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Freed v. St. Jude Medical, Inc.

United States District Court, D. Delaware

September 17, 2017

KATHLEEN M. FREED, et al.
v.
ST. JUDE MEDICAL, INC., et al.

          MEMORANDUM

          KEARNEY, J.

         A patient suffering injury allegedly caused by a medical device approved by the Food and Drug Administration must carefully plead her products liability claim to fit within the narrow gap of claims where the federal approval does not preempt her state law products liability claim. Her complaint is the governing document although we may take judicial notice of the federal approvals. When the complaint does not plausibly allege the offending aspect of the approved device is not covered by the federal approval nor plausibly allege how her claims are different from or in addition to the federal requirements, we cannot find she avoids federal preemption. Today, we review a complaint which does not plausibly allege the facts necessary to avoid federal preemption but, subject to good faith obligations, the patient may be able to plead facts necessary for a products liability claim not preempted by the federal approvals. In the accompanying Order, we grant the device manufacturer's motion to dismiss the patient's products liability claims without prejudice for the patient to timely file an amended complaint.

         I. Pleaded Facts

         Christiana Hospital doctors surgically implanted a neurostimulator and battery components of a spinal cord stimulator device (the "Device") into the soft tissue of Kathleen Freed's left buttocks to address chronic lower back and lower extremity pain.[1]The St. Jude Defendants[2] designed, manufactured, marketed, distributed, and/or sold the Device for implantation in patients suffering from chronic lower back and lower extremity pain.[3] Mrs. Freed did not receive information or warning of any defects, faults, or contraindications regarding the Device.[4]

         Mrs. Freed alleges the Device "started giving off severely painful electrical shocks and a burning sensation throughout the left buttocks."[5] Her doctors removed the Device.[6] Mr. and Mrs. Freed then sued St. Jude alleging state law breach of express warranty, breach of the implied warranty of merchantability and fitness for a particular purpose, manufacture or sale of dangerous chattel, and loss of consortium.

         II. Analysis [7]

         St. Jude moves to dismiss, arguing: federal law expressly and impliedly preempts the Freeds' state law claims; the complaint fails to meet the pleading standards of Twombly and Iqbal; the claims are barred by St. Jude's warranty disclaimer; and, the derivative loss of consortium claim fails because the other claims fail. St. Jude additionally requests we take judicial notice of Food and Drug Administration ("FDA") approval letters and the device's Limited Warranty.[8]

         A. We take judicial notice of FDA approval letters only.

         We first address St. Jude's request we take judicial notice of three exhibits: a November 21, 2001 FDA approval letter for the Device (Exhibit 1); a March 21, 2014 approval letter supplementing the premarket approval application of the Device (Exhibit 2); and the Limited Warranty for the Protege Device (Exhibit 3).[9]

         Under Federal Rule of Evidence 201, we may take judicial notice of "a fact that is not subject to reasonable dispute because it: (1) is generally known within the trial court's territorial jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned."[10] We may also consider "an undisputedly authentic document that a defendant attaches as an exhibit to a motion to dismiss if the plaintiff's claims are based on the document."[11]

         The FDA approval letters "can be accurately and readily determined" from the FDA's website, a source "whose accuracy cannot reasonably be questioned." The Freeds do not object to the FDA approval letters or question the authenticity of these documents.[12] We take judicial notice of St. Jude's Exhibits 1 and 2 because they are publically available on the FDA's website and are indisputably authentic.[13]

         St. Jude argues we should also take judicial notice of the Limited Warranty for the Device because it is a document upon which the complaint necessarily relies and is central to the Freeds' breach of warranty claims. St. Jude argues the Limited Warranty cannot be reasonably disputed. We disagree. Rule 201 allows judicial notice of a fact "that is not subject to reasonable dispute" and where it can be "accurately and readily determined from sources whose accuracy cannot be reasonably questioned." Unlike the FDA's website, we have nothing to determine the source of this document and whether its accuracy "cannot be reasonably questioned." We have only the Declaration of St. Jude's counsel swearing the Limited Warranty is a "true and correct copy" of the Limited Warranty and "which [counsel is] informed and believe accompanied the Protege Spinal Cord Stimulator used" by Mrs. Freed.[14]

         We cannot say the Limited Warranty submitted by St. Jude is an "undisputedly authentic document" on which the Freeds base their claims. The Freeds object to the Limited Warranty, arguing it is not subject to judicial notice at the pleading stage and it is not a document attached to or referenced in their complaint. The Freeds concede they assert a breach of express warranty claim, but argue they do not refer or rely on the disclaimer language. The Freeds' warranty claims are based on St. Jude's marketing materials and we have no information the Limited Warranty is part of its marketing materials. We will not take judicial notice of the Limited Warranty (Exhibit 3).

         B. The Medical Device Amendments and express preemption. 1. The FDA's premarket approval process for the Device.

         The Medical Device Amendments of 1976 ("MDA")[15] requires FDA approval of medical devices intended for human use, establishing levels of oversight for medical devices depending on the risks they prevent.[16] Class III devices receive the most federal oversight, requiring a "rigorous regime" of premarket approval.[17] The FDA grants premarket approval "only if it finds there is a 'reasonable assurance' of the device's 'safety and effectiveness, '" after weighing '"any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.'"[18] The Device is a Class III device.[19]

         On November 21, 2001, the FDA granted premarket approval for the Device subject to certain conditions.[20] The conditions include approving labeling before commercial distribution and "adverse reaction and device defect reporting" requiring the manufacturer to report to the FDA any information concerning adverse reactions, side effects, injuries, or sensitivity reactions attributable to the Device not addressed by the Device's labeling or addressed by the Device's labeling but "occurring with unexpected severity or frequency."[21]

         2. The MDA's express preemption provision.

         The MDA expressly preempts state law claims challenging the safety and effectiveness of a medical device granted premarket approval by the FDA]:

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement -
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.[22]

         The Supreme Court in Riegel defined the two steps we must use in deciding whether federal law preempts state law claims regarding a Class III device: "(1) the Federal Government has established requirements applicable to the device and (2) the plaintiffs claims are based on state requirements related to safety and effectiveness that are 'different from, or in addition to' the federal requirements."[23]

         In the first step, we determine whether the FDA established requirements applicable to the Device. If there are FDA requirements applicable to the Device, we must then determine whether the Freeds' products liability claims are "different from, or in addition to" the FDA's safety and effectiveness requirements for the Device. Our court of appeals cautions "[generalized common law theories of liability ... are precisely the type of claims the MDA sought to preempt."[24]

         3. Did the FDA establish requirements for the Device?

         The FDA's approval of the Device identified its components: "the Model 3608 pulse generator, the Model 3850 patient programmer, the Model 1232 programming wand and the Model 1210 patient magnet."[25] The pulse generator implanted in Mrs. Freed is powered by an internal battery.[26] The approval letter does not specifically mention the battery used to power the pulse generator as a component of the Device.

         St. Jude asserts the first prong of the Riegel test is "irrefutably met" because the FDA granted premarket approval for the Device in its approval letter. The Freeds disagree. Although they allege injuries caused by the "device" generally, the Freeds contend the battery is "primarily at issue." The Freeds argue their allegations "relate (in large part) to the battery component" of the Device, pointing to allegations of injury resulting from a warming and burning sensation and electrical shocks emanating from the battery, [27] and "to the extent the battery component of the [Device] caused injury, those allegations fall outside the scope of the MDA's express preemption provision.[28] It appears the Freeds continue to maintain both the Device and the battery caused injury.

         To support their theory the battery caused injury, the Freeds argue the FDA's approval letter does not list the battery used to power the pulse generator as a component of the Device. Although not pleaded, the Freeds contend the battery is separate and distinct from the Device itself and is not the subject of the FDA's premarket approval process. The Freeds do not cite a case where the battery in a spinal stimulation device is found to be separate from the Device, specifically the pulse generator component.

         The cases cited by the Freeds do not support their argument the battery component is not expressly preempted. For example, in Michael v. Shiley, Inc., our court of appeals found all state law claims preempted by the MDA except for the state law claims for express warranty based on the manufacturer's packaging and fraud based on the manufacturer's advertising and promotional materials sent to physicians.[29] Michael did not hold a component part of an FDA approved device escapes the preemptive force of the MDA. The Court of Appeals for the Sixth Circuit's decision in Jacobs v. E.I. Dupont de Nemours & Co. is inapposite. There, the court addressed the specific question of whether a supplier of raw materials used in a medical device can invoke MDA preemption.[30] Here, there is no allegation the battery is "raw material" and outside the scope of MDA preemption. Similarly, Lake v. TPLC[31]does not support the Freeds' argument. In Lake, the plaintiff brought claims for injury allegedly caused by a cardiac pacemaker and pacemaker leads manufacturer by defendant Teletronics. The pacemaker underwent the FDA's premarket approval process, while the leads underwent a more relaxed premarket process where the FDA found the lead "substantially equivalent" to devices already on the market. The court found claims involving the lead were not preempted by the MDA, rejecting Teletronics' argument the premarket approval of the pacemaker should be considered the equivalent to premarket approval of the leads, and thus preempted. The court found Teletronics' argument "would seem to depend on the scope and scale and the evaluation of the system."[32]

         We are left with no allegations the battery underwent a separate review process from the pulse generator to bring it outside the scope of MDA preemption. Based on the allegations as currently pleaded, we find the Device includes the battery and is subject to federal regulation and the MDA's express preemption.

         4. Are the Freeds' claims based on parallel federal requirements?

         We next determine the second prong of the Riegel test - whether the Freeds' state law claims impose requirements different from, or in addition to, federal requirements. Under the second prong, the Freeds' claims will be preempted under the MDA "only to the extent that they are 'different from, or in addition to, ' the requirements imposed by federal law."[33] Preemption does not apply where a state's law "parallels" federal requirements.[34] A "parallel" claim "must show a link between a specific violation of an FDA regulation and the plaintiffs' injury."[35]

         St. Jude argues none of the Freeds' state law claims parallel the federal scheme and they otherwise fail to plead facts the Device failed to comply with federal requirements. The Freeds concede their complaint "does not reference specific federal regulations" and ask for leave to amend their complaint. Nevertheless, the Freeds argue their claims are parallel to federal requirements, pointing to federal regulations pertaining to labeling and compliance with good manufacturing practices post-approval raises questions whether St. Jude complied with federal requirements.[36] The problem is the Freeds, by their own admission, fail to plead the Device failed to comply with a federal regulation.[37]

         Restatement ...


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