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.

Gadolinium Lawsuits and Our Commitment to Our NSF Clients

21 Mar, 2008  1 Comment

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

Gadolinium Contrast Agent and Serious Personal Injuries

17 Sep, 2007  No Comment

The FDA is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). An MRA test uses magnetic resonance imaging to take pictures of blood vessels. During an MRA test, a drug known as a gadolinium-contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues.

The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan®, a gadolinium-containing contrast agent, and took the MRA test. The FDA is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD. While FDA conducts its investigation, the following recommendations are being provided to health care providers and patients:

• Gadolinium-containing contrast agents, especially at high doses, should be used only if clearly necessary in patients with advanced kidney failure (those currently requiring dialysis or with a Glomerular Filtration Rate (GFR) = 15 cc/min or less).
• It may be prudent to institute prompt dialysis in patients with advanced kidney dysfunction who receive a gadolinium contrast MRA. Although there are no data to determine the utility of dialysis to prevent or treat NSF/NSD in patients with decreased kidney function, average excretory rates of gadolinium are 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Okada, et al, Acta Radiologica, vol 42 p. 339, May 2001).

Five gadolinium-containing contrast agents are FDA-approved for use during magnetic resonance imaging (MRI), a test that can look at internal body organs and tissues. The trade names of the U.S. approved gadolinium-containing contrast agents are: Omniscan, OptiMARK, Magnevist, ProHance, and  MultiHance. None of these drugs are FDA approved for MRA. The dose of gadolinium-containing contrast agent given to patients undergoing an MRA test is often higher (up to three times) than the approved dose for MRI.

NSF/NFD appears to occur in patients with kidney failure along with high levels of acid in body fluids a condition known as acidosis that is common in patients with kidney failure. Patients with NSF/NFD have tight and rigid skin making it difficult to bend joints. NSF/NFD may also result in fibrosis, or scarring, of body organs resulting in the inability of body organs to work properly and can lead to death. Diagnosis of NSF/NFD is done by looking at a sample of skin under a microscope.

Scientists first identified NSF/NFD in 1997 and the cause of NSF/NFD is unknown. Worldwide, there are approximately 200 reports of NSF/NFD.

The 25 cases of NSF/NFD were reported on May 29, 2006, by the Danish Medicines Agency. Among these, 20 cases occurred in Denmark and five cases occurred in Austria. The patients developed NSF/SFD within 3 months (range 2 weeks to 3 months) after receiving the gadolinium-containing contrast agent. The five patients from Austria are described in a publication: Grobner T. Gadolinium – a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis Nephrol dial Transplant. 21(4):1104-8.

The FDA has not yet determined whether exposure by patients with kidney failure to gadolinium-containing contrast agents during an MRA test causes NSF/NFD. The FDA is gathering additional information about NSF/NFD and investigating whether other patients who received gadolinium-containing contrast agents developed NSF/NFD.

The FDA urges health care providers and patients to report adverse event information to the FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.
Gadolinium is never found in nature as the free element, but is contained in many rare minerals such as monazite and bastnäsite. It occurs only in trace amounts in the mineral gadolinite which was also named after Johan Gadolin. Today, it is prepared by ion exchange and solvent extraction techniques, or by the reduction of its anhydrous fluoride with metallic calcium.