FDA May Not Have Adequately Tested Heart Devices for Short-Circuiting, Physician Says
The Food and Drug Administration is about to approve the use of a new electrical component for heart device implants, but it may not have adequately tested the device for potential risks, said Dr. Robert G. Hauser of the Minneapolis Heart Institute in an article he wrote with Dr. Adrian K. Almquist, published in The New England Journal of Medicine.
The problem, Dr. Hauser says, is in the design of a new way of connecting defibrillators to the wires that carry high-voltage electrical volts between the units and the heart. Currently, the two high-voltage wires enter the housing of a device through separate, insulated channels. In the new design, they effectively enter together and are insulated in a different way. This could increase the risk of short-circuiting, which could prevent the defibrillator from giving an electrical jolt to restore an erratically beating heart to a normal rhythm.
The new design will also be used in cardiac resynchronization therapy units, which combine defibrillators and pacemakers.
The FDA reasons that the new wiring connectors are a design modification, and not new technology, so human testing is not required. Instead, producers must carry out mechanical stress tests of the new connectors, and study testing done in animals. The FDA will also require manufacturers to carefully monitor the performance of the new units once they go on sale and are implanted. But Dr. Hauser believes testing should be done before the devices have gone into many patients. “Let’s test it first, before we put it into tens of thousands of people,” he said.
The FDA said in a letter published on the New England Journal of Medicine’s website that the required mechanical and animal testing was adequate to determine the unit’s risks. “Sometimes, nonclinical studies can be more informative than clinical evaluation with regard to device safety and effectiveness,” said the letter. Medtronic, the leading maker of heard devices, said the method of testing the new connectors was the same as the procedure used to develop the models currently in use.
Medtronic had some problems with the adequacy of their testing in 2007, however, when it recalled a new electronic lead for defibrillators called the Sprint Fidelis. The FDA approved the lead in 2004 on the basis of stress tests and animal studies, rather than human trials. The new leads, however, began to fracture and fail at high rates, leading to the recall after 235,000 people had them implanted. Dr. Hauser was one of the first to note a problem with Fidelis.
Dr. Hauser was also one of two cardiologists to go public years ago about short-circuiting problems in defibrillators made by former Guidant Corporation, now Boston Scientific. Those problems resulted in at least six deaths.
FDA officials said they would require manufacturers to conduct post-marketing studies of patients as soon as the sale of the units begins. Dr. William H. Maisel, a heart device expert in Boston, said, “[m]y concern is that the FDA does not have a great history of performing post-marketing studies on a timely basis.”
Originally posted at InjuryBoard by Greg WebbFormer Doctor Suing HCA
A former doctor from West Virginia who is currently faced with dozens of medical malpractice suits has filed a suit of his own against the former Putnam General Hospital.
The suit filed by John King also names Hospital Corporation of America, the former owner of the hospital, among other defendants.
King claims that the hospital had been paying surgeons bonuses for processing patients more quickly. The suit also claims that his surgical privileges were lost as retaliation for not investing in a physician’s business.
The suit was filed in the U.S. District Court in Nashville, Tennessee, where HCA is based.
HCA is the largest for-profit hospital chain in the U.S. It and Putnam General have already paid millions in settlements over the malpractice suits.
Originally posted at InjuryBoard by Ben GlassPermanent Eye Injury from Unacceptable Treatment
A medical malpractice suit has been filed in Illinois by Traci Woolfolk against Dr. Wen Chen, alleging that during treatment of her eye issues he deviated from the acceptable standard of care.
According to Woolfolk, on July 18, 2006 she was treated by Chen for uveitis in her right eye. She claims that he treated her with a steroid cortisone injection and sulfa eye drops, a treatment which continued until November of 2006.
Uveitis is an inflammation of the middle layer of the eye. It is estimated to cause ten percent of the cases of blindness in the U.S.
Woolfolk’s suit was filed in the Circuit Court of Madison County, Illinois on July 14.
In court papers, Woolfolk alleges that prior to her treatment she informed and reminded Chen of her allergy to sulfa.
According to Woolfolk, through his careless and negligent administering of a steroid cortisone injection into her right eye, despite knowledge that it would cause or contribute to ocular hypertension in her right eye, Chen disregarded his duties as a reasonably prudent ophthalmologist.
Woolfolk also claims that Chen negligently administered sulfa eye drops despite knowledge of her allergy, failed to diagnose episcleritis, and failed to properly listen to and review history which would have revealed her history of steroid responsive ocular hypertension.
According to Woolfolk, she suffered severe and permanent injuries that resulted in a permanent drooping eye lid, sustained ocular hypertension and episcleritis, and intermittent headaches because of Chen’s negligence. She seeks damages in excess of $100,000 plus costs.
Originally posted at InjuryBoard by Ben GlassCar or Truck Personal Injury Accidents: Never Overlook The Separate Insurance on the Trailer Towed Behind The Primary Vehicle
In Trailer/Towed Vehicle Accidental Injury Case, The Separate Insurance on the Trailer Behind The Primary Vehicle May Provide Further Insurance Coverage
The question a personal injury lawyer must investigate is exactly how many possible insurance sources apply to provide full compensation for a client who suffers personal injury or a wrongful death, especially if any trailer was being towed and was involved-whether being used by the victim, or the negligent driver.
In a case I handled in the 90's, my client was operating a tractor trailer unit and was in a collision with a car at a red light controlled intersection. The driver of the car was at fault and my client suffered a
