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Federal-appointed monitoring of orthopedic device companies ends
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Several leading orthopedic device manufacturing companies announced the expiration of Deferred Prosecution and Non-Prosecution agreements entered into with the United States Attorney’s Office for the District of New Jersey.
On Friday, Zimmer, Smith & Nephew, Biomet and DePuy Orthopaedics said that they complied with obligations stipulated in Deferred Prosecution Agreements (DPAs) that they entered into with the U.S. Attorney’s Office for the District of New Jersey (USAO) in September 2007. Stryker also noted that it complied with terms detailed in its Non-Prosecution Agreement (NPA) with the U.S. Department of Justice.
The end of the agreements means that the companies will no longer be subjected to oversight by government-appointed monitors.
“We are pleased to have successfully collaborated with the USAO and our monitor during these last 18 months to create a more robust compliance program,” Smith & Nephew Orthopaedics President Joseph DeVivo said in a press release. “Our substantial investment in and commitment to this program will help us continue our work as the leading innovator in orthopedic technology for active, informed patients.”
Better corporate compliance
Zimmer noted that it enhanced its corporate compliance program and processes during the past 18 months.
“While the expiration of the DPA is an important milestone, the company remains committed to operating ethically and transparently on a global basis to preserve the trust required for productive, professional collaboration that ultimately benefits patients,” Zimmer President and CEO David Dvorak said in a release.
Likewise, Biomet said that it will continue to improve its compliance programs.
“Biomet is pleased to have successfully satisfied the requirements of the DPA. Over the past 18 months, we have worked to strengthen the compliance policies and procedures for Biomet Orthopedics, such that we believe those current practices are best-in-class,” Biomet President and CEO Jeffrey R. Binder said in a press release.
“We appreciate the productive manner in which our federally appointed monitor provided oversight and guidance throughout the term of the DPA. Biomet remains committed to upholding the highest standards of ethical and legal conduct and plans to continue the enhancement of its compliance programs throughout its global operations,” he said in the press release.
Complying with the NPA
Stryker also noted that its efforts to comply with the NPA have led to several positive results, including improved analysis and strategic insight for more effective use of consultants and increased resources for its professional affairs group.
“Stryker believes that it is important for patients to have access to information that may help them in their decision-making process,” the company said in a prepared statement. “Our payments to physicians are directly related to product development, improvement and training, and we want patients to know that and be confident that their physicians are knowledgeable about and properly trained with our products. Therefore, we will continue to maintain the ‘Meet Our Consultants’ section on our Web site and update consultant contributions and compensation information on a quarterly basis.”
Corporate Integrity Agreements
Although the DPAs have been dismissed, Zimmer, Smith & Nephew, Biomet and DePuy are expected to continue to comply with the Corporate Integrity Agreements that they entered with the Department of Health and Human Services until September 2012.
“The dismissal signifies that DePuy Orthopaedics has fully complied with its obligations as outlined in the agreement,” the company told Orthopedics Today. “As a result, oversight by the DPA monitor ends and the company will continue to operate under the terms of a Corporate Integrity Agreement until 2012. DePuy Orthopaedics has established, and will maintain, a robust health care compliance program to guide its interactions with health care professionals and entities.”
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