Healthy Skepticism Library item: 14472

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E.
Lilly To Take $1.4 Billion Charge For Zyprexa Probe
Pharmalot 2008 Oct 21
http://www.pharmalot.com/2008/10/lilly-to-take-14-billion-charge-for-zyprexa-probe/

Full text:

The drugmaker is in “advanced discussions” to settle a long-standing criminal investigation into its marketing of the antipsychotic. The disclosure comes just two weeks after Lilly settled an 18-month probe with 32 states, which contended Lilly violated consumer protection laws by urging docs to prescribe Zyprexa to patients who did not need the drug (back story).

Today, Lilly says it has “incorporate an enhanced compliance program,” which includes guidelines issued by the US Department of Health and Human Service’s Office of Inspector General. “The government’s investigation…has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues,” Robert Armitage, Lilly’s senior vp and general counsel, says in a statement.

The investigation by the US Attorney in Philadelphia began in 2004 and last November, Lilly received a grand jury subpoena. Meanwhile, the State Medicaid Fraud Control Units of more than 30 states coordinated its investigation with the feds into Medicaid-related claims concerning Zyprexa marketing. However, 11 other states – Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, West Virginia, Connecticut, Arkansas and Idaho – have filed lawsuits over Zyprexa and are not participating in the coordinated probe.

Not clear what plea Lilly will make. The US Attorney’s office declined to comment, and we are awaiting comment from Lilly.

In its statement, Lilly says that, if the ongoing discussions are successfully concluded, the drugmaker expects that they would settle the Zyprexa-related federal claims, as well as similar Medicaid-related claims of states participating in the settlement. Separately, Lilly paid $15 million to settle a lawsuit last March filed by the state of Alaska (see here).

Lilly, however, continues to face a potential class-action lawsuit by third-party payors in federal court in New York (back story) and the presiding judge has urged the drugmaker to settle those cases or possibly face racketeering charges.

UPDATE: We were sent a comment from Alex Reinert, an attorney representing David Egilman, a Brown University professor and former expert witness for plaintiffs’ lawyers in the Zyprexa litigation, who was fined $100,000 for leaking Zyprexa documents to the media (back story):

“Dr. Egilman paid a heavy personal price as a result of his release of documents that revealed Eli Lilly’s criminal conduct. Eli Lilly’s guilty plea shows that, at the same time it was threatening Dr. Egilman with criminal sanctions for revealing allegedly confidential documents, it was trying to hide its own serious misconduct, criminal activity that threatened the well-being of its patients for the sake of its profits. It is doubtful that any of this would ever have come to light but for Dr. Egilman’s actions.

“Dr. Egilman’s experience is a lesson for our justice system in which secrecy has become the presumption. Unfortunately, in a case like this all of the stakeholders in the case – the attorneys on both sides and the judge – have an interest in agreeing to overbroad protective orders and protecting from open view information with substantial implications for public health. Indeed, in the end, it is often the patients, their families, and the general public that is left in the dark, to their detriment. Hopefully, we will learn from this case – if we don’t, then we had better hope that there are more individuals like Dr. Egilman out there.”