As a result of broken leads in its Sprint Fidelis defibrillator, Medtronic is facing two class action lawsuits-one has been filed in Puerto Rico and another in Canada. The Sprint Fidelis broken lead wires have been linked to 5 deaths as a result of excessive or improper shock delivered to the heart. The defibrillator is supposed to jolt the heart if its rhythm becomes uneven, too rapid, or too slow. The Sprint Fidelis sometimes works when it is not needed and on other occasions it doesn’t send the electrical jolt to the heart.

Two years ago, impotence drugs such as Levitra, Viagra, and Cialis were linked to vision loss in some patients. Now, the PDE-5 inhibitors or erectile dysfunction drugs have been associated with hearing loss in some patients. The studies which showed the link between hearing loss and the administration of Levitra, Viagra, and Cialis prompted the FDA to add a warning to the label of these drugs.

Medtronic’s Sprint Fidelis defibrillator, which has drawn scrutiny because of the potential for lead fractures. The leads connect the defibrillator to the heart and are causing the defibrillator to deliver unnecessary and massive shocks, emit a beeping sound, or to not operate at all. The young may be more affected by this defect since they tend to lead a more active life and such activities may increase the risk of lead fracture. On October 15, 2007, the FDA urged Sprint Fidelis defibrillator patients to contact their physician immediately if they experience multiple shocks, lightheadedness, fainting, or palpitations.

Byetta, Eli Lilly’s diabetes drug may be linked to a fatal form of pancreatitis, according to the FDA. The government agency is warning doctors and health professionals of the possible link. Byetta has been used by 70,000 patients since coming on the market. If you’re taking Byetta or have taken Byetta, you need to be aware of the symptoms of pancreatitis which include severe abdominal pain, nausea, vomiting, diarrhea, upper abdominal pain, and indigestion. The pain associated with pancreatitis is persistent and acute.

Medtronic has called on doctors to stop using its implanted heart device, the Sprint Fidelis because of a defect in one of its leads. The lead which connects the heart to a defibrillator, is supposed to send an electrical pulse to shock the heart back into a normal rhythm. However, the defective lead is not doing that. Medtronic is asking that all 235,000 Sprint Fidelis patients contact their cardiologists to make sure that the device has not developed a crack which causes it to misread cardiac rhythms. The consequences of this defect can be fatal and have been in five cases. The Sprint Fidelis has been on the market since 2004 and most patients who received a Medtronic defibrillator have the Sprint Fidelis.
It appears Medtronic may have learned a lesson from Guidant Corp. in disclosing the defect fairly early on. Three years ago, Guidant knew of a defect in its defibrillators but delayed informing doctors. The fallout from that debacle may have spurred Medtronic to make a quicker, more proactive response.

Gadolinium is used as a prescription dye to enhance magnetic resonance imaging (MRI) and has been linked to nephrogenic systemic fibrosis, a debilitating and sometimes fatal disease that affects the skin, muscle, and internal organs. According to the boxed warning required by the FDA, the contrast dye can cause problems for those patients with acute or chronic severe renal insufficiency. The following are symptoms of nephrogenic systemic fibrosis (NSF):
For the skin—burning or itching, reddened or darkened patches; and/or skin swelling, hardening and/or tightening
For the eyes—yellow raised spots on the whites of the eyes
For the bones, joints and muscles—joint stiffness; limited range of motion in the arms, hands, legs, or feet; pain deep in the hip bone or ribs; and/or muscle weakness

Auto accident lawyers in Tampa Bay with whom I’ve spoken about PIP see its revival as a mixed blessing. On the one hand, it’s good that those who have no health insurance have some sort of coverage in the event of an auto accident. However, Florida’s auto insurance laws still do not require drivers to purchase bodily injury liability coverage. This is important especially in case of a serious accident where the medical bills exceed the required PIP insurance of $10,000.

Earlier this year, ConAgra had to deal with a peanut butter contamination problem. Now, the problem has arisen again with its Banquet pot pies manufactured in ConAgra’s Missouri plant. The pot pies have been linked to salmonella contamination. So far, there have been 139 cases of salmonella tainted pies in 30 states. In spite of ConAgra’s statement that the pies are safe if cooked properly, the federal government has warned consumers not to eat them until the investigation is completed.

Under increasing pressure and mounting evidence, safety experts for the FDA have urged the governmental agency to ban multi symptom cold medicines for children under 6 years of age. The call comes in the midst of evidence that such medicines are ineffective in alleviating the symptoms of colds and may be dangerous to children, especially if abused or administered in too large or strong a dosage. Of course, such large pharmaceutical companies who have a large financial stake in such products, have opposed the move.

In a move that is sure to raise eyebrows among consumer safety advocates, the FDA is considering making certain drugs available to consumers without prescriptions. Essentially, the move would cede control over certain drugs to pharmacists who would screen patients for safety and dosing issues. However, with such recent drug safety problems evidenced in Zyprexa, Avandia, Vioxx, Bextra, and Zelnorm, this seems to be a curious move by the FDA.