Today’s decision by the Sixth Circuit Court of Appeals addressing the public disclosure of the ARCOS (Automation of Reports and Consolidated Orders System maintained by the Federal Drug Enforcement Agency, DEA, of controlled substances from their point of manufacturer through their distribution) database is a win for the public and for public health in this country.

With the volume of filed National Prescription Opiate Litigation cases (more than 1,800), which comprise just 10% of the nation’s counties and cities, a structure and process is needed to provide all counties and cities nationwide, filed and unfiled, with a collective and powerful voice in the litigation, and create a pre-established mechanism through which plaintiffs can consider and have a vote in potential settlements with defendants.

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.

Jodi Westbrook Flowers

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.