About 85,000 Taxus stents are being recalled voluntarily by Boston Scientific because of possible defects. Of the 42 complaints received, 30 systems showed actual performance flaws generally thought to be the result of excess heat being applied during the laser welding stage during the manufacture of the product; 200 Taxus stents were recalled earlier this month. In a meeting with the FDA in...
The FDA's prime responsibility is to insure that the public is protected from unsafe drugs and medical devices. Recent studies suggest that the FDA is falling well short of it's goal. Even more surprising, these concerns have been raised from within the FDA itself.Today, the Union of Concerned Scientists released a survey noting that more than a third of FDA scientists said agency officials...
MRL, Inc. and FDA notified healthcare professionals of a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators because of an intermittent electrical connection that could result in failure, delay in analyzing the patient's ECG or failure to deliver expected therapy and resuscitation of the patient. A Class 1 recall occurs when there is reasonable probability that use...
Today's edition of The New England Journal of Medicine sheds light on an erroneous claim often made by medical malpractice insurance companies. The insurance community-- and the current administration--- has long claimed that high premiums are brought on largely by frivolous or unfounded litigation. Today's article should settle this issue once and for all.The NEJM (the world's most prestigious...
We have all read about rising health care costs. Insurance companies would have you believe the increase is due to high medical malpractice verdicts and unscrupulous trial lawyers. As a lawyer who specializes in medical malpractice litigation and takes pride in representing the injured, it was with interest that I read the front page story in today's Wall Street Journal (April 18, 2006).The...
A Senate Finance Committee found that a top FDA official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, according to an article in the New York Times. The device has been used since 1997 to treat epilepsy, and when patients began reporting improvements in mood, the manufacturer sought approval...
As if we needed convincing, here's more proof that dogs really can be man's (and woman's) best friend. An article in HealthDay News reports a new study showing that dogs can detect lung and breast cancer in breath samples.Here's an excerpt:"When we heard anecdotally that there was a device out there that might be able to detect cancer at its earliest stages, before it even shows up on an MRI...
The statistics over the last 20 years have remained fairly consistent: 3-5% of all prescription fills at retail pharmacies result in errors, or "misfills" as they are known in the pharmacy business. This means that for every 100 prescriptions that you or your loved ones have filled, it is a statistical fact that 3-5 of them will be dispensed with some kind of error. Sometimes the wrong drug is...
In the wake of the recent and too-numerous-to-count recalls of medical devices, the FDA announced on January 20, 2006 that it is launching a new program to transform and strengthen the way it currently monitors the safety of medical devices after they reach the market -- both new technology and existing products.The FDA Center for Devices and Radiological Health's (CDRH) Postmarket...
A story from the Denver Post talks about the non-profit group Colorado Citizens for Accountability and their battle to inform the public about medical malpracticeand tort reform. Founded by Patty and David Skolnik, whose son was diagnosed with a brain cyst. Only after he was operated on did the family find out that the doctor who performed the surgery had pending malpractice suits in other...
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