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GE Healthcare Advised to Restrict Omniscan in 2006

Apr 19, 2010 | Parker Waichman LLP

GE Healthcare’s own experts recommended in May 2006 that it proactively restrict the use of Omniscan, a gadolinium contrast dye, after it was linked to nephrogenic systemic fibrosis (NSF). According to a ProPublica investigation, rather than take that advice, GE spent the next year arguing that approach wasn’t necessary.

According to ProPublica, the recommendation came at a meeting convened by GE Healthcare’s vice president for drug safety. It was prompted by reports in Europe that linked Omniscan to a potentially crippling disease that would be come to be known as NSF. Details of the meeting were revealed in a newly unsealed order in a lawsuit against the company, ProPublica said.

Instead of following the advice of its owns safety experts to restrict the use of Omniscan in high risk patients, GE publicly took the position that its drug was no more dangerous than those of its competitors and argued against putting an exclusive warning on the drug’s label.

According to ProPublica, the order also references previously sealed evidence indicating that doctors and the U.S. Food & Drug Administration (FDA) had not seen internal company research that raised questions about Omniscan’s propensity to break down chemically, releasing the potentially toxic metal gadolinium into the body.

Plaintiffs’ lawyers see the May 2006 meeting as pivotal because many patients were exposed to Omniscan afterward, ProPublica said.

NSF is a debilitating leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death. While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dyes like Omniscan.

Since 2007, all gadolinium agents have carried the same black box warning – the FDA’s strongest safety notice – regarding the risk of NSF. But last fall, the FDA released a risk assessment that indicated that Omniscan, along with two other dyes called OptiMark and Magnevist, carried a higher risk of the disease. The assessment cited 382 cases in which Omniscan was named as the single imaging agent in an NSF report. Magnevist was named in 195 reports and OptiMark in 35.

GE Healthcare and Omniscan are named in approximately 500 lawsuits filed by NSF patients. Most of these are pending in federal court. However, the unsealed order revealing the May 2006 meeting was issued in an Illinois case presided over by Cook County Circuit Judge Deborah Mary Dooling. According to ProPublica, Judge Dooling said the evidence she reviewed was sufficient to add a claim of punitive damages. However, the parties were able to reach a confidential settlement before it went to trial.

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