Monthly Archives: February 2019

COURT ORDERS $1 BILLION JUDGMENT AGAINST OPERATORS OF WOODBRIDGE PONZI SCHEME TARGETING RETAIL INVESTORS

"This resolution accomplishes one of the SEC's core missions to protect retail investors," said Stephanie Avakian, Co-Director of the SEC's Division of Enforcement. "Mr. Shapiro and other defendants will be held accountable and required to pay substantial penalties for their misconduct." "Our complaint charged that when Woodbridge's fictitious business model collapsed, the company stopped paying investors and filed for Chapter 11 bankruptcy protection," said Eric I. Bustillo, Director of the SEC's Miami Regional Office. "The settlement provides for the return of significant funds to investors."

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SEC Charges Cognizant and Two Former Executives With FCPA Violations

“Bribery to further corporate goals is an illusory path to long-term success. While always the wrong choice, it is particularly egregious when senior executives chart that course for those they lead, as our complaint alleges here. We are committed to holding them accountable for their actions,” said Charles E. Cain, Chief of the SEC Enforcement Division’s FCPA Unit.

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FDA Authorizes First Interoperable Insulin Pump Intended to Allow Patients to Customize Treatment Through their Individual Diabetes Management Devices

“Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible,” said FDA Commissioner Scott Gottlieb, M.D. “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently. Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology. We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies.

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FDA Warns Patients and Doctors About Recall of Home-use Test Strips Used with Device to Monitor Blood Thinner Warfarin, Not Authorized for Sale in U.S.

“Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots. Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That’s why it’s so concerning that this distributor continued to sell these test strips in the U.S. even though domestic sales had been stopped due to safety concerns. To reduce risks to patients, we’re warning health care providers and the public about the dangers associated with this product,” said FDA Commissioner Scott Gottlieb, M.D. “Distributing products that are not labeled or authorized for sale in the United States raises significant concerns for us in view of the serious safety issues with these test strip devices, and our work on this matter is not finished. Our top priority is the immediate safety of patients, and we’re taking steps to ensure the products that this company distributed are removed from the market.”

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