FDA warned Froedtert doctor of problems with brain device research. State board did not act.

While doing research on a brain device in 2015, Marc Lazzaro got a visit from an investigator with U.S. Food and Drug Administration.

Lazzaro, a doctor with Froedtert Hospital in Wauwatosa, was testing one device that is implanted in the brain to treat aneurysms and another one used to remove clots. The FDA was checking whether the research complied with federal rules designed to protect patients.

It did not.

The rules of one of the studies said patients who had more than one brain aneurysm could not be enrolled. However, the FDA found that at least one person with multiple aneurysms was included.

RELATED:FDA warning letters to doctors flag serious problems, but state medical boards do nothing

In addition, patients who scored above a certain level on a scale designed to measure disability were supposed to be excluded from another study, but two were not, the FDA said.

The violations were cited in a 2015 warning letter sent to Lazzaro, who is also an assistant professor of neurology and neurosurgery with the Medical College of Wisconsin.

No action was taken against Lazzaro by the medical board in Wisconsin.

A spokesman for the board said it never saw the FDA letter.

The Wisconsin Department of Safety and Professional Services, which oversees the medical board, “has since fostered a relationship with the FDA and now receives some of the warning letters they send,” said spokesman Matt Censky.

Lazzaro was one of 73 doctors around the country with active medical licenses who got FDA warning letters over a five-year period alleging serious problems. Only one was disciplined by his state medical board, an investigation by the Milwaukee Journal Sentinel and MedPage Today found. However, the state -- Texas -- did not take action against five other doctors who received FDA warning letters, records show.

The warning letters, which are publicly available in an archive, are sent after FDA officials conduct inspections at offices, clinics and medical facilities to determine if federal rules designed to protect patients are being violated.

The letter to Lazzaro noted that risks to patients enrolled in the study included brain hemorrhage, aneurysm rupture and death.

“Your enrollment of subjects who met the exclusion criteria may have increased their risk of developing these and other study related complications,” the letter said.

The FDA found other violations, including the failure to get informed consent from patients.

In one case, a patient suffered a stroke and was unable to sign the consent form, so a nurse signed the form for the patient. 

The studies both involved devices made by Penumbra Inc., an Alameda, Calif., company.

Several instances of shoddy record keeping also were cited, including cutting and pasting the signatures of trial investigators onto documents. 

The FDA warning letter also noted that many of the deviations found during the inspection were not reported to the institutional review board that was overseeing the research.

In its letter, the FDA said Lazzaro accepted responsibility for the problems that it found. 

Lazzaro told reporters he came into the clinical trial as a junior faculty member and was asked to take over as the lead investigator. It was his first stint in such as position.

In addition, the Medical College’s institutional review board has worked to correct the problems found in the FDA inspection, he said.

He said no one was harmed as the result of problems cited by the FDA.

“I should have had better oversight,” he said.

In an email, Medical College spokeswoman Holly Botsford, said the institutional review board found problems with the clinical trial and notified the FDA in October 2014, telling the agency it had suspended new enrollment in the trial a month earlier.

Botsford would not provide a copy of the letter the review board sent to the FDA. 

The FDA began its inspection of the Froedtert clinical trial site on February 24, 2015. The Medical College review board terminated the study on May 13. 

The FDA warning letter was issued on July 9 of that year.

“The Institutional Review Board at MCW meticulously reviews all research studies involving human subjects for safety, compliance with regulations, scientific quality, and ethical standards,” Botsford said.

This story was reported as a joint project of the Journal Sentinel and MedPage Today, which provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.

Read the investigation

To read the Milwaukee Journal Sentinel's Bad Medicine investigation, go to journalsentinel.com/badmedicine.

John Fauber is a reporter for the Milwaukee Journal Sentinel. Matt Wynn is a reporter for the USA TODAY network. He began his reporting for this story while at MedPage Today.