Babayev v. Medtronic, Inc. (228 F. Supp. 3d 192, 2017)

MEMORANDUM AND ORDER

TOWNES, United States District Judge:

Plaintiff Mikhail Babayev (“Plaintiff’) brings this torts action against defendant Medtronic, Inc. (“Defendant” or “Medtronic”), seeking to recover damages for a hip fracture he allegedly sustained as a result of an electric shock he received following the implantation of a neurostimulator manufactured by Defendant. Defendant now moves for summary judgment, principally arguing that the Medical Device Amendments to the Food, Drug and Cosmetics Act preempts each of the five causes of action contained in Plaintiffs Amended Complaint. Plaintiff opposes the motion and cross-moves for spoliation sanctions, urging the Court to either strike Defendant’s answer or draw an adverse inference that would permit the conclusion that Plaintiff has made out a prima facie case of products liability and negligence. For the reasons set forth below, Plaintiffs cross-motion for spoliation is denied and Defendant’s motion for summary judgment is granted.

BACKGROUND

The following facts are undisputed. Plaintiff, who emigrated from Uzbekistan in 1993 and is now in his mid-50s, was diagnosed with multiple sclerosis in 2000. (Defendant’s Statement of Facts Pursuant to Local Rule 56, 1 (“Defendant’s 56,1 Statement”), ¶¶ 1-2; Plaintiffs Counter-Statement Pursuant to Local Rule 56.1 (“Plaintiff’s 56.1 Counter-Statement”), ¶¶ 1-2; Deposition of Mikhail Babayev (“Babayev Deposition”), pp. 8-9). As a result of that condition, he suffered constant pain. (Defendant’s 56.1 Statement, ¶ 2; Plaintiffs 56.1 Counter-Statement, ¶ 2). In 2005, one of Plaintiffs neurologists referred him to Dr. Isaac Kreizman, who specializes in pain management. (Babayev Deposition, pp. 37-39; Deposition of Isaac Kreizman (“Kreizman Deposition”), p. 59).

At first, Dr. Kreizman treated Plaintiffs lower back pain with epidural injections of steroids. (Babayev Deposition, pp. 38-39; Kreizman Deposition, p, 59). After a while, the injections became less effective in that they provided relief for a shorter period. (Babayev Deposition, pp. 40, 45). In- November 2006, Dr. Kreizman proposed trying a spinal cord stimulator to see if it would provide any relief. (Babayev Deposition, pp. 40-41; Kreizman Deposition, pp. 66-67). According to Plaintiff, either Dr. Kreizman or a representative of the stimulator’s manufacturer who was in .the office at the time, provided him with “CDs and some literature or materials” relating to the neurostimulation system which Dr. Kreizman proposed using. (Babayev Deposition, p. 42).

Although Plaintiff was unable to produce the materials he received from Dr. Kreiz-man, Plaintiffs counsel has provided the Court with promotional literature and technical manuals relating to the Medtronic Restore Rechargeable Neurostimulation System (the “System”) which was used, to treat Plaintiff. The Declaration of Serhiy Hoshovsky (“Hoshovsky Declaration”) attaches a 36-page booklet entitled, “Test Stimulation System: Preparing For Your Screening Test” (hereafter, the “Booklet”) as Exhibit D; a 90-page “Percutaneous Lead Implantation Guide” (hereafter, the “Guide”) as Exhibit' E; an 18-page “Implant Manual” for Model 3776, 3777, 3778, 3876, 3877, and 3878 Leads as Exhibit F; a 30-page document entitled “Medtronic Pain Therapy: Using neurostimulation for chronic pain,” which purports to provide “Information for prescribes”' (the “Prescri-ber’s Booklet”) as Exhibit G; a 155-page users manual for “Patient Programmer” Model 37742 (the “Manual”) as Exhibit H, and an 84-page “Surgical Lead Implantation Guide” as Exhibit J.

The Hoshovsky Declaration does not indicate which, if any, of these six documents Plaintiff received. However, the Manual lists three documents which a patient “should receive during test stimulation.” (Hoshovsky Declaration, Ex. H., p. 15). The Manual itself is one of those documents listed. (Id.), The Court notes that the Manual and the Booklet are the only two of' the six documents which directly address patients. The other four documents are technical literature for clinicians.

The System

The Court has reviewed all six documents in order to obtain a complete understanding of the System and its operation. The System is designed to send electrical pulses to the spinal cord area so as to block pain signals from reaching the brain. (Id., Ex. D, p. 4). During a test of the device, the pulses are generated by an “external neurostimulator” or “ENS” that contains electronics and two AA alkaline batteries. (Id., Ex. D, p. 22, Ex. H., p. 41). The pulses are transmitted through a “Lead,” a thin, coated wire which has small metal electrodes at the tip. (Id., Ex. H, p. 42). In cases where the Lead is not long enough, a thin, coated wire “Extension” is used. (Id.).

The System is designed so that the strength, duration and frequency of the pulses can be adjusted by the patient. (Id., Ex. D, p. 15). These three parameters— which Medtronic calls amplitude, pulse width and rate—are controlled by use of a “Patient Programmer,” a hand-held device which resembles a calculator in that it has several buttons and an LED display. (Id. pp. 13-15). There is a small internal antenna on the back of the device which permits the Patient Programmer to transmit the desired parameters to the ENS via telemetry. (Id., Ex. H, p. 54).

During a trial of the System, the electrode-bearing end of one or two Leads is surgically implanted into the patient’s epidural space—the area just outside the sac of fluid that surrounds the spinal cord. (Id., Ex. E, pp. 20-28). This procedure is performed using a Touhy needle, a relatively large hypodermic needle with a curved point. (Id., p. 20). Once the needle is inserted into the epidural space, a Lead is passed through the needle and advanced to the desired location. (Id., pp. 25-26). Fluoroscopy—“a type of medical imaging that shows a continuous X-ray image on a monitor, much like an X-ray movie” (http://www.fda.gov/Radiation-Emitting Products/RadiationEmittingProductsand Proeedures/Medicallmaging/MedicalX-Rays/ucmll5354.htm)—is used throughout the procedure to ensure the correct placement of the needle and the Lead. (Hoshovsky Declaration, Ex. E, pp. 20, 27).

After the Lead is placed as desired, the non-implanted end of the Lead is then placed in a “Snap-Lip Connector” (a “Connector”), a small box containing grooves into which the non-implanted end of a Lead fit. {Id., p. 29). Once the Lead is positioned in a groove, the lid to the Connector is snapped shut and a cable emanating from the Connector is plugged into the ENS. {Id.). Once it is plugged in, the Connector connects the ENS with the Lead and permits the pulse generated by the ENS to be transmitted to the electrodes.

After the Lead(s) are implanted and the Connector is plugged into the ENS, the patient is awakened in the operating room so that a clinician can conduct “Intraopera-tive Test Stimulation.” (Id., pp. 33-35). The Guide provides a protocol for conducting this procedure. First, the clinician must “[e]nsure that the patient can provide immediate feedback.” (Id. p. 34). To make this possible, the implantation must be performed under local anesthesia with sedation, which must be monitored “closely to maintain comfort and to ensure that the patient can understand and respond during intraoperative test stimulation.” (Id. p. 16).

Next, after attaching a Clinician Programmer to the ENS, the clinician increases the amplitude while “askfing] the patient closed ended questions to identify: Perception threshold (the amplitude at which the patient first perceives paresthe-sia) [and] Discomfort threshold (the amplitude at which paresthesia is beyond the patient’s tolerance or described as uncomfortable).” (Id. p. 34), The clinician then adjusts the three parameters “until the pain area is covered and the patient has satisfactory paresthesia coverage.” (Id). If satisfactory paresthesia coverage is not attained, even after changing “electrode settings,” the Lead(s) can be repositioned. (Id). The Guide directs the clinician to “[r]eeord all settings and patient responses to stimulation in the patient’s chai't.” (Id. p, 35). In addition, the Guide directs the clinician to “[ojbtain baseline fluoroscopy images to record the lead position” and to place the images in the patient’s file. (Id).

In boldface print contained in a highlighted text box labeled “CAUTION,” the Guide warns that the patient may receive “uncomfortable or unexpected stimulation (jolting or shocking sensation)” if the amplitude is not decreased to zero volts before the ENS is turned on or before the Connector is plugged into the ENS. (Id. p. 34). The Guide repeats this warning after an instruction which directs the clinician to turn off the ENS after the testing is complete. In a text box entitled “NOTE,” the Guide states: “Decreasing the amplitude to 0.0 V before turning the ENS off may prevent possible uncomfortable or unexpected stimulation when the ENS is turned back on.” (Id. p. 35).

Similar warnings are contained in the Booklet, which is written for 'patients, not clinicians. On page 22 of the Booklet, under the heading “Replace the External Neurostimulator Batteries,” are two italicized “Cautions.” The second reads:

Before changing batteries, always decrease all amplitudes to the lowest settings, turn OFF the external neurosti-mulator and then disconnect the cable from the external neurostimulator to prevent possible uncomfortable or unexpected stimulation when stimulation is turned ON. (Id., Ex. D, p. 22).

Although the Booklet does not caution the patient about other possible causes of uncomfortable or unexpected stimulation, the Manual states that a “jolting or shocking sensation” may have several causes other than a failure to turn the amplitude to zero. First, the Manual notes that “strong sources” of electromagnetic interference (“EMI”) can result in “[unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent stimulation, which some patients have described as a jolting or shocking sensation.” (Id., pp. 24-25). While the Manual maintains that an “unexpected change in stimulation ... does not ... injure a patient directly,” it acknowledges that “[i]n rare cases, as a result of the unexpected changes in stimulation, patients have fallen down and been injured.” (Id., p. 25). The Manual also acknowledges that certain “household items,” such as cellular telephones, can create enough EMI to cause a “momentary increase in stimulation.” (Id., pp. 26, 136-37).

Second, the Manual states that “changes in posture ... can cause a perceived increase in stimulation, which some patients have described as uncomfortable stimulation (a jolting or shocking sensation).” (Id., pp. 34-35). The Manual explains that some movements, such as leaning back, “may cause the lead to move closer to your spinal cord,” which “can increase the sensation of stimulation.” (Id., p. 48). It lists various activities to avoid, including “reaching over your head,” “turning from side to side,” and “bending forward, backward, or from side to side.” (Id., p. 49). The Manual notes that sudden changes in stimulation from this cause “are most common during recovery.” (Id., p. 48).

Third, the Manual implies that patient error in operating the System can cause a jolting or shocking sensation. It notes that the clinician can create “groups” that provide stimulation to one or more pain sites, for use during certain activities. (Id., p. 43). The Manual cautions that use of a group other than the one recommended for a particular activity “may result in uncomfortable or unexpected stimulation (jolting or shocking sensation) when stimulation is turned ON.” (Id., p. 73).

While these are the only potential causes of jolting or shocking listed in the Manual, the “Prescriber’s Booklet” alludes to others. This document contains an “Adverse events summary,” which includes “Changes in stimulation ... which has been described by some patients as uncomfortable stimulation (jolting or shocking sensation).” (Id., Ex. G, p. 17). The Prescriber’s Booklet states that changes in stimulation may be “related to cellular changes around the electrode(s), shifts in electrode position, loose electrical connections, [and] lead- or extension fractures.” (Id.).

Plaintiff’s Procedure

The parties do not agree on the details of what occurred before, during, and after the surgical procedure to implant Leads in Plaintiffs back. It is beyond dispute that the procedure took place on the morning of Friday, February 23, 2007. The parties agree that Dr. Kreizman and a Medtronic representative, Michael Baker, were both present in the operating room. (Defendant’s 56.1 Statement, ¶¶ 20-21; Plaintiffs 56.1 Counter-Statement, ¶ 20-21). Although the parties may not agree on precisely who did what, there appears to be no doubt that Dr. Kreizman, assisted by Dr. Richard A. Gasalberti, implanted the Leads and that Baker “tested” or “adjusted” the System. (Defendant’s 56.1 State-raent, ¶¶ 20-23; Plaintiffs 56.1 Counter-Statement, ¶¶ 20-23).

By all accounts, Plaintiff himself connected the components while unattended in the recovery room. (Defendant’s 56.1 Statement, ¶ 25; Plaintiffs 56.1 Counter-Statement, ¶26). When he did so, he received an electric shock so severe as to prompt Plaintiff to disconnect the System with his teeth. (Id.). Baker was alerted to the incident and returned to the recovery room, where he removed the ENS and Patient Programmer. (Plaintiffs 56.1 Counter-Statement, ¶ 25; Baker Deposition, p. 59). Although the now-dysfunctional Leads were still implanted in his back, Plaintiff opted to go home. (Defendant’s 56.1 Statement, ¶ 25; Babayev Deposition, p. 62),

That evening, Plaintiff felt worse and returned to the hospital by ambulance or ambulette. (Defendant’s 56.1 Statement, ¶ 26; Plaintiffs 56.1 Counter-Statement, ¶26; Babayev Deposition, pp. 62-63). Thereafter, Dr. Kreizman removed the Leads and Connector. (Defendant’s 56.1 Statement, ¶27; Plaintiffs 56.1 Counter-Statement, ¶ 27). According to Plaintiff, he remained in the hospital in excruciating pain for over a week before a March 2, 2007, X-ray revealed a hip fracture. (Ba-bayev Deposition, pp. 102-04; Amended Complaint, 124). Plaintiff was subsequently transferred to the Hospital for Special Surgery, where he underwent bilateral hip replacement surgery on March 4, 2007. (Amended Complaint, ¶ 25).

Plaintiff’s Legal Actions

• At least initially, Plaintiff was uncertain as to the cause of his hip fracture. At first, Plaintiff attributed the fracture to medical malpractice during the implantation surgery. Sometime in 2007, plaintiff commenced a medical malpractice action against the hospital and Drs. Kreizman and Gasalberti in the Supreme Court of the State of New York, Kings County. Plaintiff and both doctors were deposed in the course of that action: Plaintiff on March 10 and 26, 2009; Dr. Kreizman on February 12, 2010; and Dr. Gasalberti on February 23, 2010. Both Plaintiff and Defendant have submitted the transcripts of Dr. Kreizman’s deposition and Plaintiffs March 10, 2007, deposition to the Court in connection with their motions. (Hoshovsky Declaration, Exs. A & B; Declaration of Shaina Stahl (“Stahl Declaration”), Exs. A & B). In addition, Defendant has submitted a transcript of Dr. Gasalberti’s deposition (Stahl Declaration, Ex. C), and Plaintiff has submitted a transcript of his March 26, 2009, deposition. (Hoshovsky Declaration, Ex. A).

Although these depositions reflect that none of the participants recall the events surrounding the February 23, 2007, surgery precisely, there is some consensus as to what occurred in Plaintiffs case. According to Dr. Gasalberti, once a patient is identified as a candidate for a neurostimu-lator trial, a doctor generally provides the patient with pamphlets, and a video to review. (Gasalberti Deposition, pp. 58-59). On a subsequent visit, the patient is introduced to a Medtronics representative, who can provide further information. (Id., 59). If the patient agrees to the trial, the Med-tronics representative educates the patient about the System both before and after the surgery. (Id., 39, 57).

Although Dr. Gasalberti did not know whether this procedure was followed in Plaintiffs case, he testified that Dr. Kreiz-man generally follows this procedure. (Id., pp. 59-60). This testimony is consistent with the. recollections of both Plaintiff and Dr. Kreizman. Plaintiff recalled having at least two conversations regarding the neu-rostimulator with pain management specialists: first with a Dr. Mogliner and later with Dr. Kreizman. (Babayev Deposition, pp. 29, 32-33). Plaintiff recalled that Dr. Mogliner described that the neurostimulator worked by emitting “electrical impulses,” and provided him with “some disks and some magazines” regarding the device. {Id., p. 33).

Plaintiff subsequently discussed the neurostimulator with Dr. Kreizman. He recalled that, at some point, he met a representative of the neurostimulator’s manufacturer in the presence of Dr, Kreizman. {Id., p. 42). At his deposition, Plaintiff could no longer recall the name :of the manufacturer, but remembered receiving “CDs and some literature or materials” that were “the same” as what he had previously received from Dr. Mogliner. {Id., p. 42), However, Plaintiff testified that he no longer had those items because his wife threw them out. {Id. p. 34).

Dr. Kreizman recalled that he first broached the possibility of a neurostimulator trial with Plaintiff during his office visit on November 1, 2006. (Kreizman Deposition, p. 66-67). Dr. Kreizman, who is fluent in both Russian and English, recalled describing the possible complications of the surgery, using‘whichever language Plaintiff “felt more comfortable with.” {Id., p. 68). Although the doctor could not recall precisely what complications he discussed, he stated that he “reviewed aE of the complications that Medtronic provides ... as possible complications of the procedure.” {Id., pp. 69-70). According to Dr. Kreizman, the complications are also described in “education material from Med-tronics,” which is provided to prospective patients {Id., pp. 52, 55).

Dr. Kreizman recalled that Plaintiff agreed to undergo the trial at an office appointment on November 9, 2006. (Kreiz-man Deposition, p. 72). There is no evidence to suggest that Plaintiff was ignorant of the possible complications at that time. To the contrary, Plaintiff testified that Dr. Kreizman and the representative “described everything, like the color .’’.(Ba-bayev Deposition, p. 44). In addition, Plaintiff testified that he spoke with another physiatrist, Dr. Fuzaylov, about the procedure, and that Dr. Fuzaylov thought it was a good idea. (Id. pp. 44-45).

In their deposition testimony, Plaintiff and the doctors agreed with respect to some aspects of what took place on the day of the surgery. Everyone agreed that Plaintiff was under anesthesia at the beginning of the procedure. (Babayev Deposition, p. 60; Kreizman Deposition, p. 79; Gasalberti Deposition, pp. 17-18). Neither Dr. Kreizman nor Dr. Gasalberti was asked about the type of anesthesia that was used, though Dr. Gasalberti volunteered that he had “forgot[ten] which anesthesia the-patient had.” (Gasalberti Deposition, p. 18). Plaintiff recalled receiving “something” that made him tired (Babayev Deposition, pp. 55, 60), but expressed uncertainty as to what it was. At one point he testified, “I believe I had some ... local anesthesia,” {id., p. 91),' then equivocated, stating “probably it was not local anesthesia.” {Id).

Regardless of the type of anesthesia used, everyone testified that Plaintiff was awakened from the surgery to participate in the testing of the System. Dr. Kreizman testified that the testing began as soon as Plaintiff was awake and able to speak. (Kreizman Deposition, p. 80). He specifically recalled that Baker conducted the testing in his presence, and that Plaintiff stated that “he felt good.” {id, 79-80).

Plaintiff testified that the first thing he remembered after surgery was “some person next to [him],” “doing some adjustments” with “some kind of equipment.” (Babayev Deposition, p. 57). The person asked him about his condition, inquiring about how he felt and what he felt. {Id). Plaintiff identified the person as a “technician” or “Representative,” and thought that he was Michael Baker, the same technician or representative with whom he had spoken in Dr. Kreizman’s office. (Id., pp. 58-59,118-19).

Dr. Gasalberti did not remember the “exact specifics” of the conversation that occurred after Plaintiff was awakened in the operating room. (Gasalberti Deposition, p. 31). However, the doctor testified that the patient is generally questioned regarding whether he is comfortable or in pain and whether the device is providing “good coverage.” (Id., pp. 19, 31). In addition, Gasalberti recalled that the patient’s statements are “recorded,” and there is “multiple imaging” to ensure that the Leads are in the right place. (Id., p. 19).

After the surgery, Plaintiff was wheeled to the recovery room. According to both Dr. Kreizman and Plaintiff, Baker made further adjustments to the System there. (Kreizman Deposition, p. 81; Babayev Deposition, p. 59). Dr. Kreizman specifically recalled that Plaintiff “felt comfortable with the stimulation,” and that he told Plaintiff he was “pleased that he responded well.” (Kreizman Deposition, pp. 81-82). Plaintiff recalled Baker “was doing adjustments,” while asking Plaintiff what he felt and on what side he felt the stimulation. (Babayev Deposition, pp. 59, 63). Although Plaintiff testified that Baker did not show him how to make those adjustments (id., pp. 63-64), he also testified that Baker “showed [him] everything,” including how to place the ENS into the pocket of a belt. (Babayev Deposition, p. 59).

The shocking incident occurred in the recovery room shortly after Baker left Plaintiff with instructions to get dressed and go home. (Babayev Deposition, p. 61). Plaintiff dressed with the help of his son and a home attendant. (Id.). Then, as instructed by Baker, he plugged the Connector into the ENS. (Id., pp. 84, 87). According to Plaintiff, he received an electric shock as soon as he connected the System. (Id., p. 92). The shock caused a “horrible spasm” that made him jump up for a “very short time.” (Id., pp. 61, 93). Plaintiff did not fall but immediately disconnected the System with his teeth. (Id., pp. 123, 125-26).

Following the incident, the hospital staff attempted to locate Dr. Kreizman, but he had already left the hospital. (Id., p. 84). They succeeded in reaching Baker, who returned to the recovery room. (Id.). According to Plaintiff, Baker took the “device and placed it in his pocket.” (Id., pp. 67, 84). After telling Plaintiff to follow up with Dr. Kreizman on Monday, Baker left the room. (Id., pp. 67, 84-85).

Although Plaintiff described his condition as “very bad,” he was sent home in a wheelchair within hours after the incident. (Id., pp. 65, 103). There, his condition worsened and he returned to the hospital that evening via ambulance or ambulette, allegedly screaming in pain. (Id., pp. 63, 69, 103). Two or three hours later, Dr. Kreizman surgically removed the Leads. (Id., p. 63).

Although the hip fracture was not discovered until more than a week thereafter, Plaintiff claims that he was told by a pain management doctor that a shock-induced spasm caused his hip fracture. (Id., pp. 105, 123). However, Plaintiff could not recall the name of the doctor, (id., p. 105), and has produced no medical records or admissible evidence to support this assertion.

The Instant Action

On February 23, 2010, plaintiff Mikhail Babayev (“Plaintiff’) commenced a torts action in the Supreme Court of the State of New York, Kings County, against Defendant. Although Plaintiff had already testified that he suffered the electric shock in the recovery room, and both Drs. Kreiz-man and Gasalberti had already testified that Plaintiff did not fall at any time during surgery (Kreizman Deposition, p. 102; Gasalberti Deposition, p. 25), the complaint alleged that plaintiff sustained a fracture of his left hip while still “under anesthesia and during surgery.” (Complaint, ¶ 6). The pleading alleged two causes of action: medical malpractice and ordinary negligence. Both causes of action relied primarily on the doctrine of res ipsa liquitor, noting that “a hip fracture is not ordinarily suffered during ... surgery in the absence of ... negligence.” (Id., ¶¶ 19, 25).

After the action was removed to this Court on diversity grounds, Defendant filed a pre-motion conference request, seeking permission to move to for summary judgment. (See Letter to Hon. Sandra L. Townes from John P. Lavelle, Jr., dated May 25, 2012). Although the complaint alleged only medical malpractice and negligence, Defendant construed the pleading as challenging “the design, manufacturing methods, testing, marketing, and labeling of the ... System” and argued that such claims are preempted by the Medical Devices Amendments (the “MDA”) to the Food, Drug, and Cosmetics Act (the “FDCA”). (Id., p. 2). Plaintiffs response to the pre-motion conference request suggested theories of liability which were not specifically alleged in the complaint. (See Letter to Hon. Sandra L. Townes from Serhiy Hoshovsky, dated May 30, 2012).

At a pre-motion conference on May 16, 2013, the Court directed Plaintiff to file an amended complaint. That Amended Complaint, which was filed on June 28, 2013, changed the theory of the case. Instead of arguing that Plaintiff suffered the electric shock and sustained the fracture while under anesthesia during surgery, the amended pleading alleges that the shock occurred after the surgery, after Baker directed Plaintiff to get dressed and to connect the components of the System. (Amended Complaint, ¶¶ 14-16). Specifically, the Amended Complaint alleges that “[a]s soon as Mr. Babayev connected the components of the ... System, he suffered severe electric shock and spasm that threw him up in the air causing excruciating pain.” (Id., ¶ 16).

Plaintiffs Amended Complaint raises five state-law causes of action: strict product liability, negligence, breach of the implied warranty of merchantability, breach of an unspecified express warranty, and failure to warn. The first cause of action is predicated on the assertion that the System was defective or adulterated, either because 1) the System as approved by the FDA was defective or 2) the components used in Plaintiffs case did not meet the premarket approval requirements or the Current Good Manufacturing Practices (“CGMPs”) established by FDA regulation. The Amended Complaint, however, does not allege facts 'suggesting how that System was defective or adulterated.

Plaintiffs second cause of action appears to incorporate four different theories of negligence. First, it retains the reference to res ipsa loquitor, asserting that this doctrine is applicable because “a proximal femur fracture is not ordinarily suffered during lumbar surgery in the absence of negligence.” (Amended Complaint, ¶ 67). The Court assumes that Plaintiff simply forgot to omit this theory, which is inconsistent with Plaintiffs own testimony that the incident occurred after, not during, the surgery.

Second, the second cause of action alleges that Defendant was negligent because it did not “properly design, manufacture, package, label, store, market, retail, distribute, supply, install, inspect, test, program, service, document proper installation, [or] maintain records .... ” (Amended Complaint, ¶ 57). Third, it alleges that Defendant was negligent in failing to remedy defective conditions or installation techniques, and failing “to attend to [Plaintiffs needs in a timely manner (Id,, ¶63). The Amended Complaint does not allege facts with respect to either of these theories.

In contrast, the second cause of action does allege some facts in support of its fourth theory; that Defendant was negligent in violating CGMPs requiring that Defendant (1) “receive, review, evaluate and investigate [Plaintiffs] complaint and injuries” and (2) “properly install and test” its devices. (Id., ¶¶ 58, 62). First, the pleading alleges that 21 C.F.R. § 820,198 requires “Medtronic to receive, review, evaluate and investigate complaints and injuries that resulted from its devices, such as the ... System.” (Id., ¶ 43). It alleges that Medtronic did not do so, noting that Medtronic did not file “the required Medical Device Report with the FDA until July 30,-2010, more than three years after the event.” (Id., ¶¶ 44-45).

Second, the Amended Complaint quotes 21 C.F.R. § 820,170, which provides, inter alia, that “[t]he person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer’s instructions and procedures and shall document the inspection and any test results to demonstrate proper installation.” (Id,, ¶ 28). The pleading alleges that Defendant violated this CGMP in five respects. First, it alleges that general, rather than local, anesthesia was used during the installation of the System, and that the use of general anesthesia rendered Plaintiff unable to provide feedback during the intraoperative testing. (Id., ¶¶ 30-35). Second, the Amended Complaint alleges that Plaintiff was not detoxified from narcotics prior to the testing of the System, making it impossible to properly assess the operation of the System. (Id., ¶¶ 36-37). Third, the pleading alleges that Defendant failed to ascertain that the Leads were in the correct place and to properly document the installation of the System by, inter alia, documenting the Lead positions that provided the appropriate stimulation and taking fluoroscopic images of the Lead positions. (Id., ¶¶ 38-39). Fourth, the Amended Complaint alleges that Medtronic failed to ascertain that Plaintiff could properly operate the System. (Id., 1142). Fifth, the pleading alleges that Medtronic did not properly program the System in that Baker failed to reduce the amplitude to zero volts before telling Plaintiff to plug the Connector into the ENS. (Id., ¶¶ 40-41).

The third and fourth causes of action assert a breach of the implied warranty of merchantability and breach of an express warranty, respectively. The third cause of action alleges that the System was unfit for its ordinary purpose in that it was “adulterated within the meaning of 21 U.S.C. § 351(h).” (Id., ¶ 72), The fourth cause of action alleges that, since the System was “adulterated,” Defendant breached an “express warranty for goods under New York UCC by representing that the ... System was designed, manufactured, packaged, labeled, stored, marketed, retailed, distributed, supplied, installed, tested, programmed and serviced within the specifications set forth in the PMA” and was “safe and effective for [its] intended purpose.” (Id., ¶ 75). However, neither cause of action alleges how the System was adulterated, other than to assert that “[n]umerous rules and regulations and Medtronic’s own instructions were violated during the designing, manufacturing, packaging, labeling, storing, marketing, retailing, distributing, supplying, installing, testing, programming and servicing of the ... System ....” (Id., ¶ 71).

The fifth and final cause of action alleges a failure to warn. This cause of action encompasses two different theories. First, the cause of action alleges that Defendant knew or should have known 1) that the System was adulterated and 2) that numerous rules and regulations and Med-tronic’s own instructions were violated during the designing, manufacturing, packaging, labeling, storing, marketing, retailing, distributing, supplying, installing, testing, programming and servicing of the ... System,” but failed to warn plaintiff of these facts. (Id., ¶¶ 81-83). Second, the cause of action alleges that Defendant not only failed to provide warnings in a language Plaintiff could understand, but also failed to 1) “instruct, educate and provide necessary information with respect to ... operation of the ... System,” or 2) “ascertain that Mr. Babayev could connect, use and operate the ... System.” (Id., ¶¶ 83-85).

Defendant’s Motion for Summary Judgment

Defendant now moves for summary judgment. Defendant principally argues that the System is a Class III medical device and that Plaintiff’s state-law claims are preempted by the MDA’s preemption provision, 21 U.S.C. § 360k. In support of this argument, Defendant has introduced evidence that the System is a Class III medical device and that the individual components of the System have received pre-market approval. (Declaration of Chris Christiansen, dated June 20, 2014 (the “Christiansen Declaration”), ¶¶ 6, 9 & Ex. B). Defendant has also introduced evidence that the Leads and Connector specifically identified in Plaintiffs hospital records were manufactured, inspected, tested, packaged, and labeled in accordance with the premarket approval requirements. (Affidavit of Glenda Boodoosingh, dated June 23, 2014 (the “Boodoosingh Affidavit”), ¶¶ 5, 13-15 & Ex. D (Lead); Affidavit of James Millin, dated June 23, 2014 (the “Millin Affidavit”), ¶¶3, 13-15 & Ex. C (Connector)), Although Plaintiffs hospital records do not specifically identify the ENS or Programmer used in Plaintiffs trial, Defendant has provided evidence that the ENS and Programmer assigned to Baker at the time of Plaintiffs -surgery were also manufactured, inspected, tested, packaged, and labeled in accordance with the premarket approval requirements. (Affidavit of Lisa Montgomery, dated June 23, 2014 (the “Montgomery Affidavit”), ¶¶ 7-8, 16-19, Exs. K & L).

Defendant also advances three additional arguments. First, Defendant argues that Plaintiff has not introduced any evidence of an express warranty that would support his fourth cause of action. In connection with this argument, Defendant has introduced evidence that the Leads were packaged with an Express Limited Warranty which disclaimed, inter alia, the implied warranties of merchantability and fitness for a particular purpose. (Boodoosingh Affidavit, ¶ 19, Ex. G).

Second, Defendant argues that there is no evidence to support a claim against Medtronic’s representative, Michael Baker. Defendant cites to portions of Dr. Kreizman’s deposition testimony to establish that Dr. Kreizman and medical personnel made all of the decisions regarding surgery, and that Baker’s only role was testing and programming the System. Defendant asserts that Plaintiff has no evidence “to establish a causal connection between any alleged actions of Mr. Baker and Mr. Babayev’s alleged injury.” (Memorandum of Law in Support of Defendant’s Motion for Summary Judgment (“Defendant’s Memo”), p. 24). Defendant notes that its literature, some of which is attached as Exhibits E, F, G, H and I to the Boodoosingh Affidavit, warns of “the very type of uncomfortable ‘shocking’ sensation” which Plaintiff experienced. (Defendant’s Memo, p. 24).

Thud, Defendant argues that Plaintiffs failure-to-warn claims are barred by the Learned Intermediary Doctrine. Defendant principally argues that it discharged its duty to warn by providing adequate warnings to the physicians on the device’s label. Defendant cites to the Prescriber’s Booklet and the Implant Manual (attached to the Boodoosingh Affidavit as Exhibits E and F), which warn of the potential for patients to experience a “shocking” or “jolting” sensation. (Defendant’s Memo, p. 24).

Plaintiff’s Response and Motion for Spoliation Sanctions

In his Memorandum of Law in Opposition to Defendant’s Motion for Summary Judgment and in Support of Plaintiffs Cross-Motion (“Plaintiffs Memo”), Plaintiff does not specifically address Defendant’s arguments. Rather, Plaintiffs Memo starts by quoting to 21 C.F.R. § 820,170— the CGMP which requires that “[t]he person installing the device ... ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer’s instructions and procedures and ... document the inspection and any test results to demonstrate proper installation.” (Plaintiffs Memo, p. 4). Plaintiffs Memo then delineates the evidence which allegedly shows that Plaintiffs medical treatment departed from the procedures set forth in Medtronic’s literature.

First, in support of his claim that he was given a general anesthetic, Plaintiff cites to portions of his deposition in which he states that he was given “something” that caused him to be unconscious during the surgery (Babayev Deposition, pp. 55, 57), and to Dr. Kreizman’s testimony that Plaintiff was “put under anesthesia” at the start of the surgery, (Kreizman Deposition, p. 79). (Plaintiffs Memo, p. 5). However, Plaintiff also provides a copy of Dr. Kreizman’s Operative Report which states that Plaintiff was only “sedated” by the anesthesiologist, and that “Lidocaine was injected at the L2 to L3 level to provide local anesthesia.” (Hoshovsky Declaration, Ex. I).

Notwithstanding this testimony, Plaintiffs Memo alleges that he was unable to provide feedback during the intraoperative testing. Plaintiff does not deny that he answered Baker’s questions. Indeed, Plaintiffs Memo itself cites to that portion of Plaintiffs deposition testimony in which he stated that he awoke from surgery to find Baker “doing some adjustments” and asking, “how do I feel, what I feel.” (Plaintiffs Memo, pp. 5-6 (quoting Babayev Deposition, p. 87)). Rather, Plaintiffs allegation that he was unable to provide feedback appears to be based solely on Plaintiffs representation that he was still feeling the effects of the sedation at the time he was getting dressed after the surgery. (Plaintiffs Memo, p. 7 (citing Babayev Deposition, pp. 83-84)).

Plaintiffs Memo also claims that Baker “failed to decrease the amplitudes to 0.0V and failed to turn the neurostimulator OFF” before giving the ENS to Plaintiff and telling him to connect it. (Plaintiffs Memo, p. 8). However, the only evidence that Plaintiff offers to substantiate this assertion is his own deposition testimony in which he states that he received the electric shock after plugging the Connector into the ENS. (Id. (citing Babayev Deposition, p. 84)).

Plaintiff also relies solely on his own testimony to argue that he was not properly instructed on the operation of the System. Specifically, Plaintiffs Memo quotes excerpts from the following portion of Plaintiffs Deposition:

Q: When the representative was adjusting the stimulator before you felt the terrible pain, do you have an understanding of what kind of adjustments he was making, what he was doing?

A: It was some buttons, some machine. I don’t remember. But he was doing some adjustments. And each time he asked me what I feel and on what side I feel.

Q: Were you instructed on how to do these adjustments on your own.

A: No. He made all adjustments. (Ba-bayev Deposition, pp. 63-64).

Plaintiff implies that this testimony substantiates his claim that he could not properly operate the System. (Plaintiffs Memo, pp. 8-9).

Finally, Plaintiffs Memo argues that Defendant failed to document proper installation of the System. Plaintiff cites to those portions of Defendant’s manuals which require documentation of the Lead position and the settings used and the patient’s responses during intraoperative testing. (Plaintiffs Memo, pp. 9-10). Plaintiff then asserts that Defendant “failed to document and demonstrate that the ... System was properly connected, adjusted, tested, programmed, and installed.” (Id., p. 10). However, Plaintiffs Memo does not allege that Plaintiff specifically requested Plaintiffs medical records and that such records did not contain this information.

In addition to setting forth this evidence of alleged violations of 21 C.F.R. § 820,-170, Plaintiffs Memo asserts that Defendant violated 21 C.F.R. § 820,198, which relates to records of complaints, and 21 C.F.R. § 803.60—one of the Medical Device Reporting (“MDR”) requirements triggered by information that a device “caused or contributed to a death of serious injury.” (Plaintiffs Memo, pp. 10-11). Plaintiff notes that Medtronic did not report the February 23, 2007, incident to the FDA until April 21,2010. (Id., p. 12). However, Plaintiffs Memo offers no evidence as to when Plaintiff filed a complaint or when Defendant received information that Plaintiff was seriously injured. Rather, Plaintiff implies that these requirements were triggered when Baker was summoned to Plaintiffs bedside and informed that something had gone “wrong” with the device. (Plaintiffs Memo, p. 10).

Plaintiffs Memo also alleges the violation of two other FDA regulations, neither of which is mentioned in his pleading: 21 C.F.R. § 820.60, which requires that a manufacturer “establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups,” and 21 C.F.R. § 820.65, which requires a manufacturer to “establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components [to] facilitate corrective action.” (Plaintiffs Memo, pp. 11-12). In support of his claim that these regulations were violated, Plaintiff cites to a portion of Baker’s Deposition testimony in which Baker stated that he did not “remember the model number” of certain components used in Plaintiffs treatment. (Plaintiffs Memo, p. 11 (citing Deposition of Michael Baker (the “Baker Deposition,” which is attached to the Ho-shovsky Declaration as Ex. C), p. 18). Plaintiff acknowledges that Defendant subsequently provided records of the ENS and Programmer that were assigned to Baker on February 23, 2007, but claims these records are insufficient to establish that these components were used during Plaintiffs procedure. (Plaintiffs Memo, p. 11).

In the discussion section, Plaintiffs Memo argues that none of Plaintiffs claims are preempted. Plaintiff principally relies on Gelber v. Stryker Corp., 788 F.Supp.2d 145, 159 (S.D.N.Y. 2011), which held that a “defective manufacturing claim based upon a violation of... CGMP requirement[s] is not preempted.” (Plaintiffs Memo, pp. 16, 20). However, Plaintiffs Memo does not specifically identify any manufacturing defects with respect to the System. Rather, it alludes to the CGMP violations alleged in the fact section.

In discussing the breach-of-warranty claims, Plaintiff reads that portion of the Booklet which discusses whether the implantation surgery will be painful as “specifically representing] that the [implantation] ... will be performed under local anesthetic and ... would not ‘hurt.’ ” (Plaintiffs Memo, p. 19). Plaintiff also implies that the portion of Defendant’s Limited Warranty which states, “The components must be used in accordance with the labeling and instructions for use provided with the Components,” can be read as making some sort of express promise to Plaintiff. (Id., p. 20).

With respect to Defendant’s argument that there is no evidence to support a claim against Baker, Plaintiff asserts Baker “actually installed the ... System.” (Id., p. 17). Plaintiff points out that Baker connected the components of the System, and “tested, programmed and adjusted the device.” (Id.). In addition, Plaintiff claims, without further elaboration, that Baker’s instruction to plug the Connector into the ENS was a “wrongful instruction.” (Id.).

Plaintiff does not directly address Defendant’s Learned Intermediary argument. Rather, Plaintiff elaborates on his failure-to-warn claim, asserting that Baker had a duty to warn Plaintiff that the System was “adulterated” and that the surgery was not being conducted in accordance with Med-tronic’s manuals. In particular, Plaintiff claims that Baker knew or should have known that the procedure was being performed under general anesthesia, should have warned Plaintiff that he would be unable to communicate during intraopera-tive testing, and should have warned Plaintiff that the amplitude was not adjusted to zero volts before leaving Plaintiff to plug the Connector into the System. (Id., p. 18).

In addition to opposing Defendant’s Motion for summary judgment, Plaintiff cross-moves for an order either “dismiss[ing] the answer filed by the defendant” or “drawing] an adverse inference that plaintiff has made out a prima facie case of product liability and negligence” as “a sanction for the spoliation of evidence.” (Id., pp. 14-15). Plaintiff argues that Defendant 1) failed to produce the Leads and Extensions for inspection; 2) violated 21 C.F.R. §§ 820,170(b), 820.65, 820,198 and 803.50 by failing to maintain documentation of proper installation and Medtronic’s handling of Plaintiffs complaint; and 3) failed to produce the ENS and Programmer for inspection. However, Plaintiff does not specifically allege that he made demands for inspection or discovery requests pertaining to specific records, and that Defendant refused to comply. Rather, Plaintiff requests that this Court enter an order compelling Plaintiff to, among other things, a) “identify by model, model number and serial numbers” the ENS and Programmer and b) produce these items for inspection. (Id., p. 13).

Defendant’s Response to Plaintiff’s Cross-Motion

Evidence regarding Plaintiffs discovery requests has, however, been submitted to the Court in connection with Defendant’s response to Plaintiffs cross-motion. Exhibit L to the Declaration of John P. Lavelle, Jr., dated Aug. 19, 2014 (“Lavelle Declaration II”) indicates that in March 2012, Plaintiff requested production of 1) the Lead and Extension that was implanted in, then removed from, Plaintiff and 2) the “patient programmer/battery pack” that was used during Plaintiffs neurostimulation trial. In response to these requests, Defendant 1) stated that it had not been in possession of the Lead and Extension “at any time after the commencement of plaintiffs trial” (Lavelle Declaration II, Ex. L, p. 4), and 2) asserted that “programmer/Battery Pack” were “undefined and ambiguous terms.” (Id., p. 5). Nonetheless, Defendant provided records relating to the Programmer and ENS which had been provided to Baker. (Id., pp. 3-4).

DISCUSSION

Spoliation

Before addressing Defendant’s motion for summary judgment, the Court will address Plaintiffs cross-motion to sanction Defendant for spoliation of evidence. “Spoliation is the destruction or significant alteration of evidence, or the failure to preserve property for another’s use as evidence in pending or reasonably foreseeable litigation.” West v. Goodyear Tire & Rubber Co., 167 F.3d 776, 779 (2d Cir. 1999). “[A] party seeking an adverse inference instruction based on the destruction of evidence must establish (1) that the party having control over the evidence had an obligation to preserve it at the time it was destroyed; (2) that the [evidence was] destroyed ‘with a culpable state of mind’; and (3) that the destroyed evidence was ‘relevant’ to the party’s claim or defense such that a reasonable trier of fact could find that it would support that claim or defense.” Residential Funding Corp. v. DeGeorge Fin. Corp., 306 F.3d 99, 107 (2d Cir. 2002) (quoting Byrnie v. Town of Cromwell, 243 F.3d 93, 107-12 (2d Cir. 2001).

With respect to the first element, “[t]he obligation to preserve evidence arises when the party has notice that the evidence is relevant to litigation or when a party should have known that the evidence may be relevant to future litigation.” Fujitsu Ltd. v. Fed. Exp. Corp., 247 F.3d 423, 436 (2d Cir. 2001) (citing Kronisch v. United States, 150 F.3d 112, 126 (2d Cir. 1998)). The Second Circuit has held that “a regulation may supply the duty to preserve records.” Byrnie, 243 F.3d at 109. “For such a duty to attach, however, the party seeking the inference must be a member of the general class of persons that the regulatory agency sought to protect in promulgating the rule.” Id. For example, if “a party has violated an EEOC record-retention regulation, a violation of that regulation can amount to a breach of duty necessary to justify a spoliation inference in an employment discrimination action.” Id. Conversely, “violation of a rule that records be retained for securities disclosure purposes would not create a duty to preserve covered records for use in a subsequent employment discrimination suit.” Id.

In this case, there is no evidence that Defendant had any obligation to preserve the Leads or extensions at a time when the components were still in Defendant’s possession. By all accounts, the Leads and Connector were removed by Dr. Kreizman within a day of their implantation and more than a week before the fracture was discovered. Defendant represents that it was not in possession of the Leads and Connector at any time after the implantation surgery began (Lavelle Declaration II, p. 4), and Plaintiff has offered no evidence to the contrary.

In contrast, there is evidence that the ENS and Programmer may have remained in Defendant’s possession during the pendency of this action. During his February 6, 2012, deposition, Baker testified that he repossessed the ENS and Programmer shortly after the incident. (Baker Deposition, p, 59). He further testified that he returned the ENS “to inventory” and that the Programmer is “with Medtronic somewhere.” (Baker Deposition, pp. 59-60). Defendant provided Plaintiff with records on April 25, 2012, which specifically identified the Programmer and ENS that had been assigned to Baker at the time of the implantation surgery, but there is no record that Plaintiff made any request for inspection of those components or moved to compel inspection. Indeed, Plaintiffs Memo requests that this Court enter an order compelling Plaintiff to, among other things, a) “identify by model, model number and serial numbers” the ENS and Programmer and b) produce these items for inspection. (Plaintiffs Memo, p. 13). This motion to compel could, and should have been made, during the course of discovery.

To the extent that Plaintiff is arguing that spoliation sanctions are appropriate for violation of 21 C.F.R, §§ 820,170(b), 820.65, 820,198 and/or 803.50, that argument is without merit. First, 21 C.F.R. § 820,170(b) requires that “[t]he person installing the device”—not the manufacturer—document proper installation. While 21 C.F.R. § 820.65 does impose a duty on manufacturers—namely, to “establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components”—there is no proof that Defendant breached that duty. Moreover, even if there were, § 820.65 specifically provides that this requirement is solely to “facilitate corrective action.” Plaintiff does not cite to any authority for the proposition that this CGMP was designed to assist litigation, or that spoliation sanctions would be appropriate in cases in which a manufacturer failed to comply with § 820.65.

Plaintiff also offers no evidence that Defendant failed to comply with §§ 820,198 or 803.50. The former section creates certain requirements pertaining to the way in which manufacturers process and record complaints, while the latter contains certain reporting requirements which are triggered when a manufacturer “become[s] aware of information, from any source, that reasonably suggests that a device ... [m]ay have caused or contributed to a death or serious injury .... ” 21 C.F.R. § 803.50(a). Although Plaintiff has provided evidence that Medtronic did not report the February 23, 2007, incident to the FDA until April 21, 2010 (see Hoshovsky Declaration, Ex. K), Plaintiff has offered no evidence as to when he filed a complaint or when Defendant received information that Plaintiff was seriously injured.

Summary Judgment

Summary judgment is appropriate only when “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). “A party asserting that a fact cannot be or is genuinely disputed must support the assertion by: (A) citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials; or (B) showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact.” Fed. R. Civ. P. 56(c). “If a party fails to properly support an assertion of fact or fails to properly address another party’s assertion of fact as required by Rule 56(c), the court may [, inter alia] ... consider the fact undisputed for purposes of the motion [or] ... grant summary judgment if the motion and supporting materials—including the facts considered undisputed—show that the movant is entitled to it.” Fed. R. Civ. P. 56(e).

The MDA

In arguing for summary judgment in this case, Defendant primarily argues that Plaintiffs claims are preempted by 21 U.S.C. § 360k, which was enacted as part of the MDA. Prior to enactment of the MDA in 1976, the FDCA did not require FDA approval for the introduction of new medical devices. Rather, “the introduction of new medical devices was left largely for the States to supervise as they saw fit.” Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-76, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)).

The MDA introduced a new “regime of detailed federal oversight” for medical devices. Id. at 316, 128 S.Ct. 999. This regime “established various levels of oversight for medical devices, depending on the risks they present.” Id. “Class III devices ‘present] a potential unreasonable risk of illness or injury5 and therefore incur the FDA’s strictest regulation.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)(II)).

New Class III devices are subjected to a “rigorous” premarket approval (or “PMA”) process, in which “the manufacturer must provide the FDA with a ‘reasonable assurance5 that the device is both safe and effective.” Lohr, 518 U.S. at 477, 116 S.Ct. 2240 (citing 21 U.S.C. § 360e(d)(2)). As of 1996, the FDA was spending “an average of 1,200 hours reviewing each application” for premarket approval, examining, inter alia, “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 ...; and a specimen of the proposed labeling.” Riegel, 552 U.S. at 318, 128 S.Ct. 999 (internal quotations and citations omitted). If a device receives pre-market approval following this exhaustive examination, a manufacturer is forbidden “to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d)(6)(A)(I)). These FDA-approved design specifications, manufacturing processes, labels, etc., are sometimes called “PMA requirements.”

Plaintiff does not dispute Defendant’s evidence that the System is a Class III device, for which Medtronic has received supplemental premarket approval. {See Hoshovsky Declaration, Ex. M). Not all Class III devices on the market, however, have undergone the premarket approval process. The MDA contained a “grandfathering” provision, permitting those Class III devices which were on the market pri- or to the MDA’s enactment to remain on the market without FDA approval until the FDA initiated and completed the pre-market approval process. Lohr, 518 U.S. at 478, 116 S.Ct. 2240. To prevent these grandfathered devices from monpolizing the market, the MDA also permitted devices which are “substantially equivalent” to the grandfathered devices to avoid the premarket approval process. Id. The process of determining whether a device is “substantially equivalent” to a grandfathered device, which is known as “§ 510(k) process,” is “by no means comparable to the PMA process,” and is “completed in an average of only 20 hours.” Id. at 478-79, 116 S.Ct. 2240.

The MDA’s Preemption Provision

The MDA contains an express preemption provision, which is codified at 21 U.S.C. § 360k. Subsection (a) of this provision states:

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.

Subsection (b) permits the FDA to enact regulations exempting certain State and local requirements from preemption under subsection (a).

The Supreme Court has articulated a two-step test for determining whether a plaintiffs state-law claims relating to a medical device are preempted by this provision. First, a court “must determine whether the Federal Government has established requirements applicable to [the device at issue].” Riegel, 552 U.S. at 321, 128 S.Ct. 999. If so, the court “must then determine whether the [plaintiffs] common-law claims are based upon [state] requirements with respect to the device that are ‘different from, or in addition to,’ the federal ones, and that relate to safety and effectiveness.” Id., at 321-22, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a)).

The Supreme Court has decided two cases relating to the scope of the MDA’s preemption provision which provide guidance with respect to this two-step test. The first—Medtronic, Inc. v. Lohr, supra—involved a torts action to recover for injuries the plaintiff sustained because of defects in her pacemaker, a device which the FDA had approved pursuant to the § 510k process. The plaintiff advanced two causes of action. The first alleged that Medtronic was negligent in the design and manufacture of the pacemaker and in the failure to warn of known defects. The second sought to impose strict liability for the defective design and manufacture and the failure to warn. See Lohr, 518 U.S. at 481, 116 S.Ct. 2240.

After Medtronic removed the case to federal court, a district court granted Med-tronic’s motion to dismiss both claims on preemption grounds. The Eleventh Circuit reversed with respect to the design claims, rejecting “Medtronic’s argument that the FDA’s finding of ‘substantial equivalence’ had any significance with respect to the pacemaker’s safety, or that the FDA’s continued surveillance of the device constituted a federal ‘requirement’ that its design be maintained.” Id., 518 U.S. at 483, 116 S.Ct. 2240. It affirmed, however, with respect to the manufacture and failure to warn theories, finding that these theories “were pre-empted by FDA’s general ‘good manufacturing practices’ regulations, which establish general requirements for most steps in every device’s manufacture .., and by the FDA labeling regulations, which require devices to bear various warnings.” Id., at 483-84, 116 S.Ct. 2240.

The Supreme Court affirmed in part and reversed in part, holding that none of Lohr’s causes of action were preempted. First, the Supreme Court upheld the Eleventh Circuit’s decision with respect to the design claims, holding that the § 510k process did not impose any federal “requirements” on the design of the pacemaker. Lohr, 518 U.S. at 492-94, 116 S.Ct. 2240. Quoting with approval that portion of the Eleventh Circuit’s de