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.

http://www.marquette.edu/omc/newscenter/recent.php?subaction=showfull&id=1288193564&archive=&start_from=&ucat=1&

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.

 

 

 

 

Safety Worries Prompt Recall Of Nearly 41,000 Drop-Side Cribs

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Posted on 23rd October 2010 by gjohnson in Uncategorized

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Last week was notable for its series of recalls of dangerous products for infants. On Friday some 40,650 drop-side cribs, sold by Kmart and Ethan Allen stores, were recalled after several children were injured by them.

http://www.nj.com/business/index.ssf/2010/10/drop-side_cribs_recalled_after.html

According to a press release from the U.S. Consumer Product Safety Commission (CPSC), Kmart recalled roughly 34,000 Heritage Collection cribs that were manufactured by Victory Land Group of Bartlett, Ill.   

The CPSC and Victory Land have received 17 reports of incidents involving drop-side rail detachments , with three infants getting bruises and abrasions to their necks, backs and legs when they got trapped when the drop-side detatched.

When the crib’s drop-side detachs, it creates a space between the drop- side and the mattress where an infact can be caught, and possibly be strangled or suffocated. 

http://www.cpsc.gov/cpscpub/prerel/prhtml11/11020.html

Ethan Allen recalled roughly 3,250 drop-side cribs after five reports of injuries to children from drop-sides detaching. For example, one child became entrapped, two fell out of the crib and one child had a pinched hand.

http://www.cpsc.gov/cpscpub/prerel/prhtml11/11018.html

And in a third drop-side crib recall, Angel Line of Pennsville, N.J., recalled roughly 3,400 cribs over the drop-side detachment. No injuries have been reported with those cribs, which are sold online.

http://www.cpsc.gov/cpscpub/prerel/prhtml11/11019.html

Earlier last week there were recalls of Graco strollers and Lollytogs overalls.

 

 

 

 

Lollytogs Recalls 10,300 Infant Overalls Due To Choking Danger

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Posted on 21st October 2010 by gjohnson in Uncategorized

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Lollytogs Ltd. of New York City this week voluntarily recalled more than 10,000 infant overalls in the United States and Canada because of the danger of babies choking on its snaps.

The U.S. Consumer Product Safety Commission and Health Canada in a press release announced the recall of the clothing, noting that it is illegal to resell or attempt to resell a recalled consumer product.

http://www.cpsc.gov/cpscpub/prerel/prhtml11/11014.html

There are about 8,300 of the overall in the United States being recalled, and 2,000 in Canada. 

Although no injuries have been reported yet, the overalls have snaps that could come loose and pose a choking hazard to young children.

The recall involves infants’ Carhartt overalls with style numbers GG8500 (100 percent cotton canvas) and GG8501 (100 percent cotton knit).

 The overalls, made in India, were sold in brown or red in infant sizes 3, 6, 9, 12, 18 and 24 months.  The Carhartt logo is sewn on the front of the garment and the style numbers can be found on the sewn-in label hanging from the sleeve.

The overalls were sold at retailers nationwide from February 2010 through July 2010 for about $25.

 Consumers should immediately take the overalls away from children and return them to the place of purchase for a full refund or store credit.

Consumer Contact: For additional information, contact Lollytogs at (800) 637-9035 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the firm’s website at http://www.ltapparel.com/.  

Graco Recalls 2 Million Strollers After Four Infants Are Strangled

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Posted on 21st October 2010 by gjohnson in Uncategorized

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Graco Children’s Products has voluntarily recalled 2 million strollers after four infant strangulations involving their Quattro and MetroLite stollers were reported.  

http://www.cpsc.gov/cpscpub/prerel/prhtml11/11015.html

 The U.S. Consumer Product Safety Commission (CPSC) announced the stroller recall Wednesday, “due to the risk of entrapment and strangulation,” saying, “CPSC and Graco have received four reports of infant strangulations that occurred in these strollers between 2003 and 2005. In addition, CPSC is aware of five reports of infants becoming entrapped, resulting in cuts and bruises, and one report of an infant having difficulty breathing.”

The CPSC warned, “Entrapment and strangulation can occur, especially to infants younger than 12 months of age, when a child is not harnessed. An infant can pass through the opening between the stroller tray and seat bottom, but his/her head and neck can become entrapped by the tray. Infants who become entrapped at the neck are at risk of srangulation.

The recall involves older versions of the Graco Quattro Tour and MetroLite strollers and travel systems manufactured prior to the existence of the January 2008 voluntary industry standard that addresses the height of the opening between the stroller’s tray and the seat bottom.

This voluntary standard requires larger stroller openings that prevent infant entrapment and strangulation hazards.

This recall involves Graco Quattro Tour strollers and travel systems manufactured prior to November 2006 and MetroLite strollers and travel systems manufactured prior to July 2007. The strollers and travel systems were distributed between November 2000 and December 2007.

The model numbers are printed on a label at the lower portion of the rear frame, just above the rear wheels or underneath the stroller. The name “Graco” appears on a label on the stroller tray and the headrest. 

The strollers were sold at AAFES, Babies R Us, Burlington Coat Factory, Fred Meyer, Meijers, Navy Exchange, Sears, Target, Walmart and other stores nationwide between November 2000 and December 2007 for between $90 and $190 for the strollers, and between $190 and $250 for travel systems.

The strollers were manufactured in China.

Consumers should immediately stop using the recalled strollers and contact Graco for a free repair kit. To order a repair kit, contact Graco toll-free at (877) 828-4046 anytime, or visit the companys website at www.gracobaby.com.

Consumers can continue use of the stroller as a “travel system.” When the stroller is used with the infant car seat, the entrapment and strangulation hazards posed by the space gap are not present. 

 http://www.bloomberg.com/news/2010-10-20/graco-recalls-2-million-strollers-after-four-babies-die-from-strangulation.html

What We Missed Out On In The Missing Brain Case In New York City

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Posted on 18th October 2010 by gjohnson in Uncategorized

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About two weeks ago I wrote about a horrendous case in New York City, where the local coroner had taken the brain of a 17-year-old youth killed in a car accident, Jesse Shipley, without notifying or getting permission from his family. In a horrifying twist of fate two months later, kids from the youth’s school went on a field trip to the morgue and saw the dead boy’s brain there, sitting in a jar with his name on it.

http://cerebral-palsy-medicalmalpractice.com/blog/2010/10/family-can-sue-medical-examiner-over-sons-missing-brain.html

The case made the front page of the Big Apple’s two tabloids, the New York Post and Daily News. In reflecting on the matter, it really entailed several tragedies: The family’s pain over the discovery of Jesse’s vital organ, which they hand’r  even known was missing; the horror of the school mates that saw it; and the fact that there was no autopsy done on that brain.

After Jesse was killed in a car accident on Jan. 9, 2005, and his family agreed to an autopsy of the body the next day. The youth’s remains were picked up and a funeral was held three days later. What the Shipley family didn’t know was that Jesse’s brain was not with his body. 

The New York City Medical Examiner’s Office had kept Jesse’s brain to do tests on it, and that those tests were done a day or so after the field trip. Jesse’s family got a temporary restraining order to stop any additional tests on his brain, which was returned to them. 

It’s unclear what kind of tests the ME’s office did in fact do on the youth’s brain, or whether the coroner can keep those results, as his office is now being sued by Shipley’s family. The Shipley family filed a claim against New York City and the medical examiner’s office in March 2006, asking for damages for the improper handling of their son’s remains. 

I’ve been a vocal advocate of the need to have autopsie done more often on brains so that we learn more about the less traumative types of head injury, namely mild traumatic brain injury. 

With no sure-fire tests in existance now to detect the more subtle kinds of brain injury, we need all the clinical research done that we can. And the best research is examining an actual brain. Having an accurate gauge on brain injury is particularly important in terms of the future treatment of the thousands of U.S. troops who have suffered concussions in the wars in Iraq and Afghanistan.   

 We could have had that research opportunity with young Jesse’s brain, if the New York coroner hadn’t violated the rules by spiriting away the brain of a family’s loved one without its permission.

Supreme Court Ponders Vaccine Lawsuit Case

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Posted on 14th October 2010 by gjohnson in Uncategorized

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The U.S. Supreme Court earlier this week heard arguments on to what degree vaccine manufacturers should face liability lawsuits. 

The case being debated, Bruesewitz v. Wyeth, is attempting to test whether federal law protects vaccine makers from some kinds of product-liability lawsuits in state courts.   

http://online.wsj.com/article/SB10001424052748703440004575548041027835592.html

The test case involves a Pennsylvania family that claims it should be able to sue Pfizer ‘s Wyeth unit, claiming that the vaccine maker could have put a safer vaccine on the market but chose not to do so. The family claims that its daughter, Hannah Bruesewitz, wound up with a seizure disorder after being innoculated when she was six-months-old with DTP, a combination diptheria, tetanus and pertussis (whooping cough) vaccine made by Wyeth.

Hannah is a teenager now, and has severe developmental problems. She needs care for the rest of her life, her family claims.  

http://www.nytimes.com/2010/10/13/business/13bizcourt.html?ref=us

During Tuesday’s arguments, some of the high court’s justices expressed concern that if more kinds of lawsuits are permitted against vaccine makers, that companies may opt to exit the vaccine market.

But other justices apparently didn’t quite buy the vaccine manufacturer’s arguments.  

The Bruesewitz family filed for compensation for their daughter through a vaccine program that is administered by the U.S. Court of Federal Claims, which rejected the claim. The family then sued in state court, and an appeals court last year found that such a suit wasn’t allowed under the National Childhod Vaccine Injury Act.

That 1986 law set up a compensation system for vaccine-injury claims, shielding drug makers from some suits. The law said that a drug manufacturer was not liable and could not be sued if an injury caused by a vaccine was the result of “unavoidable side effects.”

The $64,000 Question that the Supreme Court will have to decide is what did Congress mean by “unavoidable side effects.”

  

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

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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.  

http://www.google.com/hostednews/ap/article/ALeqM5gCEyQ9eA4fFGeudlfvUBZt2qjWiAD9ILPBG81?docId=D9ILPBG81

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.

http://cerebral-palsy-medicalmalpractice.com/blog/2010/09/drug-maker-to-pay-600-million-settlement-in-federal-probe-of-botox-for-children-with-cerebral-palsy.html

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.    

Family Can Sue Medical Examiner Over Son’s Missing Brain

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Posted on 1st October 2010 by gjohnson in Uncategorized

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It is a macabre case that shows that truth is often stranger than fiction.

The case involves the brain of Jesse Shipley, 17, a Port Richmond High School student in New York. Shipley was killed in a car accident on Jan. 9, 2005, and his family agreed to an autopsy of the body the next day. The youth’s remains were picked up and a funeral was held three days later. 

http://www.law.com/jsp/article.jsp?id=1202472788415

But two months later, according to The New York Law Journal, fellow students of Shipley’s sister Shannon, who was also hurt in the accident, went on a field trip to the Richmond County Mortuary on Staten Island. And some of the students spotted a human brain in a jar filled with formaldehyde. The jar was marked with the name Jesse Shipley.

New York Appellate Justice William Mastro called the incident “a surreal coincidence,” according to The Law Journal.

Shannon Shipley’s classmates told her about the brain, and she told her parents. They learned that the New York City Medical Examiner’s Office had kept Jesse’s brain to do tests on it, and that those tests were done a day or so after the field trip.

Shipley’s family got a temporary restraining order to stop any additional tests on his brain, which was returned to them. The family held a second funeral for their son, according to The Law Journal. 

The Shipley family sued New York City and the medical examiner’s office in March 2006, asking for damages for the improper handling of their son’s remains. 

Brooklyn’s New York Appellate Division, 2nd Department, recently ruled that the Shipley family has the right to sue the New York City Medical Examiner’s Office for violating their right of sepulcher, for removing and keeping Jesse’s brain without telling the family.