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A Gainesville medical device manufacturer files for bankruptcy over implant allegations
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A Gainesville medical device manufacturer files for bankruptcy over implant allegations

Facing more than 2,000 state and federal lawsuits from patients who claim the company sold defective hip and knee implants, Gainesiville-based device maker Exactech filed for bankruptcy protection on Tuesday.

company he said in a statement was in restructuring and was to be sold to an investor group consisting of private equity and “alternative asset” firms; this would provide approximately $85 million in financing to fund the company’s operations.

Exactech president and CEO Darin Johnson said in a statement that the company faces “unsustainable liabilities related to knee and hip lawsuits related to packaging recalls we voluntarily initiated between 2021 and 2022.” The company said it will continue operating during bankruptcy proceedings.

“We take our commitment to patient health very seriously and have provided patient reimbursements for related expenses and significant out-of-pocket support to surgeons,” Johnson said.

The bankruptcy filing in federal court in Delaware will put a pause on lawsuits from patients seeking compensation.

The surprise action horrified lawyers representing injured patients.

“Exactech’s bankruptcy filing is a slap in the face to all co-implant patients and doctors who rely on the company. “A medical device company that sells products for implantation into the human body has a special responsibility to public health,” said Joe Saunders, a Pinellas County-based attorney who sued the company on behalf of injured patients.

Saunders said the bankruptcy “served to cover up the public exposure of the company that puts profit over safety.”

“Exactech’s bankruptcy filing is a slap in the face to all co-implant patients and doctors who rely on the company. “A medical device company that sells products intended for implantation in the human body has a special responsibility to public health.”

Pinellas County attorney Joe Saunders, who sued the company on behalf of injured patients

Injured patients had been waiting for one of the first jury trials against the company to begin in circuit court in Alachua County in December. But Saunders said the bankruptcy filing “halted public litigation and obscured the truth about the company’s conduct.”

Over three decades, Exactech has grown from a small device manufacturer to a global enterprise. KFF Health News investigation It was released in October 2023.

The investigation found that in hundreds of cases, it took years for the company to report adverse events to a federal database that tracks device failures.

Most of the lawsuits allege that the company’s knee and hip implants have an “unacceptable failure and complication rate.” Exactech denied the allegations and the company had no comment on the lawsuits.

Exactech started a series of callbacks Artificial knees, hips and ankles from August 2021. Exactech initially blamed a packaging defect dating back to 2004 that caused premature wear of the plastic component in approximately 140,000 implants.

A KFF Health News analysis of more than 300 pending cases in Alachua County found surgeons removed nearly 200 implants after less than seven years; This was much shorter than the 15 to 20 years these products typically last.

“I am so angry. How could they (Exactech) think they were not responsible for this?” said Sue Sacher, 76, of New Jersey.

Sacher said that he had an Exactech implant placed on his right knee in 2006 and three years later on his left knee at New York Hospital for Special Surgery.

He has since had both implants replaced.

KFF Health News is a national newsroom producing in-depth journalism on health issues and is a core operating program of KFF, an independent source of health policy research, surveys and journalism. Learn more about KFF.

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