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
and
https://www.fda.gov/medical-devices/medical-device-recalls/penumbras-recall-jet-7-reperfusion-catheter-due-distal-tip-damage

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

Final Chapter of HuffPost’s Risperdal Series Examines Verdict in Pledger Case

In the 15th and final chapter of its series on Johnson & Johnson’s Risperdal (risperidone), the Huffington Post (10/2) “Highline” recounts how the jury in the Pledger case handed down its verdict Feb. 24, 2015, finding J&J was negligent by failing to provide an adequate warning about the risk of gynecomastia associated with Risperdal. The jury awarded $2.5 million to Austin Pledger. Meanwhile, J&J’s “latest SEC filing says there are 4,200 Risperdal claims on dockets across the country.” All in all, author Stephen Brill argues, the Risperdal scandal raises concerns about regulation of drug manufacturers. Indeed, the company’s misconduct “would have gone unchecked” if not for the work of plaintiffs lawyers who “trudged through millions of documents.” The FDA “didn’t do that work.” Meanwhile, the “recent push from the bench, emanating from the Supreme Court, to expand the First Amendment rights of corporations could upend the core principle that a regulatory agency like the FDA can stop drug companies from spending whatever it takes to put their spin on what their products can be used for.”

IVC Filters Continued to Sell After Manufacturer Aware of Deaths

In the past few weeks, more information has come to the public’s attention as C.R. Bard IVC filters were featured in a two-part NBC Nightly News segment. The year-long investigation raises more serious questions about why medical device manufacturer C.R. Bard continued to sell and market its inferior vena cava (IVC) filters even after the company became aware that its filters were failing and causing death and other serious injuries at significantly high rates. The investigation alone revealed 27 deaths and more than 300 injuries related to the Bard Recovery model IVC filter. The people and injuries featured in this story are real. Their lives were affected in real ways, the same as many others might have been as well. If you are one of those people, please contact our office immediately to see how we might be able to help – (800) 269-3050.

Medical Device to Stop Blood Clots Associated With 27 Fatalities

Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?

 

Did Manufacturer of Medical Device Linked to 27 Deaths Ignore Safety Concerns?

Holding Generic Drugmakers Accountable

By Cindy L. Nations

UPDATE: March 24, 2014 : Ever since the 2011 Supreme Court ruling in Pliva, Inc. v. Mensing, the American Association for Justice has been working to close the generic drug accountability loophole which largely immunizes generic drug manufacturers from liability for injuries caused by their products. On March 13, AAJ filed comments with the FDA in support of the agency’s rule regarding generic drug labeling. The rule, as proposed, would effectively overturn the Mensing decision by allowing generic drug manufacturers to update their labels with new safety information without prior FDA approval.

AAJ’s efforts calling for accountability and increased safety were supported by more than three dozen members of Congress, a bipartisan group of State Attorneys General and a variety of consumer and health groups. In addition, a consumer petition signed by more than 20,500 people has been sent to the FDA.

(Original: November 11, 2013) – The FDA announced a proposed rule that would allow generic drugmakers to update labels with new information, just like the brand name manufacturers, potentially exposing them to liability.  Most people don’t realize this, but under the current laws, a generic drugmaker cannot be held liable for drug defects or failure to warn about such defects.  This is based on a 2011 U.S. Supreme Court ruling (Mutual Pharmaceutical v. Bartlett, U.S. Supreme Court, No. 12-142) which noted that under current FDA rules, only name-brand drugmakers are responsible for safety warnings.

So, essentially, what is taken by most as a casual decision made at the pharmacy (choosing generic over brand name) could potentially be the difference between someone being able to seek justice for an injury or have no remedy at all.  Since the Supreme Court decision in 2011, Attorney Howard Nations, working in conjunction with the American Association for Justice (AAJ) has met numerous times with key members of Congress and the FDA to discuss this issue and advocate for the rights of consumers.  This recent decision by the FDA is a move in the right direction.