Failed public policy by Congress has put in motion an aggressive and powerful medical device industry unfettered by consequences. Joint replacements are the #1 expenditure of Medicare.
Watch the Senate HELP Hearing on Medical Devices 2:30P Tuesday, November 15, 2001
Salisbury stent doctor sentenced to federal prison.
Cardiologist falsified patient records to justify unnecessary procedures
By Tricia Bishop, The Baltimore Sun
7:43 p.m. EST, November 10, 2011
John R. McLean, a Salisbury physician, was sentenced to eight years in federal prison Thursday, making him the second cardiologist in the country to face incarceration for implanting unnecessary coronary stents in dozens of patients, then fraudulently billing insurers thousands for the work.
A Louisiana doctor was sentenced to 10 years in prison in 2009 under similar allegations. And a half-dozen other physicians, including Towson's Dr. Mark G. Midei, are accused in civil lawsuits of overusing stents, though they have not been charged criminally.
"I conclude, sadly, that this was a crime of greed," U.S. District Judge William D. Quarles Jr. said of McLean's actions, which include falsifying patient records at Peninsula Regional Medical Center to justify the expensive procedures, then prescribing gratuitous follow-up tests for months afterward.
He was ordered to spend 97 months in prison, forfeit $579,000 in illegal proceeds and to pay the same amount in restitution to the public and private insurers he illegally billed. His lawyer plans to file an appeal and will ask that McLean, who was ordered to report for prison in February shortly after his 60th birthday, be allowed to remain free until the matter is resolved.
The sentence stunned his family, some of whom sobbed throughout the lengthy hearing, and sent a message about the "seriousness" of the crime, Quarles said.
Improper stenting has been a focus at the state and national levels over the past several years after Midei, a star cardiologist at St. Joseph Medical Center, was accused of implanting the tiny mesh tubes in hundreds of people whose arteries didn't need them. The allegations led to national media attention, a U.S. Senate inquiry, a multimillion-dollar settlement from the hospital and a debate in the medical community about the role of a physician's judgment in medical care.
Supporters of the embattled cardiologists — many of them stent patients — contend that the physicians are making sound calls based on certain symptoms. But malpractice attorneys, and in some cases prosecutors, say the doctors are overdoing the relatively simple procedures — which typically cost about $10,000 — driven by money and their egos.
McLean's desire to be the "biggest and the best cardiologist" at PRMC drove him to perform the unwarranted procedures, said Assistant U.S. Attorney Sandra Wilkinson.
"There's just some arrogance there," Wilkinson said. "At the end of the day, he made a lot of money, but he also made a really good reputation for himself."
McLean was indicted last year on charges he ran the fraudulent stent scheme from 2003 through 2007, when he resigned his practice privileges at PRMC after a hospital investigation. He was convicted this summer of health care fraud and of making false statements, and PRMC agreed to a $1.8 million settlement afterward to settle claims it did not put a stop to the improper procedures.
Several patients who received improper stents testified during the trial, according to court papers.
One man said he nearly died from blood loss after being required to take blood thinners. Another patient said she had a heart attack, brought on by the dye used in the procedure, while on the operating table.
"These people are looking to their cardiologists almost as if they're a god … we're talking about [their] hearts," Wilkinson said. "They're thinking that Dr. McLean is saving their life when really he's just looking for an opportunity."
McLean insisted he never meant to hurt anyone.
"I've worked hard all my life," he told the judge, characterizing himself as a perfectionist who lived for his practice, spending every other night on call for a decade and missing many of his daughter's milestones. The young woman, now 25, wiped away tears as he spoke.
"I never ever did anything intentionally dishonest to a patient," he said, denying that money drove him to do wrong. "I did the best I could, I always did the best I could."
He called himself a "broken man" and ticked off a list of ailments, including diabetes, vision problems and a previous heart attack. He said his mother is elderly and begged the court for "leniency and mercy" in sentencing.
His lawyer, Richard W. Westling, said he feared McLean would die in prison if forced to serve a lengthy term.
Quarles noted that McLean, a Baltimore native, had never been in trouble before, and commended him for the many good works he has done. Some of his supposed victims wrote letters to the court praising the doctor for saving lives and doing excellent work.
He "has done many positive things," Quarles said before sentencing him. "It's also clear that Dr. McLean implemented medically unnecessary stents for the basest of reasons … largely for the money."
Louisiana cardiologist Mehmood M. Patel, who was sentenced to 10 years in prison in 2009 after being convicted of 51 counts of fraud connected to improper stents, is also appealing his conviction and is free on bond. Arguments were heard in Patel's appeals case Tuesday.
Westling said he will be watching closely for the outcome.
Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!