Medtronic Pacemakers Recalled

Medtronic pacemakers are recalled on 05/18/2009 by the FDA. 

This is a Class 1 recall, the most serious type of recall action. The major concern of the recall was its failure, “due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.” The malfunctioning pacemakers can cause abnormal heart rates, fainting or lightheadedness. More serious concerns are serious injury or death.

 

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300 manufactured primarily between November 2000 and November 2002. Most were implanted at least 5 years ago. 

 

The Pintas Law Firm is currently investigating these claims. If your pacemaker is affected by this recall contact our firm now for additional free information. See the following websites for more information on the recalled pacemakers and the adverse health effects they may cause:

 wwwp.medtronic.com/ProductLookup/lookup.html

wcms.fda.gov/ucm/groups/fdagov-public/documents/image/ucm162880.gif

Posted In Medtronic
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Raptiva Withdrawn from Market

On April 8, 2009 notice was sent to physicians that Genentech, Inc. voluntarily withdrew the psoriasis medication Raptiva.  This was prompted because of increased risk of progressive multifocal leukoencephalopathy (PML)

Our law firm is accepting clients who have suffered injuries from Raptiva

 

Posted In Raptiva (efalizumab)
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Avandia Stays on the Market

Recently, the FDA overwhelmingly refused to take Avandia, the diabetes drug, off the market, despite studies that showed increased heart attack as a very realistic side effect. Weaknesses in those studies were one of the reasons cited by the FDA for their decision. However, one of the solid conclusions reached was that Avandia does increase heart attack risk.

The FDA did suggest a "black box" warning, the most severe, to warn consumers about the risk. Further suggestions included discouraging joint use of Avandia and insulin, as this also increases heart attack risk. FDA experts also recommended that the drug be investigated further.

In early 2007, Avandia was the second highest grossing diabetes drug in the United States. An analysis of 42 studies showed that there is a 43 percent higher chance of heart attack risk with diabetic patients taking Avandia than those taking any other or no diabetes medication. Avandia is used to control the body's blood sugar by increasing sensitivity to insulin. Before the studies, this treatment was commonly perceived to decrease heart risks already associated with diabetes. Diabetes affects more than 18 million Americans today.

Congress is in the process of overhauling the FDA's decision, and points to the Avandia situation as evidence of the FDA's inability to handle the safety risks of drugs that have been approved for the market.

In the case of Avandia, it appears that the FDA is too lax in dealing with hazards associated with certain drugs. Conversely, many poor countries around the world are not even close to lax with their policies surrounding drugs that should be deemed necessities. Morphine is one prime example, as a pain reliever. Countless poor countries find it extremely difficult to secure this drug even in the cases of uncontrollable cancerous tumors that cause excruciating pain. However, even in these cases, morphine is not allowed due to an intense fear of patient addiction.

Is the FDA too lax in their drug safety control policies? Are foreign countries not lax enough?

See the following articles for more information:
Avandia:
www.msnbc.msn.com/id/20036086/from/ET/
Morphine:
www.nytimes.com/2007/09/11/health/11pain.html
www.nytimes.com/2007/09/10/health/10pain.html
Posted In Pharmaceutical Litigation
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A Feline Harbinger of Death

In the story of Oscar the cat lies a temporary light-hearted break with the serious nature of our blog:

Residents at the Steere House Nursing and Rehabilitation Center in Providence, Rhode Island, have their very own grim reaper...in the form of a feline. Oscar the cat displays an uncanny accuracy in predicting death of the residents on the third floor dementia unit of the nursing home. He has been accurate in 25 cases, beating even a doctor in his predictions of death. Dr. Joan Teno of Brown University, an expert in terminal illness care, had predicted the death one patient. which turned out to be ten hours too early. Oscar wouldn't stay in the room until some hours later, when the patient had two hours left to live.

Most of the families appreciate Oscar's accuracy in allowing them to say a final farewell to their loved ones. Although the cat recently received a wall plaque commending his "compassionate hospice care", animal experts say that his behavior could be driven by a desire for personal comforts, such as heated blankets placed on dying patients. Or, it could be due to a keen sense of smell or attentiveness to unconscious changes in behavior in those surrounding him upon impending death. Regardless, Oscar the cat's behavior is another example of the powers of animals that we have not yet fully comprehended, but find so phenomenal.


For more: visit  edition.cnn.com/2007/US/07/25/death.cat.ap/index.html#cnnSTCText
Posted In Nursing Home Abuse
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Impending Dangers of Food Poisoning

Every year, people travel in droves to visit the Taste of Chicago to sample delicacies from a variety of different restaurants. This year, some consumers who visited the Pars Cove booth contracted food poisoning due to salmonella. Thus far, the problem food has been identified as an herb tomato cucumber salad that was served with their hummus.

Another recent salmonella outbreak was traced to the makers of Veggie Booty, a snack that was recalled and is produced by a Sea Cliff company. The FDA recalled the product June 28 after it received over 50 cases of salmonella poisoning in 17 states from  consumers who had eaten Veggie Booty. The salmonella may have been a result of additional seasoning added to the product after it had been cooked.

Numerous lawsuits have since been filed against the makers of Veggie Booty. One such case was filed by the parents of an 18 month old named Xavier Allen from Indiana in the U.S. District Court in Brooklyn. The suit seeks at least $75,000 in damages.

Salmonella can cause serious infections. Some symptoms include vomiting, fever, nausea, and abdominal pain.

Food poisoning is a serious problem that faces consumers today. How do you think we should face this problem? Should the FDA impose more stringent regulations?

See the following articles for more information on food poisoning and salmonella.
http://en.wikipedia.org/wiki/Food_poisoning
http://en.wikipedia.org/wiki/Salmonella Posted In Recalls
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New Guidelines for Detecting Down Syndrome

Having a baby is a joyous experience. Every mother wants their child to be healthy. Imagine a mother's consternation in the realization that her baby has Down Syndrome. And imagine her reaction when she is informed that she has the power of prevention.

Previously, only women over 35 had amniocentesis and chorionic villus sampling tests in addition to the typical blood test and ultrasound for detection of the disease. This precaution for older women is associated with higher risk of having babies that test positive for Down's.

To provide mothers with the option of prevention, new guidelines published in January by the American College of Obstetricians and Gynaecologists (ACOG) urge all women to have the same comprehensive tests at their 20th week or earlier. Before the amendment, younger mothers were only screened at their 20th week with blood tests.

The new guidelines are mostly advantageous. The new tests are more accurate and give mothers more time to decide what to do. However, they also carry a slight risk of miscarriage, and about 80% of women who test positive for Down's have abortions. The latter statistic is particularly unsettling to advocates of Americans with the genetic disease.

In addition, caution must also be exercised in believing the doctor's statistics. In their zeal to catch Down syndrome early in the mother's pregnancy, many Arizona clinics have cited a figure that as many as one in four  40 year olds has a baby with the disease. Rather, academic research suggests the number is one in one hundred.

For more information, see www.economist.com/world/na/displaystory.cfm
Posted In Medical Malpractice
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Pending Lawsuits for Faulty Defibrillators

"Boston Scientific Corp. said it agreed to settle all pending federal lawsuits against the company alleging harm from faulty defibrillators and pacemakers for $195 million, well below the sum the company had estimated as its likely liability.

The company acquired liability for the suits through its 2006 acquisition of Guidant Corp., which was forced to recall more than 100,000 cardiac-assist devices in 2005. One of its defibrillator models occasionally failed to deliver lifesaving shocks to the heart when needed.

Several attorneys representing plaintiffs declined to comment, saying they were subject to a judge's order not to speak.

Guidant already has settled some cases brought on behalf of patients who died. The vast majority of pending cases -- about 1,850, covering more than 5,000 individuals -- were brought by patients who had their devices removed because of the Guidant recalls, complaining that the company waited too long before informing them and doctors of the flaw."

For Full article, http://online.wsj.com/article_email/SB118436796413866300-lMyQjAxMDE3ODE0NTMxNjU3Wj.html

 

Posted In Medical Device Litigation
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Nursing Home Abuse

"While the traditional view of elder abuse in nursing homes involves staff harming residents, new research suggests residents may have more to fear from their peers..."

Read the full article at http://www.msnbc.msn.com/id/19712822/from/ET/

Posted In Nursing Home Abuse
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Chinese Tires Recalled

"Federal officials have told a small New Jersey importer to recall 450,000 radial tires for pickup trucks, sport utility vehicles and vans after the company disclosed that its Chinese manufacturer had stopped including a safety feature that prevented the tires from separating.

Jeffrey B. Killino, a personal-injury lawyer from Philadelphia, said the company came forward only after it was named as a defendant in a lawsuit, filed in May, involving an accident in which two construction workers were killed and a third was severely injured when a van rolled over. The lawsuit contended that the accident was caused by tread separation in a Hangzhou Zhongce tire.

Earlier, an ambulance in New Mexico rolled over after a Hangzhou Zhongce tire came apart, though there were no significant injuries, according to documents supplied by Foreign Tire Sales to the federal safety agency."

Read the full article in the NY Times. Posted In Recalls
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Hospital Staph Infections Rampant

"As many as 1.2 million hospital patients are infected with dangerous, drug-resistant staph infections each year, almost 10 times more than previous estimates, based on findings from a major new study.


And 48,000 to 119,000 hospital patients a year may be dying from methicillin-resistant staphylococcus aureus (MRSA) infections, far more than previously thought, the study suggests.

The Tribune obtained the results during the weekend from the Association for Professionals in Infection Control & Epidemiology (APIC), which is releasing the report publicly on Monday. The author is Dr. William Jarvis, former acting director of the hospital infections program at the Centers for Disease Control and Prevention."

Read the full article in the Chicago Tribune.

Posted In Medical Malpractice
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