The Boppy Newborn Lounger (“BNL”) was on the market for nearly sixteen years, and during that time, Boppy sold over 3.3 million BNLs. Boppy’s warnings and marketing made clear that the BNL was intended to give caregivers a place to lay infants down for supervised awake time only, but never for sleeping. As with any product, there were risks associated with improper use, against which Boppy warned and for which Boppy provided instructions concerning safe use.
On October 2, 2020, Plaintiff Danielle Clark swaddled her infant daughter (“D.B.”) in a blanket that was loosely wrapped around D.B.’s head, but not covering her face. D.B. was then placed “mainly on her side” and in the center of the BNL, which was sitting on the couch. Around 10:30 or 11:00 p.m., Clark fell asleep with her head on the side of the Boppy pillow. When Clark awoke approximately three to four hours later, she found her daughter unresponsive. The decedent was proclaimed dead, and according to the coroner, the cause was “probable asphyxia in the setting of co-sleeping and soft bedding.”
Plaintiffs alleged that the tragic death of their infant was caused by the BNL. Plaintiffs’ purported expert witness, Dr. Erin Mannen opined that “the design of the Boppy Newborn Lounger resulted in a dangerous biomechanical position that explains the death of [D.B.].” Dr. Ian Noy, also retained by the Plaintiffs, opined that the BNL’s warnings were inadequate.
Boppy filed motions to exclude the opinions provided by Erin Mannen and Ian Noy.
Human Factors Expert Witness
Ian Noy has a Ph.D. and M.S. in industrial engineering from the University of Toronto. He is a distinguished human factors and ergonomics consultant and forensic expert with extensive background in innovative and
applied safety research, industrial engineering, behavioral sciences, and science management.
Mechanical Engineering Expert Witness
Erin M. Mannen earned a Ph.D. in Mechanical Engineering from the University of Kansas in 2014, completed a Postdoctoral Fellowship in the Center for Orthopaedic Biomechanics within the Department of Mechanical and Materials Engineering at the University of Denver in 2017, and has been researching biomechanics for over 14 years.
She is currently employed full-time as an assistant professor in the Mechanical and Biomedical Engineering Department at Boise State University in Boise, Idaho.
Discussion by the Court
Noy’s Report
Boppy has moved to exclude the report of Plaintiffs’ expert witness, Ian Noy. Most of Boppy’s challenges do not relate to Noy’s qualifications or the relevance of his opinions, but rather, the reliability of his methodology. Specifically, Boppy takes issue with the following: (1) his failure to supply an alternative warning; (2) his reliance on the American National Standard Institute’s (“ANSI”) safety standards; (3) his failure to consider evidence regarding Clark’s refusal to follow the BNL’s warnings; and (4) his opinions about the design of the BNL.
His failure to supply an alternative warning
Boppy argued that an expert testifying on the inadequacy of a product’s warning is required to draft an adequate alternative warning. In the absence of a proposed alternative, Boppy argued, Noy’s opinions are unreliable.
Here, Noy was made personally aware of the label’s content through examining the BNL at issue. After examining the BNL and consulting a myriad of other materials, Noy highlighted alleged design deficiencies in the BNL’s safety alert signs on the product and its carrying case.
Noy appeared to suggest that, for example, the alternative proposed warning would include a safety label with no busy background, the font would be larger, there would be a distinction made between suffocation hazard and positional asphyxia hazard, there would be a description provided as to the nature and severity of hazards, and there would be a more effective message prohibiting “chin-on-chest” and providing contrasting symbols for “chin-on-chest” and “chin-off-chest” positions.
The Court found that “it would be simplistic to view [Noy’s] failure to ‘draft’ an alternative warning as being fatal to his opinion,” in light of the reasoning gleaned from his report and his expertise in human factors engineering.
His reliance on the American National Standard Institute’s (“ANSI”) safety standards
Boppy also challenged Noy’s reliance on standards from the American National Standards Institute (“ANSI”). According to Boppy, there is no ANSI standard that applies to the BNL or any baby lounging products.
It is noteworthy that Noy’s report summarizes ANSI Z535’s key requirements, and uses those requirements to outline the deficiencies in BNL’s warning label. According to the Court, this is not a situation where an expert is attempting to substitute scientific methodology for their personal observations.
Boppy also challenged Noy’s reliance on ANSI standards as a substitute for user testing.
The Court held that Noy’s opinions are not unreliable just because his report offered a comparative analysis based on ANSI standards, rather than results from user testing on the BNL’s warnings. While having expert testimony on this point would certainly aid Plaintiffs in proving causation, it is not essential for Daubert purposes.
His failure to consider evidence regarding Clark’s refusal to follow the BNL’s warnings
Boppy argued that Noy’s opinion is unreliable because he failed to consider evidence regarding Clark’s failure to follow the BNL’s warnings. The Court is unconvinced. In his deposition, Noy stated that Clark’s deposition was made available to him when he generated his expert report. Additionally, Noy confirmed that he knew Clark did not read the BNL’s labels.
His opinions about the design of the BNL
Boppy contended that Noy’s “report is littered with statements” that offer opinions about the BNL’s design, a topic which Noy is not qualified to speak on.
Boppy specifically takes issue with Noy’s statements about the hazard control hierarchy. According to Noy, the hazard control hierarchy is “a widely accepted process for eliminating or mitigating hazards through prioritized intervention strategies.”
As a human factors expert, the Court held that Noy can incorporate the hazard control hierarchy, a theory “[d]eveloped within the fields of safety and human factors,” into his expert report. Moreover, Noy can acknowledge that, for example, Boppy did not explore design alternatives and that Boppy did not conduct studies to inform safe product design, without opining on the biomechanical or related mechanism design defects in the BNL.
Mannen’s Report
Boppy filed a motion to exclude Erin Mannen’s expert report, which relates to the alleged design defects of the BNL. Boppy argued that Mannen (1) failed to consider the material facts of this case, (2) her opinions violate Rule 26, (3) she is not qualified to opine on cause of death, and (4) her opinion fails to account for alternative causes.
She failed to consider the material facts of this case
According to Boppy, Mannen failed to consider the facts and circumstances surrounding D.B.’s death. It is true that Mannen did not review Clark’s deposition before writing her report. Mannen did, however, consider Plaintiff’s Complaint, the autopsy report, photos of the reenactment of the incident, and the coroners file which contained the Howard County Police report.
Mannen explained that even taking into consideration the unsafe sleeping practices exercised by Clark, the BNL’s defective design was a substantial factor in D.B.’s death.
Boppy also takes issue with Mannen’s report being premised on an infant’s “ideal body position” in the product, when here, D.B. was placed on her side. When confronted with this discrepancy, Mannen explained that she “understand[s] that there was a blanket, and . . . that the baby was partially on her side, but that [did not] change the fact that even in an ideal body position, [she had] identified all these hazards in the [BNL].”
Mannen believes that there are inherent hazards in the BNL’s design, even if there is no misuse of the product or unsafe sleeping practices employed. The Court held that Mannen’s opinions are not deprived of a sound factual basis just because her opinion hones the BNL’s alleged inherent design flaws.
Her Opinions Violate Rule 26
According to Boppy, Mannen’s report should be excluded under Rule 26 because she has not shared information about the underlying incidents, products, and manufacturers included in the 2019 and 2022 U.S. Consumer Product Safety Commission (“CPSC”) studies her report relies on. In her report, Mannen concluded that, “[b]ecause of the similarities in the designs of inclined sleep products and the Boppy Newborn Lounger Pillow products . . . the concepts from our published in vivo biomechanics studies can be applied to the Boppy Newborn Lounger Pillow.” This is problematic, Boppy argued, because Mannen has refused to disclose the products involved in the studies. With the products left unidentified, Boppy states that it is “left to simply take her word for it,” that the unidentified products are similar to the BNL.
While Mannen cannot disclose the “incidents, products, and manufacturers” in her previous studies, the 2022 CPSC study provides photos of the sample pillows that were studied, and descriptions of the sample pillows, including their shape, mass, overall diameter or height and length, tube circumference or width, and thickness, as well as their cover and filler material. Albeit the 2019 CPSC study does not similarly provide photos of the fourteen inclined sleep products that were evaluated. However, Mannen’s report summarizes the sample measurements and characteristics of the products.
Thus, Boppy is not simply left to take Mannen’s word for it—Boppy has within its possession sufficient information to challenge Mannen’s assertion that the sample products are functionally similar to the BNL. The Court held that Boppy can surely critique Mannen’s opinions and attempt to distinguish the sample products tested in the 2019 and 2022 studies from the BNL on cross-examination. But exclusion of her testimony under Rule 26(a) is not appropriate in this case.
She is not qualified to opine on cause of death
Boppy also contended that Mannen’s report offers an opinion on D.B.’s cause of death.
Boppy asserts that by stating that “the design of the Newborn Lounger Pillow resulted in a dangerous biomechanical position that is capable of causing suffocation and/or positional asphyxia, like in the death of [D.B.],” Mannen impliedly offered a medical causation opinion.
As a biomechanical expert, the Court held that Mannen can attest to the design deficiencies in the BNL she believes contributed to D.B. rolling and suffocating.
Her opinion fails to account for alternative causes
Boppy expressed its dissatisfaction with Mannen’s failure to consider alternative causes—namely, the blanket, the side-lying, co-sleeping, and misuse of the BNL on the couch. In her rebuttal report, Mannen addressed the foregoing biomechanical problems that Boppy’s expert states played a role in D.B.’s death and offers her dissent.
These alleged contributors to D.B.’s ultimate suffocation certainly may prove problematic for Plaintiffs. That said, the Court held that Boppy can press Mannen on the extent to which these alleged biomechanical problems contributed to D.B.’s movement and ultimate suffocation at trial.
Held
- The Court denied Plaintiffs’ motion to exclude the opinions provided by Dr. Ian Noy.
- The Court denied Plaintiffs’ motion to exclude the opinions provided by Dr. Erin Mannen.
Key Takeaway:
The Daubert inquiry is a flexible one. Where, as here, an expert’s qualifications are clear and their methodology is sound, “helpful, legitimate expert testimony reaches the jury.”
Boppy’s qualms with Noy and Mannen’s opinion will no doubt be addressed on cross-examination.
Case Details:
| Case Caption: | Clark Et Al V. The Boppy Company, Llc Et Al |
| Docket Number: | 1:22cv2120 |
| Court: | United States District Court, Indiana Southern |
| Order Date: | November 06, 2024 |
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