Forest Pharmaceuticals pleaded guilty to violating U.S. Food and Drug Administration (FDA) laws on 3 counts. The drug in question, Levothroid, was sold to treat hypothyroidism.
The 3 counts that Forest Pharmaceuticals pled guilty to include:
- marketing and distributing an unapproved drug;
- distribution of a misbranded drug; and
- obstructing FDA investigations.
Forest Pharmaceuticals, despite receiving a warning that it was to stop the manufacturing and distribution of Levothroid, not only continued to distribute the drug but also increased the distribution.
They also distributed a misbranded drug for an off-label promotion of Celexa. This drug was approved only for adult use, yet they promoted it for pediatric use.
Additionally, Forest Pharmaceuticals obstructed investigations by the FDA when employees made false statements concerning the drug during a 2003 FDA inspection.
They have agreed to pay more than $300 million, which includes criminal penalties of $164 million. The FDA hopes that this serves as a warning to other pharmaceutical companies that marketing and distributing unapproved drugs are a serious violation.
Consumers should know, however, that this lawsuit is pertaining to a previously unapproved drug. Levothroid has since been approved by the FDA and is in compliance with FDA regulations.
Injuries from a medication error can be life-altering. If you've been injured by a medication error or any other type of medical negligence, contact a Louisville medical malpractice attorney who can evaluate your case and determine liability.
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A Louisville medical malpractice attorney at Gray and White Law can help you handle every aspect of your medical malpractice injury claim from determining liability to working with medical experts to validate your claim. If you've been injured in Kentucky, contact us today for a free evaluation of your case 888-450-4456 or 502-210- 8942