Gadolinium-Based Contrast Agent Toxicity Litigation – a Long History

After several years of flying under the radar, gadolinium injury litigation is once again coming to public attention.  Part of the reason has to do with film actor Chuck Norris and his wife Gena.  The couple filed a lawsuit in November 2017 against three manufacturers of gadolinium-based contrast agents (GBCA) after Gena Norris became seriously ill following a routine MRI scan, during which she was injected with a GBCA.  However, GBCAs have been a cause of action in lawsuits for over a dozen years.

Nearly four years ago, the Sixth Circuit Court of Appeals upheld a $5 million judgment against GE Healthcare (GEHC) in a case brought by an Ohio man suffering from end-stage renal disease.  The plaintiff, Paul Decker, alleged that he developed nephrogenic systemic fibrosis (NSF) as the result of being injected with Ominscan (gadodiamide) prior to undergoing an MRI scan.  Decker, who already suffered from impaired kidney function, claimed that the manufacturer failed to issue a warning about the dangers of administering the product to patients with renal disorders.

Decker’s case, filed in 2012 as part of multi-district litigation involving hundreds of similar cases, was the first to go to trial.  When the jury rendered a verdict in Decker’s favor, GEHC filed a motion requesting a new trial.  Soon after the district court rejected the motion, the defendants filed an appeal. 

Counsel for the defendant argued that even if they had issued a more comprehensive warning, Decker’s physician would have used the product in any event. GEHC suggested that its label at the time Decker received the product in 2005 was sufficient, based on what was known at the time, arguing that the link between gadolinium and NFS was not established until 2006.

However, there was expert testimony during the trial in which it was revealed that GEHC had received four adverse event reports related to its product prior to 2005 – and these reports should have raised a red flag.  In fact, during a deposition, a chemist who had served as a consultant for GEHC provided a copy of an internal study from 1995.  The study found that Omniscan did indeed release free gadolinium into the bloodstream.  However, these findings were never published, indicating that GEHC was aware of the dangers of gadolinium and deliberately withheld that information from the medical community.

In earlier litigation, Bayer AG, a manufacturer of the GBCA Magnevist (gadopentetate dimeglumine), reached settlements with a number plaintiffs who had experienced serious side effects as the result of gadolinium exposure.

In December of 2017 – eight years after the Bayer settlements – the FDA finally got around to updating its requirements for package label warnings, advising patients and doctors of the dangers of gadolinium retention.  The safety announcement states that “Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function,” and concludes that “the benefit of all approved GBCAs continues to outweigh any potential risks.”  However, it has recently come to light that a specific form of GBCA, known as linear, releases more free gadolinium into the system and remains in the tissues for a greater length of time.  Furthermore, linear GBCAs affect patients with healthy kidneys as well as those with renal dysfunction.