A Medical Device Daily

The mother of a 24-year-old Norwalk, Ohio, man who died in 2004, shortly after receiving his second injection of the drug Magnevist, has filed a lawsuit against Bayer Healthcare Pharmaceuticals (Wayne, New Jersey), a business of Bayer (Berlin, Germany), claiming that the drug — a contrast agent containing the heavy metal gadolinium — caused her son's death.

Beverly Rockwell is seeking compensatory and punitive damages on behalf of the estate of her son, Trevor Drake, alleging that he was injected at the Cleveland Clinic (Cleveland, Ohio) with Magnevist prior to an MRI for end-stage kidney disease.

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.

The case is believed to be the first against Bayer stemming from the effects of Magnevist. The Spangenberg firm in March filed a suit 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 debilitating joint injuries and he requires physical therapy to walk, according to the suit.

The FDA in 2006 acknowledged in a Public Health Advisory that there had been 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.

Last week, the FDA advised manufacturers of gadolinium-based contrast agents to place "black box warnings" in their product directions to manufacturers about the risks of NSF/NFD (Medical Device Daily, May 25, 2007).

The FDA said the warning should state that use of these 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.

Berlex Laboratories (Montvale, New Jersey), the U.S. arm of Schering (Berlin), originally manufactured Magnevist. Bayer bought Schering in 2006 and continues to manufacture Magnevist.

"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 administered Magnevist to Drake before an MRI.

Not long afterwards, the suit says, Drake developed skin hardening and joint stiffening — hallmarks of NSF/NFD — and was confined to a wheelchair.

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

The Drake suit follows a case filed in Denver this month on behalf of a former nurse against General Electric, GE Healthcare and GE Healthcare Bio-Sciences, claiming 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.

In other legalities: Orthopedic device manufacturer Biomet (Warsaw, Indiana) has disclosed that federal prosecutors have subpoenaed it to obtain documents related to products now manufactured, marketed and sold by its subsidiary EBI Ltd.

Biomet, which in December agreed to be bought for $10.9 billion by a group of private equity firms (MDD, Dec. 20, 2006), said it is cooperating with the subpoena issued through the U.S. Attorney for the Southern District of West Virginia for documents relating to products manufactured from January 1999 through the present.

Receipt of the subpoena was disclosed following the close of regular business ahead of the Memorial Day weekend observance in the U.S.

Biomet acquired EBI in 1988 to gain a foothold, it said, in the electrical bone growth stimulation market, and since then the unit has added spinal and bracing products to its product mix.