Atherectomy Amputation Lawsuit

Lawsuits have been filed by people who had to have their legs amputated after suffering complications from artery-clearing procedures called atherectomies.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting atherectomy induced amputation cases in all 50 states. If you or somebody you know needed an amputation after undergoing an artery-clearing atherectomy procedure, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: Lawsuit Claims Medtronic Bribed VA Doctors to Perform Atherectomies

A whistleblower lawsuit alleges that Medtronic engaged in a bribery scheme at a veterans hospital in Kansas where doctors performed dangerous atherectomy procedure. Click here to read more.

What is an Atherectomy?

An atherectomy is a medical procedure that is used to open up arteries that are blocked by plaque. During the procedure, a doctor inserts a long tube called a catheter into the blocked vein. The catheter may be tipped with a sharp blade, laser, or rotating device to scrape off the plaque. This is supposed to improve blood-flow in the legs, but it also poses serious risks.

The Profit-Driven Rise in Artery-Clearing Procedures

The skyrocketing rate of artery-clearing procedures, especially atherectomies, is due to two factors:

Greater Profits for Doctors: The government changed Medicare reimbursement policies to make it significantly more profitable for doctors to perform atherectomies in outpatient clinics rather than hospitals.
Profits for Medical Device Companies: Major medical device companies have capitalized on the growing market for atherectomies by providing doctors with loans to open clinics, incentives to use more of their devices on more patients, training, financial support, and other kickbacks.

Do I Really Need an Atherectomy?

Atherectomies are only appropriate for a small subset of patients with severe artery disease, who already face a high risk of amputation.

However, most people with peripheral artery disease have mild symptoms or no symptoms at all. For these patients, undergoing atherectomies actually increases their risk of needing an amputation or developing other injuries due to complications from the procedures. This is especially true when doctors do repeated atherectomies in a short period of time.

What Should I Do?

Experts recommend that doctors hold off on performing invasive, risky procedures like atherectomies on patients who are still in the early stages of peripheral artery disease.

This is because many patients do just fine with exercise, blood-thinning medications, and interventions to treat the underlying cause of artery disease, such as high blood pressure, smoking, or diabetes.

Instead, some profit-driven doctors are recommending immediate atherectomies — even on patients who have no symptoms, or just minor leg pain — putting the patient at risk of injuries during the procedures that can lead to amputations, infections, bleeding or death.

Lawsuits Claim Excessive & Unnecessary Atherectomies Lead to Amputations

Lawsuits have been filed by patients who were harmed by amputations following artery-clearing procedures. In many cases, doctors told patients they had to undergo atherectomy procedures in order to save their legs. Instead, these patients lost their legs due to complications from the artery-clearing procedure itself (or malfunctioning medical devices).

Some doctors have been hit by lawsuits after performing more than a dozen procedures on a single patient within the span of a few months — and instead of saving their patient’s legs, the excessive number of procedures caused severe damage to the patient’s arteries, ultimately leading to an amputation.

Michigan Doctor Accused of Causing Amputations from Excessive Atherectomy Procedures

Lawsuits have been filed against Dr. Jihad Mustapha, a doctor from Michigan who calls himself the “leg saver.” Instead, plaintiffs allege that his overuse of atherectomy procedures has caused dozens of people to need amputations, according to the New York Times.

At least 45 of his patients needed amputations after being treated at his clinics over the past 4 years, accoriding to insurance data.

One lawsuit was filed by Kelly Hanna, a woman who said Dr. Mustapha performed at least 18 atherectomies on her legs within two years. She claims he told her the procedures would save her legs. They didn’t. Instead, she had to have her leg amputated in 2020.

Surgeons at local hospitals were seeing so many of Dr. Mustapha’s patients that they notified the medical board. The Michigan Attorney General’s Office also filed a lawsuit, concluding that his practice was “characterized by over-treatment” of patients with mild artery disease.

Dr. Mustapha agreed to pay $25,000 and take medical education courses.

Doctors Profit As Atherectomy Procedures Skyrocket

In recent years, doctors and researchers have uncovered an alarming pattern of excessive, unnecessary, and inappropriate use of artery-clearing atherectomy procedures.

Use of this procedure “more than doubled” from 2010 to 2019, mostly driven by an increase in office-based procedures, where doctors can bill $10,000 or more to Medicare and insurers. The researchers warned, “Atherectomy overuse is a real problem.”

Patients Risk Amputations as Doctors Get Huge Payouts

In June 2023, an investigation by ProPublica blamed increases in Medicare payments for a skyrocketing number of unnecessary atherectomies, which can sometimes lead to amputations or death. About $1 billion in government payouts went to a group of 90 doctors.

Medical Malpractice Lawsuits Filed Against Maryland Doctor

Jeffery Dormu, D.O., a doctor in Maryland, made millions of dollars by billing Medicare for thousands of vascular procedures — even on patients who didn’t need it, and as more and more people were hurt.

He was eventually disciplined by the state medical board for using an excessive number of inappropriate treatments that put patients at risk.

He has also been hit by numerous medical malpractice lawsuits for patients who were injured or killed. One of Dr. Dormu’s patients had a leg amputated. Another woman bled to death soon after he began operating on her, according to a wrongful death lawsuit filed by her daughter in 2022.

What is Peripheral Artery Disease?

Peripheral artery disease occurs when fatty plaques build up in arteries, which blocks blood-flow to the legs. The condition affects around 6.5 million Americans over the age of 40.

How To Recognize Signs of Peripheral Artery Disease

Leg pain is usually the first symptom of peripheral artery disease, but it may be symptomless. Painful walking is the another common symptom, but it if gets worse, the pain may also occur when lying down or while resting. This severe pain can be interrupt sleep.

Symptoms of Peripheral Artery Disease

Leg pain
Muscle pain or weakness in the legs
Pain when walking (stops when resting)
Numbness or weakness in the legs
Feeling cold in the lower leg or foot
Shiny skin on the legs
Sores on toes, feet, or legs that won’t heal
And more

Long-Term Complications of Untreated Artery Disease

Left untreated, peripheral artery disease can lead to leg amputations. This is because poor circulation in the legs increases the risk of skin lesions, sores that do not heal (ulcers), or gangrene. Patients who have diseased blood vessels in their legs almost certainly have it elsewhere in their body, which is why about 20% of people will have a heart attack or stroke.

Medtronic Recalls HawkOne Atherectomy System

In January 2022, Medtronic recalled about 95,110 HawkOne Directional Atherectomy System due to a risk of tip damage during use, which poses a life-threatening safety risk to the patient. At least 55 people were injured by a HawkOne device.

According to the recall, some of the serious risks include:

Tear along the inside wall of an artery (arterial dissection)
A rupture or breakage of an artery (arterial rupture)
Decrease in blood flow to a part of the body because of a blocked artery (ischemia)
Blood vessel complications that could require surgical repair
Additional surgeries or other procedures to capture and remove the detached and/or migrated (embolized) tip.

Medtronic Recalls TurboHawk Atherectomy Device

In March 2022, Medtronic recalled the TurboHawk Plus Directional Atherectomy System devices due to a similar risk of tip damage during use compared to the HawkOne device. No injuries were reported, but the problem could cause severe injuries or deaths. About 686 of the devices were distributed from September 27, 2021 to January 25, 2022.

Do I have an Atherectomy Amputation Lawsuit?

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