'Qui Tam' Suit Says Hospira Billed Government For Faulty Infusion Pumps
A newly unsealed whistleblower suit filed in Illinois federal court in 2016 alleges the company failed to alert US FDA or customers to software and power cable issues that could have harmed patients and users. Pfizer, which purchased Hospira in 2015 and sold the infusion pump unit in 2017, says the case has no merit, and the government has declined to intervene.
You may also be interested in...
In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the US FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.
The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.
The all-day event will include sessions on Medical Device Reports, recalls and Sec. 522 postmarket studies.