A team of researchers from the University of Sydney, Australia published a study in the January 28, 2008 edition of the World Journal of Gastroenterology which supports earlier literature linking Kava to liver failure. The United State Food and Drug Administration (FDA) had issued a health warning for the risk of liver failure in 2002 but many health food, herbal remedy, and natural food stores have continued to sell the product in the U.S.A.
The new study entitled “Influence of kavain on hepatic ultrastructure” was an animal study in which rat livers that had been exposed to kava were examined with an electron microscope.
This study provides additional scientific evidence that will likely be used in personal injury and death lawsuits pending in the U.S. against the manufacturers and distributors of Kava products. This study also provides further evidence that could lead the FDA to issue additional warnings for Kava. It is not clear that the FDA has authority to order a drug recall for Kava because it is considered a food supplement under U.S. law. The FDA tried to do a drug recall for ephedra a few years ago and was reversed by the courts because ephedra was also classified as a food supplement
There have been a number of liver transplants and deaths associated with the use of Kava around the world.

Auto accidents remain the leading cause of death for Americans under the age of 34. Each year, 40,000 people lose their lives in auto crashes. The resulting psychological, economic, and physical toll places tremendous strain on families and individuals alike. If the accident is not stressful enough, the aftermath can be a nightmare dealing with issues such as medical treatment, car repairs, mounting hospital bills, lost time from work, and lost wages. Yet, the decisions you make during this stressful period can have lasting impact upon you and your family. Florida Accident Lawyers
If you’re involved in an accident what should you do?
Call the Police immediately
Fill out an accident report thoroughly
Obtain names and phone numbers of witnesses
Seek medical treatment even if you feel ok at the scene (your adrenaline may mask a serious injury)
Florida Accident Lawyer
Saunders & Walker Accident Attorney Florida accident on I-4 information page Tampa Florida I-4 Accident Page

Trasylol, or aprotinin as it is known generically, had been on the market for 14 years to help stop bleeding in heart bypass surgery patients. The FDA approved Trasylol’s use in 1993 and it became popular among surgeons as a way to control bleeding and avoid transfusions. However, two studies in 2006 revealed serious dangers with Trasylol. Bayer which funded one of the studies hid the preliminary findings from a federal committee investigating Trasylol’s safety. In the study, the death rate among patients who were administered Trasylol was 64% higher than the control group.
Trasylol Recall Lawyer

A February 20, 2008 U.S. Supreme Court decision in Estate of Riegel v. Medtronic protects large corporations at the expense of injured consumers. Justice Scalia authored the Supreme Court decision handed down today that finds that civil liability claims involving Class III medical devices that have been approved by the FDA under the premarket approval process (PMA) are preempted by federal law. As a result, many lawsuits by injured consumers may be dismissed even though the device manufacturing company was negligent in causing the injury or death. This ruling will restrict some of the legal claims that have been made against Medtronic as a result of the defects in the Medtronic Sprint Fidelis heart device leads. However, there still may be some legal theories upon which these claims can be brought.
This decision does not apply to class II medical devices such as the Kugel Mesh Hernia Patches and the Stryker defective hip failure cases. It also does not apply to pharmaceutical drug liability cases such as Seroquel or Zyprexa. Nor does the decision apply to medical devices approved through the FDA’s 510(k) approval process.
I hope that the U.S. Congress will act to pass a bill to restore consumer rights. The combination of FDA approval and review as well as state consumer protection laws that has co-existed for many years has served as a double layer of protection of the public health. The Court decisions reduces consumers rights and remedies with respect to defective and dangerous medical devices marketed in our Country.

It’s always easy to pile one when someone is down. This is true for elected officials as well as government agencies. Currently, the FDA is under heavy scrutiny and criticism for harmful drugs, faulty medical devices, and even cosmetic products. While the scrutiny is warranted, unfair criticism is not helpful. Rep. Bart Stupak (D-Mich) has stated that a cancer has permeated the FDA and that the federal agency is doing very little to protect our drug and food supply. Stupak is leading the investigations into such drugs as heparin from Baxter International and Vytorin from Merck and Schering-Plough. He’s also leading the charge on a series of hearings on the safety of medicines, devices and imported food. Yet, a closer inspection underscores the reality that the FDA doesn’t have the resources to deal with the tremendous growth in the pharmaceutical industry as well as the myriad of food imports. Times have changed while the resources available to the FDA have remained stagnant. The FDA can’t possibly monitor the myriad of food stuffs, medical devices, and pharmaceuticals without adequate funding. I applaud the Congressman’s efforts to protect the consumer. I just don’t believe the FDA can do more without adequate resources. That’s the real issue.

It turns out that the FDA did inspect a Chinese drug manufacturing plant after all. It just wasn’t the plant manufacturing the active ingredient in heparin. If you haven’t been following this story, the plant where the active ingredient in heparin was manufactured has a similar name as the one the FDA inspected. Oh well, we could say mistakes happen, especially when you factor into the equation an overworked, understaffed FDA and a plant inspection that took place in China. However, people died as a result of the mistake and hundreds of others had adverse reactions to the heparin.
It’s scary to think that the FDA isn’t required by law to inspect such Chinese plants. The task would be impractical anyway. Yet, we don’t even know the number of foreign plants shipping pharmaceuticals into this country. How could we possibly inspect them or monitor them. It seems to me that this issue has risen to the level of a serious threat to the US. If our pharmaceutical supply can not be monitored for safety, how can we guarantee consumer safety and a decent quality of life?

When Chantix, Pfizer’s so-called smoking cessation drug, was brought onto the market, it was touted as a good method to quit the habit. However, Pfizer’s pre-marketing trials didn’t include 44% of the smoking population-those with diagnosed mental disorders such as schizophrenics and alcoholics. This month, the FDA has reported 34 suicides among Chantix users. Increased suicides have not been reported with other smoking cessation drugs such as nicotine-replacement therapies like gum, lozenges or patches, or with bupropion, marketed by GlaxoSmithKline PLC as Zyban or Wellbutrin.

It turns out that the FDA did inspect a Chinese drug manufacturing plant after all. It just wasn’t the plant manufacturing the active ingredient in heparin. If you haven’t been following this story, the plant where the active ingredient in heparin was manufactured has a similar name as the one the FDA inspected. Oh well, we could say mistakes happen, especially when you factor into the equation an overworked, understaffed FDA and a plant inspection that took place in China. However, people died as a result of the mistake and hundreds of others had adverse reactions to the heparin.
It’s scary to think that the FDA isn’t required by law to inspect such Chinese plants. The task would be impractical anyway. Yet, we don’t even know the number of foreign plants shipping pharmaceuticals into this country. How could we possibly inspect them or monitor them. It seems to me that this issue has risen to the level of a serious threat to the US. If our pharmaceutical supply can not be monitored for safety, how can we guarantee consumer safety and a decent quality of life?

The judge in charge of the Kugel Mesh hernia patch lawsuits has allowed for the expansion of claims against the manufacturer Davol, Inc. Essentially, the judge has ruled that legal claims may include hernia patches that did not contain an internal ring, but were made of a special bi-layered material similar to the Kugel Mesh patches. This means that if you have experienced abdominal pain, bowel adhesions, bowel obstructions or bowel perforations and have a hernia patch that was not recalled you may have a legal claim. The recall had only involved the Kugel Mesh hernia patch because its internal ring did not function properly.

The US Department of Agriculture has just announced the largest beef recall in the nation’s history. 143 million pounds of frozen beef has been recalled. The beef recall stems from beef manufactured at Chino, a California-based Westland/Hallmark Meat Co. The recall affects all beef dating back to February 1, 2006. The California company has provided beef to school lunch programs. According to the USDA, the company violated health regulations when it failed to contact veterinarians when cattle became non-ambulatory after passing inspection.
Westland has been under investigation for animal abuse after a Human Society video captured employees kicking, shoving, and shocking cattle too sick or crippled to enter the slaughterhouse. While Westland has not faced charges yet an investigation is ongoing. Two former employees were charged Friday. Five felony counts of animal cruelty and three misdemeanors were filed against a pen manager. Three misdemeanor counts — illegal movement of a non-ambulatory animal — were filed against an employee who worked under that manager. Both were fired.
Officials at the USDA estimate that 37 million pounds of beef have been transported to schools.
Sick or non-ambulatory cattle are deemed not appropriate for human consumption because they are more susceptible to mad cow, salmonella, and E. coli since the sick cattle tend to wallow in fecal matter.