FDA Demands Medical Device Manufacturer Provide Information to Determine Device Safety

The U.S. Food and Drug Administration is losing its patience.  In a recent letter to St. Jude's Medical, the FDA has called for more information on its popular heart defibrillator lead, called Durata.  After over 278,000 patients have been implanted with the lead, the FDA is still lacking the information it requires to determine whether consumers have suffered any injuries.  The FDA is demanding the company provide information it desperately needs to assess its safety and potential for injury to consumers. 

Last fall, FDA inspectors visited their factory in California and came away with serious concerns.  These focused upon nonconformities in their manufacturing processes, which the FDA feels could be problematic. Specifically, the FDA wants to know how St. Jude Medical monitors device safety, what kinds of records are kept, and how they address safety concerns. 

Could You Be at Risk for Injury

The FDA is essentially worried that consumers may be at injury given their lack of information.  Specifically, the FDA wants the following information:

• rates of injury among users in clinical trials and continuing data
• testing procedures
• corrective action procedures
• testing design verification
• multiple lead holders

According to the FDA's public letter to St. Jude Medical, these procedures are not being followed to ensure safety of its devices. If St. Jude Medical fails to provide evidence that these have been corrected, the FDA has warned the company that these devices will not be approved for use in America. 

The FDA is desperately trying to asses whether or not consumers have suffered injury due to "misbranded" leads.  Because reports were not submitted in a timely fashion, the FDA is unsure of whether the device has malfunctioned and potentially injured or killed people. 

If You Have Been Injured

The FDA has not been able to assess whether consumers have suffered injury from the device as evidenced by their public letter available here.  In an absence of this critical information, the agency is threatening to impose civil penalties and to notify federal agencies currently using the device.  Consumers who have suffered injury using this device are encouraged to call the FDA to report it.  Consumers should also notify a skilled product liability attorney to determine whether or not they may have a case against the manufacturer. 

New Study Links Aspirin to Degenerative Eye Disease

A new study was released in the Journal of the American Medical Association which claims that aspirin may be a bigger danger than previously thought.  This over the counter drug is taken regularly for everything from headaches to reduce inflammation to even encouraging heart health.  But this recent study is claiming that it may also be linked to a rare form of macular degeneration.

This may be particularly troubling to the estimated 20% of Americans who take low doses of aspirin daily for heart health.  This wonderful drug which is linked with reducing risk for heart attack may now be associated with a rare risk to a patient's eyes, called age- related macular degeneration.

What is AMD?

Age- related macular degeneration (or AMD) is a progressive eye disease which affects millions of Americans every  year.  According to the Macular Degeneration Project, approximately 15 million Americans are affected by this progressive eye disease. AMD is associated with a progressive form of near blindness, wherein a patient's vision degenerates almost completely.  Patients suffering from AMD can suffer near blindness except a fuzzy peripheral vision.  Approximately 14-24% of Americans over the age of 65 suffer from this disease.

AMD can be recognized by the following symptoms:

• fuzzy vision
• a dark spot in the center of your vision, or lack of anything in the center of your vision
• dimmed vision when concentrating such as reading
• straight lines start to appear curved

How Aspirin May Contribute to AMD

Researchers claim that after 10 years, there was an association between aspirin use and AMD, wherein unusual blood vessels grew behind the eye's retina. Leaking blood or fluids caused a "wet" form of AMD, and according to researchers, this was more prevalent among regular aspirin users. The study asserts a stronger link to aspirin related "wet" AMD, although previous studies found no such links.  

If you have developed "wet" AMD as a result of your aspirin usage, you should consult a physician right away.  In addition, you may want to discuss your experience with a skilled product liability lawyer to determine if you are eligible to collect damages for your injury.  

Study Suggests Warfarin Might Be More Dangerous Than Originally Thought

Things just seem to keep getting worse for heart patients on blood thinners.  For years, Warfarin was the standard blood thinner that many heart patients took to prevent blood clots and strokes.  However, new information has emerged which paints a bleaker picture.  This drug may be much riskier than originally believed.

The Canadian Medical Association Journal is reporting that 4% of the 125,000 patients studied experienced  bleeds per year. In the first month of treatment alone, roughly 12% experienced a bleed as well. Researchers followed this group of patients for years, and after 4 years, determined 9% of them, or an estimated 11,000 patients, had to be hospitalized.  1/5 of these patients later died.  These results are higher than original study outcomes and researchers suggest additional study may be required. 

How Warfarin Works to Prevent Strokes

Warfarin is the most common blood thinner in America.  On any given day, approximately 3 million people take the drug to thin the blood to prevent blood clots.  In patients with irregular heart beats, blood clots can accumulate and travel to the heart or brain, causing a stroke. To prevent this clotting, patients take the drug to thin the blood in a therapeutic manner. This is used in conjunction with a strict diet and strict doctor monitoring. 

Warfarin is a complex drug and works within a rather narrow window to thin the blood, but not produce blood thin enough to cause a fatal bleed.  Because the body changes and adapts to treatment, frequent blood tests are required to keep the bleeding time in a therapeutic range.  Warfarin specifically inhibits Vitamin K from interacting with enzymes to produce blood clots.  Because 4 of the 13 clotting factors require Vitamin K to produce clots, Warfarin is able to slow these clotting interactions by as much as 50%.  Should a potentially fatal bleed occur, patients can counteract these affects with large amounts of Vitamin K introduced into their system at once. 

How You May Be at Risk

Researchers in the Institute for Clinical Evaluative Sciences (ICES) study assert the drug may not be suitable for everyone that is prescribed this blood thinner.  The reason why is that many of their observed patients suffered sever hemorrhages, particularly in the brain, which led to death.  Researchers admitted that further study was needed to adequately determine the risks that potential side effects could have on patients.  But the study's observed results recorded higher percentages of potentially serious health outcomes than the drug's initial clinical trials suggested. 

There are many heart medications on the market, and unfortunately, the news is full of reported serious outcomes.  Heart patients should speak to their doctor about the risks and which might be appropriate for them.  However, if you suffer a serious health outcome as the result of your heart medication, you may want to speak to a skilled product liability attorney to determine whether you may be eligible for compensation to help with your medical costs. 

New Study Shows Increased Cardiac Death Risk for Smokers Even After they Quit

If you didn't have cause to quit smoking sooner, you might want to put that item on your New Year's Resolution list.  According to a new study published in Circulation: Arrhythmia & Electrophysiology,  the link between sudden cardiac death (SCD) and smoking is further explained.

Hold onto your seats and put down the cigarettes because you may be horrified to learn that as a long term smoker, you may not be able to decrease your risk for SCD significantly until 15 years AFTER you've quit smoking. And at the 20 year mark, your risk is apparently akin to a person who has never smoked.

How Much are Smokers at Risk

According to statistical data, smokers are at varying risks, dependent upon the duration of their smoking and how many cigarettes people consumed in a day.  

• Smokers who consume between 1-14 cigarettes experience a 1.84 fold increase
• Smokers consuming over 25 cigarettes per day experience a 3.3 fold increase in risk
• Every 5 years of smoking increased risk by an estimated 5%
• Smokers with histories of coronary disease had increased risk
• Only after 15-20 years of not smoking does risk fall to that of a nonsmoker

What this Means for You

It's nearly 2013 and you know that smoking is damaging to your health.  You know that these chemicals can be deadly.  But this study is the first of its kind to provide conclusive evidence regarding instances of SCD after cessation of smoking. 

Because of the obvious health risks, law makers are currently considering new packaging on cigarettes that clearly alerts smokers, including children, to the potential for death.  Do you think law makers will be able to push that bill through to protect the children?

Nonsmokers are often the unintended victims of smoking.  If you have been injured by second hand smoke and have found your heath in serious decline due to egregious circumstances, you may want to discuss your legal options with an attorney.  There are still people who are forced to work in these hazardous conditions and who are falling severely ill because of their work environment.  Call a skilled personal injury attorney to discuss your case.

New Study Claims Eating Healthy Can Improve Heart Health

This morning as I was reading the news, I came across a study, whose results should come as a surprise to no one.  A healthy diet can improve your health.  I'll pause for your shock to wear off.  But notably, the study claimed that when heart patients ate a healthy diet, they enjoyed better health benefits than medication. 

Heart patients who ate healthy diets enjoyed significant and traceable heart benefits.  This included:

• 35% reduction in death 
• 14% reduction in risk of heart attack
• 28% reduction of heart failure
• 19% reduction of stroke

Recommendations for a Healthy Heart

This study, conducted out of McMaster University in Hamilton, Ontario, Canada, recommended a healthy diet rich in the following foods, among others: 

• fresh herbs instead of salts and spices 
• black beans with heart healthy folate, antioxidants, magnesium, and fiber
• red wine with healthy antioxidants
• salmon with omega-3's which may helpt to regulate heart beats
• tuna with similar omega- 3 power
• extra- virgin olive oil with both antioxidants and monosaturated fats
• walnuts, which can help to lower cholesterol and reduce artery inflammation
• almonds, which help to lower cholesterol and diabetes risk
• edamame which help to lower blood triglycerides 
• tofu, which is rich in many kinds of heart healthy fats, fibers, protein, you name it
• sweet potatoes, which are low in glycemic index 

Try asking your doctor for the full list.  There are many kinds of foods which can help you to attack heart disease.  Perhaps if people begin eating healthier, they can avoid the complications associated with many heart medications.

Heart Medications Can Have Severe Complications

It's no secret that there are a variety of medicines on the market which can hurt patients more than they could help them, depending upon the drug and the unique circumstances.  Among the drugs cited as dangerous is Pradaxa, an anti-coagulant blood thinner taken to prevent blood clots and stroke.  However, this drug does not have a reversal agent, making it extremely dangerous to someone who may fall and hit their head.  Potentially, patients could experience fatal bleed outs as a result.

If eating healthy could prevent the need for potentially deadly medications, shouldn't it at least be a consideration for heart patients?  For patients who have instead gone the route of medication, if you have suffered an injury as the result of your heart medication, you may be entitled to compensation.  Try calling a skilled product liability and personal injury attorney to discuss your case.