New Mexico issues
By Colleen Heild / Journal Investigative Reporter on Sun, Jul 24, 2011
Tommy Sowards is a 62-year-old former heavy-equipment operator who lives with a machine in his chest — a heart device his new doctors say he never needed but would be too risky to remove.
Karin Marie Puett is a 53-year-old teacher at La Tuna federal prison who spent nearly a year with a dual-chamber pacemaker in her body.
She alleges in court documents that she couldn’t sleep at night, despite the fact she was always tired. She couldn’t work, had to avoid physical activity and was put on pills for high blood pressure.
Like Sowards, she consulted with other doctors who told her she never needed a pacemaker. She had it removed and discovered that her blood pressure was fine without the medication.
Once patients of New Mexico cardiologist Dr. Demosthenis Klonis, these Las Cruces-area residents are plaintiffs making medical negligence claims against him in separate lawsuits.
They aren’t alone.
In the past two weeks, 21 other former patients of Klonis’ filed suit in Santa Fe alleging medical negligence, unfair trade practices and civil conspiracy.
The cases share a common thread: Klonis allegedly performed invasive cardiac procedures involving implants, such as pacemakers, that his patients didn’t need.
Klonis has denied any negligence or other wrongdoing both in court documents and through his personal attorney, Blaine T. Mynatt of Las Cruces.
Mynatt told the Journal that the claims against Klonis are baseless and that the doctor was confident he would ultimately prevail.
The Sowards and Puett lawsuits, filed in 2009, also allege Klonis manipulated patients’ medications to create physical symptoms necessary to justify the insertion of the pacemakers.
And the pacemaker records that might prove or disprove Sowards’ and Puett’s claims? They are missing, and hundreds more may also be lost, according to court documents.
Klonis couldn’t be reached for comment, but a woman who said she was his wife, Demee Klonis, told the Journal her husband has been unfairly maligned.
“No one’s been killed; no one’s been harmed; the standard of care has been upheld,” she said in a recent telephone interview. “He’s a great physician with a 25-year track record who has helped thousands of patients and saved thousands of lives.”
One of the lawsuits alleges that, in addition to billing for his medical services, Klonis was paid by a pacemaker company to do research, teach and lecture out of state.
The Sowards case also alleges that other defendants in the case reaped financial rewards from Klonis’ unnecessary heart device insertions and should have known his use of the devices was out of line.
Those defendants include Mountain View Regional Medical Center in Las Cruces; its owners, Community Health Systems Inc. of Tennessee; and the German pacemaker manufacturer Biotronik Inc. They have denied any wrongdoing or liability.
The Sowards lawsuit alleges Biotronik sold the pacemaker to Mountain View for about $8,000. The hospital charged Sowards more than $20,000 for the device, and Klonis charged Sowards $757 for “perhaps one hour’s work to implant the unnecessary pacemaker.”
Biotronik has been under scrutiny by the U.S. Justice Department for allegedly paying physicians consulting fees to use its devices on patients. Biotronik says those accusations are “flatly wrong.”
After The New York Times reported that a group of heart device specialists started using Biotronik heart devices for the majority of its patients in Las Vegas, Nev., Nevada Gov. Brian Sandoval ordered a state inquiry as to whether Biotronik’s payments to physicians were legitimate consulting fees or inducements.
The Times reported that, under federal law, anyone who gives or receives something of value to induce the use of a drug or medical device paid for by a taxpayer-financed program like Medicare can face civil or criminal charges.
Klonis has said that, in addition to teaching other physicians about implanting heart devices, he opened the White Sands Institute for Clinical Research for Biotronik in 2005.
Asked whether his revenue from that research venture would be as much as $100,000 a year, Klonis responded, “I don’t have any idea.” The center is now closed.
Klonis, an osteopath with specialities in cardiology and internal medicine, has practiced in New Mexico since 2005. Before that, he worked in several Midwestern states, seldom staying at any one medical practice for more than several years, his New Mexico licensing documents show.
Klonis left southern New Mexico last year to move his practice to Santa Fe, where he was born and still has family.
He said in a deposition last year that he signed a recruitment contract with Christus St. Vincent Regional Medical Center as a staff cardiologist, but a spokesman for the hospital told the Journal last week that Klonis is not employed there.
Klonis does have privileges to operate and perform procedures at the hospital, “but I can tell you the privileges are under review right now,” hospital spokesman Arturo Delgado said.
Delgado declined to say whether the review was routine or for cause. He also declined to comment on the recruitment contract issue.
Informing or soliciting?
Albuquerque attorneys James Bromberg and Corbin Hildebrandt, who represent Sowards and the 21 new plaintiffs, sent a random notice to about 10,000 people in the Las Cruces area in March seeking information about patients who received pacemakers or other heart devices.
Mynatt characterized the notices as “solicitation letters” that entice “individuals to believe that they have a claim for money damages against Klonis for implanting devices without medical indication.”
Mynatt said in a letter to the Journal that the notices went out, despite a prior unanimous decision at the state Medical Review Commission “that Dr. Klonis did not commit malpractice” in the Sowards case.
Sowards’ attorney Bromberg said that ruling was made before the discovery of important information, including that Sowards’ pacemaker records were missing.
As for Puett, her lawsuit says that the review commission found against Klonis and determined that she was “entitled to the assistance of the New Mexico Medical Society in obtaining an expert cardiologist” for her lawsuit.
Mynatt’s office didn’t respond to a Journal email question about the ruling in her case.
Commission officials say its pre-litigation reviews are confidential. Rulings aren’t admissible in court.
Klonis’ attorney David Lawrenz, who represents Klonis in the medical negligence lawsuits, declined to comment.
Mynatt’s letter says Klonis “strenuously denies all allegations of impropriety or negligence against him. Nonetheless, Dr. Klonis must defend against them.”
He added: “The costs of defending the lawsuits may force a dedicated professional out of serving in New Mexico.”
Pacemakers are generally set to turn on when a patient’s heart rate becomes too high or too low and might never activate in a healthy patient.
But records that would show pacemaker activity after surgery for Sowards — Pruett had a different brand implanted — were reportedly destroyed when a Biotronik computer pacemaker “programmer” in Klonis’ office crashed in November 2008.
Biotronik sales representative Edward Tague told Sowards’ attorneys he sent the programmer device back to Germany to be evaluated and has no idea what Biotronik did with it.
He said that hundreds of reports from other patients were stored in the machine, according to a transcript of the conversation filed in the lawsuit. There was no backup storage of data.
Klonis said at deposition that he never informed his patients their pacemaker information had been destroyed.
The crash occurred just days after Sowards’ attorneys asked for the records, court records state. Biotronik Inc. contends the records destruction wasn’t intentional.
The issue of missing medical records has surfaced in another pending legal action involving Klonis.
A Las Cruces cardiologist contends he discovered electronic patient medical records missing once he bought Klonis’ cardiology practice in July 2010. Klonis has sued the physician for stopping payment on the $300,000 purchase.
In his lawsuit, Sowards said he went with his wife, Barbara, to the Mountain View emergency room with symptoms of high blood pressure and fatigue Jan. 6, 2007.
The lawsuit said Klonis recommended Sowards have bypass surgery. Days later, Klonis concluded a permanent pacemaker was necessary.
“In fact, Mr. Sowards suffered from a temporary disorder of heart rate and blood pressure induced by drugs which Dr. Klonis himself had prescribed,” the lawsuit alleges.
Sowards testified at deposition that he later consulted another cardiologist.
“He looked at my wife and he looked at me and he said, ‘Tell me again why they did this.’ He told me that the surgery was unnecessary and I didn’t need it.”
Sowards did have some blockage of his coronary arteries but said at deposition his new cardiologist concluded that a stent would have been a less invasive remedy.
Bromberg said Sowards has a congenital blood clotting abnormality, so his new doctors concluded it was too risky to remove the pacemaker. All they could do was turn it off.
Puett was referred to Klonis in January 2006 for a checkup after her brother was diagnosed with heart muscle disease.
Though she had no history of heart disease or abnormal heart conditions, Klonis was concerned she had reported a dizzy spell in the bathroom, her lawsuit states. He put her on blood pressure medication, the lawsuit added.
After numerous tests showed no abnormalities, the lawsuit stated, Klonis told her she needed a pacemaker for the rest of her life.
At deposition, Klonis said he needed to address the unexplained dizzy spell because she couldn’t afford to lose consciousness as a prison employee or while driving.
During the operation, she suffered a collapsed lung. Months later, Puett felt so bad she could no longer work, her lawsuit says. After she was turned down for disability retirement, she consulted cardiologists in Albuquerque and Dallas.
Now, about $100,000 in medical costs later, she is off the medication and the pacemaker is out.
But what happened to the heart rhythm records that would have shown she needed a pacemaker? Klonis has said those records were stored differently from the Biotronik readouts.
But according to Puett’s lawsuit, neither Mountain View Regional Hospital nor Klonis can produce them.
— This article appeared on page A1 of the Albuquerque Journal
Read more: ABQJournal Online » Pacemaker Troubles http://www.abqjournal.com/main/2011/...news/pacemaker