Opioid Crisis Victims Seeking Vengeance Against Purdue Pharma L.P.

The opioid crisis is seeking vengeance against Purdue Pharma L.P. and associated debtors, but what about the Sackler Family? Patrick Radden Keefe, a staff writer at The New York Times, wrote ‘How Did the Sacklers Pull This Off?’ an article that explains and answers many questions several Americans have regarding the immunity that the Sackler family is receiving. Mr. Radden Keefe explains two scenarios, a small-time drug dealer facing consequences in federal prison for the sale and indirect purchase of fentanyl, versus the Sackler Family and their known history of addictive opioids who continued to market their drugs as non-addictive, while the death-toll relating to opioids climbed. The family is not only receiving immunity against any criminal charges, but they have also settled investigations without any retributions, instead agreeing to pay financially.

To read the full article, follow the link below (subscription). https://www.nytimes.com/2021/07/14/opinion/sackler-family-opioids-settlement.html?searchResultPosition=2

To learn more about how we’re helping people fight the opioid crisis, view our Purdue Pharma Opioid Bankruptcy Page

Purdue Pharma Bankruptcy Hearings

By Brittany Mierzwa – Purdue Pharma faces over 600,000 claims in the United States Bankruptcy Court, Southern District of New York, in front of the Honorable Judge Robert D. Drain. Approximately 130,000 of these claims are Personal Injury, with a proposed settlement of a collective 700 to 750 Million Dollars. In the proposed restructuring plan published by Prime Clerk on March 15th, a three-tier scoring system was introduced to determine how claimants will get paid. Tiers have not been defined with definitive details; additional information is expected to be required to qualify a claim into a tier. An easy payment option has been suggested for claimants to accept a lower award amount if they are unable to provide the required information.

While hearings continue, two dozen State Attorneys General have rejected the proposed plan demanding more money up front from the Sackler Family, suggesting the family could walk away with impunity. In the proposed plan the Sackler Family would give up ownership and make payments over the next decade in the amount of 4.2 billion dollars of personal money to the settlement. Currently unnamed, referred to as NewCo, Purdue Pharma will transfer remaining assets to NewCo with a focus to address the opioid crisis.

The Nations Law Firm is actively watching the Purdue Pharma Bankruptcy claim, if you have questions about your case please call our office at (800)269-3050.



FDA Urgent Voluntary Recall of Brain Catheter

On January 29th, the FDA revised Penumbra’s Urgent Voluntary Recall of the Jet 7 Catheters with Distal Tip. The FDA has received over 200 reports of adverse reactions to their Medical Device Reporting system (MDRs) including death, serious injury and malfunctions. Serious injuries have been described as vessel damage, hemorrhage, and cerebral infarction. The Penumbra system is used in stroke patients to remove blood clots, during a bench test performed by the manufacturer, the distal tip was not able to withstand the same burst pressure as the other catheters manufactured by the same company.

‘Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.’

Over twenty-thousand devices have been recalled, Health Care officials were notified on December 15th, 2020, when the voluntary recall was initiated.

URL: https://www.fda.gov/medical-devices/letters-health-care-providers/penumbras-urgent-voluntary-recall-jet-7-catheters-xtra-flex-technology-due-increased-risk-mortality

Florida Sets Bellwether Case for Deepwater Horizon Litigation

By Brittany Mierzwa – On Monday January 18th, U.S. District Judge Casey Rodgers of the Northern District of Florida announced the selection of a bellwether case in the Deepwater Horizon BELO litigation. Christopher F. Causey’s case was selected to go to trial as a test of more than 500 similar lawsuits related to the 2010 disaster on file in the Florida court. The Judge is handling cases filed by plaintiffs who were diagnosed with medical problems after the cut-off date set in a settlement agreement in the main multidistrict litigation based in Louisiana federal court.

‘Causey’s case was selected at random from a list of 10 individual suits raising claims over eye-related injuries – five submitted by the plaintiffs and five submitted by BP – according to the order.’

The 2010 Disaster, known as BP Deepwater Horizon, killed 11 people and caused 4 million barrels of oil to spill into the Gulf of Mexico. Clean-up workers like Mr. Causey worked extensive hours digging and picking up tar balls along the shore. Workers were exposed to oil and chemicals without proper protection as they cleaned the coast. Judge Rodgers set an August 23rd start date for a two-week trial.

URL (subscription): https://www.law360.com/trials/articles/1346163/bellwether-trial-set-for-fla-deepwater-horizon-cases

Deep Water Horizon Litigation .PDF document

Artificial Intelligence/Machine Learning -Based Software as a Medical Device

By Brittany Mierzwa – FDA Press Release January 12th 2021 – The FDA has published their Action Plan as they move forward with Artificial Intelligence/Machine Learning (AI/ML) -based software as a Medical Device. The FDA’s vision through AI/ML -based software ‘will deliver safe and effective software functionality that improves the quality of care that patients receive’. AI is being introduced through Radiological Imaging and Cardiac Ultrasound software, both received their first marketing authorizations in February of 2020.

The Action Plan addresses 5 specific concerns that stakeholders have such as apprehensions of cybersecurity, clear transparency as the software trains the algorithm, and regulatory review to ensure the algorithm does not present biases while learning the importance of racially and ethnically diverse patient populations. As the FDA moves forward with their January 2021 Action Plan, AI/ML has become a rapidly progressing field all while maintaining a patient centered approach.

Link: https://www.fda.gov/media/145022/download

Remembering Fredric G. Levin

This week we lost our dear friend and colleague, Attorney Fredric G. Levin of Levin Papantonio Rafferty Law Firm, when he succumbed to the ravages of COVID-19 at age 83. He was an award-winning attorney who fought tirelessly against the tobacco industry and other Big Corporation malfeasance, while advocating for civil rights and helping the people of his own hometown of Pensacola with generous donations. He will forever be remembered with respect and admiration as one of the most pro-active attorneys of our era.
He will be greatly missed.