Doctor Says a Device Poses Risk

Doctor Says a Device He Invented Poses Risks
By BARRY MEIER

Dr. Scott D. Augustine, the inventor of a widely used piece of surgical equipment, now has a better idea — he wants hospitals to stop using the device during certain operations, asserting that it poses a danger to patients.

Two decades ago, Dr. Augustine, an anesthesiologist in Minnesota, helped pioneer the idea of keeping a patient warm during surgery. Doing so, studies have shown, produces benefits like less bleeding and a faster recovery.

Dr. Augustine’s invention, the Bair Hugger, changed surgical practices and made him a fortune. The device, which works like a forced-air heater, carries warmed air through a hose to a special blanket that is draped over a patient.

These days, Dr. Augustine asserts that his invention is a danger to surgical patients receiving implant devices like artificial heart valves and joints. The forced air, he says, can spread bacteria associated with hospital-acquired infections.

Coincidentally, Dr. Augustine, who no longer has a financial stake in the Bair Hugger, also says he has a safer alternative, a warming device that works more like an electric blanket and does not use forced air.

“I am very proud of the old technology,” he said. “But I am also proud to spread the word that there is a problem.”

It is not unusual for a developer or a company to assert that a new device is safer, more efficient or cheaper than an existing one. But Dr. Augustine’s campaign against his own creation is notable for several reasons.

For one, some specialists in patient warming say that Dr. Augustine has yet to produce clear evidence that devices like the Bair Hugger pose a threat, a position that an independent testing laboratory sought out by Dr. Augustine also reached. But that has not stopped the inventor from lashing out against the Bair Hugger, the company that sells it, Arizant Inc., and even some researchers who do not share his views.

His campaign also comes amid the backdrop of a long-running feud between him and Arizant. Dr. Augustine resigned in 2002 as chairman and chief executive of the company, which used to be known as Augustine Medical, after a dispute with other board members, court papers show. Arizant was acquired this fall by 3M for $810 million.

Last year, Dr. Augustine and Arizant settled a court battle arising in part out of a Medicare fraud investigation involving a different device that Dr. Augustine invented.

In 2004, the inventor pleaded guilty to a single misdemeanor charge stemming from that inquiry, paid a $2 million fine and was subsequently barred for five years from participating in federal health care programs.

Dr. Augustine then sued Arizant in a Minnesota state court asserting that it owed him, under an indemnification agreement, that $2 million fine plus millions of dollars more in salary. Under a settlement, Dr. Augustine received about $5 million, the company and the doctor said.

Dr. Augustine’s campaign against the Bair Hugger has taken various forms. He has spoken out against the device at professional medical meetings and has underwritten studies intended to show that it may pose a bacterial threat.

Videos on a Web site promoting his new device, which is called the HotDog, suggests that heat generated by a Bair Hugger can redirect circulation in specialized rooms where joint implant surgeries are performed. That change in air flow can bring airborne contaminants in contact with patients, the videos assert.

Last April, the inventor also wrote to Arizant executives, accusing the company of a cover-up of the device’s problems, according to a copy of that letter which Dr. Augustine provided to The New York Times.

“The question for you to answer is the following; is Bair Hugger going to be replaced quickly and catastrophically by a mandatory recall, or do you survive a voluntary recall and live to fight another day?” he wrote.

Arizant executives declined to be interviewed about their interactions with Dr. Augustine. However, Arizant has sued the inventor’s new company, Augustine Biomedical and Design, in Germany, charging it is distributing information there that falsely disparages the Bair Hugger.

3M, Arizant’s new owner, said in a statement: “We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless.”

Several researchers in the area of patient warming said they respected the contributions that Dr. Augustine, who has some 150 patents to his credit, had made. And they added that the HotDog, which acts like an electric blanket rather than an air blower, appears to work as well as the Bair Hugger.

But they also said that there did not seem to be enough science to back his assertion that the Bair Hugger was dangerous.

“He simply has a new device now and wants to promote it,” said Dr. Andrea Kurz, an anesthesiologist at the Cleveland Clinic, who has studied the HotDog. “And when you promote a new device by making something old look bad, it doesn’t work well in our community.”

Not long ago, Dr. Augustine presented data to the ECRI Institute, a group in Plymouth Meeting, Pa., that evaluates medical devices, to support his contention that bacteria generated by the Bair Hugger might be linked to hospital infections, said Dr. Jeffrey Lerner, the group’s executive director.

Dr. Lerner added that the group concluded that current data was inadequate to prove that link.

Along with Arizant, Dr. Augustine has turned his sights on other experts. For example, he filed an ethics complaint this year with the Cleveland Clinic, charging that a leading specialist there on patient warming, Dr. Daniel Sessler, was biased against him.

In an interview, Dr. Sessler said that Dr. Augustine, whom he has long known, approached him several years ago to be a consultant on the HotDog. Dr. Sessler said that he told the inventor he would need a sizable payment to consider the position because he would no longer be able to accept research financing from competitors like Arizant.

The men did not reach an agreement and soon, Dr. Sessler said, Dr. Augustine turned on him.

“He started getting on my case, sending me funny notes saying I was biased,” he said.

For his part, Dr. Augustine said he filed his ethics complaint after Dr. Sessler made a speech at a recent professional meeting that discussed only forced-air warmers like the Bair Hugger and did not mention devices like the HotDog.

A spokesman for the Cleveland Clinic said that its legal department had looked into Dr. Augustine’s charge that Dr. Sessler was biased and determined that it was unfounded.

Dr. Jeffrey P. Gumprecht, an infectious disease expert in New York, said that he was hired by Dr. Augustine’s company to review its data. He said he found the inventor’s theory about the potential dangers of forced-air warming compelling, but added that proving such a link might be impossible because it would require mounting a huge clinical study.

http://www.nytimes.com/2010/12/25/business/25invent.html?_r=1&nl=todaysheadlines&emc=a25&pagewanted=print

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