Mass Attorney General Files Suit Against Ortho-McNeil-Janssen for Illegally Marketing Risperdal

MARTHA COAKLEY
ATTORNEY GENERAL
Press Release
August 01, 2011

BOSTON – Drug manufacturer Ortho-McNeil-Janssen (“Janssen”) is being sued by Attorney General Martha Coakley’s office for illegally marketing Risperdal, an atypical antipsychotic medication. The lawsuit alleges that Janssen promoted the drug to treat elderly dementia and a number of uses in children and adolescents when these uses had not been shown to be safe and effective and had not been approved by the U.S. Food and Drug Administration (“FDA”).

The complaint, filed in Suffolk Superior Court, further alleges that Janssen failed to disclose serious risks associated with Risperdal’s use, including the risk of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.

“Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Attorney General Coakley said. “Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing to disclose serious risks associated with Risperdal’s use.”

According to the Attorney General’s lawsuit, Janssen’s unfair and deceptive practices included:

Omitting and/or concealing material facts regarding Risperdal’s efficacy and safety in its communications with Massachusetts health care providers and consumers;

• Concealing, omitting or minimizing the side effects and risks associated with Risperdal’s use;
• Promoting Risperdal to treat elderly dementia without disclosing to prescribers the serious risks associated with Risperdal’s use in dementia patients, including an increased risk of death;
• Promoting Risperdal to treat elderly dementia without disclosing to prescribers that the U.S. Food & Drug Administration had rejected the company’s request to market Risperdal for this use because of unaddressed safety concerns;
• Promoting Risperdal’s use as safe and effective to treat conduct disorder and other conditions in children for more than a decade before receiving FDA approval to market Risperdal to treat any conditions in children;
• Making misleading and deceptive statements to prescribers about Risperdal’s safety, particularly with respect to weight gain and the risk of developing diabetes;
• Paying physicians to participate in sham consulting programs that were, in fact, thinly disguised marketing programs touting unapproved uses;
• Targeting its sales and marketing efforts to prescribers who rarely, if ever, prescribe Risperdal for its FDA-approved uses, primarily the treatment of schizophrenia and bipolar mood disorder.

Janssen’s illegal marketing and sales tactics helped the company generate hundreds of millions of dollars in sales in the Commonwealth, according to the complaint. Citing company documents, the lawsuit notes that these illegal tactics helped make Risperdal a market leader in both the children and adolescent and elderly market segments.

This matter is being handled by Assistant Attorneys General Sarah Ragland, Wendoly Langlois and Emiliano Mazlen, with assistance from division chief Thomas O’Brien and paralegal Marie Defer, all of the Attorney General Coakley’s Health Care Division.

Former Glaxo Lawyer Charged With Obstruction of Probe

Former Glaxo Lawyer Charged With Obstruction of Probe


By THOMAS CATAN And PETER LOFTUS

Federal prosecutors charged a former GlaxoSmithKline PLC attorney with lying to obstruct a U.S. investigation into whether the pharmaceutical company illegally marketed an antidepressant as a weight-loss drug.

The Department of Justice on Tuesday indicted Lauren Stevens, a former vice president at the drug company, with four counts of making false statements to the Food and Drug Administration, as well as obstructing its investigation and withholding documents.
The indictment reflects a new U.S. effort to hold company executives legally accountable for criminal wrongdoing, rather than simply fining the companies for violations.

"This indictment shows that we will investigate those responsible for unlawful acts done on a company's behalf," said Richard DesLauriers, a special agent at the Federal Bureau of Investigation.

Ms. Stevens's lawyer said she did nothing wrong.

"Lauren Stevens is an utterly decent and honorable woman," Brien O'Connor said. "Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer."

The indictment didn't identify the company or drug involved, but Glaxo confirmed that Ms Stevens formerly worked in its U.S. legal department and that the investigation involved its antidepressant Wellbutrin SR. It declined to comment further.

In its 2009 annual report, Glaxo disclosed that the government was inquiring about the company's response to an October 2002 letter from the FDA. The letter asked for information on the company's "alleged promotion of Wellbutrin SR for off-label use," meaning a use for which the drug didn't have FDA approval. Antidepressants have at times been associated with weight loss, though also with weight gain.

The U.S. attorney's office in Massachusetts has been leading a long-running investigation into Glaxo's marketing of several products between 1997 and 2004, including Wellbutrin SR, Glaxo has disclosed.

Glaxo first disclosed the existence of the investigation in 2004, and last year said it was taking a $400 million charge in relation to the probe, in a possible sign that it was approaching a settlement.

The Justice Department, acting on behalf of the FDA, has recently reached a slew of recent legal settlements with pharmaceutical companies for various violations, many of them prompted by information from whistleblowers.

Last month, GSK pleaded guilty to charges that it knowingly sold adulterated drugs made at its factory in Puerto Rico, paying $750 million in fines. The previous month, Allergan Inc. pleaded guilty to charges that the company actively promoted its top-selling product, the wrinkle-smoothing drug Botox, for unapproved medical uses such as treating headaches and pain. It paid $600 million to resolved the charges.

No individuals were indicted in those cases. To have an effective deterrent effect, the Justice Department has emphasized that it wishes to prosecute individual executives involved in corporate wrongdoing, so that the fines aren't simply seen as a cost of doing business.

The Wall Street Journal reported in March that the Food and Drug Administration planned to increase prosecutions of industry executives and corporate counsel.

Tuesday's indictment alleged that Ms. Stevens made a series of false statements and deliberately withheld potentially incriminating evidence from investigators. For example, she allegedly decided not to submit presentations made on the company's behalf by doctors who promoted the drug for unapproved purposes, prosecutors said.

A memorandum she requested to help decide whether she should hand over the slide sets warned that such a move would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation," the indictment said.

Instead of providing the slides, Ms. Stevens wrote that the company's responses to the FDA's requests were "final" and "complete." The indictment says a company employee reported the alleged off-label promotion of the drug and sent the FDA some of the missing slides.
—Jeanne Whalen and Alicia Mundy contributed to this article.

Write to Thomas Catan at thomas.catan@wsj.com and Peter Loftus at peter.loftus@dowjones.com