Grandfather Clause Left Gaping Loopholes in Regulation of Medical Devices

Most medical devices have never been shown to be safe or effective. The US Food and Drug Administration have promised for years to subject some of the riskiest devices to a rigorous review.

The agency has failed to adequately regulate medical devices leaving certain types of devices already on the market approved for sale with less stringent reviews until the F.D.A. would require them to pass a more rigorous test. Consumers responded that the agency was failing to protect the public, and the industry groups acknowledged that the system was flawed in many different areas.

The agency has turned … Read the rest

Lack of Consumer Response Prompts Unusual Re-announcement of Recall of Dehumidifiers That Have Caused More Than One Million Dollars in Property Damage

Initially recalled in December of 2009, yesterday LG Electronics Tianjin Appliance Co., in cooperation with the U.S. Consumer Product Safety Commission (CPSC), urged consumers to check if they have Goldstar or Comfort-Aire dehumidifiers.

The firm is re-announcing the recall of these dangerous products because only two percent of the 98,000 consumers who purchased these units have received a free repair, which means that consumers and their property remain at serious risk. The power connector for the dehumidifiers compressor can short circuit, posing fire and burn hazards to consumers and their property. The initial recall followed eleven incidents, including four significant … Read the rest

Criminal Charges Brought Against Driver of Tour Bus That Crashed in Bronx Returning From Mohegan Sun Casino On Same Day as State Inspector Generals Report Released

The driver of the tour bus that crashed into a highway sign post on I-95 in the Bronx, killing 15 people and injuring seven others on March 12, 2011, has been charged with 15 counts each of second-degree manslaughter and criminally negligent homicide, plus reckless driving, assault and third-degree unlicensed driving.

Ophadell Williams, Jr. plead not guilty, and his bail was set at $250,000. Alsolast Thursday, New York State Inspector General Ellen Biben today released an investigative report that found the bus driver was able to exploit weaknesses in the state regulatory system and obtain a commercial bus driver license … Read the rest