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.

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

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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.

http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=503974

 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. 

http://www.google.com/hostednews/ap/article/ALeqM5gCEyQ9eA4fFGeudlfvUBZt2qjWiAD9HV7NBG0

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.

Doctors’ Brawl Leads To Botched Birth In Italy

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Posted on 31st August 2010 by gjohnson in Uncategorized

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I don’t know what the medical malpractice laws are in Italy, but if this family doesn’t have legal recourse, it’s a crime.

In Messina, Sicily, a mother had to have her uterus removed and her newborn sustained possible brain damage and heart problems after her two doctors got into a fist fight during the baby’s delivery last Thursday.  

 http://www.bbc.co.uk/news/world-europe-11129608

 The incident at Messina’s public hospital was such a disgrace and embarrassment that Italy’s health minister, Ferruccio Fazio, trekked to Sicily to apologize to Laura Salpietro, 30.  

Her husband Matteo Molonia told officials that her two physicians disagreed about whether Salpietro should have a Caesarean section, and fists flew while the woman was in labor. One doctor grabbed the other by the neck and banged him into a wall, while the other doctor punched a window and hurt his hand, according to BBC News. 

The fistfight wound up delaying the C-section for about an hour, which lead to the problems for Salpietro and her son Antonio.

Physician, first do no harm. Why can’t some of them remember that?

 

 

 

http://www.independent.co.uk/news/world/europe/minister-says-sorry-for-doctors-fight-2066153.html

New York Tests Program To Curb Medical Malpractice Costs, But Will It Be Fair To Patients?

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Posted on 23rd July 2010 by gjohnson in Uncategorized

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Five New York City hospitals will be taking part in a pilot program that aims to reduce medical malpractice costs through mediation, avoiding trial, The Wall Street Journal reported Friday. One of the cornerstones of the program is for hospitals to admit their mistakes and to offer potential defendants settlements early on. 

 http://online.wsj.com/article/SB10001424052748703467304575383501123709186.html?mod=WSJ_NY_LEFTTopStories

While I believe this is an intriguing initiative that could help curb medical errors at hospitals, I share some of the concerns raised in the story by the president of the New York State Trial Lawyers Association, Nichlas Timko. 

The issues are will the early disclosure and settlement program essentially let negligent doctors and hospitals off the hook for their mistakes, and will this system take advantage of patients who don’t retain counsel.

The pilot program, which starts in the fall, is getting $3 million in federal funding, and “aims to cut the $1.4 billion spent annually in New York State on medical-malpractice premiums,” according to The Journal.

The participating hospitals are Beth Israel Medical Center, Mount Sinai Medical Center, New York-Presbyterian Hospital, Maimonides Medical Center and Montefiore Medical Center. Four of the hospitals will focus on trying to cut down on mistakes in obstetrics, while New-York Presbyterian is looking to stop surigcal mistakes.

 The program will use state “health courts,” where judges will help hospitals and patients negotiate settlements, avoiding such cases going to trial. 

State officials stressed that patients can still decide to take their cases to trial, and if they choose the judge-directed negotiations, they will be notified that they have the right to have an attorney at their settlement talks.

It will be worth studing the results of this pilot program. But again, the proper measures must be taken so that patients aren’t railroaded into settling a lawsuit for far less money than they are due.       

        

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