`
`UNITED STATES DISTRICT COURT
`
`FOR THE EASTERN DISTRICT OF MICHIGAN
`
`SOUTHERN DIVISION
`
`
`In Re Flint Water Cases,
`
`No. 5:16—cv—10444—JEL—MKM
`
`(consolidated)
`
`Hon. Judith E. Levy
`
`Mag. Mona K. Majzoub
`
`
`
`Anderson, et al.,
`
`No. 5:17-cv—l3 890—JEL—MKM
`
`Plaintifls
`
`v.
`
`City ofFlint, Michigan, et 61].,
`
`Defendants.
`
`
`
`OBJECTIONS OF DR. LAWRENCE A. REYNOLDS, M.D., FAAP
`REGARDING THE PROPOSED FLINT WATER SETTLEMENT
`
`AGREEMENT
`
`Pursuant to the Revised Settlement Agreement, ECF 1394—2, PageID.54184,
`
`Article XX — Objections, filed with this Cou1t on January 15, 2021, the following
`
`are my “.
`
`.
`
`. written objections why
`
`(I) believe the Settlement Agreement, as
`
`currently proposed, for the sections discussed in this objection only, should not be
`
`approved...” by this Court:
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55022 Filed 02/26/21 Page 2 0f 30
`
`My name is Dr. Lawrence A. Reynolds, MD, FAAP.
`
`I am a resident of the
`
`city of Flint, living in the 9th Ward, since 1991. My wife, Dr. Jacquinne Reynolds,
`
`and I raised our three children and a niece in Flint, Michigan.
`
`Professionally, my qualifications and experience,1 include:
`
`I am a graduate of Howard University School of Medicine (1979);
`
`I am a Board Certified Pediatrician, certified by the American Board of
`
`Pediatrics;2
`
`I practiced pediatric medicine for nearly 40 years, retiring fi‘om clinical
`
`practice 4 years ago to assist in a broader community health focus;
`
`I am the former President and Chief Executive Officer of Mott Children’s
`
`Health Center3 in Flint, Michigan;
`
`
`
`‘ Objection Exhibit 1 — Complete Curriculum Vitae of Dr. Lawrence A. Reynolds, MD, FAAC.
`
`2 Founded in 1933, the American Board of Pediatrics (ABP) is one of the 24 certifying boards of
`the American Board of Medical Specialties (ABMS). The ABP is an independent, nonprofit
`organization whose certificate is recognized throughout the world as a credential certifying a
`high level of physician competence. Objection Exhibit 2 — The American Board of Pediatrics,
`History of the ABP.
`
`3 A brief description from the web site: Mott Children’s Health Center was founded nearly 80
`years ago with afocus on children ’s health. Today, we have the same focus — the overall health
`and well—being of our community’s children. For us, patient care comes first. No eligible child
`will be turned away. To do this, we are guided by our core values.
`
`We deliver quality, reliable medical, dental and behavioral services based on each child’s needs
`— from basic to specialty care. Our team also advocates for children’s health and provides health
`education and prevention programs within the Genesee County community.
`It’s true, children’s
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55023 Filed 02/26/21 Page 3 0f 30
`
`I practiced pediatric medicine at Hurley Medical Center and had regular
`
`close contact with Dr. Mona Hanna-Attisha regarding pediatric lead poisoning in
`
`Flint, Michigan;
`
`I was appointed by Governor Rick Snyder as a member of the 2015 Flint
`
`Water Advisory Task Force (FWATF)4,
`
`the 2016 Flint Water
`
`Interagency
`
`Coordinating Committees, and the
`
`2017 Environmental Justice Work Group
`
`(EJWG)6;
`
`I am currently an At—Large Board Member of the Greater Flint Health
`
`Coalition7;
`
`I am the former President of the Genesee County Medical Society;
`
`
`
`4 The FWATFH—composed of five members with experience and backgrounds in public policy,
`public utilities, environmental protection, public health, and health care—was appointed by
`Governor Rick Snyder on October 21, 2015. We were charged with conducting an independent
`review of the contamination of the Flint water supply: what happened, why it occurred, and what
`is needed to prevent a reoccurrence in Flint or elsewhere in the state. Objection Exhibit 3, Flint
`Water Advisory Task Force, Final Report, March 21, 2016.
`
`5 The Flint Water Interagency Coordinating Committee, was created by Executive Order 2016-1,
`January 11, 2016. Objection Exhibit 4.
`
`6 An excerpt from the Executive Summary of the 2018 report from the Environmental Justice
`Work Group (EJWG) defined our work as “The EJWG was charged “to develop and provide
`recommendations
`to the Governor
`that
`improve
`environmental
`justice awareness
`and
`engagement in state and local agencies. The EJWG will examine policy and recommend for
`implementation environmental justice guidance, training, curriculum, and policy that further
`increases quality of life for all Michiganders.” Objection Exhibit 5.
`
`7 A brief description from their web site of the Greater Flint Health Coalition:
`
`Mission — Improve the health status of our residents. Improve the quality and cost effectiveness
`of the health care system in our community.
`
`Vision — A healthy Genesee County community practicing healthy lifestyles with access to the
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55024 Filed 02/26/21 Page 4 0f 30
`
`I am the former president of the Michigan Chapter of the American
`
`Academy of Pediatricss;
`
`Between 1993 and 2001, I was the Medical and Clinical Director of the
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`Hamilton Family Health Center, now known as the Hamilton Community Health
`
`Network;
`
`I am currently the Health Advisor to the Mayor of the City of Flint,
`
`responsible for coordinating with the Genesee County Health Department and the
`
`Genesee County Emergency Operations Center regarding the response to the
`
`Covid—l9 crisis in Genesee County;
`
`Since 2015,
`
`I have been involved with the lead crisis
`
`in Flint,
`
`the
`
`Legionnaires’ crisis in Flint, the Hepatitis-A outbreak in Genesee County, and now
`
`the Covid-l9 crisis in Genesee County;
`
`In 2015, on behalf of the Greater Flint Health Coalition, I was a member of a
`
`group of community organizations, non-profits, and physicians, that approached
`
`the Flint area state~level elected officials and requested their assistance in
`
`contacting Genesee County officials to ensure that a public health emergency was
`
`declared in Flint regarding the contamination of the water in Flint;
`
`
`
`8 A brief description from their website: The Michigan Chapter of the American Academy of
`Pediatrics is committed to improving the physical, mental and social health of Michigan’s
`infants, children, adolescents and young adults; partnering with pediatric providers, parents and
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55025 Filed 02/26/21 Page 5 0f 30
`
`In my capacity as a doctor,
`
`the focus of my work has been in health
`
`advocacy for the underserved parts of the Flint community, applying the greater
`
`public health knowledge/data within the Flint community; and
`
`In my involvement with the Flint Water Crisis I have been in regular
`
`discussions with local, state, and national
`
`leaders in public health, pediatric
`
`medicine, several types of engineers, and metallurgists.
`
`Pursuant to Article XX — Objections, Section 20.1, my written statement of
`
`objection follows:
`
`ALL OF MY OBJECTIONS BEGIN WITH THE SAME PREMISE:
`
`FOR MORE THAN A YEAR THE STATE OF MICHIGAN OFFICIALS
`
`TOLD RESIDENTS OF FLINT THERE WAS NOTHING WRONG WITH
`
`THEIR DRINKING WATER.
`
`I. OBJECTION TO BONE LEAD TESTING
`
`My First Objection is that the use of Bone Lead testing results in Settlement
`
`Categories 19, 2, 3, 4, 8, 9, 10, 11, 15, 16, 17, and 18, regarding children, and
`
`
`
`9 The specific language, quoted from Settlement Category 1 regarding children under the age of
`six (6) at the time of their first exposure to Flint Water, ECF 1319-2, Exhibit B, PageID.40791
`provides:
`
`Bone Lead Test: Test with an X—Ray fluorescence (XRF) device optimized to measure bone
`lead in vivo in humans and to perform measurements of in vivo bone lead in bones. Test must
`have been taken between May 16, 2014, and 90 days after the date of the Preliminary Approval
`Order, except that the end date of 90 days after the date of the Preliminary Approval Order shall
`not be applied to Future Minor Claimants, who shall not be subject to that end date restriction.
`XRF bone test results must be signed and verified as properly calibrated, reliable and accurate by
`a board-certified PhD and/or M.D. qualified to do so in the appropriate fields of study.
`
`For the remaining categories, 2, 3, 4, 8, 9, 10, 11, 15, 16, 17, and 18, regarding children and 22,
`23 and 25, regarding adults, the required proofs are described as: Blood or Bone tests: as
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55026 Filed 02/26/21 Page 6 0f 30
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`Settlement Categories 22, 23, and 25, regarding adults, by use of the XRF hand—
`
`held device is not appropriate in any setting.
`
`In January 2021 I was
`
`informed by Attorney Michael Pitt,
`
`in a
`
`teleconference that a pediatrician for the project involving the use of the XRF
`
`hand—held device was needed and it was suggested that I be that person. After
`
`expressing strong reservations and concerns along with subsequent personal
`
`research and review, I declined to become the pediatrician for this project.
`
`It is my
`
`belief that any ethical medical practitioner should have declined as well.
`
`XRF is the acronym for X—ray fluorescence. As the name suggests, it is an
`
`X-ray.
`
`In a medical setting, limiting exposure to X—rays is required and X-rays
`
`should only be done if medically necessary ~ especially in the case of infants and
`
`children. Use of this unapproved10 industrial device to perform a bone scan on live
`
`humans in the settlement process as is being done,
`
`is at best, unauthorized
`
`research.
`
`It is neither a part of an approved diagnostic procedure, nor a proven
`
`beneficial treatment protocol, especially for children. It is not an approved practice
`
`by any global regulatory agency or professional body.
`
`It is being promoted by
`
`misinformed attorneys, for an undisclosed research project, not licensed medical
`
`practitioners. The XRF hand held device is not designed to be used on human
`
`It presents the risks of exposure to radiation without the benefit of
`beings — at all.
`
`
`1° Unapproved by the manufacturers of the portable XRF devices. Objection Exhibit 6 — TS—
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55027 Filed 02/26/21 Page 7 0f 30
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`any information that would change the mitigation interventions for the lead
`
`poisoned child or adult.
`
`The XRF hand-held device is made by several manufacturers. Included with
`
`this objection is the complete thirty-one (31) page e-book by one manufacturer -
`
`Thermo Fisher Scientific.
`
`(Objection Exhibit 6 - TS—eBook—XRF-Technology-in—
`
`the—field — XRF Technology for Non—Scientists). At page 14, the manufacturer
`
`states the following “These systems are routinely used for rapid quality control
`
`inspection and analysis to ensure product chemistry specifications are met.”
`
`Continuing at page 15, Thermo Fisher Scientific says “EDXRF is the technology
`
`commonly used in portable analyzers.
`
`and EDXRF is a convenient way to
`
`screen all kinds of materials for quick identification and quantification of elements
`
`from magnesium (Mg) to uranium (U).”
`
`Particularly relevant is the manufacturers statement at page 19:
`
`Did you know?
`
`While the radiation emitted from a portable XRF
`analyzer is similar to the exposure received in a normal
`medical or dental X—ray, care must be taken to always
`point a handheld XRF analyzer directly at the sample and
`never at a Qerson or a body gart. (emphasis added.)12
`
`
`
`‘2 Although the portable XRF machine is made by multiple companies, I have been unable to
`locate any documentation from any manufacturer indicating it is designed for, and is safe for use
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55028 Filed 02/26/21 Page 8 0f 30
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`In addition to the warning from Thermo Fisher Scientific, I was informed in
`
`a January 29, 2021, and one additional
`
`teleconference with three co-counsels that
`
`Napoli Shkolnik PLLC has received a letter from a manufacturer of a portable
`
`XRF device advising them their industrial device WOULD NOT BE CLEARED
`
`by them for use on humans.
`
`Should the court still determine that XRF test results should be used in these
`
`cases, the question arises regarding what warnings have or have not been given to
`
`persons tested or who might be tested. Dr. Arron Specht is NOT a medical doctor,
`
`and clearly, he is not a Board Certified Pediatrician. He has a PhD in Medical
`
`Physics. (Objection Exhibit 7, Aaron Specht
`
`| Harvard T.IH. Chan School of
`
`Public Health). He is currently a Research Assistant and states that he is interested
`
`in developing “. .. novel technologies to increase understanding of the role of
`
`environmental exposures in human health.” Objection Exhibit 7.
`
`In the medical setting, “novelty” means a clinical trial setting. This type of
`
`study requires at a minimum that there be approval and monitoring oversight by an
`
`Institutional Review Board, with the protections of informed consent after the
`
`patient has been provided information regarding the type of testing, the type of
`
`product to be used, any of the possible risks or dangers associated with the use of
`
`the product, and the involvement of a licensed medical doctor who is not involved
`
`in providing care to the test subject. Attached as Objection Exhibit 8 is a
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55029 Filed 02/26/21 Page 9 0f 30
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`document authored by the Food and Drug Administration (FDA) entitled
`
`“Regulations: Good Clinical Practice and Clinical Trials” which lists all of the
`
`protocols/requirements that must be followed in a clinical trial.
`
`I repeat in the strongest possible terms, my objection that the use of the
`
`portable XRF in any way to promote the settlement of this litigation,
`
`is an
`
`unauthorized/unsupeivised research project, masquerading as an accepted medical
`
`procedure, as a condition for compensation to claimants.13
`
`The Clinical Laborat01y Improvement Amendments of 1988 (CLIA),14
`
`requires all entities that perform even one single test, including a waived test on "...
`
`materials derived from the human body for the purpose of providing information
`
`for the diagnosis, prevention or treatment of any disease or impairment of, or the
`
`assessment of the health of human beings," to meet certain Federal requirements.
`
`They must have a CLIA certificate. If an entity performs tests for these purposes,
`
`it is considered under CLIA to be a laboratory and must register with the CLIA
`
`program.
`
`
`
`in China in 2016,
`I am aware of a research project conducted in part by Dr. Specht,
`13
`concerning the use of XRF—measured bone lead (Pb) as a biomarker for Pb exposure and toxicity
`among children diagnosed with Pb poisoning. Published in final edited form as: Biomarkers.
`2016 June ; 21(4): 347—352. doi:10.3109/1354750X.2016.1139183. The article does not address
`the use or approval for use on humans in the United States. See Supplemental Material.
`
`14 Objection Exhibit 9, LARA — Clinical Laboratory Services, for the Michigan Licensing and
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.5503O Filed 02/26/21 Page 10 0f 30
`
`Pursuant to the “Research Testing and Clinical Laboratory Improvement
`
`Amendments of 1988 (CLIA) Regulations” (see Objection Exhibit 12”):
`
`What types of research testing are subject to CLIA ?
`
`In most cases, research testing where patient—specific results are
`reported from the laboratory, and those results will be or could
`be used “for the diagnosis, prevention, or treatment of any
`disease or impairment of, or the assessment of the health of,
`human beings” are presumed to be subject to CLIA absent
`evidence to the contrary. (emphasis added)
`
`The use of XRF test results, as a part of the settlement process in this case,
`
`are clearly intended to be used for “...
`
`the assessment of the health of, human
`
`beings” where the test results are being used to determine in which Settlement
`
`Category a person is to be placed in, and how much compensation they will receive
`
`from the settlement funds for their original poisoning.
`
`According to
`
`the Michigan Department of Labor
`
`and Economic
`
`Opportunity, “Any X—ray machine, including a portable X—ray machine, is required
`
`to be registered with its Radiation Safety Section.” Objection Exhibitle and ll.
`
`Before any reliance is placed on the use of a portable XRF device“, Dr.
`
`Specht, and those attorneys advocating for the use of his experimental device, must
`
`be required to follow the laws and regulations of the United States of America and
`
`the State of Michigan to provide the following:
`
`
`1) A sworn, written statement
`
`'5 Objection Exhibits 10 and 11, also discuss the registration process for X-ray machines.
`Registration and certification of all X—ray machines is required before their use in Michigan.
`16 Mt. Sinai Hospital in New York City does use a medical grade XRF testing device. However,
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.5503l Filed 02/26/21 Page 11 0f 30
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`from the specific device manufacturer that the device is designed to be and is
`
`approved for use on human beings. 2) The current, mandatory State of Michigan
`
`registration. 3) The documentation demonstrating that Dr. Specht is complying
`
`with CLIA. 4) The documentation given to the parents of the children being tested
`
`that demonstrates they have been completely informed and agree that their children
`
`can be used in a research project”. This same information must also be provided
`
`for the adults that are being tested with this device.
`
`Simply put, my objection is that the use of XRF bone scans are not
`
`appropriate for use on any claimant in this case for any reason.
`
`ALL OF MY OBJECTIONS BEGIN WITH THE SAME PREMISE:
`
`FOR MORE THAN A YEAR THE STATE OF MICHIGAN OFFICIALS
`
`TOLD RESIDENTS OF FLINT THERE WAS NOTHING WRONG WITH
`
`THEIR DRINKING WATER.
`
`II. OBJECTION TO BLOOD LEAD TESTING RESULTS
`
`My Second objection is that the use of blood lead testing results for samples
`
`“taken during the period of May 16, 2014 through August 31, 2016” in Settlement
`
`Categories 118, 2, 3, 4, 8, 9, 10, 11, 15, l6, l7 and 18, regarding children, it’s use in
`
`
`
`‘7 Parents may consent to medical treatment for their children, but may not waive/release any claims of the child
`without Court approval as is identified in the Amended Settlement Agreement.
`18 Settlement Category 1, ECF 1319-2, Exhibit B, PageID.40790 -40791, Category Description
`provides “... (3) Tested between May 16, 2014 and August 31, 2016 with a blood lead level
`(“BLL”) at or above 10.0 mcg/dL; or tested between May 16, 2014, and 90 days after the date of
`the Preliminary Approval Order, with measurements of in vivo lead quantification in an
`individual’s bone at or above 10.0 ug/G.” The remaining categories, with the exception of
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55032 Filed 02/26/21 Page 12 0f 30
`
`Settlement Categories 22, 23 and 25, regarding adults, and samples taken between
`
`“May 16, 2014 and April 30, 2017” for women who miscarried in Settlement
`
`Category 26, regarding adults is also inappropriate.
`
`Unless there is an older toddler or child in the home with an elevated blood
`
`lead level or it is known that the water is contaminated with lead, a child health
`
`professional would not order blood lead testing for any child between birth and 8
`
`months of age. The American Academy of Pediatrics, the American College of
`
`Family Physicians, the Michigan Department of Health and Human Services, and
`
`the Center for Disease Control do not recommend blood lead screening until the
`
`child is becoming mobile — creeping and crawling on floors and standing, which
`
`occurs around nine months of age.19
`
`While Medicaid and W1C20 recipients must be screened for lead with a
`
`capillary or venous sample, the timing of that testing is critical. Unless there are
`
`clear occupational, cultural practices and remedies, and/or hobby exposures by
`
`adult activities in the child’s environment, blood lead tests would not be required
`
`for children unless they consumed water, formula, food or beverages prepared with
`
`Flint water between 2014 and 2016 subject to this rule. If the blood lead level test
`
`
`broken down by ages of first exposure, providing “Blood or Bone tests: as described in required
`proofs for Category 1” for required proofs.
`
`19 Objection Exhibit 13, Standard Surveillance Definitions and Classifications for Lead Testing.
`20 Medicaid is an insurance program for low/no—income persons/families. WIC provides services
`to Women, Infants and Children. A provider in that program provides a referral for a blood lead
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55033 Filed 02/26/21 Page 13 0f 30
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`is not performed during the time of highest consumption of contaminated water,
`
`the result is inaccurate based on the half—life21 of lead. If a test is performed more
`
`than 36 days after the peak consumption level, or before peak consumption, the
`
`results are flawed.
`
`The notion that every child should be or should have been tested is incorrect
`
`due to the actions of those State of Michigan Officials who were in charge of the
`
`City of Flint — as a result of concealment and denial by the State of Michigan
`
`actors,
`
`contractors,
`
`and local government officials under
`
`state
`
`appointed
`
`emergency managers, medical professionals practicing medicine in Genesee
`
`County in general, and the City of Flint in particular, were not made aware that the
`
`drinking water supply was contaminated.22 If this information had been disclosed
`
`to prevent further harm, health providers, families, local government, and health
`
`agencies would have required testing.
`
`Testing for lead, ordered by doctors, did not happen until
`
`independent
`
`environmental engineers, and a Hurley Medical Center pediatrician, Dr. Mona
`
`Hanna—Attisha, made the discovery of increased levels of lead in the blood of Flint
`
`children. The limitations of belated emergency blood lead level testing for either
`
`
`
`21 The time required for half of something to undergo a process: such as the time required
`for half of the atoms of a radioactive substance to become disintegrated. https://www.merriam—
`
`webster.com/dictionary/half—life
`22 Objection Exhibit 14 — ACS Publications, Flint Water Crisis Caused by Interruption of
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55034 Filed 02/26/21 Page 14 0f 30
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`children or adults only heightened the injury, uncertainty, and anxiety for Flint
`
`water customers. Those who did receive blood lead level testing did not regularly
`
`receive the testing at the time of the exposure to, and ingestion of contaminated
`
`water, so their test results are extremely low.23 How are the children to blame for
`
`this?
`
`There is no medical requirement that adults be subjected to periodic blood
`
`lead level testing, unless due to occupation or hobbies. Had it been revealed
`
`contemporaneously with exposure that adult Flint residents were exposed to
`
`improperly treated, corrosive water that
`
`leached lead from service lines or
`
`plumbing fixtures, a public health alert would have been announced and proper
`
`testing could have been required. Again, doctors practicing medicine in Genesee
`
`County in general, and the City of Flint in particular, were not aware that the water
`
`was contaminated so they did not regularly prescribe blood lead level testing.
`
`Those that did receive blood lead level testing did not regularly receive the testing
`
`
`23 At significant risk to her career, Hanna—Attisha revealed her findings at a September 24, 2015
`press conference before her research was scientifically peer reviewed, because of the public
`health implications. Hanna—Attisha's findings were later published in the American Journal of
`
`Public Health. Hanna Attisha's findings were confirmed in a Morbidity and Mortality Weekly
`
`Report published by the Center for Disease Control and Prevention (CDC) in July 2016, and is
`recognized as an underestimate of exposure.
`
`Dr. Hanna—Attisha's research was initially ridiculed by the State of Michigan, when a Michigan
`Department of Environmental Quality spokesperson accused her of being an "unfortunate
`researcher" "splicing and dicing numbers” who was causing "near hysteria."
`
`Objection Exhibit 15, Dr. Mona: Don't downplay lead problems, or solutions, for kids in Flint
`water crisis, an article written by Dr. Mona Hanna—Attisha explaining the inadequacy of the
`
`
`
`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PageID.55035 Filed 02/26/21 Page 15 0f 30
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`at the appropriate time. Once again, their test results are extremely low. How are
`
`the adults to blame for this?
`
`Inadequate testing and thus deceptively low blood lead level results for both
`
`children and adults lies squarely on the shoulders of the state of Michigan and/or
`
`City of Flint officials who repeatedly stated there was nothing wrong with the
`
`water in Flint and who engaged in a cover up.
`
`Further, the use of residential water lead test results or the presence of a lead
`
`or galvanized steel service line in Settlement Categories 524, 12 and 19 is similarly
`
`unfair. Flint residents were told to “flush” their water systems before collecting
`
`samples for testing. Once the city had knowledge of other contaminants from
`
`April 2014 and beyond, they attempted to flush out contaminated water lines by
`
`opening fire hydrants throughout the city. The corrosive damage and leaching of
`
`lead was already in progress. Protective inner pipe coatings - biofilm — built up by
`
`
`
`24 The language of Settlement Category 5, ECF 1319-2, Exhibit B, PagelD.40799 ~ 40800,
`regarding children who were under the age of six at
`the time of first exposure provides
`“Residence with water lead level of 15 ppb or higher: Water lead level test from: a laboratory
`certified by the State of Michigan; the list on the State of Michigan Flint Water Test Results
`website; the United States Environmental Protection Agency; or Virginia Polytechnic Institute
`and State University; with a result of 15 ppb or higher dated between May 16, 2014 and August
`31, 2016.
`
`01‘
`
`Residence with lead or galvanized steel service lines (“LSL”): City of Flint Report evidencing
`that Claimant’s residence had a LSL at the time of exposure to Flint water between April 25,
`2014 and July 31, 2016.”
`
`The language of Settlement Categories 12, PageId.4080 and 19, PageID.40816, required proofs
`provide “Water lead level and LSL: as described in required proofs for Category 5” for children
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`
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`years of using properly treated water had been disrupted and flushed away by
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`turbulent corrosive water flow. Officials discontinued any use of the proper
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`chemical treatments to prevent corrosion at the same time they added too much
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`disinfectant. These decisions accelerated pipe and fixture corrosion, releasing lead
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`and other contaminants into the tap water of homes and other buildings. The
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`responsible officials concealed the contamination by manipulating the EPA’s 1991
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`Lead and Copper Rule sampling protocol and providing invalid sample collection
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`instructions and improper collection bottles. Hundreds,
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`if not
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`thousands of
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`residential test kits were collected and delivered to various public collection sites
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`in Flint between 2014 and 2016. Today, many of those residents are still have not
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`received the water test results for their households City of Flint Water Department
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`officials and State of Michigan officials have publicly played “a blame game,”
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`each accusing the other of providing misleading information, yet acknowledging
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`that their record keeping in this regard is incomplete or inaccurate. 25
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` Today, when a person contacts the City of Flint to determine if they had a
` lead or galvanized steel service line at their house, they are given a form that
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`allows city employees to come look at
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`their property. Records were lost,
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`inaccurate, or illegible. Tap water has to be tested after the lead service line
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`replacement to be certain lead is not coming from damaged inside plumbing,
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`25 Objection Exhibits 16 and 17, articles regarding the inadequacy of Flint water testing and thus,
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`fixtures, or solder after the lead service line replacement. The blame for these
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`issues fell squarely on the City of Flint, but it is the residents, whether property
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`owner or renter or business servicing the Flint community, who again suffer
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`through this requirement in the partial settlement protocol.
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`ALL OF MY OBJECTIONS BEGIN WITH THE SAME PREMISE:
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`FOR MORE THAN A YEAR THE STATE OF MICHIGAN OFFICIALS
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`TOLD RESIDENTS OF FLINT THERE WAS NOTHING WRONG WITH ‘
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`THEIR DRINKING WATER.
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`III. OBJECTION TO THE USE OF MATERNAL/FETAL BLOOD
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`TEST RESULTS — MISCARRIAGES
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`My Third objection is to the use of maternal or fetal blood lead level test
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`results for those unfortunate women who suffered miscarriages between “May 16,
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`2014 and April 30, 2017 in Settlement Category 25, ECF 1319—2, Exhibit B,
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`PageID.40824 - 40825,26 as it is also unfair.
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`As the former Medical Clinical Director of Hamilton Family Health Center,
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`I am aware of the standard/scope of practice for those health care professionals
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`providing prenatal services to pregnant women.
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`It is beyond the standard/scope of
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`
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`26 The category description for Settlement Category 26 provides “... 3) Suffered a miscarriage
`any time between May 16, 2014 and April 30, 2017, with the mother’s or fetus’ cord BLL of 5
`mcg/dL or higher.”
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`The required proofs for Settlement Category 26 provides “Contemporaneous Medical Records:
`Copy of medical records dated between May 16, 2014 and April 30, 2017, which includes an
`opinion from a board—certified physician in obstetrics and gynecology stating that the Claimant
`suffered from the claimed injury between May 16, 2014 and April 30, 2017.
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`Blood test: as described in required proofs for Category 1, but subject to date restrictions in this
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`practice for a Doctor, Mid-Wife, PA—C or Nurse Practitioner to perform blood lead
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`level testing when a miscarriage occurs.
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`More frequently than not, a woman suffers a miscarriage outside of a
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`medical
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`facility. When, and sadly if,
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`that person reports to their medical
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`practitioner, they do not bring in the miscarried fetal material for testing. When
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`there is nothing to test, how can a lead level test be performed? Also, it is beyond
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`the standard/scope of practice to examine why a woman may have suffered a
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`miscarriage until there have been multiple miscarriages or some other medical
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`condition is known to exist.
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`It is beyond the standard/scope of practice for a medical practitioner to order
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`a blood lead level test for a pregnant woman unless there is a known environmental
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`reason for doing so.
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`In the Executive Summaiy of Guidelines For
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`the Identification and
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`Management of Lead Exposure in Pregnant and Lactating Women, prepared by the
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`National Center for Environmental Health, November 2010, US. Department of
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`Health and Human Services Atlanta, GA, it states:
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`[g]uidance for clinicians regarding screening and managing
`pregnant and lactating women exposed to lead has not kept pace
`with the scientific evidence. There are currently no national
`recommendations by any medical or nursing professional
`association that covers lead risk assessment and management
`during pregnancy and lactation. Currently, New York State,
`New York City, and Minnesota are the only jurisdictions that
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`Case 5:16-CV-10444-JEL-MKM ECF N0. 1436, PagelD.55039 Filed 02/26/21 Page 19 0f 30
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`requirements for pregnant women by physicians or other
`providers of medical care.
`See Objection Exhibit 19, p iii, emphasis added.
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`According to the American Academy of Family Physicians, the standard
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`elements of prenatal care include a routine physical examination (including pelvic
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`examination) at the initial Visit, maternal weight and blood pressure at all visits,
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`fetal heart rate auscultation after 10 to 12 weeks with a Doppler monitor or after 20
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`weeks with a fetoscope, fundal height after 20 weeks, and fetal lie by 36 weeks.
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`Objection Exhibit 20, Update on Prenatal Care, American Family Physician, 2014
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`Feb 1;89(3):199-208.
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`In the article The Effect of an Increase in Lead in the Water System on
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`Fertility and Birth Outcomes: The Case of Flint, Michigan, by Daniel S. Grossman
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`David J.G. Slusky, August 7, 2017, it states:
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`In this paper, we estimate the effect of the higher lead content
`of water sourced from the Flint River on fertility and birth
`outcomes. Importantly, during the period in which water was
`sourced from the Flint River (beginning on April 25, 2014),
`local and state officials continually reassured residents that
`the water was safe. Officials did not issue a lead advisory until
`September 2015, just a