Product News and Recalls

Critics doubt record settlement will be enough

The $3 billion fine recently leveled against GlaxoSmithKline is the largest settlement ever involving a pharmaceutical company. But in light of the enormous profits that the British pharmaceutical giant brings in, some critics wonder whether even that will be enough to dissuade companies from engaging in dangerous fraud.

GlaxoSmithKline pleaded guilty to marketing drugs for unapproved uses, according to a New York Times report. Among the charges is that the company promoted the use of one of its drugs for children, using tactics that included helping to publish a medical journal article that misreported data from a clinical trial.

A warning was later added to that drug that it, like other antidepressants, might increase the risk of suicidal thoughts in teenagers. GlaxoSmithKline’s tactics allegedly included courting doctors by paying for trips to Jamaica and Bermuda, as well as spa treatments and hunting excursions.

The New York Times quotes Eliot Spitzer, the former New York attorney general who sued GlaxoSmithKline in 2004 over similar accusations involving its drugs, as saying:

“What we’re learning is that money doesn’t deter corporate malfeasance. The only thing that will work in my view is C.E.O.’s and officials being forced to resign and individual culpability being enforced.”

Plaintiffs in thousands of lawsuits allege that manufacturers of antidepressants classified as selective serotonin reuptake inhibitors deliberately withheld information about risky side effects from patients.

A number of studies have linked SSRI antidepressants – which include Prozac and Zoloft – with potentially dangerous birth defects in babies born to mothers who take the drugs during pregnancy.

The New York Times reports that this has been a record year for money recovered by the federal government under its so-called whistle-blower law. In May, Abbott Laboratories settled for $1.6 billion over its marketing of the antiseizure drug Depakote. And an agreement with Johnson & Johnson that could result in a fine of as much as $2 billion is said to be imminent over its off-label promotion of an antipsychotic drug, Risperdal.

Patrick Burns, spokesman for the whistle-blower advocacy group Taxpayers Against Fraud, said at least $10 billion has been agreed to in settlements this fiscal year, which ends in September.

But Burns said the settlement amount represents only a fraction of what GlaxoSmithKline made on the drugs at the center of the fraud allegations.

“So a $3 billion settlement for half a dozen drugs over 10 years can be rationalized as the cost of doing business,” Burns said.

Patients should consult their doctors before making any changes in their medication. A consultation with an SSRI lawyer is also important if there are significant injuries from SSRIs.

See the story here:

http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=1&_r=1