Colorado Law Blog

The Contract Dye Manufacturer’s Letter on Gadolinium

24 Apr, 2008  No Comment

Manufacturers of Gadolinium-based contrast dyes issued a Dear Healthcare Professional letter to doctors about an addition of a WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents used in Magnetic Resonance Imaging (MRI).

It reads:

Dear Healthcare Professional,

Post-marketing reports show that the use of these agents increases the risk of the development of a serious medical condition called Nephrogenic Systemic Fibrosis (NSF), in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2) and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.

NSF leads to excessive formation of connective tissue in the skin and internal organs.

NSF is progressive and may be debilitating or fatal. As of today, the FDA has received reports of over 250 cases of NSF after administration of gadolinium-based contrast agents.As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents have been revised to include the following Boxed Warning and update to the WARNINGS section.

The manufacturers of gadolinium-based contrast agents would like to inform you of important revisions to the prescribing information for the products listed in alphabetical order above. Gadolinium-based contrast agents are approved by the U.S. Food and Drug Administration (FDA) for use in magnetic resonance imaging (MRI).

Call 1-800-FDA-1088 (1-800-332-1088)

For more information, contact the Gadolinium Lawyers and Attorneys at Beth Klein, P.C.  You can contact us through this link  GADOLINIUM LAWYER HELP.

Gadolinium Lawyers, Lawsuits, NSF, NSD, and Contrast Dye- the Basics

19 Apr, 2008  No Comment

Today, www.USRecalNews.com featured an article on the basics about Gadolinium Lawyers, NSF, NSD and Contrast Dyes written by our law firm.   The article can be accessed if you click on GADOLIUM HEALTH ALERT.

Magnetic resonance imaging (MRI) uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The MRI is valuable for the diagnosis of a number of conditions in all parts of the body, including cancer, heart and vascular disease, stroke, and joint and musculoskeletal disorders. 

Because MRI can give clear views of soft-tissue structures near and around bones, it is the most sensitive exam for spinal and joint problems, and its is used to diagnose sports-related injuries, especially those affecting the knee, shoulder, hip, elbow, and wrist. The images allow the physician to see even very small tears and injuries to ligaments and muscles.   MRIs of the heart, aorta, coronary arteries, and blood vessels is used to diagnose coronary artery disease and heart problems. Doctors can examine the size and thickness of the chambers of the heart, and determine the extent of damage caused by a heart attack or progressive heart disease.  Organs of the chest and abdomen—including the lungs, liver, kidney, spleen, pancreas, and abdominal vessels—can also be examined in high detail with MRI, enabling the diagnosis and evaluation of tumors and functional disorders.

Gadolinium looks clear like water and is non-radioactive. After it is injected into a vein, Gadolinium accumulates in the abnormal tissue that may be affecting the body or head. Gadolinium causes these abnormal areas to become very bright (enhanced) on the MRI. This makes it very easy to see.

The problem occurs when Gadolinium cannot be excreted by the body.  This occurs in patients who have kidney problems.

Further, Gadolinium based contrast agents should only be used in pregant and nursing women with great caution.

Trasylol (Aprotinin) Dangerous Drug Lawsuits - Colorado Lawyers

8 Mar, 2008  No Comment

In November 2007 Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.

Read the US World and News Report Here

“In addition, in February 2007, a study published in the Journal of the American Medical Association found patients on the drug were at greater risk of dying over the next five years than those given two other medications. The same researchers had linked the drug to an increased risk of kidney failure, heart failure and stroke in a study published in 2006.”

“Our present findings deal with death,” one of the JAMA study’s authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that “the death rate for aprotinin patients far outstrips that for the other two drugs.”

In interviews with CBS 60 Minutes, Researchers expressed the opinion that had the drug been pulled fromt the market earlier, over 22,000 deaths could have been avoided.

See the 60 Minutes News Report Here

Patients who were given the blood clotting agent Trasylol during heart bypass, heart valve replacement, or other cardiac procedures were deemed by the FDA more likely to die from complications than patients who were given similar, competing drugs.  The maker of Trasylol, Bayer AG, suspended sales of the drug that more than 4.5 million people had been administered worldwide.  Nearly one third of the users were in the United States during the 14 years that it was available in the US market. 

Trasylol was found to contribute to:

• Strokes
• Kidney failure
• Heart attacks
• Heart failure
• Death

If you or a family member have suffered adverse side effects after using Trasylol, you may be eligible to file a claim. Beth Klein has years of experience successfully representing clients in personal injury cases involving dangerous and defective prescription drugs.  More about your rights here.

Toy Recalls and Lead Lawsuits - Lawyers and Laws v. Safety

22 Jan, 2008  No Comment

Ty, Inc. the manufacturer of Beanie Babies has refused to comply with a request from the State of Illinois to recall the Jammin Jenna doll.   State law bans vinyl toys that contain more than 600 perts permillion of lead.  Federal law does not. 

Initially, Ty agreed to stop distributing the Ty Girlz Doll in Illinois after the Chicago Tribune reported that the red vinyl shoes on three of the dolls exceeded lead limits.  Now, Ty indicates that it would rather battle over which law takes precedence - state or federal - rather than recalling the defective dolls.

 Both the state attorney general’s ofice and the federal Consumer Product Safety Commission have siad the Illinois ban is valid because states can adopt their own regulations where no federal law exists.

Toy Hazard Recalls

9 Nov, 2007  No Comment

This year the Consumer Product Safety Commission has issued hudreds of recalls for defective toys.  The problems range in severety from violation of a lead paint standard, to serious injury risks caused by Aqua Dots, which if ingested, metabolize to a “date rape” drug.  The list of recalled products continuously grows, and please use this link to determine whether a product you are considering or have purchased has been recalled.   CPSC TOY HAZARD RECALLS