Retired Cleveland Businessman Sues Tyco International for Rare Disease Caused by its MRI Drug, Optimark Through Law Firm of Spangenberg, Shibley & Liber

CLEVELAND, March 14 /PRNewswire-USNewswire/ -- John G. Walker, a retired 71-year-old suburban Cleveland restaurant supplier, today filed a lawsuit in U.S. District Court here against Tyco International and two healthcare subsidiaries, Tyco Healthcare Group and Mallinckrodt, Inc., claiming that their drug Optimark caused him a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF).

The suit, which seeks damages for nine separate causes of action, may be the first against Tyco stemming from the effects of Optimark, a contrast agent containing the metal gadolinium. Optimark is injected into patients prior to magnetic resonance imaging (MRI) to help diagnosticians distinguish blood vessels from nearby tissues.

"Within days of his Optimark injection last year, Mr. Walker experienced excruciating pain and suffered serious, progressive, and incurable injuries," says Peter J. Brodhead, a partner in the Cleveland litigation law firm of Spangenberg, Shibley & Liber, who filed the suit.

"This man-made disease caused his skin to harden and his joints to lock up and to swell," says Brodhead, whose firm handles complex product liability and medical malpractice cases. "He was sent to a nursing home and confined to bed and a wheel chair. Today he is at home, but he continues to require regular physical therapy in order to walk."

The U.S. Food and Drug Administration (FDA) last year acknowledged that there were 200 reports worldwide of Nephrogenic Systemic Fibrosis, also sometimes called Nephrogenic Fibrosing Dermopathy (NFD).

The suit further notes that in 2006 the FDA issued Public Health Advisory alerts about the development of serious, sometimes fatal, NSF/NFD following patient exposure to gadolinium-based contrast agents, including Optimark.

The suit claims that Tyco was aware -- or should have been aware -- of the risks of Optimark. "During the years that defendants have manufactured, marketed, and sold Optimark, there have been numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of certain gadolinium-based contrast agents, including Optimark," states the suit.

"Despite this, defendants have repeatedly failed to adequately revise their package inserts, material safety data sheets, and other product-related literature, and to conduct appropriate post-marketing communications in order to convey adequate warnings."

The lawsuit asserts that Walker was admitted to University Hospitals in Cleveland in January 2006 for dialysis and other treatment. Before his MRI, he was injected with Optimark. Shortly afterward, Walker developed NSF with its incapacitating consequences, according to the complaint.

"Neither John G. Walker, nor his prescribing physician, nor the performing radiologists or technicians were warned or cautioned by defendants about the serious health risks presented by the administration of Optimark," states the suit.

Much has been made public recently about the relationship between gadolinium-based contrast agents and NSF.

In its Public Health Advisory last December, the FDA said it was notifying health care providers that patients with moderate to end-stage kidney disease that receive an MRI with a gadolinium-based contrast agent may get NSF. The FDA called NSF "debilitating" and added "it may cause death."

The Clinical Journal of the American Society of Nephrology reported on NSF in its February issue. "NSF is a fibrosing disorder that involves predominantly the skin but also affects systemic organs, such as the liver, heart, lungs, diaphragm, and skeletal muscles," said the publication.

The U.S. Centers for Disease Control (CDC) also has been investigating illnesses related to metallic dyes containing gadolinium used in MRI scans. "When possible, use of gadolinium-containing contrast agents should be avoided in patients with advanced renal failure, particularly in patients who are undergoing peritoneal dialysis," the CDC concluded in its late February Morbidity and Mortality Weekly Report.

The American College of Radiology, in a Guidance Document for Safe Practices, recently recommended that gadolinium-based contrast agents not be administered to patients with advanced kidney disease unless the benefits clearly outweigh the risks. Even more strongly, the European Agency for the Evaluation of Medicinal Products issued a recent advisory against the use of Optimark and one other gadolinium-based contrast agent for patients with severe renal disease.

Walker's wife, Marilyn, is also a plaintiff. She contends that she has been deprived of the "society, aid, services, consortium, and support of her husband." The Walkers live in Chagrin Falls, a Cleveland suburb.