In the largest settlement yet reached against a pharmaceutical company, the British drug manufacturer GlaxoSmithKline (“GSK”) has agreed to plead guilty to criminal charges and pay $3 billion in fines for marketing of three of its antidepressant drugs for off label uses (i.e., uses not approved by the FDA). The…
In a case that illustrates the growing number of off-label promotion cases filed under the False Claims Act, on May 7th it was announced that Abbott Laboratories had agreed to pay $1.6 billion to settle allegations that it engaged in fraudulent marketing of its drug Depakote. The global settlement included…
The U.S. Supreme Court has agreed to hear a challenge to the Ninth Circuit’s recent ruling in a securities fraud class action lawsuit against Amgen Inc., the world’s largest biotechnology company. In the shareholder action, investors in Amgen have alleged that the company misrepresented safety concerns surrounding two of its…
Abbott Labratories Inc., manufacturer of the pharmaceutical drug Depakote, has pleaded guilty to charges that the company misbranded Depakote by promoting unapproved uses of the drug to control schizophrenia as well as agitation and aggression in elderly patient with dementia, when neither use was approved by the Food and Drug…
Allergan recently brought an injunctive action against the FDA asserting the unconstitutionality of several of its provisions regulating off-label promotion. Advancing their First Amendment argument, Allergan employs many of the same arguments put forth in Caronia (for more information on this topic, see here). However, a primary difference distinguishing Allergan…
The First Amendment of the United States Constitution protects the freedom of speech. Not all forms of speech, however, receive total protection, such as yelling “fire” in a crowded theater if doing so is likely to cause injury. So-called “commercial speech” is a category of speech afforded partial, but not…
In the wake of a large settlement (for more, see here), GlaxoSmithKline attorney Lauren Stevens was indicted for obstruction and making false statements to the FDA. Allegedly, the attorney withheld incriminating documents and made misrepresentations in letters sent to the FDA. In addition to actions related to poor manufacturing, charges…
The DOJ reported today that SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, pleaded guilty to False Claims Act charges and agreed to a fine totaling $750 million. The total includes a criminal fine of $150 million and a civil False Claims Act fine of $600 million. This case…
U.S. Senator Charles Grassley (R-Iowa), a long-time proponent of the False Claims Act and an anti-fraud advocate, has recently criticized reports of high-volume prescribers. In particular, Grassley addresses those prescribing extremely large quantities of mental health drugs. Recently, many pharmaceutical companies have agreed to large settlements involving the off-label promotion…
On November 17, 2008, two whistleblowers filed a qui tam action against Medtronic, a medical device manufacturer, alleging off-label promotion of Cardioplate, a heart device. The U.S. District Court in Houston recently granted Medtronic a motion to dismiss the case. The device is FDA approved for ablating (removing) tissue to…