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.       

        

Michigan Mother Sues Over Carbon-Monoxide Death Of Her Son By His Father

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Posted on 21st July 2010 by gjohnson in Uncategorized

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This is one of the more unusual lawsuits I’ve come across relating to a fatal carbon monoxide poisoning: A Michigan mother whose son was killed by his father has filed suit against state child welfare employees.

http://www.chicagotribune.com/news/chi-ap-mi-boysdeath-lawsui,0,7027514.story

The mother, Rebecca Jasinski of Saginaw County, lost her son Nicholas Braman, who was one of the victims of a murder-suicide engineered by his abusive father, Oliver Braman. The father killed himself, his wife and his son Nicholas by carbon monoxide poisoning about three years ago. 

In her lawsuit, filed in federal court in Grand Rapids, Jasinski charges that her son’s life could have been saved if Michigan officials had taken the boy away from his father’s home in Montcalm County.  

The murder-suicide happened about a month after the Montcalm County prosecutor’s office recommended that the state remove Nicholas from his father’s home. And just a few days before the deaths, Braman didn’t appear in court to be sentenced for child abuse charges. He had been convicted of putting a cattle prod to his two other sons to punish them.

I think that transgression alone should have made Michigan child welfare workers rescue Nicholas from his sick father’s home. And in fact the Michigan Department of Human Services’s watchdog group, the Office of Children’s Ombudsman, determined that the state should have taken Nicholas once Braman was convicted of abusing the other siblings.

The negligence suit names seven people, present or past employees of the department and its Child Protective Services unit, and asks for unspecified damages greater than $75,000. That’s the threshold for a civil case to be heard in federal court.     

 

 

 

 

       

Whistle-Blower Suit Alleges Rush University Medical Center Violated Medicare Rules

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Posted on 9th July 2010 by gjohnson in Uncategorized

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Would you want a medical resident to operate on you, without a surgeon present to supervise? We didn’t think so.

Well, that’s allegedly what happened at Rush University Medical Center in Chicago, just one of several charges made against the facility in a whistle-blower lawsuit, according to United Press International.  

http://www.upi.com/Top_News/US/2010/07/08/Rush-U-center-doctors-named-in-lawsuit/UPI-84601278617314/”>http://www.upi.com/Top_News/US/2010/07/08/Rush-U-center-doctors-named-in-lawsuit/UPI-84601278617314/

 The suit was filed by Rush surgeon Dr. Robert Goldberg and a former hospital executive. They charge that Rush risked patient health to gain “monetary rewards and celebrity status.”

The hospital in a statement said “the lawsuit has no merit and (it) intends to vigorously defense the case.”

The suit names six physicians, charging that they violated Medicare billing rules in 2004 and 2005 that mandate that teaching doctors be physically present when difficult parts of surgey are being performed by residents.

According to UPI, residents are post-graduate doctors who get specialized training under the supervision of a fully licensed physician.

At Rush, the suit alleges that one surgeon never was in the operating room to supervise a procedure a resident was doing. It also charges that in another case, a surgeon monitored residents’ operations via a TV monitor while performing his own surgeries in another room.    

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

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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.

http://www.ctvbc.ctv.ca/servlet/an/local/CTVNews/20100615/bc_cerebral_palsy_lawsuit_100615/20100616?hub=BritishColumbiaHome

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.

 

Epilepsy Drug Connected To Major Birth Defects In Babies

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Posted on 16th June 2010 by gjohnson in Uncategorized

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The epilepsy drug valproic acid, when taken by expectant mothers in their first trimester, has been linked to birth defects in the brain, heart and arms of newborns, according to a new study.

http://news.yahoo.com/s/hsn/20100609/hl_hsn/epilepsydruglinkedtoseriousbirthdefects

For example, babies whose moms took valproic acid , whose brand names include Depakene and Depakote, were almost seven  times more likely to suffer with craniosyostosis, which is a fusion of the skull when the fetus is still in the womb. That fusion put hinders skull and brain development.

In terms of other birth  defects, mothers who took valproic acid during the first three months of their pregnancy incresed their odds, by 12.7  times, of  having a baby with spina bifida, which is when the spinal cord and backbone don’t develop properly, compared to women who didn’t take the drug.

Newborns whose mothers took valproic acid were also five times more likely to have a cleft palate;  2.5 times more likely to have the athrial septal heart defect; and more than two times as likely to have an extra finger on their hand. 

Those statistics have to be put in context. Even though there is a higher risk of birth defects for children of  mothers who took the anti-seizure medication, that risk overall is not huge. In the case of spina bifida, the risk went from 0.6 percent, or six in 1,000, compared with 0.5, or five in 1,000, for children whose mother’s hadn’t taken the anti-sezure medication.

Scientists are advising women of childbearing age to find a substitute drug to ward off seizures.

The study was published in The New England  Journal of  Medicine.

http://content.nejm.org/cgi/content/abstract/362/23/2185

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Brain-Injured Wisconsin Boy And His Mother Win $23.3 Million In Medical Malpractice Case

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Posted on 29th May 2010 by gjohnson in Uncategorized

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A Wisconsin jury has awarded $23.3 million in a medical malpractice case involving a boy who suffered brain damage, and now has cerebral palsy, after a doctor delivered him with forceps five years ago, according to the Milwaukee Journal Sentinel.

http://www.jsonline.com/news/milwaukee/95161269.html

The Milwaukee County jury rendered the verdict last Thursday against Dr. Donald Baccus and the Injury Patients and Families Compensation Fund on behalf of plaintiffs Laron Birmingham, 5 years old, and his mother Kishia Lee. But the panel cleared St. Joseph Regional Medical Center of any negligence in the case.

Baccus’s attorney told the Journal Sentinel that he plans to appeal the verdict.

During the trial, which began May 10, the plaintiffs argued that because Lee had prolonged labor and was having other problems in May 2005, Baccus should have performed a Cesarian section delivery.

Baccus didn’t do the C-section, but instead had a medical resident deliver Yaron using forceps, and that instrument injured the newborn’s brain.

As a result of that brain damage, Laron had cerebral palsy, and will never be able to live on his own or get a job, according to testimony at the trial.

The award will compensate Laron for his past and future medical bills; his pain A Wisconsin jury has awarded $23.3 million in a medical malpractice case involving a boy who suffered brain damage, and now has cerebral palsy, after a doctor delivered him with forceps five years ago, according to the Milwaukee Journal Sentinel.

 

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

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Posted on 18th May 2010 by gjohnson in Uncategorized

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

 http://www.businessweek.com/lifestyle/content/healthday/639106.html

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. http://latimesblogs.latimes.com/booster_shots/2010/05/a-new-predictor-of-newborn-health-cord-blood-ph.html

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.ientists 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.’

                    

St. Vincent’s Hospital Closure In New York Leaves Those With Malpractice Suits In ‘Legal Limbo’

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Posted on 13th May 2010 by gjohnson in Uncategorized

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St. Vincent’s Hospital in Manhattan has closed, creating a quandary for hundreds of plaintiffs that have medical malpractice suits pending againt the shuttered facility, the New York Daily News reported Thursday.   http://www.nydailynews.com/ny_local/2010/05/13/2010-05-13_st_vincents_hospital_closing_threatens_hundreds_of_medical_malpractice_lawsuits.html

These New Yorkers, an estimated 260 people, have been left in what The News calls “legal limbo” in terms of their litgation against the now bankrupt hospital.

 These victims may never collect damages against St. Vincent’s, because the hospital’s assets are now in Bankruptcy Court. 

The pending lawsuits include cases where babies suffered brain damage during delivery, according to The News. 

St. Vincent officials decided to close the hospital, creating a furor in its Greenwich Village neighborhood, because the facility is in debt for $1 billion. The hospital then filed for bankruptcy.

The News reported that St. Vincent’s was self-insured against medical malpractice suits, and had set up a trust fund to pay for successful claims.       

But that fund “is underfunded by $150 million to $250 million — and its holdings would first be doled out to priority creditors rather than potential victims,” according to The News.  

A number of the malpractice suits are either in the pretrial or trial stage.

So these the unfortunate familes of victims, those who died and those still living, have no recourse, and must bide their time to see if St. Vincent’s real estate generate enough money to ultimately reach them.    

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