Shire fined $350 million in largest-ever bribery case of its kind
Shire Pharmaceuticals is set to pay a $350 million settlement over accusations that it had bribed clinicians and physicians by using kickbacks to encourage the use of its bioengineered human skin substitute Dermagraft, a diabetic foot ulcer treatment, in the largest ever case of its kind.
Dermagraft is manufactured by Advanced BioHealing (ABH), a company focused on the development and commercialisation of cell-based and tissue-engineered products which Shire picked up in 2011 and sold in 2014; it is during this period which the accusations fall into, according to the Department of Justice (DoJ).
"The settlement resolves allegations that Dermagraft salespersons unlawfully induced clinics and physicians with lavish dinners, drinks, entertainment and travel; medical equipment and supplies; unwarranted payments for purported speaking engagements and bogus case studies; and cash, credits and rebates, to induce the use of Dermagraft," the DoJ said.
On top of these accusations, Shire allegedly illegally marketed the product for indications outside of those already approved by the FDA and increased its price by using falsified evidence.
Benjamin C. Mizer, head of the Justice Department's Civil Division added: "This settlement represents the largest False Claims Act recovery by the United States in a kickback case involving a medical device...Kickbacks by suppliers of healthcare goods and services cast a pall over the integrity of our health care system. Patients deserve the unfettered, independent judgment of their health care professionals."
The company spoke out in a statement, confirming the settlement but denying any wrongdoing: "As the DoJ announced today, that settlement has now been finalised. In entering into the settlement, Shire has not admitted wrongdoing of any kind. We are pleased to have reached a resolution on this matter, and believe that the terms of the resolution reflect Shire's extraordinary cooperation with the Department of Justice throughout its lengthy investigation."