J&J Disagrees with Crucial Evidence Released in Ortho Evra Case
In the case In re Ortho Evra Products Liability Litigation, MDL 1742, in the U.S. District Court, North District of Ohio (Toledo) internal Johnson & Johnson documents have been made public that show that J&J, “withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels of estrogen than oral contraceptives. Obviously unaware of the withheld information, the FDA approved Ortho Evra for marketing” according to the motion filed Ortho Evra users Nov. 20 in federal court. Further, pre-trial interviews with Johnson & Johnson scientists show the company knew of the risk in 1999 and still misled the FDA when they were seeking approval in 2001. This new information was previously kept from the public’s knowledge when a judge considered it confidential. The documents being made confidential gave J&J the perfect opportunity to settle out of court in all previous lawsuits. Of course J&J disagrees and a spokeswoman said of the new filing it, “Takes out of context a few documents produced by the defendants in the course of this litigation to create a misleading and unfair presentation. The proper forum for these documents is the courtroom where, looked at in context, the evidence will show that Ortho Evra is safe and effective.” Janet Abaray, the Cincinnati attorney for seven women, declined to comment.
