Fred Schulte, KFF Health News
Exactech, a Florida gadget producer that faces greater than 2,000 state and federal lawsuits from sufferers who allege the corporate bought faulty hip and knee implants, filed for chapter safety Tuesday.
The Gainesville-based firm said in a statement it was restructuring and can be bought to an investor group of personal fairness and “alternative asset” companies, which would offer about $85 million in financing to fund the corporate’s operations.
Darin Johnson, Exactech’s president and chief government officer, mentioned within the assertion that the gadget firm faces “unsustainable liabilities associated with knee and hip litigation related to the packaging recalls we voluntarily initiated between 2021 and 2022.” The firm mentioned it will proceed to function through the chapter proceedings.
“We take our commitment to patient well-being very seriously and have provided substantial out-of-pocket patient reimbursements and surgeon support for related expenses,” Johnson mentioned.
The chapter proceedings in federal court docket in Delaware will pause the lawsuits from sufferers searching for damages.
The shock motion dismayed attorneys representing injured sufferers.
“Exactech’s bankruptcy filing is a slap in the face to all the joint-implant patients and doctors who trusted the company. A medical device company that sells products for implantation in the human body has a special responsibility for public health,” mentioned Joe Saunders, a Florida legal professional who has sued the corporate on behalf of injured sufferers.
Saunders mentioned the chapter “serves to cover up public disclosure of the company putting profits ahead of safety.”
Injured sufferers have been anticipating one of many first jury trials towards the corporate to start in December within the circuit court docket in Alachua County, Florida. But the chapter submitting “stops the public trial and conceals the truth about the company’s conduct,” Saunders mentioned.
Exactech, which grew over three many years from a small gadget producer into a worldwide entity, was the topic of a KFF Health News investigation revealed in October 2023.
The investigation discovered that, in a whole bunch of situations, the corporate took years to report antagonistic occasions to a federal database that tracks gadget failures.
Many of the lawsuits allege that the corporate’s knee and hip implants had an “unacceptable failure and complication rate.” Exactech has denied the allegations, and the corporate had no touch upon the lawsuits.
Exactech started a series of recalls of synthetic knees, hips, and ankles, beginning in August 2021. Exactech initially blamed a packaging defect relationship again so far as 2004 for probably inflicting the plastic part to wear down prematurely in about 140,000 implants.
The KFF Health News evaluation of greater than 300 pending instances in Alachua County discovered that surgeons eliminated about 200 implants after lower than seven years, far before the 15 to twenty years these merchandise sometimes final.
“I’m so angry. How did they [Exactech] think they are not responsible for this?” mentioned Sue Sacher, 76, a New Jersey resident. She mentioned she had her proper knee changed with an Exactech implant in 2006 and the left one accomplished three years later, each on the Hospital for Special Surgery in New York.
Since then, she’s had each implants changed.
KFF Health News is a nationwide newsroom that produces in-depth journalism about well being points and is among the core working applications at KFF—an impartial supply of well being coverage analysis, polling, and journalism. Learn extra about KFF.
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