MRI Dye/Gadolinium Litigation Update - 4/14/09
Dan Thornburgh, a Florida attorney whose practice focuses in drug and medical device litigation, recently sat down with us to provide an update on the nearly 400 hundred lawsuits currently filed against gadolinium manufacturers.
Most lawsuits currently in discovery process
Many of the lawsuits filed are currently in multi-district litigation, or MDL, a procedure which allows a judge to look at the similarities between cases filed throughout the nation. We asked Thornburgh to provide us with a status of the MDL. He said:
It’s currently making its way through the discovery process. Oftentimes what happens is that we have what I call generic discovery rather than case specific discovery. So, we’ll obtain expert witness depositions that were taken from both sides and those generally involve discussions of causation such as whether there is an increased risk, how this is happening and why people are being affected by it.
Incidentally, NSF (Nephrogenic Systemic Fibrosis) is caused by nothing other than gadolinium exposure. So, it’s not hard to argue that my client, whose been diagnosed with Nephrogenic Systemic Fibrosis, was caused by gadolinium exposure – because that’s the only thing that causes it.
There is some case specific discovery going on with the MDL as well and the whole thing is moving forward. What I mean by discovery is conducting interrogatories – which are questions that we get to send to the defendant. They answer or object to answering those questions and they do the same to us.
Discovery also involves requests for production of documents – which is another tool where we ask the defendant to produce documents responsive to a particular request. Finally, it also includes taking depositions – which is a process where we’re allowed to ask questions to directly to their witnesses and they’re allowed to ask our witnesses or plaintiff(s) questions.
Thornburgh says that all of these tools are used to flesh out and understand the facts on both sides and that fact finding process allows us to develop themes or theories and get ready for trial.
How has the FDA been involved?
The U.S. Food & Drug Administration has been involved with gadolinium warnings. According to Thornburgh, “The FDA has reviewed the science and ultimately required a black box warning to be added. A black box warning is the most strict warning issued and it was added to gadolinium product labels. So, that’s the first thing you see now instead of having to dig through four pages of labels to find out what some of the risks may be. This is printed at the top of the label in a black box.”
Manufacturers’ deceptive practices
There have been several reports of drug manufacturers hiding clinical studies which produced unfavorable results. We asked Thornburgh whether he’s seen this happening in his practice. He told us, “Yes, some manufacturers do hide their studies. In addition, some, and I’m not referring to any one manufacturer specifically, hire what we call ghost writers. They pay doctors, who claim to be independent, a sum of money to write an article or do a study. Then, the company will actually write the study and the ghostwriter or doctor who was paid to do it will sign his or her name to it. It’s very deceptive and very concerning.”