The Contract Dye Manufacturer’s Letter on Gadolinium
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
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.
Gadolinium Lawsuits and Our Commitment to Our NSF Clients
In September 2007 our law firm began representing people in Colorado who have suffered serious injuries as a result of gadolinium contained in contrast dyes used in MRI and MRA’s. Today, we announce that we have agreed to a joint venture with the law firm of Howard Nations so that we can help even more people who have been diagnosed with NSF as a result of gadolinium.
It is a key commitment of this firm to establish and maintain a close attorney client relationship with all of our clients. We want to be able to spend significant time with our clients and their families so that we can fully represent them and give them their voice in their cases. These cases are about their lives, their hope, their sorrow and loss, and their opportunity for healing and justice.
In mass tort litigation, many times the clients get lost in an “inventory,” and we want to ensure that we have the manpower to keep our clients front and center in our work and our thoughts. We do not want to be one of the firms who talks about their clients as numbers; we never will be. We know your names and what is uniquely happening to you and your family.
The Nations firm shares our vision of what an attorney client relationship should be, and both firms put that vision into action.
We will be launching our sister website www.gadolinium-law.com in early April. We hope this will be a significant resource for all people who are suffering from NSF. Please send us information that you believe will help other people about the status of the contrast dye litigation, trials, treatment to improve quality of life, charity, and support, and we will do our best to make sure that it is available to all of the NSF patients and families through our site.
Beth A. Klein
Uninsured and Underinsured Motorist Coverage - Auto Accidents
Effective January 1, 2008 every automobile insurance policy in Colorado will be improved by a new Colorado Insurance Law which will help insureds receive the coverage that they pay for if injured by an uninsured driver. This new law will effect the important auto accident coverage known as uninsured/under-insured motorist coverage (UM/UIM).
UM/UIM coverage is the coverage you purchase in order to protect yourself and your family if you are the victim of a car accident and the person who caused the accident doesn’t have insurance or hase too little insurance to pay for the injuries and losses that they caused.
Read the Changed to the Auto Accident Insurance Coverage Law Here
Before January 1, 2008 an insurance company could refuse to pay the full coverage under an insured’s policy through an “offset” of the amount paid by the at-fault driver’s insurance company. Insurance companies were also able to use language in their policies that prevented an insured who had multiple cars and multiple policies to add, or “stack,” their own insurance. This meant that seriously injured people in this state could not benefit from all of the coverage that they purchased. The new law makes UM “setoff” and stacking provisions illegal for policies issued or renewed in Colorado as of January 1, 2008. This important change in Colorado law means that you will finally get full coverage that you paid for.
Carrie Frank, a member of the Board of Directors of the Colorado Trial Lawyers Association, worked with others to make sure that Colorado drivers get the full benefit of the insurance coverage that they purchased.
Trasylol (Aprotinin) Dangerous Drug Lawsuits - Colorado Lawyers
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.
Sculpture Dedication to Hoot Brown
Telluride Planet Articles On the Dedication
On March 1, 2007, the town of Telluride once again came together to celebrate the life of Hoot Brown. We join in the celebration of a life that was lived in joy and a person that stood for bringing people together. We were lucky to meet and represent this family that was determined to find a way to heal, and in doing that, they remain an important and respected part of their community.
From the Artist: The spinning base, without the bearing system weighs 1,100 pounds. The sculpture, by itself, weighs 435 pounds. The bearing system had been mounted on the 4′ wide x 5′ deep concrete foundation last week, and was ready for the other components when they arrived last night. Two cats, 4 men and a fork lift waited ’till all the skiers and employees had vacated the slopes before heading up to the location above Hoot’s Hood.
The sun was low, temperatures were plummeting, and it was a beautiful evening. The fork lift had little traction, was sinking in the deep snow, and had to be pushed, shoved, and towed into place to lift Hoot and the heavy base. When everything was in place, the ‘guys’ cut the welds that held Hoot to Michael’s long bed trailer, and up he went.
Spectators on the Gondola had their noses pressed to the windows as their cars traveled by the installation sight. Grins were sported by all. Even as employees passed the sculpture while it was waiting for transport, they grinned, and nodded their heads with approval.
Michael and Mark Bosse (employee who fabricated Michael’s spinning design) were the first ones to ‘give it a spin’ after all the bolts held him fast. They just stood there and smiled. Grrrreeaatt Bbiiiigg smiles.
Welcome home.
Our firm urges all ski resorts to keep the mountains safe for our children.
Hoot Brown was killed on March 30, 2006 as detailed in this article A Young Life. His family has created a foundation that Keeps on Giving to kids in Telluride and the Freeride Program.
USING FOCUS GROUPS TO OVERCOME JURY BIAS - OUR SERVICE TO LAWYERS
Wednesday, Feb. 20, 3:00-5:30 PM at NITA in Louisville. 3 general and .6 ethics $45. Sign up by responding here or with a credit card at www.boulder-bar.org, go to calendar.
USING FOCUS GROUPS TO OVERCOME JURY BIAS, presented by Carrie Frank and Beth Klein
The Boulder County Bar Association invites you to a program designed to teach you how to use focus groups to guide your case preparation and improve your mediation and courtroom performance. Focus groups have long been used by corporations to test a new product before it is introduced into the marketplace. Focus groups can also be used to test your case before you present it at a settlement conference or trial.
You will learn about the different types of focus groups that can be conducted, when to run a focus group and how to use the information learned from the group. You will learn why focus groups are critical in your case preparation from the moment the case is accepted, and maybe even before. Why wait for your case to be heard the first time that you walk in the courtroom; focus groups will give you the edge in knowing the best way to prepare and present your case.
Drunk Driving, Auto Accidents and MADD
The firm met with the executive director of MADD to get information about the resources available for victims of drunk driving accidents. MADD has many resources to help, but one of the most impressive resource is the work the organization has done to help accident victims who are in grief and the anger associated with coping because of profound loss. Here are some of the very good pieces of advise that the experienced counselors at MADD shared with us:
- Everyone’s grief and anger journey is unique
- Tell your story, over and over to those you trust
- Write about your feelings in a journal
- Engage in physical activity to release feelings of anger
- Channel the negative to the positive through advocacy work
- Identify what g your anger and develop a plan for coping during those times
- Don’t allow abusive behavior from yourself or others
Toy Recalls and Lead Lawsuits - Lawyers and Laws v. Safety
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.
