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Home/Company News/Orthofix Ends Blackstone Legal Problems
Company News

Orthofix Ends Blackstone Legal Problems

November 5, 2012 1 min read Premium comments

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Orthofix Ends Blackstone Legal Problems
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Orthofix International N.V. has put its Blackstone Medical, Inc. legal problems to bed by executing a $32 million final settlement with the U.S. Government.

Orthofix acquired Blackstone in 2006 and will pay for the entire settlement with funds from an escrow fund set aside when it purchased the company.

The settlement agreement, entered into on October 29, 2012, was between the U.S. Department of Justice and on behalf of the Office of Inspector General of the Department of Health and Human Services; the TRICARE Management Activity, through its General Counsel; the Office of Personnel Management, in its capacity as administrator of the Federal Employees Health Benefits Program; the United States Department of Veteran Affairs and Blackstone Medical, Inc.

Whistleblower Settlement

The settlement also includes resolution of the whistleblower lawsuits filed by Susan Hutcheson and Philip Brown. Hutcheson will reportedly receive $8 million as her share of the settlement amount.

Orthofix also agreed to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

Bob Vaters, Orthofix’s president and CEO noted that the company also finalized a Foreign Corrupt Practices matter in the third quarter of 2012. “Orthofix has made significant improvement to its compliance practices, and I look forward to a continued stronger focus on the company’s operations, including investments in R&D to position the company for long-term growth.”

Third Quarter Sales and Earnings

Vater’s comments came on the heels of the company’s third quarter sales results which showed constant currency growth of 1% on $114.8 million in sales. Currency negatively impacted net sales by 3%. Adjusted net income climbed by 13% during the quarter, prompting Vaters to note the company’s ability to achieve operating margin leverage while navigating through a challenging environment. “Finishing the quarter with a net cash balance and continued strong adjusted earnings, we are well positioned to make product portfolio and distribution investments that will drive long-term growth.”

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

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?

8
JT
James Thornton, MDSpine Fellow · HSS

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.

5
RP
R. PatelSports Medicine · Stanford

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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