UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF FLORIDA

TAMPA DIVISION

DENISE OCASIO and CARMELO 

OCASIO,

Plaintiffs,

v. Case No: 8:13-cv-1962-T-36AEP

C.R. BARD, INC. and BARD 

PERIPHERAL VASCULAR, INC.,

Defendants.

___________________________________/

ORDER

This cause comes before the Court upon the Defendants C.R. Bard, Inc. and Bard 

Peripheral Vascular, Inc.’s (collectively, “Bard”) Motion to Exclude the Opinions of William A. 

Hyman (Doc. 45), Motion to Exclude the Opinions of Robert McMeeking and Matthew Begley 

(Doc. 46), and Motion to Exclude the Opinions of Robert Ritchie, Ph.D. (Doc. 51). Plaintiffs

Denise Ocasio and Carmelo Ocasio responded in opposition to the Motions (Docs. 65, 64, 66, 

respectively). Bard replied in further support of its Motions (Docs. 78, 77, 79, respectively).

Plaintiffs filed a Notice of Supplemental Authority (Doc. 82). Bard filed three Notices of 

Supplemental Authority (Docs. 104, 125, 128). On January 21 and February 20, 2015, the Court 

held evidentiary hearings and oral argument on the Motions. See Docs. 95, 112. The following 

witnesses testified at the hearings: William A. Hyman, Robert Ritchie, and Matthew Begley. 

Upon due consideration of the parties’ submissions, the evidence presented at the hearing, and the 

oral argument, the Court will GRANT-IN-PART and DENY-IN-PART each of Bard’s Motions.

Case 2:15-cv-01627-DGC Document 134 Filed 05/04/15 Page 1 of 15
I. BACKGROUND

This case arises from the injuries suffered by Denise Ocasio as a result of the allegedly 

defective inferior vena cava (“IVC”) filter implanted in her. Briefly, the Complaint alleges that 

Ms. Ocasio was implanted with a Bard G2®X filter (“G2 filter”); the G2 filter subsequently 

perforated her IVC; she was forced to undergo surgery to clip the perforating strut; the filter 

remains implanted in her body; and she suffered and continues to suffer severe medical 

consequences as a result of the perforation. Plaintiffs seek to offer a number of expert opinions 

regarding the various alleged defects of the filter, including those of William A. Hyman 

(“Hyman”), Robert Ritchie (“Ritchie”), and Matthew Begley, Ph.D. (“Begley”).

Bard now argues that those experts’ opinions should be excluded, for various reasons,

under Federal Rule of Evidence 702 and Daubert.

1

II. LEGAL STANDARD

Rule 702 governs the admissibility of expert testimony. It states:

A witness who is qualified as an expert by knowledge, skill, 

experience, training, or education may testify in the form of 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 Daubert, the Supreme Court charged district courts with a “gatekeeping 

function” of “ensur[ing] that any and all scientific testimony or evidence is not only relevant, but 

reliable.” 509 U.S. at 589; see also United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004) 

(en banc). Accordingly, the admission of such testimony is a matter within the discretion of the 

1 Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).

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district court. Cook ex rel. Estate of Tessier v. Sheriff of Monroe Cnty., Fla., 402 F.3d 1092, 1108 

(11th Cir. 2005). In performing its gatekeeping function, the Court must consider whether:

(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 reliable 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.

Frazier, 387 F.3d at 1260 (quoting City of Tuscaloosa v. Harcros Chem., Inc., 158 F.3d 548, 562 

(11th Cir. 1998)). The proponent of the challenged expert opinion testimony carries the burden of 

proving its reliability by a preponderance of the evidence. Id. (citing Daubert, 509 U.S. at 592-93 

& n.10).

III. DISCUSSION

A. William A. Hyman

Hyman offers various opinions as to the adequacy of the design, testing, and labeling of 

the G2 filter. Hyman also offers opinions as to Bard’s compliance with the FDA regulatory process 

through which the G2 filter was approved. Further, Hyman offers opinions summarizing Bard’s 

internal documents, including opinions as to Bard’s knowledge, intent, and/or state of mind. 

1. Opinions regarding the G2 filter’s design and testing

Bard argues first that Hyman is unqualified to opine on the G2 filter’s design and testing. 

The Court disagrees. Hyman holds advanced degrees in engineering mechanics, and is a professor 

of biomedical engineering at Texas A&M University. Further, as Hyman testified at the hearing, 

he has worked his entire thirty-plus year career in the area of design, testing, and regulation of 

medical devices; he has instructed both students and professionals in the medical device industry 

on the design, testing, and regulation of medical devices and biomaterials; he has written 

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extensively about medical device design, testing, and regulatory affairs, he has consulted 

extensively on those subjects; and he actively participates in industry groups concerning the same. 

The Court finds that Hyman is clearly qualified to opine upon the G2 filter’s design and testing.

Bard notes that Hyman lacks training specifically in regard to implantable medical devices, 

such as IVC filters. The Court recognizes that Hyman’s background as a biomedical engineer, 

standing alone, does not qualify him to opine on every aspect of every conceivable biomedical 

device. See, e.g., McCorvey v. Baxter Healthcare Corp., Case No. 99-cv-1250, 2001 WL 

36393134, at *4 (S.D. Fla. Sept. 30, 2001) (finding a mechanical engineer unqualified to opine on 

a foley catheter), aff’d in relevant part by 298 F.3d 1253 (11th Cir. 2002). Here, however, 

Hyman’s qualifications do not rest solely on the ground that he is a biomedical engineer. Rather, 

as noted above, Hyman has extensive experience regarding the design and testing of biomedical 

devices. Thus, although Hyman may not have previously worked specifically on IVC filters, the 

Court finds that his background and experience is sufficiently relevant to the opinions that he seeks 

to offer regarding the design and testing of the G2 filter. Accord Tillman v. C.R. Bard, Inc., Case 

No. 13-cv-222, 2015 WL 1456657, at *15 (M.D. Fla. March 30, 2015); Cason v. C.R. Bard, Inc., 

Case No. 12-cv-1288, Doc. 112, at 25-28 (N.D. Ga. Feb. 9, 2015) (hereinafter “Cason”) (Doc. 

104-1).

Bard argues that Hyman’s opinions regarding the design and testing of the G2 filter should

nevertheless be excluded because they are not based on sufficient facts or data, and are not the 

product of reliable principles and methods. The Court agrees.

To begin with, Hyman failed to test or examine the G2 filter or any other type of IVC filter. 

Indeed, as Hyman acknowledged, he has never even seen in person or touched the G2 filter or any 

other IVC filter. The only facts Hyman used to support his opinions were gleaned from documents 

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selected by Plaintiffs’ counsel. Although that fact does not necessarily mandate the

disqualification of his opinions, see In re Seroquel Prods. Liability Litig., Case No. 06-md-1769, 

2009 WL 3806436, at *4 (M.D. Fla. July 20, 2009), the Court is concerned with the total lack of 

any independent verification of the data or testing of the device. The Court accordingly finds that

Plaintiffs have failed to establish that Hyman’s opinions regarding the design and testing of the 

G2 filter are based upon sufficient facts or data. Accord Tillman, 2015 WL 1456657 at *17; Cason 

at 30-31. 

The Court likewise finds that Plaintiffs have failed to establish that the methodology 

employed by Hyman was reliable. Hyman testified that his methodology was as follows: he first 

reviewed the underlying facts, the known failure modes of the device in question and similar 

devices, and the relevant medical literature; he then used this information in combination with his 

existing knowledge and background to compare Bard’s approach to what he believed a prudent 

product manufacturer would have done. In other words, it appears that Hyman arrived at his 

opinions based solely upon a comparison of the underlying facts to his own subjective idea of what 

a prudent manufacturer would have done. Hyman has failed to articulate any scientific or 

regulatory bases for his methodology. He has not developed any test protocols that he believes 

should have been performed on the device. There is no objective standard that could be employed 

to evaluate Hyman’s design and testing opinions. Accordingly, Hyman’s design and testing 

opinions are not the product of sufficiently reliable methodology. See Fed. R. Evid. 702(c), 

advisory committee notes to 2000 amendments (an expert’s methodology is not sufficiently 

reliable if it is “simply a subjective, conclusory approach that cannot reasonably be assessed for 

reliability”); accord Tillman, 2015 WL 1456657 at *17; Cason at 32-34.

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2. Opinions regarding the G2 filter’s labeling

Bard argues that Hyman is not qualified to opine upon the adequacy of the G2 filter’s 

labeling. The Court agrees. At the hearing, Hyman testified that he has never drafted a complete 

Instructions for Use (“IFU”) for any medical device. Rather, as Hyman testified at his deposition,

he has only had input into and/or commented on pieces of “a few” unspecified IFUs. See Doc. 45-

2 (“Hyman Dep.”) at 26-27, 136. Moreover, Hyman does not have a medical degree or medical 

experience, so accordingly, he has never personally relied upon an IFU to make a medical decision. 

Like the courts in Tillman and Cason, the Court here concludes that Hyman’s limited experience

in this arena fails to qualify him as an expert on the adequacy of the labeling of the G2 filter. 

Accord Tillman, 2015 WL 1456657 at *16; Cason at 28-30. Hyman’s opinions regarding the 

adequacy of the G2 filter’s labeling must therefore be excluded.

3. Opinions regarding the FDA regulatory process

Bard does not challenge Hyman’s qualifications as an expert on the FDA regulatory 

process as it relates to medical devices. Rather, Bard contends that Hyman’s opinions regarding 

FDA regulations and Bard’s alleged noncompliance therewith would not be helpful to the jury. 

The Court disagrees. Expert testimony on this topic would be helpful because, as the court in 

Cason noted, “a lay jury cannot be expected to understand the complex regulatory framework that 

informs the standard of care in the pharmaceutical industry.” Cason at 35 (quoting In re Fosamax 

Prods. Liab. Litig., 645 F. Supp. 2d 164, 191 (S.D.N.Y. 2009)); see also Tillman, 2015 WL 

1456657 at *16. Further, because Plaintiffs are not asserting a claim for fraud on the FDA, such 

opinions would not run afoul of preemption law or infringe upon the jury’s role in determining the 

ultimate issue in this case. See Cason at 35-36. Accordingly, as in Cason and Tillman, the Court 

will permit Hyman to testify regarding the regulatory process by which medical devices like the 

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G2 filter are brought to market, as well his opinions as to whether Bard complied with the FDA 

regulatory requirements applicable to the G2 filter. However, also as in Cason and Tillman, the 

Court will not permit Hyman to opine as to whether Bard should have done more than was required 

by FDA regulations to address the hazards of the G2 filter.

4. Opinions regarding Bard’s corporate documents and state of mind

Bard argues that Hyman’s summaries of Bard’s internal corporate documents, along with 

his testimony as to Bard’s knowledge, intent, or state of mind, must be excluded because they are 

not helpful to the finder of fact. The Court agrees. 

To begin with, Hyman may not testify as to Bard’s knowledge, intent, or state of mind 

because such testimony invades the province of a jury, which is capable of deciding such matters 

without an expert’s help. See In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 

2004). As noted in Cason, “the jury should hear and/or see firsthand any relevant evidence 

pertaining to the Defendant’s intent. Then the jury . . . should consider the facts and make its own 

determination regarding Defendant’s intent.” Cason at 37-38 (quotation marks and citation 

omitted). 

Hyman’s testimony summarizing Bard’s documents is likewise improper. Plaintiffs 

contend that Hyman’s characterization of Bard’s documents is non-speculative and accurate. 

Regardless of the accuracy of Hyman’s characterization, however, such testimony must be 

excluded because “[a]n expert cannot be presented to the jury [] for the purpose of constructing a 

factual narrative based upon record evidence.” In re Fosamax, 645 F. Supp. 2d at 192 (quotation 

marks and citation omitted). Rather, the jury may consider only the underlying evidence itself, 

which should be presented directly to the jury through percipient witnesses and exhibits. See In 

re Rezulin, 309 F. Supp. 2d at 551. The Court will, therefore, limit Hyman’s commentary on any 

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documents and exhibits in evidence “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.” Tillman, 2015 WL 

1456657 at *17 (quoting Cason at 39) (quotation marks omitted). 

B. Robert Ritchie

Ritchie opines primarily as to the causes of fracture in the G2 filter, which include

manufacturing and design defects as well as migration, perforation, and tilt. Ritchie also opines 

as to the causes of perforation by the G2 filter. 

1. Opinions regarding causes of fracture of the G2 filter

Bard concedes that Ritchie is qualified to testify competently regarding the G2 filter’s 

propensity to fracture, and that the methodology by which he reached his fracture opinions is 

sufficiently reliable. Bard argues that Ritchie’s fracture opinions, however, would not assist the 

trier of fact in understanding the evidence or in determining a fact in issue. Specifically, Bard 

contends that Ritchie’s fracture opinions do not “fit the facts of this case” because the device 

implanted in Ms. Ocasio did not fracture. Bard, accordingly, seeks to exclude Ritchie’s opinions 

under Daubert or, alternatively, Federal Rule of Evidence 403, which permits a court to exclude 

relevant evidence “if its probative value is substantially outweighed by a danger of . . . unfair 

prejudice.” 

The Court finds that Ritchie’s fracture opinions should not be excluded on the basis of 

Daubert, because they would be helpful to the trier of fact. For example, Ritchie’s opinion that 

perforation increases the chance of fracture is clearly relevant to the injury suffered by Ms. Ocasio, 

including the need for ongoing medical monitoring. The fact that Ritchie was unable to establish

the increase in likelihood of fracture due to perforation to a reasonable degree of engineering 

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certainty does not warrant the exclusion of these opinions under Daubert—they need only be 

“helpful” to the trier of fact. See Briscoe v. White, Case No. 03-cv-154, 2004 WL 5488228, at *2 

(M.D. Fla. May 24, 2004) (“absolute certainty is not required”). 

The Court recognizes that the wholesale introduction of Ritchie’s fracture opinions, many 

of which appear, at least facially, to be tangential to the issues presented in this case, poses a 

potential risk of unfair prejudice to Bard. The Court, however, will consider any requests to 

preclude specific testimony through either motions in limine or objections at trial. Accord Calta

v. N. Am. Arms, Inc., Case No. 05-cv-1266, 2008 WL 6839018, at *1-2 (M.D. Fla. Mar. 17, 2008). 

Accordingly, the Court will deny Bard’s Daubert challenge to Ritchie’s fracture opinions.

2. Opinions regarding causes of perforation by the G2 filter

In Appendix I to his report, Ritchie opines that the same factors that result in a high 

incidence of fracture also likely caused perforation by Ms. Ocasio’s filter. See Doc. 51-1 (“Ritchie 

Rpt.”) at 22 (opining that “a lack of proper chamfering . . . and a lack of an undamaged surface 

from surface gouges and grinding and draw marks . . . coupled with poor mechanical design, 

limited stress analysis, and an inadequate assessment of their fatigue resistance . . . likely rendered 

Ms. Ocasio’s filter unable to withstand the normal physiological stresses exerted upon it within 

the human body, causing specific problems of perforation the struts [sic]”). 

Bard challenges this specific opinion on the grounds that it is not the product of reliable 

scientific methodology and is not based upon sufficient data. The Court agrees. As noted by the 

court in Tillman, even accepting the assumption that Ms. Ocasio’s filter has the same surface 

defects and lack of chamfering present in the other filters examined by Ritchie, Ritchie offers 

nothing more than his own ipse dixit to conclude that these conditions also cause tilt, migration, 

and perforation. See Doc. 66 at 13 (asserting vaguely that Ritchie’s opinions as to the causes of 

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perforation stem from his “extensive training, knowledge and experience”). As the Eleventh 

Circuit has cautioned, courts must be wary of leaping from an accepted scientific premise to an 

unsupported one. See Allison v. McGhan Med. Corp., 184 F.3d 1300, 1314 (11th Cir. 1999). The 

Court, therefore, will exclude this particular opinion only. Accord Tillman, 2015 WL 1456657 at 

*8.

C. Matthew Begley2

Begley conducted a theoretical and computational stress/strain analysis of the G2 filter,

and opines as to the implications of stress and strain on the fracture and fatigue of the G2 filter. 

Begley also opines that Bard failed to adequately test and design the G2 filter for perforation, tilt, 

and migration. Begley finally opines that Bard failed to exert sufficient control over the 

manufacturing process for the G2 filter, resulting in significant variations between each filter. In 

opining on these issues, Begley characterizes Bard’s behavior as, inter alia, “reckless,” 

“incompetent,” “negligent,” “misleading,” and “unethical.” 

1. Opinions regarding manufacturing and qualify control for the G2 filter

Bard argues that Begley is not qualified to opine as to the adequacy of its manufacturing 

process and quality control for the G2 filter. Bard argues that these opinions should also be 

excluded because they are not supported by sufficient data or reliable methodology. The Court 

agrees.

To begin with, the Court finds that Begley is not qualified to offer opinions as to Bard’s 

manufacturing process and/or quality control. Plaintiffs note that Begley holds a doctorate degree 

2 Matthew Begley and Robert McMeeking submitted a joint expert report. See Doc. 46-2 

(“Begley Rpt.”). However, Plaintiffs have since withdrawn McMeeking as a testifying expert, 

see Doc. 116, so the discussion herein pertains only to Begley. In any case, Begley and 

McMeeking share the same opinions. See Doc. 46-4 (“McMeeking Dep.”) at 43-44, Doc. 46-5

(“Begley Dep.”) at 15-16. 

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in Mechanical Engineering, is a Professor of Mechanical Engineering and Professor of Materials 

at the University of California, Santa Barbara, and has performed extensive research into problems 

of mechanical failure in a wide range of structural components. However, although Plaintiffs have 

established Begley’s expertise in relation to his opinions on the structural integrity of the G2 filter, 

they have set forth no evidence that Begley has any training or professional experience in 

manufacturing techniques or manufacturing quality control measures. These fields are not so 

closely related such that expertise in one would necessarily establish expertise in the other. 

Compare Maiz v. Virani, 253 F.3d 641, 665 (11th Cir. 2001) (finding an experienced professional 

economist with a substantial background in estimating damages qualified to offer expert testimony 

on the economic losses suffered by the plaintiffs as a result of defendants’ fraudulent real estate 

venture, even though the proffered expert lacked real estate development experience).

Moreover, Begley’s opinions appear to rest solely on others experts’ observations of 

variability between the filters and his review of certain of Bard’s internal documents that generally 

describe Bard’s manufacturing controls. Begley did not conduct any actual tests to verify that 

these manufacturing controls would lead to the observed variability. Begley has also failed to 

articulate any scientific or objective bases for his methodology. And, at the hearing, Begley 

testified that he could not recall if he even reviewed the actual specifications that describe the 

manufacturing process for the G2 filter. Plaintiffs have therefore failed to demonstrate that 

Begley’s manufacturing opinions are the product of sufficient data and reliable methodology. 

Because Plaintiffs have failed to carry their burden of demonstrating that Begley’s 

manufacturing opinions satisfy the Daubert standard, the Court will exclude these opinions.

2. Opinions regarding stress/strain analysis

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Bard does not challenge the sufficiency of Begley’s qualifications, data, or methodology

in relation to his opinions on the effects of stress and strain upon the fatigue and fracture of the G2 

filter. Rather, similar to its challenge to Ritchie’s fracture opinions, Bard contends that Begley’s 

stress/strain opinions are not helpful to the finder of fact because Ms. Ocasio’s filter did not 

fracture. See Doc. 46 at 15. As with Ritchie’s fracture opinions, however, the Court finds that 

Begley’s stress/strain opinions would assist the trier of fact. These opinions, like Ritchie’s fracture 

opinions, are relevant, inter alia, to the damages suffered by Ms. Ocasio, including the need for 

ongoing medical monitoring. See Section III.B.1, supra. The Court, therefore, will deny Bard’s 

motion to exclude these opinions.

3. Opinions regarding adequacy of Bard’s testing

Bard likewise challenges as unhelpful Begley’s opinion that Bard failed to adequately test 

the G2 filter’s design for the risk of perforation, tilt, and migration, on the ground that Begley 

cannot identify any specific defect that more likely than not caused Ms. Ocasio’s filter to perforate. 

The Court disagrees that Begley’s testing opinions should be excluded for this reason. There is no 

requirement that Plaintiffs or their experts establish that any one specific defect caused Ms. 

Ocasio’s filter to perforate. Rather, Begley’s opinion that the combination of defects together 

more likely than not caused the perforation sufficiently establishes the relevancy of his testing 

opinion. 

Moreover, Begley’s opinions regarding the inadequacy of Bard’s testing would assist the 

jury in determining the ultimate fact of whether the filter was defectively designed and/or whether 

Bard’s warnings were sufficient. See Adams v. G.D. Searle & Co., Inc., 576 So. 2d 728, 730-31 

(Fla. 2d DCA 1991) (“The duty to test . . . is a subpart of a manufacturer’s duty to design a product 

with reasonable care, and [] is subsumed in the plaintiffs’ claims for defective design and failure 

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to warn.”). The fact that Begley does not offer an opinion on the ultimate issue itself is not a 

reason to exclude the testimony; his testimony need only be “helpful.” See City of Tuscaloosa v. 

Harcros Chemicals, Inc., 158 F.3d 548, 565 (11th Cir. 1998) (“[The] data and testimony need not 

prove the plaintiffs’ case by themselves; they must merely constitute one piece of the puzzle that 

the plaintiffs endeavor to assemble before the jury.”). The Court, therefore, will not exclude 

Begley’s testing opinions. Accord Tillman, 2015 WL 1456657 at *10.

4. Characterization of Bard’s conduct

Bard challenges Begley’s choice of vocabulary in characterizing its conduct as, inter alia,

“negligent,” “incompetent,” and “reckless,” and “unethical” and “misleading.” The Court agrees 

that certain of these characterizations are improper and must be excluded. 

Specifically, the Court agrees that Begley’s characterization of Bard’s behavior as 

“negligent” and “reckless” is improper. It is well-established that a testifying expert may not offer 

legal conclusions. See Cook v. Sheriff of Monroe County, Fla., 402 F.3d 1092, 1112 n. 8 (11th 

Cir. 2005) (“testifying agents may not offer legal conclusions”). Plaintiffs argue, and Begley 

testified, that he did not use those words in any legal sense, but rather in an engineering (or 

vernacular) sense. Nevertheless, it is undisputed that these words carry a specialized meaning in 

the law different from that present in the vernacular. Under these circumstances, precluding 

Begley from using these terms is proper. See Torres v. County of Oakland, 758 F.2d 147, 151 (6th 

Cir. 1985) (a court should exclude terms that have a “separate, distinct and specialized meaning in 

the law different from that present in the vernacular”); In re Rezulin, 309 F. Supp. 2d at 541, 547

(“[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.”); accord Tillman, 2015 WL 1456657 at *13.

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On the other hand, the Court finds no basis to exclude Begley’s use of the word 

“incompetent” to characterize Bard’s testing protocol. “Incompetence” does not carry a distinct 

legal definition and is not contingent on a legal standard of care. Rather, Begley uses this word 

only in relation to the principles of science and engineering, areas in which Begley undisputedly 

qualifies as an expert. Moreover, such testimony would assist the trier of fact in determining 

whether Bard breached its duty of care. The Court, therefore, will not exclude this opinion. Accord 

Tillman, 2015 WL 1456657 at *13.

Begley characterizes Bard’s claim that G2 filters are twelve times more fatigue resistant 

than Recovery filters to be “unethical” and “misleading.” The Court agrees with Bard that 

Begley’s characterization of Bard’s behavior as “unethical” is impermissible. To begin with, 

Plaintiffs offer nothing that would establish Begley’s expertise in the field of ethical or 

professional standards in the medical device industry. Further, there is no evidence that this 

opinion is reliable. Indeed, Begley does not identify the ethical or professional standards upon 

which he bases his opinion. It appears that Begley’s ethics opinion, like Hyman’s design and 

testing opinions, is founded only upon his own subjective ideas on how a medical device 

manufacturing company should act. Accord Section III.A.1, supra. Finally, it is unclear to the

Court how Begley’s ethics opinion would assist the trier of fact. Begley’s ethics opinion, therefore, 

must be excluded.

However, the Court will permit Begley to opine that it was “misleading” for Bard to make 

such a claim. Such an opinion does not carry a distinct legal meaning, and does not implicate 

impermissible subject matter such as Bard’s knowledge or state of mind. Moreover, this opinion 

is otherwise admissible under Daubert. Begley reviewed the testing done to support Bard’s claim,

and determined that Bard’s claim was misleading based on his analysis of what the testing actually 

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showed. Begley’s opinion as to the accuracy of Bard’s claim falls within the scope of his expertise 

and would be helpful to a fact finder. The Court, therefore, will not exclude this opinion. Accord 

In re Seroquel, 2009 WL 3806436, at *8 (permitting expert testimony as to the accuracy and 

adequacy of a drug warning label); Tillman, 2015 WL 1456657 at *14. 

IV. CONCLUSION

It is hereby ORDERED:

1. Bard’s Motion to Exclude the Opinions of William A. Hyman (Doc. 45) is 

GRANTED-IN-PART and DENIED-IN-PART. The Motion is GRANTED to 

the extent set forth in the body of this Order, and otherwise DENIED.

2. Bard’s Motion to Exclude the Opinions of Robert McMeeking and Matthew Begley 

(Doc. 46) is GRANTED-IN-PART and DENIED-IN-PART. The Motion is 

GRANTED to the extent set forth in the body of this Order, and otherwise 

DENIED.

3. Bard’s Motion to Exclude the Opinions of Robert Ritchie, Ph.D. (Doc. 51) is 

GRANTED-IN-PART and DENIED-IN-PART. The Motion is GRANTED to 

the extent set forth in the body of this Order, and otherwise DENIED.

DONE AND ORDERED in Tampa, Florida on May 4, 2015.

Copies to:

Counsel of Record and Unrepresented Parties, if any

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