A Nevada Judge substantially reduced a Prempro and Premarin judgment a jury awarded to three women who charged that the Wyeth drugs caused their breast cancer. But the $58 million award still stands as the largest personal injury award in Nevada history, and it is the largest award to date against Wyeth, which faces about 5,300 other Prempro and Premarin lawsuits across the country in state and federal courts.

ANevada jury had originally ordered Wyeth to pay the three women $134 million after finding that Prempro and Premarin caused their breast cancer. But Washoe County District Judge Robert Perry granted Wyeth’s motion to find the damages excessive. He ordered them reduced to about $58 million total. In his ruling, Judge Perry said he was concerned that “passion and prejudice” had inflated the original award. (more…)

Activis Inc. has recalled 14 lots of its Fentanyl transdermal pain patches because of fentanyl overdose fears.  The action comes less than a week after Johnson & Johnson recalled some of its defective Duragesic Pain Patches.

According to the Food & Drug Administration (FDA), the 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal. The FDA has warned that the affected patches should not be handled directly. Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1- 877-422-7452. Patients using fentanyl patches who have medical questions should contact their health-care providers. (more…)

A worker at the The Alon USA refinery near Big Spring, Texas was injured in explosion  this morning.  The Alon USA refinery explosion also resulted in the evacuation of a one mile area around.

All workers of the Alon USA refinery have been accounted for, and the fire from the Alon USA refinery explosion is reportedly under control. The worker injured by the Alon USA refinery explosion was transported to a Lubbock hospital, according to Midland television station KWES, but the condition of the worker is not known. (more…)

The Food & Drug Administration (FDA) wants to loosen rules for the off-label marketing of drugs and medical devices. In the past, drug and medical device makers were permitted to provide doctors with copies of medical journal articles that discuss off-label uses of their products. However, that rule lapsed in 2006. Now, the FDA wants to not only renew the off-label marketing rule, but loosen it even further.

In 1997, Congress created a temporary exception to the off-label marketing ban by allowing drug makers and medical device companies to distribute reprints of peer-reviewed research from reputable medical journals that discussed off-label uses to physicians. Drug makers and medical device manufacturers were able to do so long as they submitted the articles to the FDA for advance review and had formally asked the FDA to approve the new use described in the journal article. That law expired, and Congress never bothered to renew it. (more…)

The largest beef recall in US history was issued this weekend, following the release of undercover video showing that the Hallmark/Westland Meat Packing Company violated federal rules regarding “downer cattle”.  According to the US Department of Agriculture (USDA), the Hallmark/Westland beef recall involves143 pounds of meat – including some sold to the National School Lunch Program. Downer cattle are at a high risk of contracting E. coli, Mad Cow Disease and other illnesses that can be passed on to people who eat contaminated beef. The Hallmark/Westland Meat Packing Company beef recall is by far the largest meat recall ever issued in the US.

The USDA said it had evidence Hallmark/Westland did not routinely contact its veterinarian to check on downer cattle, which violates health regulations. Federal regulations call for keeping downed cattle out of the food supply because they may pose a higher contamination risk from E. coli, Mad Cow Disease or salmonella. In most cases, beef from downer cattle is barred from the food supply. The rule was adopted as a safeguard against Mad Cow Disease, a deadly, brain-wasting illness. People can contract a version of the disease by eating tainted products. The USDA said there are many other safeguards against Mad Cow, and so far, no illnesses have been linked to the recalled beef. (more…)

More Polaris All-Terrain Vehicle (ATV) have been recalled due to a defective Electronic Control Modules (ECM) which could fail and overheat, causing a fire hazard.  This latest recall icludes nearly 50,000 more defective Polaris ATVs, and doubles the number of defective Polaris vehicles recalled since 2005, and now includes near 100,000 ATVs. The original Polaris ATV recall included about 61,000 vehicles.

According to the CPSC, since the original Polaris ATV recall announced in June 2005, Polaris has received 372 additional reports of smoking and/or melted ECMs on the recalled ATVs, and 20 reports of fires, nine of which involved property damage beyond the ATV. No injuries have been reported. (more…)

Trasylol should have been off the market much sooner, according to one researcher who brought the defective drug’s problems to the attention of the Food & Drug Administration (FDA) in 2006. Trayslol, manufactured by Bayer AG, was taken off the market last November, after a Canadian clinical trial was halted due to a high rate of Trayslol deaths.

In September 2006, Dr. Dennis Mangano presented a study he authored to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death. Mangano told the TV program“60 Minutes” the he believes Trasylol should have been taken off the market when he published his study in 2006. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month.” Trasylol is a drug used to prevent bleeding during heart bypass surgery, and before it was removed from the market, about a third of all bypass patients had received Trasylol. (more…)

The Vytorin congressional investigation is now focusing on postings to message boards on the website Cafepharma.com made by pharmaceutical sales representatives in 2007. These postings indicate that their authors were already aware of the ENHANCE study results which showed Vytorin was ineffective. ENHANCE was released last month, but the Vytorin study was finished nearly two years ago.  The delay in releasing ENHANCE has raised suspicions that Vytorin makers Merck and Schering-Plough new Vytorin was ineffective, but kept it secret.  Executives from both companies have maintained that they did not learn about the ENHANCE conclusions until the study was officially released in January.

The Cafepharma.com postings that have caught attention of congressional investigators where made in 2007, months before Merck and Schering-Plough released ENHANCE. One set of postings from March 2007 states “have a buddy at (Schering-Plough Research Institute). He says that the study is a bust. Adding Zetia to already maxed out statin is useless.” Another from June 2007 said “heard it crashed and burned!” (more…)

All-Terrain Vehicles (ATV) accidents continue to take a tragic toll – especially on children. According to the Consumer Products Safety Commission (CPSC), ATV accidents killed more than 500 people in 2006 and of those victims nearly 1 on in 5 was a child. What’s more, defective ATVs like the Yamaha Rhino ATV sent 146,600 people to hospital emergency rooms that same year.

In its annual report being released Thursday, the CPSC said Pennsylvania has had the highest number of reported ATV deaths since 1982, followed by California, West Virginia, Texas and Kentucky. Every state had at least one death attributed to ATVs. And the CPSC expects the ATV accident problem to only get worse. The agency is still gathering data as far back as 2003. The report updates CPSC data with numbers from 2006, the latest year that agency staff have analyzed. In 2005, there were 666 confirmed deaths related to ATVs, and CPSC estimates that the toll for that year could reach 870. (more…)

Gulf Coast residents still living in Federal Emergency Management Agency (FEMA) trailers need to be out of the toxic structures no later than summer, federal health officials said yesterday. The urgent plea came from the Centers for Disease Control (CDC) after tests it conducted found extremly high levels of formaldehyde in the toxic FEMA trailers that still house thousands of Gulf Coast Hurricane victms.

Formaldehyde is an invisible gas that is known to cause cancer. It can also cause other illnesses ranging from nose bleeds to chronic bronchitis. Commonly used in manufactured homes, formaldehyde can cause respiratory problems and has been classified as a carcinogen by the International Agency for Research on Cancer and as a probable carcinogen by the U.S. Environmental Protection Agency. The CDC testing found that residents of the toxic FEMA trailers were being exposed to at least five times the level of formaldehyde found in typical homes. In the worst FEMA trailers, formaldehyde levels were nearly 40 times customary exposure levels, raising fears that residents could contract respiratory problems. (more…)