     IN THE COURT OF APPEALS FOR THE STATE OF WASHINGTON




ANNA CHESTER,
                                                 No. 73225-1-1
                     Appellant,
                                                 DIVISION ONE
      v.



DEEP ROOTS ALDERWOOD, LLC,                       PUBLISHED OPINION
A WASHINGTON CORPORATION;
AND BONNIE GILLSON

                     Respondents.                FILED: April 4, 2016



       Spearman, C.J. —Anna Chester suffered an adverse reaction after being

tattooed with ink that appears to have been contaminated with bacteria when the

tattoo artist received it from the distributor. Chester brought negligence claims

against the tattoo artist and the tattoo parlor, arguing that they had a duty to use

sterile ink. The trial court dismissed her claims on summary judgment and

Chester appeals. We affirm, because neitherthe regulations governing the tattoo

industry nor the common law impose a duty to use sterile ink.

                                       FACTS

       Bonnie Gillson, a tattoo artist, applied a tattoo to Anna Chester at Deep

Roots Alderwood, LLC, a shop specializing in tattoos and body piercing. For the

black portion of the tattoo, Gillson used One brand tattoo ink. One was a popular
No. 73225-1-1/2


ink that Gillson had used for about a year and a half without problem. She

ordered the ink from Kingpin, a distributor from whom she ordered many tattoo

supplies.

       A few weeks after applying Chester's tattoo, Gillson learned that several of

her clients were experiencing adverse reactions to the black ink portions of their

tattoos. An investigation by King County Public Health traced the reactions to a

particular bottle of One brand black tattoo ink. The investigation indicated that the
ink had likely been contaminated during manufacture. Gillson contacted every

client she tattooed during the period oftime she used the contaminated bottle of
ink. Most clients suffered only a minor skin irritation that did not require medical

treatment.

       Chester, however, suffered a serious reaction to the contaminated ink.

She consulted a doctor who diagnosed a bacterial infection at the tattoo site and

prescribed a course of antibiotics. The infection did not respond to the prescribed
treatment. Chester's kidney function declined rapidly. In the opinion of Chester's
doctor, the bacterial infection aggravated an underlying chronic kidney disease.

Chester was eventually referred to an infectious disease specialist, Dr. Warren L.
Dinges. Dinges successfully treated the infection. But before the infection was
brought under control Chester's kidneys had failed, requiring her to begin

dialysis.
No. 73225-1-1/3


       Chester brought product liability and negligence claims against Gillson

and Deep Roots.1 To support her negligence claims, Chester relied on two

declarations from her medical expert, Dinges. Gillson and Deep Roots moved to

strike Dinges's second declaration. The trial court granted the motion in part.

       Gillson and Deep Roots moved for summary judgment. Chester conceded

dismissal of her product liability claims, but opposed the motion as to her

negligence claims. The trial court found as a matter of law that Chester's

evidence failed to establish the essential elements of negligence and granted

summary judgment for Gillson and Deep Roots. Chester appeals.

                                      DISCUSSION


       Chester argues that the trial court erred in finding that she did not show

the elements of negligence. We review a decision on summary judgment de

novo, engaging in the same inquiry as the trial court. Camicia v. Howard S.
Wright Constr. Co., 179 Wn.2d 684, 693, 317 P.3d 987 (2014). To survive

summary judgment on a negligence claim, Chester had the burden to produce
evidence that the respondents owed her a duty of care and breached that duty.

Hurley v. Port Blakelv Tree Farms LP.. 182 Wn. App. 753, 773, 332 P.3d 469

(2014) review denied, 189 Wn 7d 2008 (2015V (citing Crowe v. Gaston, 134

Wn.2d 509, 514, 951 P.2d 1118 (1998)). She also had to show that the breach

resulted in injury and was the proximate cause of that injury. Id.




        1 Chester also brought product liability claims against Kingpin and one of Kingpin's
suppliers. These claims were not dismissed on summary judgment and are not before this court.
No. 73225-1-1/4


       Chester first argues that the respondents were negligent per se because

they violated a statutory duty of care. Chester relies on RCW 5.40.050(3), under

which the breach of tattooing regulations related to the use of sterile needles is

negligence per se. She asserts that WAC 246.145.050(1), which requires that

tattoo artists use "sterile instruments and aseptic techniques at all times during a

procedure," imposes a duty to use sterile ink.

       We review questions of statutory interpretation de novo. Pham v. Corbett,

187Wn.App. 816, 831, 351 P.3d 214 (2015) (citing State v. Wentz. 149Wn.2d

342, 346, 68 P.3d 282 (2003). In interpreting statutes, our aim is to discern and

implement the Legislature's intent. \± (citing State v. J.P.. 149 Wn.2d 444, 450,
69 P.3d 318 (2003)). We begin with the plain language of the statute. ]d. Where

the plain language is unambiguous and the legislative intent is apparent, we "'will
not construe the statute otherwise.'" Id. (quoting JP,, 149 Wn.2d at 450).

Legislative intent may be discerned from the statutory scheme as a whole. |d.
(quoting Dep't of Ecology v. Campbell &Gwinn. LLC. 146 Wn.2d 1, 11, 43 P.3d 4
(2002)). The same principles apply to the interpretation of regulations as to the

interpretation of statutes. Silverstreak. Inc.. v. Washington State Dep't. of Labor

and Industries. 159 Wn.2d 868, 898, 154 P.3d 891 (2007).

       The Legislature authorized the secretary of health to regulate the tattoo
industry and instructed the secretary to adopt rules "in accordance with nationally
recognized professional standards." RCW 70.54.340. The legislature further
directed the secretary to "consider the standard precautions for infection control,

as recommended by the United States centers for disease control." RCW
No. 73225-1-1/5


70.54.340. In compliance with these directives, the secretary of health adopted

chapter 246-145 WAC to regulate electrology, body art, body piercing, and

tattooing.

       WAC 246-145-050 details 24 "universal precautions" applicable to tattoo

artists and body piercers. Three subsections include sterilization requirements.

Artists must use "sterile instruments and aseptic techniques at all times during a

procedure." WAC 246-145-050(1). They must use only presterilized single-use

disposable tattoo needles. WAC 246-145-050(2). Artists must obtain jewelry

used in body piercing presterilized or sterilize the jewelry on site prior to the

procedure. WAC 246-145-050(20). The regulation includes two provisions

concerning tattoo ink. Tattoo artists must use single-use ink containers for each

client to prevent contaminating the unused portion of ink. WAC 246-145-050(15).

Artists may not use inks that are banned or restricted by the FDA. WAC 246-145-

050(18).2

       The next regulation, WAC 246-145-060, details the requirements for

"[s]terile procedures in body art, body piercing and tattooing." The

regulation repeats the requirement to use only single-use, presterilized

disposable needles. WAC 246-145-060(1 )(a). It requires artists to only reuse

instruments intended for multiple use that have been cleaned and sterilized

between clients. WAC 246-145-060(1 )(c). The regulation gives specific


        2 The FDA does not require that tattoo inks be sterile. See Centers for Disease Control,
Morbidity and Mortality Weekly Report (MMWR), Tattoo-Associated Nontuberculous
Mycobacterial Skin Infections—Multiple States. 2011-2012 (August 24, 2012) Vol. 61, No. 33,
653-656 at http://www.cdc.gov/mmwr/pdf/wk/mm6133.pdf
No. 73225-1-1/6


requirements for sterilizing and storing reusable instruments. WAC 246-145-

060(1)(c)-(g). The regulation includes no requirements for ink.

       There is no regulation that, by its plain language, creates a duty to use

sterile ink. The regulatory scheme as a whole indicates that the secretary

carefully considered sterilization as it applies to the tattoo industry. The

regulations require that some items be obtained presterilized and that others be

sterilized on site, according to detailed procedures. The secretary also

considered tattoo ink and issued rules concerning what ink may be used and how

ink must be dispensed.

       Considering the detail of the regulatory scheme, the specific requirements

concerning sterilization, and the attention given to tattoo ink, it is not reasonable
to conclude that the secretary intended to require the use of sterile ink but
couched that duty within the requirement to use sterile instruments and aseptic
technique. We conclude that the plain language ofthe regulation is not
ambiguous and the legislative intent is clear. There is not a regulatory
requirement to use sterile ink.

       Chester next argues that the definition section of RCW 70.54.330 is an

independent basis for finding the respondents negligent perse. RCW
70.54.330(4) defines "tattooing" as an indelible mark "introduced by insertion of
nontoxic dyes or pigments into or under the subcutaneous portion of the skin."
Chester contends that this section creates a duty to use only nontoxic ink and

that the respondents breached this duty by using contaminated ink. The
No. 73225-1-1/7


respondents argue that the section does not apply to the negligence per se

statute, RCW 5.40.050(3). We agree with the respondents.

       RCW 5.40.050 establishes negligence per se for the breach of a duty

created by statute or rule relating to "(3) sterilization of needles and instruments

used by persons engaged in the practice of body art, body piercing, tattooing, or

electrology, or other precaution against the spread of disease, as required under

RCW 70.54.350." The referenced statute, RCW 70.54.350 states, "[a]ny person

who practices electrology or tattooing shall comply with the rules adopted by the
department of health under RCW 70.54.340." The negligence per se statute thus
applies to the breach ofany tattooing regulation having to do with precautions
against the spread of disease. The definition of tattooing in RCW 70.54.330(4) is
not such a regulation.

       This reading is in harmony with other statutory and regulatory provisions
defining tattooing. RCW 18.300.010, which became effective at the same time as
the tattoo regulations, explicitly states that its definitions apply to RCW 5.40.050,
the negligence per se statute. The statute defines "tattooing" as "to pierce or
puncture the human skin with a needle or other instrument for the purpose of
implanting an indelible mark." RCW 18.300.010(8). The regulations also use this
definition. WAC 246-145-101(25). Neither the statutory nor the regulatory

definition encompassed by the negligence per se statute includes the word

"nontoxic."

       At oral argument and in a statement of additional authorities, Chester also
asserted that the respondents were negligent per se because they violated the
No. 73225-1-1/8


Federal Food, Drug, and Cosmetic Act (FDCA). Chester argued that the

respondents violated 21 U.S.C. § 331, which prohibits introducing or receiving in

interstate commerce any adulterated cosmetic. This argument is without merit

because the FDCA does not create a private right of action. 21 U.S.C. § 337.

Furthermore, the Act does not impose penalties on retailers who deliver

adulterated cosmetics in good faith. 21 U.S.C. § 333(c).

       We conclude that Chester has not shown the existence of a statutory duty

to use sterile ink and we reject her claim of negligence per se.

       Chester argues in the alternative that she established the elements of

common law negligence. Chester asserts that even if the respondents owed only

a duty of reasonable care, they breached that duty by not using sterile ink or

confirming that the ink was not contaminated.

       Chester does not assert that sterile ink is the industry standard. But she

argues that even if sterile ink is not routinely used, the risks associated with using

contaminated ink far outweigh the burden of using sterile ink. She argues that the

respondents thus breached a duty of reasonable care by failing to ensure the ink

they used was sterile.

       Chester relies on Helling v. Carey, 83 Wn.2d 514, 519 P.2d 981 (1974), in

which the Supreme Court quoted Judge Learned Hand and followed his cost-

benefit analysis. \± at 519. In Helling, a 32-year-old patient became partially

blind due to undetected glaucoma. \± at 516. The defendant ophthalmologists

presented evidence that glaucoma is uncommon in young patients and the

industry standard was to administer routine glaucoma tests after the age of 40.


                                          8
No. 73225-1-1/9


jd. But the court held that, given the severity of glaucoma and the availability of a

simple and harmless test to detect the disease, the doctors breached a duty by

failing to administer the test. jd. at 519.

       Chester's argument falls short because she glosses over the burden of

using sterile ink. In Helling, it was undisputed that the ophthalmologists could

easily administer a simple glaucoma test. Helling, 83 Wn.2d at 519. Chester
asserts that using sterile ink is similarly easy as "Gillson can simply order sterile

rather than non-sterile ink       " Br. of Appellant at 23. She further argues that the

respondents had not only a duty to purchase ink advertised as sterile, but also a
duty to ensure that ink was in fact sterile. However, Chester has not shown that
sterile ink was widely available at the time in question, that claims of sterility were
reliable, or that tattoo artists had the means to test ink for contamination and

sterilize it on site.

        Chester presented evidence that Intenze brand tattoo ink was advertised
as sterile about the time that Gillson purchased the One brand ink. She also

produced the article Microbial status and product labelling of 58 original tattoo
inks (2011) as evidence ofthe association between tattoo ink and bacterial
infection. The article reports on a study of 58 inks for sale in the European

market. Concerning those inks claiming to be sterile, the authors found that none
of the claims could be verified and some were demonstrably false. The authors

found that Intenze black ink, advertised as sterile, contained a high level of

 bacterial contamination.
No. 73225-1-1/10


       The record includes a further example of an unreliable claim of sterility. At

some point prior to March 2012, the One brand website claimed that its ink was

sterile. An inspection determined that, although the manufacturer was having the

ink treated with gamma radiation, the dosage of radiation was not sufficient to

support the claim of sterility.

       Chester has not shown that sterile ink was readily available or that claims

of sterility were reliable. She offered no evidence that tattoo artists have the
means to test ink for contamination or sterilize ink received from distributors. We

conclude that Helling is distinguishable. Chester has not established that the

respondents' duty of reasonable care required them to use sterile ink.
       Chesteralso argues that the trial court erred in striking one paragraph of
Dinges's second declaration and in considering another paragraph only as
medical opinion. She argues that the court should have considered the
declaration in its entirety and that the declaration is evidence that the

respondents had a duty to use sterile ink.

       The de novo standard applies to evidentiary rulings on admissibility. Keck

v, Collins. 184 Wn.2d 358, 368, 357 P.3d 1080 (2015) (citing Folsom v. Burger

King, 135 Wn.2d 658, 663, 958 P.2d 301 (1998)). Affidavits in support of a

summary judgment motion must contain facts that would be admissible in
evidence. CR 56(e). Statements in an affidavit are not inadmissible because they
"embraced an ultimate issue to be decided by the trier offact." ER 704. However,
a witness may not draw "conclusion[s] of law." Everett v. Diamonds, 30 Wn. App.
787, 791, 638 P.2d 605 (1981). Statutory interpretation is the province of the


                                          10
No. 73225-1-1/11


court, and is not a proper subject of testimony. kL at 792 (citing Ball v. Smith, 87

Wn.2d 717, 722-723, 556 P.2d 936 (1976)).

       In his second declaration, Dinges comments on the use of "sterile

instruments and aseptic technigues at all times during a procedure" as required

by WAC 246-145-050(1). Dinges states:

       Regardless of the credentials of the person performing the
       injection, the requirement to "use sterile instruments ...at all times
       during a procedure" seems unambiguous to me. The only meaning
       that I can attach to that rule is that, if a tattoo artist inserts into a
       customer, by way of an instrument, understood to be a needle used
       to penetrate the surface of the skin, ink that is contaminated with
       bacteria, then clearly "sterile instruments" were not used at all times
       during the procedure because the instrument, meaning the
       instrument used to penetrate the customer's skin, was
       contaminated with bacteria.

Clerk's Papers (CP) at 369.

       Chester asserts that the trial court erred in striking this passage as legal

opinion. She argues that the statement that the tattoo needle was not"sterile" is
a statement of fact, not a legal opinion. Chester further argues that this

paragraph contains only explanations of the regulatory terms.

       In the stricken paragraph, Dinges does not merely explain the term

"sterile" or state that a tattoo needle is no longer sterile after it has come into

contact with contaminated ink. Dinges states that it "seems unambiguous" that by

requiring "'sterile instruments'" the regulation prohibits the use of any non-sterile
ink. (Quoting CP at 369). Dinges then draws the conclusion that, in the

circumstances of the present case, "clearly 'sterile instruments' were not used."

The paragraph both construes the regulation and reaches the legal conclusion



                                             11
No. 73225-1-1/12


that the respondents violated the regulation. Conclusions of law and statutory

interpretation are not proper subjects for testimony. Everett. 30 Wn. App. at 791.

      Chester next argues that the statement is admissible as Dinges's

understanding of the standard of care and a breach of that standard. Chester

quotes White v. Kent Med. Ctr.. Inc.. P.S.. 61 Wn. App. 163, 171, 810 P.2d 4
(1991), for the proposition that the standard ofcare and a breach of that standard
"'ordinarily must be shown by expert medical testimony.'" White, however, is
inapposite because it involved a claim of medical negligence, jd. Expert
knowledge of the profession at issue is necessary to testify to the standard of
care within that profession. Young v. Kev Pharmaceutical. Inc.. 112Wn. 2d a
216, 227-230, 770 P,2d 182 (1989) (pharmacist not qualified to testify that
physicians breached their standard of care). Dinges does not claim to be a tattoo
artist or an expert in tattooing. His testimony is therefore not admissible to
establish the standard of care for tattoo artists. The trial court did not err in

striking the paragraph as legal opinion.

       Chester also argues that the trial court erred in considering the following

paragraph of Dinges's declaration only as medical opinion:
              In my opinion the absolute minimum that is required for a
       tattoo artist (or any person intending to inject a substance into a
       person) to be able to claim the use of sterile instruments and
       aseptic technique at all times during the procedure is that the artist
       only use ink that is in fact sterile. In this case, the artist did not use
       ink that was in fact sterile because the black ink in Ms. Chester's
       tattoo was contaminated with bacteria.
               To ensure sterile instruments and aseptic technique
       throughout the procedure, the procedure has to start with sterile
       tattoo ink.




                                           12
No. 73225-1-1/13


CP at 370.

       Chester argues that the legislature directed the secretary of health to

"consider the standard precautions for infection control, as recommended by the

United States centers for disease control" (CDC). RCW 70.54.340. She asserts

that this directive indicates that medical doctors and the secretary of health share

the same understanding of sterility, and Dinges is qualified to testify to that

shared understanding. She argues that the trial court erred in not considering the

challenged paragraph to establish the elements of negligence.

       Chester's argument fails because, while Dinges is qualified to testify to the

meaning of the term "sterile," his statement goes beyond explaining the term.
The challenged statement includes Dinges's opinion that the regulation requiring
the use of sterile instruments and aseptic technique includes an unstated

requirement to use sterile ink. To the extent Dinges interprets the statute, his
statement is inadmissible because statutory interpretation is the province of the

court. To the extent Dinges testifies to the standard of care, his testimony is

inadmissible because he is not an expert in tattooing.

       Chester's argument concerning the CDC does not change this result. The

legislature instructed the secretary to adopt rules "in accordance with nationally
recognized professional [tattoo] standards" and to "consider the standard
precautions for infection control, as recommended by the United States centers
for disease control." RCW 70.54.340. This instruction to the secretary does not

impose CDC or other medical standards on tattoo artists. The secretary of health
and medical professionals may share an understanding of sterility, as Chester


                                          13
No. 73225-1-1/14


asserts, but the secretary did not promulgate regulations imposing medical

standards on tattoo artists. Dinges is a medical expert. We conclude that the trial

court did not err in considering his statement as medical opinion, but not as

evidence of duty and breach within the tattoo industry.



Affirmed.


                                                  5«      •4_A-^( s~\4~—
                                                                       7
                                                                           CX
WE CONCUR:




                                                                                  CD




                                         14
