Please login to the form below

Not currently logged in
Email:
Password:

Shire pays record $350m to settle US kickback allegations

Charges centred around diabetic foot ulcer treatment Dermagraft, which it sold in 2014

ShireUK drugmaker Shire has agreed to pay $350m to the US government to settle charges that it used "kickbacks and other unlawful methods" to persuade clinics to use one of its products.

The Department of Justice contended that Shire and ABH made "hundreds of millions of dollars of false claims" for Dermagraft, a human skin substitute product for diabetic foot ulcers which the company acquired along with Advanced BioHealing in 2011 for $750m, and then divested three years later.

The DoJ accused Shire salespersons of unlawfully inducing clinics and physicians with "lavish dinners, drinks, entertainment and travel," as well as providing medical equipment and supplies. The DoJ also claims Shire made payments for "purported speaking engagements and bogus case studies", as well as other financial inducements, to boost Dermagraft sales.

The settlement also resolves allegations that Shire and ABH promoted Dermagraft for off-label uses. It stems from six lawsuits brought against the company under the whistleblower provisions of the US False Claims Act.

"This settlement represents the largest False Claims Act recovery by the United States in a kickback case involving a medical device," commented Principal Deputy Assistant Attorney General Benjamin Mizer, who heads the DoJ's civil division.

"Kickbacks by suppliers of healthcare goods and services cast a pall over the integrity of our healthcare system. Patients deserve the unfettered, independent judgment of their health care professionals," Mizer added.

Dermagraft has proved to be something of an expensive debacle for Shire, which took a $650m charge when it offloaded the product to Organogenesis, a decision prompted by its failure to get approval for leg ulcers.

The UK firm said last year it planned to settle the allegations, but the scale of the payment has only just been finalised. Shire said it has not admitted "wrongdoing of any kind" in deciding to settle. 

Article by
Phil Taylor

13th January 2017

From: Sales

Share

Tags

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Havas Lynx Group

We are the Havas Lynx Group. Devoted to fresh thinking. Changing the way the world does healthcare communications for the...

Latest intelligence

Choose to challenge for women’s health on this International Women's Day
Today, you could be taking the time to reflect on the inspirational achievements of many women across the world. Or maybe you’re a woman yourself, and you want to take...
#DemandDiversity: For International Women's Day, we ask... why do women often suffer from more side effects than men?
Women are largely prescribed exactly the same treatment regimens as men, with no account for the underlying differences in physiology and drug metabolism between the sexes....
Good design saves lives
Good design and creative thinking are essential if we are to improve on existing problems in new ways, which is why design and creativity within healthcare is vital. Health is...

Infographics