Temporary Restraining Order

    IN THE UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF TEXAS 

DALLAS DIVISION 

LOIS THOMPSON on behalf of and 

as next friend to TAYLOR 
KEONDRA DIXON, ZACHERY X. 

WILLIAMS, CALVIN A. THOMPSON 

and PRENTISS LAVELL MULLINS, 

Plaintiffs, 

No. 3-92 CV 1539-R 

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, 

Defendants. 

O
X
 

OE
 

OX
 

NH
 
OX

 
XH
 
X
H
 

¥ 
XH

 
FH
 
ON

 
NH

 
FH
 

¥ 
¥ 

¥ 
F*

 
¥ 

TEMPORARY RESTRAINING ORDER 
  

I. Preliminary relief sought 

The USA continues to sanction, support, and finance the use 

of the totally ineffective and deceptive EP test as the States’ 

primary screening test for childhood lead poisoning. The contin- 

ued use of the EP test will subject hundreds of thousands of poor 

children to the irreversible effects of lead poisoning. These 

injuries are entirely preventable for many children if the USA 

and the States would comply with the Medicaid statute and use the 

blood lead level test which all authority, including the U.S. 

Department of Health and Human Services, recognizes as the only 

medically and scientifically appropriate blood test for lead 

poisoning diagnosis, treatment, and prevention. 

Plaintiffs seek a temporary restraining order enjoining 

1 

 



  

defendant the USA, through the actions of HCFA, from supporting, 

allowing or financing the States’ use of the EP test as an appro- 

priate screening test for lead poisoning and ordering defendant 

USA, through the HCFA, to require the States to use a blood lead 

level test as a screening device for childhood lead poisoning. 

Plaintiffs also seek a preliminary injunction that continues the 

temporary relief. 

Plaintiffs’ motion for a temporary restraining order is 

granted for the reasons set out below. Defendant USA, through 

the actions of HCFA, is enjoined from supporting, allowing or 

financing the States’ use of the EP test as an appropriate 

screening test for lead poisoning in the EPSDT program and is 

ordered, through the HCFA, to require the States to use a blood 

lead level test as a screening device for childhood lead poison- 

ing in the EPSDT program. The Secretary of the U.S. Department of 

Health and Human Services, the Honorable Louis W. Sullivan, is 

the federal official personally responsible for compliance with 

the terms of this order pursuant to the authority and require- 

ments of 5:U.8.C. §.-702, 

Plaintiffs’ motion for preliminary injunction is set for 

hearing on at . 
  

II. Probable Success on the Merits 

A. Relevant legal principles 
  

1. The USA through the actions of the U.S. Department of 

Health and Human Services [HHS] and the Health Care Financing 

Administration [HCFA], a division of HHS, administers the Early 

 



  

Periodic Screening, Diagnostic, and Treatment program under the 

Medicaid Act, 42 U.S.C. § 1396d(r). 

2. The Medicaid Act requires the States to provide certain 

mandatory health care services to eligible low-income children. 

Among these mandatory services are "early and periodic screening, 

diagnostic, and treatment (EPSDT) services ... for individuals 

who are eligible under the [state] plan and are under the age of 

21." 42 U.S.C. § 1396d(a)(4)(B). 

3. These EPSDT services are required to include "screening 

services... which shall at a minimum include laboratory tests 

(including lead blood level assessment appropriate for age and 

risk factors)...." 42 U.S.C. § 1396d(r)(1)(B)(iv). The EPSDT 

services must provide treatment for the effects of lead exposure 

discovered during the screen. 42 U.S.C. § 1396d(r). 

B. Probable violations of the Medicaid Act 
  

1. The USA implements the requirements of the Medicaid Act 

through regulations and non-requlatory guidelines issued to the 

states. The primary non-regqgulatory guideline is the HCFA "State 

Medicaid Manual". 

2. The current State Medicaid Manual states "In general, use 

the EP test as the primary screening. Perform venous blood lead 

measurements on children with elevated EP levels." 

3. The amendments to the State Medicaid Manual, to take 

effect on Sept. 19, 1992 continue to sanction the use of the EP 

test as the primary screening test for lead poisioning in young 

children throughout the country. E.g. "States continue to have 

 



the option to use the EP test as the initial screening blood 

test." 

4. 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." 

5. The HHS "Strategic Plan for the Elimination of Childhood 

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]. 

6. The HHS "Strategic Plan" 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. 

7. The HHS "Strategic Plan" correctly stated that the CDC 

action should mean an end to the use of EP testing for childhood 

lead screening. "This change will mean that blood lead measure- 

ments must be used for childhood lead screening instead of EP 

measurements." HHS, "Strategy", 1991, page 23 (emphasis added). 

8. The class members are children eligible for Medicaid. All 

of these children, because of their age and the environmental 

conditions in many areas of the country, are at risk of lead 

poisoning. Many of them are at a high risk for lead poisoning. A  



substantial percentage have lead poisoning. 

9. Rather than comply with the Medicaid requirements of lead 

blood level assessment and treatment for the lead exposure 

discovered, defendant USA has deliberately and willfully chosen 

to disobey that mandate. Instead of requiring the States to test 

for blood lead level, defendant USA allows, encourages, and 

provides financial assistance for the use a laboratory test to 

detect levels of Erythrocyte Protoporphin (EP) as the primary 

screening test for childhood lead poisoning.l While elevated EP 

levels can exist along with elevated blood lead levels, the 

Federal Centers for Disease Control prescribes "Screening should 

be done using a blood lead test. Since erythrocyte protoporphin 

(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 41]. 

10. HHS’s 1988 "The Nature and Extent of Lead Poisoning in 

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

existing research on the reliability of the EP test as a screen- 

ing test for lead poisoning and concluded "This means that 

reliance on EP level for initial screening can result in a 

  

! The blood lead level tests given to plaintiffs were not 
given as part of the normal EPSDT screening but were rather an 
accomodation of a special request. The Carver clinic, where 
plaintiffs receive their EPSDT services, continues to use the EP 
test as its primary blood lead screening indicator. 

5  



  

significant incidence of false negatives or failures to detect 

toxic Pb-B levels." page II-9. 

11. The statute requires blood lead tests, not EP tests. 

Defendant USA’s only rationale for the continued use of the EP 

test is that it is cheaper than the mandated blood lead level 

tests. 

12. Defendant USA’s continued financial and administrative 

support for the States’ use of the EP test violates the Medicaid 

Act, 42 U.S.C. § 1396d(r)(1)(B)(iv) and is a cause of the States’ 

violations of the statute. 

III. Irreparable Injury 

A. Injury from failure to require the states to use blood 
  

lead test 
  

Plaintiffs have already incurred injury from defendant’s 

failure to require the States’ use the blood lead level test. 

They went from November, 1991 to May, 1992 diagnosed as without 

indication of lead poisoning. Even though each plaintiff has now 

obtained a blood lead test indicating poisoning, that diagnosis 

is outside of the EPSDT screening system and the plaintiffs are 

not receiving EPSDT treatment for the condition. The USA as of 

September 19, 1992 is continuing to sanction the use of the EP 

test as a screening device, so when the plaintiffs continue in 

the EPSDT screening system they may never receive the appropriate 

blood lead test. 

The other class members in the country who were either not 

tested or tested only with the EP test continue to go undiagnosed 

 



  

by a proper blood lead level assessment procedure and those with 

lead poisoning continue to go untreated. The irreversible 

effects of childhood lead poisoning are the irreparable injury 

caused by defendant’s wrongful conduct. 

IV. Balance of harms 

There is no legally cognizable harm to the defendant. 

Defendant is merely being ordered to comply with the requirements 

of the Medicaid Act which require a "lead blood level assessment" 

as part of the EPSDT screens. 42 U.S.C. § 1396d(r)(1)(B) (iv). 

The only harm that could be asserted by defendant USA is 

that the EP test is cheaper to perform than a blood lead test. 

Unfortunately, the real cost, as defendant has found, will 

be the loss to our country as a whole since "Lead exposure among 

U.S. children has been estimated to cost society billions of 

dollars annually (e.g., Levin, 1986)." HHS, "Strategic Plan For 

the Elimination of Childhood Lead Poisoning," February 1991 

[Appendix II, Page 1]. In light of the severe harm to our 

country’s children and the great cost of ignoring the problem, 

the required use of a blood lead test that is accurate instead of 

the EP test that misses completely lower levels of lead poisoning 

and is grossly inaccurate in diagnosing high levels of lead 

poisoning will not harm the USA. 

Public interest 

Ending childhood lead poisoning is a national policy of the 

highest priority. 

"Lead poisoning remains the most common and societally 
devastating environmental disease of young children...Poor, 

7 

 



  

minority children in the inner cities, who are already disadvan- 
taged by inadequate nutrition and other factors, are particularly 
vulnerable to this disease [page xi]...Children should be 
screened for elevated blood lead levels so that affected children 
will receive appropriate medical attention and environmental 
follow-up [page xii]...Furthermore, lead poisoning is entirely 
preventable. We understand the causes of lead poisoning and, most 
importantly, how to eliminate them [page xiii]" U.S. Department 
of Health and Human Services, Public Health Service, Centers for 
Disease Control, February 1991. 

Congress has incorporated this policy into the Medicaid Act. 

The public interest cannot help but be served by orders requiring 

defendant to properly diagnose and treat lead poisoning in little 

children. 

V. Preliminary relief bond 

Plaintiffs are children in a very low-income family as are 

the other class members. There is no cognizable financial harm 

to defendant. Plaintiffs’ request that the Court waive bond, 

Fed. R. Civ. P. 65(c), is granted. The Court has determined that 

the amount of security required is $0.00. 

  

  

Date United States District Judge