Yaz lawyers want confidential Bayer documents presented to FDA

By Steve Korris | Nov 11, 2011


EAST ST. LOUIS – Lawyers who obtained secrets from German owners of Bayer drug companies in litigation over oral contraceptives Yaz and Yasmin claim Bayer must reveal those secrets to the U.S. Food and Drug Administration.

On Oct. 27, they asked U.S. District Judge David Herndon to strip confidentiality from 1,241 pages of documents they want to present to FDA committees on Dec. 8.

On behalf of Kaitlyn Dietrick, one of about 10,000 women claiming injuries in Herndon's court, they asserted a constitutional right to petition the government.

They wrote that without Dietrick's assistance, FDA might overlook safety information and public health risks relating to contraceptives containing drospirenone.

They 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," they wrote.

"Bayer claims that it could be sanctioned for violating German law, but even the claimed threat of criminal sanctions in the foreign country for producing information does not compel a U.S. court to defer to the foreign national law," they wrote.

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

Bayer sold $3.4 billion in pharmaceutical products in North America last year. It employs more than 16,000 persons in North America, Dietrick's lawyers wrote.

They wrote that Dietrick brought her claim "to raise awareness surrounding this important safety issue."

They wrote that Bayer will submit massive briefing and have a carefully choreographed presentation to FDA advisory committees.

"Yet an individual citizen of the United States who, no one seriously denies, was almost killed by a drospirenone medication, is barred by the foreign and domestic corporations from presenting the evidence she has chosen in opposition," they wrote.

They wrote that the documents they would present to the committees were part of 3.65 million pages that Bayer marked as confidential.

"Defendants have broadly designated millions of pages of documents as confidential without a legitimate reason," they wrote.

"Although many documents designated by defendants contain information adverse to the defendants' interests in this litigation and perhaps even their public image, such reasons clearly do not satisfy the requirements for protected status," they wrote.

They proposed to unseal another 771 pages of documents showing conflicts of interest among FDA committee members.

On Nov. 9, Bayer answered that Dietrick could freely petition FDA and support her position with non confidential information.

"That plaintiff is restricted from petitioning FDA with confidential materials acquired from Bayer for use in this litigation does not constitute a First Amendment violation," Bayer's lawyers wrote.

"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," they wrote.

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

"Moreover, data protection enforcement agencies have the authority to shut down the business operations of companies found to be in violation," they wrote.

"If the information contained in these reports is made public, the highly competitive nature of the pharmaceutical industry would nearly guarantee that Bayer's competitors would use it to gain a competitive advantage over Bayer in the oral contraceptive market," they wrote.

John Galvin, of Fox Galvin of St. Louis, signed Bayer's brief.

Roger Denton, of Webster Groves, Missouri, signed Dietrick's brief.

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