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.
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
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.
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.
By Brittany Mierzwa – As we ring in the new year, twenty-four states have increased their minimum wage. With the largest increase being $1.50 in New Mexico to $10.50 per hour, other states are seeing an increase to $12 and even $14 per hour. Some states such as Minnesota and California have different requirements based on the size of the business and employer, Nevada takes a different look at minimum wage having different wages if health benefits are offered. US News breaks it down by state.
By Lacey Crawford – For nearly four hours Congress questioned two members of the billionaire Sackler family, David Sackler, 40, and his cousin, Dr. Kathe Sackler, 72, both having served on Purdue Pharma’s board for years. Purdue Pharma is the maker of OxyContin, the aggressively promoted painkiller that began America’s massive opioid epidemic that has killed more than 450,000 Americans.
From 2008 through 2017, the family skimmed approximately $10 billion from Purdue Pharma, placing the money in “offshore shell companies” as the two family members tried to lay blame on “management” and independent, nonfamily board members.
Eight members of the Sackler family have been named in several state cases.