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Challenging expert witness testimony in Florida products liability cases under Frye.

Trials are often won or lost on the testimony of expert witnesses. Thus, successfully excluding the testimony of an opposing expert witness can deal a devastating blow to the opponent's case. Because scientific expert witness testimony is virtually inescapable in products liability cases, it is crucial for counsel handling those cases to be well-versed in the relevant case law and equipped with a full arsenal of tactics for challenging the testimony of an opponent's expert witness. This article examines the current state of Florida law with regard to the exclusion of expert witness testimony about scientific or technical issues and discusses techniques that may be particularly useful in challenging such testimony in products liability cases.

Evolution of Florida Case Law Regarding Admissibility of Expert Witness Testimony

F.S. [sections]90.702 provides the framework for the admission of expert witness testimony in Florida state courts. It states "if scientific, technical, or other specialized knowledge will assist the trier of fact in understanding the evidence or in determining a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education may testify about it in the form of an opinion; however, the opinion is admissible only if it can be applied to evidence at trial." (1) Over time, there has been much dispute about the proper role trial courts should play in assessing the scientific or technical merits of expert witness testimony when determining its admissibility. In Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), the court affirmed the trial court's refusal to admit the expert witness testimony of a scientist who conducted a lie detector test because the scientific principles upon which the test was based had not "gained general acceptance in the particular field in which it belongs." (2)

For nearly 70 years, the Frye standard of "general acceptance" controlled the admissibility of scientific expert witness testimony. Then, in 1993, the U.S. Supreme Court decided Daubert v. Merrill Dow Pharmaceuticals, 509 U.S. 579 (1993), and placed the responsibility on the trial court to act as a "gatekeeper." This displaced the Frye test of general acceptance in federal courts, giving trial judges leeway to determine that new and novel scientific ideas and techniques are reliable and admissible as a basis for expert witness testimony even though they have not yet gained general acceptance in the scientific community. (3) In this respect, many viewed Daubert as expanding the type of scientific expert witness testimony that is admissible by abandoning the brightline general acceptance standard of Frye and asking courts to instead evaluate the reliability of scientific evidence based on falsifiability, peer review, error rates, and acceptability in the relevant scientific community.

Florida courts have declined to adopt Daubert, instead continuing to apply the Frye "general acceptance" standard, requiring "acceptance by a clear majority of the members of the relevant scientific community with consideration by the trial court of both the quality and quantity of those opinions." (4) The requirement that scientific evidence meet the Frye standard applies only to new or novel theories and does not apply to pure opinion testimony based on an expert witness' experience and training. (5) In choosing to use Frye, Florida courts have stated the preference to maintain what is viewed to be the higher standard of reliability as dictated by Frye, rather than the more lenient Daubert standard used by the federal courts. (6)

In the past four years, the Florida Supreme Court has issued two opinions discussing the factors a trial court should consider in determining the admissibility of scientific expert witness opinions under Frye. In Ramirez v. State, 810 So. 2d 836 (Fla. 2002), the court stated that a trial court is not required to accept only a "nose count" of experts in determining whether a method used by an expert witness is generally accepted and, therefore, admissible. (7) The Ramirez court found that trial courts could consider different sources including expert witness testimony, scientific and legal publications, and judicial opinions to decide whether the theories or assumptions used by the expert witness have been sufficiently tested and accepted in the relevant scientific community. (8) The court held that in applying the Frye test, "the burden is on the proponent of the evidence to prove the general acceptance of both the underlying scientific principles and the testing procedures used to apply that principle to the facts of the case at hand." (9)

In 2003, the Florida Supreme Court addressed the admissibility of expert witness testimony under Frye in a products liability case. In Castillo v. E.I. Dupont de Nemours & Co., 854 So. 2d 1264 (Fla. 2003), the plaintiff's child suffered birth defects that the plaintiff claimed were caused by exposure to a pesticide while she was pregnant. The plaintiff's expert witness used information from studies conducted on rats and in vitro laboratory studies and extrapolated that data to determine whether and at what levels a pregnant woman's exposure to the chemical could cause birth defects. Retreating from Ramirez, the Castillo court held that Frye only required the trial court to examine the general acceptance of the underlying science and experiments from which the expert witness obtained the data used to draw his conclusions, not the reasoning or conclusions themselves. (10) Finding that the science underlying each method was generally accepted, the court concluded that the opinions of the plaintiff 's expert witness were admissible. (11) The Castillo court explained that even if the methods used to interpret the data from the underlying valid science are not generally accepted, any questions about how the expert reached his conclusion go to the weight a jury should give to the expert witness' opinion and not to whether the opinion is admissible. (12)

* Challenges to Expert Witness Testimony in Products Liability Cases

Products liability cases almost always involve scientific expert witness testimony. There are many challenges a party in a products liability case can, and should, make under Frye to attack the testimony of the opponent's expert witness. As the Florida Supreme Court established in Castillo, the trial court is instructed not to examine the expert witness's ultimate conclusion when applying the Frye test. (13) Therefore, a challenge to an expert witness' opinion based on Frye must focus on establishing that the basic methods, data, or assumptions used by the expert witness in formulating the expert witness' ultimate opinion are not generally accepted in the relevant scientific community.

* Challenges to Methodology

A party may be able to succeed in excluding an opposing expert witness' testimony by challenging the methodology underlying the expert witness' opinion. For example, in Clegg v. Medical Engineering Corp., 2004 WL 471694 (Fla. 4th Cir. Ct. Feb. 25, 2004), the court excluded the plaintiffs' expert witness' testimony that silicone breast implants cause disease because the plaintiffs failed to meet the burden under Frye of establishing the reliability and general acceptance of the principles and methodologies that formed the basis for the testimony. (14) In reaching this conclusion, the Clegg court engaged in a detailed analysis of the methodologies underlying the testimony of the plaintiffs' expert witness and compared them with the epidemiological studies submitted by the defendant. The court stated that epidemiological studies are generally accepted as a way of determining causal links between disease and an agent, (15) and, while not required, they are "certainly relevant to the scientific reliability and acceptance of testimony regarding causal links." (16) The Clegg court held that the epidemiological studies and other evidence submitted by the defendant constituted substantial and convincing evidence that the methodologies and principles underlying the plaintiffs' proposed expert witness testimony were not generally accepted. (17)

Similarly, in General Motors Corporation v. Porritt, 891 So. 2d 1056 (Fla. 2d DCA 2004), the court ruled that the trial court erred in allowing the plaintiff's expert witness to present a videotape that showed how a seatbelt buckle can "be caused to release when struck by a hammer or a hand." (18) The court, citing Castillo and Ramirez, found that the test shown in the plaintiff's expert witness' videotape was not generally accepted in the relevant scientific community because the test did not replicate real world conditions. (19) The Porritt court held that when an expert witness attempts to offer an experiment as evidence to support his or her opinion, the conditions in the experiment "must be substantially similar to those at the time of the occurrence." (20)

Additionally, in Brito v. County of Palm Beach, 753 So. 2d 109 (Fla. 4th DCA 1998), the court excluded an expert engineer's testimony that truck wheels were defective because the opinion was not based on any methodology, literature, or studies, and the only evidence in the record to support his opinion was the expert witness' testimony itself. (21) Thus, the court found that the expert witness' opinion did not satisfy the Frye standard. (22)

What can be gleaned from these cases is that challenges to an expert witness' underlying methodology can be mounted successfully from many different fronts--an unfavorable comparison to a more accepted methodology, a challenge to the conditions under which the experiment was conducted, or the exposure of the lack of any methodology underlying the opinion, to name just a few.

* Daubert-type Challenges

Despite Florida's rejection of Daubert in favor of the purportedly higher standard of reliability required by the Frye test, Florida courts have continued to look to Daubert-type considerations in determining whether to exclude scientific expert witness testimony. (23) As a result, litigants may be able to successfully use Daubert-type challenges to exclude scientific expert witness testimony in Florida products liability cases.

In Ramirez v. State, the court explained that trial courts must look to properties that traditionally inhere in scientific acceptance for the type of methodology or procedure under review--i.e., "indicia" or "hallmarks" of acceptability. (24) The Ramirez court considered the fact that the record did not show that the expert witness' methodology--and particularly his claim of infallibility--had ever been formally tested or otherwise verified. (25) Nor did the record show that the expert witness' test had ever been subjected to meaningful peer review or publication as a prerequisite to scientific acceptance. (26) In fact, the expert's testimony was belied by the published articles in the record before the court. (27)

Further, the record did not establish that the error rate for the expert's method had ever been quantified, nor did it show that the method was governed by objective scientific standards. (28) Finally, the record contained no written authority--not even the expert's own published article--that upheld the expert's current methodology. (29) For each of these reasons, the Ramirez court concluded that the expert witness' testimony was not admissible. (30) Although Castillo limited the scope of Ramirez and instructed trial courts not to consider an expert witness' reasoning or application of the scientific principles underlying the opinion, parties should still attack an expert witness' methodology or theories based on the Daubert-like criteria employed by the Ramirez court.

Additionally, in Cerna v. South Florida Bioavailability Clinic, Inc., 815 So. 2d 652 (Fla. 3d DCA 2002), the court considered whether the methodologies underlying the expert witness' testimony that the plaintiff's blindness was caused by ingesting two pharmaceuticals had been sufficiently tested. (31) The court focused on the fact that the expert witness never had peer review articles published on the topic, that he had formulated his opinion solely for purposes of the litigation, and that he had done no testing or experimentation on the issue. (32) The court also noted the absence of supporting dose-response or quantitative analysis, (33) a ruling out of alternative causes, and evidence of association other than by temporal proximity. (34) Finding that there were no epidemiological or scientific tests associating the chemical ingestion with the injury suffered by the plaintiff, the Cerna court held that the expert witness' testimony was inadmissible. (35)

Accordingly, despite rejection of Daubert by Florida courts, attorneys handling products liability cases in Florida should consider challenging the admissibility of scientific expert witness testimony based on challenges often associated with Daubert, such as testability of the theory, peer review, quantitative analysis, and error rate.

* Challenges to Consistency of Multiple Expert Witnesses' Opinions

Another strategy for challenging expert witness testimony, when the offering party has more than one expert witness, is to look for and exploit inconsistencies between those expert witnesses. For example, in Kaelbel Wholesale, Inc. v. Soderstrom, 785 So. 2d 539 (Fla. 4th DCA 2001), the plaintiff claimed that the ciguatera food poisoning she contracted from the defendant's fish caused her to develop Guillain-Barre Syndrome (GBS). The plaintiff offered two expert witnesses who each testified that GBS could be caused by ciguatera poisoning. (36) Although both expert witnesses believed that ciguatera poisoning could cause GBS, they held different views as to the biochemical reaction that could result in GBS from ciguatera poisoning. (37) The court held that when the two expert witnesses offered by the plaintiff "directly contradicted each other as to the alleged general scientific principles applicable to their opinions" and neither of the contradictory principles was generally accepted in the scientific community, the expert witnesses' opinions did not meet the Frye test. (38) The court stated that allowing the expert witnesses to testify to opinions based on such principles would be "tantamount to saying that because the court qualifies a witness as an expert, and the expert testifies to the methodology and opinion, it is therefore accepted in the field." (39)

* Challenges to Assertions Testimony Is "Pure Opinion"

Not only is it necessary to be armed with the various Frye challenges, it is also crucial to understand the ways in which an opponent may, in the first instance, attempt to sidestep the requirement of conducting a Frye analysis. One common method used to circumvent Frye is to couch the expert witness's testimony as "pure opinion" and, therefore, not subject to Frye. This argument often succeeds because Florida courts have held that Frye is not applicable to "pure opinion" testimony based on an expert witness' personal experience and training. (40)

"Pure opinion" testimony, i.e., testimony based on an expert witness' personal experience and training, has been treated differently from testimony based on scientific studies and tests because testimony that relies on studies and tests "implies infallibility not found in pure opinion testimony." (41) As a result, Florida courts have held that "pure opinion" testimony need not survive a Frye analysis to be admissible. (42) Successfully characterizing an expert witness' testimony as "pure opinion," therefore, often prevents the scrutiny invited by Frye and is, thus, a characterization that should be strongly contested by the other side.

For example, in Holy Cross Hospital, Inc. v. Marrone, 816 So. 2d 1113, 1117 (Fla. 4th DCA 2001), an expert witness offered an opinion as to when cancer spread to the plaintiff's lymph nodes. Plaintiff argued that the testimony was pure opinion, and, therefore, not subject to Frye because the opinion was based on personal experience and training. (43) The court rejected this characterization, stating that it was clear that, in addition to experience and training, the expert witness' opinion was at least in part derived from conclusions drawn from staging studies done by others. (44) As a result, the opinion was not "pure opinion" and should have been subject to the Frye analysis. (45)

Drawing the proper distinction between "pure opinion" and opinions subject to Frye is particularly important with respect to testimony of causation. (46) In product liability actions, especially those alleging exposure to chemicals or adverse reaction to pharmaceutical products, the ability of plaintiff's expert witness to establish causation is necessary to establishing liability. Plaintiffs are unlikely to be able to withstand a motion for summary judgment without offering admissible expert witness testimony as to causation. (47) As a result, successful Frye challenges to expert witnesses proffering testimony on causation can quickly change the course of litigation.

One method commonly relied upon by expert witnesses opining on causation is differential diagnosis, the process by which an expert witness eliminates possible causes of a medical condition to arrive at a conclusion as to the actual cause. (48) Generally, the use of differential diagnosis to opine on specific causation (whether the product caused the plaintiff's injury (49)) is considered "pure opinion" and not subject to Frye. (50) However, differential diagnosis may be subject to Frye when general causation--that is, that the product at issue is capable of causing the type of injury suffered by the plaintiff (51)--is not generally accepted in the scientific community. (52) As a result, a challenge that can be made to an expert witness who relies on differential diagnosis to support an opinion on specific causation is that the general causation premise upon which the diagnosis is based is not generally accepted.

For example, in Marsh v. Valyou, 917 So. 2d 313 (Fla. 5th DCA 2005), the plaintiff attempted to offer expert witness testimony that her development of fibromyalgia was caused by trauma from car accidents, asserting that the testimony was not subject to Frye because it was "pure opinion" based only on an examination of the patient and the patient's clinical history. The court affirmed the trial court's exclusion of the plaintiff's expert witness' testimony because there was not sufficient evidence to show a link between trauma from car accidents and fibromyalgia. (53) In essence, the court found that because there was no evidence that car accidents can cause fibromyalgia, the expert witness could not opine that, after examining the patient and reviewing her history, her fibromyalgia was caused by a car accident. (54)

The court explained that an expert witness' opinion is "pure opinion" and immune from Frye only if the opinion is based on clinical experience without the need for making underlying assumptions. (55) If the opinion requires an underlying assumption (in the Marsh can cause fybromyalgia) then it is not "pure opinion" and it should be subject to Frye. (56) The court concluded that the underlying scientific principle of general causation would be subject to the Frye analysis. (57)

What can be learned from Marsh is that an expert witness cannot use differential diagnosis to support a specific causation conclusion if there is not generally accepted medical support with respect to general causation. Such an opinion as to causation is not "pure opinion" testimony when general causation is not recognized in the scientific community; thus, differential diagnosis relying on the assumption that the connection does exist is inadmissible. (58) If expert witness testimony relies on an underlying assumption of general causation, the underlying assumption must be generally accepted, and if it is not, then the opinion is subject to Frye and should be challenged.


The one concept that is clear and unassailable regarding the admissibility of expert witness testimony in Florida is that the standard for courts to apply is the Frye "general acceptance" test. (59) The degree of flexibility a court has to determine whether an expert witness' opinion is based on generally accepted science hinges on where the line is drawn between the methods, data, and assumptions an expert witness utilizes in formulating opinions and the ultimate opinions themselves. Despite the lack of certainty concerning Frye, particularly in the product liability context, a variety of challenges can be made to expert witness testimony. Because ultimate opinions cannot be challenged, the most important lesson is to focus the challenge one level below the witness' ultimate opinion, asserting that the basic methods, data, or assumptions used by the expert witness in formulating the expert's opinion are not generally accepted in the relevant scientific community. These challenges must be made, and they must be made on as many fronts as possible, to expose and exclude expert witness testimony premised on science that has not reached a level of acceptance worthy of the "aura of reliability" associated with expert witness testimony.

(1) Compare Federal Rule of Evidence 702 which provides that expert witness testimony is only admissible if "the testimony is based upon sufficient facts or data, the testimony is the product of reliable principles and methods, and the witness has applied the principles and methods reliably to the facts of the case."

(2) Frye, 293 F. at 1014.

(3) See 509 U.S. 579 (1993).

(4) Hadden v. State, 690 So. 2d 573, 576 n.2 (Fla. 1997).

(5) Flanagan v. State, 625 So. 2d 827, 828 (Fla. 1993).

(6) See Brim v. State, 695 So. 2d 268, 271-71 (Fla. 1997)("Despite the federal adoption of a more lenient standard in [Daubert], we have maintained the higher standard of reliability as dictated by Frye.").

(7) Ramirez, 810 So. 2d at 844.

(8) Id.

(9) Id.

(10) Castillo, 854 So. 2d at 1270, 1272-74.

(11) Id. at 1276.

(12) Id. at 1275-76.

(13) Id.

(14) Clegg, 2004 WL 471694 at *3.

(15) The "generally accepted set of standards for evaluating epidemiological studies" are 1) strength of association; 2) temporal relationship; 3) consistency of the association in other research; 4) biological plausibility; 5) consideration of alternative explanations; 6) specificity of the association; and 7) dose-response relationship. Berry v. CSX Transp., Inc., 709 So. 2d 552, 559 n.6 (Fla. 1st D.C.A. 1998).

(16) Id.

(17) Id.

(18) General Motors, 891 So. 2d at 1058.

(19) Id.

(20) Id. See also Morton v. Hardwick Stove Company, 138 So. 2d 807 (Fla. 2d D.C.A. 1961).

(21) Brito, 753 So. 2d at 113-14. Compare Jones v. Goodyear Tire & Rubber Co., 871 So. 2d 899 (Fla. 3d D.C.A. 2003) (holding that because the expert witness' testimony regarding a design defect in the tires at issue was "pure opinion" testimony, it was not subject to Frye).

(22) Id.

(23) See Note, General Acceptance Versus Scientific Soundness: Mad Scientists in the Courtroom, 31 Fla. St. U. l. Rev. 303, 2004; see also Castillo, 854 So. 2d at 1275-76 (making clear that the one aspect of Daubert that is not to be considered is whether the expert witness used sound reasoning to reach his or her conclusion).

(24) Ramirez, 810 So. 2d at 844.

(25) Id. at 849.

(26) Id.

(27) Id. at 850-51.

(28) Id. at 851.

(29) Id.

(30) Id. at 852-53.

(31) Cerna, 815 So. 2d at 655.

(32) Id. at 654.

(33) A dose-response relationship is a "relationship in which a change in amount, intensity, or duration of exposure is associated with a change--either an increase or decrease--in risk of disease." Berry, 709 So. 2d at 559-60. In Cerna, the expert witness did not know at what dosage the drug would become toxic, and did not know the effect a normal dosage would have on humans. 815 So. 2d at 654. An expert witness should be required to offer evidence supporting both a qualitative association between an agent and a disease and evidence linking a dose of the agent to an incidence of the disease. See Poulin v. Fleming, 782 So. 2d 452, 457 (finding expert witness' methodology unreliable because the experts could not opine on how much radiation could cause schisencephaly).

(34) Cerna, 815 So. 2d at 654-55. Temporal proximity, by itself, is insufficient to support causation. See Kaelbel, 785 So. 2d at 550.

(35) Cerna, 815 So. 2d at 655-56.

(36) Kaelbel, 785 So. 2d at 544-45.

(37) One expert postulated the ciguatera toxin would cause prolonged activation of the sodium channels and cause them to be distorted, thereby causing the body to form antibodies against the abnormal sodium channels. The expert claimed that the antibodies are then directed against the sodium channels leading to the development of GBS. Id. at 544. The other expert witness testified that he believed the body created antibodies that attached to both the ciguatera toxin and the sodium channels. Id. at 545.

(38) Id. at 549.

(39) Id.

(40) Gelsthorpe v. Weinstein, 897 So. 2d 504, 509 (Fla. 2d D.C.A. 2005)(expert witness testimony based on analysis of medical records and differential diagnosis should not have been subjected to Frye because it was pure opinion based upon clinical experience).

(41) Flanagan v. State, 625 So. 2d 827, 828 (Fla. 1993).

(42) Id.

(43) Holy Cross, 816 So. 2d at 1116.

(44) Id. at 1117.

(45) Id. at 1118.

(46) See Neal D. Kodsi, Confronting Experts Whose Opinions Are Neither Supported nor Directly Contradicted by Scientific Literature, 80 Fla. B.J. 80 (June 2006) (discussing cases involving challenging foundation of testimony claimed to be pure opinion).

(47) Accord Castillo v. E.I. DuPont De Nemours & Co., Inc., 854 So. 2d 1264 (Fla. 2003). The admissibility of the expert testimony was the determining issue as to whether the plaintiff prevailed or the defendant was entitled to a directed verdict.

(48) See Gelsthorpe, 897 So. 2d at 510-11.

(49) See In re Breast Implant Litigation, 11 F. Supp. 2d 1217 (D. Colo. 1998).

(50) See Gelsthorpe, 897 So. 2d at 509 (Fla. 2d D.C.A. 2005); David v. Nat'l Railroad Passenger Corp., 801 So. 2d 223 (Fla. 2d D.C.A. 2001)(stating that if the court determines that the expert witness' opinions are based on an acceptable underlying scientific theory, and that they have used the differential diagnosis method to arrive at their theories of causation, it should permit them to testify).

(51) See In re Breast Implant Litigation, 11 F. Supp. 2d 1217 (D. Colo. 1998).

(52) See Marsh v. Valyou, 917 So. 2d 313 (Fla. 5th D.C.A. 2005)

(53) Marsh, 917 So. 2d at 329.

(54) Id.

(55) Id. at 327.

(56) Id.

(57) Id. Approximately one year prior to Marsh, the Second District took a contrary position in State Farm Mut. Auto. Ins. Co. v. Johnson, 880 So. 2d 721 (Fla. 2d D.C.A. 2004) (admitting expert witness testimony that plaintiff 's fibromyalgia was caused by an automobile accident based on differential diagnosis as "pure opinion" testimony). Marsh certified conflict with Johnson, and the Florida Supreme Court heard oral argument on February 15, 2007. Although it is impossible to know how the conflict will be resolved, Johnson is the only known published case, from any state using Frye, that has admitted evidence of causation of fibromyalgia under Frye. See Melody D. Farance, Challenging Admissibility: Causation Evidence in Fibromyalgia Claims, 48 FoR the DeFenSe 4 (2006). Moreover, decisions reached by courts in other states have sided with Marsh. See Grant v. Boccia, 137 P.3d 20, 24 (Wash. App. 2006)(holding that trial court properly ruled that expert testimony on specific causation was subject to Frye, where plaintiff did not establish general acceptance as to the cause of fibromyalgia).

(58) Marsh, 917 So. 2d at 327, 329.

(59) See, e.g., Hadden v. State, 690 So. 2d 573 (Fla. 1997).

Rebecca Cavendish and Nicole Atkinson are senior associates with the West Palm Beach office of Gunster, Yoakley & Stewart, P.A. Both Ms. Cavendish and Ms. Atkinson focus their practice on defending product liability suits.

This column is submitted on behalf of the Business Law Section, Diane N. Wells, chair, and Samuel A. Lewis and Hans Christian Beyer, editors.
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Author:Cavendish, Rebecca; Atkinson, Nicole
Publication:Florida Bar Journal
Date:Mar 1, 2007
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