January 22, 2009 The Pump Handle 1Comment

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.

One thought on “Crimes and Confidentiality

  1. Homicide Charges For Corporations

    , longtime district attorney of Milwaukee County,
    (retired 12 / 31 / 2006 ), was best known for prosecuting Jeffrey Dahmer.
    But McCann has also prosecuted ten corporations for
    reckless homicide over the last two decades and had won every case. (Rough draft posted with active reference links)


    My prior rough draft of “Toxic Revelations” can be found witrha Google search “Toxic Revelations”. The rough draft comes right up at the top of the search.The reference “Poison For Profit” cited in “Toxic Revelations” and below was  removed from the Internet (censored) and IS NOT in the Internet Archive Wayback Machine
    But a simple Google search on the title and authors name will reveal multiple re-posting of the entire web cite report that has been and still is being re-posted by “advocates”.Google search terms:
    By Ashley Simmons Hotz May 15, 2002
    The huge transnational companies that produce toxic chemicals found in
    pesticides, herbicides and industrial and household products profit not only from the sale of these products, but also from the symptoms and chronic illnesses that they can trigger.

    (“They” also control the major pharmecuetical companies).
    h t t p : / / w w w . redflagsweekly .  c o m/storm_warnings/poison . h t ml

    I believe the pharmaceutical companies are using
    the revolving door
    ” from these companies into Washington DC
    to get their executives into many of the high ranking administration
    offices of our government, in Washington DC. From the National
    Institute of Health to the Food and Drug Administration and beyond.

    The revolving door” is easily shown with an
    Internet http://www.google.com search term,
    “revolving door washington DC drugs chemical companies”.

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