LawyersUSA

With almost 400 lawsuits already filed across the country, gadolinium litigation is heating up.

Gadolinium is a metal used in contrast solutions to enhance the images when a patient undergoes magnetic imaging, such as an MRI or MRA.

The plaintiffs claim that the gadolinium-based contrast agents used when they underwent magnetic imaging procedures caused Nephrogenic Systemic Fibrosis, a debilitating disease with no cure.

NSF causes scarring or fibrosis of the skin and internal organs. Symptoms include red or dark patches of skin or thick, coarse and hard patches of skin; generalized muscle weakness; stiff joints; and burning, itching or swelling skin.

Symptoms may appear as early as two days after receiving an injection or up to 18 months after exposure.

The vast majority of NSF cases involve people whose kidney function was already compromised at the time they received a gadolinium injection.

Most cases have been consolidated into a MDL before U.S. District Court Judge Dan Polster in the Northern District of Ohio, but a few remain in various state courts – California, Missouri and New Jersey – according to Peter W. Burg, co-chair of the plaintiffs' steering committee and a partner at Burg Simpson in Englewood, Co.

Peter Brodhead, a partner at Spangenberg, Shibley & Liber in Cleveland and the plaintiffs' liaison counsel for the MDL litigation, predicted that "between 500 and 1,000 total cases" will ultimately be filed.

Brodhead, who has about 25 cases, said the plaintiffs are alleging that the defendants' products were not adequately designed and that they failed to warn about the dangers of using their contrast agents.

Four manufacturers of gadolinium agents are named as defendants in the suits – GE Healthcare, Bayer HealthCare Pharmaceuticals, Tyco/Mallinckrodt, and Bracco Diagnostics.

Heidi Levine, a partner at DLA Piper in New York and the lead counsel for GE Healthcare, was the only defense lawyer to respond to a request for comment.

In a statement, she expressed concern about the health of patients diagnosed with NSF but said plaintiffs' attorneys "face a significant challenge in proving their legal case" because "both the causes of NSF and the mechanism of injury remain unknown."

FDA warnings

In June 2006, the FDA issued its first warning about the effects of gadolinium contrast agents on people suffering from renal failure.

The agency urged physicians to screen patients for kidney problems prior to using gadolinium in MRIs. In December 2006, the FDA announced that it had received 90 reports of patients with moderate to end-stage kidney disease who had developed NSF after being exposed to gadolinium-based contrast agents.

More recently, in May 2007, the FDA requested that the manufacturers of gadolinium based contrast agents include a warning on their product labels highlighting the risk posed to patients with kidney problems.

The agency also set up a program for healthcare providers to report instances of NSF. (Click here for a link to the FDA's page with information on gadolinium.)

Potential issues for trial

The parties are still in the discovery stage of litigation, but have set an aggressive calendar with the goal of a first trial around May 2009.

Both sides are reviewing documents and beginning the deposition process, especially in cases where the plaintiffs are close to death.

To date, the parties have not engaged in any meaningful settlement talks, said Burg, whose firm has about 100 cases.

Key issues will include:

• Identifying the correct defendant.

Levine said that plaintiffs' attorneys must confirm a diagnosis of NSF for each of their clients, and "face a difficult problem in identifying whether a specific contrast agent, if any, was used in any given diagnostic procedure."

"It is not always readily apparent from a patient's medical records which gadolinium contrast agent was used, so we sometimes have to do further investigation to find out," Brodhead explained.

Typically, the radiology department can determine which contrast agents it was using at the time a patient received an MRI.

• Preemption.

The defendants have raised a preemption defense, but Burg said that plaintiffs' lawyers aren't concerned.

"Preemption is in the background of any pharmaceutical litigation these days," he said, adding that both sides are keeping their eyes on the case currently pending before the U.S. Supreme Court, Wyeth v. Levine, No. 06-1249. (Click here for more information on the case.)

• Causation.

As in any personal injury litigation, Brodhead expects issues to arise regarding causation.

Burg argues, however, that "the medical literature is abundantly clear on the specific causation between [gadolinium-based agents] and NSF."

Because the overwhelming majority of those afflicted with NSF already suffered from some form of kidney problem this could affect potential damages.

Burg expects legal wrangling over life expectancy as well.

"I have a significant number of clients who already had kidney transplants who would be leading relatively normal, productive lives but for this disease," he said.

For links to court orders and more information on the litigation, visit the website for the plaintiffs' steering committee: http://www.gadoliniumpsc.org/.

Questions or comments can be directed to the writer at: correy.stephenson@lawyersusaonline.com