Two Brain Injury Verdicts Make Top 10 List For 2011

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Posted on 21st January 2012 by gjohnson in Uncategorized

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Lawyers USA’s list of the Top 10 Jury Verdicts in 2011 includes two cases involving traumatic brain injury, with one of them regarding Botox.  

The unusual Botox case resulted in a $212 million award against Allergan, which makes Botox, by a federal jury in Virginia last April. The sad part is that Virginia has a state cap on punitive damages, which could knock down the jury’s $200 million in punitive damages to just $350,000, according to Lawyers USA.

http://lawyersusaonline.com/blog/2012/01/17/%e2%80%98ground-breaking%e2%80%99-botox-case-results-in-212-million-jury-verdict/

The Botox case involved Douglas Ray Jr., 67, who had developed hand tremors ever since his return from Vietnam. Ray’s doctor told him to get Botox treatments for his hand. After his third visit and injection, Ray first got a rash, then appeared to be confused and eventually sustained brain damage, according to Lawyers USA. Now he can’t walk, talk or feed or dress himself.

Ray’s lawsuit charged that Allergan failed to warn him about the risks of Botox. In Ray’s case, apparently the active ingredient in Botox –  botulinum toxin type A, made from botulism – moved from his arm muscle to his bloodstream and traveled to his brain.      

Botox doesn’t have Food and Drug Administration approval to be used to treat hand tremors, according to Lawyers USA. In fact, last year Allergan forked over $600 million in fines for marketing Botox for off-label uses.

The second case on Lawyers USA’s Top 10 List involving brain damage was a $144 million verdict for the birth of a baby who developed cerebral palsy. The lawsuit involved the botched birth of Kimberly VanSlembrouck’s daughter at William Beaumont Hospital in Michigan. It  charged that her baby should have undergone a Caesarian, not a vaginal, birth.

http://lawyersusaonline.com/blog/author/carollundberg/

According to Lawyers USA, VanSlembrouck had gained a lot of weight during her pregnancy, and her doctor should not have risked her doing a vaginal birth. Markell, the newborn girl, suffered serious injuries coming through the birth canal, including three brain hemorrhages, Lawyers USA reported. She was purple with bruises.

The hospital did testing on Markell after she was born, and found that she had abnormal brain development, which it later blamed on a genetic condition called pontocerebellar hypoplasia.   

After being in intensive care for three weeks, doctors determined that Markell had cerebral palsy secondary to birth trauma, according to Lawyers USA.   

The girl is a 15-year-old now, and can’t walk or talk. She needs 24/7 care and assistance doing everything from eating to dressing.

After a three-week trial, the Michigan jury granted the $144 million award. It looks like it didn’t buy the hospital’s gambit that Markell’s medical problems were genetic.

Johnson & Johnson Settles Texas Risperdal Case For $158 Million

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Posted on 21st January 2012 by gjohnson in Uncategorized

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Johnson & Johnson Thursday agreed to pay a $158 million settlement to end a trial over Texas officials’ charges that the pharmaceutical maker improperly marketed  its antipsychotic drug Risperdal. 

In the Johnson & Johnson case, officials in the Lonestar State back in 2004 alleged that the drugmaker’s Janssen unit  defrauded  Texas’s Medicaid program by marketing Risperdal for unapproved uses. A trial had been in progress for four weeks before the settlement, according to Bloombeg News.   

http://www.bloomberg.com/news/2012-01-19/johnson-johnson-to-pay-158-million-to-settle-texas-risperdal-drug-case.html

The Food and Drug Administration had approved Risperdal for uses as treatment of schizophrenia. But Janssen also began promoting the drug for other treatments, including psychiatric problems in children and adolescents, Bloomberg reported.  

The drug maker in 2004 mounted a campaign to “flood clinics” with Risperdal and increase its usage for children, according to Bloomberg. The strategy was to compete against drugs such as AstraZeneca’s Seroquel.

Although the $158 million seems like a large sum, Texas had been seeking $579 miillion, according to Bloomberg. Sources also told Bloomberg that about a month ago Johnson & Johnson agreed to pay a $1 billion settlement to several states and the U.S. government in order to put an end to a probe of fraudulent Risperdal marketing.  

 

Novartis Recalls OTC Drugs For Fear Of Contamination By Prescription Pain Killers

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Posted on 10th January 2012 by gjohnson in Uncategorized

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With the Food and Drug Administration warning Monday of the potential danger, Novartis AG has voluntarily recalled batches of  over-the-counter drugs – Excedrin,  Bufferin, No-Doz and Gas-X — for fear they may contains bits of prescription pain killers.

The FDA held a press conference on the recall, which involves 1,645 lots of the OTC drugs.

http://online.wsj.com/article/SB10001424052970204124204577150901110351484.html?KEYWORDS=Novartis+recall

The problem stems from a plant in Lincoln, Neb., that was closed last month. In addition to making Novartis products such as Exedrin, that plant also manufactured  prescription drugs such as Percodet and morphine tablets for Endo Phamaceuticals, according to The Wall Street Journal and other press reports.

A press release from Parsippany, N.J., based Novartis Consumer Health Inc. (NCH) said, “NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.”

 http://www.novartis.com/newsroom/media-releases/en/2012/1575836.shtml

The recall involves Excedrin and NoDoz products with expirarion dates of Dec. 20, 2014, or earlier as well as Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013 or earlier, in the United States.

” The Novartis Consumer Health Inc. Lincoln, Neb., facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site,” the drug maker said. “This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).”

http://www.fda.gov/Safety/Recalls/ucm286240.htm

According to NCH, “Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.”

However, NCH said that it is not aware of adverse events reported with the issues leading to the recall.

The recalled OTC products were distributed nationwide to wholesalers and retailers. NCH is notifying its distributors and customers and is arranging for return of all recalled products.

“We are committed to a single quality standard for the entire Novartis Group and we are making the necessary investments and committing the right resources to ensure these are implemented across our entire network,” Swiss Novartis CEO Joseph Jimenez said in a statement.  “The high quality of our products and operations has been critical to building the Novartis reputation over the past 15 years. We are committed to ensuring the highest standard for patients who rely on our products and medicines.”

NCH said that it is is recalling these products as a precaution due to an internal product review and complaints that identified issues such as broken gelcaps, chipped tablets and inconsistent bottle packaging line clearance practices, where a potential for a tablet mix up could not be ruled out.

NCH plans to gradually resume operations at its Lincoln site following implementation of planned improvements and in agreement with the FDA. That plant produces a variety of products mainly for the U.S. market with annual sales value of less than 2 percent of Novartis Group sales.

At this stage, the drug maker said that it’s  not possible to determine when the plant will resume full operations and the full financial impact of these events. NCH will take a one-time charge currently estimated at $120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln facility.

Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them.

Consumers that have the product(s) being recalled should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive a full refund.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

 

 

Third Infant Ill With Bacteria That Led To Enfamil Being Pulled From Store Shelves

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Posted on 29th December 2011 by gjohnson in Uncategorized

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Just days after the manufacturer of Enfamil said its tests found the baby formula to be safe, a third infant has tested positive for a rare bacterial infection, according to Reuters.

http://www.huffingtonpost.com/2011/12/27/enfamil-recall_n_1171915.html?ref=parents&icid=maing-grid7|myaol|dl1|sec3_lnk1%26pLid%3D123522

An Oklahoma infant has come down with Cronobacter, a bacteria that has been found in some milk-based powdered baby formula, according to Reuters. 

Retailers such as Wal-Mart pulled Enfamil Premium formula off their shelves after one infant in Missouri died as a result of Cronobacter, and a second one in Illinois became ill with the bacteria, after having the formula. 

Those incidents lead to a probe of Enfamil by federal health officials as well as the formula’s maker, Mead Johnson Nutrition Co.  The baby in Oklahoma had not had Enfamil, and was treated and released, Reuters reported.

Over the weekend Mead Johnson announced that it had tested batches of the suspect Enfamil formula, and found no contamination.

  

 

Baby Formula Maker Claims Product, Suspected In Infant’s Death, Is Safe

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Posted on 25th December 2011 by gjohnson in Uncategorized

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The maker of Enfamil baby formula, which has been pulled from the shelves by retailers after a baby’s death, said Sunday that its tests didn’t find any deadly bacteria in the product.

In a statement, Mead Johnson Nutrition said it tested the same batch of formula that is  being tested by the Food and Drug Administration, which is investigating the cases of two babies in Missouri who fell ill after having the formula. One of them, 10-day-old infant Avery Cornett, died.    

http://www.nytimes.com/2011/12/26/business/baby-formula-is-called-safe.html?_r=1&pagewanted=print

Mead Johnson stated that it didn’t find any Cronobacter, a bacteria than can be lethal, in its formula. Cornett was diagnosed wth Cronobacter, as was a second baby who survived.

Last week retailers such as Wal-Mart, Walgreen, Kroger and Super-Valu pulled the formula, 12.5-ounce cans with the batch code ZP1K7G, off their shelves. They said  they were taking the precautionary measure until regulators tested the formula.

 http://online.wsj.com/article/SB10001424052970204552304577116651051958544.html?KEYWORDS=enfamil

On Sunday Mead Johnson officials told Bloomberg News that they didn’t know how long it would take the FDA and the Centers for Disease Control to complete their investigations.

Arizona Husband-And-Wife Doctors Awarded $12 Million In Defamation Case Against Patient

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Posted on 21st December 2011 by gjohnson in Uncategorized

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Usually patients sue and win judgments against doctors, but in Arizona last week a plastic surgeon and his doctor wife received a $12 million verdict against a patient, according to The Arizona Republic. They alleged that the patient defamed them on her website.

http://www.azcentral.com/community/scottsdale/articles/2011/12/16/20111216scottsdale-doctors-win-lawsuit.html

Following a trial, last week a jury awarded Dr. Albert Carlotti of Scottsdale and his wife, Dr. Michelle Cabret-Carlotti, $11 million in actual damages and $1 million in punitive damages from Sherry Petta, a local singer, The Republic reported.

In 2007 Petta had work — including a nose job – done by the Carlottis, who run the Desert Palm Surgical Group. But the relationship went sour when Petta, a jazz singer, alleged she got a skin infection after having work done by the Carlottis, according to The Republic.

In 2008 Petta launched a website that was critical of the husband-and-wife doctor team, prompting the Carlottis to sue her for defamation that same year. They obtained a temporary restraining order that directed Petta to immediately take down the website, The Republic reported.

But she did not relent. Petta filed a complaint against the Carlottis with the Arizona Medical Board, and would pop up at its public meetings to voice criticism of the two doctors. And she posted negative items about the Carlottis on various websites.

The Carlottis claimed that their medical practice took a nosedive, drawing less patients for cosmetic procedures, because of the false information that Petta posted about them on the Internet, The Republic reported.   

First Driver Distraction, Now ‘Doctor Distraction,’ Threatens Lives

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Posted on 16th December 2011 by gjohnson in Uncategorized

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Distracted driving had been a hot topic this year, with states and federal officials passing laws banning the use of cellphones and texting by drivers. But these devices are now being blamed for causing “distracted doctoring,” with physicians and nurses being accused of paying more attention to their new-media gear than their patients.

The New York Times Thursday outlined the problem in a Page One story, where it reported that “some hospitals have begun limiting he use of devices in critical settings, while schools have started reminding medical students to focus on patients instead of gadgets.”

http://www.nytimes.com/2011/12/15/health/as-doctors-use-more-devices-potential-for-distraction-grows.html

The Times quoted an official from the University of Rochester Medical Center who was disturbed by the doctors and nurses that he has spotted using iPhones, iPads and computers. That official, Dr. Peter Papadakos, authored a recent article on ”electronic distraction” for Anesthesiology News, according to The Times.

Another article in the medical journal Perfusion talked about research that found roughly half  of the techs who are in charge of bypass machines had chatted on their cellphones and texted during heart surgery.

If you believe these fears about doctor distraction are overstated, try this on for size. In Denver a patient whose left side became partly paralyzed after surgery filed a medical malpractive suit, The Times reported. Guess what the neurosurgeon was doing during the surgery? Talking on his cellphone via a wireless headset. The case was settled before trial.

In another eyebrow-raising anecdote, a doctor at Yale-New Haven Hospital told The Times that he has seen youthful anesthesiolgists in the OR using a compuer during surgery, for tasks such as checking their email. In the intensive care unit, this doctor has seen his colleagues use computers to shop on Amazon and eBay.

A hospital in Oregon, according to The Times, has made operating rooms “quiet zones” that prohibit multi-tasking that isn’t specificaly related to a patient.

As many of the doctors quoted by The Times said, computers and iPads are a boon that can help prevent errors by giving physicians immediate access to patient records and data.

But the patient must not be neglected while doctors fiddle with these devices during surgery.            

Illinois Hospital To Pay $7.5 Million Settlement For Girl With Cerebral Palsy

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Posted on 4th December 2011 by gjohnson in Uncategorized

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The grandparents of a 9-year-old girl who got cerebral palsy as the result of alleged malpractice at Christ Medical Center in Oak Lawn, Ill., will get a $7.5 million settlement, according to the Southtown Star. 

http://southtownstar.suntimes.com/news/9180559-418/advocate-agrees-to-75m-malpractice-award.html

 Advocate Health and Hospitals Corp., parent company of Christ Medical, agreed to the settlement of a lawsuit filed by Tom and Donna Tribble, legal guardians for Elliana Tribble. The suit, filed in 2009, alleged that the physicians and nurses at Christ Medical “delayed in responding to signs of fetal distress before” Elliana’s birth in August 2002, the Southtown Star reported Friday.

Elliana sustained brain damage from oxygen deprivation during her birth, and has cerebral palsy.

Under the settlement, the hospital does not admit any malpractice on the part of its staff, according to the Southtown Star. 

Tom and Donna Tribble, who live in Northbrook, Ill., are the parents of Elliana’s father, Sean Tribble. Sean and Joan Soka, Elliana’s parents, never got married, and the grandparents got custody of the child.

Elliana is disabled and in a wheelchair. Her grandparents told the Southtown Star that they will take part of the settlement to buy her a wheelchair that she will be able to steer with head movements and to make the doors in their home handicapped accessible.   

  

Family Awarded $1 Million From Medical Examiner’s Office That Kept Their Son’s Brain

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Posted on 27th November 2011 by gjohnson in Uncategorized

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Justice sometimes does triumph.

A Staten Island, N.Y., couple has won a $1 million judgment against the New York City Medical Examiner’s Office, which retained their dead son’s brain without their permission or knowledge, the New York Post reported Saturday.

http://www.nypost.com/p/news/local/staten_island/sitting_on_their_brains_rYp0ijgNEZRVOmtijfRMMK

In a macabre twist in an already freaky case, the parents of Jesse Shipley, 17, didn’t discover that they didn’t have his brain until some of his high school friends saw it in a marked jar during a field trip to Staten Island’s morgue.

Jesse was killed in a car crash in January 2005, and was autopsied by the local medical examiner. But the Medical Examiner’s Office returned Jesse’s body to his parents for burial without his brain, without mentioning that little tidbit to the Shipley family. Doctors wanted to perform tests on the organ, according to the Post.

Jesse’s family only learned that their son’s body was missing its brain when they buried it because of the shocking incident during the field trip. That when Jesse’s schoolmates chanced upon his brain in the jar, the Post reported.

Needless to say, the teens told Shipley’s surprised family what they had seen. If that wasn’t disturbing enough, ”a Catholic priest told the family that Jesse’s burial wasn’t proper without his brain,” according to the Post.

The family didn’t get the brain back until October 2005, and they subsequently filed suit against the Medical Examiner’s Office. The city was liable, according to a Staten Island Supreme Court judge, under the so-called right of sepulcher, which says that a family is entitled to all the remains of a relative, according to the Post.

The defense didn’t have a leg to stand on. The city apparently contended that Jesse’s father Andre Shipley “would have known his son’s brain were being kept for further testing if he’d known to ask,” the Post reported.

What?

It probably didn’t help the defense’s case, either, when a medical examiner said he keep Jesse’s brain hanging around in a jar because he waits until he has a half dozen brains before calling in a neuropathic examiner to study them, the Post said.

We hope in those other cases that the families knew their loved one’s brains had been withheld from them, unlike the Shipleys.

The Shipleys did lose one legal acton last year, when the family sued claiming that their son’s brain had been displayed unlawfully. An appellate court threw that claim out, the Post reported.     

 

Two Reports Explain Why Medical Malpractice Caps Hurt Consumers

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Posted on 19th November 2011 by gjohnson in Uncategorized

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Despite the rheroric of many lawmakers and the misconceptions of the public, putting caps on medical practice cases doesn’t hold down spiraling health care and insurance costs, according to two recent reports on the topic.  

“A Failed Experiment: Health Care in Texas Has Worsened in Key Respects Since State Instituted Liability Caps in 2003,” done by the public advocacy group Public Citizen, and “Can Mandatory Caps on Medical Malpractice Damages Harm Consumers?,” by the think tank the Cato Institute, were both released last month.  

http://www.citizen.org/documents/a-failed-experiment-report.pdf

http://www.cato.org/pubs/pas/pa685.pdf

And they both come to somewhat similar conclusions, namely that medical malpractice awards don’t drive up the cost of health care.

But what is disturbing in these reports is that consumers, people who have been harmed and have a cause of action against a medical provider, are being short-changed because of the caps. In fact, even worse, they are losing their ability to sue as lawyers shy away from bringing litigation that is expensive to try, with little potential reward.

The Public Citizen report dealt with Texas, which set a $250,000 limit on noneconomic damages for medical malpractice suits in 2003.

“A common misconception among policymakers and pundits is that medical malpractice litigation is significantly, or even chiefly, to blame for our country’s skyrocketing health care costs and steadily diminishing access to care,” the report said. “Those who blame malpractice litigation for the broken economics of our health care system typically tout laws limiting physicians’ liability as the answer.”

But the data in Texas doesn’t bear that out, despite the claims to the contrary by Texas Gov. Rick Perry,  who spearheaded the legislation limiting cap awards, according to the Public Citizen report.

“While litigation over malpractice in Texas has plummeted dramatically since the caps were imposed, residents of Texas (except for people with financial connections to liability insurance companies and, to a lesser extend, doctors) have realized few, if any, benefits. Instead, the health care picture in Texas has worsened significantly by almost any measure,” the report said.         

Since the Lone Star State imposed the caps, its Medicare spending has outpaced the national average. 

“Per enrollee spending for Medicare’s two main programs ranked second-highest in Texas among the 50 states in 2009,” the report said. “In 2003, Texas ranked seventh … These figures contradict the theory that medical malpractice litigation is driving health care costs.”

In addition, premiums for private health insurors have risen and outpaced the national average. Oh, by the way, the percent of Texans who are uninsured has also increased, “solidifying the state’s dubious distinction of having the highest uninsured rate in the country,” according to the report.

In addition, the per capita increase in the number of doctors practicing in Texas has been slower than prior years, and ”the prevalence of physicians in non-metropolitan areas has declined,” according to the report.

The cap in Texas appears to have been a boon to insurance companies and doctors. For one insuror, premiums for doctors were 50 percent less in 2010 versus 2003.  But the medical malpractice payments that insurors are issuing have dropped 74 percent, adjusted for inflation, from 2003 to 2010, the report said. That translates into a “windfall” for insurance companies, according to the report.

“But the benefits realized by these two groups have not translated into savings for regular Texans or for the taxpayers who  fund Medicare,” the report said.

The Public Citizen report is very detailed, and it all can’t be presented here. But one of the highlights is the section on health insurance premiums. Caps have not kept those costs down.

“Although health insurance costs in Texas have not outpaced national rates as dramatically as have Medicare expenditures in the state, they have risen faster than the national average since the caps were imposed,” according to the report. “Family health insurance premiums in Texas rose by 51.7 percent between 2003 and 2010. Nationally, they rose by 50 percent. Since 2004, health insurance premiums in Texas have risen 13.1 percent faster in Texas than nationally.”

Here are the report’s conclusions.

“Despite the sales campaign to promote Texas as an exhibit of the merits of limiting doctors’ liability for mistakes, the real world data tell the opposite story. Health care in Texas has become more expensive and less accessible since the state’s malpractice caps took effect.

The beneficiaries of the new system are the doctors who escape accountability for their errors and the liability insurance  companies that reap a windfall of inflated premiums. Regular Texans are the losers. They include not only the victims of medical malpractice who are deprived of the chance to recover damages but also the taxpayers who must foot the bill for the future medical costs of seriously injured patients.”

That conclusion is similar to the one made in the study by the Cato Institute, on whether mandatory caps on medical malpractice damages harm consumers. The executive summary of that report makes its position pretty clear.

“Supporters of capping court awards for medical malpractice argue that caps will make health care more affordable,” the Cato report said. “It may not be that simple.”

That’s the understatement of the year.

“First, caps on awards may result in some patients not receiving adequate compensation for injuries they suffer as the result of physician negligence,” the Cato report said.

“Second, because caps limit physician liability, they can also mute incentives for physicians to reduce the risk of negligent injuries,” the report added.

And contrary to what supporters of caps claim, “medical malpractice awards do track actual damages,” according to the Cato report.

But here is the heart of the matter, from the report.

“If the medical malpractice liability insurance industry does indeed protect consumers, then policies that reduce liability or shield physicians from oversight by carriers may harm consumers,” it said.

In its conclusion, the Cato report said that patients are protected by a interdependent system of oversight that includes evaluations, hospital oversight and the medical malpractice industry.

“Underlying nearly all of these activities is the threat of legal liability for negligent injuries,” the report said. “Reducing physician liability for negligent care by capping court awards, all else equal, will reduce the resources allocated to medical professional liability underwriting and oversight and make many patients worse off. Legislators who see mandatory liability caps as a cost-containment tool should look elsewhere.”

Amen.