An expert panel commissioned by Guidant Corporation to assess its handling of problems with cardiac medical devices cited the company for failure to properly assess patient safety. The commission noted that Guidant’s decisions were guided by statistical projections provided by engineers rather than
Northfield Laboratories has come under heavy criticism for the unorthodox manner in which it is testing its new blood substitute PolyHeme. However, it’s not the substitute itself that has caused the uproar. It’s the fact that the 31 hospitals around the country participating in the study have failed
Florida police officers would be required to take four hours of training before using the Taser stun gun under HB 303 which was unanimously approved by the Florida House Criminal Justice Appropriations Committee. Presently, no training is required. The training requirement bill surfaced after many p
In a hastily called briefing for Congressional staffers, authorities at the James A. Haley VA Center in Tampa announced that an unsterilized cranial implant was placed into a patient last month. The mistake was nearly duplicated a few weeks later at the same hospital. The hosptial officials waited n
Doctors who had been heavily courted by Merck, the manufacturer of Vioxx, are now some of the drug’s most outspoken foes. In the ongoing Vioxx trial, doctors have come forward and testified that if they had been told of the potential risks the drug posed, they would never have prescribed the drug to
According to a report published in the NY Times, Guidant Corporation has issued a warning to doctors about possible battery defects in two of its implantable defibrillator devices. The devices in question, the Contak Renewal 3 RF and Renewal 4 RF cardiac defibrillators, have not been implanted in an
Armed with a $650,000 grant from the Department of Justice, two University of South Carolina research professors will undertake a study of the controversial Taser stun gun. The study will focus on the weapon’s safety as well as its ability to reduce injuries to police officers and suspects. The stud
Senate Judiciary Committee Chairman Arlen Specter (R-PA) has introduced legislation that would toughen penalties for companies and their executives who sold products that cause injury or death. Presently, there are only civil penalties for such behavior. In announcing the legislation, Specter single
A Guidant Corporationconsultant told the medical device company that it had an ethical obligation to inform doctors of defects in its defibrillator device. Dr. Richard N. Fogoros, also told company executives that their decision to withhold such data, while statistically defensible, was questionable
A California judge has dismissed Taser International’s Motion to Dismiss in a lawsuit arising from a 2004 death of a Monterey CA man who had been tasered. Taser International, Inc., asked the district court to dismiss the claims of the Rosa family, contending that (1) Michael Rosa’s death was not re
An FDA panel has recommended that the risky and controversial MS drug Tysabri be returned to the market. The panel argued that the decision to use the drug should be made by the doctor and the patient, in spite of evidence that the drug causes a deadly brain disease. If the FDA accepts the panel’s r
You’ve all seen the ads for the popular sleep aid Ambien. Yet, behind this popularity is a little known fact: the sudden rise in Ambien related impaired driver arrests. Some of those arrested state that they have no recollection of driving a vehicle prior to the arrest. In some state toxicology labo
