Colorado updates in category: Medical Malpractice

The FDA issued a warning to Medtronic, Inc. on Friday, September 29, 2006 regarding the delayed filing of a post market surveillance interim report on the AneuRx Stent Graft System. According to Medtronic, Inc. the letter is not related to the quality, design or manufacture of the product. However, the purpose of the Postmarket study is to make sure the device is appropriately labeled for use...

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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...

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Medical device manufacturer Cardiac Science Corp. received a formal warning from the FDA demanding that they correct safety procedures used to manufacture defibrillators. The automated external defibrillators (AEDs) are used in public locations such as government offices, sports stadiums, shopping centers and schools. They are designed to treat heart attacks by restoring healthy heart rhythms....

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The US Food and Drug Administration (FDA) and MRL, Inc (a Welch Allyn company), recently notified healthcare professionals about the class 1 recall of 1184 automated external defibrillators ([AEDs] Welch Allyn PIC 50, catalog #97108X) manufactured during February 2002 to October 2004; 673 units were sold within the United States.The recall occured because of an electrical contact problem that...

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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...

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Pharmacists and physicians belong to two of the most trusted professions in America. We routinely follow our doctors advice regarding drugs they prescribe and then trust that our pharmacists will correctly fill the order. Unfortunately, many times our trust is misplaced. Today the Institute of Medicine released a report noting that medication errors harm 1.5 million people each year. The...

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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...

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I read a story today about a Tacoma physician filing a medical malpractice lawsuit involving his wife's recent death. While you cannot make a good determination based on just what you read in the papers, it appears as if her death should have been prevented. We, of course, sympathize with the family and offer our condolences.Medical malpractice damage caps affect us all. I hope our legislators...

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Many of you have learned of recent problems associated with implantable cardiac devices. Guidant Corporation's implantable defibrillator has been associated with potentially fatal complications. As a result of negative publicity, Guidant created a panel to investigate complaints. The May 18 edition of the New England Journal of Medicine contains an early release of their findings. Of note,...

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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...

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The FDA and the National Institute for Occupational Safety and Health (NIOSH)issued a safety alert April 24, 2006, warning that 12 incidents have been reported in which regulators used with oxygen cylinders have burned or exploded, in some cases injuring personnel. Improper use of gaskets/washersin the regulators are a major factor in the ignition and severity of the fires, and FDA and NIOSH...

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A recent study by HealthGrades indicates that the most serious problem in U.S. hospitals is medical error. This study ranked hospitals in New York, New Jersey, Nevada, Tennessee and the District of Columbia as those ranking lowest in patient safety.For more information about the medical errors study...

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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...

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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...

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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...

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