Monday, February 8, 2010

Suing doctors who use drugs as chemical straitjackets for children

It's true that the drug industry was hard hit last year with some pretty hefty fines for the illegal off-label promotion of drugs -- $1.4 billion against Eli Lilly for its off-label promotion of Zyprexa and $2.3 billion against Pfizer for doing the same with several drugs. But such fines, many say, are still considered the cost of doing business in an industry that raked in close to $300 billion in U.S. drug sales in 2008 (and more in 2009), according to IMS Health Reports.

Now, Alaska attorney Jim Gottstein has proposed a different and potentially more effective approach toward curbing the systemic over-drugging of economically disadvantaged youngsters in this country, a sad reality which I've written about here and here. According to one recent study, children covered by Medicaid are given anti-psychotics such as Zyprexa and Seroquel (which have serious side effects) four times as often as children whose parents have private insurance. These drugs are often prescribed as chemical straitjackets to control children whose parents or foster families are unable to give them the attention and parenting they need. That was certainly the case for four-year-old Rebecca Riley, who died from an overdose of psychoactive drugs prescribed by a psychiatrist at Tufts Medical Center, Kayoko Kifuji.

Gottstein has launched an initiative to sue doctors like Kifuji who blithely prescribe potent drugs that are not approved for use in children. These lawsuits, filed under a federal Qui Tam complaint, would target not only the individual doctors but the hospitals and clinics that employ them and the pharmacies that fill their prescriptions and submit them to Medicaid for reimbursement. It is Gottstein's contention that these prescriptions constitute Medicaid fraud since they are written for uses that are not medically accepted (i.e. off-label). There is legal precedent for this kind of argument. Indeed, the Department of Justice's news release announcing its $2.3 billion settlement with Pfizer says that the drug giant caused false claims to be submitted to government health care programs for uses that were not medically accepted indications. So if the feds can succeed with this kind of argument, why not individual claimants?

Gottstein is planning to discuss his medicaid fraud initiative in a lecture webinar on Feb. 24, sponsored by the International Center for the Study of Psychiatry and Psychology. So if you know of a disadvantaged child who was slapped on drugs he or she didn't need, you might want to listen in.


Michael Kirsch, M.D. said...

Alison, I read your post and the Boston Globe link about this tragic circumstance. Of course, ideally everyone should receive a drug for the right reason. Respectfully, the Globe piece, and your post, do not offer a balanced view of what occurred and the relevant facts (which are probably not known at present). Before I conclude that physician or hospital was negligent and reckless - as the article suggests - I would want to know the facts. Articles like this understandably affect readers. If those who are presented as 'guilty' are ultimately exonerated, then the damage has already been done. We physicians are sensitive to the unfairness of making flimsy allegations after an adverse event or tragedy has occurred.

marilynmann said...


How is a False Claims Act action against Eli Lilly precedent for FCA actions against individual physicians?


Alison Bass said...

As I understand it, Pfizer settled under the False Claims Act for promoting Geodon and other drugs in children for non-medically accepted indications. So the idea behind these lawsuits against individual physicians is that if they knowingly prescribed drugs in children for non medically accepted indications (i.e. indications not approved by the FDA), then they are liable under the False Claims Act. The courts, of course, will decide the merits of this argument.

Dr. Toby Watson said...

Yes Alison, you are exactly right. Any MD and employer to engages in prescribing a medicine to a child, whereby that drug is not FDA approved AND the bill is being paid for by Medicaid, has committed fraud/a crime. Any individual can sue on behalf of the government, in an attempt to recapture the financial loss. This may help promote Evidence Based Practices and slow down the massive drugging of children and promotion by drug companies. $20-$29...this is a must attend webinar.
Dr. Toby Watson, PsyD,

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