Monthly Archives: November 2010

Latest News

Thousands may need revision surgery to replace bad artificial hip

Thousands of the 93,000 people who received artificial hips made by DePuy Orthopedics will have to have surgery to have their implants replaced because the products can dislocate, come loose, or cause bone fractures. The affected parts include the ASR XL Acetabular System and the ASR Hip Resurfacing System, both made by DePuy Orthopedics, a subsidiary of Johnson & Johnson. Most hip replacement systems can last up to 35 years with a failure rate of about 12 percent. However, studies show that DePuy artificial hips have the same failure rate in just five years after being implanted. The defective implants ... Read More

Historical food safety bill passes Senate

The U.S. Senate today passed a sweeping overhaul of the country’s food safety system, a move triggered by the steadily growing number of food-borne illness outbreaks occurring throughout the country. If signed into law, the Food Safety Modernization Act will strengthen the Food and Drug Administration’s powers to prevent contaminated foods from entering the nation’s food supply. Consumer advocates, safety experts, and a number of bipartisan legislators pushed for the overhaul, which will affect about 80 percent of the nation’s food supply, including fresh fruits and vegetables, eggs, dairy products and processed foods that do not contain meat. Meat supplies ... Read More

Study on HIV drug halted as World AIDS Day gears up

Merck announced it will end a study of its HIV drug Isentress after early results showed that a once-daily treatment was less effective than the currently approved twice-daily dosage. The once-daily version would have been a convenient option to HIV-positive patients who generally take several drugs throughout the course of a day. The news comes just as World AIDS Day gears up for its annual awareness day December 1st. Isentress was approved by the Food and Drug Administration (FDA) in 2007, and was the first of a new class of HIV drugs known as HIV integrase inhibitors. The drug works ... Read More

Federal judge gives a green light to sudden acceleration lawsuits

A federal judge in Santa Ana, California dealt Toyota a major legal blow when he rejected the automaker’s petition to have all class-action lawsuits seeking damages related to sudden-unintended-acceleration (SUA) issues thrown out. Toyota argued that many plaintiffs did not state specific losses in dollars and that many of them did not experience any malfunctions that caused their vehicles to speed out of control and were suing on the basis of the loss in resale value. In his Nov. 19 ruling however, Judge James V. Selina said that specific damages are not required at this stage in the legal process ... Read More

Scientists say BP oil spill likely culprit in massive coral die-off

According to National Geographic magazine, scientists discovered a massive deep-sea coral die-off this month about 7 miles southwest of the site where BP’s blown-out well spewed millions of gallons of crude oil for months. Scientists who made the discovery said that vast communities of bottom-dwelling coral in the Gulf of Mexico were dead or dying under a strange dark substance. The damaged coral beds were found at depths of up to 4,600 feet. Scientific team member Timothy Shank of Woods Hole Oceanographic Institution told National Geographic that he’s never seen anything like it before. “When we tried to take samples ... Read More

Trucker hits and destroys a Pennsylvania bridge … again

A report in the Pittsburgh Post-Gazette demonstrates the considerable costs to society when commercial trucking companies fail to take industry rules and regulations seriously. On Thursday, the paper reported that a driver who ignored a sign on Interstate 70 just south of Pittsburgh and struck a bridge had a similar crash two years ago. The Post-Gazette reports that Tony D. Kyle, 49, of Cleveland, Texas, was driving west on I-70 in Washington County and failed to follow the directions of his Pennsylvania Department of Transportation-issued Special Hauling Permit, which instructed him to exit the interstate before the McIlvaine Bridge and ... Read More

FDA postpones decision to approve experimental MS treatment

The Food and Drug Administration (FDA) will take more time to decide whether to approve Merck KGaA’s Cladribine, an oral medication to treat relapsing forms of multiple sclerosis (MS). The agency had given the drug Priority Review status in July, which reduced the standard 10-month review process to six months. A decision was to have been made by Nov. 28, but the FDA voted to extend the review period in order to give a full review of additional information provided under the new drug application. If approved, Cladribine would be the first oral medication for MS. Cladribine was recently rejected ... Read More

Malfunctioning hearing devices recalled, may shock wearer

Cochlear implants used to provide a sense of sound to people who are profoundly deaf or hard of hearing are being recalled by the manufacturer because the devices may malfunction and cause recipients to experience severe pain, overly loud sounds, and/or shocking sensations 8-10 days after the device was activated. ... Read More

Clinical trials to begin on stem cell treatment for eye disease

The Food and Drug Administration (FDA) has cleared the way for clinical trials to begin on a therapy derived from human embryonic stem cells designed to treat children with a form of macular degeneration known as Stargardt’s macular dystrophy. This is the second clinical trial involving embryonic stem cells that has been approved by the FDA. Last month, a patient in Atlanta was treated in an FDA-approved clinical trial with a drug for people with spinal cord injuries. Stargardt’s macular dystrophy affects about one in 10,000 children. Patients typically begin to lose their central vision between the ages of 6 ... Read More

feds announce CSA 2010 changes after trucking industry feedback

The Federal Motor Carrier Safety Administration has announced revisions to its Comprehensive Safety Analysis (CSA) 2010 safety measurement program, the federal initiative designed to improve large truck and bus safety and reduce the number of commercial motor vehicle (CMV)-related crashes, injuries, and fatalities. Although the changes are minor, they were implemented in response to feedback from trucking professionals and worth noting, especially if you or your company has been directly affected by the new CSA 2010 rules. One of the changes to CSA 2010 involves placing an “alert” on a motor carrier’s score when it hovers just above the threshold for intervention in one ... Read More