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?utm_medium=email&utm_source=govdelivery

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.

 

 

Twenty-four States Increase Minimum Wage

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.

URL: https://www.usnews.com/news/articles/best-states/minimum-wage-by-state

Perdue Pharma Family Questioned by Congress

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.

URL: https://www.nytimes.com/2020/12/17/health/opoids-sacklers-purdue-testimony.html

Fighting For Those Who Fight For Us

By Cindy Nations –

The American Association for Justice (AAJ) just released a new research report titled Fighting for Those Who Fight for Us: Protecting the Rights of Service members and Veterans. The report examines the many ways in which our country fails to protect veterans from harmful products and services and highlights the role trial lawyers play in protecting their rights.  At The Nations Law Firm, we are proud to represent veterans who were injured by terrorist attacks in Iraq.  For more information, see our Iraq War Fund page.  As AAJ members, we have made it our mission to protect civil justice and will continue to fight for those who fight for us.

JURY AWARDS $3.6 MILLION IN FIRST BARD IVC TRIAL

In the first bellwether trial of the Bard IVC Filter litigation, a federal jury ruled against the manufacturer C. R. Bard. On March 30, 2018, jurors in Phoenix ordered Bard to pay $1.6 million in compensatory damages to Plaintiff Sherr-Una Booker, who was harmed by an inferior vena cava (IVC) filter made by C. R. Bard. Howard L. Nations of The Nations Law Firm was a member of the trial team and represented Ms. Booker in Court. In the trial that lasted more than 2 weeks, the jury decided that Bard is 80% liable for Ms. Booker’s injuries. Bard was also ordered to pay an additional $2 million in punitive damages, taking the jury only 16 minutes to reach their decision.

This is one of several thousand lawsuits filed against the New Jersey-based Bard Company, the first IVC trial against Bard, and only the second trial against an IVC filter manufacturer, the first being a case against Cook Medical last November in Florida.

In Ms. Booker’s case, the IVC filter tilted, perforated her vena cava, broke apart, and pieces of the metal device then traveled to her spine and heart. As a result, she underwent open-heart surgery in 2014 to repair the damage and attempt to remove the broken filter parts. They were unable to remove a piece of the filter near her heart and it remains there today, leaving Ms. Booker with the ever constant fear that at any moment the piece of metal could move again and cause an imminent risk of death.

WHAT IS AN IVC FILTER?

IVC filters (inferior vena cava filters) are implanted in the vena cava, the largest vein in the body, which carries de-oxygenated blood to the right atrium of the heart and to the lungs. The implants are used in patients for various conditions, namely deep vein thrombosis in the legs. These devices are intended to prevent blood clots from breaking off and migrating to the organs such as the heart, brain and lungs, where blood clots settle and can become life-threatening.

If you or someone you know may have developed complications after IVC implantation, please contact our offices at (800) 269-3050 or fill out this form for a free case evaluation.