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.

One of the things that I neglected to mention in yesterday’s blog post about priest sexual abuse of minors is the disturbing aspect of the abuse in the Diocese of Pensacola-Tallahassee. Fr. Vijay Godugunuru, a visiting priest from India, was charged and convicted of a sexual offense against a minor. He was ordered deported from the US, his passport was confiscated, but Indian authorities were not notified. In other words, who’s protecting children from this sexual abuser back in India? As far as I know, no one knows about Fr. Vijay and his molestation of a minor in the United States. Children in India should be afforded the same protection as those in the US.

I just completed a three day road trip during which I filed three lawsuits against the Dioceses of Pensacola-‘Tallahassee, St. Augustine, and Orlando. While the venues were dissimilar, the circumstances of each abuse tale were somewhat similar. A priest had ingratiated himself into the lives of devout Catholic families, targeted an unsuspecting minor, and attacked when the child was most vulnerable. One of the tragic cases occurred two years ago while another happened over fifty years ago. The one constant between these two cases remains that lives were shattered, faith lost, and justice was not served.
Priest Abuse Lawyer
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