In 2004, St. Jude Medical was a minor provider to Jackson Memorial Hospital of devices to fix irregular heartbeats, at a cost of up to $28,000 each.Then the firm hired sales representative Monica Rodriguez - the girlfriend of University of Miami cardiologist Alberto Interian Jr., who ordered and implanted most of the devices at Jackson.Over the next year, St. Jude's heartbeat device sales at Jackson soared by 400 percent - about $2 million.Interian's behavior has sparked an investigation at the Miami-Dade County ethics commission. Its investigators thought the evidence would support a complaint, but the commission didn't file one. UM decided Interian hadn't violated its standards but demoted him from his $419,000 job as interim head of cardiology.Interian insists Rodriguez was not the reason he switched to St. Jude products and that jealous ``enemies'' are out to get the couple. Rodriguez says the problem is her ``cut-throat industry. . . . I have done nothing wrong.''The case reflects a national debate about doctor ethics and the sales tactics of device manufacturers. In some instances, hospitals suspect manufacturers are bribing doctors with clinical study work or payment for speaking at conferences or travel.Other times, the suspicions are more personal. John Bardis of MedAssets, purchasing agent for Jackson, told investigators ``such dalliances'' between salespeople and doctors ``are not uncommon in the industry.''``This is an issue throughout the industry,'' said Jo Baxter, spokeswoman for Baptist Health South Florida, which is developing a new conflict of interest policy to deal with the problem.* * *The tale that follows is based on interviews and county ethics commission reports on Interian:In January 2003, Monica Rodriguez, a nurse practitioner with 12 years of hospital experience, joined Medtronic, which along with Guidant and St. Jude dominate the market for implantable heartbeat devices. She was paid $40,000 a year, plus commissions.Like all device sales reps, she went into operating rooms to ensure the pacemakers or defibrillators worked properly before surgeons used them. She won an award for District Rep of the Quarter; her sales team won a national award. Her boss, Nick Rutsis, gave her an ``acceptable contributor'' evaluation in May 2003.On April 4, 2004, Rodriguez took Interian to dinner at Joe's Stone Crab and submitted an expense to Medtronic for $206.01.Interian, born in Cuba and educated in Miami, started UM's department of electrophysiology about 20 years ago. He is a tenured professor, now 50. He does not suffer from a small ego. When told of a hospital executive's statement that he was widely respected locally, he said, ``I am widely respected throughout the world.''Rodriguez, once his patient, listed him as a recommendation on her application to Medtronic. She said she asked him to dinner to thank him, and both said they went as business colleagues.Rutsis, her boss, was surprised at the expense account because her territory was Miami Beach, not Jackson. ``When I questioned her, she became very defensive,'' Rutsis later told investigators. She told him Interian was her personal doctor.EVALUATIONOn May 26, 2004, Rutsis gave her an evaluation of ``needs improvement,'' Medtronic's lowest rating. ``She had a difficult time grasping the technology,'' Rutsis told investigators. He noted ``complaints from physicians that she couldn't basically do the more complicated cases.''Rodriguez was furious. She told The Miami Herald she was certain one or more doctors had complained unfairly. ``She simply got up from the table and left,'' Rutsis said in a later deposition. ``She said, `I am not taking this.' ''A few days later, she resigned. Medtronic paid her salary for the next two months.ACQUAINTANCE GROWSThat summer, Interian and Rodriguez say, they began seeing each other socially. At a medical conference at the Biltmore, each talked about a difficult separation and divorce. ``We never did anything clandestine,'' Interian said.In July, Interian told Rodriguez's former boss at Medtronic that she felt she ``might have acted kind of irrationally'' and recommended hiring her back, Rutsis later told investigators. ``He indicated that if I didn't hire her somebody else most likely would and that it would cost us a lot.''Rene Machado, regional sales manager for Guidant, told investigators Interian urged him too to hire Rodriguez, saying ``she was probably worth around $2 million.'' But he decided against it after a Guidant associate said Rodriguez ``lacked the spark of a great salesperson.''Interian said the managers were sour because they lost business and had ``twisted'' his comments ``out of context.'' He denied threatening to take business away from them.JOINING ST. JUDESt. Jude hired Rodriguez in December 2004, with a base salary of $50,000 plus commissions. Gilson Markham, the firm's regional director, said Interian had recommended her as ``very professional.'' Nobody mentioned a personal relationship.Markham said it was only coincidence that Rodriguez was also assigned to doctors at Cedars, Mercy and the Veterans Administration, hospitals where Interian practiced.In the final four months of 2004, Jackson paid $499,145 to Medtronic, $405,750 to Guidant and $166,000 to St. Jude. That changed.SALES GROW FASTStarting in February 2005, St. Jude sales led the other two for the next six months. In 2005, investigators say, St. Jude's sales at Jackson increased about $2 million. Medtronic's fell about $2 million at Jackson and about $1.8 million at the VA hospital. Guidant didn't offer figures but said sales fell.Interian said he was turning toward St. Jude even before Rodriguez was hired. He said he was upset because Medtronic stopped giving prestigious grants to Jackson/UM. St. Jude gave his department grants.Rodriguez defended her skills: ``If I were not competent, Dr. Interian would not work with me,'' she said. She added that St. Jude does not want her to talk about her work with the company.A RIVAL COMPLAINSFor a while, competitors didn't know about the romance. Then one day, Rutsis said, he received a call from a sales rep who handled Medtronics accounts at Jackson: ``She was incensed. She . . . said they were dating. She said, `We are going to lose our shirt.' . . . She started losing business right away.''Markham of St. Jude told investigators he did not believe St. Jude's more than 400 percent increase in sales was ``especially remarkable.''In June 2005, anonymous letters faxed to UM President Donna Shalala and Jackson chief executive Marvin O'Quinn revealed the romance and the shift of sales to St. Jude.``They just took a cruise in Europe together,'' said the fax to O'Quinn. ``He makes no bones about it and simply thinks that he is above any rules or laws that exist.''Interian said he, not St. Jude, paid for the trip, and when questioned by UM officials, he readily admitted to the relationship. On July 28, he sent a formal letter to Jackson's purchasing manager: ``I am writing to advise you that I have a personal relationship with one of the representatives for St. Jude. If this is of a concern to Jackson, I will be happy to discuss this.''Jackson then found a 2003 conflict of interest statement from Interian, saying he received $2,000 from Medtronic and $3,000 from Guidant for lectures. But officials couldn't find forms from the doctor for 2004 or 2005.Interian said that as a UM employee, he did not have to file Jackson conflict of interest forms. He estimated he received $2,000 or $3,000 a year in 2004 and 2005 from St. Jude for speaking engagements.AUDITOR'S REPORTOn Aug. 16, UM's internal audit department decided there was ``at the very least, a possible perception of conflict of interest.'' The UM report indicated Interian said ``it's a coincidence that he's come to view [St. Jude] as better since he started dating her.''On Oct. 13, Ted Lucas, Jackson's vice president of logistics and distribution, told investigators: ``I think this is a blatant case of the worst sort of thing that physicians do, and seemingly with impunity.''UM officials apparently felt differently. An e-mail between UM lawyers said the case probably did not come within anti-kickback statutes because ``the relationship would not be considered remuneration.''Interian said a UM auditor told him, ``Basically I should make this girl disappear.'' He and Rodriguez decided she should move from Jackson. ``For me perception is everything,'' the doctor told The Miami Herald.However, Interian says, another sales rep quit St. Jude, delaying Rodriguez's exit from Jackson. In November 2005, two Jackson executives saw the couple having dinner at Berry's restaurant in Coconut Grove.On Nov. 17, Interian's boss, Laurence B. Gardner, fired off a heated e-mail to Interian: ``Al, the board of trustees has told me your `friend' still has Jackson. I would remind you that is exactly the opposite [of what] you told me.''FIRED AS CHIEFThat's when Interian was fired as interim chief of cardiology, costing him about $50,000 a year. He says he's now earning about $350,000.Eventually, Rodriguez left Jackson but kept working at Mercy Hospital, where Interian operates under a contract as medical director of the Arrythmia/Syncope Center.In April, ethics investigators Karl Ross and Kennedy Rosario submitted a report noting that taxpayer dollars had been spent at Jackson and that the county code states no person ``shall use or attempt to use his official position to secure special privileges or exemptions for himself or others.''The report concluded that the ``primary beneficiary'' of St. Jude's rise in sales was Rodriguez, who earned more than $100,000 from sales to Interian's department at Jackson alone, along with tens of thousands at other hospitals where he worked.``Industry experts and internal analysts at JMH and UM are at a loss to find any explanation for St. Jude's sales gains - short of conflicted and/or exploitive behavior on Interian's part.''HANDS-OFF DECISIONFor months, the report sat. Jon A. Sale, a lawyer for Interian, argued the commission had no jurisdiction over the doctor because he was a full-time UM employee. Finally, on Sept. 28, the commission concluded Interian is outside its control.``He's a UM employee,'' Michael Murawski of the commission said last week. ``Let UM take care of it.''Jeanne Antol Krull, spokeswoman for the med school, said Interian remains ``a faculty member in good standing . . . . He did not violate any ethics standards of the University of Miami.''TIGHTENED POLICYHowever, because of the Interian case, UM has tightened its conflict of interest policies to include anyone who has a personal relationship.Several days ago, Interian's lawyers heard the university might launch a new investigation against the doctor. They sought and obtained a statement from the commission saying its findings were allegations that had not been litigated.The couple's relationship continues. Interian said he spends 60 to 70 percent of his time now at Mercy, and Rodriguez still works there for St. Jude.Interian said she is now on fixed salary, so she doesn't earn extra when he orders St. Jude devices.Mercy Chief Executive John E. Matuska said Interian is ``very well respected'' at the hospital, and he has no problem with Interian continuing to order many St. Jude devices.
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