Personal Injury Law Update

FDA Confirms 13 Cases of Progressive Multifocal Leukoencephalopathy in Patients Receiving Natalizumab (Tysabri) for Multiple Sclerosis

Tom D'Amore — 2009-11-03T22:19:00-08:00

The FDA announced earlier this fall that it had confirmed 13 cases of progressive multifocal leukoencephalopathy (PML) in patients receiving natalizumab (Tysabri) monotherapy for multiple sclerosis. There were no reported confirmed cases in patients receiving natalizumab for Crohn's disease, an indication the FDA approved in January 2008. However, according to the FDA, less than 2% of natalizumab use in the U.S. has been for Crohn's patients.

The first reports of PML from Tysabri surfaced in 2005. Because of the risks of PML, Tysabri is now only prescribed through a program developed by the FDA and the drug's manufacturer called The TOUCH Prescribing Program.

The FDA said the risk for developing PML appears to increase with the number of natalizumab infusions received. The 13 patients who developed PML received an average of 12 to 35 monthly infusions per patient. The average number of infusions received before the diagnosis of PML was 25.

Read the full story on MedPage Today.

Even Low Levels of Lead Cause Problems in Children

Tom D'Amore — 2009-11-01T10:16:59-08:00

As reported on MedPage Today, a recent study found that blood lead levels at least 50% below the currently recommended Center for Disease Control level were associated with greater anti-social behavior and poorer standardized test scores in children.

The reason children are particularly at risk for problems stemming from lead exposure is that the metal is more readily absorbed in their developing bodies and tissues. As researchers explained, kids absorb up to 50% of the lead they take in, as compared with adults who absorb only about 10% to 15%. Once in the body, lead tends to affect the peripheral nervous system in adults but can do permanent damage to the central nervous system in children.

Read the full article.

Congress Holds Hearing on Link Between Football and Brain Injury

Tom D'Amore — 2009-10-29T08:18:00-07:00

On Wednesday, Congress held a hearing on the legal issues relating to head injuries sustained by professional football players. Testimony was heard from Roger Goodell, the NFL Commissioner, as well as various physicians, retired football players, and others with expertise in the subject.

In his opening statement, the chairman of the House Judiciary Committee, John Conyers (D-Mich.), observed that over the last several years, an increasing number of retired professional football players have developed long-term memory and cognitive diseases, such as dementia, Alzheimer’s, depression, and Chronic Traumatic Encephalopathy (also known as “CTE").

Congressman Conyers further noted that reducing the long term mental and cognitive health risks from playing football was important not just for the future well-being of NFL players, but the safety of millions of football players at the college, high school, and youth levels playing in leagues that tend to follow the lead of the NFL when it comes to such medical questions as how to handle players who suffer concussions during football games.

Conyers then noted that:

there appears to be growing evidence that playing football may be linked to long-term brain damage;
the NFL largely denies any linkage between playing football and long-term brain injuries; and
the absence of a consensus on how to respond to the growing incidence of long term cognitive health problems suffered by former NFL players.

As a first step, Congressman Conyers requested that the the NFL, the NFL Players Association, all relevant medical researchers, the NCAA, and the National Federation of State High Schools Association make their relevant medical records available to Congress for review and analysis.

Following the hearing, Goodell, and NFL Players Association head DeMaurice Smith, agreed to turn over players' medical records to the House Judiciary Committee.

The issue is an important one for parents to follow due to studies showing that every year, as many as 1 in 10 high school football players has a concussion (according to Kevin Guskiewicz of the University of North Carolina at Chapel Hill who is lead author of the National Athletic Trainers' Association position statement on concussion management).

Mark Lovell, director of the sports medicine concussion program at the University of Pittsburgh Medical Center, has begun to collect data on long-term consequences of high school football concussions. In the meantime, he says, players, coaches and parents must learn to recognize the symptoms of a concussion, and be ready to pull affected players out of competition until a health professional clears them to play again. Further, players should not return to action until their brains heal, because it's dangerous to get a second concussion when the brain is still recovering from the first one.

Washington and Oregon Pilots Suspended for Air Traffic Safety Violations

Tom D'Amore — 2009-10-28T08:01:55-07:00

Hard to believe, but here's a story about two Northwest Airlines pilots, one from Washington State and one from Oregon, who were were working on their personal laptop computers, lost track of time and place, and overshot their Minneapolis destination by 150 miles. The pilots also neglected to touch base with air traffic controllers despite repeated attempts by air traffic controllers in two states to reach the airliner. Northwest's dispatchers also tried eight times to contact the airplane, without response.

The Federal Aviation Administration said yesterday that it had revoked the licenses of the two pilots for, among other things, "operating their aircraft carelessly and recklessly."

Drinking Water Contaminated With PCE Tied to Birth Defects

Tom D'Amore — 2009-10-13T15:01:06-07:00

Researchers recently reported that an expectant mother's exposure to drinking water contaminated with the solvent perchloroethylene (PCE) increases the risk of congenital anomalies in her offspring. In particular, exposure of pregnant women to contaminated water at the time of conception was associated with an increased risk of neural tube defects and oral clefts.

The findings come from a study of children who were born to mothers living in certain areas of Cape Cod, Massachusetts between 1969 and 1983. During that period, mothers had been exposed to PCE leaching into public drinking water supplies from the inner vinyl lining of water pipes.

Read further details about this research on MedPage Today.

Lead Poisoning Concerns Lead to Warning Against Eating Certain Imported Dried Plums

Tom D'Amore — 2009-10-09T14:40:00-07:00

Earlier this month, the Texas Department of State Health Services warned consumers not to eat certain imported dried plums, as well as products containing imported dried plums, because they have elevated levels of lead.

Most of the products typically are sold as salted or candied treats in Asian and Hispanic markets, but also are available in other retail outlets. Officials believe the dried plums came from Asia, but an investigation to identify specific sources is ongoing. Test results from a Texas laboratory showed that the dried plum products contained lead levels ranging from 0.11 parts per million to 30.3 parts per million (FDA guidelines recommend a maximum of 0.1 parts per million).

For a list of affected products see here.

Voluntary Recall of Tylenol Products Due to Possible Bacterial Contamination

Tom D'Amore — 2009-10-01T15:30:00-07:00

In late September, McNeil Consumer Healthcare, a division of Johnson & Johnson, announced a recall of twenty-one children's and infants' Tylenol products manufactured between April 2008 and June 2009 due to possible contamination with gram-negative bacteria Burkholderia cepacia (B. cepacia). The company stressed that the raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, it was decided, as a precaution, to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria.

Click here to read the full recall announcement with lot numbers (which can be located on the bottom of the box containing the product and on the sticker that surrounds the product bottle).

Swimming in Chlorinated Pools Raises Children's Asthma and Allergy Risks

Tom D'Amore — 2009-09-29T22:26:55-07:00

A recent Belgian study found that teenagers who spent more than 100 hours swimming in chlorinated pools were up to six times more at risk of having asthma than other teens who swam mostly in pools sanitized with a mix of copper and silver. Similarly, the odds for hay fever were between three and six times higher for those who swam in chlorinated pools for more than 100 hours.

According to toxicologists, these figures mean that the impact of pool chemicals on the respiratory health of children and adolescents in terms of incidence of asthma and allergic diseases appears to be more significant than that associated with secondhand smoke.

Read the full story here.

Online Food Safety Resource: Ask Karen

Tom D'Amore — 2009-09-21T18:11:00-07:00

The U.S. Department of Agriculture's Food Safety and Inspection Service now offers an online resource called "Ask Karen" that allows consumers to research food safety questions 24/7. In a nutshell, "Ask Karen" is a knowledge base that contains information about preventing foodborne illness, safe food handling and storage, and safe preparation of meat, poultry, and egg products.

The service includes a list of common food safety questions such as:

How long can I keep meat in the refrigerator?
How long is meat or poultry safe to use after the sell-by date?
Is food safe after the date expires?
How can I keep food safe outdoors?
Is food safe if left out overnight?
How do you keep food safe on a picnic?
How do you avoid cross-contamination when grilling?
Is it safe to refreeze food that has thawed?
How long can you keep dairy products?
Where can I get information about the JBS Swift Beef Company recall?
Is the E coli O157:H7 toxin killed through cooking?
What are the symptoms of E. coli O157:H7 illness?
Where can consumers find information on recalls of food products?

And much more...

Seattle Company Recalls Frozen Sausage Products Due To Undeclared Allergens

Tom D'Amore — 2009-09-14T03:00:00-07:00

The U.S. Department of Agriculture's Food Safety and Inspection Service ("FSIS") announced last Friday that Cascioppo Brothers Meats, Inc., based in Seattle, Washington, is recalling approximately 2,000 pounds of frozen sausage products because they may contain undeclared allergens, milk and soy.

The FSIS stressed that it had not received any reports of illness due to consumption of these products, but that anyone concerned about an allergic reaction should contact a physician.

Click here for further details about the recall (click here to view the labels on the recalled products).