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Medical Implant Makers Pay $310M For Kickbacks
By Jeffrey Gold, AP Business Writer
Manufacturing.Net - September 28, 2007

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NEWARK, N.J. (AP) — The five companies that provide nearly all the replacement hips and knees used in America have agreed to pay $310 million and accept federal monitors to settle concerns over doctor kickbacks following a sweeping Justice Department investigation.
 
From at least 2002 through 2006, the companies paid orthopedic surgeons ''exorbitant'' amounts to be consultants and use their products exclusively, said Christopher J. Christie, the U.S. attorney for New Jersey. Patients and hospitals were unaware of the deals, which ranged from tens to hundreds of thousands of dollars a year and included trips.
 
The U.S. Department of Justice began investigating the industry in 2005 over concerns that companies might have paid kickbacks to orthopedic surgeons in return for favoring their products.
 
''The entire industry agreed their practices need to be reformed, and will be reformed,'' Christie said Thursday in announcing the settlements.
 
The settlements mandate that companies require doctors to disclose all consulting agreements to patients, and that companies post the deals and amounts on their Web sites.
 
''This will empower patients over the long term to ensure their health care decisions are being made in a medically responsible way without any influence of economic coercion,'' Christie said.
 
Four of the companies — Biomet Orthopedics Inc., DePuy Orthopaedics Inc., Smith & Nephew Inc. and Zimmer Holdings Inc. — entered deferred prosecution agreements with the government.
 
London-based Smith & Nephew has its U.S. orthopedics operations in Memphis, Tenn.
 
The companies will be monitored for 18 months. Criminal complaints charging conspiracy to violate the anti-kickback statute will be dismissed if they adhere to the requirements.
 
The fifth company, Stryker Corp., began cooperating before the others, prosecutors said, and thus was allowed to enter a non-prosecution agreement and was not charged. It will be monitored for 18 months and must also implement the same reforms as the others.
 
Christie said prosecutors needed to balance the mandate to enforce laws aimed at fair business practices with the possibility that prosecutions could hurt innocent employees and consumers. ''We will not use the power and authority of our office to destroy companies,'' he said.
 
Christie would not say if any doctors would be charged in the continuing investigation, but said no company employees were being charged at this time. He said that only a minority of the consulting contracts companies had with surgeons were considered improper.
 
Biomet will pay $26.9 million; DePuy, $84.7 million; Smith & Nephew, $28.9 million; and Zimmer will pay $169.5 million and be monitored by former U.S. Attorney General John Ashcroft.
 
The amounts were based on market share. Stryker will not pay any money.
 
''This investigation uncovered evidence that health care decisions were being made based on a doctor's wallet and not on a patient's well-being,'' said Weysan Dun, the agent in charge of the FBI's New Jersey division.
 
Biomet said it made no admission of improper conduct and noted that the settlement ''acknowledges that the company did not engage in any conduct that adversely affected patient health or patient care.'' Biomet, of Warsaw, Ind., was acquired Tuesday for $11.4 billion by a consortium of private equity firms and ceased trading on Nasdaq.
 
DePuy issued a statement noting it admitted no fault, and adding that investigators found it had ''undertaken extensive actions and reforms.''
 
''Surgeon consultants are important sources of innovation for medical technology manufacturers, and they are integral to the training of peers on the use of new technology,'' said DePuy, also of Warsaw, Ind., and a unit of New Brunswick, N.J.-based health care giant Johnson & Johnson. ''The collaboration between government and industry will result in greater transparency in relationships between industry and surgeon consultants.''
 
Smith & Nephew, which has its U.S. orthopedics operations in Memphis, Tenn., admitted no wrongdoing.
 
In a statement, the Kalamazoo, Mich.-based Stryker said it was satisfied with the outcome of the investigation.
 
Zimmer, which is also based in Warsaw, Ind., did not admit any wrongdoing. President and CEO David Dvorak said, ''Importantly, the resolution agreements clearly define how we and our key competitors will interact with physician collaborators, thereby establishing a standard of conduct across the industry.''
 
In July 2006, another medical device maker, Medtronic Inc., agreed to pay $40 million to settle civil allegations that it paid kickbacks to doctors.
 
The allegations dealt with its Memphis-based subsidiary Medtronic Sofamor Danek, which makes implants used in back surgery to stabilize a patient's spine.
 
The government said that between 1998 and 2003, Medtronic paid kickbacks that included sham consulting fees, bogus royalty payments and trips to tourist destinations. Medtronic denied any wrongdoing in the settlement.
 
Associated Press writer David Porter contributed to this story.

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