Ex-Glaxo Lawyer Facing Charges Seeks King & Spalding Records, Filings Show - Bloomberg

A former GlaxoSmithKline Plc lawyer charged with obstructing a regulatory review of the company wants prosecutors to disclose data on law firm King & Spalding LLP’s work for the drugmaker during the probe.

Lawyers for Lauren Stevens asked the U.S. Justice Department to hand over files about Atlanta-based King & Spalding’s work on a 2002 Food and Drug Administration inquiry into Glaxo’s marketing of its Wellbutrin SR antidepressant, a Dec. 17 court filing shows.

Stevens, indicted last month on charges she obstructed the probe into whether Glaxo marketed Wellbutrin for unapproved uses, intends to tell jurors in her Feb. 1 trial that she relied on “advice of counsel” when making allegedly false statements about sales tactics, prosecutors said in a separate Dec. 17 filing in federal court in Greenbelt, Maryland.

“In responding to the FDA, the defendant worked with other attorneys, including both in-house GSK attorneys and attorneys from an outside law firm,” prosecutors said in the filing, while opposing Stevens’s request. They didn’t name King & Spalding.

Legal Advice

Stevens’s defense lawyers want all documents that “establish King & Spalding LLP received material information on which the firm based its legal advice with respect to GSK’s responses” to the FDA’s 2002 inquiry, according to a Dec. 7 letter included in court filings.

Mary Anne Rhyne, a Glaxo spokeswoman based in North Carolina, declined to comment on King & Spalding’s role in representing the London-based company in the FDA review.

Les Zuke, King & Spalding’s spokesman, said the firm wouldn’t comment on Stevens’s filing or any work done on behalf of Glaxo. Christina Sterling, a Boston-based spokeswoman for prosecutors, didn’t immediately return a phone call and e-mail seeking comment.

Prosecutors contend that Stevens, who lives in Durham, North Carolina, “engaged in a year-long effort” to deceive the FDA about the company’s off-label marketing campaign for Wellbutrin, according to court filings.

Under U.S. law, a doctor can prescribe a medicine for any condition, as long as the FDA has found its safe and effective. Drug companies aren’t allowed to promote a drug for uses other than those approved by the FDA.

In response to regulators’ request for information about Wellbutrin’s marketing in October 2002, Stevens allegedly sent a series of letters “that falsely denied the company had promoted the drug for off-label uses, even though she knew” the drugmaker had sponsored such marketing programs, prosecutors said in court filings.

Promotional Talks

The indictment alleges Stevens knew the company paid “numerous physicians to give promotional talks to other physicians” about unapproved uses for Wellbutrin and failed to provide slides given to the speakers, prosecutors claim.

Evidence will show that “a legal memorandum was prepared for Stevens that set forth the pros and cons” of producing the slides for the FDA, prosecutors said.

Stevens was warned in the memo that some of the slides “would provide incriminating evidence about potential off-label promotion of Wellbutrin SR that may be used against GSK in this or a future investigation,” prosecutors said. The government didn’t say who prepared the memo.

The case is being tried in the Maryland suburbs of Washington because the FDA is based in the area. In their letter to prosecutors, Stevens’s lawyers asked for all documents “from King & Spalding LLP regarding” the FDA’s request for Wellbutrin information.

Clarify Charges

They also want all statements by the law firm’s lawyers “related to their understanding that GSK employees did not promote Wellbutrin for off-label uses or that GSK management did not encourage” off-label sales of the drug, according to the letter.

The defense also asked U.S. District Judge Roger Titus to order prosecutors to clarify the charges against Stevens. She is charged with one count of obstructing an official proceeding, one count of falsifying and concealing documents and four counts of making false statements.

The first two charges carry maximum terms of 20 years, and the others carry terms of five years.

Defense lawyers contend that they shouldn’t have to “sift through millions of pages” of documents to identify statements and files prosecutors seek to use against Stevens.

“A review of the millions of documents alone will not enable Ms. Stevens to determine which statements the government alleges are false and which documents it alleges Ms. Stevens falsified, altered or concealed,” according to the filing.

The case is U.S. v. Stevens, 10-cr-694, U.S. District Court, District of Maryland (Greenbelt).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net

To contact the editor responsible for this story: David E. Rovella at drovella@bloomberg.net.

via bloomberg.com

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