by: Rebecca M. Katz
Eight years after its inception, the SEC’s Whistleblower Program continues to have a significant, positive impact in protecting not only whistleblowers, but investors, markets and by extension, the public. In addition, the Whistleblower Program allows the SEC to bring enforcement actions in considerably less time, using fewer resources.
by: Lee M. Heath
We put a lot of faith in auto manufacturers. As our vehicles become loaded with technological advancements, we have trust the manufacturers have installed these features to help protect us. We often assume that manufacturers tested and vetted this technology appropriately. And, we trust these features will actually work as intended and save us from harm during an accident. But are we too quick to make this assumption?
by: Robert T. Haefele
As we pause to reflect, we stop not only to remember those who were lost and injured, but also to honor those who continue to seek justice and accountability for those responsible for the September 11, 2001 attacks.
by: Fidelma L. Fitzpatrick
Generally speaking, manufacturers are required to submit individual reports to the FDA for each patient who sustains an injury or complication caused by a medical product. Established in 1997, Alternative Summary Reporting Program allowed manufacturers to bypass that standard by submitting quarterly summaries for cases that involve “well-known” complications. The FDA claims that this policy allowed the agency to “more efficiently review reports of well-known, well-understood adverse events.” However, the public was largely kept in the dark because this massive database was kept hidden, available only to the FDA – until now.
by: Rebecca M. Katz
July 30 is National Whistleblower Appreciation Day, commemorating the signing of our country’s first whistleblower law in 1778. In the midst of the Revolutionary War, and faced with the dilemma of how to address the retaliatory dismissal and jailing of a pair of Navy sailors who had reported the mistreatment of enemy soldiers, our country’s earliest leaders made the critical choice to stand by these whistleblowers.
by: Annie E. Kouba
Social media is a prevalent part of almost all of our lives. Nearly everyone is on Facebook, Twitter, Instagram, or some other social platform today. But most of us aren’t thinking about the effect these platforms could have on pension funds or retirement plans. What happens when the CEO of the company you or your pension fund hold stock in is also on Twitter?
by: Motley Rice
Vaping among today’s youth has reached crisis levels. If you have any doubt, look at the numbers. Even as traditional cigarette use continues to decline among high school students, vaping “increased alarmingly” between 2017 and 2018 by 78 percent, according to the FDA, to more than 3 million American teens. Shockingly, when accounting for middle schoolers, that number rises to more than 3.6 million.
by: Joseph F. Rice
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.
by: Joseph F. Rice
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.
by: Louis M. Bograd
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.