The Shaked Law Firm…the whole philosophy about the firm is aggressively taking your case from day one and getting it resolved as fast as possible, trial lawyer not a settlement lawyer. We try cases and we do it hard, and we work hard for you.
When you come to my firm, you’re getting individualized attention. From day one, you’re going to speak to me or speak to another attorney. We’re going to give you our cell phone number. We’re always available. We’re not just going to shoot you off to a paralegal.
To me, anyone who’s involved in a bike accident, has a motorcycle accident, even a bicycle, it’s near and dear to my heart. I try those cases. I like helping people.
Video originally created by FDA -- posted by Lawsuit.com on February 4th, 2010
FDA is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or arrhythmias.
The manufacturer, Cardiac Science Corporation, has received multiple complaints that these devices have malfunctioned, and that their self-test features may not show that there’s anything wrong. Before each use, operators are supposed to check for a green light on the front of the AED that shows the device is rescue-ready. But the light may come on even when certain electronic components inside the device have failed.
Malfunctions could cause these AEDs to interrupt ECG analysis and thus prevent shock delivery, or fail to recognize that the pads have been placed. Malfunctions could also cause interference or background noise, which could prevent the device from accurately analyzing heart rhythm and delivering a shock.
About 300,000 Cardiac Science G3 series Powerheart and CardioVive AEDs are affected by this problem worldwide. They were manufactured between August 2003 and August 2009. FDA recommends that users contact Cardiac Science Corporation immediately to arrange for repairs or replacement.
Until the company repairs or replaces the affected devices, FDA recommends that users switch to alternate AEDs if they are available, or that they consider obtaining another AED. If an alternate AED is not available, trained responders should use manual defibrillators. If a manual defibrillator is not available, responders should use the Powerheart or CardioVive AEDs, since they may still be able to deliver the necessary shock.
In the home or in public places, FDA recommends continuing to use these devices if an alternate AED is not available. That’s because the consequences of not trying to defibrillate a patient outweigh the risk that the AED may fail.
FDA is gathering more data about this situation, and as we learn more, we will share any new information that might affect the use of these AEDs.
Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
GlaxoSmithKline is alerting healthcare professionals about the dangers of reconstituting Relenza (zanamivir) Inhalation Powder into a liquid and using it in a nebulizer or mechanical ventilator. The powder, which is used in the treatment and prophylaxis of influenza, is only intended to be inhaled using a Diskhaler.
In a recent letter, the company notes that some practitioners have dissolved Relenza Inhalation Powder in various solutions. Using a mechanical ventilator, they then delivered the drug in nebulized form to patients who could not take oral influenza medications or could not inhale the drug using a Diskhaler.
The letter describes the death of a pregnant woman with influenza who was treated with Relenza Inhalation Powder that had been solubilized and administered by mechanical ventilation. The patient’s death was attributed to obstruction of the ventilator, possibly from stickiness caused by lactose in the Relenza Inhalation Powder.
The letter reminds practitioners that the safety, effectiveness and stability of Relenza Inhalation Powder have not been established for nebulization, that this use has not been approved by the FDA, and that this drug should only be administered using the Diskhaler device that comes with it.
Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
Qualitest Pharmaceuticals is recalling all lots of AccuSure insulin syringes because the syringe needle may detach from the syringe. If that happens, the needle could get stuck in the insulin vial, or get pushed back into the syringe, or even stay in the skin after injection.
The recalled AccuSure insulin Syringes were distributed to wholesale and retail pharmacies nationwide between January 2002 and October 2009. Anyone who has AccuSure insulin syringes should stop using them. For more information , call Qualitest at 1-800-444-4011.
Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
Pointe Scientific has recalled certain lots of its Liquid Glucose Hexokinase Reagent. These reagents have failed to produce accurate results at glucose values above 200 mg/dL. A list of the affected lot numbers can be found below. The company is instructing distributors and testing laboratories to destroy any of the recalled products that remain in their inventories. Laboratories should consider all test results obtained with the recalled reagents to be questionable and consult with the patient’s physician about whether re-testing will be required.
