Gadolinum Personal Injury Litigation Update

Discovery is proceeding at a brisk pace in the Gadolinium Based Contrast Agent (GBCA) federal litigation.  Plaintiffs have served 104 interrogatories and 104 document request on GE Healthcare.  To date, GE Healthcare has produced two million pages of documents and will produce at least another additional million pages by October.  GE has produced the entire global adverse event database, which is every adverse event for the product, NSF or other adverse events, reported to the company since it’s been on the market.  GE Healthcare has also produced 13 foreign custodial files. The custodial files comprise 13 witnesses or employees of GE Healthcare who are located in the UK or in another way, including the scientists involved in the development of the product.  GE also produced all of their science-based documents, from the development of the drug back in the late 80’s and early 90’s to the clinical and preclinical trials and studies to date.  All of the safety and efficacy studies that have been done are being produced to the Plaintiffs. Additionally, GE is producing the entire FDA regulatory file, which includes foreign matters the company is obligated to produce to the FDA.  Plaintiffs have hundreds of thousands of pages of documents that relate to foreign issues of science-based regulatory labeling. 

A lot of Nephrogenic Systemic Fibrosis (NSF) cases were first reported out of Denmark, and the Danish authorities asked GE and other companies to do an analysis of NSF cases in their databases.  Plaintiffs are attempting to secure these analyses and reports.  In Europe, experts write reports to submit to various agencies about the risks and benefits of a drug.  For example, if GE sends a chemistry review about the stability of a scan, and the German authorities review it and say there is a problem with stability; this is something that plaintiffs are attempting to obtain because it is useful in our cases.  Additionally, we know in some countries, they limited the ability of GBCAs to be marketed to renally-impaired patients.  Plaintiffs are attempting to obtain the documents relating to the reasons for limited access of GBCAs in foreign countries.

Plaintiffs can establish that it has been well known and acknowledged by GE scientists since the late 1980s that these drugs had the ability to break down in the body and that the consequence of that is that you have free Gadolinium lodged in the tissues of people.  The internal documents that we are receiving from the GBCA manufacturers will establish what the defendants knew about this fatal condition caused by their products and when they knew it.

Finally, plaintiffs are permitted to begin deposition one person per week starting September 15th.  Plaintiffs contemplate deposing up to 65 GE employees.  All of this work is building towards trials beginning in the Spring of 2009.