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Entries in surgery (83)

Friday
Jul192013

Surgeon Accused of Fake Surgeries

Courtesy Debra Nenni McNamee(POUGHKEEPSIE, N.Y.) -- Constance Nenni died after having a "phantom" knee surgery, according to a legal complaint filed against her orthopedic surgeon, Dr. Spyros Panos.

In March 2010, Nenni underwent surgery to repair a left knee that had grown arthritic from 76 years of wear and tear, her daughter Debra Nenni McNamee said. She died less than 24 hours after having surgery.

McNamee said she recalled Panos explaining the procedure as "a simple in and out." He asked her mother sign a consent form to have a scope with a camera surgically inserted in her knee and to remove any dead or damaged tissue he found. Then, McNamee said she sat for two hours in the waiting room of the Hudson Valley Center at Saint Francis Hospital in Poughkeepsie, N.Y., waiting for her mother to come out of surgery.

"Afterwards, a nurse came out and said that my mother's blood pressure had dropped so they had to put her under a heating blanket for a while, but she didn't seem concerned so I relaxed," she said.

Less than 24 hours later, Nenni collapsed and died at home on the bathroom floor of a pulmonary embolism, according to a medical examiner's report.

A pulmonary embolism is a dangerous side effect of surgery where a blood clot breaks free and blocks the lung's main artery. Older people are especially vulnerable to this risk. Although McNamee didn't know it at the time, she said doctors later told her that a spike in blood pressure can be a warning sign that the condition is developing.

But Brian Brown, McNamee's lawyer, said the medical examiner's report also revealed some shocking news: Panos never performed a single procedure on Nenni.

Despite writing post-operative notes stating that he had performed six procedures on Nenni, including the removal of torn cartilage, smoothing areas of arthritic wear and removal of soft tissue from within the knee joint, the autopsy and hospital records revealed Panos did none of those things.

"He put her under anesthesia, placed the scope in her knee and then closed her up without performing any surgery," Brown said. "The reports showed no hardware in place and, certainly, no evidence of a total knee reconstruction."

If true, it didn't appear to be an isolated incident. There have been at least 250 legal actions filed against Panos in state Supreme Court of Dutchess County, N.Y., noted JT Wisell, an attorney for 154 of the plaintiffs.

Panos is also the subject of a criminal investigation by the U.S. Attorney's Office, though he has not been charged with a criminal offense, Wisell said.

Wisell said that most of the pending legal cases against Panos fall into three broad categories: fraudulent surgeries like Nenni's, unnecessary or excessive procedures, and medical negligence.

Jeffery Feldman, Panos' attorney, said that it would be unethical to speak about matters currently under litigation and that he had no comment. He added that Panos could not be reached for comment.

The Mid Hudson Medical Group is named as a defendant in many of the legal cases against Panos. So, too, are the hospitals where he performed surgery, Saint Francis Hospital and Vassar Medical center, both located in Poughkeepsie, N.Y.

Lawyers for the Mid Hudson Medical Group and Vassar Medical Center declined to comment. Larry Hughes, a spokesman for Saint Francis Hospital said the hospital also declined to comment.

Another lawsuit against Panos describes how he performed rotator cuff surgery on a patient's shoulder even though her X-ray was clean, yet he ignored a severely fractured collarbone, Wisell said.

Numerous plaintiffs claim Panos didn't cement joint replacements together properly or used the wrong components to repair a joint, Wisell added.

Brown said that Panos used his patients like human cash registers, scheduling as many as 22 surgeries a day. The average orthopedic surgeon typically schedules no more than 32 procedures a month, according to American Academy of Orthopaedic Surgeons statistics.

McNamee said the bills for her mother's care were more than $50,000. She also received a bill from Mid Hudson for her mother's post-operative follow up -- more than two years after her mother had passed away.

"We lost her because someone was looking to make money on her," McNamee said. "He took an oath to care for people not to kill people and cover it up."

Wisell, who referred to Panos as "The Hudson Valley Hack," agreed that Panos was after money. He also said he is certain other medical professionals knew Panos was scheduling too many surgeries and should have spoken up.

"I'm a million percent sure that the proper safeguards were put in place but they were completely ignored," Wisell said. "His employers and colleagues had to know what he was doing but there was too much money at stake so they looked the other way."

Both Brown and Wisell noted that clients with potential cases against Panos began flooding their offices with calls immediately after journalist Sarah Bradshaw wrote about the first few lawsuits for the Poughkeepsie Journal in September 2010. Bradshaw said she was tipped off to the litigation from an anonymous source.

Panos was terminated from his employer, Mid Hudson Medical Group, in 2011, Brown said.

Panos is currently licensed to practice in New York State and the New York State Office of Medical Conduct does not list him in its database of professional misconduct and physician discipline. The Medical Conduct Office did not immediately have an answer for why Panos was not in its system.

Panos appeared to be blogging and maintaining active Facebook page and Twitter accounts until at least July 2012.

In one blog post, he wrote that a patient once referred to him as a "21st century Marcus Welby," and that he is, "in fact, humanizing medical care and treatment." In another post, he stressed the importance of pre-operative care for better patient outcomes.

Copyright 2013 ABC News Radio   

Sunday
Jun022013

General Anesthesia Linked to Increased Risk of Dementia in Elderly

Pixland/Thinkstock(NEW YORK) -- A new study shows that senior citizens who go under general anesthesia during medical procedures may experience an increased rate of dementia.

General anesthesia is used to make a patient unconscious and unable to feel pain or discomfort during medical procedures. Often, anesthesia is delivered through intravenous drugs or inhaled gases.

Elderly patients frequently develop a conditioned known as post-operative cognitive dysfunction (POCD) after major surgeries. Experts believe that POCD may be a precursor to lasting dementia.

In a study, researchers in France followed over 7,000 patients who did not suffer from dementia and analyzed data taken from those patients over a span of ten years.

Over 22 percent of those who had a medical history including general anesthesia developed dementia. That rate is 35 percent higher than in patients without a history of general anesthesia, 18.7 percent of whom developed dementia.

It is possible that other health conditions contributed to a higher rate of dementia, as senior citizens who undergo procedures requiring general anesthesia may be less healthy than those who did not require those procedures.

Copyright 2013 ABC News Radio

Thursday
Dec202012

Surgeons Still Make Preventable Mistakes

Image Courtesy The Turkewitz Law Firm(NEW YORK) -- There are certain mistakes that should never happen to you during surgery.  The surgeon should never accidentally leave a sponge in your body after he sews you up, perform surgery on the wrong part of your body, or perform the entirely wrong surgery on you.

These mistakes are known as “never events” because the medical community has agreed there is no legitimate reason for their ever happening.  But new research finds that they still do occur at unacceptable rates, costing the healthcare system millions of dollars each year.

Using the National Practitioner Data Bank, an electronic warehouse of medical malpractice claims, researchers at John Hopkins University estimated the number of times that “never events” occurred within the past 20 years.  They found that there were close to 10,000 reported instances when a foreign object was left in a patient, the wrong surgery was performed, or the surgery was performed on the wrong patient or wrong part of the body.  These surgeries cost the healthcare industry an estimated $1.3 billion in malpractice payments over that same time period.

“It’s a rare event but it’s still an event that is entirely preventable,” said Dr. Martin Makary, the lead investigator of the study published this week in the journal Surgery.

He and his team believe these figures underestimate the actual number of errors that occur, since prior studies have shown that most patients don’t file medical claims when a mistake is made.  Although the annual number of reported “never events” is on the decline, Makary and his team believe that even a single preventable error is one too many.

“There have been a lot of efforts over the past several years to make significant changes in patient care,” said Dr. Sonali Desai, ambulatory medical director for patient safety at Brigham and Women’s Hospital in Boston.  She lists the creation of surgical safety checklists, improvements in communication and team training, and the development of better technology as key steps in ensuring that patients are safer.

“Surgeons are the captain of the ship, but it’s a team effort,” said Dr. Jeffrey Port, a cardiothoracic surgeon at New York Presbyterian-Weill Cornell who invented a product that uses radio-frequency technology to confirm that a patient’s body is 100 percent sponge-free.

Mandatory safety procedures prior to the start of surgery were a nuisance at first, but over time proved valuable at ensuring patient safety, according to Port.

“I don’t think we’ll ever see zero [errors], but we can get very close,” he said.

The study is not without its limitations, according to Dr. Desai, who points out that evaluating claims data through the National Practitioner Data Bank is only the tip of the iceberg.  Hospital-based safety reporting systems keep track of not only medical malpractice claims, but also those medical errors that never make it into the legal system.  This individualized hospital data may be more comprehensive, but it is also more difficult to aggregate and analyze on a national scale.

Makary acknowledges that the data sets are not perfect, and can only provide a rough estimate of the amount of preventable medical errors made every year, but the study serves to highlight the need for more accurate record keeping.

“Healthcare is operated by good people, but they’re still human,” he said.  “The better able we are to remove errors from the system, the safer healthcare can be for everybody.”

Check out your hospital’s error rate at http://www.hospitalcompare.hhs.gov.

Copyright 2012 ABC News Radio

Monday
Dec102012

Heart Surgeon Gives Patients Infection When Glove Rips

Jochen Sand/Thinkstock(LOS ANGELES) -- A heart surgeon at Cedars-Sinai Medical Center accidentally gave cardiac infections to five patients because his latex gloves tore during surgery, hospital officials confirmed.

Of the five patients who were diagnosed with endocarditis, or an infection of the heart chamber lining and valves, four of them had to return to the hospital for a second operation, according to a story first published in the Los Angeles Times. The patients survived and are still recovering.

“Because our ultimate goal is to have zero hospital acquired-infections, any hospital-acquired infection at Cedars-Sinai is unacceptable,” a hospital statement read.

“Endocarditis in general is a problem in that it describes an infection inside the heart, and when we have an infection inside the heart, bacteria from the infection is pumped all over,” said Dr. Mark Adelman, the chief of vascular surgery at NYU Langone  Medical Center. “It’s a particularly bad infection.”

Adelman, who has not been involved in the Cedars-Sinai case, said valve replacement infections can be especially problematic because the new valves are artificial and have no blood vessels to carry antibiotics to the infection.

“Usually the valve has to be removed,” he said. “Artificial materials don’t have blood vessels running through them, so there are little cracks and crevices that don’t see much blood flow. They’re difficult to sterilize.”

According to the National Institutes of Health, endocarditis can require a second valve replacement surgery when the infection results in heart failure, results in other organ damage or when blood clots break off into little pieces to cause strokes. Complications can include brain abscesses as well.

Cedars-Sinai called the incident a “very unusual occurrence,” according to the Los Angeles Times. Administrators told the newspaper that the nature of valve replacement surgery can lead to microscopic rips in the surgeon’s gloves because he has to tie more than 100 knots and use thick sutures, both of which put extra stress on the gloves.

“It’s just like tying your shoes a thousand times; it wears a lot on your fingers,” Adelman said, adding that heart surgeons have to sew the heart muscle with strong knots and sutures because the heart is an organ that is constantly moving. “The gloves definitely degrade. They have to be thick enough that they protect from transmitting infections, but then you have to feel tissues.”

Although surgeons will sometimes wear double gloves, it’s not mandated and can sometimes make the surgery more difficult because thick gloves don’t allow surgeons’ fingers to be as sensitive or as nimble, Adelman said.

He said he’s been asked why surgeons scrub their hands if they’re going to wear gloves. The answer is twofold: Surgeons scrub their hands and wear gloves to protect the patient, but they wear the gloves to protect themselves. It’s possible that a patient could spread a disease to a surgeon, too.

The California Department of Public Health has an open investigation at Cedars-Sinai, department spokesman Ralph Montano said. Because the department’s investigation is ongoing, Montano could not elaborate on the details.

Hospitals nationwide reported 529,038 surgical site infections to the Centers for Disease Control and Prevention in 2010.

News of the endocarditis infections comes less than a month after Cedars-Sinai announced that it reduced surgical site infections by more than 60 percent for colorectal procedures because of new protocols.

Copyright 2012 ABC News Radio

Wednesday
Nov212012

Baby Born with Heart Outside Her Chest Saved by Surgery

Photodisc/Thinkstock(HOUSTON) -- Five weeks ago, Audrina Cardenas was born with her heart outside her body. The condition is usually fatal. But Audrina has survived, and doctors are hopeful after they performed surgery to tuck her heart back where it belongs.

Audrina had a rare congenital malformation known as "ectopia cordis," where the heart is abnormally located either partially or totally outside the chest. Audrina was born on Oct. 15 with her heart exposed.

Eight babies out of every million are born with her condition and 90 percent of the eight are either stillborn or die within the first three days of life.

A statement by Texas Children's Hospital in Houston, where Audrina was born and operated on, said that on Oct. 16 "a multidisciplinary team of surgeons at Texas Children's saved Audrina's life during a miraculous six hour open-heart surgery where they reconstructed her chest cavity to make space for the one-third of her heart that was outside of her body.

 

Audrina's mother, Ashley Cardenas of Odessa, Texas, told ABC News she learned of the baby's condition when she was 16 weeks pregnant.

"I was told that it is a very rare condition and that the survival rates are really low and that if she did survive they don't know what kind of life she will have," she said.

"They gave me the option to terminate the pregnancy, continue with the pregnancy and do something called comfort care at the time of delivery, where instead of doing anything painful to her or do surgery they let you spend as much time with her until she passes, or opt for a high-risk surgery to help repair the heart," said Cardenas.

Cardenas decided to carry on with the pregnancy despite low chances of Audrina's survival.

"As soon as I made my decision to continue with the pregnancy, the physicians in Midland referred me to Texas Children's Hospital where a team of miracle workers provided the specialized treatment and care my baby and I both needed," she said.

"This risky operation on such an uncommon condition required specialists from a variety of care teams including cardiovascular surgery, plastic surgery and general pediatric surgery," Dr. Charles D. Fraser, surgeon-in-chief at Texas Children's Hospital and professor of surgery and pediatrics at Baylor College of Medicine (BCM) told ABC News.

"I have only seen this condition a few times in my career and these are always very tricky cases; in fact, many of these babies do not survive ... Audrina is a true fighter and we are so excited that this was a good outcome," he said.

"She's a fortunate child to have gotten through difficult circumstances. She is a very strong baby and is also fortunate because her other systems are normal," said Dr. Fraser, who added that it was promising that she still is showing improvements.

"We're not definitive about her prognosis, but so far, so good. We are very optimistic about the long-term prognosis. The baby will probably have to have operations in the future. Her sternum is about half formed but these are things we can deal with," said Fraser.

"Despite Audrina's misplaced heart, she was born with no other syndromes or genetic conditions that would cause additional stress or complications on her heart," Dr. Carolyn Altman, a pediatric cardiologist at Texas Children's Hospital and associate professor of pediatrics at BCM, told ABC News.

Dr. Larry Hollier, chief of plastic surgery at Texas Children's, played a key role in the surgery. "After reducing the heart into the chest we needed to mobilize the surrounding soft skin tissue to cover the heart itself to get it back in," he said when explaining his part of the surgery.

Audrina is still at Texas Children's for an open-ended stay, said Dr. Fraser.

"It would be a great blessing if she can celebrate Christmas with all of us at home," said Audrina's mother. "I want to tell the team at the hospital, 'Thank you for everything.' If it wasn't for them and the grace of God she wouldn't be here," she said.

Copyright 2012 ABC News Radio

Monday
Nov122012

Post-Surgery Baby Pic Goes Viral

Joseph Powling / Facebook(NEW YORK) -- Three-month-old Joey Powling is the latest Internet meme, thanks to his cool smirk just five days after open-heart surgery.

The baby best known to the world as “Ridiculously Good-Looking Surgery Baby” was born with tetralogy of Fallot, a heart defect that hampered blood flow to his lungs.

“The lower ventricles didn’t grow and connect, leaving a little hole there,” said, Joey’s dad, Joe Powling, who found out about the defect when his wife was 24 weeks pregnant. "It was kind of nerve-wracking."

Because the lungs keep the blood rich with oxygen, babies with tetralogy of Fallot need early surgery to correct the problem.

“The long term risk of arrhythmias is lower, and the function of the heart is much better if the repair is done earlier,” said Dr. Christopher Snyder, chief of pediatric cardiology at Rainbow Babies and Children’s Hospital in Cleveland.

On Oct. 25, the Powlings held their breath during the 7-hour procedure.

“It felt like forever,” said Joe Powling. “You have no control over the situation. There’s really nothing you can do.”

The surgery to repair tetralogy of Fallot has been around since the 1960s, according to Snyder.

“It’s the first heart defect that we were actually able to fix,” he said, adding that the prognosis after surgery is good. “There is no simple cardiovascular surgery, but this repair’s been going on for a long time.”

Joey’s surgery went well, but he was hooked up to a ventilator for two more days, according to his dad.

“He was still intubated and had about 15 different lines and tubes into him,” said Joe Powling. “But by the fifth day he was back to himself.”

That’s when the Powlings snapped the now-famous photo, which, with more than 1.6 million likes on Facebook, has been transformed into a string of Internet memes like, “If Chuck Norris had a baby, he’d almost be as tough as this.”

“That one’s my favorite,” Joe Powling said, noting his baby’s knowing grin. “He’ll usually give you a little smirk like that.”

But Joey’s not out of the woods yet. He might need a second round of surgery in a year, according to his father.

In the meantime, the Powlings are using their Internet fame to raise awareness about tetralogy of Fallot.

“So many children are born with congenital heart disease, and the world needs to know that it is common and it can be treated,” they said on their website, JoeyHeartsYou.com. “With the proper medical attention, many children can grow up to live normal lives. Joey wants you to know that it will be okay.”

Copyright 2012 ABC News Radio

Friday
Aug032012

Rare Spinal Surgery Cuts Chronic Pain for Wounded Marine

Jupiterimages/Thinkstock(BETHESDA, Md.) -- Mark Burleson awoke to unimaginable pain a month after the bomb he had been disarming detonated in his hands.

"My injuries were extensive, to say the least," said the 31-year-old Marine staff sergeant, who had severe burns, shattered bones and a brain injury from the December 2011 blast in Afghanistan's Helmand province.

Burleson's right arm was gone below the elbow; his left arm spared but paralyzed.

"All the nerves were ripped from my spinal cord at the root," he said, describing the damage that drove waves of pain down the otherwise senseless and limp limb.  "It felt like someone was lighting my arm on fire with a cutting torch.  And, occasionally, they'd stop and tie anchors to the ends of my fingers to rip out the bones."

Powerful drugs were no match for Burleson's constant agony.  And despite coming home from a war zone, the married father of three felt world's away.

"It was to the point where the kids would just walk past him because they know he couldn't bear to interact with them," said Burleson's wife, Sara.  "He became like a ghost."

Willing to try anything for relief, Burleson was quick to sign up for risky surgery to slice open his spine and singe the offending nerves.

"The pain was ripping our lives apart," the Camp Lejeune, N.C.-based Marine said.  "This was our last-ditch effort at having a normal life."

On July 26, Burleson left Walter Reed Army Medical Center in Bethesda, Md., for Johns Hopkins Hospital in Baltimore, where neurosurgeon Dr. Allan Belzberg agreed to try the high-stakes, high-risk surgery.

"It's a dangerous operation, so we only use it when we've exhausted all other options," said Belzberg, who performs the procedure three or four times a year.

Using a microscope and a tiny electrode, Belzberg made 140 burns in the damaged nerves dangling from Burleson's spinal cord; nerves intermixed with healthy connections to his lower limbs.

"If you get it just right, you get rid of the pain," Belzberg said of the stressful six-hour procedure.  "If you're the slightest bit off, you paralyze his leg."

But the surgery went smoothly.  And one week later, Burleson is a new man, although he expects to be at Walter Reed for at least a year.

"It was like instant clarity," Burleson said.

Sara Burleson, who spoke to her husband by phone before he returned to Walter Reed on Tuesday, said, "I could tell even before I saw him that it had worked.  His voice sounded lighter.  Even though he was groggy from the surgery, this huge weight had been lifted."

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Copyright 2012 ABC News Radio

Thursday
Aug022012

Boston Mayor Recovering from Droopy Eyelid Surgery

Paul Marotta/Getty Images(BOSTON) -- Boston Mayor Thomas Menino is recovering from surgery to lift his droopy eyelids, his office said.

Menino, 69, was diagnosed with dehiscence ptosis, a condition caused by the slow stretching of tiny tendons that hold up the upper eyelids.

"Over time, the tendons can stretch or detach from their anchor point on the eyelids," said Dr. Mami Iwamoto, the Boston-based ophthalmologist who performed the procedure on Wednesday.  "If that occurs, the lids hang lower than they should."

The upper eyelids usually hang two millimeters above the pupil, the tiny window through which light enters the eye.  But in Menino's case, the window was partially blocked.

"It's like there's a shade coming down into that view," said Iwamoto, describing how Menino's eyelid covered half of his pupil.  "People often compensate by raising their brows to pull the lids up or by tipping their head back to look under the shade, but he reached a point where he'd be much better off if the lid position was higher."

Menino was awake but sedated for the hour-long surgery, called blepharoplasty, to shorten the stretched-out tendons through tiny incisions in his eyelids.  And while the outpatient operation went off without a hitch, swelling and bruising will force the mayor to lie low for a week.

"He'll feel fine, but it's an awkward situation for making public appearances," said Iwamoto.

Because eyelids can droop with age, some people opt for blepharoplasty for cosmetic reasons.  A February 2012 study found that face and eyelid lifts could knock 7.5 years off a person's estimated age.  But Menino's motivation was not cosmetic, Iwamoto said.

"It was purely medical need," said Iwamoto.

Some blepharoplasty patients require additional surgery to tweak changes in tendon length that occur during the healing process.

"I told the mayor, 'most of time, people heal exactly the way we planned.  But in 10 to 15 percent of cases, we may need to make adjustments,'" Iwamoto said.  "He's such a nice gentleman.  But he joked that if that happens, 'You're in big trouble!'"

Copyright 2012 ABC News Radio

Wednesday
Aug012012

Boston Mayor Undergoing Droopy Eyelid Surgery

Paul Marotta/Getty Images(BOSTON) -- Boston Mayor Thomas Menino is undergoing surgery today to lift his droopy eyelids, his office said.

Menino, 69, was diagnosed with dehiscence ptosis, a condition caused by the slow stretching of tiny tendons that hold up the upper eyelids.

“His ptosis occurred over a long period of time,” Dr. Mami Iwamoto, the Boston-based ophthalmologist who will perform the procedure, told the Boston Globe. “It can creep up on people.”

The upper eyelids usually hang two millimeters above the pupil, the tiny window through which light enters the eye. But in Menino’s case, the window was partially blocked.

“It’s like looking out a porthole with a shade down,” Iwamoto said, describing how low-hanging can obscure vision. “The shade interferes with the view out the porthole.”

Menino will be awake but sedated for the hour-long surgery to shorten the stretched-out tendons through tiny incisions in his eyelids. Swelling and bruising is expected to keep him out of the public eye for a week or so, the Globe reported.

Menino is no stranger to surgery. Since he was elected in 1993, the Mayor has gone under the knife at for a cataract, a torn tendon and two tumors, his office confirmed.

Copyright 2012 ABC News Radio

Friday
Jul272012

Two Surgeons Banned After Human Experiments

Stockbyte/Thinkstock(WASHINGTON) -- Two University of California at Davis surgeons have been banned from doing human research after they injected bacteria into the head wounds of consenting terminally ill patients without university authorization, according to a letter sent from the school to the U.S. Food and Drug Administration.

The university ordered Drs. J. Paul Muizelaar and Rudolph J. Schrot to immediately "cease and desist" doing the procedure last fall, according to the letter, dated Oct. 17, 2011, obtained by the Sacramento Bee.

Chancellor Linda P.B. Katehi has ordered a review into the actions of Muizelaar, who is chairman of the department of neurological surgery at UC Davis, and Schrot, an assistant professor.

The lack of approval before conducting human research could jeopardize the school's federal funding, said Rosamond Rhodes, director of bioethics education at the Mount Sinai School of Medicine.

"You are required to comply with federal rules if you are an institution accepting federal funding for research," she said. "Whether or not the project is funded by the federal government, it still has to comply with the rules."

A spokesperson for the FDA told ABC News it "cannot confirm nor deny the existence of an investigation."

The surgeons said they were given consent by three terminal patients with glioblastomas, tumors that arise from the supportive tissue of the brain, to insert bacteria into their head wounds. The doctors believed the bacteria would create a postoperative infection that could help the patients live longer, according to documents included in the letter to the FDA.

The surgeons insisted they were conducting an innovative treatment, not research.

"There are people who blatantly break the rules that endanger all of their research programs. We certainly didn't blatantly trample any rules," Muizelaar told the Sacramento Bee.

Two of the patients contracted sepsis and died as a result of the procedure, according to the university.

Harris A. Lewin, vice chancellor for research, wrote that the experimental procedure, which had been conducted on three patients without university or FDA permission, "constituted serious and continuing noncompliance reportable to the FDA."

Muizelaar was ordered to hand off his clinical investigations, while Schrot was required to take the FDA's Clinical Investigator Training Course "to assure he possesses requisite knowledge to perform future studies, if and as permitted," the letter stated.

On Thursday, the California Institute for Regenerative Medicine awarded the university $53 million for research into Huntington's disease, limb ischemia and osteoporosis.

Copyright 2012 ABC News Radio







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