United States District Court, W.D. New York
JOHN J. TEIXERIA, Plaintiff,
ST. JUDE MEDICAL, INC., ST. JUDE MEDICAL S.C., INC., and PACESETTER, INC. d/b/a St. Jude Medical Cardiac Rhythm Management Division, Defendants.
REPORT AND RECOMMENDATION
HUGH B. SCOTT, Magistrate Judge.
The Hon. Richard J. Arcara referred this case to this Court under 28 U.S.C. § 636. (Dkt. No. 6.) Pending before the Court are two motions by defendants St. Jude Medical, Inc., St. Jude Medical S.C., Inc., and Pacesetter, Inc. ("St. Jude" collectively). St. Jude has moved (Dkt. Nos. 4, 16) to dismiss the amended complaint of plaintiff John Teixeira ("Teixeria") under Rule 12(b)(6) of the Federal Rules of Civil Procedure ("FRCP"). St. Jude argues that Teixeira's claims regarding his implantable defibrillator and heart lead are preempted by regulations administered by the U.S. Food and Drug Administration ("FDA"). To the extent that any of Teixeira's claims would survive preemption, they would fail to establish enough of a connection between any alleged regulatory violations by St. Jude and the injuries that Teixeira suffered. Teixeira opposes this motion by arguing that he has demonstrated how the regulatory violations led to a defective device and by arguing that his state-law claims are only parallel to any federal regulations in question.
Additionally, St. Jude has filed a motion (Dkt. No. 18) to strike a number of paragraphs from the amended complaint, under Rules 11(b)(3) and 12(f). St. Jude originally included with this motion a request to impose sanctions on Teixeira and his counsel for making factual contentions that St. Jude considered baseless. In its reply papers (Dkt. No. 24), St. Jude withdrew the request for sanctions but still asked to strike portions of the amended complaint that allegedly copied complaints from other cases that rejected those same allegations as unsubstantiated. Teixeira opposes this motion by denying that he copied any language from any other complaint and by asserting that the allegations in the amended complaint reflect original research about the history of the defibrillator and heart lead in question.
The Court has deemed the motions submitted on papers under FRCP 78(b). For the reasons below, the Court respectfully recommends granting the motion to dismiss in part and denying the motion to strike in its entirety.
This diversity case concerns an implantable cardiac defibrillator whose heart wire, or lead, had to be replaced just 14 days after implantation. On September 6, 2011, doctors implanted in Teixeira a defibrillator equipped with a particular lead called the Durata, Model No. 7121Q/65. On September 20, 2011, doctors operated on Teixeira again to replace the lead. The record contains no allegations or other information about where the replaced lead is and whether anyone has examined it.
St. Jude designed and manufactured the Durata lead and has a history of making products like it. Briefly, heart leads of any kind run from a defibrillator planted in the chest wall into the heart itself. The lead sends information to the defibrillator about irregular heart rhythms. The defibrillator, when needed, delivers electrical shocks to the heart through the lead. Among other features, the wires making up the lead are coated with insulation to prevent bodily fluids from short-circuiting the defibrillator or otherwise disrupting communication between the lead and the defibrillator. In 2002, St. Jude received FDA approval to market a predecessor to the Durata lead called the Riata lead. Over the next few years, St. Jude received FDA approval for modifications to the Riata design that led to new models and a new line of models called Riata ST. St. Jude later developed a new material, trademarked Optim, to use as insulation for leads within the Riata ST family. According to FDA databases, St. Jude initially called leads with the new material the Riata STS Optim leads. On January 10, 2008, the FDA approved a change in the trade name for this newest lead, from Riata STS Optim to Durata.
Medical devices such as the Durata lead are subject to significant oversight from the FDA, by way of the Medical Device Amendments of 1976 ("MDA"), Pub. L. 94-295, 90 Stat. 539 (1976) (codified as amended at 21 U.S.C. §§ 351-360fff-7). The MDA creates three classes of medical devices. 21 U.S.C. § 360c. The FDA has classified the Durata lead as a Class III device, which means, inter alia, that it "is to be subject, in accordance with section 360e of this title, to premarket approval to provide reasonable assurance of its safety and effectiveness." 21 U.S.C. § 360c(a)(1)(C). "Premarket approval is a rigorous process. A manufacturer must submit what is typically a multivolume application. It includes, among other things, 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. Before deciding whether to approve the application, the agency may refer it to a panel of outside experts and may request additional data from the manufacturer." Riegel v. Medtronic, Inc., 552 U.S. 312, 317-18 (2008) (internal quotation marks and citations omitted). "FDA further assures the safety and effectiveness of medical devices by regulating their manufacture. To make sure that drugs and medical devices are manufactured to the same high standards that are required for their approval, FDA has developed a set of regulations called the current Good Manufacturing Practices (GMPs). The ultimate purposes of the GMPs is enforcement of quality standards. The GMPs contain systems-oriented requirements for quality control and compliance, which serve the FDA's enforcement purposes and give operational guidance' to FDA-regulated firms. They govern personnel and organization, facilities and sanitation, equipment, component control, production and process controls, control of packaging and labeling materials, distribution and installation of devices, and records." Charles S. Zimmerman, 1 Pharm. & Med. Device Litig. § 1:20 (Westlaw 2015).
According to Teixeira's amended complaint, filed on October 15, 2014, St. Jude's Riata leads ran afoul of FDA oversight in ways that raise questions about their Durata leads. In 2012, the FDA inspected one of St. Jude's manufacturing facilities and issued warnings about noncompliance with GMPs that mentioned the Durata lead by name. ( See Dkt. No. 8 at 5.) The warnings prompted media coverage in late 2012 that raised questions about the Durata lead and about the Optim insulation. The FDA followed up its warnings with a formal warning letter to St. Jude in early -. In the warning letter, the FDA accused St. Jude of producing adulterated devices by way of manufacturing violations pertaining to product testing, verifying device design, maintaining design history files, implementing corrective and preventive actions, and misbranding the Durata lead. ( See id. at 5-10.) This warning letter came a little over a year after the FDA initiated a recall, on November 28, 2011, of Riata and Riata ST leads. The recall occurred out of concern that insulation on the Riata and Riata ST leads would fail and expose the underlying wiring. From here, Teixeira asserts upon information and belief several factors that led to defective Durata leads. These factors include: lack of consistent insulation diameters as required by federal regulations; lack of consistency in the application, preparation, and manufacturing of wire insulation; failure to follow approved processes for curing and sterilization of insulation; failure to crimp the leads as required by federal regulations; inadequate product inspections and calibrations; and inadequate training of personnel. ( See generally id. at 19-26.) Teixeira includes in his amended complaint a particular theory of how St. Jude's alleged manufacturing defects and regulatory violations manifested themselves in a lead that had to be replaced after 14 days:
A natural process of abrasion occurs in situ with the insulation surrounding the lead wires or electrical conductors. It is foreseeable that such abrasion will occur with the insulation surrounding the lead wires and the bad wires after implantation. As a result, the lead wires protrude through the insulation, causing them to be in contact with materials and fluids that can prevent the proper functioning of the ICD [the defibrillator]. This protrusion is called "externalization."
The breach of insulation and externalization of the lead wires on the Riata and Durata Leads can cause the leads 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 are unavailable.
( Id. at 21 ¶¶ 72-73.)
Teixeira's amended complaint contains six formal claims for relief. In the first claim, Teixeira accuses St. Jude of violating numerous particular regulations and thereby incurring strict liability for a manufacturing defect. In the second claim, Teixeira accuses St. Jude of negligence in manufacturing by violating its duty to manufacture the Durata lead in conformance with federal regulations. In the third and fourth claims, Teixeira asserts negligence and strict-liability theories of a failure to warn, alleging that St. Jude failed to warn him and his doctors that his lead was associated with adverse events and was unsuitable for use. In the fifth claim, Teixeira accuses St. Jude of negligent representation by failing to provide him, his doctors, and the FDA with accurate information about the reliability and safety of the Durata lead. Finally, in the sixth claim, Teixeira accuses St. Jude of breaching express and implied warranties by disseminating information that the Durata lead was safe for foreseeable and intended uses for which it was designed, manufactured, and assembled. The sixth claim includes assertions that representatives of St. Jude made personal representations to Teixeira and/or his doctors that the Durata lead was safe and long-lasting, that it would not prematurely erode, and that it would not require a surgical intervention.
St. Jude seeks dismissal of the amended complaint for two reasons. First, St. Jude asserts that Teixeira's claims are expressly and implicitly preempted. Specifically, St. Jude argues that the FDA already has approved its design, manufacturing, and labeling processes. According to St. Jude, most of Teixeira's allegations come too close to questioning those processes in themselves, which means that they improperly would add requirements beyond those in the federal regulations. To the extent that any of Teixeira's claims or allegations survive preemption, St. Jude argues that they do not connect any alleged regulatory violations to his injuries. In an effort to avoid preemption, Teixeira attempts to link his allegations of design and manufacturing defects to specific federal regulations. Citing the regulations, though, requires Teixeira to bridge the gap between administrative violations in themselves and actual harm to patients like himself. St. Jude argues that Teixeira has failed to bridge that gap and has only cribbed language from other complaints that does not address his situation. Teixeira opposes the motion by citing the specific manufacturing problems that he stated in his amended complaint and noting how those manufacturing problems each violated federal regulations. Teixeira also notes his theory of how the alleged manufacturing defects translated into a particular form of product failure that caused his injuries. Because Teixeira has linked his allegations of manufacturing defects to specific federal regulations, he asserts that he is not adding to those regulations and thus does not face preemption.
St. Jude also seeks to strike a number of paragraphs and allegations from the amended complaint. Principally, St. Jude argues that the allegations about federal regulations requiring certain manufacturing specifications are plainly false and copied from another case, Pinsonneault v. St. Jude Med., Inc., No. 12-CV-1717 PJS/JSM, from the District of Minnesota. St. Jude asserts that Pinsonneault is the case "where the false allegations originated and were thereafter adjudicated as having no merit." (Dkt. No. 24 at 8.) St. Jude also insists that Teixeira is confusing the Riata and Durata leads. St. Jude concludes that striking the allegations is necessary to protect it from having to defend itself repeatedly against copied allegations that are fabricated. Teixeira opposes this motion by denying any knowledge of Pinsonneault when he filed the amended complaint and by denying that he copied any language from any other case. Teixeira then asserts that the Durata lead derived from the Riata lead and is not a completely new device. Finally, Teixeira argues that he has conducted significant original research showing that the FDA, media outlets, and medical professionals all have raised questions about both the Durata and Riata leads, meaning that allegations about each product necessarily will have some features in common.
III. DISCUSSION-MOTION TO DISMISS
A. Motions to Dismiss ...