The US Department of Justice collected more than $5.6bn in settlements from civil cases involving fraud and false claims against the government in fiscal year 2021. Of that total, $1.6bn stemmed from cases brought by whistleblowers.
The $5.6bn in settlement and judgement claims the US Department of Justice obtained last year is the second-largest annual total in the history of the False Claims Act, which was enacted in 1863, and the largest net since 2014.
Since Congress strengthened the FCA in 1986 by increasing potential damages and penalties, the government has collected more than $70bn in claims, according to the DoJ.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
