Monthly Archives: October 2007

Medtronic Faces More Problems with Cardiac Implant

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 Poses Serious Kidney Dangers

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

Tampa Bay Car Accident Lawyers See Renewal of PIP as a Mixed Bag

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.

More Food Contamination Problems for ConAgra

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.

FDA Experts Seek to Ban Multi-Symptom Cold Medicines for Children Under 6

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.

FDA Considers Easing Restrictions on Prescriptions

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.