Hip replacement surgeries in Vancouver Coastal Health Authority hospitals are being performed with implant devices sourced through firms that are increasingly mired in legal difficulties and controversy in the U.S.

Four companies that supply the Lower Mainland hospitals with hip transplant devices were named last year in a settlement with U.S. Attorneys that saw them accused of making kickbacks to surgeons.

The four include the Stryker Corporation, which issued a product recall this January on hip implant products made in its Cork, Ireland plant.

Meanwhile, Health Canada has encouraged Canadian hospitals to access Stryker products from a New Jersey plant that has been the subject of a U.S. federal regulator's warnings about deficient and unsanitary conditions.

Stryker has experienced legal difficulties again this year, with the U.S. Justice Department filing a lawsuit this month against the firm related to a new investigation.

According to a Sept. 3 story on the business news website Bloomberg.com, the investigation is looking into $40 million U.S. in consultant's fees paid to American surgeons, allegedly to induce them to use Stryker products in surgeries reimbursed by Medicare.

Nothing improper: Stryker rep

A Stryker spokesman told The Tyee that there is nothing improper in its relations with consultants.

"Stryker's consultants are primarily inventors and educators that play a very important role in advancing the science and practice of orthopaedics. They participate in research, implant design and surgeon training activities that ensure the safe and effective use of our implants and improve patient outcomes," wrote J. Pat Anderson, a Stryker vice president in an e-mail to The Tyee.

Anderson, citing "competitive reasons," declined to reveal any detail about Stryker product sales into the Canadian, B.C. or Vancouver Coastal Health markets.

Five companies, Stryker Corporation, Biomet, DePuy (a unit of Johnson &Johnson), Zimmer, and Smith & Nephew, made an agreement with the U.S. Attorney's Office in Newark, New Jersey on Sept. 27, 2007. Those firms control 95 per cent of the hip and knee replacement market in the U.S. All but Smith & Nephew, according to a list provided to The Tyee by VCH spokesman Gavin Wilson, supply Lower Mainland hospitals. Although the agreement will see four of the five companies pay out $311 million in penalties, none of the firms admitted to any wrongdoing.

Stryker Corporation, the first of the five to make a deal with the U.S. government, was not required to pay any penalties. However, it did, like all of the other firms named in the 2007 agreement, accept federal supervision for 18 months.

Kick-back violations 'routine': US Attorney

"This industry routinely violated kick-back statutes by paying physicians for the purpose of exclusively using their products," U.S. Attorney Christopher J. Christie of Newark, New Jersey told the New York Times.

Gavin Wilson, who speaks for the Vancouver Coastal Health Authority, told The Tyee, "I can tell you that we do things very differently in Canada in terms of equipment procurement. Decisions are not made by physicians alone, but through the health authority's procurement department. Our procurement takes place in a more public domain with competitive bidding and obligations for disclosure.

"As I've reiterated before, as long as Health Canada approves a medical device for use in Canada, then we will continue to use it," continued. "In terms of our policies, we are not making any changes to our procurement policies as a result of the issues being experienced in the U.S."

The supervision imposed by the U.S. Justice Department on the five implant manufacturing firms last year under a deferred prosecution agreement has since generated its own storm of controversy. One of the companies, Zimmer, will be supervised by Ashcroft Group Consulting Services of Washington, D.C., a firm headed up by former Bush administration attorney general John Ashcroft, according to the Boston Globe, and the supervision contract could pay Ashcroft and his colleagues up to $52 million in fees.

U.S. Attorney Christopher Christie, who led the government's case against the five hip implant device makers and reportedly "hand picked" the companies hired to supervise the agreements, once worked under Ashcroft. However, Christie was quick to deny any impropriety in the choice of Aschcroft's firm for the contract.

"If he were still my boss or potentially my boss in the future, I guess that would be something to talk about, but you know I just don't see it as an issue," Christie said. "I hired him because I know he's somebody of honesty and integrity and who has the experience to be able to do a job like this."

World's largest

Brad Bishop, a media spokesman for Zimmer, confirmed to The Tyee that the Ashcroft Group has been his firm's monitor under the agreement with the U.S. Justice Department for a year now of the 18-month term prescribed. He said that the monitoring involved Ashcroft Group staff on site at Zimmer facilities from time to time, as well as more remote contact from the monitor's D.C. offices.

While declining, like the Stryker Corporation, to disclose its market share in Canada, B.C. or the VCH, Mr. Bishop did note that Zimmer is the world's largest maker of hip and knee implant devices.

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