Full opinion text
ORDER PATRICK J. SCHILTZ, District Judge. In this lawsuit, plaintiff Donald Kapps, M.D., seeks to recover for injuries he suffered after the tip of a catheter made by defendant Biosense Webster, Inc. (“Biosense”) and reprocessed by defendant Ascent Healthcare Solutions, Inc. (“Ascent”) broke off in his heart during a medical procedure at the Mayo Clinic. Kapps filed a motion for summary judgment, Biosense filed a motion for summary judgment, Ascent filed two motions for summary judgment, and the parties together filed the equivalent of eight motions to exclude expert testimony under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The Court heard arguments on these motions at a day-long hearing on March 17, 2011. The Court ruled on many of the parties’ motions from the bench. Specifically, the Court denied Kapps’s motions for summary judgment and granted in part and denied in part Kapps’s motions to exclude the testimony of various defense experts. The Court also granted in part and denied in part Ascent’s motion to exclude the testimony of David G. Benditt, M.D., one of Kapps’s expert witnesses. Those rulings were reduced to writing the following day. Order Mar. 18, 2011 [Docket No. 121]. The Court took under advisement the motions of Biosense and Ascent to exclude the testimony of Kapps’s primary expert witness, Bruce H. Barkalow, Ph.D. The Court also took under advisement the motions of Biosense and Ascent for summary judgment. Biosense’s and Ascent’s motions raised a host of difficult issues— including legal issues on which there appears to be little helpful authority. The Court now rules on Biosense’s and Ascent’s Daubert and summary-judgment motions. For the reasons that follow, the Court excludes Barkalow’s testimony with respect to Biosense and grants summary judgment to Biosense. With respect to Ascent, the Court excludes Barkalow’s testimony only to the extent that it relates to approval by the United States Food and Drug Administration (“FDA”) of Ascent’s reprocessing procedures, and the Court grants in (small) part and denies in (large) part Ascent’s motions for summary judgment. The Court also denies Kapps’s motion for leave to amend his complaint to add a claim for punitive damages. Kapps initially submitted his motion to Magistrate Judge Janie S. Mayeron, but in light of the pendency of the parties’ Daubert and summary-judgment motions, Judge Mayeron referred the motion to the undersigned. I. BACKGROUND A. Facts 1. Kapps’s Injuries Kapps suffers from atrial fibrillation, a condition in which the heart’s rhythm is fast and irregular. In June 2005, during a procedure at the Mayo Clinic to treat the condition, a Lasso catheter made by Biosense and reprocessed by Ascent was manipulated inside Kapps’s heart by Dr. Ming Wong, a visiting fellow who was supervised by Dr. Douglas L. Packer. The Lasso catheter is a “mapping” catheter whose function is to measure the conductivity of areas within the heart before and after treatment of those areas with an ablation catheter. The Lasso takes its name from the circular open loop (or “lasso”) that forms the catheter’s tip. While Wong was manipulating the Lasso catheter inside the left atrium of Kapps’s heart, the lasso portion of the catheter’s tip flipped across the mitral valve into Kapps’s left ventricle and became entrapped in the mitral valve and its supporting structures or “chordae.” Packer then took over for Wong and attempted to extricate the catheter by rotating it. The lasso portion snapped off and remained entangled in Kapps’s mitral valve and chordae; Packer withdrew the rest of the catheter. Various other doctors assisted Packer in attempting to snare the detached loop with devices introduced through a catheter, and eventually they succeeded in removing the loop. In the meantime, however, Kapps’s blood pressure dropped, and he experienced bleeding into the pericardium (the sac surrounding the heart). His mitral valve was also damaged. To treat his pericardial bleeding and the damage to his mitral valve, Kapps underwent open-heart surgery, and his mitral valve was replaced with a porcine prosthesis. He has suffered various health problems as a result of the surgery. 2. The Lasso Catheter The Lasso catheter is one of a number of different types of catheters made by Biosense. The loop or “lasso” portion that detached in Kapps’s heart is basically a single length of nitinol wire. The length of wire has two parts, each of which is covered with a different material: (1) a straight portion that fits inside a lumen in the body of a catheter and that is covered with a plastic sheath; and (2) a curved open loop that projects out of the catheter body and that is covered with what is called a “spine cover.” (The spine cover exposes small individual conductive areas attached to electrical leads running along the nitinol wire.) The open loop’s circular shape is perpendicular to the straight portion. Thus, an assembled catheter looks like a lasso being twirled overhead by a cowboy: The curved open loop of the length of nitinol wire corresponds to the loop of the cowboy’s lasso, and the catheter body (which contains the straight portion of the length of nitinol wire) corresponds to the rope in the cowboy’s hand. Roughly speaking, the tip of the Lasso catheter is assembled in two steps. In the first step, the lasso portion — which, as noted, begins as a single length of nitinol wire — is assembled separately from the catheter body. During this step, the spine cover and leads are attached to the open loop of nitinol wire, and the plastic sheath is glued to the straight portion of the wire. (A small area of wire remains exposed between the straight and curved portions of wire.) In the second step, the lasso portion is attached to the catheter body. During this step, polyurethane glue is applied to the (now mostly sheathed) straight portion of the lasso up to the base of the spine cover, and the straight portion is inserted within a lumen of the catheter body. The polyurethane glue forms a dome at the point where the loop exits the catheter body. Thus, the lasso portion is attached to the catheter body by the polyurethane dome and by the polyurethane glue that was applied along the straight portion of the lasso. During Kapps’s procedure, the entire lasso portion — including both the straight part and its sheath, and the loop and its spine cover — pulled cleanly out of the catheter body, leaving the polyurethane dome basically intact. The lasso portion was discarded sometime after Kapps’s procedure and thus was not examined by any of the parties’ experts. Instead, the experts examined only the catheter body and the polyurethane dome. As noted, the catheter at issue in this case was made by Biosense. In the Instructions for Use (“IFU”) document that accompanies each Lasso catheter, Biosense warns that the catheter is “[f]or one single use only.” McLain Aff. [Docket No. 93] Ex. 18 at BW001109; id. at BW001110 (“The Biosense Webster LASSO Circular Mapping Catheter is intended for single patient use only.”). Biosense affixes a lot number to each Lasso catheter so that, if a problem arises with respect to a catheter, the circumstances surrounding the making of that catheter can be ascertained. The catheter at issue in this case was sold by Biosense to the Mayo Clinic and used in a patient. Contrary to Biosense’s instruction that the catheter should be used only once, the Mayo Clinic then shipped the used catheter to Ascent for reprocessing, so that the catheter could be used in a second patient. In general, when reprocessing a Lasso catheter, Ascent inspects the catheter, cleans and sterilizes it, and repackages it. Ascent also takes some steps that go beyond simply inspecting and cleaning the used catheter. In this case, for example, Ascent eliminated the Biosense lot number and replaced it with an Ascent serial number. Barton-Varty Dep. at 121-23. Ascent also provided its own IFU — replacing Biosense’s IFU — when it returned the reprocessed catheter to the Mayo Clinic. See McLain Aff. [Docket No. 93] Ex. 24. And finally, Ascent provided its own warranty — a warranty that guaranteed not just that the catheter had been properly cleaned, but that the catheter would work properly. Specifically, the “warranty” section of Ascent’s IFU said that the “Medical Facility” (here, the Mayo Clinic) “acknowledges that [Ascent] performs a service, and that Medical Facility retains the title and ownership of all medical instruments, under this Agreement.” Id. at AHS002619. The warranty section then provided: [Ascent] warrants the sterility of reprocessed medical instruments unless the packaging of the medical instrument has been damaged or opened. [Ascent] warrants the functionality of reprocessed medical instruments until such medical instruments have been used in one medical procedure. [Ascent] shall refund the cost of reprocessing any medical instrument that does not meet the total satisfaction of Medical Facility.... [Ascent] shall indemnify and hold harmless Medical Facility against all claims, demands and liability all sums for which Medical Facility shall become legally obligated to pay as damages caused by bodily injury to patients as a result of [Ascent’s] performance of services under this Agreement.... Id. Further, in a marketing document directed at hospitals and physicians and dated January 2009, Ascent made the following assertions: Reprocessed and remanufactured devices from Ascent are cleared for remanufacturing/reprocessing by FDA. This means that in terms of safety and quality, Ascent reprocessed and remanufactured devices are substantially equivalent to OEM [i.e., original equipment manufacturer] devices. Additionally, Ascent devices go through a careful inspection process in which every single device is tested for functionality and visually inspected to ensure process performance .... [W]e do not operate under license from the OEM. In fact, legally and practically, we are the manufacturers of our reprocessed and remanufactured devices. We engineer the devices, we re-manufacture/reprocess the devices, and we warranty the devices. FDA inspection routines are as stringent, if not more stringent, than those of other manufacturers and assure that our process as well as the devices we market are equivalent to OEM devices.... [T]here is no need to ask patients whether they are willing to have a reprocessed or remanufactured device used for their procedure. Ascent devices are substantially equivalent to OEM devices, they are warranted by Ascent, and their performance is similar to that of OEM devices.... We have never had a patient or a hospital make a claim against us. Should a problem occur, Ascent warranties the devices we remanufacture and reprocess. We carry $25 million in liability coverage. Our customers and clients are fully indemnified against any potential for liability.... [Ascent’s] inspection and testing process, which far exceeds that of OEMs in rigor, actually renders Ascent devices more reliable in terms of safety and quality than OEM devices.... Ascent Healthcare Solutions, Questions & Answers: Ascent Answers Hospital Physicians’ Remanufacturing/Reprocessing Questions, January 2009 at 1-5, BartonVarty Jan. 12, 2010 Dep. Ex. 44 at AHS012967-71 (emphasis added). B. FDA Approval According to Kapps’s theory of this case, FDA approval of Ascent’s reprocessing operations is of central importance. The Court does not agree with Kapps, for reasons given below in connection with the Court’s discussion of Barkalow’s testimony about the FDA. Nonetheless, to provide context, the Court summarizes in general terms the FDA approval process as it relates to the Lasso catheter at issue in this case. Medical devices are regulated by the FDA under the 1976 Medical Device Amendments (“MDA”), 21 U.S.C. §§ 360e et seq., to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq. The FDA classifies devices into three categories: Class I, which includes things like elastic bandages and gloves; Class II, which includes things like powered wheelchairs, electrocardiograph machines, and diagnostic catheters; and Class HI, which includes things like heart valves, pacemakers, and implantable cerebellar stimulators. Class I devices are the least regulated; they are subject to only “general controls” such as labeling requirements. 21 U.S.C. § 360c(a)(1)(A). Class II devices are somewhat more regulated; they are subject both to general controls and to “special controls” such as performance standards and postmarket-surveillance measures. 21 U.S.C. § 360e(a)(1)(B). Class II devices are the most regulated; with certain exceptions, they are “subject ... to premarket approval to provide reasonable assurance of [their] safety and effectiveness.” 21 U.S.C. § 360c(a)(1)(C). Roughly speaking, devices in Class II and Class III (and some in Class I) may not be marketed until they pass through one of two processes: the premarket-wiification or “510(k)” process, or the more-rigorous premarket-approval or “PMA” process. The 510(k) process comes in three versions: traditional, abbreviated, and special. An abbreviated 510(k) application may be used for certain devices that are subject to existing FDA guidance or controls or other recognized standards. A special 510(k) application can be used for a modification to a device that has previously been cleared under the 510(k) process. Most Class II devices go through some version of the 510(k) process. Class III devices developed after the MDA’s effective date must go through the much more rigorous PMA process, which involves a lengthy application and extensive FDA review. See Riegel, 552 U.S. at 317-18, 128 S.Ct. 999. But certain Class III devices that were developed before the MDA’s effective date may be marketed after passing through only the 510(k) process. See id. The Lasso catheter at issue in this case is a Class II device, and it was subject to two different approval processes — one that applied to Biosense (when the catheter was made) and one that applied to Ascent (when the catheter was reprocessed). Biosense obtained 510(k) approval of the Lasso catheter in August 2000 through a special 510(k) application. Sheridan Rept. at 14. Ascent filed a 510(k) application in August 2001 seeking approval to market various reprocessed devices. Among the devices listed in Ascent’s 510(k) application were 68 different mapping catheters made by Biosense. Id. The FDA approved the 510(k) application in August 2002, and then again in 2004, after Ascent submitted additional information required under FDA regulations imposed on medical-device re-processors in 2003. Id. at 13-14. The specific model of Lasso catheter at issue in this case was not among the 68 Biosense mapping catheters listed in Ascent’s 510(k) application that was approved in August 2002 (and again in 2004). Instead, in December 2002, Ascent made an internal decision that the Lasso was sufficiently similar to some of the 68 models that had been listed in Ascent’s earlier 510(k) application that Ascent was not required to file a separate 510(k) application with respect to the Lasso. In the language of the medical-device industry, Ascent decided that the Lasso was a “line extension” of a previously approved device, rather than a new device. A line extension does not require its own 510(k) application. Id. at 16-17. Because medical-device manufacturers are continuously developing and improving their products, manufacturers must often decide whether changes to a device are sufficiently insignificant that the changed device is a mere line extension or sufficiently significant that the changed device requires a new 510(k) application. Under 21 C.F.R. § 807.81, a new 510(k) application is required when a manufacturer makes “[a] change or modification in [a previously approved] device that could significantly affect the safety or effectiveness of the device.... ” 21 C.F.R. § 807.81(a)(3)(i). Because some modifications to a device will not “significantly affect” its safety or effectiveness, the FDA does not expect or require a device manufacturer to submit a new 510(k) application every time a device is modified. Instead, the manufacturer must decide whether to submit a new 510(k) application in light of the FDA’s guidance about what modifications are likely to require submission of such an application. C. Expert Opinions 1. Bruce H. Barkalow, Ph.D. Barkalow received a Ph.D. in biomedical engineering in 1972. Since then, he has been a biomedical-engineering consultant to hospitals, medical-device companies, and the FDA. He has served as the president of a medical-device manufacturer since 2005. He has been an adjunct professor of biomedical engineering at Michigan Technological University since 1992, and he has regularly given presentations and published articles in the field of biomedical engineering. In preparing his expert report, Barkalow reviewed medical records relating to Kapps, engineering documents and product information from both Biosense and Ascent, and deposition testimony from various witnesses. Barkalow physically inspected the catheter at issue, and he observed the testing and inspection of the catheter conducted by Ascent’s expert in March 2010. Barkalow’s opinions in his expert report differ somewhat from the opinions he later expressed in his deposition. The Court therefore first summarizes Barkalow’s expert report, then turns to his deposition testimony. a. Barkalow’s Expert Report Based on the March 2010 testing and inspection of the catheter that came apart in Kapps’s heart, Barkalow found that the used catheter differed from an unused comparison catheter in several ways. First, the polyurethane dome of the used catheter was darkened, not clear. Second, the used catheter had what appeared to be a smear of polyurethane on the outside of the body of the catheter, while the unused catheter had no such smear. Third, the lasso portion was missing from the used catheter, and it appeared to have pulled cleanly out of the catheter without damaging the surrounding polyurethane adhesive or the lumen of the catheter. Barkalow Rept. at 8-9. Based on his review of the evidence, Barkalow concluded that the lasso portion of the used catheter pulled out because of “inadequate adhesion” between the lasso portion and the catheter body. Id. at 10. Barkalow also opined that despite becoming entangled in Kapps’s mitral valve, “the [lasso] portion should not have come separated from the main catheter body.” Id. In other words, according to Barkalow the lasso portion of a nondefective catheter would have been glued strongly enough to the catheter body to withstand the forces exerted during Kapps’s procedure without pulling out of the catheter body. Barkalow did not, however, offer a clear opinion that Biosense made a defective catheter. Indeed, Barkalow said that the catheter “was manufactured with sufficient structural integrity to perform the initial use.” Id. at 10. As noted above, Biosense had warned that its catheter was “[f]or one single use only,” and thus the “initial use” referred to by Barkalow was the only use that was consistent with Biosense’s instructions. Far from blaming Biosense for making a defective catheter, then, Barkalow opined that “[t]he subject catheter on its second use after remanufacture by Ascent was defective and unreasonably dangerous ....” Id. (emphasis added). To support his opinion that the catheter was defective after Ascent’s reprocessing, Barkalow relied on the fact that the lasso portion of the catheter had pulled cleanly out of the catheter body under what Barkalow considered to be predictable circumstances: entrapment in Kapps’s mitral valve followed by ordinary attempts at extrication. Barkalow cited only one other piece of evidence to show that the catheter was defective: the smear of polyurethane glue on the catheter body’s exterior. According to Barkalow, the smear showed that the catheter had “either an original manufacturing fault or a reprocessing fault such as the inappropriate use of a chemical that affected the clear [polyurethane] dome material and caused it to disperse onto the main catheter body.” Id. In his rebuttal expert report, Barkalow suggested that the polyurethane smear was more likely to have been made during manufacturing than reprocessing. He said: “It is not obvious that this anomalous spread of material that appears to be [polyurethane] could have happened in the reprocessing steps. It may be an indication of a manufacturing problem.” Barkalow Rebuttal Rept. at 2-3. Barkalow did not otherwise connect the polyurethane smear to the device’s failure. In fact, Barkalow said that the “failure of the adhesion bond” between the lasso and the catheter body “could be a result” of four different things, two being the fault of Biosense and two being the fault of Ascent. Barkalow Rept. at 10. With respect to Biosense, Barkalow said that the catheter might have had an unspecified “latent problem” caused by “Biosense manufacturing technique/materials,” and that because of this latent problem, the catheter — from the time it was first made — was too weak to withstand “normal mitral valve extrication technique ....” Id. On this theory, the catheter would have failed in the first patient if it had become entrapped in that patient’s mitral valve, and the catheter survived the procedure only because it did not become entrapped. Alternatively, Barkalow said that the catheter might have failed because it “could not withstand the Ascent remanufacture processes” and thus “could not withstand normal mitral valve extrication techniques....” Id. On this second theory, the catheter could have survived entrapment and normal extrication efforts in the first patient, and the catheter failed during Kapps’s procedure only because it was weakened by reprocessing. Implicit in this second theory — if it is to be a basis for finding Biosense liable — -are two assumptions: (1) that the catheter, if properly made, should have been able to withstand entrapment and extrication after being subjected to ordinary reprocessing techniques; and (2) that the catheter was in fact subjected only to ordinary reprocessing techniques. With respect to Ascent, Barkalow said that its reprocessing might have damaged the catheter in one or both of two ways. First, Ascent might have damaged the catheter by “us[ing] inappropriate chemicals” that “chemically weakened” the catheter. Id. Second, Ascent might have “physically damaged” the catheter during reprocessing. Id. at 11. Of course, these four theories are not mutually exclusive. For instance, the catheter might have been so defective when it left Biosense’s hands that it could not survive ordinary entanglement in and extrication from a mitral valve — and the catheter might also have been subjected to such abuse by Ascent that, even if it had not been defectively made by Biosense, the catheter would have failed just as it did. Barkalow opined in his report, however, that “it is most likely that the subject Biosense LASSO catheter was damaged by the nonvalidated Ascent remanufacturing process such that [it] could not withstand normal mitral valve extrication techniques as used by Dr. Packer.” Id. In offering this opinion, Barkalow did not distinguish between chemical and physical damage by Ascent, and he did not appear to suggest that the catheter was defectively made by Biosense. Finally, Barkalow opined that Ascent violated FDA regulations by not securing 510(k) approval for reprocessing Lasso catheters. This particular opinion underlies Barkalow’s description of Ascent’s reprocessing techniques as “nonvalidated” (or “unvalidated”). Id. b. Barkalow’s Deposition Testimony As noted, Barkalow’s deposition testimony differed in some respects from his expert report. At his deposition, Barkalow said that the smear of polyurethane on the outside of the catheter must have occurred during the catheter’s manufacture, not during reprocessing. Barkalow Dep. at 79 (“[T]he only source of the polyurethane is from Biosense, it’s not from Ascent. And the isopropyl alcohol I don’t think is a strong enough solvent to have caused the polyurethane to smear over the body.”). But he gave equivocal and conflicting testimony about whether the smear indicated that a flaw that existed when the catheter left Biosense’s hands — that is, before it was reprocessed by Ascent — contributed to its failure during the procedure on Kapps. On the one hand, when Barkalow was asked whether the catheter was defective before it was reprocessed, he said several times that he did not know. For instance, Barkalow and a defendant’s attorney had this exchange: Q: [D]o you have an opinion in this case as to whether the eleetrophysiology catheter was defective and unreasonably dangerous prior to reprocessing? A: It obviously survived the first utilization, so it was safe for that, a single use. That’s all I can really say. But for the second application, it’s a different story. Q: So you don’t have an opinion? A: I don’t know if that device, had it been entangled — let’s say that you could go back in time and you could recreate the exact incident that Dr. Packer encountered, but the Biosense Webster catheter was on its first deployment. Would it have separated? I think that’s what you’re asking. We don’t know. But all I can say is there’s something not right with the polyurethane on that particular catheter. Id. at 75-76 (emphasis added); see also id. at 75 (“[W]hether or not it would be strong enough to withstand the mitral valve entanglement in the first use, I don’t know.”); id. (“Q: Do we know whether [the catheter] had that integrity before reprocessing or not? A: We don’t know.”); id. at 33 (“Q: Did that bond deficiency exist before the reprocessing or was it caused by the reprocessing? A: I don’t really know.... ”). Yet immediately after saying that he did not know whether the catheter was defective when it left Biosense’s hands, Barkalow opined that there was a “good possibility” that the polyurethane holding the lasso to the catheter body was weaker than it should have been even before the catheter was reprocessed by Ascent. Barkalow and a defendant’s attorney had this exchange: Q: Do you know what the exact mechanisms of separation were after reprocessing? A: Yes. The polyurethane adhesion bond was weak, and the LASSO portion pulled out of the catheter body. Q: And when was that weakness introduced into the catheter? A: I would say that there’s a good possibility that it was introduced in the manufacturing of it because it didn’t follow all of the techniques, as evidenced by the polyurethane being on the catheter body.... Id. at 77-78. In this testimony, Barkalow seemed to assert that the smear of polyurethane glue on the outside of the catheter shows that the catheter was defectively weak, contrary to his testimony that he did not know whether the catheter was defectively weak before its first use. When asked to explain how the polyurethane smear related to the hypothesized weakness of the glue joint between the lasso and the catheter body, Barkalow could not do so. For one thing, he did not offer a specific opinion about how the smear arose. Instead, he speculated as to three possible causes: The polyurethane itself might have been so runny “that it ran out over the body of the catheter.... ” Id. at 144. Or an assembler, through “extra handling,” might have “smeared the polyurethane” on the catheter. Id. Or there may have been “excess” polyurethane at some step that “smear[ed] out” during assembly. Id. at 149. More important, whatever the source of the smear may have been, Barkalow did not explain how the smear was evidence of the catheter’s weakness. After Barkalow described the smear as “indicative of some sort of manufacturing anomaly,” Barkalow and a defense attorney had this exchange: Q: ... The manufacturing anomaly that you described, the smearing of the [polyurethane] on the outside of the catheter body, would that alone affect the structural integrity or the strength of the catheter? A: Not necessarily. It may. I mean if you just talk about everything else is followed perfectly and then you add smearing of the polyurethane on top of it, no. Q: So just by virtue of the fact that it has been assembled, there’s a dome, and there’s some smear of polyurethane wouldn’t necessarily indicate that there’s a defect in the catheter, correct? A: It means something wasn’t right in the manufacturing process, but that wasn’t the extent of it. We don’t know exactly. Q: But it doesn’t necessarily follow that there is a structural defect that would affect the strength of the catheter, correct? A: That’s right, but it’s consistent with what happened in this case. It’s suspect. Q: Well, how is it suspect? A: It’s suspect because after the reprocessing, the catheter came apart. Q: Right. So before the reprocessing would it be suspect? A: We don’t necessarily know because we don’t believe that it was trapped in the first patient’s mitral valve. Q: [Wlbat you’re saying though is ... there’s nothing about the smearing of the catheter on the outside ... that would necessarily by itself affect the strength and function of the catheter, correct? A: In isolation, that’s correct. Id. at 159-61. As this exchange indicates, Barkalow’s opinion that Biosense made a defective catheter — to the extent that he even offers this opinion — depends largely on the fact that the catheter failed during Kapps’s procedure. Indeed, the catheter’s failure was the sole basis for Barkalow’s speculation that too little polyurethane may have been used during assembly. Id. at 158 (testifying that it is “a possibility” that too little polyurethane was used, but responding “that’s correct” to an attorney’s assertion that “other than the sheer fact of separation, you have no other indicia that there was too little polyurethane applied”). Notably, Barkalow’s speculation about too little polyurethane causing the catheter’s failure is inconsistent with his speculation that the smear on the catheter body resulted from the application during assembly of too much polyurethane. Compare id. at 149 (“if there’s excess [polyurethane], it could smear out”) with id. at 154-55 (“there could have been an insufficient amount of polyurethane applied on the inside”). With respect to Ascent, Barkalow likewise testified that the catheter’s failure showed that it was defective. He summarized his opinion as follows: I think if you look at the overall situation here, it’s fairly straightforward. What happened was that Ascent assumed responsibility for the used catheter, put it through its nonvalidated reprocessing technique, and then it broke. And there’s no evidence here that Dr. Packer used [undue] force, so that means something’s wrong with the catheter. Id. at 118. Barkalow identified a number of procedures connected to Ascent’s reprocessing that might have weakened the catheter. Specifically, he said that the catheter might have been damaged during any or all of eight steps: (1) collecting the used catheter by hospital personnel after its first use and before reprocessing; (2) shipping the catheter to Ascent for reprocessing; (3) untangling the catheter from other catheters at Ascent; (4) exposing the catheter to isopropyl alcohol either by wiping the catheter with alcohol or by soaking the catheter in a disinfecting solution called Cavicide that contains isopropyl alcohol; (5) cleaning the catheter with a nylon brush; (6) manually inspecting the catheter by running fingers along it; (7) manipulating the catheter during other inspection procedures; and (8) shipping the reprocessed catheter to a hospital for use. Id. at 88-91. Barkalow did not say that any one of these steps, alone, damaged the catheter. Rather, he said: I think it’s a combinatorial sort of thing; that it’s most probable that all of these steps that we’ve talked about moved the situation in the wrong direction to weaken the polyurethane joint that was critical. Id. at 88. Barkalow did, however, discuss in some detail Ascent’s use of isopropyl alcohol during reprocessing as a potential cause of the catheter’s failure. Barkalow was unable to say exactly what happens when polyurethane adhesive comes into contact with isopropyl alcohol. Id. at 80. In fact, he admitted that he was not “a recognized expert in analyzing and opining upon how polyurethane adhesive reacts to other chemicals[.]” Id. at 28. In concluding that Ascent’s use of solutions containing isopropyl alcohol might have damaged the catheter’s glue joint, Barkalow relied primarily on the fact that Biosense recommends against exposing the catheter to isopropyl alcohol, as this exchange between him and a defendant’s attorney shows: Q: What happens when you introduce polyurethane adhesive to isopropyl alcohol? A: I haven’t had enough time to really investigate that. I think that’s something that we need to look at a bit further. Q: As you sit here, do you know? A: I don’t know of the exact mechanisms, but I know that it’s contraindicated by Biosense. Q: Why is it contraindicated? A: Obviously because it could damage the catheter. They wouldn’t contraindicate it if that wasn’t the case. There’s really no other reason. Q: Are you qualified to talk about the chemical reaction between isopropyl alcohol and polyurethane adhesive? A: Sure. I can say that isopropyl alcohol is a solvent and it interacts with plastics and it’s not appropriate for all of them to be exposed to it without some kind of damage, and Biosense has clearly stated that ... isopropyl [alcohol] is contraindicated to be used with this catheter. Id. at 80-82. Barkalow also testified that Ascent did not properly inspect the catheter before reprocessing it. According to Barkalow, an inspector would have spotted the polyurethane smear on the outside of the catheter, and the catheter “would have been culled and not reprocessed.” Id. at 16. The significance of Ascent’s alleged failure to inspect is unclear. At one point, Barkalow asserts that the catheter “should never have been reprocessed in the first place” because “there may have been something wrong with this catheter because the polyurethane is not supposed to be on the body....” Id. at 32; see also id. at 59 (“I don’t think Ascent should have reprocessed this catheter.”). But when Barkalow was asked a few moments later whether a defect in the catheter’s glue joint existed before reprocessing or was caused by reprocessing, Barkalow replied, “I don’t really know. I can say that this particular Biosense catheter has an anomalous appearance.” Id. at 33 (emphasis added). Barkalow also testified — consistent with his expert report — that Ascent violated FDA regulations when it failed to secure 510(k) approval that was specific to the Lasso, but instead used the “line extension” method. Id. at 17, 45-52. 2. David G. Benditt, M.D. Dr. David G. Benditt is a specialist in cardiovascular medicine and cardiac electrophysiology. He is a professor at the University of Minnesota Medical School and a co-director of the school’s Cardiac Arrhythmia Center. Benditt Rept. at 1. His qualifications as a medical expert are undisputed. In his expert report, Benditt offered opinions on three subjects: (1) the adequacy of the warnings provided by Biosense and Ascent with respect to the Lasso catheter; (2) the differences between the Lasso catheter and the catheters that were listed in Ascent’s 510(k) application; and (3) the cause of Kapps’s injuries. With respect to the warnings, Benditt said: I am prepared to testify that it was inappropriate for [Biosense and Ascent] not to warn physicians or patients about a known, potentially dangerous defect in the Biosense Webster Circular Mapping Catheter (“Lasso catheter”) that allowed the Lasso catheter to become entrapped in the mitral valve. Additionally, I will testify that it was inappropriate for [Biosense and Ascent] not to warn physicians about how to properly untangle the Lasso catheter after it became entrapped in the mitral valve. This failure to communicate played a substantial part in causing Dr. Kapps’[s] injuries. Benditt Rept. at 4. According to Benditt, “doctors are not generally aware of the heightened risk” of mitral-valve entrapment when using the Lasso catheter, and thus, “[d]octors should be warned that careful manipulation of the LASSO Catheter is mandatory and particularly important.” Id. at 10. Benditt also said that Biosense and Ascent “should have provided instructions for catheter removal after entanglement,” but he did not describe what those instructions should have been. See id. at 10-11. With respect to Ascent’s 510(k) application, Benditt said that the Lasso was “substantially different in design, construction and application” from the Halo model of catheter that Ascent expressly listed in its 510(k) application. Id. at 12. Based on this assessment, Benditt further opined that “[i]t was inappropriate for Ascent to have used the HALO as a predicate device” for the Lasso when Ascent was deciding whether to file a new 510(k) application for the Lasso. Id. Given Benditt’s experience and training as a cardiac electrophysiologist, he is qualified to opine about the differences between the Halo and Lasso catheters. But Benditt is not an expert with respect to FDA regulations. Accordingly, the Court ruled after the March 17, 2011 hearing that Benditt could not offer an opinion about whether Ascent properly treated the Lasso as a line extension of the Halo when deciding whether to file a 510(k) application with respect to the Lasso. Order Mar. 18, 2011 at 5-6. Finally, Benditt opined that “Dr. Kapps’[s] injuries were directly caused by the failure of the LASSO catheter....” Id. at 4. Relatedly, Benditt said that he expected the Lasso catheter “to be strong enough to withstand” the force applied by Packer when he tried to extricate the Lasso’s loop portion from Kapps’s mitral valve. Id. at 11. II. DISCUSSION A Legal Principles 1. Summary Judgment Summary judgment is appropriate “if 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 dispute over a fact is “material” only if its resolution might affect the outcome of the lawsuit under the substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A dispute over a fact is “genuine” only if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Id. “The evidence of the nonmovant is to be believed, and all justifiable inferences are to be drawn in his favor.” Id. at 255, 106 S.Ct. 2505. 2. Admissibility of Expert Testimony Rule 702 of the Federal Rules of Evidence provides: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon-sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case. Fed.R.Evid. 702. Put simply, expert testimony is admissible under Rule 702 only if it is both reliable and relevant. Daubert, 509 U.S. at 589, 113 S.Ct. 2786; Junk v. Terminix Int’l Co., 628 F.3d 439, 448 (8th Cir.2010). The proponent of expert testimony bears the burden of establishing the reliability and relevance of the proposed testimony. Wagner v. Hesston Corp., 450 F.3d 756, 758 (8th Cir.2006). Expert testimony is reliable only if the expert is qualified to render the opinion and the underlying methodology is scientifically valid. See Daubert, 509 U.S. at 589-90, 113 S.Ct. 2786; Barrett v. Rhodia, Inc., 606 F.3d 975, 980 (8th Cir.2010). Expert testimony is relevant only if the expert properly applies her methodology or reasoning to the facts in issue. See Daubert, 509 U.S. at 591-93, 113 S.Ct. 2786; Barrett, 606 F.3d at 980. District courts have wide latitude in determining whether an expert’s testimony is reliable. Olson v. Ford Motor Co., 481 F.3d 619, 626 (8th Cir.2007). In assessing reliability, district courts consider such factors as: (1) whether the theory or technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether the theory or technique has a known or potential error rate and standards controlling the technique’s operation; (4) whether the theory or technique is generally accepted in the scientific community; (5) whether the expertise was developed for litigation or naturally flowed from the expert’s research; and (6) whether the proposed expert ruled out other alternative explanations. Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686-87 (8th Cir.2001); see also Daubert, 509 U.S. at 592-94, 113 S.Ct. 2786. Because the reliability inquiry is necessarily fact-specific, no single standard for reliability exists. See Unrein v. Timesavers, Inc., 394 F.3d 1008, 1011 (8th Cir.2005). Instead, these factors are flexible and should be considered as the case demands. Id. In general, courts should resolve doubts about the usefulness of an expert’s testimony in favor of admissibility. Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 758 (8th Cir.2006). But overly speculative testimony should not be admitted. Junk, 628 F.3d at 448; Grp. Health Plan, Inc. v. Philip Morris USA, Inc., 344 F.3d 753, 760 (8th Cir.2003) (“A certain amount of speculation [by an expert] is necessary, an even greater amount is permissible (and goes to the weight of the testimony), but too much is fatal to admission.”). For example, a court should not admit opinion evidence that “is connected to existing data only by the ipse dixit of the expert.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). Thus, when “there is simply too great an analytical gap between the data and the opinion proffered,” an expert’s opinion should be excluded. Id.; Junk, 628 F.3d at 448 (quoting Joiner). 3. Products Liability Under Minnesota Law Under Minnesota law, a plaintiff can recover in a products-liability action by showing three things: (1) the product at issue was “in a defective condition, unreasonably dangerous for its intended use”; (2) the product’s defect existed when the product left the defendant’s control; and (3) the defect was the proximate cause of the plaintiffs injury. Lee v. Crookston Coca-Cola Bottling Co., 290 Minn. 321, 188 N.W.2d 426, 432 (1971); see also Schafer v. JLC Food Sys., Inc., 695 N.W.2d 570, 576 (Minn.2005) (citing Lee). This is the doctrine of strict liability as set forth in Restatement (Second) of Torts § 402A, which Minnesota has adopted. Lee, 188 N.W.2d at 432; McCormack ex rel. McCormack v. Hankscraft Co., 278 Minn. 322, 154 N.W.2d 488, 499-501 (1967). In a products-liability case, the distinction between theories of strict liability and negligence is typically insignificant. As Lee explained, under the theory of strict liability, “[w]hile in conventional tort terms no proof of negligence is necessary, in many cases proof of a defect may simply be a substitute word for negligence.” 188 N.W.2d at 432. Indeed, the Minnesota Supreme Court held in Bilotta v. Kelley Co. that with respect to failure-to-warn and design-defect claims, the theories of negligence and strict liability are effectively merged into a single theory of products liability. 346 N.W.2d 616, 623 (Minn.1984) (“[Assuming proper instruction to ensure the broadest theory of recovery, a trial court could properly submit a design-defeet or failure-to-warn case to a jury on a single theory of products liability.”). Bilotta leaves open the theoretical possibility of a distinction between theories of negligence and strict liability in a manufacturing-defect case. Id. at 622 (“It has been suggested by commentators that ... strict liability and negligence are distinct theories in manufacturing flaw cases ....”); Johnson v. Zimmer, Inc., No. 02-1328, 2004 U.S. Dist. LEXIS 6007, at *32, 2004 WL 742038, at *10 (D.Minn. Mar. 31, 2004) (citing Bilotta for the proposition that “[njegligence and strict liability are distinct theories in manufacturing flaw cases”). But the core of a manufacturing-defect case is some manufacturing flaw— some deviation from a flawless product— that renders a product unreasonably dangerous. Bilotta, 346 N.W.2d at 622. If a dangerous manufacturing flaw existed and resulted from negligence, a plaintiff could in theory recover in negligence; if a dangerous flaw existed but did not result from negligence, a plaintiff could recover in strict liability. Either way, the plaintiff would be able to recover for injuries caused by a product rendered unreasonably dangerous by a manufacturing flaw. See Lee, 188 N.W.2d at 432. Further, in a manufacturing-flaw case, a defendant may rely on the doctrine of res ipsa loquitur to establish, through circumstantial evidence, that a product was dangerously defective, and the plaintiff may recover in either negligence or strict liability. As the Minnesota Supreme Court held in Holkestad v. Coca-Cola Bottling Co. of Minnesota: When a plaintiff has proved that he was injured by a product claimed to have been defective, and where the claimed defect is such that there is circumstantial evidence from which it can be inferred that it is more probable than not that the product was defective when it left defendant’s hands, absent plaintiffs own want of care or misuse of the product, there is an evidentiary basis for submitting the issue of liability to the jury on both the theory of negligence and strict liability in tort. 288 Minn. 249, 180 N.W.2d 860, 865-66 (1970). In a manufacturing-flaw case based on a theory of res ipsa loquitur, the doctrines of negligence and strict liability are connected because “the factor essential to the application of res ipsa loquitur — that it must be the kind of event which does not occur in the absence of negligence — is a circumstance tending to prove a [manufacturing] defect____” Id. at 866. The Minnesota Supreme Court’s application in Holkestad of res ipsa loquitur to products-liability cases is consistent with Restatement (Third) of Torts: Products Liability § 3, which provides: It may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale or distribution, without proof of a specific defect, when the incident that harmed the plaintiff: (a) was of a kind that ordinarily occurs as a result of product defect; and (b) was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution. Restatement (Third) of Torts: Products Liability § 3 (1998). This consistency between Holkestad and Restatement (Third) § 3 was expressly noted by the Minnesota Supreme Court in Schafer v. JLC Food Systems, Inc., 695 N.W.2d 570, 576 & n. 2 (Minn.2005). Schafer held: [I]n defective food products cases a plaintiff may reach the jury, without direct proof of the specific injury-causing object or substance, when the plaintiff establishes by reasonable inference from circumstantial evidence that: (1) the injury-causing event was of a kind that would ordinarily only occur as a result of a defective condition in the food product; (2) the defendant was responsible for a condition that was the cause of the injury; and (3) the injury-causing event was not caused by anything other than a food product defect existing at the time of the food product’s sale. Id. at 577. In effect, Schafer was an application to a defective-food-products case of res ipsa loquitur, which Minnesota has long held to apply in ordinary produetsliability eases. See id. at 576 (“Permitting the use of circumstantial evidence in [defective-food-products] cases is consistent with our jurisprudence on the use of circumstantial evidence to infer negligence in other contexts.”). B. Admissibility of Barkalow’s Expert Testimony Although defendants point out that Barkalow is not a medical doctor and is not an expert in the properties of polyurethane adhesives, they do not seriously challenge his basic qualifications as an expert in medical devices. And to the extent that defendants do argue that Barkalow is not qualified as an expert, the Court rejects the argument. Barkalow has extensive training and experience in biomedical engineering, and the Court finds that Barkalow’s expertise is sufficiently related to the issues in this case to render him qualified to offer expert testimony. The more difficult question is whether Barkalow’s testimony is sufficiently reliable to be admissible. Because Barkalow’s testimony differs with respect to Biosense and Ascent, the Court discusses separately the admissibility of his testimony with respect to each defendant. 1. Barkalow’s Testimony With Respect to Biosense Biosense argues that Barkalow’s testimony with respect to a manufacturing defect by Biosense is unreliable under Daubert and Rule 702 and thus should be excluded. The Court agrees. To begin with, it is questionable whether Barkalow ever actually opined — either in his expert report or in his deposition testimony — that the catheter was defective when it left Biosense’s hands. Specifically, in his expert report, Barkalow said that “[t]he subject catheter on its second use after remanufacture by Ascent was defective and unreasonably dangerous.... ” Barkalow Rept. at 10 (emphasis added). Notably, Barkalow did not assert that the catheter was “defective and unreasonably dangerous” before it was reprocessed. Further, when asked at his deposition whether the catheter was defective before it was reprocessed, Barkalow said — over and over again — that he simply did not know. See Barkalow Dep. at 33, 75-76. But Barkalow did sometimes seem to assert at his deposition — although not in his expert report — that the catheter was defective because of the smear of polyurethane on the exterior of the catheter body. To the extent that Barkalow’s testimony can be interpreted as making an assertion that the smear shows that the catheter was defectively made by Biosense, the Court excludes Barkalow’s opinion as unreliable. Under Rule 702 and Daubert, an expert witness must reliably connect his opinion to the underlying data. The data at issue here is actually a single datum: a smear of polyurethane glue that was visible on the exterior of the Lasso catheter. Barkalow does not offer any reason for connecting that smear to the catheter’s failure. In effect, Barkalow’s opinion equates correlation — i.e., a smear existed, and the catheter failed (facts that are not disputed)— with causation — i.e., the catheter failed because of a gluing defect that also gave rise to a smear (a causal connection that Barkalow does not establish). Nothing but Barkalow’s say-so (his ipse dixit) connects the smear on the outside of the catheter to the catheter’s failure, and thus “there is simply too great an analytical gap” between Barkalow’s opinion and the underlying facts to permit Barkalow to testify as an expert against Biosense. See Joiner, 522 U.S. at 146, 118 S.Ct. 512; Junk, 628 F.3d at 448 (quoting Joiner). 2. Barkalow’s Testimony With Respect to Ascent Barkalow offered two separate opinions with respect to Ascent. First, he opined that the catheter was damaged by Ascent during reprocessing and was therefore defective. Second, he opined that Ascent violated FDA regulations by using the line-extension procedure to obtain clearance to reprocess Lasso catheters instead of using the more-involved 510(k) approval procedure. The Court addresses in turn Ascent’s objections to these two opinions. a. Barkalow’s Opinion About the Catheter’s Defect Ascent breaks down Barkalow’s opinion about the catheter’s defect into two theories: (1) the theory that alcohol degraded the polyurethane holding the lasso portion inside the catheter body, and (2) the theory that some kind of physical mishandling weakened the joint between the lasso portion and the catheter body. Ascent Mem. Supp. Mot. Exclude Barkalow at 2-3 [Docket No. 61]. Ascent criticizes the second theory (physical mishandling) as being: (1) untested; (2) unpublished and not subject to peer review; (3) not generally accepted; and (4) developed for litigation. Id. at 14-17. Ascent criticizes the first theory (glue degradation) on these same four grounds, as well as on a fifth ground: having an unknown error rate. Id. at 8-12. Ascent also argues that Barkalow is not sufficiently knowledgeable about polyurethane to offer an opinion about whether Ascent’s use of alcohol-containing compounds in reprocessing may have degraded the glue joint. Id. at 12-13. The Court agrees that Ascent has identified a number of genuine weaknesses in Barkalow’s testimony. The Court does not, however, agree that Barkalow’s opinion with respect to Ascent is so speculative or unreliable that it should be excluded. Ascent criticizes Barkalow for not singling out a specific step in Ascent’s reprocessing procedure as the step in which the catheter was damaged. Id. at 14 (“Dr. Barkalow’s hypothesis is based solely on speculation that one or more steps undertaken by Ascent during reprocessing could have the potential to weaken the catheter.”). But under Minnesota’s products-liability law, Kapps is not required “to prove specifically what defect caused the incident, but may rely upon circumstantial evidence from which it can reasonably be inferred that it is more probable than not that the product was defective when it left [Ascent’s] control.” Lee, 188 N.W.2d at 434. Because Kapps need not prove specifically which aspect of Ascent’s process rendered the Lasso defective, Barkalow may testify that the broken catheter was weaker than it should have been and that one or more of several different steps in Ascent’s reprocessing procedure may have contributed to the catheter’s weakness. The core of Barkalow’s opinion is, as he said in his deposition, “fairly straightforward.” Barkalow Dep. at 118. According to Barkalow: (1) Ascent reprocessed the catheter; (2) Packer did not use excessive force when the catheter became entangled in Kapps’s mitral valve; (3) the catheter’s tip (i.e., the lasso portion) nonetheless pulled out of the catheter body; ergo (4) the catheter was defective. Id. Barkalow’s conclusion that the catheter was defective rests on the premise that a nondefective catheter would not have failed had it been subjected to the same conditions as the catheter at issue in this suit. And Barkalow offered exactly this opinion in his expert report when he said that despite becoming entangled in Kapps’s mitral valve, “the [lasso] portion should not have come separated from the main catheter body.” Barkalow Rept. at 10. Given Barkalow’s expertise in biomedical engineering, the Court finds that he is qualified to offer this opinion. Whether a medical device should be expected to withstand certain conditions is a factual question on which expert testimony is generally required. Thus, in Kaplon v. Howmedica, Inc., the Eighth Circuit upheld judgment as a matter of law dismissing a plaintiffs products-liability claim where the plaintiff argued that a surgical nail was defective because it failed seven months after implantation when (according to the plaintiff) it should have lasted twelve months. 83 F.3d 263, 266 (8th Cir.1996). Two doctors testified in Kaplon, and neither of them testified “that the nail should have lasted twelve months or that they believed the nail was defective because it did not.” Id. at 267. The Eighth Circuit held that the evidence was “not sufficient to support a finding that a [surgical] nail that does not last twelve months is defective” and that “[s]uch a finding would depend upon unwarranted speculation or conjecture on matters outside the scope of the jury’s experience.” Id. In this case, a jury of laypersons could not, on its own, decide whether the tip of a Lasso catheter should have been able to withstand entrapment in Kapps’s mitral valve without separating from the catheter body. Just as a layperson cannot know how long a nondefective surgical nail should last, a layperson cannot know what type of forces a nondefective catheter should be able to withstand without coming apart. Barkalow offers precisely the type of testimony that was missing in Kaplon: testimony that the medical device at issue was defective because it failed under circumstances in which a defect-free device would not have failed. Moreover, Benditt also opined that a nondefective Lasso would not have failed as did the Lasso used in treating Kapps. And Packer, testifying as a fact witness, said essentially the same thing. Barkalow’s, Benditt’s, and Packer’s testimony on this point is directly relevant to a strict-liability claim brought under the theory of res ipsa loquitur. See Lee, 188 N.W.2d at 434-35. b. Barkalow’s Opinion About FDA Approval The Court excludes Barkalow’s opinion with respect to FDA approval of Ascent’s reprocessing procedures. The Court assumes, without deciding, that Barkalow is qualified to offer this opinion. Nonetheless, the Court excludes the opinion because it is not relevant to any of Kapps’s claims against Ascent. Further, even if the opinion had some limited relevance, the Court would exclude it under Fed.R.Evid. 403. Whether Ascent’s reprocessing procedures damaged the failed catheter is an entirely separate question from whether Ascent sought FDA approval for those procedures through the proper route. That is, even if Ascent had received 510(k) approval for reprocessing Lasso catheters, Ascent could still be liable for selling a defective Lasso catheter if, in reprocessing a particular catheter, Ascent damaged the catheter and rendered it defective. And, conversely, if Ascent did not damage a catheter during reprocessing, then even if Ascent should have sought 510(k) approval for its reprocessing procedures, Ascent’s failure to seek such approval would not render an undamaged catheter defective. Further, even if Ascent failed to comply with FDA regulations, Kapps cannot recover from Ascent for this failure alone. Under Buckman Co. v. Plaintiffs’ Legal Committee, a private litigant may not sue a medical-device manufacturer for violating the FDCA. 531 U.S. 341, 349 n. 4, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions ...see generally Riley v. Cordis Corp., 625 F.Supp.2d 769, 775-77 (D.Minn.2009) (discussing preemption of FDCA-related claims). Yet Kapps’s arguments about Ascent’s compliance with FDA regulations amount to nothing other than an attempt to hold Ascent liable for violating the FDCA. Kapps argues, in cursory fashion, that Ascent’s alleged failure to comply with FDA regulations is “admissible as evidence of negligence per se.” Pl. Mem. Opp. Defs. Mots. Exclude Expert Testimony at 28 [Docket No. 92]. But this argument cannot be reconciled with Buckman. Under Minnesota law, negligence per se “is a form of ordinary negligence that results from violation of a statute.” Seim v. Garavalia, 306 N.W.2d 806, 810 (Minn.1981); see also Anderson v. State, 693 N.W.2d 181, 189 (Minn.2005) (quoting Seim). That is, negligence per se “substitutes a statutory standard of care for the ordinary prudent person standard of care, such that a violation of a statute (or an ordinance or regulation adopted under statutory authority) is conclusive evidence of duty and breach.” Gradjelick v. Hance,