St. Jude Medical Inc. isn't the only medical device manufacturer to chafe at Dr. Robert Hauser's scrutiny -- just the latest.
In 2005, the Minneapolis Heart Institute cardiologist blew the whistle on a defective defibrillator made by Guidant after it failed to revive a young patient. In 2007, Medtronic Inc. pulled its Sprint Fidelis lead off the market after a study by Hauser found that some of the wires, used to connect a defibrillator to the heart, failed. Aggrieved patients eventually won a $114 million settlement from the Fridley-based company.
Now, St. Jude and its recalled Riata defibrillator leads are facing questions after Hauser last month published an article in Heart Rhythm Journal tying the lead to at least 20 patient deaths. St. Jude has assailed Hauser's research as biased and flawed and asked for a retraction. Hauser and the editor of the online publication refused, saying they stand by the findings and that the work was peer-reviewed. The week after St. Jude made its request and disputed Hauser's findings, the Little Canada-based company's stock price fell 10 percent.
Hauser has made a career out of monitoring and sometimes challenging the medical device industry over the safety of its products. It's a role that has repeatedly brought him into conflict with the industry, several of whose biggest players are in Minnesota.
Ask Hauser to describe his role, and his answer is basic: "I am an advocate for patients."
Even his targets say they respect his work, even if they don't always agree with his findings.
Those who have worked with Hauser during his four decades of prodding device-makers and the U.S. Food and Drug Administration toward greater safety and accountability use other terms to describe him -- ethical, passionate, persistent.
"It's not anything against any company. He is out to find the truth to serve patients best," said Dr. William Katsiyiannis, director of clinical electrophysiology and vice chairman of cardiology at Abbott Northwestern Hospital's Minneapolis Heart Institute. "I think it takes quite a man to stand up for that and to keep your head down and do the right thing."
Years fighting
Hauser's passion for medical device safety began, he said, when he was a cardiology fellow in Chicago more than 40 years ago. He participated in a research project involving nuclear battery pacemakers with the help of funding from the National Institutes of Health.
"We were told, 'Go ahead and test them and write a favorable report,'" Hauser said. "All of them failed."
Hauser later started a program at Rush University Medical Center in Chicago to follow pacemaker recipients and a registry to keep track of how they're doing. In 1987, Hauser left Rush to join Cardiac Pacemakers Inc. and served as its president and CEO from 1988 to 1992 -- before it was acquired by Guidant. Guidant would later be purchased by Boston Scientific.
In 1992, Hauser joined the staff at the Minneapolis Heart Institute and used seed money to start an Internet-based device registry. He has continued his advocacy for patient safety and device accountability, conducting his own research and challenging a device establishment that he says sometimes puts profits ahead of prudence.
"It's not good business to put bad devices out there," he said.
Linda Callinan has worked with Hauser for 25 years, since starting a pacemaker follow-up program at the Minneapolis Heart Institute.
"He's got drive that is unbelievable," she said of the research that he often does on his own time.
Hauser, 72, doesn't wait for the FDA or device-makers to spot issues. Callinan said their program actively follows about 6,000 patients with pacemakers and defibrillators from a variety of manufacturers, alert for signs of problems.
Hauser acknowledges that devices aren't perfect -- and likely never will be. Still, he said, in a marketplace where manufacturers feel pressure to quickly develop devices to grab market share, the FDA has an obligation to remain vigilant. The agency should require more premarket testing of lifesaving devices and enact more stringent post-market surveillance of implanted devices, he said.
"You have to go out and look for problems," Hauser said. "If you wait for problems to come to you, it's too late."
Of course, he was saying the same thing back in 2005.
Going public
In March 2005, Joshua Oukrop, a 21-year-old college student from Grand Rapids, Minn., was on a spring break bicycling trip in Utah. He took a break from a ride, saying he was tired. He then collapsed to the ground and died.
Oukrop, who had a genetic heart disease, had a Guidant defibrillator. But the device short-circuited and failed to keep the young man alive.
Oukrop's doctors, Hauser and Barry Maron, later learned that Guidant had known that some devices short-circuited years before Oukrop collapsed. Guidant had changed its manufacturing processes to fix the problem.
But, after the company failed to disclose the problem to doctors and patients who still had the device, Hauser and Maron took their concerns to the media. Guidant eventually recalled the device.
Boston Scientific Corp., which acquired Guidant in 2006, paid $240 million in 2007 to settle lawsuits brought by patients. In 2011, the company pleaded guilty to federal charges, including making false statements to the FDA about the devices' safety, and paid a $296 million fine.
Oukrop's father credits Hauser and Maron for fighting for greater device oversight.
"If it hadn't have been for those two, it would have just blown over and nothing would have happened," Lee Oukrop said. "He has the courage of his convictions."
Sally Hauser knows all about her husband's persistence. More than 50 years ago, he saw her climb a hill at the University of Cincinnati and wanted to get to know her better. A year later, they eloped.
She also knows what kind of doctor he is.
"It's all about integrity," she said.
Fighting to get information into patients' hands about the devices in their bodies has been his passion -- even at the expense of friendships over the years. Not all doctors, many of whom are paid consultants to device-makers, have been willing to take the stands her husband has, she said.
"You lose friends. People are really funny," Sally Hauser said one day last week. "You know what the bottom line is? It's money."
Dr. Paul Friedman, a heart rhythm specialist at the Mayo Clinic in Rochester, has collaborated with Hauser on several studies.
"He has a passion for improving patient care and providing information to guide caregivers," Friedman said. "I think he has demonstrated that when you are committed to a goal, if you are persistent and consistent, I think with time you can lead to important changes."
Work continues
Hauser's most recent work has led to a public tussle with St. Jude Medical.
In December 2010, St. Jude discontinued selling its Riata lead after studies showed that the wires could work free from their outer insulation. Last December, St. Jude told doctors that the problem was more prevalent than previously thought. The FDA recalled the device.
In an article posted March 26, Hauser said he found least 20 deaths caused by high-voltage failures in the Riata leads.
St. Jude quickly went on the offensive, calling Hauser's report biased and inaccurate. It asked Heart Rhythm Journal Editor Douglas Zipes to retract the article. Zipes refused.
In recent weeks, St. Jude's rhetoric has softened a bit. St. Jude CEO Dan Starks said in a recent earnings conference call that "very sincerely, we have a lot of respect for Dr. Hauser's contributions over the years to raising awareness about medical device safety issues."
Starks said in a recent e-mail that he had not spoken to Hauser about his study, but "that my sense is that we have agreed to disagree."
He added that "St. Jude Medical shares Dr. Hauser's focus on patient safety and on getting as much accurate information as possible to physicians to help them make the best decisions for their patients."
Sally Hauser admitted that she and her husband are relying on that commitment to safety. Robert Hauser had a St. Jude heart valve implanted last May.
"He said to me: "Well, I guess I really have to trust them that it's a good valve,'" she said, smiling.
James Walsh • 612-673-7428
