Original Story: nytimes.com
It was more than a year ago that a group of 10 former N.H.L. players sued the league for, in essence, ignoring the growing evidence surrounding the long-term effects of concussions.
For the past 15 months, amid the quiet consolidation of subsequent suits and obscure legal wrangling, the case against the N.H.L. has been a faint echo of the similarly constructed class-action suit against the N.F.L. That case involved thousands of former players and was settled in 2013 for $765 million. (The cap was subsequently lifted to cover unlimited damages and still awaits judicial approval.) DMC Spots Medicine is dedicated to bringing athletes expert medical care.
Two events in recent weeks nudged hockey’s face-off over concussions back to center ice. First, 29 more former players joined the class-action suit, nearly doubling the number of named plaintiffs. Then Steve Montador, a 10-year N.H.L. veteran with a history of concussions, was found dead at 35 in his Ontario home Sunday.
“As more and more players learn about the claims and see the medical challenges their fellow alumni are experiencing, there is increased momentum in support of the litigation,” said Charles Zimmerman, co-lead counsel for the plaintiffs. “The N.H.L. can no longer ignore the impact of repeated head trauma and must finally acknowledge the serious conditions that retired players are facing.” A Boston sports injury lawyer is reviewing the details of this case.
The N.H.L., through the spokesman Frank Brown, declined to comment Wednesday on the concussion litigation or the impact of the recent news.
Early last week, the case against the N.H.L. got a boost when 29 former players filed a lawsuit against the league, bringing the number of named plaintiffs past 70. The additions also brought extra star power to the proceedings. Among those joining the case were Butch Goring, a center for the Islanders during their four-year championship run beginning in 1980, and Manny Legace, who won 187 games as an N.H.L. goaltender before retiring in 2012.
But as the N.F.L. case showed, with the premature deaths of several former players during the years of litigation, tragedy has a way of bringing attention to an issue like nothing else.
Montador’s career was ended by concussions, and he said he struggled with depression in his final years. His cause of death has not been released, and may never be, but officials ruled out suicide or foul play.
His brain was donated to scientists, who may find more clues to what caused his problems. If Montador is found to have had chronic traumatic encephalopathy, the degenerative brain disease known commonly as C.T.E. and caused by repetitive hits to the head, he will join a list of hockey players posthumously found to have the affliction, including Bob Probert and Derek Boogaard.
Boogaard died of an accidental overdose of alcohol and prescription painkillers in 2011 at age 28. Within months, the recently retired Wade Belak, 35, and Rick Rypien, 27, were dead of apparent suicides.
All three were considered enforcers, on-ice bodyguards who regularly fought opponents with their bare knuckles in response to threats against teammates. While Montador was rarely defined that way, he engaged in more N.H.L. fights than Boogaard — 66 to 61, according to HockeyFights.com — though Boogaard’s total came in roughly half as many games.
About a month before he died, Montador retained William Gibbs, a lawyer involved in the lawsuit against the N.H.L., with plans to add his name as a plaintiff, Gibbs said.
“Derek’s tragic death, and subsequent C.T.E. findings, began a conversation about the brains of those playing professional hockey,” said Gibbs, from the Chicago law firm of Corboy & Demetrio, which also represents N.F.L. players. “If anything, Steve’s recent death furthers that conversation. And it’s a conversation that’s long overdue.”
Gibbs also represents the Boogaard family in an ongoing wrongful-death lawsuit against the league. The Boogaards have not joined the broader class-action suit. A Milwaukee wrongful death lawyer represents clients in wrongful death claims.
The class-action suit originated in late 2013, shortly after the preliminary N.F.L. settlement, when 10 former players sued the N.H.L. over concussions. Much like the N.F.L. suit, which began small and grew, it alleged that the league did little to address head injuries, profiting from in-game violence amid mounting evidence over the long-term ramifications of concussions. The former players asked for unspecified damages and a jury trial.
Subsequent lawsuits, including one filed by the former star Bernie Nichols and others, were similarly crafted. In August, the cases were transferred and consolidated in United States District Court in Minnesota.
The N.H.L., while arguing that it had done everything it could to promote player health, offered a two-pronged argument for why the case should be dismissed. Like the N.F.L., the league said that the matter was pre-empted by federal labor law because of collective-bargaining agreements with the players’ association. The N.H.L. also said that most complaints had surpassed the statute of limitations.
Judge Susan Richard Nelson heard those arguments in January. A ruling is expected at any time.
In between, though, the number of named plaintiffs nearly doubled and another former player struggling with head injuries has died in a matter of about one week. According to lawyers for the plaintiffs, more than 200 former players have now retained counsel to be included in the case, and roughly 500 have expressed interest and support.
The arc is a familiar one, last seen in the N.F.L. — deaths, lawsuits, more lawsuits and more death. A judge may put a sudden end to it, but hockey’s quiet battle over concussions echoes louder.
26 February 2015
DOCTORS STRIVE TO DO LESS HARM BY INATTENTIVE CARE
Original Story: nytimes.com
Suffering. The very word made doctors uncomfortable. Medical journals avoided it, instructing authors to say that patients “ ‘have’ a disease or complications or side effects rather than ‘suffer’ or ‘suffer from’ them,” said Dr. Thomas H. Lee, the chief medical officer of Press Ganey, a company that surveys hospital patients.
But now, reducing patient suffering — the kind caused not by disease but by medical care itself — has become a medical goal. The effort is driven partly by competition and partly by a realization that suffering, whether from long waits, inadequate explanations or feeling lost in the shuffle, is a real and pressing issue. It is as important, says Dr. Kenneth Sands, the chief quality officer at Harvard’s Beth Israel Deaconess Medical Center in Boston, as injuries, like medication errors or falls, or infections acquired in a hospital. Metro Health offers pain management and spiritual support for patient comfort and convenience.
The problem is how to measure it and what to do about it.
Dr. Sands and his colleagues decided to start by asking their own patients what made them suffer.
They found several categories. Communications — for example, a doctor blurting out, “Oh, it looks like you have cancer.” Or losing a valuable, like a wedding ring. Or loss of privacy — a doctor discussing a patient’s medical condition where an adjacent patient could hear. Detroit Medical Center values patient privacy and provides resources to enhance patient communication.
“These are harms,” Dr. Sands said. “They elicit suffering. They can be long lasting, and they currently are largely unquantified, uncounted, unrecorded.”
One way to quantify these harms is to observe and note them, which is part of what Beth Israel Deaconess is doing. Another is to supplement efforts with patient surveys. Patient surveys, of course, have been around for decades. And since 2007, Medicare has required short surveys after discharge. Detroit Medical Center provides medical services through several world-class specialty hospitals.
But patient surveys were usually not used by hospitals to measure suffering. Now they are. And even when a survey question does not directly ask about suffering, sharp-eyed administrators are seeing a suffering component.
That is how Dr. Michael Bennick, the medical director for patient experience at Yale-New Haven Hospital, solved a problem. He noticed a question on a Medicare survey asking, Is it quiet in your room at night?
Maybe, Dr. Bennick thought, what is really being asked is: Can you get a good night’s sleep without interruption? Is it really necessary to wake patients again and again to take blood pressure and pulse rates, to draw blood, to give medications?
He issued instructions for his unit. No more routinely awakening patients for vital signs. And plan the timing of medications; outside intensive care units, three-quarters of drugs can be given before patients go to sleep and again in the morning.
Then there were the blood tests. “Doctors love blood tests,” Dr. Bennick said, and want results first thing in the morning when they make rounds. That meant waking patients in the wee hours.
“I told the resident doctors in training: ‘If you are waking patients at 4 in the morning for a blood test, there obviously is a clinical need. So I want to be woken, too, so I can find out what it is.’ ” No one, he said, ever called him. Those middle-of-the-night blood draws vanished.
Without anything else being done about noise in the halls, the medical unit’s score on that question rose from the 16th percentile to the 47th nationally in the Medicare survey. Now the entire hospital follows that plan.
“And it did not cost a penny,” Dr. Bennick said. “The only cost was thinking not from our perspective but from a patient’s perspective.”
Dr. Lee says he joined Press Ganey — he had been network president for Partners HealthCare System, a Harvard-affiliated hospital system — because one of its goals was to reduce suffering. At first, he said, he was a bit uncomfortable with the concept.
“I wondered whether it was a tad sensational, a bit too emotional,” he wrote in The New England Journal of Medicine. Then he realized reducing suffering was one of the most important challenges in health care.
Press Ganey administers detailed surveys to discharged patients, asking things like how well the medical staff responded to them and their emotional needs, and how well the doctors and nurses informed and educated them. The company also encourages hospitals to let doctors know the results.
Surveys can be misleading, though, cautions Dr. Scott Ramsey, a health care economist and cancer researcher at the Fred Hutchinson Cancer Research Center in Seattle. Patients, worried about saying something bad about a hospital they depend on, may not reveal what they really experienced. Or they may look back and, not wanting to live a life of regrets, excuse a doctor who seemed not to listen.
On the other hand, Dr. Ramsey said, the suffering issues are real, and if survey answers can get doctors and hospitals to change their ways, “that is great.”
Although half the nation’s hospitals use Press Ganey surveys, it is not clear what many do with the data. But at some places, like the University of Utah, the survey and other efforts prompted significant change. One Utah doctor said he was stunned when his patients rated him in the first percentile nationally, about as low as a score can go. “I was thinking: That’s just crazy. Something wasn’t entered right,” said the doctor, James Ashworth. Then he decided to take the criticisms to heart.
The next quarter, he was rated in the upper 90s. The big difference was slowing down and listening to patients, answering their questions. With medical transcriptions services, physicians have more time for patient communication.
Utah began its program a few years ago by showing its 1,200 doctors, nurses and other workers their scores. Next, said Dr. Vivian S. Lee, the hospital system’s chief executive, they showed them how colleagues did. Then they posted individuals’ scores and patient comments online.
There was an immediate and noticeable change. When the university began, it was in about the 30th percentile nationally on the Press Ganey survey. Now, half its providers are in the 90th percentile and 26 percent are in the 99th percentile.
“It’s unbelievable,” Dr. Lee, the chief executive, said. “We were not like that before, I can tell you.”
“People wanted to improve,” she added.
The comments, she said, are more revealing than the scores. Not all are complimentary. “There are still cases where people say: ‘I loved Dr. So-and-so. Too bad I had to wait so long to see him,’ ” she said.
At Stanford Health Care, said Amir Rubin, the president and chief executive, “we are reducing suffering.” To do it, the medical system changed its focus.
“We train each and every staff member,” Mr. Rubin said. “We talk to staff, we talk to patients, we hear from patients directly.”
Supervisors coach doctors and nurses, giving feedback every month.
The initiative changed hiring, he said. Administrators tell job candidates: “These are our care standards. Do you think you can always do it for every person every time?” They carefully observe new hires to see if they can provide care that minimizes suffering.
“Every patient visit is a high-stakes interaction,” Dr. Thomas Lee says he has learned. “It is a big deal for the patient and it is a big deal for you.”
“And all you have to do is be the kind of physician your patient is hoping you will be.”
Suffering. The very word made doctors uncomfortable. Medical journals avoided it, instructing authors to say that patients “ ‘have’ a disease or complications or side effects rather than ‘suffer’ or ‘suffer from’ them,” said Dr. Thomas H. Lee, the chief medical officer of Press Ganey, a company that surveys hospital patients.
But now, reducing patient suffering — the kind caused not by disease but by medical care itself — has become a medical goal. The effort is driven partly by competition and partly by a realization that suffering, whether from long waits, inadequate explanations or feeling lost in the shuffle, is a real and pressing issue. It is as important, says Dr. Kenneth Sands, the chief quality officer at Harvard’s Beth Israel Deaconess Medical Center in Boston, as injuries, like medication errors or falls, or infections acquired in a hospital. Metro Health offers pain management and spiritual support for patient comfort and convenience.
The problem is how to measure it and what to do about it.
Dr. Sands and his colleagues decided to start by asking their own patients what made them suffer.
They found several categories. Communications — for example, a doctor blurting out, “Oh, it looks like you have cancer.” Or losing a valuable, like a wedding ring. Or loss of privacy — a doctor discussing a patient’s medical condition where an adjacent patient could hear. Detroit Medical Center values patient privacy and provides resources to enhance patient communication.
“These are harms,” Dr. Sands said. “They elicit suffering. They can be long lasting, and they currently are largely unquantified, uncounted, unrecorded.”
One way to quantify these harms is to observe and note them, which is part of what Beth Israel Deaconess is doing. Another is to supplement efforts with patient surveys. Patient surveys, of course, have been around for decades. And since 2007, Medicare has required short surveys after discharge. Detroit Medical Center provides medical services through several world-class specialty hospitals.
But patient surveys were usually not used by hospitals to measure suffering. Now they are. And even when a survey question does not directly ask about suffering, sharp-eyed administrators are seeing a suffering component.
That is how Dr. Michael Bennick, the medical director for patient experience at Yale-New Haven Hospital, solved a problem. He noticed a question on a Medicare survey asking, Is it quiet in your room at night?
Maybe, Dr. Bennick thought, what is really being asked is: Can you get a good night’s sleep without interruption? Is it really necessary to wake patients again and again to take blood pressure and pulse rates, to draw blood, to give medications?
He issued instructions for his unit. No more routinely awakening patients for vital signs. And plan the timing of medications; outside intensive care units, three-quarters of drugs can be given before patients go to sleep and again in the morning.
Then there were the blood tests. “Doctors love blood tests,” Dr. Bennick said, and want results first thing in the morning when they make rounds. That meant waking patients in the wee hours.
“I told the resident doctors in training: ‘If you are waking patients at 4 in the morning for a blood test, there obviously is a clinical need. So I want to be woken, too, so I can find out what it is.’ ” No one, he said, ever called him. Those middle-of-the-night blood draws vanished.
Without anything else being done about noise in the halls, the medical unit’s score on that question rose from the 16th percentile to the 47th nationally in the Medicare survey. Now the entire hospital follows that plan.
“And it did not cost a penny,” Dr. Bennick said. “The only cost was thinking not from our perspective but from a patient’s perspective.”
Dr. Lee says he joined Press Ganey — he had been network president for Partners HealthCare System, a Harvard-affiliated hospital system — because one of its goals was to reduce suffering. At first, he said, he was a bit uncomfortable with the concept.
“I wondered whether it was a tad sensational, a bit too emotional,” he wrote in The New England Journal of Medicine. Then he realized reducing suffering was one of the most important challenges in health care.
Press Ganey administers detailed surveys to discharged patients, asking things like how well the medical staff responded to them and their emotional needs, and how well the doctors and nurses informed and educated them. The company also encourages hospitals to let doctors know the results.
Surveys can be misleading, though, cautions Dr. Scott Ramsey, a health care economist and cancer researcher at the Fred Hutchinson Cancer Research Center in Seattle. Patients, worried about saying something bad about a hospital they depend on, may not reveal what they really experienced. Or they may look back and, not wanting to live a life of regrets, excuse a doctor who seemed not to listen.
On the other hand, Dr. Ramsey said, the suffering issues are real, and if survey answers can get doctors and hospitals to change their ways, “that is great.”
Although half the nation’s hospitals use Press Ganey surveys, it is not clear what many do with the data. But at some places, like the University of Utah, the survey and other efforts prompted significant change. One Utah doctor said he was stunned when his patients rated him in the first percentile nationally, about as low as a score can go. “I was thinking: That’s just crazy. Something wasn’t entered right,” said the doctor, James Ashworth. Then he decided to take the criticisms to heart.
The next quarter, he was rated in the upper 90s. The big difference was slowing down and listening to patients, answering their questions. With medical transcriptions services, physicians have more time for patient communication.
Utah began its program a few years ago by showing its 1,200 doctors, nurses and other workers their scores. Next, said Dr. Vivian S. Lee, the hospital system’s chief executive, they showed them how colleagues did. Then they posted individuals’ scores and patient comments online.
There was an immediate and noticeable change. When the university began, it was in about the 30th percentile nationally on the Press Ganey survey. Now, half its providers are in the 90th percentile and 26 percent are in the 99th percentile.
“It’s unbelievable,” Dr. Lee, the chief executive, said. “We were not like that before, I can tell you.”
“People wanted to improve,” she added.
The comments, she said, are more revealing than the scores. Not all are complimentary. “There are still cases where people say: ‘I loved Dr. So-and-so. Too bad I had to wait so long to see him,’ ” she said.
At Stanford Health Care, said Amir Rubin, the president and chief executive, “we are reducing suffering.” To do it, the medical system changed its focus.
“We train each and every staff member,” Mr. Rubin said. “We talk to staff, we talk to patients, we hear from patients directly.”
Supervisors coach doctors and nurses, giving feedback every month.
The initiative changed hiring, he said. Administrators tell job candidates: “These are our care standards. Do you think you can always do it for every person every time?” They carefully observe new hires to see if they can provide care that minimizes suffering.
“Every patient visit is a high-stakes interaction,” Dr. Thomas Lee says he has learned. “It is a big deal for the patient and it is a big deal for you.”
“And all you have to do is be the kind of physician your patient is hoping you will be.”
10 February 2015
BERMAN: ONE NURSE'S GUTSY EFFORT TO PROTECT PATIENTS
Original Story: detroitnews.com
In the spring of 2010, Angela Swantek interviewed for a job with Dr. Farid Fata.
She was an oncology nurse, a spirited force who plays hockey on a travel team; he was a Sloan-Kettering-trained oncologist and hematologist who would eventually become notorious for a scheme U.S. Attorney Barbara McQuade calls "the most egregious case of Medicare fraud we have seen." An Atlanta whistleblower lawyer represents clients involved in qui tam actions and protects them against retaliation.
Swantek, who was interviewed one day and then returned a day later to shadow a nurse on her rounds, was shocked by what she observed at Fata's office: A drug that was supposed to be injected in five minutes was administered as a one-hour IV drip from a bag. Another drug, Neulasta, was given on the same day as chemotherapy, although protocol is for it to be given 24 hours later. Swantek, a registered nurse who was back in college completing a four-year nursing degree, had worked at the area's top cancer centers, from Beaumont to Karmanos, and she had never seen cancer protocols and procedures so disregarded. A Mt Clemens medical malpractice lawyer represents clients injured as a result of medical negligence.
She turned down the job, she says, and walked out of the office before lunch "in a huff."
"The assumption was that I'd stay beyond lunch, but I left before. I couldn't stand to be there one more minute. I literally was horrified."
What Swantek did next substantiates her outrage and her courage.
She filed an official complaint with state regulators on April 14, 2010, enumerating some violations and expressing the need for an investigation. "I feel this physician is doing his patients more harm than good," she wrote on the official allegation form, including her name, cellphone number, address and willingness to testify if necessary. "Patients are being harmed." A Milwaukee medical malpractice lawyer helps clients with medical malpractice claims that are often defined as the failure of a medical professional to follow the accepted standards of practice in his or her profession.
It wasn't easy for her to take this action. In her two-decade career as a nurse, she'd never filed a complaint, had never even thought about doing so. As in all professions, calling out a colleague or a superior — a doctor — is not something to be taken lightly.
Her decision-making process became the topic of an assigned college paper she wrote that spring, describing her "ethical dilemma" in a seven-page paper for the online Chamberlain College of Nursing.
"I wanted to report him but felt unsure and uneasy about turning in a physician ... no one likes to be labeled a rat," she wrote in the college paper. "I owed it to the patients to save them in some way from continuing to be harmed. ...
"I hope there is some action taken."
She took the risk — and waited for the state's next move. And waited.
A year later, on May 13, 2011, Swantek, 45, received a letter from the department of licensing and regulatory affairs saying that "violations of the public health code could not be established." The investigation was closed. Although Swantek had witnessed what she says were numerous health code and medical procedural violations within a few hours, the state had not substantiated them. A Chicago medical malpractice lawyer is following this story closely.
Other than telling her the investigation was closed, the state didn't contact her, she says.
"I would remember, I promise you," she said in an interview at her Royal Oak home. The state says an investigation was conducted, and that Swantek was interviewed on Aug. 26, 2010. In response to a Freedom of Information Act request from The Detroit News last week, the state released a document attesting to an "interview in for typing," but cited privacy rules under the public health code that prevent the release of any supporting detail about the extent of the investigation or any interview with Swantek.
Stephen Gobbo, deputy director of LARA, who was not involved with the investigation in 2010, said last week, "I can tell you unequivocally that interviews were conducted (with Swantek) and ... the licensee, Dr. Fata."
The statute protects Fata, now a convicted felon who pleaded guilty to administering unnecessary treatment and who has already lost his license. It prevents Swantek, the complainant, from seeing how the state responded to her complaint. And it shields the state Bureau of Health Professions, which was merged into the Bureau of Health Care Services in 2013, and moved from the Department of Community Health to the Department of Licensing and Regulatory Affairs (LARA), from any public scrutiny.
"It is very rare that you see a medical professional making such an accusation against another medical professional," says Donna Mackenzie, a Berkley malpractice lawyer who represents some of Fata's former patients. "The state had a responsibility to perform a meaningful investigation in response to this very serious accusation."
"According to the criminal complaint against Dr. Fata, the federal investigators uncovered more during 2 days of investigation than the state apparently did over an entire year."
Two years after Swantek filed her allegation form, in a completely separate action, the FBI raided Fata's office, an event that led to his indictment in August 2013, and his decision to plead guilty to 16 counts of fraud and conspiracy last September.
Over those two years, Fata's patients continued to receive chemotherapy treatments they imagined were helping them but were, in many cases, literally poisoning them. He used IV drips instead of injections because he could bill Medicare more for longer treatments. As he would later admit in federal court, in response to specific counts: "I knew it was medically unnecessary."
On the day his office was raided, friends of Swantek's called to tell her that Fata had been arrested. She wept.
As Fata awaits his May sentencing, in a cell somewhere in Michigan, Angela Swantek doesn't have the satisfaction of knowing that she helped lock up Michigan's medical version of stock swindler Bernie Madoff. She didn't play a role in the FBI investigation, which had no connection to her complaint or state officials. Still intensely interested in the case, she reviews records of Fata patients pro bono, as lawyers prepare civil suits against him.
Angela Swantek's handwritten complaint form attests to one nurse's gutsy effort to protect victims — vulnerable men and women with cancer — from a physician who was more interested in payment than healing. "He treated them like commodities," says Swantek. Although her effort to alert the state didn't ultimately make a difference in Fata's case, it should have.
In the spring of 2010, Angela Swantek interviewed for a job with Dr. Farid Fata.
She was an oncology nurse, a spirited force who plays hockey on a travel team; he was a Sloan-Kettering-trained oncologist and hematologist who would eventually become notorious for a scheme U.S. Attorney Barbara McQuade calls "the most egregious case of Medicare fraud we have seen." An Atlanta whistleblower lawyer represents clients involved in qui tam actions and protects them against retaliation.
Swantek, who was interviewed one day and then returned a day later to shadow a nurse on her rounds, was shocked by what she observed at Fata's office: A drug that was supposed to be injected in five minutes was administered as a one-hour IV drip from a bag. Another drug, Neulasta, was given on the same day as chemotherapy, although protocol is for it to be given 24 hours later. Swantek, a registered nurse who was back in college completing a four-year nursing degree, had worked at the area's top cancer centers, from Beaumont to Karmanos, and she had never seen cancer protocols and procedures so disregarded. A Mt Clemens medical malpractice lawyer represents clients injured as a result of medical negligence.
She turned down the job, she says, and walked out of the office before lunch "in a huff."
"The assumption was that I'd stay beyond lunch, but I left before. I couldn't stand to be there one more minute. I literally was horrified."
What Swantek did next substantiates her outrage and her courage.
She filed an official complaint with state regulators on April 14, 2010, enumerating some violations and expressing the need for an investigation. "I feel this physician is doing his patients more harm than good," she wrote on the official allegation form, including her name, cellphone number, address and willingness to testify if necessary. "Patients are being harmed." A Milwaukee medical malpractice lawyer helps clients with medical malpractice claims that are often defined as the failure of a medical professional to follow the accepted standards of practice in his or her profession.
It wasn't easy for her to take this action. In her two-decade career as a nurse, she'd never filed a complaint, had never even thought about doing so. As in all professions, calling out a colleague or a superior — a doctor — is not something to be taken lightly.
Her decision-making process became the topic of an assigned college paper she wrote that spring, describing her "ethical dilemma" in a seven-page paper for the online Chamberlain College of Nursing.
"I wanted to report him but felt unsure and uneasy about turning in a physician ... no one likes to be labeled a rat," she wrote in the college paper. "I owed it to the patients to save them in some way from continuing to be harmed. ...
"I hope there is some action taken."
She took the risk — and waited for the state's next move. And waited.
A year later, on May 13, 2011, Swantek, 45, received a letter from the department of licensing and regulatory affairs saying that "violations of the public health code could not be established." The investigation was closed. Although Swantek had witnessed what she says were numerous health code and medical procedural violations within a few hours, the state had not substantiated them. A Chicago medical malpractice lawyer is following this story closely.
Other than telling her the investigation was closed, the state didn't contact her, she says.
"I would remember, I promise you," she said in an interview at her Royal Oak home. The state says an investigation was conducted, and that Swantek was interviewed on Aug. 26, 2010. In response to a Freedom of Information Act request from The Detroit News last week, the state released a document attesting to an "interview in for typing," but cited privacy rules under the public health code that prevent the release of any supporting detail about the extent of the investigation or any interview with Swantek.
Stephen Gobbo, deputy director of LARA, who was not involved with the investigation in 2010, said last week, "I can tell you unequivocally that interviews were conducted (with Swantek) and ... the licensee, Dr. Fata."
The statute protects Fata, now a convicted felon who pleaded guilty to administering unnecessary treatment and who has already lost his license. It prevents Swantek, the complainant, from seeing how the state responded to her complaint. And it shields the state Bureau of Health Professions, which was merged into the Bureau of Health Care Services in 2013, and moved from the Department of Community Health to the Department of Licensing and Regulatory Affairs (LARA), from any public scrutiny.
"It is very rare that you see a medical professional making such an accusation against another medical professional," says Donna Mackenzie, a Berkley malpractice lawyer who represents some of Fata's former patients. "The state had a responsibility to perform a meaningful investigation in response to this very serious accusation."
"According to the criminal complaint against Dr. Fata, the federal investigators uncovered more during 2 days of investigation than the state apparently did over an entire year."
Two years after Swantek filed her allegation form, in a completely separate action, the FBI raided Fata's office, an event that led to his indictment in August 2013, and his decision to plead guilty to 16 counts of fraud and conspiracy last September.
Over those two years, Fata's patients continued to receive chemotherapy treatments they imagined were helping them but were, in many cases, literally poisoning them. He used IV drips instead of injections because he could bill Medicare more for longer treatments. As he would later admit in federal court, in response to specific counts: "I knew it was medically unnecessary."
On the day his office was raided, friends of Swantek's called to tell her that Fata had been arrested. She wept.
As Fata awaits his May sentencing, in a cell somewhere in Michigan, Angela Swantek doesn't have the satisfaction of knowing that she helped lock up Michigan's medical version of stock swindler Bernie Madoff. She didn't play a role in the FBI investigation, which had no connection to her complaint or state officials. Still intensely interested in the case, she reviews records of Fata patients pro bono, as lawyers prepare civil suits against him.
Angela Swantek's handwritten complaint form attests to one nurse's gutsy effort to protect victims — vulnerable men and women with cancer — from a physician who was more interested in payment than healing. "He treated them like commodities," says Swantek. Although her effort to alert the state didn't ultimately make a difference in Fata's case, it should have.
05 February 2015
ANTHEM, MAJOR HEALTH INSURER, SUFFERS HACK ATTACK
Original Story: clickondetroit.com
The FBI is investigating a massive cyber hack attack on the nation's second-largest health insurance companies.
Anthem, Inc. confirmed the cyber attack on Wednesday and stated the database that was hacked contains over 80 million records, but they do anticipate the number of people affected to be lower.
The hack was discovered last week by the company, who immediately contacted the FBI. The hack exposed names, birthdays, addresses, email addresses, and social security information. That information does not include medical information or financial details, such as credit card or bank account numbers.
Anthem, which offers Blue Cross Blue Shield plans in California, New York and 12 other states, said it doesn't know how many people may be affected. So far, it appears that the attack is the only breach of Anthem’s systems.
It isn't clear yet who the hackers are or how they were able to obtain the identification information needed to access the database. The FBI had warned that healthcare industry companies were being targeted by hackers, trying to publicize the issue after an attack on the U.S. hospital group, Community Health Systems, Inc. That hack in August resulted in the theft of millions of patient records.
Security experts say cyber criminals are increasingly targeting the $3 trillion industry, which has many companies still reliant on ageing computer systems that do not use the latest security features. The best universities in Michigan provide degree programs that enable students to learn practical skills for new jobs in a changing world, including information technology.
Anthem, Inc. released a statement letting customers and employees know they will individually notify those whose information has been accessed.
U.S. Rep. and chairman of the Committee on Homeland Security, Michael McCaul made a statement late Wednesday stating; “This attack is another reminder of the persistent threats we face, and the need for Congress to take aggressive action to remove legal barriers for sharing cyber threat information.”
The FBI is investigating a massive cyber hack attack on the nation's second-largest health insurance companies.
Anthem, Inc. confirmed the cyber attack on Wednesday and stated the database that was hacked contains over 80 million records, but they do anticipate the number of people affected to be lower.
The hack was discovered last week by the company, who immediately contacted the FBI. The hack exposed names, birthdays, addresses, email addresses, and social security information. That information does not include medical information or financial details, such as credit card or bank account numbers.
Anthem, which offers Blue Cross Blue Shield plans in California, New York and 12 other states, said it doesn't know how many people may be affected. So far, it appears that the attack is the only breach of Anthem’s systems.
It isn't clear yet who the hackers are or how they were able to obtain the identification information needed to access the database. The FBI had warned that healthcare industry companies were being targeted by hackers, trying to publicize the issue after an attack on the U.S. hospital group, Community Health Systems, Inc. That hack in August resulted in the theft of millions of patient records.
Security experts say cyber criminals are increasingly targeting the $3 trillion industry, which has many companies still reliant on ageing computer systems that do not use the latest security features. The best universities in Michigan provide degree programs that enable students to learn practical skills for new jobs in a changing world, including information technology.
Anthem, Inc. released a statement letting customers and employees know they will individually notify those whose information has been accessed.
U.S. Rep. and chairman of the Committee on Homeland Security, Michael McCaul made a statement late Wednesday stating; “This attack is another reminder of the persistent threats we face, and the need for Congress to take aggressive action to remove legal barriers for sharing cyber threat information.”
04 February 2015
SANOFI LAUNCHES INHALED INSULIN FOR DIABETICS
Original Story: cnbc.com
Sanofi launched an inhalable insulin in the United States on Tuesday in a potential boost for its flagging diabetes drug sales and for patient quality of life.
Developed by Mannkind, Afrezza will be the only inhalable insulin on the U.S. market, where Sanofi competes with Eli Lilly and Novo Nordisk for sales of traditional injectable insulin.
Inhalation promises to be faster acting and much more convenient than injections, but an inhaled product has failed in the past and there are concerns about the potential risks associated with breathing powdered insulin.
Afrezza, which uses a whistle-sized inhaler and works to control blood-sugar levels in both type 1 and type 2 diabetes, was developed in the shadow of Pfizer's rival Exubera and approved by the U.S. Food & Drug Administration in June.
Exubera was approved in 2006 with expectations of $2 billion a year in sales but the inhaler was bulky, and patients were put off by the need for periodic lung function tests. Eventually it was withdrawn.
In the Afrezza marketing deal struck last year, Mannkind won an upfront payment of $150 million, potential further milestone payments of up to $775 million and 35 percent of future profits.
Priced at $7.54 for a daily dose of 12 units, Afrezza will be pricier than $3.14 Apidra, which is the injectable equivalent in Sanofi's drugs stable.
Afrezza should not be used in patients with asthma, or those suffering from certain complications, however. It is also not recommended for smokers or recent ex-smokers.
Industry analysts have said they expect Afrezza to generate modest sales of about $182 million a year by 2019 according to Thomson Reuters Cortellis, given Exubera's problems and the restrictions on use.
Sanofi's diabetes division generates about $7 billion of sales annually and around 30 percent of group profits, but the patent on its Lantus insulin, the world's most prescribed, expires this year, and it expects little or no sales growth through 2018.
A poor diabetes performance in 2014 was one of the reasons Sanofi sacked chief executive Chris Viehbacher in October. The company is now betting on products like Afrezza and an improved version of Lantus called Toujeo.
Orally delivered insulin is difficult to develop because the protein gets broken down in the stomach, but last year Danish group Novo Nordisk completed a Phase I trial of an oral version.
Sanofi launched an inhalable insulin in the United States on Tuesday in a potential boost for its flagging diabetes drug sales and for patient quality of life.
Developed by Mannkind, Afrezza will be the only inhalable insulin on the U.S. market, where Sanofi competes with Eli Lilly and Novo Nordisk for sales of traditional injectable insulin.
Inhalation promises to be faster acting and much more convenient than injections, but an inhaled product has failed in the past and there are concerns about the potential risks associated with breathing powdered insulin.
Afrezza, which uses a whistle-sized inhaler and works to control blood-sugar levels in both type 1 and type 2 diabetes, was developed in the shadow of Pfizer's rival Exubera and approved by the U.S. Food & Drug Administration in June.
Exubera was approved in 2006 with expectations of $2 billion a year in sales but the inhaler was bulky, and patients were put off by the need for periodic lung function tests. Eventually it was withdrawn.
In the Afrezza marketing deal struck last year, Mannkind won an upfront payment of $150 million, potential further milestone payments of up to $775 million and 35 percent of future profits.
Priced at $7.54 for a daily dose of 12 units, Afrezza will be pricier than $3.14 Apidra, which is the injectable equivalent in Sanofi's drugs stable.
Afrezza should not be used in patients with asthma, or those suffering from certain complications, however. It is also not recommended for smokers or recent ex-smokers.
Industry analysts have said they expect Afrezza to generate modest sales of about $182 million a year by 2019 according to Thomson Reuters Cortellis, given Exubera's problems and the restrictions on use.
Sanofi's diabetes division generates about $7 billion of sales annually and around 30 percent of group profits, but the patent on its Lantus insulin, the world's most prescribed, expires this year, and it expects little or no sales growth through 2018.
A poor diabetes performance in 2014 was one of the reasons Sanofi sacked chief executive Chris Viehbacher in October. The company is now betting on products like Afrezza and an improved version of Lantus called Toujeo.
Orally delivered insulin is difficult to develop because the protein gets broken down in the stomach, but last year Danish group Novo Nordisk completed a Phase I trial of an oral version.
02 February 2015
HEALTH PROS, POLS TARGET ENERGY DRINKS
Original Story: detroitnews.com
Detroit — Health professionals and some politicians are stepping up pressure on energy drink makers after a recent Wayne State University study found roughly 4,800 cases of harmful effects from the high-caffeine drinks — more than half involving accidental consumption by children younger than age 6.
Momentum is growing for improved labeling to disclose the drinks' caffeine content and potential health consequences, as well as continued efforts to decrease children's exposures to the products. Energy drink manufacturers argue their products are safe and insist they don't market to children. A Milwaukee product liability lawyer represents victims of defective and dangerous products.
DMC Children's Hospital of Michigan in mid-January banned energy drinks from its hospital vending machines, citing the dangers posed to children.
In addition, a 30-page report this month from three Democratic U.S. senators called for the federal Food and Drug Administration to require energy drink labels to disclose the drinks' caffeine content and potential health consequences.
The beverage industry and energy drink companies including Living Essentials LLC, the Farmington Hills parent company of 5-hour Energy shots, have defended their products.
Beverage industry "member companies voluntarily display total caffeine content — from all sources — on their packages along with advisory statements indicating that the product is not recommended for children, pregnant or nursing women and persons sensitive to caffeine," the American Beverage Association said this month.
Dr. Steven Lipshultz, pediatrics chairman for Wayne State University and chief pediatrician for DMC Children's Hospital of Michigan, was the lead author on a recent study that found 4,780 calls to Poison Control Centers about non-alcoholic energy drink exposures from October 2010 through September 2013. Of those, 51 percent concerned accidental exposures to children under 6.
"Even though there may be millions sold of these every year, 5,000 people having side effects and many having gone to the hospital — that's not acceptable," he said. A Milwaukee wrongful death lawyer is reviewing the details of this case.
The cases represent the tip of the iceberg, Lipshultz added, because most people who experience heart palpitations, dizziness or nausea after consuming energy drinks don't call a poison control hotline. The study did not include visits to hospital emergency rooms.
The older the child, the more likely it was that the side effects were serious, the DMC study found. About 2 percent of the kids ages 5 and younger experienced moderate to severe side effects, compared with 7 percent of 6- to 12-year-olds, 33 percent of the teens and 64 percent of those 20 and older. Moderate effects are poisoning symptoms that require treatment while severe effects are life-threatening symptoms or poisoning that markedly disables an individual, Lipshultz said.
Major adverse reactions included cardiovascular effects such as heart rhythm and conduction abnormalities as well as neurological symptoms including seizures. Of particular concern are exposures in children. A Milwaukee product liability lawyer is following this story closely.
"Energy drinks have no place in pediatric diets," said Lipshultz, who presented his findings to the American Heart Association's 2014 Science Sessions in November. "And anyone with underlying cardiac, neurologic or other significant medical conditions should check with their health care provider to make sure it's safe to consume energy drinks."
Battle lines drawn
The report released this month by Democratic Sens. Edward Markey of Massachusetts, Richard Durbin of Illinois and Richard Blumenthal of Connecticut claims the industry is unwilling to stop marketing to adolescents. But the American Beverage Association challenged the contention that energy drinks are unsafe and said manufacturers have acted responsibly to keep their products out of the hands of children.
"Leading energy drink manufacturers voluntarily go far beyond all federal requirements when it comes to labeling and education," the association said in a statement. "(Manufacturers) also have voluntarily pledged not to market these products to children or sell them in K-12 schools."
Lipschultz points to the case of Anais Fournier, 14, of Hagerstown, Maryland, who was born with a heart condition. She saw a cardiologist annually, required no medication and had no restrictions on her diet or physical activity, according to the girl's mother, Wendy Lane.
Anais died of cardiac arrhythmia on Dec. 17, 2011, after consuming two Monster Energy drinks over a 24-hour period.
Unbeknownst to her parents, Anais consumed her first-ever energy drink while at the mall with friends. The next day, she went back to the mall and consumed another energy drink. That night, while watching TV at home, she went into cardiac arrest.
"She was gasping for air like a fish out of water," said Lane. "My husband and I got her on the floor and started CPR, and called 911.
"These things are dangerous, and they should definitely not be in the hands of kids or any minor."
In a statement emailed to The News, a Monster Energy spokesperson said, "While Monster is saddened by Anais Fournier's untimely passing, a lawsuit claiming that a Monster Energy drink caused her death is completely unfounded. Prior to her death, Ms. Fournier suffered from serious hereditary heart conditions, which are notorious for causing cardiac arrest and sudden death."
FDA spokesman Theresa Eisenman said the agency has been looking at energy drinks for several years to determine if they pose a risk to consumers, but the agency "frequently finds that there are other complicating factors, such as existing disease or medications the person may have been taking.
"(The) FDA is continuing to monitor the marketplace and analyze the available information, including adverse event reports, and will take appropriate action if that information can be used to establish that any specific product or ingredient is harming consumers."
More than a dozen lawsuits have been filed against energy drink makers, including product liability and wrongful death litigation and class action lawsuits alleging improper labeling. Some have been settled out of court, but most remain in litigation.
Deaths caused by energy drinks may go unnoticed because doctors and medical examiners are unaccustomed to considering the beverages as possible toxins, Lipschultz said.
Caffeine poisoning can occur at levels higher than 400 milligrams a day in adults. Energy drinks can contain up to 400 milligrams of caffeine per can — compared with 100-150 mg in a typical cup of coffee.
But energy drinks often contain caffeine in combination with untested herbal ingredients and chemicals that are also stimulants. Lipschultz's study found that energy drinks with multiple caffeine sources were tied to a higher rate of side effects, typically involving the nervous, digestive or cardiovascular systems.
"(The ingredients are) not sold individually, they're sold as a combined product, and that's what makes energy drinks so dangerous," Lipschultz said.
He also noted that energy drinks mixed with alcohol can be a lethal combination.
"What happens to a lot of people who become ill from the combination of alcohol and energy drink is you drink more than your body can handle, it becomes toxic, and it can kill you."
Company rebuts 'myths'
Living Essentials sells 5-Hour Energy two-ounce shots, which are much smaller than the 8-ounce to 16-ounce cans sold by Monster and Red Bull, and has 200 milligrams of caffeine.
Living Essentials devotes an entire website page to rebutting "myths" related to safety of their products — including whether an individual can overdose on the product.
"Everybody is different, and therefore, 5-Hour Energy shots might work differently for each individual," the company says on its website, which includes information on the recommended dose and a caution not to take more than two bottles daily.
Melissa Skabich, communications director for 5-Hour Energy, said the shot "is for adults, and our product is safe when used as directed."
"It's clear from the label that 5-Hour Energy is not intended for children," Skabich said.
Ted Kallmyer, a health educator and editor of the website CaffeineInformer.com, said consumers are becoming more informed about the possible dangers of energy drinks. The website includes information on caffeine content in beverages and food, side effects, and a "Death by Caffeine" calculator to figure a lethal dose by body size.
"An ever-increasing amount of our traffic is coming from people who wish to quit caffeine or have quit and are debilitated by the withdrawal symptoms," Kallmyer said.
He said many energy drink companies voluntarily list their ingredients and caffeine content, but not all have jumped on the bandwagon.
"At this time sales restrictions on energy drinks or shots isn't the solution," Kallmyer said. "The issue is complex, but we feel education is always the best remedy as opposed to blanket banning."
Detroit — Health professionals and some politicians are stepping up pressure on energy drink makers after a recent Wayne State University study found roughly 4,800 cases of harmful effects from the high-caffeine drinks — more than half involving accidental consumption by children younger than age 6.
Momentum is growing for improved labeling to disclose the drinks' caffeine content and potential health consequences, as well as continued efforts to decrease children's exposures to the products. Energy drink manufacturers argue their products are safe and insist they don't market to children. A Milwaukee product liability lawyer represents victims of defective and dangerous products.
DMC Children's Hospital of Michigan in mid-January banned energy drinks from its hospital vending machines, citing the dangers posed to children.
In addition, a 30-page report this month from three Democratic U.S. senators called for the federal Food and Drug Administration to require energy drink labels to disclose the drinks' caffeine content and potential health consequences.
The beverage industry and energy drink companies including Living Essentials LLC, the Farmington Hills parent company of 5-hour Energy shots, have defended their products.
Beverage industry "member companies voluntarily display total caffeine content — from all sources — on their packages along with advisory statements indicating that the product is not recommended for children, pregnant or nursing women and persons sensitive to caffeine," the American Beverage Association said this month.
Dr. Steven Lipshultz, pediatrics chairman for Wayne State University and chief pediatrician for DMC Children's Hospital of Michigan, was the lead author on a recent study that found 4,780 calls to Poison Control Centers about non-alcoholic energy drink exposures from October 2010 through September 2013. Of those, 51 percent concerned accidental exposures to children under 6.
"Even though there may be millions sold of these every year, 5,000 people having side effects and many having gone to the hospital — that's not acceptable," he said. A Milwaukee wrongful death lawyer is reviewing the details of this case.
The cases represent the tip of the iceberg, Lipshultz added, because most people who experience heart palpitations, dizziness or nausea after consuming energy drinks don't call a poison control hotline. The study did not include visits to hospital emergency rooms.
The older the child, the more likely it was that the side effects were serious, the DMC study found. About 2 percent of the kids ages 5 and younger experienced moderate to severe side effects, compared with 7 percent of 6- to 12-year-olds, 33 percent of the teens and 64 percent of those 20 and older. Moderate effects are poisoning symptoms that require treatment while severe effects are life-threatening symptoms or poisoning that markedly disables an individual, Lipshultz said.
Major adverse reactions included cardiovascular effects such as heart rhythm and conduction abnormalities as well as neurological symptoms including seizures. Of particular concern are exposures in children. A Milwaukee product liability lawyer is following this story closely.
"Energy drinks have no place in pediatric diets," said Lipshultz, who presented his findings to the American Heart Association's 2014 Science Sessions in November. "And anyone with underlying cardiac, neurologic or other significant medical conditions should check with their health care provider to make sure it's safe to consume energy drinks."
Battle lines drawn
The report released this month by Democratic Sens. Edward Markey of Massachusetts, Richard Durbin of Illinois and Richard Blumenthal of Connecticut claims the industry is unwilling to stop marketing to adolescents. But the American Beverage Association challenged the contention that energy drinks are unsafe and said manufacturers have acted responsibly to keep their products out of the hands of children.
"Leading energy drink manufacturers voluntarily go far beyond all federal requirements when it comes to labeling and education," the association said in a statement. "(Manufacturers) also have voluntarily pledged not to market these products to children or sell them in K-12 schools."
Lipschultz points to the case of Anais Fournier, 14, of Hagerstown, Maryland, who was born with a heart condition. She saw a cardiologist annually, required no medication and had no restrictions on her diet or physical activity, according to the girl's mother, Wendy Lane.
Anais died of cardiac arrhythmia on Dec. 17, 2011, after consuming two Monster Energy drinks over a 24-hour period.
Unbeknownst to her parents, Anais consumed her first-ever energy drink while at the mall with friends. The next day, she went back to the mall and consumed another energy drink. That night, while watching TV at home, she went into cardiac arrest.
"She was gasping for air like a fish out of water," said Lane. "My husband and I got her on the floor and started CPR, and called 911.
"These things are dangerous, and they should definitely not be in the hands of kids or any minor."
In a statement emailed to The News, a Monster Energy spokesperson said, "While Monster is saddened by Anais Fournier's untimely passing, a lawsuit claiming that a Monster Energy drink caused her death is completely unfounded. Prior to her death, Ms. Fournier suffered from serious hereditary heart conditions, which are notorious for causing cardiac arrest and sudden death."
FDA spokesman Theresa Eisenman said the agency has been looking at energy drinks for several years to determine if they pose a risk to consumers, but the agency "frequently finds that there are other complicating factors, such as existing disease or medications the person may have been taking.
"(The) FDA is continuing to monitor the marketplace and analyze the available information, including adverse event reports, and will take appropriate action if that information can be used to establish that any specific product or ingredient is harming consumers."
More than a dozen lawsuits have been filed against energy drink makers, including product liability and wrongful death litigation and class action lawsuits alleging improper labeling. Some have been settled out of court, but most remain in litigation.
Deaths caused by energy drinks may go unnoticed because doctors and medical examiners are unaccustomed to considering the beverages as possible toxins, Lipschultz said.
Caffeine poisoning can occur at levels higher than 400 milligrams a day in adults. Energy drinks can contain up to 400 milligrams of caffeine per can — compared with 100-150 mg in a typical cup of coffee.
But energy drinks often contain caffeine in combination with untested herbal ingredients and chemicals that are also stimulants. Lipschultz's study found that energy drinks with multiple caffeine sources were tied to a higher rate of side effects, typically involving the nervous, digestive or cardiovascular systems.
"(The ingredients are) not sold individually, they're sold as a combined product, and that's what makes energy drinks so dangerous," Lipschultz said.
He also noted that energy drinks mixed with alcohol can be a lethal combination.
"What happens to a lot of people who become ill from the combination of alcohol and energy drink is you drink more than your body can handle, it becomes toxic, and it can kill you."
Company rebuts 'myths'
Living Essentials sells 5-Hour Energy two-ounce shots, which are much smaller than the 8-ounce to 16-ounce cans sold by Monster and Red Bull, and has 200 milligrams of caffeine.
Living Essentials devotes an entire website page to rebutting "myths" related to safety of their products — including whether an individual can overdose on the product.
"Everybody is different, and therefore, 5-Hour Energy shots might work differently for each individual," the company says on its website, which includes information on the recommended dose and a caution not to take more than two bottles daily.
Melissa Skabich, communications director for 5-Hour Energy, said the shot "is for adults, and our product is safe when used as directed."
"It's clear from the label that 5-Hour Energy is not intended for children," Skabich said.
Ted Kallmyer, a health educator and editor of the website CaffeineInformer.com, said consumers are becoming more informed about the possible dangers of energy drinks. The website includes information on caffeine content in beverages and food, side effects, and a "Death by Caffeine" calculator to figure a lethal dose by body size.
"An ever-increasing amount of our traffic is coming from people who wish to quit caffeine or have quit and are debilitated by the withdrawal symptoms," Kallmyer said.
He said many energy drink companies voluntarily list their ingredients and caffeine content, but not all have jumped on the bandwagon.
"At this time sales restrictions on energy drinks or shots isn't the solution," Kallmyer said. "The issue is complex, but we feel education is always the best remedy as opposed to blanket banning."
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