Marquette University Awarded $4.75 Million Grant To Improve Gear, Treatment For Children With Disabilities Like Cerebral Palsy

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Posted on 27th October 2010 by gjohnson in Uncategorized

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Marquette University has won a $4.75 million grant from the federal government to work on improving the treatment of children with disabilities such as cerebral palsy, spina bifida and clubfoot, the school announced Wednesday.

Gerald Harris, professor of biomedical engineering, is the principal investigator for the MU-RERC project, which will also involve other departments at Marquette, as well as the Department of Orthopaedic Surgery at the Medical College of Wisconsin, Shriners Hospital for Children in Chicago, the Rehabilitation Institute of Chicago, the University of Wisconsin-Milwaukee and the Milwaukee School of Engineering.

“Everything we are undertaking is designed to have a direct impact on children, to improve their care, rehabilitation and quality of life,” Harris said. The intent of the grant is to transfer and commercialize the research to “offer new tools, better technologies and improved treatment strategies” for  children with cerebral palsy, clubfoot, spina bifida, spinal cord injury, brittle bone disease (osteogenesis imperfecta) and other conditions that cause mobility and manipulation problems.

Harris, director of the Orthopaedic and Rehabilitation Engineering Center (OREC) at Marquette, has been working with these populations of children for more than 30 years.

“Some of the processes we use have never been definitively studied or applied to patients,” Harris said. “We want to design better devices and improved protocols that will help alert doctors, therapists, caregivers and family members of joint overload concerns. The intent is to have an impact in modifying activities and treatments in order to improve functional activities and quality of life.”

Those devices will include the development of an elliptical machine to improve neuromuscular control and stability in children. Other development projects are a novel pediatric robotic gait trainer; a biplanar (3-D) fluoroscopic imaging system that will allow researchers to see the internal motion of the bones inside the foot; and a customized orthotic (brace) based on sensor technologies to treat pediatric flat foot.

The research projects funded under the grant include:

•    Gait analysis of children with OI and severe clubfoot  deformity to determine strain on the femur and humerus in those using crutches in order to modify activities or design better devices to absorb forces (and thus prevent fractures) and to better direct surgeons so they are aware of high load areas.
•    Using MRI and fMRI imaging for children with cerebral palsy to assess if there are changes in brain activity as a result of surgery or robotic-assisted rehabilitation of the arms and legs.
•    Evaluation of home-based robot-guided therapy, combined with interactive game elements to keep children interested, and tele-assessment to determine effectiveness in maintaining mobility in children with cerebral palsy; and
•    Mobility modeling of the upper and lower extremities (armsand legs) to determine the relationship between internal joint forces, assistive devices, ankle arthroeresis (implants) and longer-term tissue level effects as they relate to pain and function.

The technology transfer inherent in the grant is one of the focal points of the Clinical and Translational Science Institute, a partnership of all the major academic institutions in the region —  Marquette, MCW, UWM and MSOE, as well as Froedtert Memorial Lutheran Hospital, Children’s Hospital of Wisconsin, Zablocki VA Medical Center and Blood Center of Wisconsin. Formed in 2008, the institute recently received a $20 million grant from the National Institutes of Health to create an infrastructure for biomedical research in the Milwaukee region.

Harris said CTSI was helpful in the grant preparation and will be involved in the grant’s extensive training and dissemination activities, including development of a website to provide information for physicians, parents and children.

“This is all about improving the quality of life for these children,” he said.

A State of the Science Conference will be held in the fourth year of the grant.

The grant of $950,000 per year for five years, totaling $4.75 million, was awarded under the Rehabilitation Engineering Research Centers Program. It provides 87.8 percent of the program costs, with 12.2 percent or $659,274 funded through non-government sources.





Judge Approves $600 Million Settlement Over Use Of Botox To Treat Kids With Cerebral Palsy


Posted on 5th October 2010 by gjohnson in Uncategorized

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 A U.S. Ditrict Court judge Tuesday approved the drug maker Allergan’s guilty plea to misbranding Botox and to paying $600 million in fines stemming from that infraction.

Judge Orinda Evans in Atlanta sentenced Allergan to pay $375 million as part of the guilty plea for the misleading marketing of Botox, while the drug maker also agreed to fork over $225 million in civil fines.

About a month ago Allergan announced that it had reached a settlement with authorities and was goig to plead guilty of marketing Botox, the wrinkle-smoother, for uses not approved by the Food and Drug Administration, such as cerebral palsy in children, headaches and pain. These infractions took place from 2000 to 2005. Allergan also agreed to pay the $600 million fine as part of that deal.

Botox is widely used to erase lines on faces, but it is also approved for use on neck spasms and underarm sweating, according to the Associated Press. Last year Botox was approved to treat spasms in the wrists, fingers and elbows, but doctors still also use it on children with cerebral palsy. 

Allergan has said that it’s working with health officials to get Botox approved for use with childen with that disorder.    

Drug Maker To Pay $600 Million Settlement In Federal Probe Of Botox For Children With Cerebral Palsy


Posted on 1st September 2010 by gjohnson in Uncategorized

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 The manufacturer of Botox has agreed to pay $600 million to settle an ongoing federal investigation of its marketing, which included promoting the wrinkle smoother to treat children with cerebral palsy.

Allergan, which makes Botox, put out a press release Wednesday about the resolution of the five-year-old investigation by the U.S. Department of Justice.

 The drug maker will plead guilty to one misdemeanor of “misbranding” from 2000 to 2005 and pay the government $375 million for that count. Allergan will also ante up $225 million in civil fines stemming from the probe, even though the drug maker denies any liability in the civil allegations. 

“This settlement is in the best interest of our stockholders as it resolves all matters at issue in the investigation, avoids substantial costs of litigation, as well as the substantial risks to Allergan associated with Government enforcement action in these matters, and permits us to focus our time and resources on productively developing new treatments for patients and the medical community,” Douglas Ingram, Allergan’s executive vice president, said in a prepared statement.

The Justice Department was investigating Irvine, Calif.-based Allergan’s marketing of Botox, a wrinkle smoother, from 2000 to 2005.  The marketing push prompted doctors to use Botox for unapproved treatments, including cerebral palsy in children, headaches, spasticity and pain, according to the Associated Press.

Drug makers are barred from marketing drugs for so-called “off-label,” or non-approved, uses.

Botox became a household name because of its success temporarily erasing facial wrinkles, but it also has approval for use for eye muscle problems, underarm sweating and spasms of the neck, elbows, wrists and fingers.

It’s also been used off-label to treat cerebral palsy in children and adults, and Allergan is talking to the federal regulators about getting formal approval for Botox to be used for children, according to AP.

The wire service also reported that this year the American Academy of Neurology gave Botox its imprimatur as an “effective and generally safe treatment” for children with cerebral palsy.      

Under the settlement, Allergan will drop a lawsuit it has pending against the Food and Drug Administration. In the suit,  the company argued that it had a First Amendment right to talk to doctors about safe uses for Botox, even off-label uses it doesn’t have approval for.        

 The criminal resolution is subject to approval by the federal court in Northern District of Georgia, and the civil settlement is contingent upon such approval.

Medical Malpractice Judge Finds That Short Delay Led To Girl’s Cerebral Palsy


Posted on 18th June 2010 by gjohnson in Uncategorized

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Mere minutes made the difference that resulted in a newborn getting cerebral palsey, according to a judge who found a doctor and nurse negligent in the botched birth.

In a case in British Columbia, Canada, Judge Ian Pitfield on Monday ruled in favor of the family of Mirella Steinebach, finding that her physician Dr. Jodi Lock O’Brien and nurse Charito Hermogenes were liable for negligence during  her March 31, 2005 birth at Surrey Memorial Hospital.

The girl, now five, has cerebral palsy, a result of oxygen deprivation to her brain. It happened when her placenta separated fomr her mother’s uterus during the birth.

The damages in the civil case haven’t been determined yet, but estimates are in the $730,000 range. 

In his ruling, the judge noted that Mirella was born ar 5:37 a.m.,  but oxygen to her brain was cut off sometime between 5:17 a.m. and 5:27 a.m. 

“It follows that if Mirella had been delivered at any time before 0517 hours, it would it is more likely than not that she would not have suffered hypoxic-ischemic encephalopathy,” or the brain damage that led her to get cerebral palsy.    

The judge wrote that Mirella likely won’t live past 20 years old.

Her birth had several complications that the Dr. O’Brien seemed to overlook, including the fact that Mirella’s mother had gestational diabetes and low weight gain for a pregnancy.

“Dr. O’Brien owed a duty to Ms. Steinebach to consult with an obstetrician regarding the appropriate course for the management of the labour,” the judge wrote in his ruling.


Low Umbilical Cord pH Levels Linked To Brain Damage, Cerebral Palsy In Newborns


Posted on 18th May 2010 by gjohnson in Uncategorized

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New research has found that babies who are born with high acidity in their umbilical cords appear to be at a higher risk for cerebral palsy, brain damage and infant death.

The study’s findings, out of research done at the Birmingham Women’s Hospital in England, were reported online by the journal BMJ. 

 When a baby doesn’t receive adequate oxygen during delivery, its umbilical cord blood pH declines. This condition, called hypoxia, is the most common cause of brain damage, mainly among premature and very tiny babies, according to Bloomberg Businessweek. But there had not been any direct connection established between a low pH reading in umbilical cord blood and complications like brain damage.

For this research, Dr. Gemma Malin combed through and combined the results of 51 studies regarding low-umbilical cord pH, studies that covered nearly 500,000 children. The results of the studies were similar despite the wide variety of ways they were conducted, namely that there was a consistent and strong link between pH levels and infant death, cerebral palsy and brain damage.

An editorial was published along with the study in the BMJ, and it urged careful surveillance of infants that have low umbilical cord pH.  

“Malin and colleagues’ systematic review of observational data suggests that a strong association exists between low umbilical artery pH at birth and major adverse outcomes including death, hypoxic ischaemic encephalopathy (usually manifesting as neonatal seizures), potentially serious brain abnormalities identified by imaging (periventricular leucomalacia or intraventricular haemorrhage), and cerebral palsy,” the editorial said.

 “Ultimately, given the findings of this study, we should aim to reduce the number of babies born with a low cord pH, without increasing unnecessary obstetric intervention. Hopefully this can be achieved by more hands-on input to labour ward care by fully trained obstetric specialists for some time have thought that acidity of the blood was linked to potential problems with newborns, but only the new study found a definitive connection between pH levels and adverse conditions such as brain damage.”


Jury Awards $18.5 Million In New Jersey Cerebral Palsy-Birth Malpractice Case


Posted on 1st May 2010 by gjohnson in Uncategorized

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The family of a 12-year-old New Jersey boy, who developed cerebral palsy after his emergency Caesarean-section was delayed, last week was awarded $18.5 million by a jury against Beth Israel Medical Center in Newark, according to The Star-Ledger of Newark.

The medical malpractice judgment was not only against the hospital but also Dr. Joan Lieser, a Springfield, N.J., obstetrician.

During a trial in Essex County, jurors heard testimony about the birth of Darius Morgan of Middlesex County, N.J. In 1998, Beth Israel was too slow to do an emergency Caesarian-section on his mother. Because of that delay, Morgan now has cerebral palsy, the family attorney had argued.

If Morgan had been born a mere eight minutes earlier, he would have been healthy, according to trial testimony. Now, he needs to be taken care the rest of his life.

Morgan’s mother had filed suit against Beth Israel in 2002, but she died in 2004. The boy was adopted by his great aunt and current legal guardian, Darlene Kim, in 2007.

Saint Barnabas Health Care System, which oversees Beth Israel, declined to comment on the judgment to The Ledger.


Illinois Hospital, Midwife Settle Cerebral Palsy Suit For $9.5 Million


Posted on 16th April 2010 by gjohnson in Uncategorized

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An Algonquin, Ill., family that charged that a hospital was to blame for its son being born with cerebral palsy has settled its malpractice suit for $9.5 million.

A mediator said Thursday that an Elgin hospital, a nurse midwife and the nurse’s employer all agreed to pay the settlement. 

Plaintiff Helen O’Came arrived at Sherman Hospital on Oct. 26, 1996, in labor with her son, Patrick, according to a statement from her attorneys Barry Chafetz, Margaret Power and Shawn Kasserman of Corboy & Demetrio.

When O’Came started experiencing complications, she asked the nurse to summon a doctor. But the nurse failed to get a physician, the mother’s attorneys allege.

Retired Cook County Circuit Court Judge and mediator Daniel Localla agreed to the settlement Thursday.

Jury Awards Florida Mom $10 Million in Cerebral Palsy Lawsuit


Posted on 13th April 2010 by gjohnson in Uncategorized

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 A Florida mother was awarded $10 million in a case where she alleged an ambulance service’s negligence lead to her son getting cerebral palsy. That’s because the ambulance took her to the wrong hospital when she was in labor.

 The medical malpractice lawsuit had been brought by Margarita Chess of Volusia County, naming as defendants EVAC Ambulance, Bert Fish Medical Center, Halifax Medical Center, Arnold Palmer Hospital in Orlando and two physicians.

 All of the parties except the ambulance service had settled with Chase for $1.4 million before the case when to trial, the Orlando Sentinel reported.

 Chess’s son was premature, born when she was just six months into her pregnancy. As she went into labor in 2003, she was first at Bert Fish Medical Center in New Smyrna Beach. She was then supposed to be transferred and transported by EVAC to Halifax Medical Center. But somehow, the ambulance was instead sent to Arnold Palmer Hospital, more than 50 miles away.

 Chess’s son, Addison Chase, was born on the way to Arnold Palmer.

 The malpractice suit alleged that the infant had trouble breathing after he was born. The paramedics performed CPR, but Addison’s brain was deprived of oxygen. As a result he sustained brain damage, and now has the long-term disabilities of cerebral palsy.      

Illinois Family Awarded $29.1 Million In Malpractice Case That Left Their Baby a Quadriplegic


Posted on 11th April 2010 by gjohnson in Uncategorized

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  A family has secured $29.1 million in a medical malpractice case where they claimed their son became a quadriplegic due to negligence during his birth at Northwestern Memorial Hospital.,CST-NWS-verdict06.article

  The payout for the Arroyo family is a combination of an award they received last Friday from Judge Amy St. Eve of the Northern District of Illinois and a prior settlement. The judge awarded the family $22.6 million, in addition to the $6.5 million settlement the family reached with the hospital in 2009.

  The Arroyo’s son, Christian, is a spastic quadriplegic who has cerebral palsy and can’t walk, talk or eat through his mouth.

  Maria Arroyo came to Northwestern Hospital on May 16, 2003 with labor pains. Because of the baby’s premature condition and the fact that the mother’s water had broken, Maria was supposed to receive antibiotics to ward against Group Beta Strep Infection for the baby.

  But the obstetrician, a federal employee, didn’t administer the antibiotics to Maria, and during the baby’s first few hours he was showing symptoms of infection. But the government pediatricians still didn’t step in and order the antibiotics for Christian.

  The infection spread from Christian’s blood stream to his brain, causing permanent damage and cerebral palsy.        

  “Had the federal government’s doctors followed the standard of care and provided the antibiotics to Maria or Christian at the appropriate timed, Christian would have been a normal baby boy,”  David Pritchard, one of the family’s lawyers, said in a prepared statement.  









Hospitals Look At Ways to Curb Errors, Help Staff That Make Mistakes


Posted on 18th March 2010 by gjohnson in Uncategorized

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Hospitals Look At Ways to Curb Errors, Help Staff That Make Mistakes

The Wall Street Journal Tuesday offered an intriguing take on how hospitals are trying to deal with errors by staff – including consoling physicians and doctors who make mistakes.

The story, headlined “New Focus on Averting Errors: Hospital Culture,” leads off by noting that errors by medical staffs lead to the deaths of an estimated 44,000 to 98,000 people a year.

The piece by one of the Journal’s star reporters, Laura Landro, says that hospitals are not only addressing the problem of staff errors but are also “coming up with procedures for handling – and even consoling – staffers who make inadvertent mistakes.”

A government advisory board, the National Quality Forum, has crafted a Care of the Caregiver guide, which has hospitals treating “traumatized staffers” who made errors with patients as if they are patients, too. Those guides even suggest that such staffers take part in the investigation of the error as long as they are not believed to acted recklessly or intentionally.

Noting that sometimes hard to assign blame for an error, the story cites a case that happened at St. Mary’s Hospital in Madison, Wis., four years ago. A nurse, Julie Thao, mistakenly gave a 16-year-old teen, Jasmine Gant, about to give birth an IV with an filled with an epidural pain killer.

The baby was delivered through a Caesarian section, but the mother Gant died. Thao lost her job, and was prosecuted for criminal negligence.

St. Mary’s paid a $1.9 million settlement to dispose of the malpractice suit brought by Gant’s family.

A study on that case that will be published in the April issue of the Joint Commission Journal on Quality and Patient Safety. That study found that although Thao skirted some safety procedures, there were weak links in the safety guidelines that contributed to her error. That study was also critical of the way St. Mary’s fired Thao.

Eventually, Thao plead guilty to reduced charges of two misdemeanors, and her nursing license was suspended. But Thao, who once considered suicide, got work as a researcher with an official of the National Quality Forum.