Tillman v. C.R. Bard, Inc. (96 F. Supp. 3d 1307, 2015)

United States District Court for the Middle District of Florida 2015-03-30

Citations

Full opinion text

ORDER

MARCIA MORALES HOWARD, District Judge.

THIS CAUSE comes before the Court as a products liability action pertaining to an inferior vena cava filter, known as the G2®, designed and manufactured by Defendants C.R. Bard, Inc., and Bard Peripheral Vascular, Inc. On February 19, 2008, a physician implanted a G2® Filter (the Filter) in Plaintiff Lessie Tillman (Tillman). Although the physician intended for the Filter to be retrieved later, it changed position within Tillman’s body such that it cannot be removed safely. Tillman contends that the Filter is defective and, because it cannot be removed, exposes her to an ongoing risk of serious harm for which she requires medical monitoring. On March 19, 2013, Tillman filed an Amended Complaint for Damages (Doc. 10; Complaint) asserting a state law negligence claim, as well as strict liability claims for failure to warn, design defect, and manufacturing defect. See Complaint at 12-16. This matter is presently before the Court on several motions.

On August 1, 2014, Bard filed four motions seeking to exclude the testimony of certain of Tillman’s expert witnesses. See Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s Motion to Exclude the Opinions of Michael Freeman, Ph.D. and Memorandum of Law in Support (Doc. 95; Motion to Exclude Freeman); Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s Motion and Memorandum of Law to Exclude the Opinions of William A. Hyman (Doc. 96; Motion to Exclude Hyman); Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s Motion to Exclude the Opinions of Robert McMeek-ing and Matthew Begley and Incorporated Memorandum of Law in Support Thereof (Doc. 99; Motion to Exclude McMeek-ing/Begley); Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s Motion to Exclude the Opinions of Robert Ritchie, Ph.D. and Memorandum of Law in Support (Doc. 100; Motion to Exclude Rit-chie). Tillman filed responses in opposition to these Motions on August 22, 2014. See Plaintiffs’ Opposition to Defendants’ Motion to Exclude the Opinions of William Hyman and Brief in Support Thereof (Doc. 96; Hyman Response); Plaintiffs Opposition to Defendants’ Motion to Exclude the Opinions of Michael Freeman, Ph.D. and Brief in Support Thereof (Doc. 120; Freeman Response); Plaintiffs Opposition to Defendants’ Motion to Exclude the Opinions of Robert Richie [sic], Ph.D. and Brief in Support Thereof (Doc. 122; Ritchie Response); Plaintiffs Opposition to Defendants’ Motion to Exclude the Opinions of Robert McMeeking and Matthew Begley as .to Manufacturing and Legal Conclusions and Brief in Support Thereof (Doc. 123; McMeeking/Begley Response). With leave of Court, see Order (Doc. 141), Bard filed reply briefs on October 9, 2014. See Bard’s- Reply in Support of its Motion to Exclude the Opinions of Michael Freeman, Ph.D. (Doc. 144; Freeman Reply); Bard’s Reply in Support of its Motion to Exclude the Opinions of Robert McMeeking and Matthew Begley (Doc. 145; McMeek-ing/Begley Reply); Bard’s Reply in Support of its Motion to Exclude the Opinions of William A. Hyman (Doc. 146; Hyman Reply); Bard’s Reply in Support of Its Motion to Exclude the Opinions of Robert Ritchie, Ph.D. (Doc. 147;' Ritchie Reply).

In addition, both parties filed motions for summary judgment on August 1, 2014. See Plaintiffs Motion for Partial Summary Judgment Against Defendant C.R. Bard and Bard Peripheral Vascular, Inc. (Doc. 93; Tillman Motion); • Defendants’ Motion for Summary Judgment (Doc. 98; Bard Motion). The parties filed their respective responses in opposition to the summary judgment motions on August 22, 2014, and with the Court’s permission, the parties filed replies on October 9, 2014. See Defendants’ Response in Opposition to Plaintiffs Motion for Partial Summary ■Judgment (Doc. 116; Bard Response); Plaintiffs Response to Defendants’ Motion for_ Summary Judgment (Doc. 121; Tillman Response); Plaintiffs Reply to Defendant’s Opposition to Plaintiffs Motion for Partial Summary Judgment Against Defendant C.R. Bard and Bard Peripheral Vascular, Inc. (Doc. 142; Tillman Reply); Bard’s Reply in Support of its Motion for Summary Judgment (Doc. 143; Bard Reply). Accordingly, the various pending motions are ripe for review.

I. Background

This case concerns a medical device known as an inferior vena cava (IVC) filter. An IVC filter is a “device that’s implanted into the inferior vena cava.... And its responsibility essentially is to capture a clot that may become dislodged from a [deep vein thrombosis] and potentially be a life-threatening pulmonary embolism to the patient.” See Deposition of Andrew Stockland, M.D. (Doc. 137-7; Stockland Dep.) at 13. These filters originated in the 1960’s and 1970’s, and were first used as permanently implanted devices. See Bard Motion, Ex. A: Report of Clement J. Grassi, M.D. (Doc. 98-1; Gras-si Report) at 2-3. With advances in technology and design, manufacturers began developing “retrievable” or “option” filters. Id. Bard’s expert, Clement J. Grassi, M.D., a physician and interventional radiologist, explains that all IVC filters carry the risk of complications. See id. at 4. “Well known” filter complications include “filter migration, filter fracture, component em-bolization, access site thrombosis, IVC occlusion, filter tilt, penetration or perforation, and others.” Id.; Stockland Dep. at 14-17. According to Grassi, “there is no perfect filter device available in the market today.” Grassi Report at 4. Indeed, Matthew Begley, Ph.D., one of Tillman’s engineering experts, concedes that it is not possible to design an IVC filter that never migrates, tilts, perforates, of fractures. See Bard Motion, Ex. I: June 19, 2014 Deposition of Matthew Begley, Ph.D. (Doc. 98-9; June Begley Dep.) at 43.

Bard originally marketed a permanent IVC filter known as the Simon Nitinol Filter (SNF), and later developed a retrievable filter named the Recovery. See Tillman Response, Ex. EE: Report of Jeffrey Hull, M.D. (Doc. 134-16; Hull Report) at 2. The FDA approved the Recovery filter as a permanent filter in November 2002, and as a retrievable filter in July 2003. See Tillman Response, Exs. F, G. Bard obtained this approval via the “ § 510(k) process,” through which the FDA will clear a device for marketing if it is substantially equivalent to a predicate device. Id. The Recovery’s predicate device was the SNF. Id., Ex. F. Bard withdrew the Recovery from the market in 2005, and replaced it with the G2 filter. See Hull Report at 2. On August 29, 2005, Bard obtained FDA clearance to market the G2 filter through this same process by identifying the Recovery filter as a substantially equivalent predicate device. See Tillman Response, Ex. H.

In early 2008, Tillman, who was in a rehabilitation center recovering from two knee replacement surgeries, woke up with leg pain. See Bard Motion, Ex. B: Deposition of Lessie Tillman (Doc. 98-2; Tillman Dep.) at 70-71. Testing revealed the pain was caused by a blood clot in her leg. Id. As a result, on February 19, 2008, Dr. Luis Anez ordered the implantation of an IVC filter. See Tillman Dep. at 71-72; Tillman Response, Ex. Z. According to Tillman, she was informed that the filter was needed to protect her from “the blood clot that was in my left leg to make sure that it didn’t go all the way up.” See Tillman Dep. at 80. Andrew Stockland, M.D., an interventional radiologist, performed the placement procedure that same day, implanting a G2 filter manufactured by Bard. See Tillman Response, Ex. Z; Stockland Dep. at 10, 32. Stockland states that the Filter was centered in the IVC when it was placed, and “was very vertical” in his opinion. See Stockland Dep. at 79.

In the Final Report following the implantation, Stockland notes that “[t]his filter may remain as a permanent device, or be potentially retrieved within 12 months. Given the patient’s young age, consider retrieval in the very near future when her current medical issues have resolved.” See Tillman Response, Ex. Z. Stockland explains that

[t]he plan was to potentially take it out if possible ... [b]eeause I think the filter served a purpose for [Tillman] in the current situation that she presented with, but when she was done with rehab and done with her getting back on anti-coagulation and we felt it was safe and the risk of a [pulmonary embolism] was low, then we should seriously consider removing it.

See Stockland Dep. at 63. Stockland explains that “[t]he preference is to place a retrievable with the hope of getting it out. But unless I ... was convinced that someone needed a permanent filter, I would place a temporary or a retrievable. But there’s always an understanding that a retrievable can turn into a permanent device.” Id. at 75.

Tillman saw Dr. Kedra Williams on June 18, 2008, “[t]o have some medications refilled and to follow up some labs that were done.” See Bard Motion, Ex. D: Deposition of Kedra Williams, M.D. (Doc. 98-4; Williams Dep.) at 24. At that time, Tillman was taking Coumadin to treat her previous deep vein thrombosis (DVT), and Williams ordered a venous Doppler examination of Tillman’s legs to see if the DVT had cleared. See id. at 24-25. Williams commented in Tillman’s medical records on that visit that “[w]ill need to follow up with a vascular surgeon for the filter— Greenfield filter removal when Dopplers are negative.” Id. at 25. On July 24, 2008, Williams assessed that the Doppler results were negative such that Tillman could stop taking Coumadin, and included a note in her records that Tillman was to talk to her surgeon about getting the Filter removed. Id. at 29-30. Although Williams does not recall whether she told Tillman to follow up with the surgeon that placed the Filter, it would have been her typical practice to do so. Id. at 25.

Tillman saw Williams again in October 2008, and February 2009. On the February 4, 2009 visit, Williams referred Tillman to a vascular surgeon for the removal of the Filter. Id. at 41. Tillman underwent a venous procedure on March 4, 2009, in an attempt to remove the Filter. The Final Report from that procedure states that “[a] scout film was obtained which demonstrated the previously placed' G-2 Bard JVC filter to have slightly migrated and is now tilted to the left.” See Bard Motion, Ex. F at 2. The Final Report further states that “[t]he apex of the filter was noted to be incorporated into the left.renal vein and no thrombus or filling defects were identified within the filter or within the vena cava.” Id. Although multiple attempts were made at recovering the Filter with the Bard recovery device, “[d]ue to the extensive nature of tilting of the device, length of the duration of placement of the device and probable incorporation into the left renal vein further attempts at recovering filter were abandoned.” Id.

Three days after the attempted retrieval, on March 7, 2009, Tillman returned to the hospital because she felt “sick and couldn’t stand up.” See Tillman Dep. at 137; Tillman Response, Ex. CC. According to Tillman, she was informed that she had a blood clot in her kidney “that came from the pulling up to try to get the filter out.” See Tillman Dep. at 138. Tillman was treated with Coumadin, and by June 2009, the clot had cleared. Id. at 138-39; Williams Dep. at 53-54. Since that time, Tillman has not been diagnosed with another DVT or clot. See Tillman Dep. at 140. Tillman and her husband met with Williams in September 2013, to discuss their concerns about the Filter. See Williams Dep. at 58, 60-61; see also Bard Motion, Ex. G. An October 3, 2013 imaging, diagnostic report on Tillman indicates that the IVC filter now “appears to extend outside the inferior vena cava....” See' Tillman Response, Ex. DD. In 2014, Tillman met with a specialist, Dr. Erin Moore,, to discuss getting the Filter removed. See Tillman Dep. at 133-34, 145-46; Williams Dep. at 80. Williams explains that Moore noted in his records that:

[b]ased on the independent visualization of the patient’s imaging, I do not feel removal of the IVC filter is necessary and ... only an open surgical repair is likely to be possible for achieving retrieval. I have assured the patient the risk of surgically intervening and removing of filter [sic] as comparatively greater than leaving it in place.

See Williams Dep. at 80. According to Tillman, Moore did not tell her that the Filter’s tilted position or perforation of her IVC was causing any of her symptoms., See Tillman Dep. at 217.

When asked what injuries, damages, or problems she claims are caused by the Filter, Tillman responds that:

I’m not saying I have anything that’s-caused by the filter. I’m just saying that the filter’s there, and I don’t know what’s going to happen down the line.... It should be taken out, but now they can’t take it out. So I got to live with the fact of it being there and hoping and praying that if I have a blood clot or something, that it work....

See Tillman Dep. at 153. She further explains that “it’s there, and it needs to be taken out. I just don’t want anything to happen, like it rupture or something or fall apart or start pulling apart and moving around in my body or something like that....” Id. at 166-67. Tillman also believes that “Dr. Moore said ... that it needs to be watched to make sure that it doesn’t break loose.” Id. at 170. In addition, Tillman indicates that although she has not experienced any emotional problems or depression as a result of the Filter, she does worry “about what’s going to happen with it being in.” Id. at 171. After meeting with Dr. Moore, Tillman began to “really kind of start worrying about the rupture or coming apart or something like that or it’s stretching out.” Id. at 171-72. Tillman emphasizes that if she had known “that [the Filter] wasn’t going to be able to be taken out, I would have never had it put in....” See Tillman Dep. at 154, 208-09.

II. Motions to Exclude Expert Opinions

A. Standard of Review

Rule 702 of the Federal Rules of Evidence (Evidence Rule(s)) provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) the expert’s scientific technical or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

Fed.R.Evid. 702. In Dauberb, the Supreme Court explained that Evidence Rule 702 imposes an obligation on a trial court to act as gatekeeper, to ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). To determine the admissibility of expert testimony, a trial court must consider if:

(1) the expert is qualified to testify competently regarding the matters he intends to address; (2) the methodology by which the expert reaches his conclusions is sufficiently rehable as determined by the sort of inquiry mandated in Daubert; and (3) the testimony assists the trier of fact through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue. •

See United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir.2004). The burden of establishing qualification, reliability and helpfulness lies with the party offering the expert opinion. See McClain v. Metabolife Int'l, Inc., 401 F.3d 1233, 1238 (11th Cir.2005). For the purpose of conducting the reliability inquiry mandated by Daubert, the Supreme Court has suggested that a trial court consider a number of factors, which include: (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) the known or potential rate of error; and (4) whether the theory has attained general acceptance in the relevant scientific community. See Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. These factors are not exhaustive, and the Eleventh Circuit Court of Appeals has also considered whether an expert has relied on anecdotal evidence, such as case reports; temporal proximity; and improper extrapolation. See Allison v. McGhan Med. Corp., 184 F.3d 1300, 1312 (11th Cir.1999). The Court’s inquiry under Evidence' Rule 702 must focus on the methodology, not conclusions, but the Court is not required to admit opinion testimony only connected to existing data by an expert’s unsupported assertion. See Daubert, 509 U.S. at 595, 113 S.Ct. 2786; Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997).

In addition to determining the reliability of the proposed testimony, Daubert instructs that Evidence Rule 702 requires the Court to determine whether the evidence or testimony assists the trier of fact in understanding the evidence or determining a fact in issue. See Daubert, 509 U.S. at 591, 113 S.Ct. 2786. This consideration focuses on the relevance of the proffered expert testimony or evidence. The Court explained that to satisfy this relevance requirement, the expert testimony must be “relevant to the task at hand.” Daubert, 509 U.S. at 591, 113 S.Ct. 2786. Because scientific testimony does not assist the trier of fact unless it has a justified scientific relation to the facts, the Eleventh Circuit has opined that “there is no fit where a large analytical leap must be made between the facts and the opinion.” McDowell v. Brown, 392 F.3d 1283, 1289 (11th Cir.2004) (citing Gen. Elec. Co. v. Joiner, 522 U.S. 136, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997), finding too great an analytical gap between data suggesting that one type of cancer was caused in mice and the conclusion or opinion that such data established causation of another type of cancer in humans).

The proponent of expert testimony need not show that the opinion proffered is scientifically correct, but only, based upon a preponderance of the evidence, that the opinion is reliable. See Allison, 184 F.3d at 1312. Thus, absolute certainty is not required. See Jones v. Otis Elevator Co., 861 F.2d 655, 662 (11th Cir.1988). However, an expert must know “facts which enable him to express a reasonably accurate conclusion instead of mere conjecture or speculation,” see id., and an expert’s assurances that he has used generally accepted scientific methodology are insufficient, see McClain, 401 F.3d at 1244.

B. Discussion

i. Ritchie

Robert Ritchie, Ph.D. is the “H.T. & Jessie Chua Distinguished Professor of Engineering and Professor of Materials Science and Engineering and of Mechanical Engineering at the University of California, Berkeley.” See Motion to Exclude Ritchie, Ex. A (Doc. 113; Ritchie Report) at 1. He has extensively researched “the problem of fracture and fatigue of metallic alloys and other structural materials” and has “extensive experience in the analysis of failures in a wide range of structures and components, in particular from the medical device industries.” Id. Bard does not challenge Ritchie’s qualifications as an expert. See generally Motion to Exclude Ritchie. Instead, Bard contends that Rit-chie’s opinions regarding the causes of fracture in Bard’s Recovery and G2 filters do not fit the facts of this case. Id. at 2. In addition, to the extent Ritchie does offer opinions specific to the complications Tillman experienced, Bard argues that those opinions are “neither the product of reliable scientific methodology nor based on sufficient data.” See id.

Ritchie’s opinions are “based on [his] personal knowledge, education, training and decades of experience.” Ritchie Report at 1. He examined fourteen failed G2 filters, and has previously examined ten failed Recovery filters. Id. He also scrutinized four “exemplar” unimplanted filters of each type. Id. Of course, because Tillman’s Filter remains implanted in her IVC, Ritchie has not been able to examine that specific device. Id. at 22. In addition, Ritchie reviewed various depositions pertaining to this case, as well as documentary evidence produced in discovery. Id. at 2. Ritchie is further informed by his knowledge of the fatigue and fracture of Nitinol (a Ni-Ti alloy from which the filters are made), obtained from twenty years of research on this material. Id. Based on his analysis of the foregoing, Ritchie concludes that Bard IVC filters .“were inadequately and defectively designed and manufactured to withstand the physiological loading that they experienced in vivo,” causing these filters to fail in service. Id. at 19.

Specifically, Ritchie addresses the causes of fracture in the Recovery and G2 filters. He asserts that fractures are caused by “cyclic fatigue failure involving fatigue cracks that initiated on the surface of the wire arms (and legs).... ” See Rit-chie Report at 18. These cracks spread through the wire until it completely fractures “due to ductile overload failure (mi-crovoid coalescence).” See id. Ritchie explains that the presence of “surface gouges” or other imperfections on the surface of the wires “could be directly identified with the initiation of the fatigue crack that fractured the wire.” Id. Ritchie maintains that these gouges and imperfections are defects which could have been removed by “electropolishing” or avoided by improved manufacturing procedures. Id. at 18-19. In addition, Ritchie asserts that fractures initiate where the wires emerge from the filter sleeve, specifically where the wire contacts the edge of the inner-diameter rim. Id. at 19. According to Ritchie, the inner rim of the filter sleeve is inadequately chamfered such that it has an exceedingly sharp radius of curvature. Id. Ritchie posits that this lack of chamfer “represents a severe design and/or manufacturing' defect.” Id. Ritchie also opines that fractures can occur when a filter tilts, migrates, or perforates the IVC. Id. Ritchie adds that Bard did not sufficiently analyze these diverse scenarios in their stress analyses, and that the filters “were inadequately tested prior to distribution, particularly with respect to their fatigue endurance.” Id. Ritchie explains that the testing was inadequate “either because Bard inadequately estimated the severity of the loading condition in vivo in their testing protocol, and/or the duration of the tests was too short. Id. As such, Ritchie concludes that the Bard filters fail in service because they are inadequately designed and manufactured to withstand the stresses and strains experienced in the human body. Id.

Bard is correct that there is no evidence that the Filter implanted in Tillman’s IVC has fractured. See, e.g., Rit-chie Report at 22. Rather, the medical records demonstrate that the Filter has tilted and perforated her IVC such that it cannot be removed, and may or may not have slightly migrated. See Bard Motion, Ex. F; Tillman Response, Exs. DD, EE at 6; Stockland Dep. at 78, 101-102; see also Hull Dep. at 111. Ritchie, himself, acknowledges that “the medical reports do not provide evidence of the fracture of any specific arms or legs in Mrs. Tillman’s filter or of the migration of fragments .... ” See Ritchie Report at 22. As such, Bard contends that Ritchie’s opinions on filter fracture do not “fit” the facts of this case. However, Tillman argues that the defects Ritchie identifies create an increased risk of fracture such that she is exposed to an “on-going preseht danger with the G2 filter lodged in her body.” See Ritchie Response at 7. Because of this risk, Tillman seeks the cost of medical monitoring necessary to detect the onset of physical harm, see Complaint ¶49, and absent any argument from Bard to the contrary, it appears such damages are recoverable under Florida law. See Petito v. A.H. Robins Co., Inc., 750 So.2d 103, 104-06 (Fla. 3d Dist.Ct.App.1999); see also Bouldry v. C.R. Bard, Inc., 909 F.Supp.2d 1371, 1375-76 (S.D.Fla.2012). Thus, evidence that G2 filters are prone to fracture due to design or manufacturing defects is relevant to Tillman’s , claim for medical monitoring damages. In addition, having found that Ritchie’s fracture opinions are relevant to this case, the Court also rejects Bard’s unsupported contention that these opinions are somehow unduly prejudicial. Therefore, the Court will deny Bard’s Motion to Exclude Ritchie to the extent Bard requests the exclusion of Ritchie’s fracture opinions.

As to Tillman’s current complications, Ritchie concedes that “[ljacking the failed filter itself, we do not have direct structural evidence for the cause of the migration, tilting and probable perforations of the struts of Mrs. Tillman’s filter....” Id. Nonetheless, Ritchie draws the following conclusion regarding the Filter:

the evidence from other failed G2 filters described in this report does indicate' fractures of the arms and of the legs and feet in failed filters which would interrupt the proper placement of the filter, leading to potential tilting and migration and would of course increase the load on the remaining anchored legs. Based upon my review and examination of these failed G2 filters, as well as the exemplar filters, it is my opinion that the likely causes of their malfunction are their design and/or manufacturing defects that I have observed. In this regard, the filter implanted in Mrs. Tillman would more likely than not have had the same characteristics as the filters that I have examined, namely a lack of proper chamfering of the interior edge of the Nitinol sleeve and a lack of an undamaged surface from surface gouges and grinding and draw markings, all of which represent manufacturing and/or design defects of the device, coupled with poor mechanical design, limited stress analysis and an inadequate assessment of their fatigue resistance during all modes of in vivo operation. These likely rendered Mrs. Tillman’s filter unable to withstand the normal physiological stresses exerted upon it within the human body, causing problems of tiling, migration and perforation.

Id. at 22-23. However, Ritchie offers no explanation or analysis to support the leap from his contention that the identified defects cause fracture to his conclusion that the identified defects also cause tilt, migration and perforation. Id. Indeed, as Bard aptly points out, Ritchie’s analysis of tilt, migration and perforation in the body of his Report is limited to the ways in which these events can lead to fracture, and includes no discussion of what or how the purported design or manufacturing defects can also cause tilt, migration or perforation. See Ritchie Report at 12, 19. A number of Dauberb decisions “warn against leaping from an accepted scientific premise to an unsupported one.” See Allison, 184 F.3d at 1314 (collecting cases). Here, Ritchie does precisely that in leaping from his scientifically supported opinions regarding the causes of filter fracture, to his unsupported conclusion that, absent any evidence of fracture, these same deficiencies cause tilt, migration and perforation.. Even accepting Ritchie’s assumption that Tillman’s Filter has the same surface defects and lack of chamfering that are present in the filters he examined, Ritchie offers nothing more than his own ipse dixit to conclude that those conditions also cause tilt, migration, and perforation. As such, the Court determines that Rit-chie’s opinion on the cause of tilt, perforation and migration is not sufficiently reliable under Daubert and will grant Bard’s Motion to Exclude Ritchie as to that opinion only. See McDowell, 392 F.3d at 1289.

ii. McMeeking/Begley

Robert M. McMeeking, Ph.D. is a “Tony Evans Professor of Structural Materials and Professor of Mechanical Engineering,” and Matthew R. Begley, Ph.D. is a “Professor of Mechanical Engineering and Professor of Materials,” both at the University of California, Santa Barbara. See Motion to Exclude McMeeking/Begley, Ex. A (Doc. 112; McMeeking/Begley Report) at 1. McMeeking and Begley (the Engineers) have performed “extensive research” into “problems of mechanical failure in a wide range of structural components, including biomedical implants.” Id. at 2. The Engineers issued a joint report based on their “personal examination of the Bard design and qualification documentation produced during discovery ... in cases [they] previously worked on,” and the Report describes “the design, mechanical analysis, finite element analysis (FEA) and testing of Bard filters.” See McMeeking/Begley Report at 1. Bard seeks exclusion of the Engineers’ opinions in their entirety. See Motion to Exclude McMeeking/Begley at 2. As with Ritchie, Bard argues that the Engineers’ opinions on filter fatigue and fracture do not “fit” the facts of this case because Tillman’s Filter did not fracture. Id. at 5-6, 15. Next, Bard challenges the Engineers' opinion that Bard inadequately tested the Recovery and G2 filter designs for the risk of perforation, tilt and migration. Id. at 6. Bard asserts that these opinions are unhelpful to the jury because the Engineers "fail to identify any aspect of the Bard G2® Filter that is allegedly defective such that it caused [Tiliman's] filter to tilt, perforate, or migrate." Id. at 7, 16. In addition, Bard argues that the Engineers' opinions regarding Bard's manufacturing process and quality controls should be excluded because the Engineers are not qualified to opine on manufacturing processes and the opinions are unreliable. Id. at 16-18. Last, Bard contends that the Court should exclude the Engineers' opinions characterizing Bard's conduct as reckless, negligent, incompetent, misleading, or unethical because such opinions constitute inappropriate legal conclusions, or purport to discern Bard's intent, matters about which the experts are not qualified to opine. See id. at 18-20.

First, the Engineers' opinions concerning filter fracture are relevant to Tillman's claims for the same reasons that Ritchie's opinions on fracture are relevant. As discussed above, Tiiman contends that the Filter is defectively designed such that it poses an unreasonable risk of fracture and requires her to obtain ongoing medical monitoring. The Engineers' opinions with respect to whether G2 filters contain design defects which make them unreasonably prone to fracture, and whether Bard adequately tested its filters for this risk, are relevant to this claim. Bard does not challenge the Engineers' qualifications or the reliability of their opinions on this issue, thus, the Court finds no basis to exclude the Engineers' opinions on filter fracture, and will deny Bard's Motion to Exclude McMeeking/Begley in that respect.

Next, the Engineers opine that Bard failed to conduct adequate testing on the risk of tilt, perforation and migration. Bard argues that these opinions should be excluded as unhelpful to the jury because the Engineers "cannot identify a single defect-or anything else-that allegedly caused [Tiliman's] filter to tilt, perforation [sic], or migrate." See Motion to Exclude Begley/lVlcMeeking at 16. Evidence Rule 702 requires that "the evidence or testimony `assist the trier of fact to understand the evidence or determine a fact in issue.'" See Daubert, 509 U.S. at 591, 113 S.Ct. 2786 (quoting Evidence Rule 702). However, "[t]he expert need not have an opinion on the ultimate question to be resolved by the trier of fact in order to satisfy this requirement." Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir.2000). Indeed, "the testimony need only assist the trier of fact, through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue." City of Tuscaloosa v. Harcros Chems., Inc., 158 F.3d 548, 565 (11th Cir.1998). The Engineers' "data and testimony need not prove [Tillman's] case by themselves, they must merely constitute one piece of the puzzle that [Tillman] endeavor[s] to assemble before the jury." Id.

Upon review, the Court finds that the Engineers' opinions regarding the adequacy of Bard's testing for the risk of perforation, tilt and migration would be helpful to a jury in determining a fact in issue, specifically whether Bard breached its duty of care in designing the G2 filter, or failing to issue adequate warnings, as alleged in Count One. See Adams v. G.D. Searle & Co., Inc., 576 So.2d 728, 730-31 (Fla. 2d Dist.Ct.App.1991) ("The duty to test ... is a subpart of a manufacturer's duty to design a product with reasonable care, and thus is subsumed in the plaintiffs' claims for defective design and failure to warn.”); Kociemba v. G.D. Searle & Co., 707 F.Supp. 1517, 1528 (D.Minn.1989) (“The duty to test is subpart of duties to design a product non-negligently, manufacture a product non-negligently, and provide adequate warnings of dangers associated with its use.”); see also Smith, 215 F.3d at 721. Although the Engineers do not offer opinions on the ultimate issue of whether the G2 filter’s design was actually defective, or whether a specific defect caused Tillman’s G2 filter to tilt, perforate and possibly migrate, their testimony need not be excluded simply because they do not opine on these ultimate factual issues. See Dartey v. Ford Motor Co., 104 F.Supp.2d 1017, 1024-25 (N.D.Ind.2000) (“Relevant testimony is not excluded simply because the testimony does not relate to the ultimate issue in the case.”). Because the Engineers’ opinions on the adequacy of Bard’s testing and whether Bard accurately determined the degree of risk associated with the G2 filter will be helpful to the trier of fact in determining whether Bard acted negligently in its design, manufacture, and marketing of the Filter, the Court will not exclude this testimony.

Bard also seeks to exclude the Engineers’ opinion that Bard does not exert sufficient control over its manufacturing processes such that there is variability in certain aspects of the G2 filters leading to failure in some devices. See Motion to Exclude McMeeking/Begley at 9-10. Specifically, Bard challenges the Engineers’ opinions that the magnitude of the bend in the arm of the G2 Filter is an “arbitrary outcome of the manufacturing process,” and that “the radius of the sheath edge where it contacts the arms and legs is not controlled in the manufacturing process .and therefore it can vary considerably.” See McMeeking/Begley Report at 7, 11. As support for these opinions, the Engineers observe that “the radius of the bend is not specified in any of Bard’s engineering drawings that we have reviewed.” Id. at 7. In addition, the Engineers note differences in the radius of the sheath shown in micrographs obtained from other experts, but have not “cut open a filter to look at that” themselves. See Motion to Exclude McMeeking/Begley, Ex. C: April 22, 2014 Deposition of McMeeking (Doc. 99-3; McMeeking Dep.) at 146. However, McMeeking concedes that he “would not claim to know in detail what” the manufacturing controls are, and does not know in specific detail “how uncontrolled or how variable the filters coming off the line were” for the Recovery and G2 filters. See id. at 146r47. As such, Bard contends that these opinions “are unsupported by facts and are unreliable,” and that the Engineers “have no qualifications that would provide them the expertise to proffer these opinions.” See McMeeking/Beg-ley Reply at 5.

It is Tillman’s burden to demonstrate that the expert opinions on which she relies satisfy the Daubert standards. See McClain, 401 F.3d at 1238. In her Response, although she broadly discusses the Engineers’ general qualifications, Tillman does not specifically explain how the Engineers are qualified to opine on Bard’s manufacturing processes. See McMeek-ing/Begley Response at 3-5, 9. Indeed, she identifies the Engineers’ particular area of expertise as “theoretical and computational stress/strain analysis.” Id. at 9. Notably, she does not include these particular manufacturing opinions in her summary of the Engineers’ findings. See id. at 8. Likewise, Tillman does not rely on the Engineers’ opinions on the variability of Bard’s manufacturing process in her summary judgment briefing. See Tillman Response at 11-12. As such, it is unclear whether Tillman intends to offer the Engineers as experts on the manufacture of these devices. Nonetheless, upon review of the Report, the Court finds that while the Engineers are qualified to opine on mechanical failure and stress-strain analysis, they do not identify any qualifications specific to the area of manufacturing controls and processes. See McMeeking/Begley Report at 2. Moreover, the experts do not identify any documents or materials pertaining to Bard’s manufacturing process that they reviewed in preparing their Report. Id. at 3. While McMeeking states that he has “read some of the documents that describe” Bard’s manufacturing controls, he “would not claim to know in detail what those controls are.” See McMeeking Dep. at 146. Rather, it appears McMeek-ing’s opinion in this respect is based on his examination of Bard’s finite element calculations. Id. at 146^7 (“[T]hey made a variety of assumptions about boundary conditions.... And that suggests to me that they realized that there was a variability in the constraint of the weld imposed on 'the wires, and that that was something they were accounting for in their calculations.”). Accordingly, with respect to Bard’s manufacturing process in particular, Bard’s argument is well-taken and the Engineers will not be permitted to opine on Bard’s manufacturing controls or lack thereof.

Last, Bard argues that the Engineers’ opinions characterizing Bard’s conduct as reckless, negligent, incompetent, misleading, or unethical are legal conclusions which should be excluded. Tillman responds in a conclusory fashion that “Plaintiffs [sic] would simply assert that the use of such terms in the experts’ reports does not constitute a proper basis for a Daubert challenge as these terms do not render the experts incompetent to testify nor does such language establish that the experts’ testimony is not reliable.” See McMeeking/Begley Response at 12. Tillman does not offer any legal authority in support of this argument. Id. Throughout their Report, the Engineers assert that Bard was incompetent, negligent and reckless in its failure to run certain tests or calculations, as well as in the manner in which it tested design features. See generally McMeeking/Begley Report. In addition, the Engineers opine that Bard acted “unethically, unprofessionally and recklessly” in asserting to the FDA, and stating in its marketing brochures, that the G2 filter was twelve times more resistant to fatigue failure than the Recovery model. See id. at 5. They explain that Bard’s claim was premised on the results of only one test and that

Bard has provided no evidence to support the claim that when the Recovery and G2 filters are subjected to expansion and contraction as occurs when they are in the vena cava, or subjected to repeated impacts as occurs when blood clots are arrested by the filter, or subjected to repeated drag loadings as occurs when blood flows by the filter in the vena cava, that the G2 filter will last 12 times as long as the Recovery filter.

Id. at 5-6. Based on an internal memorandum, the Engineers further opine that “Bard was fully aware that its claims regarding improved fatigue resistance for the G2 filter were false, misleading and reckless.” Id. at 6.

Evidence Rule 704 provides that “[a]n opinion is not objectionable just because it embraces an ultimate issue.” However, “courts must remain vigilant against the admission of legal conclusions, and an expert witness may not substitute for the court in charging the jury regarding applicable law.” See United States v. Milton, 555 F.2d 1198, 1203 (5th Cir.1977) ; Cook ex rel. Estate of Tessier v. Sheriff of Monroe Cnty., Fla., 402 F.3d 1092, 1112 n. 8 (11th Cir.2005) (noting that “testifying experts may not offer legal conclusions ... ”). As such, courts have excluded expert testimony that employs terminology with legal import, such as negligence. See Emp’rs Ins. of Wausau v. Latex Contr. Co., No. 1:01-CV-1909-BBM, 2003 WL 26087498, at *8 (N.D.Ga. Sept. 2, 2003) (excluding portions of expert’s testimony which relate to “negligence”); Andrews v. Metro N. Commuter R.R. Co., 882 F.2d 705, 709 (2d Cir.1989) (holding that trial court should have excluded expert’s testimony that the defendant was negligent); Schober v. Maritz Inc., No. 07-CV-11922, 2008 WL 544948, at *3 (E.D.Mich. Feb. 26, 2008) (“Further, [the expert’s] opinion that Defendant was ‘negligent’ • amounts to a legal conclusion, and is therefore particularly problematic.”); In re Rezulin Prods. Liab. Litig. (In re Rezulin), 309 F.Supp.2d 531, 541, 547 (S.D.N.Y.2004) (“[The expert’s] opinion that [defendant’s] conduct with respect to clinical trial data potentially constituted ‘negligence’ or ‘something more serious’ is excluded for the additional reason that it impermissibly embraces a legal conclusion.” (internal footnote omitted)); see also Haney v. Mizell Mem’l Hosp., 744 F.2d 1467, 1473-74 (11th Cir.1984). As the Sixth Circuit explained in Torres v. Cnty. of Oakland, 758 F.2d 147 (6th Cir.1985), “[t]he problem with testimony containing a legal conclusion is in conveying the witness’ unexpressed, and perhaps erroneous, legal standards to the jury. This ‘invadefs] the province of the court to determine the applicable law and to instruct the jury as to that law.’ ” Torres, 758 F.2d at 150 (quoting F.A.A. v. Landy, 705 F.2d 624, 632 (2d Cir.1983)) (alteration in original). The Sixth Circuit offered guidance that “[t]he best resolution of this type of problem is to determine whether the terms used by the witness have a separate, distinct and specialized meaning in the law different from that present in the vernacular. If they do, exclusion is appropriate.” Id. at 151.

Based on the foregoing, the Court will exclude the Engineers’ opinions that Bard acted negligently or recklessly. These terms carry special meaning under the law and are contingent upon application of the appropriate standard of care. The Engineers do not indicate what standard of care they are applying to reach this opinion, and Tillman does not explain how these experts are qualified to opine on the standard of care applicable to the medical device design and manufacture industry. Accordingly, the Court will grant, in part, Bard’s Motion to Exclude MeMeek-ing/Begley to the extent the Court will not permit the Engineers to offer opinions on whether Bard was negligent or reckless.

However,- throughout their Report the Engineers also identify flaws in Bard’s testing of the Recovery and G2 filters’ ability to withstand stresses and strains, and conclude that as a • result of these flaws, Bard’s engineering analyses were incompetent. The term incompetence does not carry with it a legal definition and is not contingent on a legal standard of care, but rather on the applicable principles of science and engineering. Bard does not dispute that the Engineers are qualified to testify regarding stress-strain analysis, nor does Bard contend that the engineering analyses performed by these experts is unreliable. Indeed, the Engineers explain that their assessment is “typical of those routinely conducted during.the design validation and verification of devices.” See McMeeking/Begley Report at 2. The testimony that Bard performed its testing iñ a scientifically incompetent manner would be helpful to the trier of fact in determining whether Bard breached its duty of care and the Court does not find it to be unduly prejudicial. Accordingly, the Court will not exclude the Engineers’ opinions , that the testing performed was incompetent as a matter of engineering and design principles.

As to the Engineers’ opinions on Bard’s claim that G2 filters are twelve times more fatigue resistant than Recovery filters, the Court finds that the Engineers’ may not opine that Bard’s conduct was unethical and unprofessional. Tillman offers no argument or information to show that the Engineers are qualified to opine on the ethical or professional standards in the industry. Moreover, Tillman fails to demonstrate that these opinions are reliable or relevant to this case. The Engineers themselves do not purport to have any expertise on the relevant ethical or professional standards, and they do not identify the ethical or professional standard on which they base this opinion. As such, these opinions appear to be simply their subjective views on how a medical device manufacturing company should act, and therefore, are due to be excluded as unreliable. See In re Rezulin, 309 F.Supp.2d at 543. Moreover, Bard’s compliance with an unidentified standard of ethical or professional conduct is not relevant to the issues in this case. See id. at 543-44. Rather, the issues here are limited to whether the Filter is defective in its design, manufacture, or warnings, whether Bard breached a legal duty to Tillman in designing, manufacturing, or labeling the device, and whether the defects or breaches caused Tillman’s damages. Id. at 544. “While [Bard] may be liable in the court of public opinion, or before a divine authority for any ethical lapses, expert opinion as to the ethical character of their actions is not relevant” to this lawsuit. See id.

In addition, to the extent the Engineers offer opinions on Bard’s intent, state of mind, or motivations, this testimony is outside the bounds of appropriate expert testimony. Id. at 546-47; In re Flonase Antitrust Litig., 884 F.Supp.2d 184, 193 (E.D.Penn.2012); Kaufman v. Pfizer Pharms., Inc., No. 1:02-CV-22692, 2011 WL 7659333, at *9 n. 8 (S.D.Fla. Aug. 4, 2011); In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769-Orl-22DAB, 2009 WL 3806436, at *5 (M.D.Fla. July 20, 2009); Baldonado v. Wyeth, No. 04 C 4312, 2012 WL 1802066, at *7-8 (N.D.Ill. May 17, 2012) (collecting cases). Based on their interpretation of a memorandum produced in discovery, the Engineers opine that “Bard was fully aware that its claims regarding improved fatigue resistance for the G2 filter were false, misleading and reckless.” See McMeeking/Begley Report at 6. The Court finds that this opinion is due to be excluded as unhelpful in that a jury is fully capable of drawing its own inferences from this memorandum without assistance from an expert. See In re Rezulin, 309 F.Supp.2d at 546-47. Indeed, the experts do not appear to rely on any of their scientific expertise in drawing conclusions about the import of the cited memorandum. Accordingly, the Court will grant Bard’s Motion to Exclude McMeek-ing/Begley to the extent that it will exclude the Engineers’ opinion that Bard acted unethically or unprofessionally, as well as their opinion regarding Bard’s intent as extrapolated from the March 23, 2006 memorandum.

However, the Engineers also opine that it is misleading for Bard to claim that G2 filters are twelve times more fatigue resistant than Recovery filters, and upon consideration, the Court finds this opinion to be permissible. See Deutsch v. Novartis Pharms. Corp., 768 F.Supp.2d 420, 440 (E.D.N.Y.2011). The Engineers reviewed the testing done to support Bard’s claim and determined 'that the claim is misleading based on their analysis of what that testing actually showed. An opinion that Bard’s claim was misleading because it was not supported by the tests performed does not relate to legal standards, nor is it a question of Bard’s state of mind or intent. Whether the scientific data supported the claim made regarding the G2 filters is within the realm of the Engineers’ expertise and would be helpful to a fact-finder. See In re Seroquel, 2009 WL 3806436, at *8 Accordingly, the Court will deny Bard’s request for the exclusion of this opinion.

iii. Hyman

William A. Hyman, Sc.D., P.E., is an engineer with a masters and doctorate degree from Columbia University in engineering mechanics. See Motion to Exclude Hyman, Ex. A (Doc. 110; Hyman Report) at 1. He has extensive educational and professional experience in biomedical engineering, biomaterials, biomechanics, medical device design and system safety, and FDA regulatory processes. See Hy-man Report at 1-2. He has spent a substantial amount of time researching, writing, teaching and consulting in these areas, and has published on topics of medical device design and system safety, as well as FDA regulatory issues. Id. To generate his Report, Hyman employed the following methodology:

[reviewed] the underlying facts, [reviewed] the known failure modes of the device in question and similar devices, and [reviewed] the relevant medical literature. This information was then used, in combination with [his], existing knowledge of FDA regulations and medical device design and safety, to analyze Bard corporate documents ... to compare the adequacy, of their approach to regulatory matters and design to [his] understanding of what a prudent manufacturer should have done under the circumstances surrounding vena cave [sic] filters throughout Bard’s involvement with such filters, and at least up to the time of Ms. Tillman [sic] implantation.

Id. at 3. Based on the foregoing qualifications and methodology, Hyman draws several conclusions regarding Bard’s filters, including, inter alia, that the design of the G2 filter was defective, that Bard’s design, testing, and marketing of the G2 filter was below industry standards, that Bard conducted inadequate testing on the G2 filter, that Bard’s promotion of the G2 filter was misleading, that Bard did not adequately warn physicians of the risks associated with the G2 filters, and that, as a “direct result” of the foregoing, Tillman “received and suffered from, and continues to suffer from, a device that was defective and should not have been on the market as designed, at least at the time of [Tillman’s] implantation.” Id. at 31-32.

Bard maintains that the Court should exclude Hyman’s opinions because Hyman “lacks sufficient knowledge, skill, experience, training, and education to qualify as an expert regarding Bard’s [TVC] filter testing, design, and labeling.” See Motion to Exclude Hyman at 1. In addition, Bard asserts that Hyman’s opinions are unhelpful to the jury in that they are summaries of documents which do not require expertise to understand, regulatory opinions which are improper conclusions of law, improper opinions on corporate knowledge or intent, and irrelevant opinions on alleged fracture and migration complications. Id. at 1-2. Bard also maintains that Hyman’s opinions are not based on sufficient facts or data, and that his opinions are not the product of reliable principles and methods. Id. at 2.

First, with respect to Hyman’s qualifications, the Court finds that Hyman is 'qualified to testify regarding the applicable FDA regulations, as well as medical device design and testing. Bard challenges Hyman’s qualifications to render opinions on the design and testing of the G2 filter because Hyman “lacks any meaningful training or experience with’implantable medical devices, let alone IVC filters.” See Motion to Exclude Hyman at 4. In support, Bard relies on cases where courts have found experts unqualified due to their lack of expertise with the particular product at issue. See id. at 4-5. However, the cases on which Bard relies are distinguishable because, unlike Hyman, the experts in those eases had only general engineering or scientific backgrounds and lacked any expertise in the design of medical devices. See Cason v. C.R. Bard, Inc., 1:12-CV-1288-MHS, slip op. at 25-28 (N.D.Ga. Feb. 12, 2015) (discussing and distinguishing the cases Bard cited for this proposition). Here, Hyman is not only a mechanical engineer but one with extensive experience in the design of medical devices. Accordingly, the Court agrees with the decision in Cason that Hyman is qualified to render an opinion on Bard’s medical device design and testing. Id.; Compton v. Subaru of Am., Inc., 82 F.3d 1513, 1520 (10th Cir.1996) (“As long as an expert stays within the reasonable confines of his subject area, ... a lack of specialization does not affect the admissibility of [the expert] opinion, but only its weight.” (internal quotation omitted) (second alteration in original)) reversed on other grounds by Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 146-47, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999); DaSilva v. Am. Brands, Inc., 845 F.2d 356, 361 (1st Cir.1988); see also In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164, 202 (S.D.N.Y.2009).

However, with respect to Hyman’s opinions on the adequacy of Bard’s warnings, Tillman fails to establish that Hyman is qualified to opine on this issue. Although Hyman has had “input” into instructions for use (IFU) on a “few” occasions, he has never drafted an entire IFU. See Motion to Exclude Hyman, Ex. B: May 6, 2014 Deposition of William Hyman (Doc. 96-2; Hyman Dep.) at 26-27. Hyman has only “commented on pieces” of the complications section of an IFU, and has “commented on warnings” in the context of litigation, as well as “in writing” to inform a manufacturer of his “perception on their warnings.” Id. at 136. Tillman does not present any evidence that Hyman has reviewed the warnings or labeling of other IVC filters, nor has Hyman drafted an alternative warning for the G2 filter. Indeed, Hyman’s Report never specifically discusses the G2 filter’s IFU as currently drafted. Without this experience, the Court finds that Hyman is not qualified to testify regarding the adequacy of the warnings accompanying the G2 filter. See Cason, 1:12-CV-1288-MHS, slip op. at 28-29; Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 969-70 (10th Cir.2001). Moreover, the Court agrees with the reasoning in Cason that Hyman’s lack of medical training or expertise in the relevant medical specialty renders him further unqualified to offer an opinion on the adequacy or appropriateness of the G2 filter’s warning label. See Cason, 1:12-CV-1288-MHS, slip op. at 29; King v. Synthes (U.S.A.), 532 F.Supp.2d 828, 833 (S.D.Miss.2006) (excluding labeling opinion of medical technology expert because the expert had no medical training, had never drafted a label for the device, did not design an alternative label, or review the label of competitor devices); See In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prods. Liab. Litig., No. MDL 1203, 2001 WL 454586, at *9 (E.D.Penn. Feb. 1, 2001) (“[The expert] also lacks expertise in the medical specialties that would qualify a witness to testify about the accuracy and appropriateness of. warning labels.... ”). Accordingly, Hy-man’s opinions on the adequacy of the G2 filters’ warning labels are due to be excluded.

Next, Bard seeks to exclude Hyman’s opinions regarding “FDA regulations (including the 510(k) clearance process), FDA guidelines, and Bard’s compliance or alleged noncompliance with these regulations and guidance documents.” See Motion to Exclude Hyman at 7. Bard does not challenge Hyman’s qualifications as an expert on the FDA regulation of medical devices, but contends that these opinions would not be helpful to the jury. Id. In addition, Bard argues that “[a]ny allegation that Bard misled the FDA or committed fraud on the FDA is preempted.” Id. These arguments are unavailing. Hy-man’s testimony on FDA guidelines and regulations, and Bard’s compliance therewith, is helpful to the trier of fact because “[a] lay jury cannot be expected to understand the complex regulatory framework that informs the standard of care in the [medical device] industry.” See In re Fosamax, 645 F.Supp.2d at 191. Moreover, because Tillman is not alleging any claim for fraud on the FDA, Bard’s preemption arguments are inapposite. Indeed, the court in Cason considered these same arguments and determined that Hyman’s regulatory opinions were permissible. See Cason, 1:12-CV-1288-MHS, slip op. at 34-37. This Court agrees with the reasoning in Cason, and holds that Hyman “may testify regarding the regulatory process by which medical devices like the G2 Filter are brought to market, and he may express his opinion as to whether Bard complied with all FDA regulatory requirements applicable to the G2 Filter.” Id. at 36; see also In re Fosamax, 645 F.Supp.2d at 192. However, as in Cason, Hyman “will not be allowed to express any opinion as to whether Bard should have done more than was required by FDA regulations to address the hazards of the G2 Filter.” Cason, 1:12-CV-1288-MHS, slip op. at 37.

To the extent Hyman offers opinions which amount to legal conclusions on Bard’s recklessness or negligence, or opines on Bard’s corporate intent, the Court will exclude such opinions for the same reasons discussed above regarding Begley and McMeeking. In addition, Bard argues that Hyman offers “under the guise of ‘expert opinion,’ plaintiff-slanted summaries of Bard documents that require no expertise to understand, and which will not assist the jury.” See Motion to Exclude Hyman at 1-2, 12. This argument is well-taken. In his Report, Hyman “presents a narrative of select regulatory events through the summary or selective quotation from internal [Bard] documents ... [and] regulatory filings.” See In re Fosamax, 645 F.Supp.2d at 192. “ ‘[A]n expert cannot be presented to the jury solely for the purpose of constructing a factual narrative based upon record evidence.’ ” Id. (quoting Highland Capital Mgmt., L.P. v. Schneider, 379 F.Supp.2d 461, 469

(S.D.N.Y.2005)); Baldonado, 2012 WL 1802066, at *4. To the extent such evidence is admissible, it is “properly presented through percipient witnesses and documentary evidence.” See In re Rezulin, 309 F.Supp.2d at 551. Accordingly, Hy-man’s “ ‘commentary on any documents and exhibits in evidence will be limited to explaining the regulatory- context in which they were created, defining any complex or specialized terminology, or drawing inferences that would not be apparent without the benefit of experience or specialized knowledge.’ ” See Cason, 1:12-CV-1288-MHS, slip op. at 39 (quoting In re Fosamax, 645 F.Supp.2d 164, 192 (S.D.N.Y.2009)). The Court will not permit Hyman to testify to “simple inferences drawn from uncomplicated facts that serve only to buttress plaintiffs theory of the case.” In re Rezulin, 309 F.Supp.2d at 551; see also In re Seroquel, 2009 WL 3806436, at *4 (“Plaintiffs’ counsel may not simply use these expert witnesses to provide a narrative history of [the manufacturer’s] marketing and labeling practices, or to make points that are within the province of counsel, rather than an expert witness.”).

Finally, Bard argues that Hy-man’s opinions on the testing, design and warnings should be excluded because they are based on inadequate facts or data, and are unreliable. Upon review, the Court again agrees with the well-reasoned decision in Cason, and holds that Hyman’s opinions are not-based on sufficient facts or data, and are not the product of reliable principles and methods. See Cason, 1:12-CV-1288-MHS, slip op. at 30-34. Hyman did not conduct any tests, examine a Bard G2 filter or any other type of IVC filter, and has never seen in person or touched an IVC filter. See Hyman Dep. at 23-24. Moreover, Hyman concludes that the G2 filter is defective without assessing the risks versus the benefits of the filter, the availability and safety profiles of other filters on the market, or the viability of a safer, alternative design. See McGee v. Evenflo Co., Inc., No. 5:02-CV-259-4(CAR), 2003 WL 23350439, at *5-6 (M.D.Ga. Dec. 11, 2003). Thus, based on the foregoing, and for the reasons discussed in Cason, the Court finds that Bard’s Motion to Exclude Hyman is due to be granted, in part, as to Hyman’s opinions on the design, testing and labeling of the G2 filter.

iv. Freeman

Michael Freeman, P