Monthly Archives: February 2008

FDA Rejects Injectable Zyprexa

The U.S. Food and Drug Administration refused to approve a request by Eli Lilly and Co. to approve a long action injectable version of the schizophrenia drug Zyprexa. The FDA was concerned that injecting the drug could case dangerous excessive sedation. Zyprexa and a related drug Seroquel which is made by Astra Zeneca are both the subject of many injury lawsuits on behalf of consumers who developed diabetes. The manufacturers of Zyprexa and Seroquel downplayed the risk of diabetes to increase sales of these very profitable drugs. Many Zyprexa and Seroquel users are at greater risk of diabetes due to their mental challenges and Eli Lilly and Astra Zeneca knew of this predisposition.

Baxter Recall All Heparin as Death Toll Climbs

Baxter International has announced that it is taking all of its heparin supply off the market just as the FDA is reporting that the number of deaths associated with the bad heparin has risen from 4 to 21. The FDA has inspected the proper Chinese plant this time but still has not been able to determine the exact cause of the heparin problem. However, a redacted report from the FDA indicated the plant’s failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment.

FDA and Consumer Safety

There’s a great deal of media attention as well as Congressional scrutiny concerning the safety of drugs, medical devices, and food stuffs, all of which are supposed to be monitored by the FDA. In an interview with the Wall St. Journal, Dr. Andrew von Eschenbach, FDA chief, admitted that the federal agency is understaffed and woefully underfunded. An outside agency has said that the FDA needs 150% added to its budget in order to begin to do its job effectively. At the same time, China has weighed in on the heparin debacle by stating that it’s really not their responsibility to ensure the safety of the drugs they export. Rather, the responsibility lies with the countries that import their drugs. This is ludicrous but that’s the state of affairs with China. To make matters worse, the Supreme Court has given ultimate authority to the FDA over Class III medical devices, such as Medtronic’s Sprint Fidelis cardiac defibrillator. This adds up to a nightmarish situation for consumer product and drug safety in this country.
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Pfizer Pulls Jarvik Lipitor Ad After Congressional Scrutiny

After facing a Congressional hearing and increased public scrutiny, drug manufacturer Pfizer has decided to stop using Robert Jarvik as its pitchman for the cholesterol lowering drug Lipitor. While Jarvik is best known for developing the artificial heart, he’s never practiced medicine and is not a trained cardiologist. The Lipitor ads mention that Jarvik is a doctor without mentioning that he’s never practiced medicine, a problem for Rep. John Dingell (D-MI) who sent letters to Pfizer and the FDA complaining that Jarvik’s not so subtle message could mislead patients about Jarvik’s actual qualifications. This is a positive move for consumer safety and it demonstrates that big pharmaceutical companies can succumb to public pressure to do the right thing. Often, these drug companies are more concerned about their profits than public or consumer safety. That’s my concern with the recent Supreme Court ruling authored by conservative justice Antonin Scalia. The ruling bars civil liability claims involving Class III medical devices that have been approved by the FDA. According to the ruling, such claims, under the premarket approval process (PMA), are preempted by federal law. Essentially, this means that consumer protection has been forfeited by the ruling. Even the FDA used to believe that that ability to bring civil liability claims in state courts kept the medical device manufacturers honest and more accountable to the public. The Supreme Court, with its pre-emption ruling, puts consumer safety behind big business and corporate profits.

New Scientific Study Links Kava Kava to Liver Damage

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.

Florida Accident Lawyer

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)
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Saunders & Walker Accident Attorney Florida accident on I-4 information page Tampa Florida I-4 Accident Page

Trasylol’s Deadly Dangers

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.
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Supreme Court Ruling Restricts Lawsuits For Medical Device Injuries

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.

Criticizing the FDA

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.

FDA Inspects Wrong Plant in Heparin Fiasco

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?

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