By David Egilman
On September 15, 2008 pharmaceutical giant Eli Lilly pleaded guilty to committing the crime of off-label marketing of Zyprexa, an antipsychotic. Lilly has profited handsomely from the marketing of this drug, making over $30 billion. The Department of Justice (DOJ) claims that the $1.42 billion dollar fine agreed to by Lilly as part of its guilty plea is the largest ever paid to settle such a violation, but it represents only 3.5% of the company’s Zyprexa sales. DOJ’s willingness to accept a misdemeanor plea and a trivial fine is troubling given Lilly’s two prior convictions for criminal conduct in the marketing of its drugs. In 1985, Lilly pleaded guilty to 25 counts of unintentional deception in the marketing of its anti-arthritic drug Oraflex, including hiding 23 death cases from the FDA. And in 2005, Lilly pleaded guilty to off-label marketing of Evista, a drug used to treat and prevent osteoporosis in postmenopausal women.
Under statutes like California’s notorious “three strikes” law, repeat criminals receive life sentences for committing non-violent crimes that involve far less money or harm to society (e.g., shoplifting $153 worth of videotapes). Even excluding Zyprexa, Lilly’s crimes resulted in the deaths of tens, if not thousands, of innocent victims, but have had far less severe consequences for the company than for individuals convicted of petty crimes.
I have a certain personal familiarly with the Zyprexa case, since I released some of the documents upon which the criminal case was based. These same documents had been sealed by a federal judge at the request of both plaintiffs’ and defense counsel. (About a year before I released the documents to a lawyer in Alaska, some plaintiffs’ counsel sought to unseal them, but the Judge never ruled on this motion.) In the end, these same documents were used by DOJ to build its criminal case against Lilly, and it is unclear whether that case would ever have proceeded had the documents remained secret. Most judges should be able to recognize that documents that reveal evidence of crimes should not be treated as “trade secrets” and protected from disclosure. After all, some drug companies are convicted felons for doing similar things (Pfizer and AstraZeneca) and almost all have violated FDA marketing rules, so the techniques of off-label marketing and lying are well known and commonly practiced.
Judges should stop sealing documents that contain evidence of criminal conduct and important information on drug side effects. Moreover, they should send all discovery in pharmaceutical cases to the DOJ and the FDA for review if they intend to seal them. More than pursuit of criminals and deterrence is involved here. Special Agent-in-Charge Kim Rice of FDA’s Office of Criminal Investigations said, “Today’s announcement of the filing of a criminal charge and the unprecedented terms of this settlement demonstrate the government’s increasing efforts aimed at pharmaceutical companies that choose to put profits ahead of the public’s health.” Documents produced in discovery often contain important health information that drug companies have hidden from the FDA.
The plaintiff lawyers who enrich themselves with settlements are most negligent for agreeing to these agreements, because they agree to seal documents that include information that their clients’ doctors need to treat them. The lawyers do not inform their clients or seek their approval of the secrecy agreements.
I paid Lilly $100,000 to avoid possible jail time for releasing the documents. As I have previously published , confidentiality agreements that prohibit disclosure of important information that may impact public health to state and federal authorities (such as NIOSH, OSHA, and the FDA) should be illegal. Criminal penalties should be applied to corporations and private physicians who fail to disclose this information, and Congress should grant immunity from litigation to physicians and others for violation of confidentiality agreements in these situations.
David S. Egilman, MD, MPH is Clinical Associate Professor at Brown
University’s Department of Community Health.