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The Daily Northwestern Friday, May 16, 2014
DAILYNORTHWESTERN.COM
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Trial of the heart
Senator investigates claim that NU doctor implanted an experimental device he created into woman’s heart valve — without her consent By CAT ZAKRZEWSKI
In Focus
daily senior staffer @Cat_Zakrzewski
Graphic by Jackie Marthouse/Daily Senior Staffer
Antonitsa Vlahoulis struggled to get the words out as she remembered the medical ordeal that kept her away from her children and in and out of hospitals for months. Vlahoulis first came to Northwestern Memorial Hospital in 2006, when shortness of breath made it difficult for her to exert herself at her job. She was diagnosed with a condition called mitral valve prolapse, which caused her heart valve to leak severely. Months after having open heart surgery, Vlahoulis realized her surgeon, Patrick McCarthy, had implanted a ring that was part of a clinical trial she says to which she never consented. “How could you do that to someone?” the Niles woman told The Daily as tears formed in her eyes. “I felt like I was being treated like an animal.” Vlahoulis, 46, is one of more than 600 patients from 2006-08 who were implanted with the Myxo dETlogix 500 Annuloplasty Ring 5100, a triangular piece of silicone and metal that pinches together leaky heart valves. McCarthy, the chief of cardiac surgery at NMH, invented the ring. Another top doctor on the trial, Nalini Rajamannan, accused McCarthy of “human experimentation” after hearing Vlahoulis’ story in 2007. Her accusations sparked a U.S. Senate investigation. Sen. Chuck Grassley (R-Iowa) reignited the case this year when he accused NU of withholding information about the Myxo ring he first requested in an
investigation five years ago. NU spokesman Al Cubbage said the University is preparing a response to Grassley’s April letter. Although University President Morton Schapiro was not at NU in 2006, he said administrators have been looking into the issue “for years and years and years.” “There are a lot of things that we review,” he said in an interview last month. “And typically move on unless we find something inappropriate.” “I think by and large ... the University has responded to all the requests we’ve received,” Cubbage added. McCarthy remains the chief of cardiac surgery at NMH. “Claims of human experimentation are absolutely false,” McCarthy wrote in an email to The Daily, declining a request for an interview. But eight years, a Senate investigation and at least two lawsuits later, Grassley says NU still hasn’t answered a simple question. “Did Northwestern implant an unapproved device — which it knew, or should have known, required approval — in patients without obtaining their informed consent?” Grassley wrote in an April 28 letter to the University. Grassley says that answer will have major implications for a broader discussion about what patients deserve to know before receiving a medical device.
‘I just wanted to feel better’ In spring 2006, Vlahoulis was referred to McCarthy for surgery to fix her mitral » See HEART, page 6
1 year later, questions surround worker’s death By PATRICK SVITEK
daily senior staffer @PatrickSvitek
A year after a falling beam fatally hit an iron worker on campus, questions remain about what went wrong and how the accident could have been prevented as construction continues on the lakefront. Michael Kerr, a 57-year-old veteran of Chicago-area construction, was killed May 16, 2013, after a crane knocked a 16-foot, 70-pound beam off
the sixth floor of the new Music and Communication Building. The fatal accident set off a monthslong investigation by the Occupational Safety and Health Administration. In November of last year, OSHA cited the project’s general contractor, Power Construction, saying the company, which was then based in Schaumburg, Illinois, did not protect its subcontractor employees from falling objects. Although an OSHA spokesman said Tuesday that Power Construction has met all its obligations related to the citation, a wrongful death lawsuit
Serving the University and Evanston since 1881
continues to bring attention to the accident. Lawyers are currently conducting depositions in the case, which was brought by Kerr’s son, who is also named Michael Kerr. “We’re just looking for the truth,” said Louis Cairo, the younger Kerr’s attorney. “Just tell me what happened.”
A tragic accident A police report obtained through the Freedom of Information Act suggests the beam was moved by
the crane lines, which one detective observed were three feet away from the object’s original location shortly after the accident. A witness working “in close proximity” to Kerr told a detective the two workers were receiving and unhooking a load lowered by the crane shortly before the accident, according to the police report. Kerr was standing on the ground floor when the beam hit him in the chest and head. He was taken to Evanston Hospital, where he was pronounced dead less than two hours
later. Detectives wrote in the police report they were unable to find the crane operator for questioning. One detective said he was told the crane operator was too distraught to talk to police, while another detective wrote he was informed that the crane operator wanted to wait 24 hours to talk to authorities or the company, citing his union’s advice. At the hospital, a detective said a representative of a safety group that » See CONSTRUCTION, page 11
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