IN THE COURT OF APPEALS FOR THE STATE OF WASHINGTON

ANNA CHESTER, Appellant,

v. DEEP ROOTS ALDERWOOD, LLC, A WASHINGTON CORPORATION; AND BONNIE GILLSON Respondents. No. 73225-1-1 DIVISION ONE

PUBLISHED OPINION

FILED: April 4, 2016 Spearman, C.J. —Anna Chester suffered an adverse reaction after being tattooed with ink that appears to have been contaminatedwith bacteria when the tattoo artist received it from the distributor. Chester brought negligence claims 

### against the tattoo artist and the tattooparlor, arguing that they had a duty to use sterile ink. The trial court dismissed her claims on summaryjudgment 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 intattoos and body piercing. For the blackportion of the tattoo, Gillson used One brand tattoo ink. One was a popularNo. 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 blackink portions of their tattoos. An investigation by King CountyPublic Health traced the reactions to a 

### particular bottle of Onebrand blacktattoo ink. Theinvestigation 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 sufferedonly a minor skinirritation that did notrequire 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 ofantibiotics. 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. Butbefore the infection was brought under control Chester'skidneys had failed, requiring hertobegin 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 summaryjudgment. 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 ofnegligence. We review a decision on summaryjudgment de 

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

### summaryjudgment 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 BlakelvTree 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 proximatecause of that injury. Id.

1 Chester also brought productliability claims against Kingpin and one ofKingpin's suppliers. These claims were notdismissed onsummaryjudgment and are not before thiscourt.No. 73225-1-1/4 Chesterfirst 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 thatWAC 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 reviewquestions of statutory interpretation de novo. Pham v. Corbett, 

### 187Wn.App. 816, 831, 351 P.3d214 (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.. 149Wn.2d 444, 450, 69 P.3d 318 (2003)). Webegin with the plain language of the statute. ]d. Where 

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

### Legislative intent may bediscerned from the statutory scheme as awhole. |d. (quoting Dep't ofEcology v. Campbell &Gwinn. LLC. 146 Wn.2d 1, 11, 43 P.3d 4 (2002)). The same principles apply to the interpretation ofregulations as to the interpretation of statutes. Silverstreak. Inc.. v. Washington State Dep't. ofLabor and Industries. 159 Wn.2d 868, 898, 154 P.3d 891 (2007). 

### The Legislature authorized the secretary ofhealth to regulate the tattoo 

### industry and instructed the secretary to adoptrules "in accordance with nationally recognized professional standards." RCW 70.54.340. The legislature further directed the secretary to "consider the standard precautions forinfection control, as recommended by the United States centers for disease control." RCWNo. 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 clientto preventcontaminating the unused portion ofink. 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 requirementto 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

2The 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.pdfNo. 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 ofthe regulatory scheme, the specific requirements 

### concerning sterilization, and the attention given totattoo ink, it is not reasonable to conclude that the secretary intended to require the use of sterileink but 

### couched thatduty within therequirementto usesterile instruments and aseptic technique. Weconclude that the plain language ofthe regulation is not 

### ambiguous and thelegislative intent is clear. There is not a regulatory requirement to use sterile ink. 

### Chesternext argues that the definition section ofRCW 70.54.330 is an 

### independentbasis forfinding therespondents negligent perse. RCW 

### 70.54.330(4) defines "tattooing" as anindelible mark "introduced by insertion of nontoxic dyes orpigments into orunderthe subcutaneous portion oftheskin." Chester contends that this section creates a duty to use only nontoxic ink and 

### thattherespondents breached this duty by using contaminated ink. TheNo. 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 rulerelating to "(3) sterilization ofneedles and instruments 

### used by persons engaged in the practice ofbody art, bodypiercing, tattooing, or 

### electrology, or otherprecaution against the spread ofdisease, as required under RCW 70.54.350." The referenced statute, RCW 70.54.350 states, "[a]ny person 

### who practices electrology ortattooing shall comply with the rules adopted by the 

### department ofhealth under RCW 70.54.340." The negligence perse statute thus applies to thebreach ofanytattooing regulation having to dowith precautions 

### againstthe spread ofdisease. The definition oftattooing in RCW 70.54.330(4) is
not such a regulation. 

### This reading isin harmony with other statutory andregulatory provisions 

### defining tattooing. RCW 18.300.010, which became effective at the sametime as thetattoo regulations, explicitly states thatits definitions apply toRCW 5.40.050, the negligence per se statute. The statutedefines "tattooing" as "to pierce or 

### puncture thehuman skin with a needle orother instrumentfor thepurpose of 

### implanting anindelible mark." RCW 18.300.010(8). The regulations also usethis definition. WAC 246-145-101(25). Neither the statutory nor the regulatory 

### definition encompassed bythe negligence per se statute includes the word
"nontoxic." 

### At oral argument andin a statement ofadditional authorities, Chester also asserted that the respondents were negligent per se because theyviolated theNo. 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 inthe alternative that she established the elements of

common law negligence. Chester asserts that even ifthe respondents owed only a duty ofreasonable care, they breached that duty by not using sterile ink or confirming that the inkwas 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 inkfar outweigh the burden of using sterile ink. She argues that the respondents thus breached a duty ofreasonable care byfailing 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 costbenefit analysis. \± at 519. In Helling, a 32-year-old patient became partially blinddue 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.

8No. 73225-1-1/9 jd. But the court held that, given the severity ofglaucoma 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 sterileink. 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 sterileink 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 notonly a duty to purchaseink advertised as sterile, butalso a 

### duty to ensurethatinkwasin fact sterile. However, Chester has not shown that sterile ink waswidely available at thetime in question, thatclaims ofsterility were reliable, or that tattoo artists had the means to test inkfor contamination and
sterilize it on site. 

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

### produced the article Microbial status and product labelling of58 original tattoo inks (2011) as evidence oftheassociation 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 authorsfound 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 priorto 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 ofradiation was notsufficientto support the claim of sterility. Chester has not shown that sterile inkwas readily available or that claims 

### ofsterility werereliable. She offered noevidence thattattoo 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 ofreasonable carerequired them to use sterile ink. Chesteralso argues that thetrial courterred in striking oneparagraph of 

### Dinges's second declaration and in considering another paragraph only as medical opinion. Sheargues thatthecourt should have considered the declaration in itsentirety and that the declaration is evidence that the respondents had a duty to use sterile ink. 

### The de novo standard appliesto evidentiary rulings on admissibility. Keck v, Collins. 184 Wn.2d 358, 368, 357 P.3d 1080 (2015) (citing Folsom v. Burger King, 135Wn.2d 658, 663, 958 P.2d 301 (1998)). Affidavits in support of a 

### summaryjudgmentmotion must contain facts thatwould beadmissible in evidence. CR 56(e). Statementsin an affidavit are not inadmissible because they 

### "embraced an ultimate issue to bedecided by thetrier offact." ER 704. However,
a witness may not draw "conclusion[s] oflaw." Everettv. Diamonds, 30Wn. App. 787, 791, 638 P.2d605 (1981). Statutory interpretation is the province ofthe

10No. 73225-1-1/11 court, and is not a proper subject oftestimony. 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 ofthe credentials ofthe 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 thetattoo needle was not"sterile" is

a statement of fact, not a legal opinion. Chesterfurther argues that this paragraph contains onlyexplanations 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 ithas 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

11No. 73225-1-1/12 that the respondents violated the regulation. Conclusions of law and statutory 

### interpretation are not proper subjects for testimony. Everett. 30Wn. App. at 791. Chester next argues that the statement is admissible as Dinges's 

### understanding of the standard of care and a breach ofthat standard. Chester 

### quotesWhite v. Kent Med. Ctr.. Inc.. P.S.. 61 Wn. App. 163, 171, 810P.2d 4 

### (1991), for theproposition thatthestandard ofcareand a breach ofthatstandard "'ordinarily must be shown by expert medical testimony.'" White, however, is inapposite because it involved a claim ofmedical negligence, jd. Expert 

### knowledge oftheprofession atissue is necessary totestify tothestandard of
carewithin thatprofession. Young v. Kev Pharmaceutical. Inc.. 112Wn. 2d a 216, 227-230, 770P,2d 182(1989) (pharmacist notqualified totestify that 

### physicians breached their standard ofcare). Dinges does not claim to be atattoo artist or anexpert in tattooing. His testimony istherefore not admissible to establish the standard ofcare for tattoo artists. The trial court did not err in striking the paragraph as legal opinion. 

### Chester also argues that thetrial court erredin considering thefollowing paragraph ofDinges's declaration only as medical opinion: In my opinion the absoluteminimum that is required for a tattoo artist(or any person intending to inject a substance into a 

### person) to be able toclaim the use ofsterile instruments and aseptictechnique 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 

### throughouttheprocedure, theprocedure has to startwith sterile tattoo ink.

12No. 73225-1-1/13

CP at 370. Chester argues that the legislature directed the secretary of health to "considerthe 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 ofsterility, and Dinges is qualified to testify to that 

### shared understanding. She argues that the trial court erred in notconsidering the challenged paragraph to establish the elements of negligence. 

### Chester's argumentfails because, while Dinges isqualified totestify to the 

### meaning ofthe term "sterile," his statement goes beyond explaining the term. 

### Thechallenged statementincludes Dinges's opinion that the regulation requiring the use of sterile instruments and aseptic technique includes an unstated 

### requirementto use sterile ink. To theextent Dinges interprets the statute, his statement is inadmissiblebecause 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 argumentconcerning the CDC does not change this result. The 

### legislature instructed thesecretary toadopt rules "in accordance with nationally recognized professional [tattoo] standards" and to "considerthe 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 orother medical standards ontattoo artists. Thesecretary ofhealth and medical professionals may share an understanding ofsterility, as Chester

13No. 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.

WE CONCUR: 

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