Teixeria v. St. Jude Medical S.C., Inc.
Teixeria v. St. Jude Medical S.C., Inc.
Opinion of the Court
DECISION AND ORDER
INTRODUCTION
Represented by counsel, John J. Teixe-ria (“Téixeria” or “Plaintiff’) instituted this
Defendants filed partial Objections (Dkt #27) to the Report and Recommendation, and Plaintiff filed a Reply/Response (Dkt #28) to Defendants’ objections, to which Defendants filed a Reply/Response (Dkt #30). The matter was transferred to the undersigned on May 6, 2016 (Dkt #48).
FACTUAL BACKGROUND
The underlying facts are set out comprehensively in the Report. Briefly, however, Teixeira had surgery on September- 6, 2011, to place an implantable cardioverter-defibrillator (“ICD”) (Durata Model CD1231-40Q) and lead (Durata Model 7121Q/65),
GENERAL LEGAL PRINCIPLES
I. Review of Reports and Recommendations
Where no objection is made to a report and recommendation, or the parties make frivolous, conclusive, or general objections, only “clear error” review is required by the district court. See Fed. R. Civ. P. 72(b), Advisory Comm. Notes (1983); Camardo v. General Motors Hourly-Rate Employees Pension Plan, 806 F.Supp. 380, 382 (W.D.N.Y. 1992)). In such case, the district court “need only satisfy itself that there is no clear error on the face of the record in order to accept the recommendation,” Fed. R. Civ. P. 72(b), Advisory Comm. Notes (1983).
However, a district court must review de novo those portions of the magistrate judge’s findings and recommendations to which a party has made specific and timely . objections. See 28 U.S.C. § 636(b)(1)(C); Fed. R. Civ. P. 72(b). The de novo standard requires that the district court “ ‘give fresh consideration to those issues to which specific objections have been made’ ” and “examine the entire record,” and “makfing] an independent assessment of the magistrate, judge’s factual and legal conclusions.” United States v. Raddatz, 447 U.S. 667, 675, 100 S.Ct. 2406, 65 L.Ed.2d 424 (1980) (quoting legislative history). After conducting the appropriate review, the district judge may “accept, reject, or modify, in whole or in part, the findings or recommendations made by the magistrate judge.” 28 U.S.C. § 636(b)(1)(C).
II. Rule 12(b)(6) Motions to Dismiss
When deciding motions to dismiss under Rule 12(b)(6), the court must apply a “plausibility standard,” guided by “[t]wo working principles,” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). First, although the court must accept all factual allegations as true, this tenet is “inapplicable to legal conclusions[.]” Id. Second, only complaints that state a “plausible claim for relief’ can sur
DEFENDANTS’ MOTION TO DISMISS
I. Review of the Portions of the Report to Which the Parties Have Not Objected
Plaintiff indicates that he agrees with the Report and requests that the Court accept in full the findings and recommendations therein. Thus, Plaintiff does not object to the dismissal of the third (negligent failure to warn), fourth (failure to warn under a theory of strict liability), and fifth (negligent misrepresentation) causes of action. Defendants likewise , do not object to these portions of the Report. Because the Court finds that the Report’s recommendations as to these causes of action are not clearly erroneous, the Court adopts them and dismisses the third, fourth, and fifth causes of action with prejudice.
II. Review of Defendants’ Objections
In their Objections, Defendants discuss four issues that they assert were not resolved or considered in the Report, i.e., “(1) [w]hether Plaintiff has stated a claim for breach of express warranty; (2) whether the FDA’s 2013 Warning Letter has any applicability in this case; (3) whether, to state a parallel[ ]claim
A. First Objection: Whether Plaintiff Has Stated a Non-Preempted Claim for Breach of Express Warranty
St. Jude agrees with the Report’s recommendation that the breach of express warranty claim is preempted to the extent it is based on St. Jude’s packaging and labeling, which were approved by the FDA
The Court agrees with St. Jude that the first rationale, i.e., that the representations were “volunteered,” is not a basis to deny the motion to dismiss because, whether volunteered by the manufacturer or required by law, claims based on written or oral statements whose content falls within the parameters of FDA-approved labeling are expressly preempted under the MDA. See Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 285 (E.D.N.Y. 2009) (“Plaintiffs breach of express warranty claim is preempted to the extent that it is premised on FDA approved representations made by the manufacturer.”) (citing Lake v. Kardjian, 22 Misc.3d 960, 874 N.Y.S.2d 751, 754 (Sup.Ct. 2008) (finding that “a breach of express warranty claim based upon FDA approved statements in product labeling and advertising is preempted,, because such a claim would impose requirements different from, or in addition to, the federal requirements, potentially resulting in the imposition of liability on a manufacturer who has fully complied with federal law”)).
The Court turns next to the Report’s recommendation that Plaintiffs breach of express warranty claim should survive to the extent it is based on “explicit, personal representations,” in which St. Jude allegedly “stepped outside,” Report, p. 29, of the FDA-approved labeling for the Durata lead. Under New York state law, “representations which are the subject of breach of express warranty claims are considered to be requirements imposed by the warrantor, not by the state.” Horowitz, 613 F.Supp.2d at 285-86 (citing Wallace v. Parks Corp., 212 A.D.2d 132, 629 N.Y.S.2d 570, 574 (4th Dep’t 1995)) (finding' that liability under “[bjreach of express warranty claims... arises... from a promise voluntarily made by the manufacturer”) (citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 525 & n. 23, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992)). An express warranty is an “affirmation of fact or promise made by the seller to the buyer which.. .becomes part of the basis of the bargain.” N.Y. Uniform Commercial Code § 2-313(1)(a). Thus, “an action for breach of express warranty requires both the existence of an express promise or representation and reliance on that promise or representation.” Horowitz, 613 F.Supp.2d at 286 (citing CBS Inc. v. Ziff-Davis Publ’g Co., 75 N.Y.2d 496, 503, 554 N.Y.S.2d 449, 553 N.E.2d 997 (1990)).
Defendants argue that Plaintiff has not specifically pled any explicit, personal representation made by an agent or employee of St. Jude, much less a representation the substance of which was not approved by the FDA. After independently examining Plaintiffs allegations in the Amended Complaint regarding the representations by St. Jude, contained in Paragraphs 169, 173, and 174, the Court agrees, as, discussed further below.
First, in Paragraph 169, Plaintiff alleges that St. Jude
expressly or -impliedly warranted and represented to the Plaintiff that the aforesaid defibrillator and Durata lead were safe, proper, merchantable and fixable, foreseeable [sic] and intended uses [sic] for which it [sic] were designed, manufactured and assembled; were not a danger to the user; would not be dangerous or present a risk of injury; were free from defects, were reasonably safe, were of merchantable quality and rea*225 sonably fit for the purposes for which it was designed, manufactured, assembled, inspected, tested, sold and purchased and intended to be used.
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Am. Compl. ¶ 169. These bare-bones allegations are too generic to set forth a claim for breach of an express warranty. See, e.g., Fisher, 783 F.Supp.2d at 431-32 (dismissing breach of express warranty where complaint merely stated that “[defendants expressly warranted to [the plaintiff] and his physicians that the product was of merchantable quality and safe for the use for which it was intended”; stating that the “failure to allege any specific words, promises or statements made by [the defendants] to [the plaintiff] or his physicians that would create an express warranty is fatal to the claim”).
Next, Plaintiff asserts that
[r]epresentatives of Defendants made personal representations to Plaintiff and/or his treating medical providers that the devices utilized on Plaintiff were safe, long lasting, and would not prematurely erode.
Am. Compl. ¶ 173. While courts have held that “Affirmations of fact regarding the safety of a product are actionable on a claim for breach of express warranty[,]” Williamson v. Stryker Corp., No. 12 CIV. 7083 CM, 2013 WL 3833081, at *9 (S.D.N.Y. July 23, 2013) (citations omitted),
Finally, Plaintiff asserts that
[u]pon information and belief, Representatives of Defendants made personal representations to Plaintiff and/or his treating medical providers that the devices utilized on Plaintiff would not require a surgical intervention.
Am. Compl. ¶ 174. The Second Circuit has explained that the Twombly/Iqbal plausibility standard “does not prevent a plaintiff from “pleading facts alleged ‘upon information and belief ” where the facts are peculiarly within the possession and control of the defendant,” Arista Records, LLC v. Doe 3, 604 F.3d 110, 120 (2d Cir. 2010) (citation omitted), “or where the belief is based on factual information that
Finally, the Court must address the'Report’s finding that “Teixeira will have to conform through discovery what representations St. Jude explicitly made, but for now, explicit personal representations from a manufacturer eager to sell a device plausibly could, have happened.” Report, p. 29 (emphasis supplied). The Court respectfully must disagree with this recommendation, given the clear statement by the Supreme Court in Iqbal that Rule 8 of the Federal Rules of Civil Procedure “does not unlock the doors of discovery for a plaintiff[,]” such as Teixeria, “armed with nothing more than conclusions.” 556 U.S. at 678-79, 129 S.Ct. 1937.
Because the Court finds that Plaintiff has failed to plead, under Twombly/Iqbal, a plausible claim for breach of express warranty, it need not decide whether such a claim, if well-pled, would be expressly or impliedly preempted by federal law. The claim for breach of express warranty, asserted in the sixth cause of action, is dismissed for failure to state a claim.
B. Objections Two and Three: The Relevance of the FDA’s 2013 Warning Letter and the Lack of Factual Allegations Specific to Plaintiffs Durata Device
St. Jude objects to Plaintiffs reliance on the FDA’s 2013 Warning letter and argues that its issuance does not assist'Plaintiff in articulating plausible parallel, non-preempted claims for strict liability, negligent manufacturing, and breach of implied warranty.
“To plead and prove a manufacturing flaw under either negligence or strict liability, the plaintiff must show that a specific product unit was defective as a result of ‘some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction,’ and that the defect was the cause of plaintiffs injury.” Colon ex rel. Molina v. BIC USA, Inc., 199 F.Supp.2d 53, 85 (S.D.N.Y. 2001) (emphasis supplied; quoting Caprara v. Chrysler Corp., 52 N.Y.2d 114, 129, 436 N.Y.S.2d 251, 417 N.E.2d 545 (1981)), “A breach of implied warranty claim requires proof... (1) that the product was defectively designed or manufactured; (2) that the defect existed when the manufacturer delivered it to the purchaser or user; and (3) that the defect is the proximate cause of the accident.” Plemmons v. Steelcase Inc., No. 04 CV 4023, 2007 WL 950137, at *3 (S.D.N.Y. Mar. 29, 2007) (internal quotation marks and citation omitted; emphasis supplied). As the Second Circuit has observed, “[t]here is... no older requirement in th[e] area of [tort] law than the, need to show such a [causative] link between the defendant’s actions and the plaintiffs loss.” Zuchowicz, v. United States, 140 F.3d 381, 383 (2d Cir. 1998). In the context of product liability claims involving FDA-regulated devices, showing a “causal connection is ‘a critical element’ of a properly pled parallel claim because premarket approval- does not mean that a medical device will never result in injuries, only that the benefits outweighs the risks of probable injuries.” Leonard v. Medtronic, Inc., No. 1:10-CV-
With these general principles in mind, the Court evaluates St. Jude’s objection regarding Plaintiffs reliance on the Warning Letter issued by the FDA in 2013, following an inspection of St. Jude’s production facility located in Sylmar, California, on September 25, 2012, through October 17, 2012. The FDA’s inspection revealed that the Durata devices manufactured at the facility “are adulterated within the meaning of Section 501(h) of the [FDCA], 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with'- the current good manufacturing practice [ (“OGMP”) ] requirements of the Quality System regulation found at [21 C.F.R. Pt. 820]....” Am. Compl. ¶ 15. St. Jude argues, inter alia, the Amended Complaint does not factually'link the Warning Letter to the alleged defect, namely, the supposed externalization of a conductor in Plaintiffs lead, given that the FDA inspection that led to the Warning Letter took place more than two years after Plaintiffs first surgery to implant the Durata ICD and lead. Plaintiff has set forth no allegations regarding how his Durata ICD and lead, implanted in September 2011, could have been affected by FDA investigations that occurred a year later. See Horowitz, 613 F.Supp.2d at 282-83 (dismissing complaint where “Plaintiff provide[d] no explanation as to how her Trident System, which was implanted in her body in 2005, relates to investigations conducted by the FDA in 2006 and 2007. Her complaint also fail[ed] to specify in which of defendants’ facilities her hip replacement device, or any components included in the device, was manufactured, making it -unclear which, if either, of the two letters she [was] using to substantiate her claims.”) (citation omitted). The Court agrees that specific allegations of a plausible causal connection between the 2013 Warning Letter and Plaintiffs device are entirely lacking. See, e.g., Franzese v. St. Jude Med., Inc., No. 13-CV-3203 JS WDW, 2014 WL 2863087 (E.D.N.Y. June 23, 2014).
In Franzese, the district' court found that a plaintiff who had been implanted with a Durata device failed to state a parallel claim where he incorporated the same FDA Warning Letter relied on by Teixeria, and urged the same theory of product defect, i.e., that the Durata lead suffered premature deterioration. See 2014 WL 2863087, at *5 (plaintiff alleged that Durata lead was adulterated in violation of Section 501(h) of the FDCA and that the lead and/or defibrillator had an impurity, imperfection, or other product defect). The district court in Franzese fotmd that “[e]ven assuming that' such allegations [based on the Warning Letter] assert a sufficient violatioh of federal regulations,” the plaintiffs had “not sufficiently alleged how this violation caused [their] injuries.” Franzese, 2014 WL 2863087, at *5. In Franzese, similar to the present case, the plaintiff alleged that St. Jude “‘violated federal law by máking lihsanctioned adulterations’ to the Durata lead[,]’.” but, as the district court noted, “such assertions appear to be based on the FDA warning letter, which simply stated that the Durata lead was considered adulterated within the meaning of Section 501(h) because ‘the methods used in, or the facilities or controls. used for, their manufacture, packing, storage, or installation’ are not in conformity with CGMPs.” Id. The specific CGMPs
Relatedly, St. Jude objects to the Report’s reference to unspecified “red flags” regarding the Durata lead. The Amended Complaint contains page after page of allegations concerning problems with the Ria-ta lead, an earlier model of lead manufactured by St. Jude, such as the fact that it was the subject of a Class I Recall by the FDA in December 2011. However, the FDA has not instituted a recall of the Durata lead, which has a different design and structure than the Riata lead.
The Court further finds that Plaintiffs reliance on Rosen v. St. Jude Med., Inc., 41 F.Supp.3d 170 (N.D.N.Y. 2014), is misplaced. First, Rosen involved a different device manufactured by St. Jude, a Riata lead. Second, unlike the Durata, the Riata lead was the subject of a recall by the FDA. Third, the plaintiff in Rosen pled specific facts regarding an inspection of .his particular device, namely, that his surgeon examined, the lead; after it was removed, finding that it had indeed fractured, and that the conductor coils had “externalized[,]” Rosen, 41 F.Supp.3d at 174. Although Teixeria urges the same theory as the plaintiff in Rosen regarding how and why his .device malfunctioned, Teixeria does not allege any facts supporting his theory that externalization actually occurred. The Amended Complaint contains no allegations regarding an examination of Teixeria’s explanted Durata lead, no allegations regarding statements or observations made by Teixeria’s physicians, and no allegations referencing notes from Teixeria’s medical records—which the Report acknowledges. See Report, p. 3 (“The record contains no allegation or other information about where the replaced lead is and whether anyone has examined it.”).
It bears noting that allegations which are “merely consistent with” a plaintiffs theory of liability are insufficient to meet the “plausibility” standard. See Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (“Where a complaint pleads facts that are ‘merely consistent with’ a defendant’s liability, it ‘stops short of the line between possibility and plausibility of ‘entitlement to relief.’ ” (quoting Twombly, 550 U.S. at 557, 127 S.Ct. 1955; brackets omitted in original). Based on his own documentary submissions, Plaintiffs theory of liability is not even consistent with the facts he has alleged.
C. Objection Four: Whether the Allegations Made “On Information and Belief” Are Sufficiently Supported
St. Jude objects to the Report’s acceptance of Plaintiffs allegations that are made “on information and belief,” see Report, pp. 31-33. According to St. Jude, Plaintiff has not properly used this pleading device, and the Report ignored the principle that allegations based “on information and belief’ cannot be wholly unsupported. Cf. Arista Records, LLC, 604 F.3d at 121 (rejecting defendant’s assertion that complaint’s allegations were too vague and conclusory to state a plausible claim where, “[t]o the extent that. . .allegations are made on information and belief, virtually all of them are supported by factual assertions in [the attached] [e]xhibit”).
The Court notes that the allegations Plaintiff makes “on information and belief’ were also the subject of the Motion to Strike, in which St. Jude . argued that Plaintiff copied them,, more or less verbatim, from a case out of the District of Minnesota, Pinsonneault v. St. Jude Med., Inc., No. 12-CV-1717 PJS/JSM (D.Minn. June 24, 2014), which involved a Riata lead (not a Durata lead). As Defendants noted in their Motion to Strike, Plaintiffs initial 4-page Complaint failed to identify which
4567. From 2005-2010 St. Jude applied for over—2? several manufacturing or process changes to the Riata -Leads, and Durata lead family.- The FDA approved these changes in a PMA and multiple supplements. Upon information and belief, Defendants St. Jude failed to manufacture the Riata and Durata Leads consistent with design—specifications and/or these approved'changes, thereby creating a defective products.
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5073. The breach of insulation and externalization of the lead wires on the Riata and Durata Leads can cause the Lfeads to short, and to transmit incorrect information or noise to the pacemaker/defibrillator ■ thereby causing it to produce unnecessary and very painful shocks of electricity, or alternatively, to fail to communicate with the pacemaker/defibrillator at which point the life-saving therapies of the device áre unavailable.
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527/.. Additionally, St. Jude applied and received approval for multiple changes to the cure and sterilization processes used in the manufacture of the Riata and Durata Leads. Upon information and belief, St. Jude, failed to comply with the approved methods and/or specifications , of curing and sterilization during the manufacture of the Leads. Upon information and belief, failure to follow the approved cure and sterilization processes resulted in reduced tensile strength of the silicone insulation.
?5—53. Finally, St. Jude applied and received approval for numerous modifications to the welding and crimping procedures in the manufacture of the Riata and Durata Leads. Upon information and belief, the PMA and Conditions of Approval required the application of a controlled, uniform degree of force was required when applying the crimp. Upon information and belief, failure to crimp with a controlled, uniform, degree of force, resulted in insecure crimps over, lead wire length differences both longer and/or shorter than specification for the length of the Lead.
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Dkt. #18-2, Ex. 3.
The factual similarities between Teixe-ria’s Amended Complaint and the Pinson-neault complaint are striking and impossible to ignore. Plaintiffs attorney, however,
Where, as here, the Court is evaluating the sufficiency of “information and belief’ allegations, its “task is to determine whether-viewing all of the Amended Complaint’s factual allegations in the light most favorable to Plaintiff-the pleadings made on “information and belief’ “ ‘raise a reasonable expectation that discovery will reveal evidence’ proving.. .Plaintiffs claim.” Installed Bldg. Products, LLC v. Cottrell, No. 13-CV-1112-ASC, 2014 WL 3729369, at *4 (W.D.N.Y. July 25, 2014) (quoting Twombly, 550 U.S. at 556, 127 S.Ct. 1955 (“Asking for plausible grounds to infer an agreement does not impose a probability requirement at the pleading stage; it simply calls for enough fact to raise a reasonable expectation that discovery will reveal evidence of illegal agreement.”)). Contrary to Plaintiffs attorney’s ’ suggestion, the Court is not invoking collateral estoppel based on Pinsonneault. However, the Court believes that the summary judgment decision in that case drastically decreases the reasonableness of Teixeria’s expectation that discovery will reveal evidence proving his claims. The manufacturing standards for the Riata lead which the plaintiff in Pinsonneault claimed were violated by St. Jude violated, were found—
Plaintiffs attorney asserts that in performing research in connection with the Amended Complaint, his “office found other cases involving either the Durata or Riata leads that had not been dismissed[.]” Manna Decl. (Dkt #20) ¶ 11 (emphasis omitted). Again, the Court questions why cases involving Riata leads are even relevant to this inquiry. Nonetheless, the Court reviewed them and found that they do not help Plaintiffs cause. First, as noted, Waltenburg v. St. Jude Med., Inc., 33 F.Supp.3d 818 (W.D.Ky. July 21, 2014), involved a Riata lead, not a Durata lead. Plaintiffs attorney asserts, without citation, that the medical research cited in the Waltenburg complaint “indicated” that the Durata lead “may suffer from the same complications that plagued the...Riata lead, given their similarities in design.” Manna Decl. ¶ 12. In the Waltenburg complaint (Dkt. #20-3), the only allegations regarding medical research bear the heading, “Physicians Expose the Riata Lead Defects.” Dkt. # 20-3, ¶¶ 89-84, p. 24 of 46 (emphasis supplied). The word “Durata” does not appear in any of the paragraphs under that heading. Furthermore, the medical research articles cited in the Wal-tenburg complaint studied defects in the Riata and Riata ST leads—not the Durata leads. See id.
Plaintiff also has submitted a copy of the complaint filed in Robert and Margaret Loiseau v. St. Jude Medical, Inc., et al., No. 2:14-1391-JVS(ANx), 2014 WL 839628 (C.D.Cal. Feb. 24, 2014). Plaintiff states that St. Jude did not file a Rule 11 motion for sanctions in that case “despite several nearly identical paragraphs between” that complaint and the Waltenburg complaint. See Manna Decl. ¶ 15. Although the complaint in Loiseau purports to seek damages for “injuries caused by manufacturing defects in the St. Jude Riata and Durata family of cardiac defibrillator leads,” Mr. Loiseau only was “implanted with a defective Rialta [sic] Lead and suffered a related injury first discovered several years later when the device failed and had to be surgically removed in April 2012.” Dkt. # 20-3, ¶ 3. Thus, the Loiseau complaint adds nothing to the reasonableness of Teixeria’s expectation that discovery will reveal evidence proving his claims regarding the Durata lead.
DEFENDANTS’ MOTION TO STRIKE AND FOR SANCTIONS
Because the Court is- dismissing the Amended Complaint in its entirety, the branch of the motion seeking to strike certain allegations is moot.
The request for sanctions presents a closer question. Where, as here, “a plaintiff sets out allegations on information and belief, he is representing that He has a good-faith reason for believing what he is saying, but acknowledging that his allegations are ‘based on secondhand information that [he] believes to be true.’ ” Pirelli Armstrong Tire Corp. Retiree Med. Benefits Trust v. Walgreen Co., 631 F.3d 436, 442 (7th Cir. 2011) (quoting BLACK’S LAW DICTIONARY 783 (7th ed. 1999)) (alteration in original; citations omitted). The Court has its concerns about the good faith basis for the “information and belief’ pleadings, but it is mindful that “[i]n determining whether a pleading lacked a good faith basis the court must be mindful of the fine ‘line between zealous advocacy and frivolous conduct.’ ” Knipe v. Skinner, 146 F.R.D. 58, 60 (N.D.N.Y. 1993) (quoting United States v. International Bhd. of Teamsters, 948 F.2d 1338, 1343 (2d Cir. 1991)). “Only where it is ‘patently clear’ at the time of the signing that a claim has no chance of success under existing law, and where no reasonable argument can be advanced to modify existing law are sanctions warranted.” Knipe, 146 F.R.D. at 60. The Court is only reviewing this portion of the Report for clear error, since Defendants did not lodge specific objections to it. Upon careful consideration, the Court cannot find that the Report clearly erred in denying sanctions without prejudice to renew after discovery. Since this Decision and Order is terminating this case short of discovery, the Court adopts the Report’s recommendation to dismiss the request for' sanctions, but with prejudice.
CONCLUSION
For the foregoing reasons, the Court adopts the Report and Recommendation (Dkt #26) in part and rejects it in part. The Motion to Dismiss for Failure to State a Claim (Dkt #16) is granted, and the Amended Complaint (Dkt #8) is dismissed in its entirety. The joint Motion for Sanctions and to Strike Amended Complaint (Dkt #18) is dismissed; specifically, the Motion to Strike is dismissed as moot, and the Motion for Sanctions is dismissed with prejudice.
The Clerk of the Court is directed to close this case.
SO ORDERED.
. An ICD is implanted in patients to help treat certain heart conditions and symptoms of heart failure. A lead is a thin, insulated wire that delivers electronic pulses from the ICD to the heart. Premature lead abrasion is a known and disclosed risk of harm. See Amended Complaint ("Am. Compl.") ¶ 72; Viserta v. St. Jude Med. Inc., C.A. No. 8:11-cv-00505-JMC, 2012 WL 667814, at *4 (D.S.C. Feb. 29, 2012).
. The Durata ICD and lead are categorized in the highest risk classification level (Class III) under the 1976 Medical Device Act (“MDA”), which "imposed a regime of detailed federal oversight” over medical devices. Riegel v, Medtronic, Inc., 552 U.S. 312, 316-17, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); see also 21 U.S.C. § 360c(a)(1)(C)(ii). As a Class III device, the Durata was required to undergo the FDA’s rigorous Premarket Approval ("PMA”) process, which involves an extensive application, disclosure of all investigations related to the device's safety and effectiveness, disclosure of all ingredients or device components, review of manufacturing processes and facilities, submission of device samples, and sub
. "The MDA’s pre-emption clause provides that no State " ‘may establish or continue in effect with respect to a device.. .any requirement’ ” relating to safety or effectiveness that is different from, or in addition to, federal requirements."'" Altria Grp., Inc. v. Good, 555 U.S. 70, 86, 129 S.Ct. 538, 172 L.Ed.2d 398 (2008) (quoting Riegel, 552 U.S. at 328, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)); emphasis deleted in original; ellipsis in original). In Riegel, the Supreme Court held that state-law design and manufacturing defect claims are preempted under the MDA where they impose safety requirements on medical device manufacturers that are different from, or in addition to federal requirements, btit allowed a narrow exception for state-law claims based on state-law duties that merely " ‘parallel,’ rather than add to, federal requirements.” 552 U.S. at 330, 128 S.Ct. 999 (dismissing as preempted state common-law claims related to the safety and effectiveness .of a medical device approved by FDA where plaintiffs alleged that the device violated state tort law notwithstanding compliance with the federal requirements, the state claims were preempted).
. See, e.g., Rice v. Kawasaki Heavy Indus., Ltd., No. CV-07-4031(SJF)(ARL), 2008 WL 4646184, at *10 (E.D.N.Y. Oct. 17, 2008); Spiegel v. Saks 34th St., 43 Misc.2d 1065, 252 N.Y.S.2d 852, 857-58 (1964), aff'd, 26 A.D.2d 660, 272 N.Y.S.2d 972 (2d Dept’ 1966).
. St. Jude, in connection with the Motion to Strike, submitted a screenshot from the FDA’s website showing the PMA of St. Jude’s Riata ST Optim leads, which were created by placing a second, additional layer of insulation consisting of Optim, a proprietary material, over the silicon lead body of the Riata ST leads. Malynh Decl. ¶ 5 & Ex. 4. In 2008, the FDA approved St. Jude's request to change the tradename for the Riata ST Optim lead to Durata. IcL ¶ 6 (citing http://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm ' (enter "P950022” in the PMA Number field and "1/10/2008” as both the "from” and "to” dates in the Decision Date fields; execute "Search”) (last visited June 29, 2016)).
. For essentially the same reasons, the other two cases based on Riata devices that Plaintiff cites are unhelpful to his argument. First, they involved Riata leads, and second, the plaintiff in those cases pled facts regarding the results of actual testing or examination of the explanted, defective leads. See Waltenburg v. St. Jude Med., Inc., 33 F.Supp.3d 818 (W.D.Ky. 2014) (complaint alleged externalization shown from diagnostic testing of recalled Riata lead); O'Neil v. St. Jude Med., Inc., No.
. Courts in this Circuit have dismissed complaints when presented with such similarities. See Grimes v. Fremont Gen. Corp., 933 F.Supp.2d 584, 601 (S.D.N.Y. 2013) ("The fact that so many of Plaintiff’s factual allegations are copied from pleadings in unrelated cases is an independent basis for the Court to dismiss Plaintiffs’ Civil Rights Act claims.”) (citing Triano v. Town of Harrison, 895 F.Supp.2d 526, 537 (S.D.N.Y. 2012) (dismissing municipal liability claim; plaintiff’s allegations were "troubling,” because he had “copied [a] list of 'systematic flaws’ in his Amended Complaint—which he claim[ed] supported] the existence of a municipal custom of tolerating and covering up police abuse—almost verbatim from the allegations made by another plaintiff” in a case in which the Monell claim had survived a motion to dismiss); other citations omitted).
. Here, Plaintiff alleges, inter alia, that "[u]pon information and belief, failure to crimp with a controlled, uniform, degree of force, resulted in insecure crimps, lead wire length differences both longer and/or shorter than specification for the length of the Lead.” The plaintiff in Pinsonneault similarly alleged that "[u]pon information and belief, failure to crimp with a controlled, uniform, degree of force, resulted in insecure crimps over, the length of the Lead[.]” See Dkt. #18-2, Ex. 3.
. See also Pinsonneault, 2014 WL 2879754, at *8, *9-11. (finding that there was no evidence that the FDA required the Riata leads be made with uniform insulation thickness and no evidence of any federal requirements as to curing or inclusion of a lubricious interface), Teixeria also has included allegations that St. Jude failed to follow federal requirements regarding insulation thickness, curing of the materials, and necessity of a lubricious interface.
. See Ex. I (Dkt. # 20-9) to Manna Decl. (Dkt #20) (article dated August 21, 201-2, noting that the FDA has "ordered St. Jude Medical to conduct additional studies on both the older generation of'leads, called the Riata, and the new generation of Durata leads").
Reference
- Full Case Name
- John J. TEIXERIA v. ST. JUDE MEDICAL S.C., INC., St. Jude Medical, Inc., and Pacesetter, Inc., d/b/a St. Jude Medical Cardiac Rhythm Management Division
- Cited By
- 11 cases
- Status
- Published