A federal judge has denied an effort by a plaintiff in the sprawling litigation involving the Yaz and Yasmin contraceptive pills to provide confidential documents to the FDA in advance of a December 8 advisory committee meeting. The panel will examine the risk of blood clots caused by birth control pills containing drospirenone, and the Bayer pills are among the most widely used brands.
Last month, lawyers for Kathryn Dietrick argued she should be allowed to provide the FDA panel with nearly 50 documents - including clinical trials and case studies - that they claim the agency has not had a chance to previously review. They also hoped to provide documents indicating conflicts of interest among some of the FDA panel members (see here).
Their gambit came amid growing controversy over the pills. The FDA had just released a report indicating that women taking pills containing drospirenone were 74 percent more likely to experience clots than those on low-estrogen pills (read here). Separately, a study published last month in BMJ found a six-fold increased risk of venous thromboembolism, which are clots that can start in the leg but then travel to the lungs; this was twice the risk for women taking older contraceptives containing levonorgestrel (see this).
In making their argument, they maintained her First Amendment rights make a compelling case to ‘de-designate’ the documents. The attempt highlighted an issue surrounding product-liability litigation - numerous documents are kept under wraps as part of the bargaining between drugmakers and plaintiffs to allow litigation to proceed. Judges generally approve if the parties have agreed.
Bayer responded by agreeing to drop confidentiality for 10 documents, but argued that allowing the documents to be given to the FDA would undermine the discovery process, reveal valuable trade secrets and conflict with German privacy laws, and that violations may subject Bayer employees to criminal penalties.
"When foreign law prohibits disclosure of information, a reviewing court must conduct a sensitive balancing of the competing interests at stake, taking into account the concept of international comity," a Bayer lawyer wrote, adding that violations of the German Federal Data Protection Act can result in civil or criminal prosecution that involves fines, restitution and imprisonment of up to two years (see here).
And US District Court Judge David Herndon agreed with Bayer's arguments. "Litigants do not have an unfettered First Amendment right to disseminate documents obtained through the discovery process," he wrote, adding that the disputed documents are not filed with the court. "...a litigant has no First Amendment right of access to information made available only for purposes of trying his suit."
He went on to write that legal reciprocity requires that he recognize German laws that prohibit transferring personal data to another jurisdiction that lacks similar protections. Although exceptions can apply if subjects consent, obtaining consent of all research participants was "out of the question." Why? Bayer contends that obtaining consent of all the people connected to the disputed documents would require contacting hundreds of employees, former employees and others who are unknown.
Finally, Herndon also agreed with Bayer's position that some documents contain valuable research and development information, as well as confidential marketing materials, such as strategic and planning reports on the contraceptive business. "These documents constitute trade secrets such that their dissemination would prove economically advantageous to defendant’s competitors," he concluded (read the ruling here).