Vehicle owners across the nation can be instantly informed of a safety recall under a new automated alert system announced today by U.S. Transportation Secretary Mary E. Peters. The recall alerts can be received via e-mail or RSS-feeds on personal computers, cell phones or PDA devices-automatically and free-of-charge. This ability by the consumer to be directly contacted in the case of a recall is similar to the systems set-up for recalls of car tires and child safety seats.
According to the National Highway Traffic Safety Administration, there are about 600 vehicle recalls each year. Historically, one in four motorists … Read the rest
The U.S. Food and Drug Administration warned clinical test giant Laboratory Corp. of America Holdings that it was marketing OvaSure, an ovarian cancer test, in violation of the law in that it did not have marketing clearance or approval from the FDA.
OvaSure measures six proteins in blood samples and calculates the chances that the woman has ovarian cancer. LabCorp made the $220 test available in June, under a provision that exempts tests developed and offered by a single lab from the usual FDA review. Thus OvaSure did not go through an FDA review.
But in a letter dated September … Read the rest
The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drugs containing papain must stop manufacturing these products on or before November 24, 2008, and must stop shipping such unapproved products on or before January 21, 2009, or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses, including eye inflammation, cloudy vision, permanent loss of visual acuity, a serious drop in blood pressure and increased heart rate.
Ophthalmic balanced salt solutions are used to irrigate the eye … Read the rest
This is cool! Google Transit, a feature of the Google Maps online mapping service, provides point-to-point public transit trip planning. Google Transit will now allow travelers to access streamlined, regional trip-planning based on up-to-date schedule data across the subway, bus and rail systems, including walking directions for the beginning or end of the trip.
The new service will include transit services throughout the Metropolitan Transportation Authority (MTA) service territory including: New York City Transit, Long Island Rail Road, Metro-North Railroad, MTA Bus, Long Island Bus and Staten Island Railway, as well as other regional connecting services participating in the initiative, … Read the rest
The Insurance Institute for Highway Safety is a nonprofit, scientific and educational organization aimed at reducing loss on the nation’s highways, including deaths, personal injuries and property damage. Its research has divulged that in the year 2006 alone, 42,642 people died in motor vehicle crashes. In particular, they have found young adult and teen drivers to be at risk, especially drivers younger than the age of 18.
Teen drivers are at significant risk on the road because they lack both the judgment that comes with maturity and the skill associated with experience. In attempts of ameliorating this situation, the … Read the rest
The Consumer Product Safety Commission’s National Electronic Injury Surveillance System (NEISS) provides the agency and other federal agencies with critically important incident and injury information. More than 34 million consumer product-related injuries were medically treated annually from 2004 through 2006. Of these injuries, it is estimated that more than 13 million sought treatment at U.S. emergency departments.
Below are statistics from the 2007 NEISS Data Highlights showing Product Grouping/Estimated Number of Injuries:
1. Stairs, Ramps, Landings, Floors 2,324,938
2. Beds, Mattresses, Pillows 560,129
3. Bicycles & Accessories 515,871
4. Basketball 481,011
5. Chairs, Sofas, Sofa Beds 476,109
6. Football 455,193… Read the rest
Recent federal court filings in the Ortho Evra products liability litigation disclosed that Johnson & Johnson hid data from the FDA about their birth control patches’ side effects and failed to address flaws in the manufacturing process which could increase the risk of serious and potentially fatal problems.
The factual allegations were publicly released as part of the plaintiffs opposition to a motion by Johnson & Johnson to dismiss the claims of women injured by their birth control patch. The allegations include that Johnson & Johnson applied an apparently random correction factor of 60% to tests that measured the level … Read the rest
For several years the U.S. Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Now, a television advertisement for a heart stent, metal mesh devices that are used to prop open arteries after they have been cleared of blockages, has been scrutinized and attacked in an op-ed article for failing to adequately warn consumers about the potential dangers of receiving a stent, including a ruptured coronary artery. The ad does warn of heart attack and stroke.
The ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, … Read the rest
Last week was a busy week for New York’s Governor David A. Paterson on issues often written about in this blog – medical malpractice, dangerous drugs, defective toys and sexual predators using the internet. Some bills were signed, others introduced. The most ambitious of these was on the medical malpractice front, Governor Paterson proposed legislation that offers more transparency for patients and tougher professional discipline for physicians; enhanced infection control requirements will facilitate the prevention of and response to infectious disease transmissions. Part 1 will discuss this legislation, Part 2 the others. The information herein is set … Read the rest
A feature article in the March/April 2007 issue of the Columbia Journalism Review discusses and labels as an epidemic the pervasive role hospitals play in producing “feel good” stories that are essentially advertisements for themselves and feeding the stories to television stations that run the stories as purported health news on their local TV news programs.
The stories chosen tend to promote expensive specialties and procedures like bariatric surgery for obesity and gamma knife surgery for brain cancer at the expense of stories about less profitable diagnoses, like AIDS or pneumonia, care for the uninsured, or critical stories such as … Read the rest