The Era of Deferred Prosecution Agreements (DPA) has come to a close as the industry’s most painful and drawn-out DPA has been put to bed.
Wright in the Clear
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On October 8, Wright Medical Group, Inc. announced the DPA entered into with the feds on September 29, 2010 has expired. The company said it has satisfied its obligations under the DPA and has received a Notice of Dismissal of the Complaint filed against it by the U.S. Attorney in New Jersey.
Robert Palmisano, who took over as president and CEO of the company after the feds charged the company, said, “We have taken significant steps to ensure that we successfully completed the DPA and have an effective, sustainable, global compliance program. While exiting the DPA is an important milestone, executing an effective and efficient compliance system and promoting the highest standards of ethical and legal conduct in all of the markets that we serve will remain a focal point for the company.”
The company remains subject until September 29, 2015 to the terms of a Corporate Integrity Agreement it entered into with the Office of Inspector General of the U.S. Department of Health and Human Services.
Wright’s tortuous journey through the DPA was filled with firings and departures of senior executives and compliance officers, a 12-month extension of the original DPA, surgeon training disruptions and wrongful termination lawsuits by former employees.
We think this ends the DPA Era as all major hip and knee makers are now in the clear from charges filed by the U.S. Attorney for paying surgeons to use their products. The companies will be required to publicly disclose payments to physicians when the Sunshine Law under the Affordable Care Act takes effect next year.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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