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In 2012, GlaxoSmithKline (GSK), manufacturer of such medications as Paxil, Avandia, and Wellbutrin, paid what was at the time the highest settlement for criminal allegations paid by a pharmaceutical company. Accused of promoting drugs for off-label uses not approved by the FDA, the company doled out $1 billion for criminal wrongdoing, and $2 billion to settle civil liabilities. Among its marketing activities, the company allegedly helped to publish a medical journal article that misreported data from a clinical trial.

Now, the company is paying again. On July 26, 2013, they agreed to pay the state of Louisiana $45 million to settle lawsuits also accusing it of improperly marketing the diabetes drug Avandia and other medications.

Avandia Linked with Heart Problems

It was in 2011 that Louisiana Attorney General Buddy Caldwell filed a lawsuit against GSK, alleging the company misrepresented the safety and efficacy of Avandia, causing doctors to submit more than 304,000 “false claims” for Avandia for Louisiana Medicaid recipients.

In 2007, the FDA required a black-box warning on Avandia concerning the risk of congestive heart failure and myocardial ischemia. The drug, which is prescribed for patients with type 2 diabetes, has been linked with causing or worsening congestive heart failure in some patients. Clinical studies indicate that the drug can increase risk by 43 percent, and may double the risk of heart failure after one year of use.

Plaintiffs who have filed lawsuits against GSK claiming heart injuries state the company knew about the risks and failed to provide adequate warnings for doctors and patients. A two-year investigation by the U.S. Senate Finance Committee showed that GSK knew of the cardiovascular dangers, but tried to stifle concerns from doctors.

To date, more than 50,000 Avandia lawsuits have been filed in courts across the United States.

GSK Fails to Admit Any Wrongdoing

It’s not only Avandia, however, that GSK allegedly over-promoted. In this Louisiana lawsuit and in many others, the company was also accused of marketing other drugs for off-label uses. They advertised Wellbutrin, for example, which is FDA-approved as an antidepressant, as a weight-loss aid and for the treatment of some sexual disorders.

GSK has yet to see the end of these lawsuits. This latest settlement in Louisiana comes at the same time that the company resolved pending litigation with seven other states: Mississippi, South Carolina, Utah, New Mexico, West Virginia, Maryland, and Kentucky. The company agreed to pay $229 million, which will be split among the states.

Despite all the settlements, GSK has not admitted fault. Instead, the company stated that it has agreed to settlements simply to avoid the expense and uncertainty of further litigation and trials. “The company did not admit to any wrongdoing or liability of any kind under these states’ laws in this settlement,” the company said in a statement.


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