 1286 (interpreting a 14 similar 15 devices, in this way). Gomez explained that to succeed on a breach 16 of express warranty claim under Louisiana law, the expressed 17 warranty must be “untrue.” 18 Rev. Stat. Ann. § 9:2800.58). 19 determines 20 360e(d)(1)(A). 21 warranty claim would therefore impose a requirement that was 22 “potentially inconsistent with” the federal requirements. preemption that it provision is relating to drugs, rather than Gomez, 442 F.3d at 932 (quoting La. In approving language, the FDA neither false nor misleading. § In Gomez, the court held that a breach of express Id. 23 Preemption was interpreted more narrowly by the First Circuit, 24 which held that “manufacturers will not be held liable [in breach 25 of express warranty claims] for packaging and labeling imposed by 26 the FDA.” King v. Collagen Corp., 983 F.2d 1130, 1135 (1st Cir. 12 1 2 1993) (emphasis added). Most permissively, the Third Circuit has held that no express 3 warranty claims are preempted. 4 1316, 1328 (3d Cir. 1995) overruled on other grounds as stated in 5 In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 6 817, 825 (3rd Cir. 1998); accord Hofts v. Howmedica Osteonics 7 Corp., 597 F. Supp. 2d 830, 839 (S.D. Ind. 2009). 8 not aware of any decision addressing whether a breach of express 9 warranty claim based on language not approved by the FDA was 10 Michael v. Shiley, Inc., 46 F.3d This court is preempted. 11 Although the above cases provide a useful background for 12 medical device express warranty claims, this court need not decide 13 among them, because plaintiffs’ claim suffers a separate problem. 14 Plaintiffs allege that defendant “provided express warranties that 15 the Powerlink was safe for intended and foreseeable use.” 16 succeed on this particular breach of express warranty claim, 17 plaintiffs will need to show that the product was unsafe. As noted 18 by the Supreme Court in Riegel, “safe” has different meanings under 19 the MDA and state law. 20 warranty claim to an allegation that the product was unsafe within 21 the meaning of the MDA. 22 somehow voluntarily sought to implicate the definition of “safe” 23 used by California law. 24 that the product was safe within the meaning of the MDA, but that 25 plaintiffs seek to impose liability on the ground that the product 26 is unsafe within the meaning of California law, plaintiffs’ claim To Plaintiffs do not tie their express Nor do plaintiffs allege that defendant To the extent that defendant represented 13 1 is preempted, for the reasons discussed in the following section. 2 To the extent that plaintiffs intended to allege a different basis 3 for their claim, plaintiffs have failed to put defendant or this 4 court on notice of that basis. 5 Corp., 2008 WL 2940811, *6 (N.D. Ill. 2008) (dismissing a claim 6 that 7 insufficiently pled under Twombly). 8 C. 9 10 11 was either preempted Heisner ex rel. Heisner v. Genzyme or, if construed alternatively, What Constitutes a Parallel Claim District courts have divided on what constitutes a “parallel claim” under Riegel. The first question is what the state requirements must be 12 parallel to. 13 not preempted if they parallel either specific or general FDA 14 regulations, 15 requirement will trigger the MDA’s preemption clause. 16 Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830, 835 (S.D. 17 Ind. 2009), In re Medtronic, Inc. Sprint Fidelis Leads Products 18 Liability Litigation, 592 F. Supp. 2d 1147, 1157-58 (D. Minn. 19 2009). 20 Courts have generally held that state law claims are notwithstanding the fact that only a specific See, e.g., The court follows this approach here. The second question is what it means to parallel a federal 21 requirement. 22 Northern District of Illinois in Bausch v. Stryker Corp, 2008 WL 23 5157940 (N.D. Ill. Dec. 9, 2008). 24 a claim is “parallel” to a federal requirement only when it 25 provides 26 requirement. a The most restrictive approach was taken by the cause of action In essence, the court held that for violation of the federal A strict liability claim was preempted because under 14 1 Illinois law, such a claim “would, by necessity, require a trier 2 of fact to assess whether a product is unreasonably dangerous,” and 3 the court held that a violation of federal regulations would be 4 collateral to, and not the predicate of, a finding of strict 5 liability. 6 were preempted. 7 ‘different from, or in addition to’ federal regulations.” 8 *5 (quoting § 360k). 9 Defendants violated the FDA, [plaintiff]’s negligence claim is not 10 based on a duty that is ‘substantially identical’ to the duty that 11 is imposed on the [device] by FDA regulations.” Id. at *6 (quoting 12 Lohr, 518 U.S. at 496-97). 13 even though “plaintiff alleges that the same conduct that violated 14 the FDA also” constituted the negligence. Id. at *5. Bausch would 15 therefore apparently hold that the state law claims at issue in 16 this case are preempted, because each requires proof of elements 17 other than mere violations of the federal requirements. Id. *4. The court also held that negligence claims “The preemption clause in the MDA bars all claims Id. at “[A]lthough [plaintiff] has alleged that Thus, negligence claims were preempted 18 This court declines to follow Bausch, because notwithstanding 19 the Supreme Court’s use of the phrase “substantially identical” in 20 Lohr, Bausch cannot be squared with Lohr. 21 of the court held that a state law strict liability claim was not 22 preempted despite the fact that to recover on the claim, the 23 plaintiff would need to show more than merely a violation of 24 federal requirements. 25 JJ. Stevens, Kennedy, Souter and Ginsburg) (quoting § 360k), id. 26 at 508 (concurring opinion of J. Breyer, joining this portion of In Lohr, the majority Lohr, 518 U.S. at 495 (plurality opinion of 15 1 the majority opinion). 2 liability might impose a “narrower requirement . . . ‘different 3 from’ 4 contracted, rather than expanded, liability did not conflict with 5 the federal rules. 6 the federal Even though the state law of strict rules Id. in a literal sense,” a rule that at 495. Most courts interpreting Riegel have continued to adopt this 7 view of Lohr. For example, the Southern District of Indiana held 8 that the MDA only preempts “claims that the device at issue 9 ‘violated state tort law notwithstanding compliance with the 10 relevant federal requirements.’” 11 Corp., 597 F. Supp. 2d 830, 835 (S.D. Ind. 2009) (quoting Riegel, 12 128 S.Ct. at 1011). 13 violation of FDA regulations,’” and therefore permissible under 14 Riegel, 15 regulations regardless of whether the claim incorporates additional 16 elements. 17 court therefore found no preemption of a strict liability claim 18 alleging that “deviation from the FDA's manufacturing requirements 19 was unreasonably dangerous” or of a negligence claim alleging that 20 defendant “breached the duty of care . . . by failing to adhere to 21 the FDA's manufacturing requirements.” 22 In re Medtronic, Inc. Sprint Fidelis Leads Products Liability 23 Litigation, 592 F. Supp. 2d 1147, 1157-58 (D. Minn. 2009) (holding 24 that the MDA did not preempt various manufacturing defect tort 25 claims premised on violations of federal requirements, but that 26 plaintiffs’ allegations failed to satisfy Twombly), Parker v. whenever Hofts v. Howmedica Osteonics Hofts held that “‘claims [are] premised on a they are based on a violation of federal Id. at 835 (quoting Riegel, 128 S.Ct. at 1011). 16 Id. at 836-37. The See also 1 Stryker Corp., 584 F. Supp. 2d 1298, 1302 (D. Colo. 2008) (same); 2 Horowitz v. Stryker Corp., 2009 WL 436406, *6 (E.D.N.Y., Feb. 20, 3 2009), Purcel v. Advanced Bionics Corp., 2008 WL 3874713 *3 (N.D. 4 Tex. Aug 3, 2008). 5 This court concludes that Hofts articulates the better view. 6 State law claims are preempted to the extent that they impose 7 additional requirements on device manufacturers. Thus, compliance 8 with federal requirements must preclude state law liability. 9 However, a state law claim that requires more than mere 10 noncompliance with federal requirements--for example, that the 11 violation 12 unreasonable--is not precluded, notwithstanding the fact that such 13 a claim uses a standard that is literally “different from” the 14 federal requirements. 15 claim does not impose conflicting requirements on manufacturers and 16 thereby disrupt the federal regulatory scheme. 17 of Applying federal this requirements have been Lohr, 518 U.S. at 495. standard to this reckless or Such a state law case, plaintiffs have 18 adequately alleged a parallel claim in their first claim, but not 19 in their second, third, and fourth claims. Plaintiffs’ first claim 20 is for strict liability arising out of a manufacturing defect. The 21 manufacturing defect claim alleges that the manufacturing was not 22 in compliance with the requirements imposed by 21 C.F.R. § 820, 23 resulting in a defect. 24 separation of the components of the delivery device. Plaintiffs 25 allege that the tip or cap of the stent’s delivery device became 26 disengaged during insertion into decedent. FAC ¶ 55. 17 This alleged defect concerned ¶ 24. Plaintiffs 1 further allege that prior manufacturing lots of the stents had been 2 recalled because “the tip may separate from the catheter sheath 3 inner 4 allegations undoubtedly suffice to state a parallel claim under 5 Riegel. core during insertion of the graft.” ¶ 27. These 6 Plaintiffs' second claim, for strict liability for a design 7 defect claim, is also apparently based on the separation and 8 associated malfunction of the delivery device. 9 However, the only alleged connection between this claim and a 10 federal violation is that the stent “was not safe for its intended 11 use as [defendant] represented to the FDA it would be” and “was 12 inadequately tested as [defendant] represented to the FDA it would 13 be tested.” 14 federal violation. 15 defendant misrepresented this information to the FDA, or whether 16 defendant’s representations to the FDA instead merely later proved 17 to be untrue. 18 would implicate the FRCP 9 pleading requirements, which clearly are 19 not met here. 20 a federal violation. 21 this claim is predicated on a federal violation, and this claim is 22 therefore dismissed. 23 FAC ¶ 67. Fed. R. Civ. P. 8. These allegations do not establish a It is unclear whether plaintiffs allege that While the former might be a federal violation, it The latter, however, does not appear to amount to Accordingly, plaintiffs have not alleged how Plaintiffs’ third claim, for negligence, and fourth claim, for 24 breach of warranty, contain no allegations that in any way 25 demonstrate that these claims are predicated upon violations of 26 federal requirements. Although plaintiffs’ generally allege that 18 1 many violations of federal requirements occur, to state a parallel 2 claim, a federal violation must be a predicate to the theory of 3 liability. 4 are not parallel, in which case they are preempted by the MDA, or 5 they are inadequately pled, in that they fail to put the defendant 6 on notice of the violation of federal requirements that serves as 7 the basis for the claim. 8 D. Accordingly, these claims are dismissed: either they Pleading Requirements for Parallel Claims 9 Courts are further divided as to what Twombly requires of a 10 plaintiff seeking to plead a parallel claim. The most liberal view 11 was taken by the Southern District of Indiana in Hofts, 597 F. 12 Supp. 2d 830. The plaintiff in Hofts brought negligence and strict 13 liability claims for manufacturing defects. 14 plaintiff predicated these claims on violations of the premarket 15 authorization and FDA manufacturing regulations. Id. However, the 16 plaintiff did not allege precisely what conduct violated these 17 federal 18 Nonetheless, the court held to require such specific allegations 19 would impose a heightened pleading requirement and exceed the 20 requirements of Twombly. 21 requirements, or what the Id. at 836. manufacturing defect The was. Id. at 838. Most courts have instead held that a plaintiff must allege the 22 particular federal requirement that was violated, and how. 23 re 24 Litigation, 592 F. Supp. 2d 1147, 1158 (D. Minn. 2009), the court 25 held that while an allegation that a product “was defective because 26 the manufacturing processes for the device . . . did not satisfy Medtronic, Inc. Sprint Fidelis 19 Leads Products In In Liability 1 the Food and Drug Administration’s Pre-Market Approval standards 2 . . . . appears to constitute [a permissible] parallel claim . . 3 . nowhere does plaintiff’s complaint provide any factual detail to 4 substantiate that crucial allegation.” 5 Corp., 584 F. Supp. 2d 1298, 1302 (D. Colo. 2008) (allegation that 6 defendant violated the PMA manufacturing process insufficient; 7 plaintiff must allege facts identifying the alleged violation), 8 Heisner ex rel. Heisner v. Genzyme Corp., 2008 WL 2940811, 5 (N.D. 9 Ill. 2008) (dismissing complaint that did not allege whether 10 11 See also Parker v. Stryker “defect” was or was not in violation of federal requirements). The court need not decide between these approaches for 12 purposes of this motion. 13 third, and fourth claims fail under either approach. 14 first claim, on the other hand, meets the stricter of these two 15 requirements. Plaintiffs’ IV. CONCLUSION 16 17 As explained above, plaintiffs’ second, For the reasons stated above, defendant’s motion to dismiss, 18 Doc. No. 15, is GRANTED IN PART. 19 to plaintiffs’ first claim. 20 claims are DISMISSED WITHOUT PREJUDICE. 21 IT IS SO ORDERED. 22 DATED: Defendant’s motion is DENIED as Plaintiffs’ second, third, and fourth July 8, 2009. 23 24 25 26 20

Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.