Justice Department closes case on Medtronic spine surgery product

MILWAUKEE — In a surprising move, the U.S. Department of Justice has ended its four-year investigation of Medtronic and its spine surgery product Infuse.Medtronic said it had been notified by the U.S. attorney for the District of Massachusetts that federal prosecutors had closed the case. No charges were issued and no settlement was reached.Since 2008, the investigation had been looking into off-label uses of the product used for spinal fusion surgery.”Given the duration of the investigation, we are surprised that the DOJ walked away empty-handed,” Larry Biegelsen, a senior analyst with Wells Fargo Securities, said in a written comment.
Biegelsen, who follows the company for investors, said he expected sales of the “beleaguered product” to continue to decline, but the end of the investigation could slow the drop.Medtronic executives were not available for comment.
“After several years of investigation, we are pleased that the Department of Justice and the U.S. attorney’s office have come to the decision to close their investigation of the company related to Infuse Bone Graft,” Chris O’Connell, a vice president who oversees the company’s spine business, said in a statement.Christina Sterling, a spokeswoman for the Department of Justice in Boston, said the office does not confirm or deny the existence of an investigation.Since coming on the market in 2002, Infuse has produced annual sales exceeding $700 million. Infuse originally was approved for a specific type of spinal fusion, but eventually more than 80 percent of its use was off-label, meaning it was used in a manner for which it was not approved by the Food and Drug Administration.Doctors are free to use products off-label, but companies are not allowed to promote their products for off-label use.Infuse also has generated an ongoing medical controversy, stemming from financial conflicts among a circle of prominent spine surgeons who co-authored papers that often failed to report serious complications with the product.As a group, the surgeons have received tens of millions of dollars in royalties from other Medtronic products.In some of those papers, those financial relationships were not fully disclosed.In other papers, the product was not linked to complications such as cancer; a condition that can cause sterility in men; and the unwanted growth of bone, though evidence indicated those side effects were known by the company.Since 2009, investigative reports in the Milwaukee Journal Sentinel and MedPage Today have focused on those conflicts and the papers written by the surgeons, as well as the complications.Despite the Justice Department decision, the controversy is not likely to go away.Last June, the U.S. Senate Committee on Finance launched an investigation into reports that doctors with financial ties to Medtronic failed to reveal serious complications in papers they wrote.That investigation, which was based in part on the Journal Sentinel/MedPage Today stories, continues, a Finance Committee aide said Thursday.
In a statement, U.S. Sen. Chuck Grassley, R-Iowa, senior member of the Senate Finance Committee, said the Justice Department apparently was not able to meet the high burden of proof needed to justify criminal charges.”Scrutiny will continue to ensure that mistakes aren’t repeated,” he said.He said payments made to doctors by Medtronic make a good case for implementing the Physician Payment Sunshine Act. The federal legislation will require that all payments made by drug and device companies to doctors be made public.
Medtronic said it had been notified by the U.S. attorney for the District of Massachusetts that federal prosecutors had closed the case. No charges were issued and no settlement was reached.Medtronic executives were not available for comment.
“After several years of investigation, we are pleased that the Department of Justice and the U.S. attorney’s office have come to the decision to close their investigation of the company related to Infuse Bone Graft,” Chris O’Connell, a vice president who oversees the company’s spine business, said in a statement.
In addition, researchers with Yale University are overseeing an independent review of the safety and effectiveness of the product. That review will include looking at individual patient data from all of the clinical trials of Infuse as well as all reports of adverse events with the product since it came on the market nearly a decade ago.Medtronic has agreed to fund the review with $2.5 million but will have no control over the process, said Harlan Krumholz, a professor of internal medicine at Yale.Krumholz has appointed Oregon Health & Science University and the University of York in theUnited Kingdom to conduct separate reviews, including looking at issues such as the quality of the Infuse studies and whether bias affected how the safety and effectiveness of the product was reported.In an interview Thursday, Krumholz said he expected the reports to be completed by the end of the summer and be published in a medical journal by mid-fall.”We are full speed ahead on the project,” he said.Eugene Carragee, a spine surgeon at Stanford University, said there is an important distinction between a criminal investigation and how the product was being portrayed in the medical literature by doctors who had financial conflicts.
“That’s a very different question than whether what they were promoting was good for patients and was factually correct,” Carragee said.Last June, Carragee, editor of the Spine Journal, presided over an unprecedented rebuke of the product published in that journal.The review found that doctors who received tens of millions of dollars from Medtronic repeatedly failed to reveal serious complications linked to Infuse in 13 papers they co-authored for medical journals over the course of nearly a decade.Among other things it found complication rates that were 10 to 50 times greater than the estimated complication rates revealed in the papers co-authored by the doctors with the financial ties to the company.Three of the papers were co-authored by Thomas Zdeblick, a spine surgeon and chairman of the department of orthopedics and rehabilitation at the University of Wisconsin School of Medicine and Public Health.Zdeblick has received more than $25 million in royalties from Medtronic since 2003. None of the royalties were for Infuse, but some of involved a product that can be used with Infuse.