# Tanessa Desranleau, V. Hylands, Inc.

> Court of Appeals of Washington · April 17, 2023

URL: https://www.frixlaw.com/law-library/cases/9898003

## Case

- **Court:** Court of Appeals of Washington
- **Decided:** April 17, 2023
- **Precedential status:** Published
- **Opinion:** Opinion
- **Cited by:** 0 later opinions in the Frix Law Library

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## How later opinions describe it (automated extraction)

- applying de novo standard to review grant of motion in limine to strike experts and grant of summary judgment

## Opinion text

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IN THE COURT OF APPEALS OF THE STATE OF WASHINGTON

TANESSA DESRANLEAU, individually
and as the Personal Representative of No. 82213-6-I
the ESTATE of JAY’BREON
DESRANLEAU, DIVISION ONE

Appellant, PUBLISHED OPINION

v.

HYLAND’S, INC., STANDARD
HOMEPATHIC LABORATORIES,
INC., and STANDARD HOMEPATHIC
COMPANY,

Respondents,

MICHELE REID,

Defendant.

CHUNG, J. — In 2014, 13-month-old Jay’Breon Bush Desranleau tragically

died in his crib. In the days before his death, Jay’Breon 1 had a cold, and his

caregiver gave him several medications, including “Hyland’s Baby Tiny Cold

Tablets,” a homeopathic cold remedy manufactured by Hyland’s, Inc.

Jay’Breon’s mother, Tanessa Desranleau, sued Hyland’s, claiming that an

ingredient in the cold tablets, Gelsemium sempervirens (GS), caused his death.

Hyland’s moved for summary judgment. Applying Frye v. United States, 293 F.

1
For clarity, we refer to Jay’Breon by his first name. We intend no disrespect.
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No. 82213-6-I/2

1013 (D.C. Cir. 1923), ER 702, and ER 703, the trial court excluded the opinion

of Desranleau’s expert, Dr. Marvin Pietruszka, who opined that the Hyland’s

tablets consumed by Jay’Breon more likely than not, and with a reasonable

degree of medical certainty, caused his death. The court then dismissed

Desranleau’s lawsuit on summary judgment. Desranleau appeals. For the

reasons below, we reverse and remand.

FACTS

On the morning of January 19, 2014, Michelle Reid found 13-month-old

Jay’Breon lying on his stomach and unresponsive in his crib. 2 He had passed

away.

Law enforcement officers and a medical examiner investigated the matter.

Reid had been taking care of Jay’Breon. She told the officers that, in the days

before his death, Jay’Breon had a cold. Reid treated the child with “Hyland’s

Baby Tiny Cold Tablets,” a homeopathic cold remedy manufactured by Hyland’s,

Children’s Tylenol, and Baby Vicks Vapor Rub.

The medical examiner who conducted the autopsy, Dr. Richard Harruff,

noted that Jay’Breon’s lungs were congested. He determined,
The cause of death of this 13 month old male is not explained by
postmortem examination. There are no natural disease or injuries
detected that could have contributed to or caused death. However

2
Hyland’s briefing on appeal discusses Jay’Breon’s living conditions and
caretaking, apparently seeking to cast them in a negative light. It claims it did so
because this information was relevant to “whether there could be a cause of death that
has not been ruled out.” But the central issue in this appeal is whether the trial court
properly excluded Dr. Pietruszka’s opinion. Hyland’s statements do not advance the
analysis of that issue.
2
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No. 82213-6-I/3

the circumstances surrounding death are not well explained. He was
apparently found with his head covered by a comforter and blanket.
Because external factors contributing to his death cannot be
excluded, the cause and manner of death are classified [as]
undetermined.

Jay’Breon’s mother, Desranleau, sued Hyland’s, asserting claims under

the Washington Product Liability Act 3 (WPLA) and the Consumer Protection Act, 4

and requesting punitive damages under California law. Desranleau alleged that

GS, a “medicinal herb” listed on the packaging as an ingredient in the cold

tablets, caused Jay’Breon’s death. 5

A. Prior summary judgment and appeal

Hyland’s moved for summary judgment, arguing Desranleau provided no

admissible evidence that Hyland’s Cold Tablets caused Jay’Breon’s death. See

Desranleau v. Hyland’s, Inc., 10 Wn. App. 2d 837, 841-42, 450 P.3d 1203

(2019). In response, Desranleau submitted an opinion from Dr. Pietruszka, who

declared, “Based upon the available information, I have been able to determine,

more likely than not and with a reasonable degree of medical certainty, that the

ingredients in the Hyland’s product that were consumed by Jay’Breon caused his

untimely death.” The trial court did not rule on the admissibility of Dr. Pietruszka’s

opinion. Id. at 846.

3
Ch. 7.72 RCW.
4
Ch. 19.86 RCW.
5
The background facts are more fully set out in this court’s prior opinion upon
review of the trial court’s previous summary judgment dismissal of Desranleau’s claims.
See Desranleau v. Hyland’s, Inc., 10 Wn. App. 2d 837, 839-42, 450 P.3d 1203 (2019).
3
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No. 82213-6-I/4

Desranleau also submitted Reid’s statements to responding law

enforcement officers that she gave Jay’Breon the cold tablets. Id. at 843. The trial

court excluded Reid’s statements as hearsay. Id. at 843. Concluding that there

was no admissible evidence that Jay’Breon ingested the Hyland’s tablets, the

trial court dismissed the claims on summary judgment. Id. at 842, 846.

Desranleau appealed. Id. at 842.

On appeal, we agreed that Reid’s statements to the officers about

administering cold tablets were inadmissible. Id. at 845. But we concluded that,

after viewing all reasonable inferences—Jay’Breon’s cold, Dr. Harruff’s report

describing Jay’Breon’s lung congestion, and the medication recovered from the

scene by responding law enforcement officers—a material question of fact

existed as to whether Jay’Breon ingested the cold tablets. Id. at 845. We also

concluded that we should not disregard Dr. Pietruszka’s then opinions based on

the arguments presented by Hyland’s at that stage. Id. at 846-47. We thus

reversed the dismissal of Desranleau’s claims under the WPLA and affirmed the

summary dismissal of her other claims. Id. at 849.

B. Expert testimony after remand

On remand, Hyland’s deposed Dr. Pietruszka. He testified that he is a

pathologist, and in this case, his focus was to use his knowledge of toxicology to

help explain Jay’Breon’s death. He identified three main topics that his opinions

addressed: toxicity of GS, a differential diagnosis of the cause of death, and

analysis of the “Bradford Hill” criteria to determine cause of death.
4
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No. 82213-6-I/5

1. Toxicity of GS

Pietruszka testified that “[GS] is a toxic chemical. It’s identified as a

poison.” Therefore, “this chemical substance should not have been incorporated

into a homeopathic medication that is prescribed to anyone, but most certainly to

infants.” He said that “nanoparticles of [GS]” contain strychnine-type chemicals

and injure cell function, and “even minute quantities [of GS] would have been

potentially fatal.” He acknowledged, “There are very few research studies that

exist for herbal medicines, especially [GS] because it’s a toxic substance, and

especially studies that involve humans don’t exist.” Thus, Dr. Pietruszka stated, “I

don’t think anyone actually knows what the toxic and lethal dose is of [GS].”

Despite the lack of available information about a dose response, asked

about whether any literature provide a specific unit of measurement at which GS

becomes lethal, Dr. Pietruszka said “[t]hose measurements play no role in this

case.” Instead, he relied on “the relationship between the science that we know

about [GS], its relationship to strychnine, and its effect on the nervous system

from the literature” to “explain what happened to this child.” The literature

“confirms the direct toxicity of [GS] on the central nervous system. . . . Even small

doses can affect respiration. Larger doses can cause paralysis of the respiratory

center.” Dr. Pietruszka relied on articles that stated that “nanoparticle toxicity

occurs . . . in [GS] administration and [GS] actually can affect the internal

organelles of the cell and thereby cause toxicity.” He testified, “[W]hen you put a

5
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No. 82213-6-I/6

tablet [containing GS] in the mouth, it can readily pass through cell membranes

and go right to the brain, which is probably 80-90 percent lipid, fat.”

Dr. Pietruszka also explained,
However, more recently, with a greater understanding of the
effects of nanoparticles on the human body and the use of
nanoparticles in various treatments, it becomes clear that
homoeopathy [sic], the concept of homeopathy and the mechanism
by which homeopathy works, deals essentially with the ability of
nanoparticles, very small particles of, in this case, a toxic substance
to enter into the system and to affect an adverse occurrence on cell
structures—on cell structures.
So in this case what my understanding is—if I want to get to
the real basic what happened, is you have—an infant is administered
at least eight tablets a day of [GS], [GS] contained within tablets. The
exact concentration of that [GS] is not known. There is some
concern about the manufacturing process. We don’t know if the
chemicals in those tablets are evenly distributed through all the
tablets or whether some have higher concentration than others.
Nevertheless, even small concentrations of [GS] are
described in the literature as potentially toxic.

In Dr. Pietruszka’s opinion, “In reviewing the literature, [GS is] not

recommended for use, or if it is recommended to be used, it is recommended to

be used with extreme caution.” He referenced medical articles that advised not to

give GS to children, as “[i]t could poison them, even a very small amount.” In his

opinion, GS “should not have been incorporated into a homeopathic medication

that is prescribed to anyone, but most certainly to infants.”

2. Differential diagnosis of cause of death

Dr. Pietruszka testified that he “performed an extensive differential

diagnosis of cause of death.” He stated,

6
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No. 82213-6-I/7

I have reviewed the autopsy [and] I did not find any aspects of the
autopsy to identify any medical condition that could have caused
this baby’s death. I believe that the biochemical nature of [GS] in
the setting in which it has been dispensed can readily explain how
and why this baby died when he died.

Based on his review of Jay’Breon’s autopsy report and toxicological literature,

and using the differential diagnosis method of ruling out other possible causes of

death, he opined, “[T]here are no inherent medical conditions that would have

caused this child to die suddenly.”

Dr. Pietruszka characterized the case as one of “toxic encephalopathy.

This baby suffered direct toxicity to the human brain, causing death. . . . [T]his is

the effect of the neurotoxin.” The pathologist who conducted the autopsy

observed cerebral edema, which Dr. Pietruszka stated was “one of the findings

that you find in toxic encephalopathy.” He also opined that “because the drug is

so toxic, because the therapeutic window is so narrow, which means that the

margin between therapeutic efficacy and toxicity is so small that death can occur

immediately . . . [and t]here’s not even enough time for very many changes to be

visualized, to be identified.”

Dr. Pietruszka determined other possible causes of death could be ruled

out. The child did not die of deprivation of oxygen because hypoxia causes red

neurons, and red neurons were not observed. He ruled out suffocation by

blankets because it occurs more commonly in younger infants who “are placed in

one position and don’t move very far,” whereas infants of 13 months of age can

change their position. Also, children who suffer from asphyxia frequently have

7
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No. 82213-6-I/8

petechial hemorrhages and abrasions of the nose that Jay’Breon did not have.

Ultimately, after reviewing the autopsy report and based on his experience as a

clinician and pathologist, Dr. Pietruszka stated,

I can’t find anything else . . . no suffocation, no entrapment, no
infection, no other metabolic disease. They checked every
metabolic disease they can think of. There’s nothing going on with
the heart. There’s nothing going on with the intestines.

Thus, he concluded that there was nothing in that autopsy to explain the cause of

death “except for the administration of a toxic chemical . . . that get[s] absorbed

right away, and it is the [sic] going to the base of the brain.”

Further, even though it had been approximately nine hours from the last

administration of the Hyland’s tablet and when Jay’Breon was found deceased,

“the repeated administration of a toxic drug that has a predilection for fatty tissue

to me suggests that [the drug] would be there for a prolonged period of time.”

Although Dr. Pietruszka said he did not know the amount of GS Jay’Breon

ingested, or the amount of GS necessary to be lethal, he testified, “[W]e don’t

have any other reasonable cause of death.”

3. Analysis of Bradford Hill criteria for causation of death

Dr. Pietruszka applied the Bradford Hill criteria for causation, a

“methodology of determining causation . . . characteristically used in medical

cases” that involves analyzing nine criteria. Dr. Pietruszka testified that the

Bradford Hill analysis was generally accepted in the medical field and described

his analysis of each of these criteria.

8
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No. 82213-6-I/9

As to the first criterion, he concluded the strength of association of GS to

causing a toxic effect, based on literature, was a strong association. Regarding

the second criterion, dose response, his opinion was a strong dose was not

needed, and “even a dose in the nano level can be significant.” As to the third

criterion, consistency of findings by different researchers, he found that the

literature was consistent that GS is a poison.

Dr. Pietruszka also analyzed the fourth criterion, determining there was

biological plausibility, and the fifth criterion, temporal causation, a direct

association between the time of administration of the toxic substance and the

death. On the sixth criterion, whether he controlled for confounding factors or

bias, Dr. Pietruszka determined the autopsy helped eliminate other reasonable

causes of sudden death.

As to specificity, the seventh criterion, he opined that the exposure caused

specific results, that the baby stopped breathing, in line with the symptoms of GS

poisoning. He determined that the eighth criteria, coherence, was also satisfied.

Finally, as to the ninth criteria, analogy, Dr. Pietruszka looked to another

Hyland’s product, a teething drug that contained belladonna that caused death of

babies, as well as COVID infection that “gets into the nose” and “causes brain

symptoms, and it affects the nervous system.”

Dr. Pietruszka noted that while one or two points could be argued, the

Bradford Hill did not require all nine criteria; a majority was sufficient to establish

causation. Applying this methodology, Dr. Pietruszka concluded to a reasonable
9
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No. 82213-6-I/10

degree of medical certainty that causation for the death was “the administration

of [GS].”

C. Trial court’s ruling on Hyland’s motion to exclude Dr. Pietruszka and
motion for summary judgment

Hyland’s moved to exclude Dr. Pietruszka as an expert witness on two

separate grounds: (1) his opinions “violate Frye as unreliable and not generally

accepted in the medical community,” and (2) his opinions “lack foundation, are

speculative, and rely on baseless assumptions, rendering them unhelpful” under

ER 702 and ER 703. Hyland’s also moved for summary judgment dismissal of

Desranleau’s WPLA claim.

The trial court delivered an oral ruling at the hearing. It explained,
[T]here’s certainly evidence in the record from which an inference
could be drawn that [GS] is present. It’s listed as an ingredient on
the product sol[d]. However, that information may be rebutted by the
hard data referred to in Dr. Phil[l]ip’s[6] declaration testimony of April
2018.
And—but I don’t need to reach that, I think, here. The—the
evidence clearly established—and I don’t think there’s any dispute—

6
Defense expert Dr. Scott Phillips declared,
[GS] is included in Hyland’s Tiny Cold Tablets at 6X. This means
that the tincture from which the [GS] is incorporated into Tiny Cold
Tablets goes through [six] dilution steps prior to being incorporated into
Hyland’s Tiny Cold Tablets.
...
Accordingly, the level at which [GS] is included in Hyland’s Tiny
Cold Tablets is 0.0015 ppm to 0.0080 ppm, or 1.5 ppb to 8 ppb. To be
clear, this is an extraordinarily miniscule amount. At this level of dilution,
strychnine (which is a highly toxic alkaloid) would not be harmful. Further
yet, at this level of dilution, no one would even experience symptoms of
exposure to strychnine. Additionally, testing performed by Hyland’s on
finished Tiny Cold Tablets demonstrates that [GS] could not even be
detected at 8 parts per billion (ppb). . . . Thus, after the product has been
completed, [GS] cannot even be detected in Hyland’s Tiny Cold Tablets.
...
10
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No. 82213-6-I/11

that, if it is present, it’s present at undetectable levels. And there is
no support part [sic] scientific theory that a—that GS present at
undetectable levels could be lethal.

The trial court excluded Dr. Pietruszka’s opinion under Frye, determining it was

not based on “science but on supposition and speculation.” In its oral ruling, the

trial court also excluded Dr. Pietruszka’s opinion under ER 702 because it lacked

foundation. It said that Dr. Pietruszka is “not able to cite to any other expert or

any published, peer-reviewed study or even—even a comparable compound that

would support his theory here.” In its written ruling, the trial court stated,

“Dr. Pietruszka’s opinions fail to satisfy the requirements of ER 702 and ER 703.”

As a result, determining that there was no evidence of causation, the trial court

dismissed the WPLA claim on summary judgment. Desranleau filed a motion for

reconsideration, 7 which the court denied.

Because the level at which [GS] is included in Hyland’s Tiny Cold
Tablets is so miniscule, substantial variations in that level, even assuming
there is any variation, could not realistically result in any risk of harm.
7
Along with the motion for reconsideration, Desranleau submitted approximately
400 pages of documents for the first time, which the trial court declined to consider.
Desranleau also included an appendix to her opening brief on appeal, which includes
some of the same articles about GS and GS poisoning submitted below on
reconsideration. Hyland’s contends, and Desranleau does not dispute, that we should
not consider the appendix. We agree. “On review of an order granting or denying a
motion for summary judgment the appellate court will consider only evidence and issues
called to the attention of the trial court.” RAP 9.12. We consider only the appendices that
were in the record and available to the trial court before Desranleau’s motion for
reconsideration. And because Desranleau presents no argument on the order denying
reconsideration, we do not review that decision.
11
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No. 82213-6-I/12

Desranleau appeals the trial court’s orders excluding Dr. Pietruszka as an

expert, granting summary judgment, denying reconsideration, 8 and denying

sanctions against counsel for Hyland’s. 9

ANALYSIS

Desranleau contends the trial court erred in excluding Dr. Pietruszka’s

opinion and in granting Hyland’s summary judgment motion. 10 We address each

argument in turn.

I. Exclusion of Dr. Pietruszka’s Opinion

In Washington, expert testimony must satisfy Frye and ER 702. Lakey v.

Puget Sound Energy, Inc., 176 Wn.2d 909, 918, 296 P.3d 860 (2013). “Frye and

8
Desranleau filed a supplemental notice of appeal, appealing the order denying
reconsideration. But on appeal, she offers no argument on the issue. Thus, we do not
address the claim. See Prostov v. Dep’t of Licensing, 186 Wn. App. 795, 823, 349 P.3d
874 (2015) (“A party abandons assignments of error unsupported by argument and will
not be considered on appeal.”).
9
After Desranleau moved for reconsideration, Hyland’s moved for CR 11
sanctions against Desranleau’s counsel. Then, Desranleau moved for CR 11 sanctions
against counsel for Hyland’s, which the trial court denied. The record does not include
the trial court’s ruling on the CR 11 motion against Desranleau’s counsel, which is not at
issue here.
In a supplemental notice of appeal, Desranleau appeals the trial court’s denial of
her motion for CR 11 sanctions against counsel for Hyland’s. However, because she
does not assign error to the trial court’s ruling and does not support her argument for
sanctions with citation to legal authority, we do not consider it. RAP 10.3(g) (“The
appellate court will only review a claimed error which is included in an assignment of
error or clearly disclosed in the associated issue pertaining thereto.”); RAP 10.3(a)(6);
Norcon Builders, LLC v. GMP Homes VG, LLC, 161 Wn. App. 474, 486, 254 P.3d 835
(2011) (holding that appellate courts will not consider arguments unsupported by
authority).
Also, on appeal, Desranleau “preemptively moves for sanctions under [CR] 11”
for any improper conduct on appeal. But she does not support her argument with citation
to legal authority showing that this court may provide such relief, so we do not consider
it. See RAP 10.3(a)(6); Norcon Builders, LLC, 161 Wn. App. at 486.

12
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No. 82213-6-I/13

ER 702 work together to regulate expert testimony: Frye excludes testimony

based on novel scientific methodology until a scientific consensus decides the

methodology is reliable; ER 702 excludes testimony when the expert fails to

adhere to that reliable methodology.” Id. at 918-19.

While we typically review decisions to exclude expert testimony for abuse

of discretion, we review de novo a trial court’s evidentiary ruling made in

conjunction with a summary judgment ruling. 11 Frausto v. Yakima HMA, LLC, 188

Wn.2d 227, 231, 393 P.3d 776 (2017) (de novo standard applies to evidentiary

ruling made in conjunction with summary judgment motions); Watness v. Seattle,

16 Wn. App. 2d 297, 305, 481 P.3d 570 (2021) (same). We also review a trial

court’s Frye ruling de novo. Id. at 305. “Our de novo review of admissibility of

scientific theory or methodology under Frye need not be confined to the record

and may involve consideration of the available scientific literature, secondary

legal authority, and cases in other jurisdictions.” Ruff v. Dep’t of Labor & Indus.,

107 Wn. App. 289, 300, 28 P.3d 1 (2001), overruled on other grounds by

Anderson v. Akzo Nobel Coatings, Inc., 172 Wn.2d 593, 260 P.3d 857 (2011);

see also State v. Copeland, 130 Wn.2d 244, 255-56, 922 P.2d 1304 (1996)

11
Hyland’s attempts to draw a distinction based on the fact that in the cases
Desranleau cited, the court was asked to strike parts of a declaration submitted in
summary judgment proceedings, whereas here, Hyland’s filed a motion to exclude an
expert witness. This is a distinction without significance when, as here, the evidence is
being considered for summary judgment purposes. See, e.g., Anderson v. Akzo Nobel
Coatings, Inc., 172 Wn.2d 592, 600, 260 P.3d 857 (2011) (applying de novo standard to
review grant of motion in limine to strike experts and grant of summary judgment).
13
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No. 82213-6-I/14

(review may extend beyond record, noting impracticality of true cross-section of

scientists testifying at a hearing).

1. Frye analysis

A Frye analysis seeks to determine “whether the evidence offered is

based on established scientific methodology.” Anderson, 172 Wn.2d at 603

(quoting State v. Gregory, 158 Wn.2d 759, 829, 147 P.3d 1201 (2006)). The Frye

test is implicated only where the opinion offered is based on novel science.

Anderson, 172 Wn.2d at 611. In making a Frye determination, the trial court

considers “(1) whether the underlying theory is generally accepted in the

scientific community and (2) whether there are techniques, experiments, or

studies utilizing that theory which are capable of producing reliable results and

are generally accepted in the scientific community.” Id. (quoting State v. Riker,

123 Wn.2d 351, 359, 869 P.2d 43 (1994)).

However, the Frye rule should not be confused with the “reasonably relied

upon” language in Rule 703:

The Frye rule relates to the expert’s scientific principles and
techniques. By contrast, Rule 703 relates to the factual information
relied upon by the expert, i.e., to the factual basis for the expert’s
opinion.

5B KARL B. TEGLAND, WASHINGTON PRACTICE: EVIDENCE LAW AND PRACTICE

§ 702.19, at 84 (6th ed. 2016).

Desranleau contends the trial court should not have conducted a Frye

analysis because the theory of GS toxicity is not novel, citing Anderson. Id. at

14
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No. 82213-6-I/15

612 (“The Frye test is implicated only where the opinion offered is based upon

novel science.”). In the alternative, Desranleau asserts that if the trial court did

not err by conducting a Frye analysis, its inquiry should have focused on the

second prong, whether Dr. Pietruszka’s testimony adhered to an accepted

methodology, rather than on his causation theory. Because the trial court

determined that the scientific community does not generally accept Dr.

Pietruszka’s theory, it did not address the second prong of the Frye analysis.

Hyland’s argues that the trial court properly excluded Dr. Pietruszka’s

testimony under Frye because “Dr. Pietruszka’s causation theory fails both steps

of the Frye analysis.” Specifically, Hyland’s challenges Dr. Pietruszka’s

“causation theory” for failing to provide analysis regarding Jay’Breon’s

metabolism, weight, or dose, or any form of quantitative analysis; the level of GS

in Hyland’s products; and because “he is unaware of chemicals that are lethal in

undetectable nanoparticles.” Thus, Hyland’s argues, because so little is known

about GS and its toxicity, under the second component of the Frye test, no

testing or analysis could possibly disprove the causation theory, so the opinion

should be excluded on that basis as well.

We agree with Desranleau that exclusion of Dr. Pietruszka’s testimony

under Frye was error. As the Supreme Court in Anderson held, “This court has

consistently found that if the science and methods are widely accepted in the

relevant scientific community, the evidence is admissible under Frye, without

separately requiring widespread acceptance of the plaintiff’s theory of causation.”
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No. 82213-6-I/16

172 Wn.2d at 609. Moreover, “[a]n expert opinion regarding application of an

accepted theory or methodology to a particular medical condition does not

implicate Frye.” 12 Reese v. Stroh, 128 Wn.2d 300, 307, 907 P.2d 282 (1995).

These principles apply to the situation here.

As described above, Dr. Pietruszka’s theory of causation rested on three

opinions, including that based on his review of the scientific literature, GS is toxic.

Rather than contest this basic premise, Hyland’s suggests that there had to be

generally accepted theories as to what was a lethal dose of GS before Dr.

Pietruszka could opine on causation. Hyland’s complains that Dr. Pietruszka did

not calculate, test, or cite studies testing the lethality of undetectable quantities of

GS. But as Dr. Pietruszka explained, there are no studies regarding specific

doses that are lethal for humans because GS is a toxic substance. Dr. Pietruszka

also testified that no test could accurately quantify how much GS would be lethal,

so testing Jay’Breon’s tissue postmortem for GS would provide inaccurate

information.

The Supreme Court rejected reasoning similar to that of Hyland’s in Reese

v. Stroh, 128 Wn.2d 300. There, plaintiff had a condition, AAT deficiency, for

which the FDA had approved therapy using a drug called Prolastin. Id. at 302-03.

The plaintiff filed suit against his doctor, claiming his failure to prescribe Prolastin

12
“A Frye objection goes to the expert’s underlying theory and methods of
analysis, not to the conclusion reached by the expert. The issue is whether the expert’s
methodology is generally accepted as being capable of producing an accurate result, not
whether the expert employed the methodology correctly.” 5B TEGLAND, supra, § 702.19,
at 84.
16
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No. 82213-6-I/17

resulted in worsening lung function. Id. at 303. Plaintiff’s expert opined that

Prolastin therapy would have been effective for the plaintiff, but the trial court

excluded the opinion because there had been no statistically significant studies

proving the efficacy of this therapy for AAT deficiency. Id. at 304-05. The Reese

court held the trial court’s exclusion of the expert opinion under Frye was

improper because the uncontroverted testimony was that the FDA approved the

use for this condition. Id. at 307. Frye was not implicated; rather, the court

assessed the admissibility of the causation opinion under ER 702 and 703’s

general reliability standards. Id. at 308.

Similarly, here, as with the theory that Prolastin could be prescribed for

AAT deficiency, Hyland’s does not dispute the basic theory that GS is toxic. Dr.

Pietruszka’s opinion in that regard does not require a Frye analysis. “The

reasonableness of the factual basis for an expert’s opinion is governed by Rule

703,” not Frye. 5B TEGLAND, supra, § 702.24, at 110.

Further, Dr. Pietruszka reached his opinion on causation by applying

widely used methodologies for determining medical causation, the process of

differential diagnosis and consideration of Bradford Hill criteria. “Many medical

opinions on causation are based upon differential diagnoses.” Anderson, 172

Wn.2d at 610; see also In re Morris, 189 Wn. App. 484, 494-95, 355 P.3d 355

(2015) (the differential diagnosis methodology is a “well-recognized and reliable”

methodology for ascertaining causation and satisfies the Frye standard). A

physician “may base a conclusion about causation through a process of ruling
17
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No. 82213-6-I/18

out potential causes with due consideration to temporal factors, such as events

and the onset of symptoms.” Id.

Further, Dr. Pietruszka’s opinion that ingesting a substance known to be

toxic caused death is an opinion about causation, which, Anderson instructs, is

not the proper focus for a Frye analysis. See Anderson, 172 Wn.2d at 609. Nor

will we deem every subset of information on which a causation opinion is based,

such as at what dose GS is lethal, to be a separate “theory” requiring general

acceptance. 13 The Anderson court rejected this type of “ever more nuanced

argument” that to satisfy Frye, there must be “general acceptance” as to “each

discrete and ever more specific part of an expert opinion.” Id. at 611. Otherwise,

the court reasoned, “virtually all opinions based upon scientific data could be

argued to be within some part of the scientific twilight zone.” Id.

We thus hold that Dr. Pietruszka’s opinion as to causation does not

implicate the Frye test. The issues here are “fully resolvable” under the evidence

rules, without Frye. See Reese, 128 Wn.2d at 308; Anderson, 172 Wn.2d at 611

(Frye is implicated only where the opinion offered is based upon novel science).

13
To the extent Hyland’s relies on its expert Carl Wigren’s opinion that Dr.
Pietruszka could not have relied on “standard autopsy methodology” because Dr.
Pietruszka himself did not perform an autopsy, this argument also does not counsel that
Dr. Pietruszka’s opinion should be subject to a Frye analysis. More properly, this
concern is analyzed under ER 703, which allows experts to base their opinion testimony
on facts or data, even if otherwise inadmissible, if “of a type reasonably relied on by
experts in the field.” We determine that it was proper under ER 703 for Dr. Pietruszka to
rely on the medical examiner’s autopsy report as it is a type of information reasonably
relied upon by medical experts opining on causation. See, e.g., State v. Lui, 153 Wn.
App. 304, 320-21, 221 P.3d 948 (2009) (in analysis of confrontation clause challenge,
noting that expert witness properly applied his own expertise after review of autopsy
report by another).
18
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No. 82213-6-I/19

2. ER 702

Even if evidence does not require a Frye analysis, “[o]f course the

evidence must also meet the other evidentiary requirements of competency,

relevancy, reliability, helpfulness, and probability.” Anderson, 172 Wn.2d at 609.

Desranleau argues the court erred in excluding the expert testimony and

“commingled” the Frye and ER 702 analyses. 14 Hyland’s contends the trial court

properly excluded Dr. Pietruszka’s testimony because he relied only on the

“possibility of stratification coupled with the potential for [GS] to be toxic in high

doses,” based on this court’s prior opinion in this case. 15 Also, Hyland’s contends

that Dr. Pietruszka did not know either the specific dose of GS that Jay’Breon

was exposed to, nor the amount of GS in Hyland’s Tablets. On de novo review,

we hold that Dr. Pietruszka’s testimony should not have been excluded, as it is

based on facts, not speculation, and will assist the trier of fact. 16

ER 702 provides, “If scientific, technical, or other specialized knowledge

will assist the trier of fact to understand the evidence or to determine a fact in

14
We note that the trial court in fact did explain, “Dr. Pietruszka’s opinions lack
foundation, are unreliable, and would invite the jury to engage in speculation.
Accordingly, Dr. Pietruszka’s opinions fail to satisfy the requirements of ER 702 and ER
703,” and incorporated by reference its oral ruling that further explained its reasoning.
Meanwhile, even as it complains about the trial court’s deficiencies, Desranleau’s own
briefing commingles arguments and provides very little specific argument on ER 702 and
none on ER 703. Because we review the trial court’s ruling de novo, its brevity is of no
moment. On the other hand, inadequate briefing to this court does a disservice to the
client, as the court may decline to consider a party’s arguments as a result.
15
Br. of Resp’t at 27-28 (citing Desranleau, 10 Wn. App. 2d at 841).
16
Although the court below excluded the expert in part based on ER 703,
Desranleau’s briefing on appeal includes no separate ER 703 argument, and Hyland’s
argument is limited to a reference in a single footnote. Br. of Resp’t at 46 n.14.
Ordinarily, “[p]assing treatment of an issue or lack of reasoned argument is insufficient to
19
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No. 82213-6-I/20

issue, a witness qualified as an expert by knowledge, skill, experience, training,

or education, may testify thereto in the form of an opinion or otherwise.” In

assessing whether expert testimony would assist the trier of fact, the court should

consider “whether the matter about which the expert would testify is beyond

common knowledge and understanding.” 5B TEGLAND, supra, § 702.15, at 69-70.

Further,

The general rule bars testimony only on the aspects of a given
subject that are matters of common understanding and knowledge.
The expert is, of course, allowed to testify as to aspects of the
subject that are beyond common understanding and knowledge.

Id. § 702.16, at 73. “It has been observed that the court ‘will interpret possible

helpfulness to the trier of fact broadly and will favor admissibility in doubtful

cases.’ ” Id. § 702.15, at 70 (citation omitted).

To assist the trier of fact, “[t]he expert’s opinion must be based on fact and

cannot simply be a conclusion or based on an assumption.” Coogan v. Borg-

Warner Morse Tec Inc., 197 Wn.2d 790, 801-02, 490 P.3d 200 (2021) (citations

omitted). When Washington courts have refused to admit expert testimony as

speculative, admission hinged on the expert’s basis for forming the opinion, not

on the expert’s conclusions. Volk v. DeMeerleer, 187 Wn.2d 241, 277, 386 P.3d

254 (2016).

merit judicial consideration.” Palmer v. Jensen, 81 Wn. App. 148, 153, 913 P.2d 413
(1996). However, as Desranleau generally challenged the ruling excluding Dr.
Pietruszka, and the ruling relied on ER 703, we determine that the FDA letters and the
information, including cited literature, in the letter from Wilfred Stock, Ph.D., are of a type
reasonably relied upon by experts. Thus, under ER 703, Dr. Pietruszka’s opinion could
properly rely on them regardless of whether the information is admissible.
20
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No. 82213-6-I/21

Regarding medical causation, “[e]xpert medical testimony must meet the

standard of reasonable medical certainty or reasonable medical probability.”

Anderson v. Akzo Nobel Coatings, Inc., 172 Wn.2d 593, 606–07, 260 P.3d 857

(2011). Such evidence “must rise above speculation, conjecture, or mere

possibility.” Reese, 128 Wn. 2d at 309. If a medical expert opines that “[a] causal

relationship is probable or more likely than not, the quality of the evidence rises

above speculation and conjecture and may be considered by the trier of fact.”

Merriman v. Toothaker, 9 Wn. App. 810, 815, 515 P.2d 509 (1973). See, e.g.,

Carlton v. Vancouver Care LLC, 155 Wn. App. 151, 168-69, 231 P.3d 1241

(2010) (rejecting challenge to rape trauma syndrome diagnosis testimony as not

helpful to the jury because it lacked “precision” as to impact of rape on victim;

experts “may express opinions if they can do so with reasonable medical

certainty”).

Here, Dr. Pietruszka determined “more likely than not and with a

reasonable degree of medical certainty, that the ingredients in the Hyland’s

product that were consumed by Jay’Breon caused his untimely death.” An expert

is “allowed to testify as to aspects of [a] subject that are beyond common

understanding and knowledge.” 5B TEGLAND, supra, § 702.16, at 73. Expert

opinion on cause of death falls within this ambit. Id. § 702.17, at 74.

Dr. Pietruszka provided the factual basis for his opinions both in his initial

declarations and in his deposition testimony. Specifically, he said he did not know

the level of GS in the cold tablets because the Hyland’s manufacturing process
21
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No. 82213-6-I/22

causes a “potential for stratification” of certain chemicals, and “ ‘stratification’ can

result in the tablets within the same product package as having varying levels of

alkaloids.” In support, Dr. Pietruszka cited to publicly available information that

Hyland’s production process for its Teething Tablets was faulty and resulted in

some tablets with unacceptably high levels of a toxic substance, belladonna, 17 as

well as to deposition testimony of a Hyland’s employee, Eric Baier, that the

company uses the same problematic production process both for the teething

tablets and the cold tablets given to Jay’Breon. Despite not knowing the specific

dose Jay’Breon consumed, Dr. Pietruszka provided the factual basis for his

opinion that a toxic amount of GS in Hyland’s cold tablets caused Jay’Breon’s

death.

Because Dr. Pietruszka testified that he did not know whether stratification

actually occurred in the manufacturing of the cold tablets, Hyland’s claims that

his opinion lacks a factual basis that stratification resulted in a toxic amount of

GS in the cold tablets. Hyland’s states that to the contrary, the amount of GS in

the tablets is “undetectable,” and/or is a safe amount. 18

17
Stratification occurs during manufacturing when an ingredient is not evenly
distributed throughout a batch of the product. In 2012, the U.S. Food and Drug
Administration (FDA) wrote to Hyland’s expressing concern about the stratification of
belladonna in manufacturing its teething tablets, and generally expressed concern about
the manufacturing process for Hyland’s products that include potentially toxic
compounds like GS. In 2016, the FDA inspected Hyland’s facility and found inconsistent
levels of belladonna in the teething tablets.
18
Hyland’s also challenges the factual basis for Dr. Pietruszka’s statement that
“there is no specific quantity of [GS] that is considered safe,” for which he cited the
October 2017 “Risk Calculation for Gelsemium sempervirens” by Dr. Wilfried Stock,
Chairman of Homeopathic Pharmacopeia of the United States’ (HPUS) Toxicological &
Safety Committee. The article states that HPUS requires over the counter (OTC)
22
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No. 82213-6-I/23

The case Reese v. Stroh is instructive on the topic of when a party claims

a lack of particular factual basis equates to speculation. In Reese, as discussed

above, the plaintiff’s medical expert opined, to a reasonable degree of medical

certainty, that therapy with the drug Prolastin would have been effective for the

patient’s condition. Id. at 304. The defendant objected because there had been

no statistically significant studies proving the efficacy of the drug for this

condition. Id. at 307. The court held, that while an expert could rely on statistics,

such support was required “neither by ER 702, ER 703, nor by our case law.” Id.

at 309. Jurors could “certainly evaluate the foundation” for the expert’s opinion,

which was “based on the information known to the medical profession at the time

of Plaintiff’s treatment,” and jurors also were “perfectly capable of determining

what weight to give this kind of expert testimony.” Id.

Similarly, here, the lack of information about the particular dose or dose

response of GS does not render Dr. Pietruszka’s opinion on causation

speculative, particularly when he presents a plausible reason why dose response

information does not exist. As Dr. Pietruszka explained, “it’s a toxic substance,

and especially studies that involve humans don’t exist.” “Even when gaps exist in

the underlying data or research, expert testimony remains admissible if there is

enough data for the expert to make a valid deduction and reach the conclusion

they present to the jury.” ROBERT H. ARONSON, THE LAW OF EVIDENCE IN

medications for the average adult human to have a GS potency of “3X,” which means it
has been diluted three times, while another organization requires it to have a potency of
“4X.” For a 10 kg child, Dr. Stock said the OTC potency level should be “5X.”
23
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No. 82213-6-I/24

WASHINGTON § 8.03[5][b], at 8-24 (5th ed. 2021) (discussing L.M. v. ex rel.

Dussault v. Hamilton, 193 Wn.2d 113, 436 P.3d 803 (2019) (in case involving

injuries to a newborn during birth, expert was allowed to testify about the “natural

forces of labor” and whether they could have caused the injury even absent

research on the subject)).

Rather than dose response, Dr. Pietruszka based his opinion on an article

about medical treatments using certain nanoparticles to alter vital cell structures

and on articles that say GS “is a known toxin.” His opinion also was based on the

fact that the label on the cold tablets’ bottle identifies GS as an “active”

ingredient. 19 Dr. Pietruszka is entitled to formulate his opinion even absent

specific evidence of the quantity of GS Jay’Breon ingested. Jurors then may

evaluate the foundation for the opinion on causation and determine the weight to

give the testimony.

The situation here, where there are no studies establishing at what dose

GS is lethal, is different from one in which there is information that an expert

could have obtained or relied on, but did not. For example, in Miller v. Likins, an

expert accident reconstructionist based his testimony about where an accident

occurred “solely on [a witness’s] declaration.” 20 109 Wn. App. 140, 149, 34 P.3d

19
The label constitutes an admission of a party-opponent, not hearsay.
Regardless, “ER 703 allows an expert witness to base their opinion on facts or data
regardless of their admissibility.” Desranleau, 10 Wn. App. 2d at 844.
20
In Miller, this court reviewed the trial court’s evidentiary ruling for abuse of
discretion. 109 Wn. App. at 147, 150. As discussed above, we review de novo a trial
court’s evidentiary ruling made in conjunction with a summary judgment ruling. See
Folsom v. Burger King, 135 Wn.2d 658, 663, 958 P.2d 301 (1998).
24
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No. 82213-6-I/25

835 (2001). The expert admitted there was no physical evidence, “he did not

perform a quantitative analysis to support his version of the facts of the

accident. . . . [And] he had no way of determining where the point of impact in

this accident occurred.” Id. This court determined the trial court properly excluded

the expert’s testimony under ER 702 and ER 703 because it was “speculative

and lack[ed] an adequate factual basis.” Id. Similarly, in Coogan, the trial court

properly excluded expert testimony as overly speculative. 197 Wn.2d 790. The

plaintiff was diagnosed with malignant mesothelioma from asbestos exposure,

and the expert would have testified that because of plaintiff’s history of heavy

alcohol use, he may have had advanced cirrhosis that could have reduced his life

expectancy. Id. at 798. But the Supreme Court affirmed the exclusion of the

evidence as overly speculative, because the expert’s opinion was based on

death rate statistics for stage 3 cirrhosis patients, and he admitted that “no one,

based on those [physical conditions] alone, would stage someone as a stage 3

cirrhosis patient.” Id. at 802 (emphasis in original). In both Miller and Coogan, the

experts relied on speculation rather than on facts.

Ultimately, Hyland’s may dispute the factual basis for Dr. Pietruszka’s

opinions; however, that differs from establishing that his opinions lack a factual

basis. “An objection that an expert employed the methodology in an improper or

unscientific manner goes only to the credibility of the expert’s opinion, not the

admissibility of the expert’s testimony.” 5B TEGLAND, supra, § 702.19, at 84. At

trial, Hyland’s is free to challenge the facts on which Dr. Pietruszka relied through
25
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No. 82213-6-I/26

cross-examination or otherwise. But a disagreement as to those facts does not

render the expert opinion inadmissible. See ER 705 (the expert “may testify in

terms of opinion or inference and give reasons therefore . . . [and t]he expert

may . . . be required to disclose the underlying facts or data on cross-

examination”) (emphasis added). 21 Rather, such arguments go to the weight of

the evidence, and a jury is perfectly capable of weighing opposing experts’

testimony. A “borderline” case “should be decided in favor of admissibility,

allowing the jury to decide for itself whether the opinion is reliable.” 5B TEGLAND,

supra, § 702.27, at 117.

The trial court erred in excluding Dr. Pietruszka’s opinion. The opinion on

causation should not have been subject to a Frye analysis. Further, it is

admissible under ER 702 because it is grounded on facts, not speculation.

II. Summary Judgment

Summary judgment is appropriate if no genuine issue exists as to any

material fact and the moving party is entitled to a judgment as a matter of law.

CR 56(c). In ruling on a summary judgment motion, a trial court must view the

evidence and reasonable inferences from it in the light most favorable to the

We do not suggest that at summary judgment, an expert may avoid providing
21

the factual basis for their opinions. “ER 705 by its language, is limited to trial testimony,
not declaration testimony,” and Washington courts have held “an expert’s testimony for
summary judgment must be supported by the specific facts underlying the opinion.”
Anderson Hay & Grain Co., Inc. v. United Dominion Indus., Inc., 119 Wn. App. 249, 259,
76 P.3d 1205 (2003) (citations omitted). Rather, we cite ER 705 to underscore its use of
the permissive “may,” which suggests a procedural safeguard for the reliability of the
expert opinion is cross-examination by the opponent, including regarding the factual
underpinnings of the opinion.
26
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No. 82213-6-I/27

nonmoving party. Blue Spirits Distilling, LLC v. Washington State Liquor &

Cannabis Bd., 15 Wn. App. 2d 779, 785, 478 P.3d 153 (2020). “The nonmoving

party may not rely on speculation or argumentative assertions that unresolved

factual issues remain.” Little v. Countrywood Homes, Inc., 132 Wn. App. 777,

780, 133 P.3d 944 (2006). We review de novo a trial court’s decision to grant

summary judgment. Lakey, 176 Wn.2d at 922.

In Desranleau’s prior appeal, we explained, “To bring a claim under the

WPLA, the plaintiff must establish that [their] harm was proximately caused by

the condition of the manufacturer’s product.” Desranleau, 10 Wn. App. 2d at 843

(citing RCW 7.72.030(1)). “A proximate cause of an injury is defined as a cause

that, in a direct sequence, unbroken by any new, independent cause, produces

the injury complained of and without which the injury would not have occurred.”

Fabrique v. Choice Hotels Int’l, Inc., 144 Wn. App. 675, 683, 685, 183 P.3d 1118

(2008). Proximate cause consists of two distinct elements—cause in fact and

legal causation—both of which the plaintiff must prove. Id. “Cause in fact, or ‘but

for’ causation, refers to the ‘physical connection between an act and an injury.’

The plaintiff ‘must establish that the harm suffered would not have occurred but

for an act or omission of the defendant.’ ” Martini v. Post, 178 Wn. App. 154, 164,

313 P.3d 473 (2013) (citation omitted) (quoting Hartley v. State, 103 Wn.2d 768,

778, 698 P.2d 77 (1985)). Ordinarily, proximate cause is a question for the jury,

but it “may be determined on summary judgment where the evidence is

27
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No. 82213-6-I/28

undisputed and only one reasonable conclusion is possible.” Fabrique, 144 Wn.

App. at 683 (citing Hartley v. State, 103 Wn.2d 768, 778, 698 P.2d 77 (1985)).

As we held in the prior appeal, the evidence in the summary judgment

record includes evidence that Jay’Breon ingested Hyland’s cold tablets.

Desranleau, 10 Wn. App. 2d at 846. There is evidence that the cold tablets were

manufactured using the same process that produced stratification in another

Hyland’s product, which could have resulted in the concentration of a toxic

material in some tablets. There is evidence that GS is a toxic substance and that

the Hyland’s cold tablets contained GS. Further, there is evidence, through Dr.

Pietruszka’s testimony, 22 that “to a reasonable degree of medical certainty,” the

Hyland’s cold tablets consumed by Jay’Breon more likely than not caused his

death. Viewing the evidence and reasonable inferences from it in the light most

favorable to the nonmoving party—here, Desranleau—we determine that there

are genuine issues of material fact. We therefore reverse the grant of summary

judgment and remand for further proceedings.

III. Sanctions

Citing RAP 18.9, Hyland’s requests sanctions against Desranleau’s

counsel for accusing Hyland’s counsel of lying to the court. Hyland’s contends

Desranleau also asserts that, even without Dr. Pietruszka’s expert opinion, an
22

inference exists that the stratified tablets “could be lethal at certain quantities” and a
“reasonable inference that Jay’Breon ingested a stratified pill that . . . killed him.” Given
our resolution of the challenge to Dr. Pietruszka’s testimony, we need not examine this
alternative argument.
28
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No. 82213-6-I/29

that Desranleau’s counsel violated court rules, but it does not identify which

rules.

RAP 18.9(a) provides,
The appellate court on its own initiative or on motion of a party may
order a party or counsel. . . , who uses these rules for the purpose of
delay, files a frivolous appeal, or fails to comply with these rules to
pay terms or compensatory damages to any other party who has
been harmed by the delay or the failure to comply or to pay sanctions
to the court. The appellate court may condition a party’s right to
participate further in the review on compliance with terms of an order
or ruling including payment of an award which is ordered paid by the
party.

(Emphasis added.) Hyland’s does not contend that Desranleau’s counsel violated

a RAP to delay or file a frivolous appeal, and Hyland’s does not specify any RAP

that Desranleau’s counsel violated. 23 We thus deny Hyland’s request for

sanctions.

23
Hyland’s also requests sanctions against Desranleau’s counsel for violating
RPC 8.4(d). But RAP 18.9 provides that this court can order sanctions for a party’s
failure to “comply with these rules.” (Emphasis added.) Thus, RAP 18.9 does not provide
an avenue for this court to impose sanctions for RPC violations.
To support its proposition that we can impose RAP 18.9 sanctions for RPC
violations, Hyland’s cites In re Welfare of R.H., 176 Wn. App. 419, 430, 309 P.3d 620
(2013), in which Division Two of this court imposed sanctions for an attorney’s violation
of RPC 3.3(a)(1). There, the attorney violated RPC 3.3(a)(1) by lying to the court. Id.
The court did not explain why the RPC violation qualified as a violation of a court rule
under RAP 18.9(a). As discussed above, and as Desranleau contends, RAP 18.9
sanctions are applicable only for violating a RAP. And we are not bound by Division
Two’s decision. See In re Pers. Restraint of Arnold, 190 Wn.2d 136, 138, 410 P.3d 1133
(2018).
Under RPC 8.4(d), a lawyer commits professional misconduct if they “engage in
conduct that is prejudicial to the administration of justice.” Even if R.H. were binding,
Hyland’s has not supported its argument—that Desranleau’s counsel’s accusations were
prejudicial to the administration of justice—with citation to the record. RAP 10.3(a)(6);
Cowiche Canyon Conservancy v. Bosley, 118 Wn.2d 801, 809, 828 P.2d 549 (1992) (we
will not consider arguments unsupported by reference to the record).
29
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No. 82213-6-I/30

CONCLUSION

We reverse the trial court’s order excluding Dr. Pietruszka’s testimony and

reverse the grant of summary judgment dismissing Desranleau’s claims. We

remand for further proceedings consistent with this opinion.

Reversed and remanded.

WE CONCUR:

30

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/9898003. Public record. Not legal advice.
