Herndon denies Yaz plaintiffs access to Bayer secrets

By Steve Korris | Nov 17, 2011




EAST ST. LOUIS – Plaintiff lawyers who possess secrets of drug maker Bayer can't reveal those secrets to the world, U.S. District Judge David Herndon ruled on Nov. 10.

He denied a motion to strip confidentiality from 48 documents that Bayer produced in litigation of claims that contraceptives Yasmin and Yaz injured women.

"Litigants do not have an unfettered First Amendment right to disseminate documents obtained through the discovery process," he wrote.

A plaintiff steering committee wanted to introduce the documents at a public meeting of a U.S. Food and Drug Administration committee on Dec. 8.

Herndon wrote that dissemination of 28 documents would violate German privacy laws.

He wrote that other documents "constitute trade secrets such that their dissemination would prove economically advantageous to defendant's competitors."

He wrote that other documents would reveal intellectual property.

Herndon presides over about 10,000 suits from federal courts around the nation blaming Yasmin and Yaz for gall bladder injuries and circulatory disorders.

Bayer has produced about 22 million pages of documents under a protective order allowing it to designate some documents as confidential.

On Oct. 27, steering committee leader Roger Denton of Webster Groves, Mo., moved to open 58 documents on behalf of plaintiff Kaitlyn Dietrick.

Denton asserted her constitutional right to petition the government.

He warned that without her assistance, the FDA might overlook health risks relating to contraceptives containing drospirenone.

He urged Herndon to override German law that would subject Bayer employees to criminal prosecution for privacy violations.

"The weight of these European laws does not even come close to that which is needed to tip the balance against the First Amendment here," he wrote.

Denton wrote that Bayer's German entities "are enjoying immense benefits by conducting business in our country."

Dietrick "was almost killed by a drospirenone medication," he wrote.

Denton also wrote that Bayer designated millions of pages of documents as confidential without a legitimate reason.

On Nov. 9, John Galvin of St. Louis replied for Bayer that Dietrick could freely petition FDA and support her position with non confidential information.

"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," Galvin wrote.

He wrote that violations of German privacy law are punishable by fines, injunctive relief, restitution, and imprisonment up to two years.

He wrote that data protection agencies have authority to shut down businesses found to be in violation.

He dropped confidentiality from 10 documents but defended privacy for the other 48.

Herndon adopted Bayer's view the next day.

He wrote that Dietrick can't present the documents "without compromising the integrity of the instant discovery process as well as the controlling German privacy laws."

He quoted the U.S. Supreme Court that, "A litigant has no First Amendment right of access to information made available only for purposes of trying his suit."

He wrote that according to the Supreme Court, liberal pretrial discovery rules have a significant potential for abuse.

"Thus, the use of protective orders does not violate the First Amendment," he wrote.

He wrote that according to the Seventh Circuit appeals court, the public right of access does not apply when parties haven't filed documents with the court.

"Further, plaintiff is not restricted from disseminating the subject information if obtained through other means," he wrote.

He wrote that principles of comity require him to recognize German laws that prohibit transfer of personal data to a jurisdiction lacking similar protections.

He wrote that an exception can apply if a subject consents, but added that obtaining consent of all research participants was out of the question.

He wrote that obtaining consent would require contacting hundreds of employees, former employees, and unknown others.

He wrote that some documents contain valuable research and development information.

"The information in these documents has cost defendant hundreds of thousands, if not millions, of dollars to produce," he wrote.

He wrote that some documents contain marketing plans with customer lists.

"The court finds the documents at issue represent substantial investments of defendant, investments defendant does not make publicly available," he wrote.

He wrote that marketing plans would prove highly valuable to competitors.

Herndon plans a series of trials next year on individual cases that the parties picked to indicate possible ranges for mass settlement.

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