Daubert v. Merrell Dow Pharmaceuticals, Inc UPDATED 2018

Application of Daubert v. Merrell Dow Pharmaceuticals, Inc. in Florida

Examples from orders on motions in limine

By F. Shields McManus

UPDATE! IN A 4-3 DECISION THE FLORIDA SUPREME COURT HAS CLARIFIED THE LAW GOVERNING ADMISSIBILITY OF EXPERT WITNESS TESTIMONY IN THE STATE COURTS OF FLORIDA. cf. Deslisle v. Crane, (No. SC16-2182)(Oct.15, 2018). The decision moves away from the Daubert standard utilized in federal courts, to the Frye standard which was used before the amendment to sec. 90.702 in 2013. After that amendment, Florida trial courts were unsure whether to analyse expert testimony and rule on pretrial motions according to Daubert or Frye. Most courts used Daubert, as discussed in the following article.

This article will present a basic review of Florida’s new rules governing the admissibility of expert testimony as well as some examples of the application of the rules.


In 2013, the Florida Legislature amended the Florida Evidence Code to adopt the standards for expert testimony as provided in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). The Daubert test applies not only to “new or novel” scientific evidence, but to all other expert opinion testimony. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999).

Section 90.702, Florida Statutes, now provides:

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 or otherwise, if:

(1) The testimony is based upon sufficient facts or data;

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

(3) The witness has applied the principles and methods reliably to the facts of the case.


A witness may be qualified as an expert through specialized knowledge, training, or education, which is not limited to academic, scientific, or technical knowledge; an expert witness may acquire this specialized knowledge through an occupation or business or frequent interaction with the subject matter, but general knowledge is insufficient. Chavez v. State, 12 So. 3d 199, 205 (Fla. 2009); see Fla. R. Civ. P. 1.390 (defining expert as one holding a professional degree with training and experience or “one possessed of special knowledge or skill about the subject upon which called to testify.”) A person does not necessarily need to have a degree in a specific field in order to qualify as an expert. See Sihle Insurance Group, Inc. v. Right Way Hauling, Inc., 845 So.2d 998 (Fla. 5th DCA 2003) (a public adjuster who prepared appraisals and negotiated settlements for property owners who had experienced losses was qualified to testify about lost profits), and Weese v. Pinellas County, 668 So. 2d 221 (Fla. 2nd DCA 1996) (a witness may testify as an expert if he was qualified to do so by reason of knowledge obtained in his occupation of business). As far as health care providers, however, the legislature has provided specific standards establishing minimum qualifications of persons giving expert testimony concerning the prevailing professional standard of care. Generally, the witness must practice the same specialty and have other qualifications similar to the defendant health care provider. §766.102 (5-8), Florida Statutes (2014).


The legislature specifically intends for trial judges to apply to all expert testimony principles which are in conformity with Daubert and Kumho Tire. The judge must be a gatekeeper to exclude evidence which is unreliable and may confuse or mislead the jury. The trial court has broad discretion, however, in determining how to perform its gate keeping function when addressing the admissibility of expert testimony. A judge’s determination that an objection was not timely raised will be reviewed for abuse of discretion. An objection to an expert’s opinion should be made in a timely fashion so that the expert’s proposed testimony can be evaluated with care. It should not be a “gotcha” tactic. See Booker v. Sumpter County Sheriff’s Office/ North American Risk Services, __ So.3d__, 40 Fla. L. Weekly D1291, 2015WL3444359 (Fla. 1st DCA 2015) (affirming judge’s finding that objection was untimely when made four days before the final hearing which was five months after the first notice of the IME report and four months after the examining physician’s deposition).


If an objection is timely raised, the party offering the expert opinion testimony bears the burden of establishing, by a preponderance of the evidence, the expert’s qualification, reliability, and helpfulness. Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1335 (11th Cir. 2010), citing McCorvey v. Baxter Healthcare Corp., 298 F.3d 1253, 1256 (11th Cir. 2002).

First, the judge must determine whether “scientific, technical, or other specialized knowledge will assist the trier of fact in understanding the evidence or in determining a fact in issue”. § 90.702. The judge should also consider §90.403. 

Exclusion on grounds of prejudice or confusion.—Relevant evidence is inadmissible if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of issues, misleading the jury, or needless presentation of cumulative evidence.

If it meets these standards, then the judge must determine if the proffered testimony is truly scientific. Under Daubert, “the subject of an expert’s testimony must be ‘scientific knowledge.'” 509 U.S. at 590. “[I]n order to qualify as ‘scientific knowledge,’ an inference or assertion must be derived by the scientific method.” Id. The touchstone of the scientific method is empirical testing — developing hypotheses and testing them through blind experiments to see if they can be verified. Id. at 593; see also Black’s Law Dictionary 1465-66 (9th ed. 2009) (“[S]cientific method [is] [a]n analytical technique by which a hypothesis is formulated and then systematically tested through observation and experimentation.”). As the United States Supreme Court explained in Daubert, “This methodology is what distinguishes science from other fields of human inquiry.” Id. at 593. Thus, “a key question to be answered” in any Daubert inquiry is whether the proposed testimony qualifies as “scientific knowledge” as it is understood and applied in the field of science to aid the trier of fact with information that actually can be or has been tested within the scientific method. Id. “General acceptance” from Frye v. United States, 293 F. 1013 (D.C. Cir. 1923) (the Frye test) can also have a bearing on the inquiry, as can error rates and whether the theory or technique has been subjected to peer review and publication. Id. at 593-594. Thus, there remains some play in the joints. However, “general acceptance in the scientific community” alone is no longer a sufficient basis for the admissibility of expert testimony. It is simply one factor among several. Subjective belief and unsupported speculation are henceforth inadmissible. Id. at 590.

Pure opinion testimony is prohibited. The Legislature expressed its intent to “prohibit in the courts of this state pure opinion testimony as provided in Marsh v. Valyou, 977 So.2d 543 (Fla. 2007).” Ch. 2013-107, § 1, Laws of Fla. (2013) (Preamble to § 90.702). No longer will pure opinion or ipse dixit expert testimony be admissible as the Florida courts had allowed under the Frye test. Perez v. Bell South Telecommunications, Inc., 138 So.3d 492 (Fla. 3d DCA 2014).

Daubert outlined four considerations: testing, peer review, error rates, and acceptability in the relevant scientific community. These four tests for reliability are known as the Daubert test. The four factors in Daubert are simply illustrative and the court may consider other factors to determine reliability. Additional factors for reliability may be found in the advisory committee notes to Federal Rule 702. These include:

(1) Whether the expert is proposing to testify about matters growing naturally and directly out of research he has conducted independent of the litigation, or whether he has developed his opinion expressly for purposes of testifying;

(2) Whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion;

(3) Whether the expert has adequately accounted for obvious alternative explanations;

(4) Whether the expert is being as careful as he would be in his regular professional work outside his paid litigation consulting; and

(5) Whether the field of expertise claimed by the expert is known to reach reliable results for the type of opinion the expert would give.


Payne v. C.R. Bard, Inc., 2014WL988754 (M.D., Orlando, Florida. 2014)

In this medical device products liability action involving defective device and causation experts, the trial judge excluded the testimony of Frederick Hetzel, Ph.D., but allowed the testimony of Timothy Harward, M.D. The case involved the failure of a Bard G2 inferior cava filter, a metal device placed in a person’s inferior vena cava (“IVC”) as a mechanical barrier to prevent thrombi from becoming a life-threatening pulmonary embolism.

The trial judge found that despite Dr. Hetzel’s impressive education in chemistry, his education did not qualify him to testify because metallurgy rather than chemistry was implicated in plaintiff’s claim. Although he had some limited experience on similar product development, it was only conceptual and occurred more than 20 years before. His experience was not tied to the opinions that he offered.

Furthermore, the judge found that Dr. Hetzel’s methodology did not support a finding of reliability. The witness reviewed only three deposition transcripts, and he referenced too few scholarly articles, most of which discussed unrelated medical products for hip implants. His work in developing his opinions was called “slipshod” and developed solely in the context of this litigation.

Dr. Harward opined that the plaintiff’s symptoms were caused by inflammatory response to the strut in his left lung and fibrosis in the pulmonary arteries which was exacerbated by recurrent pulmonary emboli that occurred when the IVC was no longer properly covered due to the failure of the G2 filter. The trial judge found that this differential diagnosis was properly based on eliminating each of the potential causes for the patient’s symptoms until reaching one that could not be ruled or determining which of those that cannot be excluded was the most likely. He did not rely solely on the temporal proximity between the G2 filter failure and the onset of symptoms to establish medical causation. The judge found that although the opinion was admittedly speculative it did not depart from the normal practice of diagnosis any more than the defendant’s causation expert. In fact, they were consistent in part. The defendant’s medical expert diagnosed the plaintiff’s illness was due to chronic pulmonary hypertension from chronic pulmonary emboli, acquired over a long period of time. Thus the court found that Dr. Harward’s opinion was reliable and admissible.

Therese Mendy v. Dianne Rennick, Case No. 31-2013-CA-786 (19th Cir. Ct., Indian River County, Fla., 2014)

The trial judge denied plaintiff’s motion to exclude testimony of Donald J. Fournier, Jr., P.E., a mechanical engineer with 22 years experience in accident reconstruction, who offered opinions on the applicability of various codes to the intersection and site lines in question. The judge found Mr. Fournier qualified and that the methods used by him were sufficiently well-established and reliable and were admissible under § 90.702.

Mr. Fournier did not consider himself a “civil engineer” and did not have a degree in civil engineering. He was a licensed professional engineer in the State of Florida, a board certified diplomat in forensic engineering by NAFE, and an ACTAR accredited Traffic Accident Reconstructionist. He had a Bachelor of Science degree in Mechanical Engineering as well as a Master’s Degree in Mechanical Engineering including studies of statics, dynamics, design, drafting, and physics. He also had education in safety, ergonomics, human factors, municipal codes, state statutes, consensus standards and DOT regulations by a metric that was at the college level. He had taken accident reconstruction courses taught beyond the college level. The judge found that accident reconstruction draws upon the fields of both mechanical and civil engineering because it is concerned with studying the interaction of the human, the vehicle and the environment.

Mr. Fournier’s opinions were based upon the physical evidence preserved by the police department, a site inspection of the intersection in question, evaluation and analysis of the measurements and photographs taken of the subject intersection, a Ford F250 truck, and plaintiff’s decedent’s bicycle; photographs and measurements taken of numerous intersections throughout the City of Vero Beach, and the application of city’s Ordinance §71.08, FDOT Standard 546, and the county’s Ordinance §911.15.

Jones v. CSX Transportation, Inc., 2014WL7670444 (Fla. 4th Judicial Circuit, Duval County, Fla., 2014).

The defendant moved to exclude the testimony of plaintiff’s expert witness, Tyler Kress, Ph.D., an engineer specializing in the areas of biomedical/ biomechanical and human factors engineering. Dr. Kress’s opinion correlated railroad work duties with the development of osteoarthritis in the knees. The trial judge found that while the witness was qualified, the proffered testimony of plaintiff’s expert witness did not reach the level of scientific or technical reliability required under the standard of Section 90.702, Florida Statutes.

There was no independent investigation into the plaintiffs work tasks. Dr. Kress’s opinion was based solely on the plaintiff’s own description of his work. There was no evidence of the amount of force or the number of repetitions necessary to cause the plaintiffs condition. Dr. Kress did not quantitatively measure the plaintiff’s exposure to the risk factors he found in the plaintiff’s duties. Further, Dr. Kress did not apply the specific facts of the plaintiff’s employment to existing studies so that his opinion could be tested or peer reviewed.

Further, Dr. Kress had not met the plaintiff in person, having only spoken to him on the phone for approximately one hour, nor had he spoken to any of the plaintiff’s co-workers or supervisors, and he did not inspect the work conditions and areas where the plaintiff worked during his railroad career. Dr. Kress was not a medical doctor, nor did he speak with any of the plaintiff’s doctors, and he did not review the plaintiff’s medical records. His recommendations regarding occupational risks for the development of osteoarthritis in the knees had never been adopted by any industry, nor had it ever been cited in any medical research on the cause of osteoarthritis or cumulative trauma to the knees.

Dr. Kress testified that, while there are ways to measure the forces generated in getting on and off moving railroad cars and engines, he performed none of those tests. Further, he did not perform any measurement of the forces applied to knees as a result of walking on large ballast, small ballast, pea gravel, mud, cinders, sand, or any other walking surface normally found on railroads. Dr. Kress opined that using smaller ballast is safer for the railroad employee because it reduces the risk factors for development of cumulative trauma, but he conceded there was no scientific evidence to support that theory. Dr. Kress testified that he was unaware of any biomechanical studies involving a reduction of risk of developing osteoarthritis by reducing the amount of weight railroad workers lift when handling knuckles and end of train devices.

Dr. Kress’s report made mention of the plaintiff climbing ladders on railroad equipment, but admitted in his deposition that he had no opinion as to when or how climbing a ladder could constitute an excessive biomechanical force.

None of the studies or programs cited by Dr. Kress amounted to peer reviewed scientific literature on the issue of musculoskeletal disorders. None of the studies cited by Dr. Kress correlated railroad work duties with the development of osteoarthritis in the knees.

The author thanks Hon. Cynthia L. Cox, Circuit Court Judge for the 19th Judicial Circuit of Florida, for her contribution of materials for this article.