MARK A. KEARNEY, District Judge.
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.
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.
The St. Jude Defendants
Mrs. Freed alleges the Device "started giving off severely painful electrical shocks and a burning sensation throughout the left buttocks."
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.
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 Protégé Device (Exhibit 3).
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."
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.
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 Protégé Spinal Cord Stimulator used" by Mrs. Freed.
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).
The Medical Device Amendments of 1976 ("MDA")
On November 21, 2001, the FDA granted premarket approval for the Device subject to certain conditions.
The MDA expressly preempts state law claims challenging the safety and effectiveness of a medical device granted premarket approval by the FDA]:
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 plaintiff's claims are based on state requirements related to safety and effectiveness that are `different from, or in addition to' the federal requirements."
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 "[g]eneralized common law theories of liability . . . are precisely the type of claims the MDA sought to preempt."
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."
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,
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.
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.
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."
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.
The Freeds argue their claim under Delaware law for "manufacture or sale of dangerous chattel"
Here, the Freeds do not allege St. Jude failed to comply with FDA regulation. We cannot find their § 388 claim, as currently pleaded, is parallel to any federal regulation.
The Freeds argue the MDA's preemption provision does not apply to their breach of express warranty claim because it arises from the parties' contract and the warranties are the basis of their bargain with St. Jude. Under Delaware law, a claim for breach of express warranty is based on state statute.
The Freeds rely on case law holding express warranties arise from the parties' representations, not from operation of state law and, consequently, not preempted by the MDA. For example, in Davenport v. Medtronic, Inc., the court found the MDA did not preempt plaintiff's express warranty claim because plaintiff based his claim on a limited warranty applicable to the device.
The Freeds do not plead the basis of their express warranty claim. In their response to St. Jude's motion, the Freeds argue their complaint does not "refer to or rely upon the disclaimer language" of the Limited Warranty, but do not clarify or explain the basis of the warranty claim.
The Freeds similarly fail to explain the basis of their breach of the implied warranties of merchantability and fitness for a particular purpose. For the reasons explained in finding the breach of express warranty defective, we find the implied warranties claim does not articulate parallel claims.
Finally, the Freeds argue the MDA "does not preempt claims that the implanted device was adulterated." Class III devices not receiving premarket approval are "adulterated."
The Freeds argue their allegations of burns and shocks in the implant area and "the recall campaign evidence" creates a reasonable inference the Device "was adulterated but nevertheless made it through the manufacturing and quality control process regulated by the [premarket process]." We disagree the complaint makes this allegation or that a reasonable inference of adulteration could be drawn from the complaint. We will not allow "recall campaign evidence" — presumably recall notices attached as exhibits to the Freeds' response — to amend the complaint. The complaint simply fails to allege the Device is "adulterated." There are no allegations of how the Device became adulterated in violation of federal regulation and we cannot determine the contours of any adulteration claim. It is additionally unclear which of the Freeds' five state law claims purport to articulate an adulteration claim to determine whether the state law claim or claims are parallel to the federal scheme or are different from or add to the federal scheme for purposes of our preemption analysis.
St. Jude also argues even if the Freeds' claims survive express preemption, their claims are impliedly preempted. The Freeds' response does not address the implied preemption argument.
"Implied preemption is based on the fact that any suit to enforce the [Food, Drug, and Cosmetic Act] `shall be by an in the name of the United States.'"
The Freeds do not presently allege facts necessary to overcome federal preemption arising from FDA's approval of the Device. They may be able to do so with an amendment. In the accompanying Order, we grant St. Jude's motion to dismiss without prejudice to the Freeds timely filing an amended complaint.
Our Court of Appeals requires us to apply a three-step analysis under a 12(b)(6) motion: (1) "it must `tak[e] note of the elements [the] plaintiff must plead to state a claim;''' (2) "it should identify allegations that, `because they are no more than conclusions, are not entitled to the assumption of truth;' and, (3) "[w]hen there are well-pleaded factual allegations, [the] court should assume their veracity and then determine whether they plausibly give rise to an entitlement for relief." Connelly v. Lane Construction Corp., 809 F.3d 780, 787 (3d Cir. 2016) (quoting Iqbal, 556 U.S. at 675, 679).
(1) Express warranties by the seller are created as follows:
(a) Any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise.
(b) Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description.
(c) Any sample or model which is made part of the basis of the bargain creates an express warranty that the whole of the goods shall conform to the sample or model.
6 Del.C. § 2-313(1).
