Defective Drugs

March 10, 2010

Closed IV Catheter Systems Recall

Millions of Becton, Dickinson and Company catheter systems are involved in a recall because of a defect in the product that may result in injury or death to a user. The direct flaw of the catheter system involves the risk of an air embolism and leakage of blood or therapeutic fluids. These risks pose an additional risk of serious injury or death.

Becton Dickson received reports that air was entering through the septum disk. Catheter system failures were reported on units that were distributed from November 2009 to November 2009.

Catheters are used in hospitals to treat a variety of medical conditions, including, but not limited to:

March 3, 2010

NSF Sparks the Need Know Your MRI Contrast Dye

by Burton A. Padove

NSF, also known as nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy, has been linked to a gadolinium-based contrast agent that has been used in 200 million MRI procedures. Dating back to 2006, investigative authorities and Omniscan, the manufacturer, had begun to receive reports of nephrogenic systemic fibrosis in people that were given the gadolinium-based contrast agent during their MRI. Later, studies have documented that gadodiamide intoxication can build in years over time. The studies also noted that loss of renal function increases the severity of NSF. Researchers have not been able to fully identify the clinical, biochemical and pharmacological factors that relate to NSF and gadolinium contrast dye. However, it is clear that the key ingredient, namely gadodiamide, is responsible for producing NSF in patients that used this contrast dye for their MRI.

NSF is a painful debilitating disease that cannot be easily treated and may result in a slow painful progression to death. People with NSF are known to suffer from skin death that may encompass the body including: fibrosis of the diaphragm, muscles, abdomen and lungs. The skin may thicken as well. People with NSF may suffer from joint dysfunction and connective tissue disorders which can limit their mobility. People with NSF may also suffer from kidney impairment.

The manufacturers Bayer Healthcare, Bracco, Covidien, GE Healthcare and Mallinckrodt have all produced gadolinium contrast dye. It is not known how many of the 200 million people that have been administered the contrast dye is affected by NSF. However, there are a high number of reports of serious injury and death due to gadolinium related NSF.

March 1, 2010

Avandia, Heart Attack and Diabetic Emacular Edema Don’t Mix

by Burton A. Padove

Diabetics taking Avandia may not be aware of the risk of heart attack and emacular edema. However some Avandia users have suffered the injury of cardiac arrest and emacular edema due to the use of the drug. Avandia is also sold as Avandaryl (rosiglitazone maleate and glimepiride), and Avandamet (rosiglitazone maleate and metformin hydrochloride), which all contain rosiglitazone, and Actos (pioglitazone hydrochloride), Duetact (pioglitazone hydrochloride and glimepride) and Actoplus met, which all contain pioglitazone. The manufacturers have strengthened the warnings about the drugs on the drug labels, but this does not improve the outlook for those who are injured or will be injured by Avandia. There have been reports of death following cardiac arrest with a link to Avandia. There have been reports of diabetics suffering from emacular edema of which has been successfully treated.

Symptoms that display the risk of heart failure include:

Rapid weight gain

February 24, 2010

Lawsuits and Drug Side Effects

by Burton A. Padove

When you go to a physician and they prescribe a medication, do they review drug side effects with you? Maybe, maybe not. Physicians are dedicated to protecting your health. Yet, this does not mean that they fully educate you about the drugs that you are taking. They are there to diagnose medical conditions, offer treatment options and alternatives to treatment. They are obligated to tell you about any complications you may experience from proposed treatments. However, they may not fully prepare you for the list of side effects that are associated with proposed medications. It’s often the pharmacist that reviews drug side effect risks and reviews your history to ensure that the drug you are supposed to take will not adversely interact with the drugs that you are currently taking. Some may say that the pharmacist has become part of the check and balance system in healthcare.

For this reason, lawsuits involving drug side effects are not usually considered medical mal practice. Lawsuits involving drug side effects are often considered defective drug liability cases. The validation of legal cases involving drug liability is determined by several factors. One factor relates to the informed consent process. Information about the drug’s side effects is presented in the package insert of the drug, on the manufacturer’s website and in advertisements that appear on television, radio or in print.

It is important to note that new drug side effects may be uncovered after a new drug filters through the mainstream population. Manufacturers gather reports from individuals that have suffered from new side effects. The FDA may receive reports from people that have suffered new side effects. At this time, the manufacturer and the FDA attempt to educate the public about the newly discovered side effect. The manufacturer also alters the package insert and advertisements in order to disclose the new drug side effects. A drug recall occurs when the number of reports becomes exceedingly high. At this time, the drug is recalled from the consumer market. People using recalled drugs may not be aware of the recall so warning letters are sent to those individuals about the recall. In the end, people should not ignore side effects associated with drugs. They should read package inserts and become fully educated about the drugs they are taking. People should report any side effects they experience to their doctor as soon as possible.