Records: Unlawful Flint use of portable X-ray scanners began in 2019, not 2020
LANSING, Mich. — A New York law firm may have used unregistered portable X-ray scanners on Flint residents for one year longer than state officials were told, records show.
A sworn affidavit from a Flint resident, along with emails showing when the Napoli Shkolnik law firm sought to lease the devices, suggest the use of scanners, which are tools in the scrap metal and mining industries but are not designed for use on human beings, began around September 2019.
That is about 18 months before either of the two devices was registered with the state of Michigan, as required by law.
A representative of the law firm, whose name was redacted, told the state in March it had been using the devices for only about six months, since August or September of 2020, before registering them in February, according to a state summary of a phone call the Detroit Free Press obtained under Michigan's Freedom of Information Act.
Failing to register a radiation machine is a misdemeanor under the Public Health Code that can bring a $10,000 fine and up to 180 days in jail, with each day that a violation continues considered a separate violation. But the state brought no criminal or civil charges against the law firm, records show.
The scanners were applied to the tibias of thousands of Flint residents, including many children and at least one pregnant woman, to measure how much lead had accumulated in their bones. Under a proposed $641.25 million partial settlement of civil claims arising from the 2014 poisoning of Flint's drinking water, results from the bone scans can be used to bolster claims seeking higher shares of the settlement money.
Lawyers and some medical experts have said radiation levels are low and use of the portable scanners is safe.
But the manufacturer of the scanners, Thermo Fisher Scientific, ultimately ordered Napoli Shkolnik to stop using them.
The company said in a May letter to the law firm that it had in rare cases authorized use of the scanners on humans for research purposes, but that had only happened under the supervision of an Institutional Review Board, which was not in place for the scans that took place in Flint.
A sworn affidavit filed in the civil case by Flint resident Claudia Perkins-Milton says she received a bone scan at the firm's offices on Flushing Road in Flint about one year earlier than what the state was told, on Sept. 20, 2019. The Perkins-Milton affidavit was filed in support of the law firm's bone scanning operation, which she said was performed by a registered nurse.
Other records filed in the case show that a Harvard scientist working with the law firm, Aaron Specht, emailed Thermo Fisher Scientific to lease the devices in August 2019. The emails filed in court do not say the law firm intended to use the scanners on human subjects, instead referencing "environmental surveillance" work.
Paul Napoli, a partner in the Napoli Shkolnik law firm, did not respond to a Friday email asking him to clarify when the use of the scanners began. The law firm has said the scanners were modified for human use by medical experts by Specht, who has a doctorate in medical physics, and a physician from New York University. Napoli also has said the manufacturer was aware of how the scanners would be used, which contradicts what the company said in its May letter to the law firm.
Jason Moon, a spokesman for MIOSHA, said earlier that the law firm apparently did not know that the devices had to be registered and the state is more interested in ensuring compliance than in bringing prosecutions.
Informed that records show the bone scans may have begun about one year earlier than MIOSHA was told, Moon said the state expects registrants to provide accurate information.
"New or corrected information may prompt additional inspection activity ... depending on the nature of the new information," Moon said.
"As we have communicated previously, there is no indication from MIOSHA's inspections that an individual operating these machines or having the machine used on them was exposed to radiation at dangerous or unsafe levels."
But former Flint Mayor Karen Weaver, who served from 2015 to 2019, said the handling of the entire issue smacks of the same type of institutional racism that led to the poisoning of Flint's water supply in the first place.
"They've broken the law and they're not being held accountable?" she asked "They're not going to have to pay a fine and nothing is going to happen? This is just ridiculous."
Moon said MIOSHA has handled the case in the same way it would handle any case.
In another development, Flint pediatrician Dr. Lawrence Reynolds wants the federal judge overseeing the settlement to appoint a neutral expert to assess the safety and accuracy of the scanners.
In asking for an evidentiary hearing in a Wednesday court filing, Reynolds, the former CEO of the Mott Children's Health Center in Flint, cited "bombshell revelations" in a recent Free Press story, which was based on state safety inspection records obtained through FOIA from the Michigan Occupational Safety and Health Administration.
"The facts from the MIOSHA investigation ... reveal that MIOSHA identified several issues with the administration of the bone scans, including that they exceeded the legal dose equivalent for radiation outside medical diagnosis and research administrations," Reynolds, who is objecting to the use of the bone scans, said in the court filing.
Reynolds, who has standing in the lawsuit as a Flint resident who was exposed to the contaminated water, filed an objection to the proposed settlement in February. Reynolds, who sees advocating for the health of residents as a central part of his medical practice, said the bone scans are a key plank of the settlement and it goes against medical ethics to expose children and others to radiation at any level when it is for no therapeutic or diagnostic medical purpose.
"It is not an approved practice by any global regulatory agency or professional body," Reynolds said in the February court filing. "It is being promoted by misinformed attorneys for an undisclosed research project, not licensed medical practitioners."
Reynolds wants the bone scan language removed from the settlement and hopes that a hearing on the issue will help Levy see things the way he does.
By May, when the manufacturer ordered the law firm to stop using the devices, which was also when the law firm agreed to implement safety changes recommended after a March inspection by MIOSHA, the court's April deadline for completing the bone scans had already passed.
In addition to revelations about the radiation doses involved, the MIOSHA records obtained by the Free Press show the law firm's scanning operation in Flint had no system for monitoring radiation exposures for scanner operators, no physician licensed in Michigan supervising operations, no mechanism to ensure the scanners would shut off after about three minutes to prevent possible overexposure, and no written notice to Flint residents of the radiation they would be exposed to and any related risks, Reynolds said in the motion filed by his California attorney, Jahmy Graham.
The records show that lawyers from Napoli Shkolnik and from the Michigan Attorney General's Office, who represent state defendants in the case, "downplayed the extent of the investigation and the resulting changes required to make the administration of bone scans safer and compliant with Michigan law," Reynolds said.
Lynsey Mukomel, a spokeswoman for Attorney General Dana Nessel, said she believes U.S. District Judge Judith Levy is "fully informed" about issues surrounding the scanners. We "are not concerned that our attorneys have made any representations that may have misled the court," she said.
Napoli has previously said that issues related to the bone scans were "addressed by various highly qualified and regarded experts," and "the safety and accuracy of this technology is unquestioned."
In a June letter to the law firm, state officials said they agree "the estimated radiation risk from this procedure is very low." However, MIOSHA said the law firm understated the amount of radiation exposure in some information submitted to the state. The amount of radiation concentrated on a small area of skin over the tibia during the procedure is 48.5 mSv (millisieverts) and "the rules were written with the understanding that individuals undergoing X-ray procedures that result in a dose to any part of their body more than 1 mSv would do so under the supervision of a physician," the letter said.
Levy has yet to rule on whether she will give final approval to the settlement.