By Gary Evans, Medical Writer
In the immediate aftermath of the birth of his son in September 2017, Philip L. Ellison, MBA, JD, was more a proud father than a crusading lawyer. Things quickly changed.
“The whole reason I am involved in this is because of my son,” he tells IRB Advisor.
An attorney in Hemlock, MI, Ellison is suing the state for its practice of routinely taking blood samples from newborns for testing and medical research. Alleging that the blood spots already are taken before any consent is given, the suit asks the court to declare that the program as currently structured violates the Fourth Amendment right to privacy and protection from illegal search and seizure.
“The main thing is, we are not trying to stop newborn blood screening,” Ellison emphasizes. “If parents want to consent to the state, that is their business — but they should be given full information and a choice beforehand, not after the fact.”
When his son was admitted to a neonatal ICU shortly after birth to resolve a blood sugar problem, Ellison waited with the angst known to any parent in such a crisis. He was shocked that in such a moment he was asked to sign off on the routine use of his son’s blood for testing and medical research.
“As a father at that point — less than 24 hours in — I don’t care about medical research. Why are we even talking about this?” Ellison says, recalling his reaction. “They said ‘no, no these are the blood samples we send to the state.’ I’m a lawyer who sues the government for a living. I said, ‘Wait — what blood samples did you send to the state?’”
As he researched the subject after the hospital experience, Ellison says he was “horrified by how expansive this was — the profiteering, and basically the lack of disclosure that was given.”
Ellison is suing for his family in a state case and filed a similar motion in federal court representing a group of nine newborns and their parents.
“We asked for both equitable relief and monetary relief, but in reality, this case is really more about this program and whether it can continue in its current form,” he says.
Ellison reasoned that the average person dealing with the birth of a child is in no position to grant informed consent in a meaningful way.
“Everyday citizens are not told anything, and they would never think to ask,” he says. “Who would think that Michigan was running a program where they are secretly extracting blood samples and storing them in a warehouse? It’s like a science fiction story. The whole point of this is to bring some sanity of consent to this process.”
The attorney likens the timing of the informed consent to asking somebody to sign something right after they have been in a car accident. “I would have signed any form and done anything necessary to get my son out of the NICU,” he says.
As outlined in the lawsuit, the key allegations include:
• the state of Michigan failed to obtain express or informed consent from the newborn and/or his or her legal guardian, or to secure a warrant from a neutral, detached magistrate before taking the blood into the permanent custody of the state government;
• parents in this legal action had no knowledge of blood or blood spots being drawn from their newborn child while in the care of hospital staff, which were then being turned over to the government for its permanent custody and/or permanent seizure, and use by said government or those third parties granted possession/custody.
The state disputes the charges and has already filed one motion to dismiss the case.
Lynn Sutfin, public information officer for the Michigan Department of Health and Human Services (MDHHS), could not comment on the case, but provided background information on the program.
The newborn screening program (NBS) is required by the state to detect rare diseases that warrant immediate treatment, she explained in an email.
“Under Michigan law, parental consent is not required to perform NBS,” Sutfin stated. “Every year, the program identifies approximately 250-280 babies affected by one of the 54 blood-spot-testable disorders included on the NBS panel.”
For example, of 111,725 babies screened in the state in 2015, 270 were diagnosed with one of the disorders — a rate of about one in every 414 babies. The program uses a paper card with designated areas for blood spots, using five to six drops of blood drawn from the heel.
“All of the blood spots are not always needed for screening,” Sutfin stated. “One blood spot from the newborn screening card is reserved for uses authorized by the baby’s parent, such as medical testing or identification. Parents are also given the opportunity to allow future use of their child’s de-identified blood spots through the BioTrust for Health program, which makes them available to qualified researchers.”
Since 2010, parents in Michigan have been able to choose if they want their infant’s de-identified blood to be used for medical research.
“Spots collected prior to May 1, 2010, can be used for de-identified medical research unless a parent submits a request to mark their child’s spots as unavailable for research,” she states. “Adults can make this request on their own behalf.”
Research requests to use de-identified blood spots are submitted to the BioTrust, where they undergo multiple levels of review, including by the MDHHS IRB, she noted. The review process is designed to ensure that the research has scientific merit, is conducted by qualified researchers, and the human subject data are protected.
The research using the Michigan blood spots has resulted in improved testing for spinal muscular atrophy and Niemann-Pick C Disease, Sutfin explained. The program also has contributed to research in the link between cancer and environmental exposure.
“The NBS process and storage of dried blood spots includes many layers of security to protect the dried blood spots,” Sutfin stated. “The dried blood spots are also protected under the law. MDHHS is only permitted to use dried blood spots for quality improvement and test development of NBS disorders, parent- or guardian-directed medical research, crime victim identification, and de-identified medical research.”
That said, Ellison is confident he has a case, expressing a willingness to take the federal version to the U.S. Supreme Court if need be. We asked him to comment further on the situation in the following interview.
IRB Advisor: These programs are run in other states. What is different in Michigan?
Ellison: In Michigan, when they designed their system, it did not build in the requirement of getting informed consent before extracting the blood, storing it, and selling the blood later on. The only time they have actually gotten some form of consent is after the blood has been drawn and it’s at the lab. They give a form to parents that says, ‘Can we use your infant’s blood for medical research?’ The form does not give all the details, and what the program is doing today is different from what the form says. My position is that even if the actual consent form is signed, the actual options being consented to have been far exceeded at that point.
IRB Advisor: You say the key is that the informed consent is not given until after the fact.
Ellison: I equate it to the state coming in and taking your car from the parking lot of where you work. They do a bunch of tests on it, and say we have your car. We didn’t ask you before we took it, but we are going to use your car to deliver Meals on Wheels. Well, that helps the greater good, but they should have asked you before they took the car for that purpose. Michigan is one of a handful of states that don’t get consent beforehand. In my opinion, Michigan has done a poor job in designing a system that fulfills the obligation of consent.
IRB Advisor: At least some of these blood samples are then available for distribution and research?
Ellison: Rather than keeping [the blood spots] as part of the state system where there is at least political oversight and transparency under government open-records laws, [the MDHHS] transferred the blood to a private entity that sells and distributes the blood samples to fourth parties. From my research, I have discovered that several university programs across the country have used Michigan blood samples. They are probably doing some good, I will give them that, but they didn’t ask before they took it all.
IRB Advisor: You note that the program began on a minor scale, but so much more is possible now with whole genome sequencing of human DNA.
Ellison: The blood program in Michigan started in the 1960s. So about from the mid-1960s to 1984, they were taking a blood sample and testing for a handful of things. Of course, as science progressed, we are up to some 60 different things they are testing for now in Michigan. Some of my opponents thought I was crazy until this whole story of the Golden State Killer came out recently. The DNA was not even from him — it was from family members. The police basically searched private medical data of a bunch of individuals to find this connection. I think this is a classic example of the law not keeping up with the science. If you are going to use it for something more than what you originally got permission for, you have to go back and ask again.