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Monday, September 08, 2008

Courts - Update on: "Judge Rules Drug Documents Must Be Returned to Eli Lilly"

The ILB has had a number of entries on the Eli Lilly Zyprexa litigation, including this one from Feb. 14, 2007, quoting the NYT:

A federal district judge in Brooklyn (ED NY) ruled yesterday that confidential marketing materials belonging to Eli Lilly & Company about its top-selling anti-psychotic drug Zyprexa must be returned to the company by a doctor and a lawyer who, the judge said, engaged in a scheme to leak them to the news media.
and including a link to the opinion.

Today Mark Fass of The National Law Journal reports, in a story headed "Narrow Zyprexa Class Certified, Sealed Files Released," that begins:

A federal judge in Brooklyn, N.Y., has certified a class of "third-party payors," such as pension funds, labor unions and insurance companies, in their claim that the drug giant Eli Lilly committed fraud by overpricing its anti-psychotic drug Zyprexa while overstating the drug's utility and understating its drawbacks.

The decision was a partial victory for both sides, as Eastern District of New York Judge Jack B. Weinstein certified only the plaintiffs' Racketeer Influenced and Corrupt Organizations Act claims and not their state-law ones, and on a narrower basis than the plaintiffs sought. The judge also declined to certify a class of individual-payor claims.

"Total denial of certification would constitute the death knell of the action," Weinstein wrote in Zyprexa Products Liability Litigation, 04-MD-1596. "Almost all plaintiffs' claims would be too small to individually support this costly litigation. Under such circumstances, absent an unusual situation, the rule to be applied in deciding to deny certification is essentially that for summary judgment."

Weinstein's 295-page decision also marks the apparent end of the controversy surrounding approximately 350 sealed documents that were obtained in a legal end-run by New York Times reporter Alex Berenson.

Eighteen months after Weinstein derided the "conspiracy" orchestrated by Berenson and two sympathetic attorneys to obtain the documents -- primarily internal Lilly documents and e-mails between its top managers -- the judge ordered the documents unsealed.

"Public access is now advisable because this litigation involves issues of great public interest, the health of hundreds of thousands of people, fundamental questions about our system of approval and monitoring of pharmaceutical products, and the funding for many health and insurance benefit plans," Weinstein wrote.

"Public and private agencies and organizations have a right to be informed. At this stage public disclosure, congruent with our long tradition of open courts, is desirable."

As summarized by Weinstein in a 78-page decision in February 2007, the Times' Berenson obtained documents, which he knew were subject to a protective order, by convincing an Alaska attorney involved in an "unconnected" case to subpoena them. After that attorney, James B. Gottstein, obtained the documents, he released them to Berenson and others, and they quickly found their way into Times articles and onto the Internet.

In his 2007 decision, Weinstein enjoined a number of the individual conspirators from further disseminating the documents and ordered them to return any in their possession.

Weinstein has now ordered the seal removed, though he referred the unsealing to a special master to "avoid any unnecessary embarrassment" to any party.

"Based on this country's long-standing tradition of open access to the courts and court records, the enormous number of people who have taken or will take Zyprexa, the involvement of government regulatory bodies, absent class members' interest in the proceeding, and the age of the documents, the motions to unseal are granted," Weinstein wrote."

Posted by Marcia Oddi on September 8, 2008 08:40 AM
Posted to Courts in general