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Orthopedic Device Manufacturer Accused of Concealing Product Failures in Lawsuits
Affordable Knee Implant Manufacturer Being Sued by Over 1,100 Patients
Ron Irby, a retired medical technologist with the Department of Veterans Affairs, filed a lawsuit against Exactech after his Optetrak knee implant failed just three years after it was implanted, causing him to undergo a painful and debilitating surgery. Irby is only one of the more than 1,100 patients suing Exactech, a Gainesville-based orthopedic device manufacturer, for failing to disclose evidence of product failures that could lead to challenging and risky revision surgeries.
According to court filings and government records, Exactech has been accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. The company allegedly took years to report adverse events to a federal database that tracks device failures. Patients argue that Exactech used packaging materials of inferior quality, leading to premature wear and failure of the implants.
Exactech, which prides itself on its durable implants in its advertising, denies the allegations and claims that its products have “an excellent history.” However, whistleblowers and surgeons have raised concerns about the fragility and premature loosening of the Optetrak implants, causing pain and limiting patients’ mobility.
Exactech’s co-founder, Bill Petty, admitted in a deposition that the company knew about the problem with the device but did not recall or address it. Surgeons and whistleblowers argue that Exactech prioritized financial gain over patient safety by not disclosing the issue and replacing the defective component in their newer products instead.
As more patients come forward with complaints and lawsuits against Exactech, the company faces ongoing litigation and scrutiny over its alleged cover-up of product failures. The outcome of these lawsuits could have significant implications for the orthopedic device industry and patient safety.
Exactech declined to comment on the ongoing litigation.
Key Points:
- Over 1,100 patients are suing Exactech, a Gainesville-based orthopedic device manufacturer, for failing to disclose evidence of product failures.
- Patients argue that Exactech used inferior packaging materials, leading to premature wear and failure of the implants.
- Whistleblowers and surgeons have raised concerns about the fragility and premature loosening of the Optetrak implants.
- Exactech denies the allegations and claims that its products have “an excellent history.”
- Exactech faces ongoing litigation and scrutiny over its alleged cover-up of product failures.
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