Norwalk, Ohio Mother Sues Bayer Healthcare Pharmaceuticals for the Death of Her 24-Year-Old Son

CLEVELAND, May 30 /PRNewswire/ -- The mother of a 24-year-old Norwalk, Ohio man who died in August 2004, shortly after receiving his second injection of the drug Magnevist, has filed a lawsuit in U.S. District Court here against Bayer Healthcare Pharmaceuticals of Wayne, New Jersey, an arm of Bayer AG of Berlin, Germany. She is claiming that the drug -- a contrast agent containing the heavy metal gadolinium -- caused her son's death.

Beverly Rockwell, who is seeking compensatory and punitive damages on behalf of the estate of her son, Trevor A. Drake, maintains the young man was injected at the Cleveland Clinic with Magnevist prior to his magnetic resonance imaging (MRI) for end-stage kidney disease. The purpose of the drug is to help diagnosticians to visualize internal organs and blood vessels.

Filed by the Cleveland litigation law firm of Spangenberg, Shibley & Liber, the suit claims that Magnevist caused a skin and joint disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD), which was fatal to Drake, an apprentice carpenter.

Berlex Laboratories, Inc., Montville, New Jersey, the U.S. arm of Schering AG, also headquartered in Berlin, originally manufactured Magnevist. Bayer bought Schering in 2006 and continues to manufacture Magnevist.

The case is believed to be the first against Bayer stemming from the effects of Magnevist. The Spangenberg firm in March filed a suit here in federal court on behalf a 71-year-old suburban Cleveland man who is suffering from NSF/NFD. At University Hospitals in 2006 prior to kidney dialysis, he was injected with a similar drug, Optimark, a product of Tyco Healthcare Group. His NSF/NFD has since caused him serious debilitating joint injuries, and he requires physical therapy to walk.

The U.S. Food and Drug Administration (FDA) in 2006 acknowledged in a Public Health Advisory that, at the time, there were 200 reports worldwide of NSF/NFD. The cases developed following patient exposure to various gadolinium- based contrast agents. The report conceded many of these were serious and some fatal.

"Since then, there has been a growing recognition that there are far more people with this man-made disease than previously assumed," says Peter J. Brodhead, the Spangenberg partner who filed the case.

Last week, in fact, the FDA advised manufacturers of gadolinium-based contrast agents to place a "Boxed Warning" in their product directions to manufacturers about the risks of NSF/NFD.

The FDA said the warning should state that use of these contrast agents increases the risk of NSF/NFD in patients with severe renal insufficiency, that the disease is debilitating and sometimes fatal, and that it affects skin, muscle, and internal organs. The use of such drugs should be avoided, added the FDA, unless diagnostic information is essential and not available with a non-contrast enhanced MRI.

The FDA warning called on health care professionals to screen patients for renal dysfunction before administering the drugs, not to exceed the recommended dosage, and to discuss with "at risk" patients the symptoms and possibility of being afflicted with NSF. It also said that patients injected with gadolinium-based agents may require clinical follow-up and long-term monitoring.

In a Wall Street Journal article on May 24 about the warning, an FDA spokesperson estimated that the risk of NSF for a person with severe kidney failure is about four in 100 patients.

"Berlex consistently failed to warn consumers and/or their health care providers that NSF/NFD could result when Magnevist is administered to patients with renal insufficiency," states the suit against Bayer.

According to the suit, Drake was admitted to the Clinic in March 2002 and again in August 2004 with renal complications. He had been on dialyses from age 19. At age 21, he received a kidney transplant from his mother, but the transplant failed. Shortly after his first admission to the Clinic, technicians, upon a doctor's instruction, administered Magnevist to Drake prior to an MRI.

Not long after receiving Magnevist, Drake developed immobilizing skin hardening and joint stiffening - hallmarks of NSF/NFD - and was confined to a wheelchair.

"Within days of initially receiving Magnevist," the complaint states, "he developed NSF/NFD, which progressed to widespread fibrosis around his brain, spinal cord, heart, hands, arms, legs, skin, and associated joints."

"As a ... result of being administered Magnevist," the complaint adds, "he suffered serious, progressive, and incurable injuries, and came to his untimely and wrongful death."

An article in 2006 in The Archives of Pathology & Laboratory Medicine Journal of the College of American Pathologists reported that an autopsy at the Cleveland Clinic confirmed a tissue match between Drake's skin fibrosis -- tough, hardened tissue -- and extensive fibrosis in his heart muscle and across the expanse of the covering of his brain and spinal cord.

"The fibrosis in his internal organs was the same nasty stuff that was in his skin," says Brodhead. "What's so stunning is that this man-made disease apparently attacks internal organs at random. In Trevor's case, it invaded his heart and the covering of his brain and spinal cord."

The Drake suit follows a case filed in Denver this month on behalf of a former nurse against General Electric, GE Healthcare, Inc. and GE Healthcare Bio-Sciences Corporation. It claims that their gadolinium-based drug, Omniscan, caused her to suffer NSF/NSD. The woman, who was under consideration for a kidney transplant, is now wheelchair bound with limited extension of her legs, fingers, and elbows.

Much has been published recently about NSF/NFD. 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 used in MRI scans. "When possible, use of gadodiamide 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.

Moreover, the American College of Radiology, in a Guidance Document for Safe Practices, recently recommended that gadodiamide 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 two separate gadodiamide contrast agents for patients with severe renal disease.