The giant United Kingdom-based pharmaceutical company, GlaxoSmithKline Plc (“Glaxo”), has allegedly agreed to pay $3 billion to settle criminal and civil claims that it illegally promoted two of its premiere drugs, Paxil and Wellbutrin, and that it failed to report clinical safety data regarding another of its premiere drugs, Avandia. as well as other claims.
The $3 billion payment includes a criminal fine in the amount of $956.8 million, forfeiture of $43 million, a civil settlement in the amount of $300 million for failing to provide Medicaid’s drug program with the best available prices and for failing to pay Medicaid the full amount of appropriate rebates, and a civil settlement in the amount of $1.04 billion for allegedly marketing some of its drugs for “off-label” uses.
Glaxo has agreed to plead guilty to marketing Paxil and Wellbutrin for uses that were not approved by the FDA, which are misdemeanors, although Glaxo does not admit to any wrongdoing (Glaxo allegedly promoted Paxil for treatment of depression in children under the age of 18 and marketed Wellbutrin for use in weight loss, treatment of sexual dysfunction, and in the treatment of substance abuse, which were uses not approved by the FDA). While medical prescribers are permitted under federal law to prescribe medications for “off-label” uses, drug manufacturers are prohibited from marketing their drugs for such unapproved uses.
The claims involving Glaxo’s diabetes drug Avandia involve Glaxo’s alleged failure to provide federal regulators with certain safety data from 2001 to 2007. In 2007, the FDA added two black-box safety warnings to Avandia’s label to warn about the potential risk of congestive heart failure and heart attack.
The investigation into Glaxo’s marketing practices with regard to nine of its drugs, including Avandia and Advair, began seven years ago in Colorado and was transferred to federal authorities in Massachusetts. The investigation focused on Glaxo’s practices from 1997 to 2004. It was reported that Glaxo’s agreement to the settlements was stated in documents filed in the U.S. federal court in Boston, Massachusetts, on July 2, 2012.
U.S. v. GlaxoSmithKline LLC, Case No. 12-10206, U.S. District Court for the District of Massachusetts.
The safety and efficacy of our nation’s drug supplies must be above and beyond reproach. We all rely on the fact that the medications that are prescribed for us are safe for our use and that the risks of their use are known, established, reported, and reasonable when our medication prescribers perform their risk-benefit analysis in light of our individual needs, our unique medical conditions, and our own circumstances.
If drug manufacturers and suppliers fail to adequately and competently research, investigate, and test the safety and efficacy of their drugs, or attempt to hide unfavorable data regarding their drugs, then lives can be devastated or destroyed. Who knows how many lives have been negatively impacted because drug manufacturers failed to fully and timely provide unfavorable but highly relevant information regarding their drugs to drug prescribers, which would have altered their decisions with regard to ordering certain medications for their patients.
Perhaps Glaxo was let off easy by paying only fines under the circumstances — if patients became debilitated or died as a result of taking certain medications that would not have been prescribed if relevant information had been disseminated and known, no amount of monetary fines paid to the government would be fair or just.
If you, a family member, or a loved one suffered serious or fatal consequences as a result of a medication or drug, you should promptly seek the advice of a medical malpractice attorney who handles such claims who may be willing and able to investigate your possible drug claim for you.
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