Opinion
C. A. N20C-01-067 PAW
12-20-2024
AMEENA BROWN and EVAN BRAGGS, Individually and as Co- Administrators of the Estate of A.B., deceased, Plaintiffs, v. FISHER-PRICE, INC. and MATTEL, INC. Defendants.
Robert J. Leoni, Esq., Shelsby &Leoni, PA, Attorney for Plaintiffs. Jennifer C. Wasson, Esq., Carla M. Jones, Esq., and Ryan Kingshill, Esq., of Potter Anderson &Corroon LLP, Attorneys for Defendants.
Submitted: November 8, 2024
Robert J. Leoni, Esq., Shelsby &Leoni, PA, Attorney for Plaintiffs.
Jennifer C. Wasson, Esq., Carla M. Jones, Esq., and Ryan Kingshill, Esq., of Potter Anderson &Corroon LLP, Attorneys for Defendants.
MEMORANDUM OPINION AND ORDER UPON CONSIDERATION OF DEFENDANTS 'MOTION TO EXCLUDE THE TESTIMONY OF PLAINTIFFS' EXPERT DARLENE VASBINDER-CALHOUN, D.O. PURSUANT TO D.R.E. 702; DENIED, IN PART, AND GRANTED, IN PART.
Patricia A. Winston, Judge.
This Memorandum Opinion and Order references the factual and procedural background outlined in the Court's Memorandum Opinion and Order upon Consideration of Defendants' Motion for Summary Judgment, which the Court incorporates by reference. Unless otherwise noted, defined terms are ascribed the same meaning as in the Court's Summary Judgment Memorandum Opinion.
Defendants move to exclude the expert testimony of Dr. Darlene Vasbinder-Calhoun under D.R.E. 702. Plaintiffs seek to introduce Calhoun's testimony to show: (1) the design of the RnP increased the risk of harm; (2) A.B. died from suffocation after rolling onto his side and pressing his face against the side of the RnP; (3) A.B. could have expected a normal life expectancy despite his premature birth; and (4) A.B. experienced conscious pain and suffering before death.Calhoun's report also touches on the topic of rebreathing. Defendants contend Calhoun: (1) lacks the requisite qualifications to opine on cause of death; (2) has no basis to conclude the RnP's design is defective aside from the opinion of other experts in this case; (3) bases her conclusions on "mere association" as opposed to "reliable scientific opinions;" and (4) relies on a theory of increased risk causation which is impermissible under Pennsylvania law.
Defs.' Mot. to Exclude Pls.' Expert Darlene Vasbinder-Calhoun, D.O., D.I. 179.
Pls.' Opp'n to Defs.' Mot. to Exclude Darlene Vasbinder-Calhoun, D.O., D.I. 215 at 7. Calhoun's testimony regarding conscious pain and suffering is examined in a separate Memorandum Opinion and Order.
D.I. 179 Defs.' Ex. C at 10 ("Dr. Calhoun's Report"); Calhoun's testimony regarding rebreathing is examined in a separate Memorandum Opinion and Order.
D.I. 179 at 2-3.
II. STANDARD OF REVIEW
Delaware Rule of Evidence ("D.R.E.") 702 governs the admission of expert testimony. Under D.R.E. 702, expert opinion testimony is admissible provided that the witness "is qualified as an expert by knowledge, skill, experience, training, or education" if:
(a) the expert's scientific, technical, or other specialized knowledge will help the trier of the 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 applied the principles and methods to the facts of the case.
The burden falls on the party seeking to admit the expert testimony to show, by a preponderance of the evidence, its admissibility under D.R.E. 702. "Once expert testimony is challenged, the reviewing court must ensure that the proffered testimony is both relevant and reliable." To fulfill this duty, this Court acts as gatekeeper, determining if "the reasoning or methodology underlying the testimony is scientifically valid and ... whether that reasoning or methodology properly can be applied to the facts in issue." In making that determination, the Court applies a five- step test that examines whether:
Bowen v. E.I. DuPont de Nemours & Co., Inc., 906 A.2d 787, 795 (Del. 2006).
Scottoline v. Women First, LLC, 2023 WL 2325701 at *3 (Del. Super. Mar. 1,2023) (citing Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993)).
Gen. Motors Corp. v. Grenier, 981 A.2d 531, 536 (Del. 2009) (internal quotations omitted) (quoting Daubert, 509 U.S. 579 at 592-93).
(1) the witness is qualified as an expert by knowledge, skill, experience, training[,] or education; (2) the evidence is relevant [and reliable]; (3) the expert's opinion is based upon information reasonably relied upon by experts in the particular field; (4) the expert will assist the trier of fact to understand the evidence or to determine a fact in issue; and (5) the expert testimony will not create unfair prejudice or confuse or mislead the jury.
Norman v. All About Women, P.A., 193 A.3d 726, 729-30 (quoting Smith v. Grief, 2015 WL 128004 (Del. Jan. 8, 2015)).
For scientific evidence to be deemed reliable, the testimony must be rooted in science and derived from the scientific method. Expert testimony is relevant when it assists the trier of fact to understand the evidence or determining a fact in issue. Thus, the core of a Daubert analysis is the "principles and methodology" used in formulating an expert's testimony, not on the expert's resultant conclusions. This Court possesses "broad latitude to determine whether any or all of the Daubert factors are reasonable measures of reliability in a particular case." "A strong preference exists for admitting evidence that may assist the trier of fact."
Daubert, 509 U.S. at 590-94.
Bowen, 906 A.2d at 794 (citing Daubert, 509 U.S. 579 at 595).
Grenier, 981 A.2d at 536 (internal quotations omitted) (quoting Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 141 (1999)).
Norman, 193 A.3d at 730.
III. ANALYSIS
Calhoun describes her experience as "clinical practice in Neonatal-Perinatal Medicine," working in Neonatal intensive care units, and conducting academic research. During her deposition, she stated "[m]y opinion is that [A.B.] died from suffocation related to the compression of his mouth and nose against the fabric of the Rock 'n Play Sleeper." Calhoun formed that opinion based on her review of A.B.'s medical records, the witness statements of A.B.'s mother, the reports of Mannen and Leshner, various studies Calhoun cited in her report, and her own training and experience.
Dr. Calhoun's Report at 1.
D.I. 179 Defs.' Ex. D at 81 ("Dr. Calhoun's Deposition Volume 2").
At oral argument, Defendants contended that all Plaintiffs' expert opinions were factually flawed because they failed to correctly account for the position of A.B.'s face as described by his mother in her deposition. This assertion is incorrect. See Dr. Calhoun's Report at 6; Dr. Hoffman's Report at 6; Dr. Mannen's Report at 5; Dr. Rosen's Report at 6; Dr. Ross' Report at 4. Further, challenges to the factual basis of an expert opinion go to credibility, not admissibility. An expert's testimony will be excluded on the factual basis grounds only in the narrow circumstance where the expert has completely neglected the core facts of the case. See Henlopen Hotels, Inc. v. United National Insurance Co., 2020 WL 233333 (Del. Super. Jan. 15, 2020). This is not the case here.
Dr. Calhoun's Report at 29-30.
A. Calhoun may not offer general causation testimony.
Defendants argue Calhoun lacks both a scientific basis and the requisite credentials to offer a either a general causation or a specific causation opinion.Defendants assert Calhoun does not qualify as a biomechanical engineer, or a forensic pathologist, and so cannot opine as to design flaws or cause of death.Further, Defendants contend Calhoun relies upon "mere association"-the fact A.B. was found deceased in the device-rather than reliable scientific opinions, testing, or data demonstrating causation.
D.I. 179 at 12, 18.
Id. at 12-13.
Id. at 20.
"General causation is whether a [device] is capable of causing a particular injury [...], while specific causation is whether a [device] causefs] a particular individual's injury." During oral argument, Plaintiffs' counsel represented that Calhoun intended to introduce an opinion on both general and specific causation. Her general causation opinion "is simply saying that here the Rock 'n Play can cause death." Calhoun bases that opinion on the published guidelines from the American Academy of Pediatrics (the "AAP"); Mannen's Consumer Product Safety Commission report; a report by Hwang on inclined sleepers; and Mr. Leshner's report on rebreathing. Calhoun includes a lengthy discussion of the recall history of the RnP, as well as internal communications at Fisher-Price discussing the design of the RnP.
Smith v. Benjamin Moore & Co., 2012 WL 2914219 at *2 (Del. Super. July 18, 2012) (quoting Merrell Dow Pharms., Inc. v. Havner, 953 S.W.2d 706, 714 (Tex. 1997)).
Tr. of Oral Arg. at 15, D.I. 276 (June 18, 2024).
Id.
Dr. Calhoun's Report at 9.
Id. at 10.
Id. at 16.
Id. at 17.
Id. at 9-11.
Expert testimony must not "create unfair prejudice or confuse or mislead the jury." Additionally, the expert's proffered testimony must be based on their "knowledge, skill, experience, training[,] or education." Here, a review of Calhoun's report as it pertains to general causation shows little analysis based upon her own expertise. Although she bases her general causation opinion on the type of "information reasonably relied upon by experts in the particular field," she does not add any of her own context as to how the design of the RnP can cause death.Permitting Calhoun to restate the opinions of other experts, absent any additional context provided by her own particular qualifications, may mislead the jury into giving that testimony unwarranted, additional weight; thereby creating unfair prejudice.
Norman, 193 A.3d at 730 (quoting Grief, 2015 WL 128004 at *2).
Id.
Id.
Many of the expert reports relied upon by Dr. Calhoun are the subject of separate Daubert motions in this case. The Court makes no pronouncement on their standalone admissibility in this Memorandum Opinion and Order.
Defendants further contend Calhoun "does not have any experience related to product safety testing" which would render her discussion of Fisher-Price's testing procedures and recall decisions admissible. Calhoun has never conducted tests on infant sleep products, and her discussion about whether Fisher-Price knew the RnP posed a threat to infants amounts to a recounting of alleged facts generated without her particularized skills and education. Admitting this testimony may also mislead the jury and would permit Calhoun to testify about recalls and test procedures of which she has no expertise to testify. Accordingly, Calhoun's general causation opinion must be excluded.
D.I. 179 at 8.
B. Calhoun's specific causation testimony is admissible.
Calhoun's specific causation opinion, however, relies on her own training and experience. Though Calhoun does not formally label her opinion as the result of a differential diagnosis, Plaintiffs contend that is precisely the methodology Calhoun utilizes in her report. A differential diagnosis involves the doctor creating a list of possible causes of death, and then working through the medical records to exclude each of those potential causes until only one reasonable explanation remains.
See State v. McMullen, 900 A.2d 103, 108-09 (Del. Super. 2006).
To analyze the admissibility of a differential diagnosis, "[t]he Court must delve into the particular witness's method of performing a differential diagnosis to determine if [ ] her ultimate conclusions are reliable." "A differential diagnosis is deemed reliable for Daubert purposes if it is rendered after the physician conducts a physical examination, takes a medical history, reviews clinical tests, including laboratory tests, and excludes obvious (but not all) alternative causes." "It is acceptable for a physician to arrive at a diagnosis by relying on examinations and tests performed by other medical practitioners." This Court must be "flexible in the exercise of their evidentiary 'gatekeeping' function" as it pertains to differential diagnoses."
Id. at 117.
Id. (emphasis in original).
Id.
Id. at 118.
In her report, Calhoun considers as possible causes of death, and then excludes: SIDS; Gastroesophageal Reflux Disease; complications from A.B.'s Atrial Septal Defect; complications from A.B.'s Nasogastric Feeding Tube; and A.B.'s respiratory conditions. She also considered A.B.'s developmental age, his preference to turn to his right side, and the way he was found in the RnP the morning of his death. Calhoun provides her reasoning, based on her training and experience, for concluding that she can rule out the alternative causes of death she considered. She then concludes, based on those exclusions and the information available to her, that A.B. died of asphyxiation. Further, she concludes due to A.B.'s developmental delays that he would have been unable to roll onto his side, absent the design of the RnP facilitating his roll. Calhoun created a list of possible causes of A.B.'s death, and her report explains why she excluded each alternative.
Dr. Calhoun's Report at 15.
Id. at 20-21.
Id. at 21-22.
Id. at 22-23.
Id. at 24-25.
Id.
Id. at 29-30.
Defendants raise several specific issues with Calhoun's methodology, but these issues relate to the credibility of her opinion, not its admissibility. Defendants contend Calhoun relies "upon a mere association" based on A.B.'s placement in the RnP in concluding the RnP contributed to his death. Calhoun, however, explained in her report why she thought the RnP facilitated an otherwise-unachievable roll for A.B., placing him in a position in which he was more prone to suffocation. Her explanation goes beyond simply stating A.B.'s death must have resulted from whatever sleep product he died in, including a breakdown of A.B.'s developmental age and the risks created by the RnP. She also discusses the different airway structure of infants as compared to older children, the increased risk infants face when they experience an airway obstruction while sleeping, and how an infant may struggle to correct his position.
D.I. 179 at 20.
Dr. Calhoun's Report at 29-30.
Id.
Id. at 18-19.
Defendants also posit Calhoun failed to rule out a death from unspecified natural causes, but that argument amounts to a critique of her failure to consider all possible alternatives in her differential diagnosis. Calhoun explains in her report that a diagnosis of Sudden Unexplained Infant Death Syndrome ("SUIDS") can only be appropriate when "the manner of death is noted to be undetermined." In other words, SUIDS equates to the absence of any apparent cause of death. Implicit in her diagnosis of positional asphyxiation, Calhoun rules out SUIDS precisely because she found a viable cause of death.
Id. at 15.
Similarly, Defendants' argument based on Calhoun's inability to know exactly what transpired during the time between Ms. Brown placing A.B. in the RnP and his death amounts to an argument against the credibility of Calhoun's diagnosis, but not its admissibility. Calhoun's conclusion on A.B.'s specific cause of death, based on her examination of the facts and her training and experience, is admissible. Defendants may attack the credibility of that conclusion in cross-examination.
C. Calhoun cannot rely on increased risk of harm to establish CAUSATION.
Defendants contend Calhoun impermissibly relies on an "increased risk" standard, which Pennsylvania law prohibits in product liability cases. Calhoun's ultimate conclusion states, "[i]t is my opinion that the design of the Rock 'n Play Sleeper increased the risk of harm for and was the direct cause of [A.B.'s] asphyxiation, physical pain and suffering, and death."
Dr. Calhoun's Report at 30 (emphasis added).
Pennsylvania law does not permit the use of "increased risk" testimony to establish causation in products liability cases. At oral argument, Plaintiffs acknowledged that increased risk standing alone does not equal causation under Pennsylvania law because the jury must later decide whether the increased risk was a substantial factor in achieving causation. After extensive argument, Defendants conceded their position with Plaintiffs as they "understood counsel to be acknowledging that they were not trying to substitute increased risk for proof of causation." Here, Calhoun offers a basis for specific causation which goes beyond her reliance on increased risk. Moreover, Defendants have conceded that Plaintiffs are not attempting to substitute increased risk for causation. Accordingly, Calhoun may not testify that increased risk establishes causation.
See In re Lipitor (Atorvastatin Calcium) Mktg., Sales Pracs. & Prod. Liab. Litig., 227 F.Supp.3d 452, 487 n. 28 (D.S.C. 2017), aff'd sub nom. In re Lipitor (Atorvastatin Calcium) Mktg., Sales Pracs. & Prod. Liab. Litig. (No II) MDL 2502, 892 F.3d 624 (4th Cir. 2018); see also Lempke v. Gen. Elec. Co., 2012 WL 94547 at *4 (W.D. Pa. Jan. 11, 2012) (finding increased risk as causation only applied to situations where the defendant has a duty to perform an act, or where defendant undertook an obligation to perform an act).
Pls' Suppl. Br. at 12; Tr. of Oral Arg., C. A. No. N20C-01-067 PAW at 102:23-104:4 (June 25, 2024). Plaintiffs further clarify that "[t]his increased risk argument is really an argument to the point of what will the jury instructions look like and what will the arguments look like to the jury, but it is absolutely a proper basis by which causation can be proved." Id. at 107:13-19.
Tr. of Oral Arg. at 147:7-15 (June 25, 2024).
IV. CONCLUSION
Calhoun's training and expertise qualifies her to opine on the specific cause of death in this case. She may not provide an opinion on general causation based on the design of the RnP. She may not opine that increased risk establishes causation.
IT IS SO ORDERED.