Plaintiffs' Response to USA's Motion for Summary Judgment with Certificate of Service

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IN THE UNITED STATES DISTRICT COURT | NUV 2 3 
FOR THE NORTHERN DISTRICT OF TEXAS | i 

DALLAS DIVISION Fe ————— 
NANCY DOHERTY, CLERK 

BY ca ei. 

  

LOIS THOMPSON on behalf of and 

as next friend to TAYLOR 
KEONDRA DIXON, ZACHERY X. 

WILLIAMS, CALVIN A. THOMPSON 

and PRENTISS LAVELL MULLINS, 

      

  

No. 3-92 CV 1539-R 

Plaintiffs Civil Action 

Vv. Class Action 

BURTON F. RAIFORD, in his 

capacity as Commissioner of 
the Texas Department of Human 
Services, 

and 

THE UNITED STATES OF AMERICA, 

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Defendants. 

PLAINTIFFS’ RESPONSE TO USA'’S 
MOTION FOR SUMMARY JUDGMENT 
  

Plaintiffs oppose the USA’s motion for summary judgment. The 

facts cited in support of the motion are either disputed, indis- 

putably contrary to the allegations of the USA, or irrelevant to 

the issues of the case. 

A. Factual Statement in opposition to USA’s factual allegations 
  

1. The USA alleges that the September 19, 1992 HCFA guide- 

lines require that all of the plaintiffs receive blood lead tests 

since the verbal assessment of the plaintiffs would place them in 

the category of "high risk". This allegation is contradicted by 

the facts and the explicit wording of the HCFA guidelines. 

1.1. Plaintiff Taylor Dixon was six months old on 6-14-92. 

She was given an initial blood lead level test at her 

 



  

grandmother’s request on 5-05-92. The blood lead level test 

showed 9 ug/dl [Lois Thompson declaration]. 

1.2. The Sept. 19, 1992 HCFA guidelines for "High Risk" 

children specifically states: "If the initial blood lead level 

test results are less than (<) 10 micrograms per deciliter 

(ug/dL), a screening EP test or blood lead test is required at 

every visit prescribed in your EPSDT periodicity schedule through 

72 months of age." [HCFA 9/19/92 guidelines 5132.2 c. Screening 
  

Blood Tests. (2) High Risk]. The State of Texas can follow the 
    

HCFA guidelines to the letter and still provide Taylor Dixon with 

only an EP test for the rest of her early childhood despite her 

"High Risk" status and despite the fact that blood lead levels 

often peak at ages greater than 12 months [CDC 1991 page 43]. 

1.3 Using the HCFA guidelines, Taylor Dixon will be screened 

using the admittedly ineffectual EP test during the period of her 

life when the most rapid rate of increase in blood lead levels 

will occur. "Blood lead concentrations increase steadily up to at 

least 18 months of age. The most rapid rate of increase occurs 

between 6 and 12 months of age." [CDC 1991 page 42] 

1.4. The 9/19/92 HCFA guidelines and the "Action Transmit- 

tal" by which the guidelines were distributed to the states are 

not mandatory or otherwise binding on the states. Lieql v. Webb, 
  

802 F.2d 623, 626 (2nd Cir. 1986) - specific discussion of HCFA 

"Action Transmittals". Should the State choose to ignore or 

otherwise refuse to implement the 9/19/92 HCFA guidelines, each 

plaintiff will be tested for childhood lead poisoning through the 

 



EP test. The last written expression of the State of Texas’ 

policy on the use of EP tests for childhood lead poisoning is in 

the Donald L. Kelley, Texas State Medicaid Director, July 9, 1992 

letter in response to an Open Records Act request. In response to 

the request for the "number of lead blood screens performed on 

children for the past five fiscal years", Kelley states "Those 

with abnormal EP test results receive lead tests." [letter 

attached to declaration of Laura Beshara]. The State’s October 9, 

1992 answer to the Second Amended Complaint admits the allegation 

in plaintiffs € 50. "Only if a child test higher than 35 on the 

EP test is a blood lead level test administered."?! 

1.5. The State of Texas has ignored other HCFA guidelines 

related to screening for childhood lead poisoning. HCFA released 

a report date July 12, 1991 that reviewed the State of Texas’ 

compliance with the risk assessment requirements of the Medicaid 

statute, 42 U.S.C. § 1396d(r), two years after the effective date 

of the statute. HCFA found "The State has not established risk 

factors (other than age) to assist providers in determining 

whether it is appropriate to perform a blood lead level test. It 

has established an age factor...however, according to Section 

5123.D.1 of the State Medicaid Manual, States should also consid- 

  

1 Although the State’s answer to the allegation goes on to 
state that the EP test will be discontinued as a blood lead level 
test in November, 1992, the State has taken no official action to 
so discontinue the practical use of the EP test. At least as of 
the date of the answer, the official practice of the State of 
Texas was to use blood lead tests only if the primary EP test 
showed a high EP count. The answer was filed after the 9/19/92 
effective date of the HCFA guidelines. 

3  



er environmental aspects when establishing risk factors" [HCFA's 

  

Medicaid Oversight Report of the Texas EPSDT Program, July 21, 

1991, attached to Beshara declaration]. Thus the State of Texas 

ignored HCFA’s guidelines for a long time without suffering any 

penalty. 

1.6. The USA’s Hiscock Declaration recounts the USA’s re- 

quirements over the years that the states conduct childhood lead 

screening and treatment. The USA’s "Strategic Plan for the 

Elimination of Childhood Lead Poisoning" U.S. Department of 

Health and Human Services, February 1991 reported that "many 

States do not conduct much screening or do not pay for environ- 

mental investigations for poisoned children." [page 18, attached 

to Beshara declaration]. 

1.7. The 9/19/92 HCFA guidelines contain statements which 

authorize the general use of the EP test regardless of the "High 

Risk" status of the child. 

"States continue to have the option to use the EP test as 

the initial screening blood test." 

"As part of the nutritional assessment conducted at each 

periodic screening, an EP blood test may be done to test for iron 

deficiency. This blood test may also be used as the initial 

screening blood test for lead toxicity." 

2. If a parent or other adult in charge of the child does 

not know the correct answer to the verbal screening questions, 

eg. whether or not the living unit has lead pipes or copper with 

lead solder joints, and the answer should be yes, then "High 

 



Risk" children will be screened using the EP test [Rosen affida- 

vit page 8°]. 

3. The USA alleges that requiring blood lead tests for all 

Medicaid eligible children without regard to a priority system 

will result in significant delays in providing blood lead tests 

for high risk children because some states, unspecified as to 

identity or number, do not have sufficient capacity to use the 

blood lead level tests. For any location without inhouse capaci- 

ty for blood lead testing, the current nationwide laboratory 

testing services provide the capacity for the blood lead level 

testing. These laboratories are available to any location with 

express mail service [Nicar Declaration; Rosen affidavit pages 

10-12]. There is no lack of "capacity" if HCFA is really willing 

to pay for blood lead level testing for all Medicaid eligible 

children. 

4. The USA alleges as a fact that the continued use of the 

EP test is based on the USA’s taking into account the current 

advances in scientific knowledge about lead screening procedures. 

This allegation is disputed by the significant sources of scien- 

tific knowledge about the use of EP as a lead screening procedure 

which contradict the USA’s position. One of these scientific 

sources is a study and report authored in part by the USA’s 

affiant, Sue Binder, MD. 

4.1. Dr. Binder is an author of the article "Evaluation of 

  

2 This is the affidavit of John F. Rosen, MD. filed with the 
amicus pleadings of the interveners. 

5  



  

the erythrocyte protoporphyrin test as a screen for elevated 

blood lead levels" October 1991, Journal of Pediatrics, 548-550 

[copy attached to Beshara declaration]. Dr. Binder’s study 

reported that the EP test was able to detect only 26% of the 

children with elevated blood lead levels > 10 ug/dL [table page 

549]. The report concludes "For identification of the children 

with BPb levels of 10 to 24 ug/dl, another screening method, 

probably BPb measurement, will be needed" [page 550]. 

4.2. The federal Agency for Toxic Substances and Disease 

Registry [ATSDR] filed its "The Nature and Extent of Lead Poison- 

ing in Children in the United States: A Report to Congress" in 

1988. The Report analyzed the existing research on the reliabili- 

ty of the EP test as a screening test for lead poisoning. "Analy- 

sis of data from the second National Health and Nutrition Exami- 

nation Survey (NHANES II) by Mahaffey and Annest (1986) indicates 

that Pb-B levels in children can be elevated even when EP levels 

are normal. Of 118 children with Pb-B levels above 30 ug/dl (the 

CDC criterion level at the time of NHANES II), 47% had EP levels 

at or below 30 ug/dl, and 58% (Annest and Mahaffey, 1984) had EP 

levels less than the current EP cutoff value of 35 ug/dl (CDC, 

1985)". HHS concluded "This means that reliance on EP level for 

initial screening can result in a significant incidence of false 

negatives or failures to detect toxic Pb-B levels." page II-9. 

4.3. The 1991 U.S. Department of Health and Human Services 

"Strategic Plan for the Elimination of Childhood Lead Poisoning" 

correctly forecast the 1991 CDC actions lowering the level of 

 



  

blood lead which should be taken as a symptom of lead poisoning. 

"In 1991 CDC will likely issue new recommendations suggesting 

that screening programs attempt to identify children with blood 

lead levels below 25 ug/dL." HHS, "Strategy", 1991, page 23. The 

HHS "Strategic Plan" correctly stated that the CDC action should 

mean an end to the use of EP testing for childhood lead screen- 

ing. "This change will mean that blood lead measurements must be 

used for childhood lead screening instead of EP measurements." 

HHS, "Strategy", 1991, page 23 (emphasis added) [excerpts at- 

tached to Beshara declaration]. 

5. The USA denies that financial considerations played any 

part in its decision to allow the continued use of the EP test. 

Dr. Sue Binder, the USA’s affiant, states the following in her 

1991 Journal of Pediatrics article: "The EP test has several 

practical advantages: it is inexpensive and easy to perform, and 

it can identify iron deficiency in children." [page 550]. 

6. The USA alleges that the HCFA guidelines are compatible 

with the CDC’s 1991 position on the use of verbal questions to 

determine whether a child is at high or low risk. The USA then 

uses this fact to imply that the HCFA guidelines allowing the use 

of the EP test for "low risk" children are also compatible with 

the 1991 CDC statement. This implication is false. The CDC 1991 

statement allows the use of verbal questions to determine high or 

low risk only if the child is given a blood lead level test no 

matter what the risk characterization. 

6.1. Page 42 of the October 1991 CDC statement unequivocally 

 



  

states "The questions are not a substitute for a blood lead 

test." (emphasis in the original). 

6.2. HCFA itself has recognized the need to confirm the 

verbal screening with a blood lead test no matter what category 

of risk the answers would seem to justify. "We agree that re- 

sponses to questions are not a substitute for a blood lead test." 

[Aug. 6, 1992 letter from Christine Nye, Director Medicaid 

Bureau, to Julius Chambers, Director-Counsel NAACP Legal Defense 

and Educational Fund, Inc. attached to interveners’ complaint]. 

7. The Federal Centers for Disease Control states "Screening 

should be done using a blood lead test. Since erythrocyte proto- 

porphyrin (EP) is not sensitive enough to identify more than a 

small percentage of children with blood lead levels between 10 

and 25 ug/dL and misses many children with blood lead levels > 25 

ug/dL (McElvaine et al., 1991), measurement of blood lead levels 

should replace the EP test as the primary screening method." 

[CDC, "Preventing Lead Poisoning in Young Children", 1991, page 

411- 

8. The EP test does not provide an assessment of blood lead 

levels that is appropriate to any age or risk. 

8.1. "This change [lowering the level of blood lead levels 

by CDC] will mean that blood lead measurements must be used for 

childhood lead screening instead of EP measurements." HHS, 

"Strategic Plan", 1991, page 23 (emphasis added). The USA's 

affiant, Sue Binder, MD., is a principal author of the "Strategic 

Plan". This statement that blood lead measurements "must" be used 

 



  

instead of EP is at least inconsistent with the position in her 

affidavit that the EP test is an effective screening test for 

childhood lead poisoning. 

8.2. The USA knows that the EP test is not an appropriate 

lead blood level assessment for any age and risk factors. The 

9/19/92 HCFA amendment acknowledges this. "The erythrocyte 

protoporphyrin (EP) test is not sensitive for blood lead levels 

below 25 ug/dL." 

8.3. The HHS "Strategic Plan for the Elimination of Child- 

hood Lead Poisoning", 1991 states "At present it is much cheaper 

and easier to perform an EP test than a blood lead measurement; 

however, the EP test is not a useful screening test for blood 

lead levels below 25 ug/dL." [Page 40]. The USA’s affiant, Sue 

Binder, MD., is a principal author of the "Strategic Plan". 

8.4. The Hiscock declaration admits that the EP test does 

not measure blood lead levels and that only the blood lead test 

directly measures blood lead levels [Hiscock Declaration { 9., 

page 5]. The EP test measures only the level of erythrocyte 

protoporphyrin in the blood [Hiscock Declaration q 9; Binder 

Declaration q 14]. 

8.5. If the EP test is used as an assessment of blood lead 

levels, only 27% of the children whose actual blood lead levels > 

10 ug/dL will be identified [Binder study table page 549, at- 

tached to Beshara declaration]. 

8.6. The EP test does not provide an assessment of blood 

lead levels at any level [Rosen affidavit pages 8-9]. The EP test 

 



  

discovered only 73% of the high risk children with blood lead 

levels > 25 ug/dl in the Binder study area. The EP test accurate- 

ly assessed only 26%, 42%, and 50% of the high risk children with 

elevated lead levels in other national and local studies [Binder 

study page 549, results of NHANES II overall and high risk 

subset, and Oakland study, attached to Beshara declaration]. 

9. The new HCFA guidelines are not consistent with the CDC 

1991 statement. 

9.1. The new HCFA guidelines allow the use of the EP test 

for the screening of children ranked "low risk" as a result of 

the verbal screening. CDC 1991 states: 

"The questions are not a substitute for a blood lead test" 

[CDC page 42]. 

"If the answers to all questions are negative, the child is 

at low risk for high-dose lead exposure and should be screened by 

a blood lead test at 12 months and again, if possible, at 24 

months (since blood lead levels often peak at ages greater than 

12 months)" [CDC 1991 page 43]. 

9.2. The new HCFA guidelines allow the use of EP testing for 

the follow up screening of high risk children whose initial blood 

lead level test results in a finding < 10 ug/dl. "If the initial 

blood lead test results are less than (<) 10 micrograms per 

deciliter (ug/dL), a screening EP test or blood lead test is 

required at every visit prescribed in your EPSDT periodicity 

schedule through 72 months of age." [HCFA 5123.2.D.c(2) High 

Risk]. CDC 1991 requires all subsequent screening to be done 

10 

 



using the blood lead test [CDC 1991 page 44]. 

10. Nothing in the new HCFA guidelines restricts the permis- 

sion to use the EP test to states which do not have the "capaci- 

ty" to administer blood lead tests. 

B. Issues on which discovery is needed 
  

1. The USA alleges several facts surrounding the process by 

which the new HCFA guidelines were developed. Plaintiffs believe 

that these facts are irrelevant to the issues before the Court. 

The USA’s allegations involve allegations of input and consulta- 

tion that plaintiffs have no ready access to or means of confirm- 

ing. The USA’s facts on consultation and input are completely 

within the control of the federal agencies involved. It is 

unlikely that any federal employee would even be willing to give 

an affidavit which did not corroborate the USA’s position. The 

USA’s motion was filed while plaintiffs are prohibited from 

obtaining merits discovery by the Local Rules. If the Court 

believes these allegations are relevant, plaintiffs request that 

the Court either refuse the application or order a continuance 

for plaintiffs to conduct discovery on these allegations. 

2. The USA alleges that there is a lack of "capacity" in 

some unspecified states which lack supports the continued use of 

the EP test. The USA furnishes no single specific instance of a 

state without the capacity. The facts upon which the USA relies 

are completely within the control of the USA. There has not been 

enough time to even attempt to obtain affidavits from each of the 

50 states on the issue of capacity. Affidavits are not likely to 

12  



  

be a good source of reliable evidence since each state will have 

a vested financial interest in at least understating its capacity 

for administration of blood lead tests. Plaintiffs have not been 

able to do any discovery on this issue because of the stage of 

the case and the Local Rule prohibiting merits discovery while 

the class motion is pending. While plaintiffs believe that the 

declarations of Rosen and Nicar put into dispute the factual 

issue of "capacity", plaintiffs request the Court to either 

refuse the application for judgment or order a continuance and 

allow plaintiffs the opportunity to conduct discovery on the 

USA’s lack of capacity allegations. 

3. The USA makes the factual allegation that the federal 

Centers for Disease Control [CDC], as an agency, believes that 

the new HCFA guidelines are consistent with the CDC’s 1991 

Statement. The only factual support for the allegation is the 

single statement by Sue Binder, MD., and employee of CDC. Dr. 

Binder is not the head of CDC and her statement does not set out 

the authority she has to make such a statement on behalf of the 

agency. Given that CDC is an agency of the USA, it is unlikely 

that plaintiffs will be able to obtain voluntary and candid 

affidavits setting out the facts underlying Dr. Binder’s state- 

ment from other federal employees. Given the explicit contradic- 

tions between major parts of the HCFA guidelines and the CDC 1991 

Statement on the use of the EP test, discovery of documents and 

depositions of witnesses are necessary to develop the issue of 

CDC's position on the issue. Plaintiffs have not been able to do 

12 

 



  

such discovery because of the stage of the case and the Local 

Rule prohibiting merits discovery until the class questions are 

resolved. Plaintiffs request the Court to either refuse the 

application for judgment or order a continuance to allow plain- 

tiffs the opportunity to conduct discovery on the issue. 

C. Issues of law 
  

1. Do plaintiffs have standing to bring this suit? 

2. Does the USA’s continued support for and financing of the 

states’ use of the EP test as a screening test for childhood lead 

poisoning in the Medicaid/EPSDT program violate the provisions of 

the Medicaid Act, 42 U.S.C. §1396d4(r)>? 

D. Conclusion 
  

Plaintiffs have met their burden to show that, based on the 

factual evidence, the USA is not entitled to summary judgment. 

Each of the critical fact issues upon which the USA relies has 

been met by credible evidence in either the declarations of Rosen 

and Nicar or in the written statements of federal agencies or 

employees such as Dr. Binder. The motion should be denied. 

13 

 



  

Respectfully submitted, 

MICHAEL M. DANIEL, P.C. 

3301 Elm Street 
Dallas, Texas 75226-1637 
(214) 939-9230 (telephone) 
(214) 939-9229 (facsimile) 

sp NEL Bi of 
Michael M. Daniel 

State Bar No. 05360500 

  

By Xana A Ae iusa 
“Tah ra B. Beshara 

State Bar No. 02261750 

  

ATTORNEYS FOR PLAINTIFFS 

CERTIFICATE OF SERVICE 

I certify that a true and correct copy of the above document 
was served upon counsel for defendant by being placed in the U.S. 
Mail, first class postage prepaid, on the XQ 3{£ day of 

oem, 1992. 

Se ura A. 2en/ a 
i ra B. Beshara 

  

  

  

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¥    
550 McElvaine et al. 

of iron deficiency in the Chicago children (a largely minor- 

ity, inner-city population) may have been higher than in the 

NHANES II children (a representative sample of U.S. 

children); unfortunately, in this study, no data were avail- 

able to assess the iron status of the Chicago children. 

These data indicate that the EP test performed accept- 

ably as a screening test for BPb levels =25 ug/dl in the 

high-risk Chicago population but that when the definition 

of an elevated BPb level was lowered to =15 ug/dl, the 

sensitivity of the EP test decreased to 37%. This decrease 

makes it a less useful screening test for BPb levels in the 10 

to 24 ug/dl range. 

The EP test has several practical advantages: it is inex- 

pensive and easy to perform, and it can identify iron defi- 

ciency in children.’ The sensitivity of the EP test is also good 

for identifying children with very high BPb levels, those who 

most urgently need follow-up. For identification of the chil- 

dren with BPb levels of 10 to 24 ug/dl, another screening 

method, probably BPb measurement, will be needed. Such 

screening would be facilitated by the development of 

cheaper, easier-to-use, portable instruments for measuring 

BPb lead levels accurately at the new, lower levels of con- 

cern. 

Information on the Childhood Lead Screening Program was 

provided by Charles R. Catania, City of Chicago Department of 

Health. Thomas D. Matte, MD, and Jeffrey J. Sacks, MD, of the 

Centers for Disease Control, provided valuable editorial assistance 

in the preparation of this manuscript. The NHANES 11 data tapes 

were supplied by the National Center for Health Statistics. Data 

management was assisted by Mary Boyd, of CDC, and Nance Du- 

laj, of the City of Chicago Department of Health Laboratory. 

  

¢ 
The Journal of Pediatrics 

October 1991 

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I. Centers for Disease Control. Preventing lead poisoning in 

young children: a statement by the Centers for Disease Con- 

trol. CDC Report No. 99-2230. Atlanta, Ga.: U.S. Department 

of Health and Human Services, 1985. 

2. Agency for Toxic Substances and Discase Registry. The nature 

and extent of lead poisoning in children in the United States: 

a report to Congress. Atlanta, Ga.: U.S. Department of Health 

and Human Services, 1988. 

3. California Department of Health Services. Childhood lead 

- poisoning in California, extent, causes and prevention: report 

to the California State Legislature. Sacramento, Calif.: State 

of California Health and Welfare Agency, 1991. 

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5. Piomelli S, Seaman C, Zullow D, Curran A, Davidow B. 

Threshold for lead damage to heme synthesis in urban children. 

Proc Natl Acad Sci USA 1982;79:3335-9. 

6. Hammond PB, Bornschein RL, Succop P. Dose-cffect and 
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toporphyrin in young children. Environ Res 1985;38:187-96. 

7. Lamola AA, Joselow M, Yamane T. Zinc protoporphyrin 

(ZPP): a simple, sensitive, fluorometric screening test for lead 

poisoning. Clin Chem 1975:;21:93-7. 

8. Blanksma L. Lead: atomic absorption method. In: Levinson 

SA, MacFate RP, eds. Clinical laboratory diagnosis. Philadel- 

phia: Lea & Febiger 1969:461-4. 
9. Mahaffey KR, Annest JL. Association of erythrocyte proto- 

porphyrin with blood lead level and iron status in the Second 

National Health and Nutrition Examination Survey, 1976— 

1980. Environ Res 1986:;41:327-38. 

10. Marcus AH, Schwartz J. Dose-response curves for erythrocyte 

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Res 1987;44:221-7.