The U.S. Supreme Court issued its decision in a Food Drug and Cosmetic Act preemption case Merck v. Albrecht. The case sought to settle whether a judge or jury should decide the fate of complex medical litigation claims barred by prior FDA action, and to articulate standards for such “clear evidence” preemption.
Allegations were recently raised that in the midst of VW’s attempts to restore broken trust, the company and its subsidiary Audi were secretly lying to customers and regulators by selling pre-production vehicles to the public that legally should have been headed for the junkyard. It’s a classic case of irony.
Oklahoma Attorney General announced a settlement in the opioid litigation with Purdue Pharma and the Sackler family. This is a significant step in the effort of the governmental entities to address the opioid epidemic.
The U.S. Supreme Court is expected this term to resolve conflicting opinions in False Claims Act (FCA) whistleblower litigation regarding whether an extended statute of limitations should apply to cases in which the government declines to intervene.
The SEC’s Office of the Whistleblower recently announced that it awarded $168 million to 13 whistleblowers in 2018 — that is more than half of the total $326 million awarded to whistleblowers since the program was created in 2010 under the Dodd-Frank Act.
Fundamental human rights include personal freedom and the right to determine the fate of one’s own mind and body. Such rights are all too often stripped away from millions of people worldwide, including what statistics indicate to be countless innocent children.
There are several areas of litigation worth keeping an eye on over the year ahead, with five in particular we’re working on that stand out to me in large part due to the urgent consumer and public health needs they hope to address. I’ve listed these five below, including my take on why they are noteworthy.
The FDA announced plans to “modernize” its fast-tracked 510(k) approval program for medical devices. Currently, this program doesn’t require clinical trials for new products that it believes are similar enough to previously approved devices to justify quickly placing them on the market.
On September 26, Mesothelioma Awareness Day, advocates will unite to raise awareness of the nearly 3,000 lives that are tragically lost each year in the U.S. due to mesothelioma and other asbestos-related diseases.