SAN FRANCISCO — An Ashland hospital that's been among the nation's leaders in the rate of coronary stenting is under federal investigation for implanting the metal mesh devices needlessly, according to its spokesman.
Federal prosecutors have been probing King's Daughters Medical Center in Ashland since 2011 for suspected overstenting, said Tom Dearing, the 373-bed hospital's marketing and public relations manager.
The investigation involves stents inserted by the heart center's namesake, cardiologist Richard E. Paulus, according to his lawyer, Robert S. Bennett of Hogan Lovells in Washington. Bennett said Paulus had done nothing wrong.
The investigation signals a new front in a series of Department of Justice probes into interventional cardiology and stenting that began surfacing in 2006. At least 11 hospitals have settled federal allegations that they billed public health programs for needless stents and related misdeeds. Federal investigations continue in five states.
Earlier this month, another Kentucky doctor, Sandesh Patil, became the third U.S. cardiologist convicted on federal charges linked to doing needless stents. He was sentenced in U.S. District Court in Frankfort to 30 months behind bars, after pleading guilty to a single charge of Medicaid fraud.
Stents, the tiny coils inserted into arteries with catheters to prop open coronary blockages, can save lives of heart-attack victims. Their use in stable patients is in dispute among medical researchers.
Paulus and King's Daughters were also named in a civil lawsuit filed Sept. 30 in Kentucky state court, alleging that the cardiologist "dramatically" misrepresented the extent of a patient's heart disease to justify implanting five unneeded stents.
Dearing declined to comment on the suit or the federal investigation. Bennett said Paulus will "vigorously contest" all charges, civil or criminal.
"We have thoroughly investigated this case and are convinced Dr. Paulus always acted in the best interest of his patients and never inserted a stent that was not medically appropriate," Bennett said. "I am hopeful that after the government completes its investigation, it will conclude that Dr. Paulus has done nothing wrong."
Kyle Edelen, spokesman for the U.S. Attorney's office in Eastern Kentucky, said on his office voicemail that he can't answer media calls during the government shutdown. A U.S. Department of Justice spokesman in August declined to comment on any investigation of unneeded stenting in Ashland.
Ashland ranked fourth out of 1,768 U.S. regions in the number of stent-related procedures per 1,000 Medicare enrollees in 2010, according to an analysis by researchers affiliated with Dartmouth College in Hanover, N.H. King's Daughters has the only cardiac-stenting facility in Ashland.
The hospital's chief executive officer, Fred Jackson, addressed "rumors in the community" about the federal investigation during a local Rotary Club speech in August, said Dearing, the hospital spokesman. Jackson told his audience the rumors drove patients elsewhere and contributed to financial losses at the hospital in the past two years, Dearing said.
As a result, King's Daughters laid off about 150 of its 3,800 employees in August, Dearing said. On Aug. 30, Moody's Investors Service downgraded $240 million of the hospital's debt, citing, among other factors, a 45.5 percent drop in cardiac catheterization procedures in its 2013 fiscal year.
In the state lawsuit, patient Robert Huron, 50, claims Paulus gave him multiple unnecessary stents from 2006 to late 2010. Huron suffers a constant allergic reaction to the stents' polymers, according to the suit. The allergy causes hives, joint pain and swelling in his throat, Huron said in an interview.
An expert hired by Huron's lawyer found his first stent was implanted at the site of a catheter-induced spasm in his artery and not a significant blockage, and his second one was done because scar tissue from the first stent had blocked the same artery, said his lawyer, Hans Poppe of Louisville. The subsequent stents were similarly unwarranted, Poppe said.
"I've lost seven years of my life, and spent a lot of money I shouldn't have spent, and now I'm worse off because of the allergy," Huron said.
Paulus, 66, retired this summer after 21 years practicing interventional cardiology in Ashland, where he was widely admired for his work ethic and concern for patients, according to an article in The Daily Independent. He was "very, very, very surprised" when the hospital in 2006 named its new heart center the Richard E. Paulus Pavilion Heart and Vascular Center, he told the paper.
In 2011, Paulus earned $2.6 million, according to an Internal Revenue Service filing by his employer, Kentucky Heart Foundation Inc.
Poppe, Huron's attorney, represents 362 plaintiffs in over-stenting suits filed against Patil and other defendants in London.
Doctors in Ashland did stent-related procedures on 27 out of every 1,000 Medicare enrollees in the area in 2010, according to an analysis by the Dartmouth Atlas of Health Care. That was about 3.5 times the U.S. average. In neighboring Huntington, W.Va., doctors performed 8.6 stent-related procedures for every 1,000 Medicare enrollees — less than one-third Ashland's rate. More than 90 percent of such procedures nationally result in the insertion of a stent.
"Ashland is a sore thumb sticking out that needs to be diagnosed," said Peter Hasselbacher, an emeritus professor of medicine at the University of Louisville who has written about high rates of cardiac stenting in Eastern Kentucky. "Income appears to be driving medical decisions, not medical need."
At its 2011 peak, King's Daughters did 28 percent more stent-related procedures than any other hospital in Kentucky, including the medical centers in Louisville and Lexington, state data show.
In 2012, after the federal investigation began, the number of the most common stent procedures at King's Daughters fell 47 percent from 2011, according to Huron's suit, which was filed in Boyd Circuit Court in Catlettsburg.
Bennett, Paulus' Washington attorney who represented President Bill Clinton in the Monica Lewinsky affair, said King's Daughters became a stenting hub because people came from miles around to his client.
"Everyone in the surrounding areas knows that King's Daughters is a great hospital and that Paulus is the person you want to see," Bennett said.