St. Louis Hospital Admits Brain-Surgery Mistake


Posted on 30th April 2013 by gjohnson in Uncategorized

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I haven’t seen this very often in my career as a traumatic brain injury lawyer: A hospital making a lengthy apology after being sued for medical malpractice.

The hospital chain involved as SSM Health Care-St. Louis, which last Friday was sued for allegedly operating on the wrong side of a patient’s brain. Actually, I can take out the “allegedly,” since the hospital quickly owned-up to the error.

Here’s what happened. The St. Louis Post-Dispatch wrote story Tuesday saying that a suit had been filed against SSM Health Care on behalf of Regina Turner, 53. She had been slated to have a left-sided craniotomy bypass on April 4 at SSM St. Clare Health Center (part of SSM Health Care) in Fenton, Mo. Instead, the surgery was done on the right side of her brain, the Post-Dispatch reported.

The malpractice lawsuit, which also named neurosurgeon “A.L.” as a defendant, claims that doctors performed a second surgery, on the correct side of Turner’s brain, six days after the mishap in the operating room, according to the St. Louis newspaper.

Now Turner can’t speak intelligibly, needs constant care, and is suffering from anxiety and depression, the suit says.

Perhaps to deflect some of the bad publicity about the malpractice suit, after the Post-Dispatch story appeared SSM Health Care admitted that its neurosurgeon and medical team had operated on the wrong side of Turner’s brain.

According to the newspaper, SSM Health Care President and CEO Chris Howard issued a long statement about Turner’s case. First of all, Howard apologized for “the wrong-site surgery in our operating room.”

“This was a breakdown in our procedures, and it absolutely should not have happened,” Howard said. “We have since taken steps to be even more vigilant to prevent such an error from happening again. Medicine is a human endeavor, and sadly, people and systems are not perfect. When an error occurs, it is tragic for the patient, their loved ones and the medical team.”

It will be interesting to see what kind of a settlement comes out of this mess.

Cerebral Palsy Kids See Brain Gains After CI Therapy


Posted on 26th April 2013 by gjohnson in Uncategorized

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Children with cerebral palsy who underwent constraint-induced movement therapy (CI therapy) saw a significant increase in grey matter volume in areas of the brain associated with movement, according to a new study from the University of Alabama at Birmingham (UAB).

UAB touted the findings, published online Monday in the journal Pediatrics, as he first to show that structural remodeling of the brain occurs during rehabilitation in a pediatric population.

“It is well understood that CI therapy produces a re-wiring of the brain, leading to functional improvement in motor skills in children and adults who have experienced a brain injury,” Edward Taub,  the developer of CI therapy and a study co-author, said in a press release. “This study reinforces the idea that CI therapy also remodels the brain, producing a real, physical change in the brain.”

CI therapy forces the use of the affected side by restraining the unaffected side, according to the American Heart Association. With CI therapy, often used on stroke patients, the therapist constrains the survivor’s unaffected arm in a sling. The survivor then uses his or her affected arm repetitively and intensively for two weeks.

The UAB study examined 10 children with cerebral palsy, ages 2 to 7, who underwent a three- week course of CI therapy.

Changes in grey matter were assessed through voxel-based morphometry (VBM), performed on images acquired through magnetic resonance imaging. Grey matter consists mainly of neuronal cell bodies, glial cells and dendrites, according to UAB.

“We saw increases in grey matter volume in the sensorimotor cortices on both sides of the brain and in the hippocampus,” said Chelsey Sterling, a graduate student in medical psychology and first author of the study. “These increases were accompanied by large improvements in spontaneous arm use in the home environment. Notably, increases in grey matter correlated with improvement in motor activity.”

The correlation between increases in grey matter volume and magnitude of motor improvement raises the possibility of a causal relationship, according to Sterling.

The researchers believe that the observed increase in grey matter could be due to one or more different processes, including an increase in synaptic density, the creation of new neurons or glial cells or the establishment of new blood vessels within the brain.

“An increase in grey matter is indicative that the brain is capable of supporting increased motor activity and function,” said Gitendra Uswatte, a study co-author. “Along with the improvements observed in the dexterity and everyday use of the arm that was the target of rehabilitation, this is a strong indication that a child with cerebral palsy can have substantial gains in motor function when provided with the correct stimulation.”

VBM analysis was performed three weeks prior to therapy, at the beginning of therapy and at the end of the three-week therapy period. The authors saidthat no significant grey matter change was seen during the three weeks before treatment.

The children underwent intensive motor training for three hours each weekday for a three-week period in which the child’s less-affected arm was continuously restrained in a long-arm cast. Each child’s caregiver received a transfer package, which included steps to induce continuation of use of the more-affected arm at home. The MRI scans were performed at Children’s of Alabama.

Taub, a university professor in the Department of Psychology, developed the CI therapy techniques. The therapy has been shown to be effective in improving the rehabilitation of movement after stroke and other neurological injuries in both children and adults.

“The motor improvement and changes in grey matter following CI therapy observed in this study are similar to those observed previously in adults,” Taub said. “It is further evidence that the brain has a remarkable capacity to heal itself when presented with an efficacious rehabilitation intervention such as CI therapy.”

N.Y. Jury Awards $130 Million For Cerebral Palsy Malpractice


Posted on 18th April 2013 by gjohnson in Uncategorized

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The family of Shannon Reilly, who during her birth sustained severe brain damage and now has cerebral palsy, were smart to heed their lawyer’s advice. And they are $122 million richer, money that will go toward their daughter’s care.

A New York jury has awarded the family $130 million in the medical malpractice lawsuit, which the New York Daily News called the second largest malpractice verdict in the state’s history.

Danni and Frank Reilly of Long Island had filed suit against St. Charles Hospital in Port Jefferson, L.I., over what they alleged was Shannon’s botched birth in 2002, according to the News and the New York Post.  The girl, who is now 10, can’t walk or talk, and needs constant care.

The hospital had offered the Reilly family $8 million in 2009 to settle the lawsuit. But lawyer Thomas Moore told the family not to accept that sum, maintaining that Shannon’s care over the term of her life would cost a lot more than $8 million.

The suit alleged that hospital staff didn’t notice Shannon wasn’t getting enough oxygen at her birth, that she wasn’t properly monitored.

It was a long path for the family to get to the $130 million judgment. The case went to trial, and the jury cleared the hospital of any liability, the News and Post said. Moore went to an appellate court, which ruled that there should be another trial on the case.

The second trial, which took place last year, ended with a hung jury.

The third trial, in Suffolk County Superior Court, ended earlier this week with the $130 million verdict.

Amazingly, Moore told the News that during his career there were 34 times when he advised clients not to take settlements of $8 million or more. And in each of those cases, he either got a verdict or settlement over $8 million, according to the News.

La. Company Recalls 468,000 Of Possibly Contaminated Meat


Posted on 13th April 2013 by gjohnson in Uncategorized

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Manda Packing Co. has expanded its recall of potentially contaminated meat products to 468,000 pounds of roast beef, ham, turkey breast, tasso pork, ham shanks, hog head cheese, corned beef, and pastrami, the U.S. Department of Agriculture’s Food Safety and Inspection Service said Friday.

Last week the Baker, La., company said it was recalling 20,166 pounds of meat due to possible contamination with Listeria monocytogenes.

Friday’s USDA press release on the expanded recall listed just over a half dozen kinds of meat sold under 41 names, and said that “these products may have been sliced at retail delis, and if so will not bear this packaging information.”

The products were shipped for further distribution, for sale at retail, and to retail deli stores in Alabama, Arkansas, Florida, Georgia, Illinois, Kentucky, Louisiana, Mississippi, Missouri, Oklahoma, South Carolina, Tennessee, and Texas.

The USDA was alerted to the problem by the Tennessee Department of Agriculture, who took an intact sample of cooked roast beef at a retail establishment on April 5, which later tested positive for Listeria monocytogenes.

The recall is now being expanded because of additional samples from additional production dates which returned positive for Listeria monocytogenes.

The USDA hasn’t received any reports of illnesses associated with consumption of these products.

Manda issued a statement Saturday on the expanded recall.

“We have been cooperating fully with the U.S. Department of Agriculture,” said Josh Yarborough, Manda director of quality assurance and food safety. “We are committed to work with USDA in reviewing and enhancing our food safety system so we can continue to ensure that our products are safe, wholesome and worthy of our brand name. Our customers deserve no less.”

Eating of food contaminated with Listeria monocytogenes can cause listeriosis, an uncommon but potentially fatal disease.

“Healthy people rarely contract listeriosis,” the USDA said. “However, listeriosis can cause high fever, severe headache, neck stiffness and nausea. Listeriosis can also cause miscarriages and stillbirths, as well as serious and sometimes fatal infections in those with weakened immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy. Individuals concerned about an illness should contact a health care provider.”

FDA Issues Warning On DMAA Workout Supplements


Posted on 13th April 2013 by gjohnson in Uncategorized

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The Food and Drug Administration (FDA) how lowered the boom on the controversial workout boosters Jack3d and OxyElite Pro, issuing a warning last Wednesday that the stimulant they contain – dimethylamylamine, or DMAA – is illegal.

The FDA said that it was using all the tools at its disposal to ensure that dietary supplements containing DMAA are no longer distributed and available for sale to consumers in the marketplace. GNC and Vitamin Shoppe have been selling the products for years.

I blogged on this topic when The New York Times did an investigative piece about the dangers of DMAA.DMAA is most commonly used in supplements promising weight loss, muscle building and performance enhancement. According to the FDA, it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.

“Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine,” the FDA said. In its warning, the FDA reported that it had received 86 reports of illnesses and deaths associated with supplements containing DMAA.

“The majority are voluntary reports from consumers and healthcare practitioners,” the warning said. “The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.”

The FDA said that is has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal. It said that such warnings offer the quickest way for the FDA to halt the further distribution of dietary supplements containing DMAA in the marketplace.

All but one of the companies sent an FDA warning letter have agreed to stop using DMAA as an ingredient in their dietary supplements, according to the agency.

The company that hasn’t agreed, USPLabs, has responded to FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions.

“However, after reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements,” the FDA said.

“FDA is finalizing a formal response to the firm to reflect its findings, according to Daniel Fabricant, director of FDA’s Division of Dietary Supplement Program.

The FDA said that its authority over dietary supplements is very different from its authority over drugs and other medical products. FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don’t voluntarily comply.

The FDA said that as it continues the process needed to get DMAA off the market, it is urging consumers to check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The agency said that its response to the use of DMAA “illustrates the challenges that the agency faces in addressing incidents involving potentially dangerous dietary supplements.”

That effort is increasingly important as the use of dietary supplements increases worldwide, the FDA said. A 2011 study found that more than half of U.S. adults used a dietary supplement between 2003 and 2006, compared to 40 percent between 1988 and 1994.

In recent years, the FDA has alerted consumers to hundreds of tainted products marketed as dietary supplements. Consumers should be aware that dietary supplements are subject to different oversight than drugs and other medical products.

“Consumers may mistakenly look at a capsule and think that FDA has signed off on that product as safe and effective prior to that product appearing on the market, as we do with drugs and other medical products,” Fabricant said. “In contrast, with dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe.”

The FDA’s role in overseeing dietary supplements is laid out in a 1994 law and subsequent amendments, and its enforcement capabilities range from issuing warning letters seeking voluntary cooperation bringing criminal charges.

In recent years, FDA enforcement actions involving dietary supplements have included banning products, executing injunctions, working with U.S. marshals to seize products, and issuing safety alerts and consent decrees—which are agreements approved and enforced by a federal court, the agency said.

In many cases, the FDA has acted when dietary supplements were found to contain ingredients approved for use in prescription drugs. DMAA was approved in 1948 for use as a nasal decongestant, but the approval was withdrawn in 1983, according to the agency.

The products cited in the warning letter to USPLabs are Oxy Elite Pro and Jack3d. These products claim, among other things, to be fat-burning and performance-enhancing supplements, respectively.

While action in that case in pending, the FDA said it is following up to ensure that other companies which promised to cease using DMAA as an ingredient in their dietary supplements are actually doing so.

The agency is also looking to see if there are other dietary supplement products containing DMAA in the marketplace, and will continue to act to ensure that such products, when identified, are no longer distributed and available for sale to consumers.