Product News and Recalls

Shire Settlement over Drug Marketing Totals $56.5 Million

In a recent announcement from the U.S. Department of Justice, a whistle-blower lawsuit against the major pharmaceutical company Shire resulted in a $56.5 million settlement. An article in First Word Pharma reports that the Shire CEO is “pleased to have reached a resolution” over the improper marketing of a number of its drugs.

The lawsuit claims that the company “violated the False Claims Act by improperly marketing and promoting several drugs.” The claim alleged that Shire was falsely marketing its ADHD medication Adderall XR (amphetamine/dextroamphetamine) for uses that were lacking clinical data and support. The suit claimed that the company overstated the effectiveness of Adderall and made marketing claims that were not supported by studies of the drug.

In addition to the Adderall claims, it was also alleged that Shire marketing and sales representatives made misleading statements regarding the addictive potential as well as efficacy of another ADHD drug, Vyvanse (lisdexamfetamine dimesylate). These statements were delivered to Medicaid formulary committees as well as physicians.

Another ADHD drug by the name of Daytrana was also a subject of the suit. Shire was accused of downplaying the addictive potential of Daytrana. Finally, the ulcerative colitis drug Lialda was also allegedly promoted and marketed for off-label use, or uses that have not been approved by the FDA.

Shire, an Irish company, denied any wrongdoing in the case.

Much of the litigation against large pharmaceutical companies involves claims of faulty marketing. Often times, in an effort to increases sales revenue, companies market their products in ways that downplay risks or encourage alternative uses that may not be supported by clinical studies. If you or a loved one suffered an injury as a result of pharmaceutical negligence or unknown risks of a medication, you may be entitled to financial compensation. Contact a Lopez McHugh attorney today at (877) 737-8525 or fill out a contact form on our website for a free initial consultation.