Doctor gave patients risky and unapproved Botox in Michigan, feds say. Now he’ll pay

A doctor in Michigan gave his patients a risky and unapproved version of Botox, then billed Medicare for the services, according to federal authorities.

Now, Derek Lado, D.O., and his Grand Rapids practice have agreed to pay $135,871, according to a May 23 news release from the U.S. Attorney’s Office for the Western District of Michigan.

The settlement resolves allegations that Lado and Elite Medical Spine & Musculoskeletal Center PLLC violated the False Claims Act by billing Medicare for a foreign and unapproved drug, officials said. The settlement resolves the allegations but does not determine liability.

McClatchy News requested comment from Elite Medical Spine & Musculoskeletal Center on May 25 and did not immediately hear back.

Prosectors said Lado and his practice originally treated patients with Botox (onabotulinumtoxinA), which is approved by the U.S. Food and Drug Administration.

But starting in 2018, he began using a foreign and unapproved onabotulinumtoxinA “in order to cut costs,” according to the release.

OnabotulinumtoxinA can be used to treat multiple conditions, including head and neck pain, muscle stiffness and urinary incontinence, according to the Mayo Clinic. It’s also “used cosmetically to temporarily improve the appearance of deep facial lines or wrinkles.”

“Unregulated goods, more importantly those used in medical treatments, present a variety or dangers and risks that no patient should be subject to,” Detroit Special Agent in Charge Angie M. Salazar, with Homeland Security Investigations, said in the release.

Investigators seized “numerous packages” of the unapproved drugs en route to Lado’s practice, authorities said, and the doctor was given warnings.

“Despite these warnings and Medicare rules that the program denies coverage of drugs that have not received approval from the FDA, Dr. Lado knowingly used these foreign, unapproved drugs to treat Medicare beneficiaries and billed Medicare for those services,” authorities said.

“Patients deserve the confidence that their medical practitioners are following the rules to keep them safe,” U.S. Attorney Mark Totten said in the release. “If you cut corners by using foreign drugs that have not been approved by the FDA as safe and effective to treat our Medicare population, there will be consequences.”