Gadolinium Litigation

The FDA began evaluating a link between gadolinium agents and development of diseases in patients starting in 2006.  These agents are have been included in MRI contrast agents or dyes, and can be especially dangerous in patients that suffer from kidney failure or renal insufficiency.  The link between these dyes in such patients and diseases such as Nephrogenic Systemic Fibrosis ,and Nephrogenic Fibrosing Dermopathy has been under investigation.  NSF usually affects people with reduced kidney function who have been injected with the dye to enhance MRI results.  Due to decreased kidney function, these patients have problems clearing the gadolinium from their systems and the toxic metal accumulates in their skin and tissues.  This causes symptoms such as burning sensations, dark patches on skin, and pain and stiffness of joints.  NSF can leave patiens with the inability to bend their joints and this can stiffness can spread to the diaphragm and internal organs where it can, literally, strangle patients from the inside out.

In 2007 the FDA ordered manufacturers to put a black box warning on their boxes explaining the dangers associated with gadolinium agents in such dyes causing NSF or NFD and allergic reactions.   The dangers of NSF are swelling of the skin, cracking of the skin, burning sensations, skin thickening, contractures, and in few cases death especially to patients that already suffer from liver or kidney disease.

In a current case against GE, manufacturer of GBCA Omniscan, the lawyer for the Plaintiff has claimed that GE and other companies may have downplayed the serious and dangerous side effects to encourage sales, placing profit above customers’ safety since they knew or should have knew that the product was unsafe for use in patients with renal insufficiency.

Some of the companies that manufacture gadolinium based or gadolinium agents are:

• General Electric
• GE healthcare, Inc
• GE Healthcare Bio-Sciences Corp.
• Bayer Healthcare Pharmaceuticals, Inc
• Bayer Healthcare, LLC
• Bayer Pharmaceuticals Corp
• Bayer Corp
• Millinckrodt, Inc.
• Tyco International Ltd
• Tyco Healthcare, Ltd.
• Tyco Holdings, Ltd.
• Ytco Healthcare Group LP
• Covidien Ltd.

There have been lawsuits filed in over 20 states and Alabama is one of those states.   For more information you can click here to go to the FDA’s website.