Medical Safety Groups Call For The End of the FDA Fast-Track Medical Device Approval Process

Bard IVC filters received fast-track FDA approval but are proving to be ill-conceived and cause serious injuries

Thursday, September 30, 2021 - The Institute of Medicine and other medical safety advocates want the FDA to cancel or reform its fatally flawed 501 k fast-track medical device approval program. The FDA's fast-track approval process rushes medical devices to market before they can be fully tested and their safety guaranteed. Reports made to CR Bard, the manufacturer of the Bard IVC filter, and the FDA, complain that the Bard IVC filter complications include the device fracturing and migrating, causing countless injuries and 27 deaths to date. One report states that the FDA received around 1000 complaints from doctors and patients during five years from 2005 to 2010. The reports describe device migration, embolization, device detachment, perforation of the inferior vena cava by the device, and filter fracture or breakage.

Blood clot patients that have had IVC filter implant surgery may not have been informed of the risks and complications that were reported to the devices manufacturer, and the FDA until it was too late. Many have filed Bard IVC filter lawsuits seeking lump-sum monetary compensation for the injuries sustained by the device. Juries in upcoming Bard IVC trials will take post-market FDA reports into account that illustrate the device design is inherently flawed and causes medical complications far above any potential benefits. According to DrugWatcher.org, "A study published in 2010 showed that up to one-quarter of the filters produced by Bard broke and caused an embolism. Another study published in 2012 in the Journal of Vascular and Interventional Radiology found that up to 40% of the devices fractured within 5.5 years since they were implanted."

The Food and Drug Administration (FDA) must take some of the blame for the injuries that defective medical devices like the IVC filters have caused. The FDA's 501 k fast-track medical device approval process allows a medical device to go to market if it can be demonstrated to a panel of experts that it is substantially similar to one already on the market even though that product may be defective, recalled, or the target of personal injury lawsuits. The approval process relies on patient and doctor reports of post-market complications, malfunctions, and injuries. There are no clinical trials or ongoing oversight. The 501 k FDA approval process uses patient experiences to determine whether or not a medical device is safe or to issue warnings or recalls.

It was not until 2010, six years after the IVC filter received FDA approval, that regulators warned the public of the IVC filter's life-threatening complications. The FDA wrote: "The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device." The adverse reports made to the FDA most likely represent only a fraction of the actual number of complications that patients experienced.

More Recent IVC Filter Lawsuit News:

• Scientific Authors Agree That IVC Filters May Have Been Overused In Anticipation of Blood Clots Occurring | 2/26/2022
• IVC Filter Use Has Skyrocketed And So Have Patient Complaints | 2/22/2022
• IVC Filter Removal Continues To Generate Controversy In Medical Circles | 2/12/2022
• Pulmonary Embolism Kills Over 100,000 People Each Year Hospitalized With Traumatic Injury | 2/7/2022
• Bard Faces Thousands Of IVC Filter Lawsuits Over The Product's Unique Inherent Design Defects | 2/2/2022
• Stanford's Dr. Kuo Has Helped Pioneer Advanced IVC Filter Laser Retrieval | 1/28/2022
• Doctors Struggle With Deciding When Is The Optimal Time To Remove A Patient's IVC Filter | 1/14/2022
• Doctors May Use IVC Filters More Often Now That Laser Removal Is An Option | 1/10/2022
• IVC Filter Lasers Highlights Focus Attention On Removal Complications | 1/4/2022
• IVC Filter Retrieval Complications Have Been Known For Years | 12/30/2021
• Lasers May Now Enable Doctors To Safely Retrieve Embedded IVC Filters | 12/22/2021
• IVC Filters May Do Nothing To Prevent Death Or Pulmonary Embolism For Trauma Patients | 12/16/2021
• IVC Filters Can Help Save The Lives Of Young People That Experience Multiple Sudden Blood Clots | 12/1/2021
• The FDA Recommends That An IVC Filter Stay In Place No Longer Than Two Months | 11/26/2021
• Bard Sales Reps, Surgeons, And Even The FDA All Looked The Other Way And Failed To Warn IVC Filter Patients | 11/18/2021
• Ozone Cleaning Products Are Not FDA Approved And May Be Responsible For CPAP Foam Insulation Breakdown | 11/12/2021
• Patients Should Know Of All Of The Risks Of Having An IVC Filter Implanted To Trap Blood Clots | 11/12/2021
• Blood Clot Patients Chest Pain Patients Are Talking To IVC Filter Lawyers About Holding Bard Accountable | 11/5/2021
• The IVC Filter Is Substantially Similar To The Faulty And Defective Essure Birth Control Device | 11/1/2021
• The Food And Drug Administration Has Been Warning Surgeons About The IVC Filters Design Flaws For More Than A decade | 10/28/2021
• IVC Filter Heart Pain Could Be From The Device Having Fractured Into Pieces | 10/25/2021
• Bellwether Bard IVC Filter Lawsuit Highlights The Design Flaws | 10/20/2021
• IVC Filters Could Be Unnecessary If A Person Leads A Healthy Lifestyle | 10/15/2021
• The EPA's Farm Flagger Ban Came Decades Too Late for Thousands of Farm Workers Who Now Have Parkinson's disease | 10/12/2021
• Bard IVC Filters May Tilt, Migrate and Perforate The Artery Where They Were Implanted | 10/11/2021
• A Report Published In 2006 Documented IVC Filter Catastrophies | 10/5/2021
• IVC Filters May Not Be Needed And Offer No Reduction In Mortality | 9/27/2021
• IVC Filters Are Implanted As A Last Resort And Left In Place Only If Blood Clotting Continues And There Is No Alternative | 9/24/2021
• IVC Filters Are A Bad Idea Fraught With Life-Threating Complications | 9/20/2021
• Doctors May Consider Vitamin K Anti-Coagulant Therapy Before Recommending IVC Filters | 9/15/2021
• Surgeons May Not Be Able To Retreive the Bard IVC Filter After Two or Three Months | 9/11/2021
• A High Failure Rate For IVC Filter Removal Can Be Expected And Surgeons Should Prepare For The Worse | 9/7/2021
• Thousands Of IVC Filters May Eventually Experience Catastrophic Failure | 9/2/2021
• Most Bard IVC Filters are Doomed To Failure and Surgeons Would Never Attempt To Retrieve It | 8/31/2021
• A California Jury Finds The Bard IVC Filter Is Negligently Designed | 8/27/2021
• Scar Tissue Build Up After 60 Days May Prevent Safe Bard IVC Filter Removal | 8/23/2021
• IVC Filter Removal Requires Using Force When Trapped In Place By Scar Tissue | 8/19/2021
• Bard IVC Filters Have Caused Severe Damage More Than 10% Of The Time | 8/14/2021
• A Fourth Jury Finds Bard IVC Filters Defective | 8/10/2021
• Patients With IVC Filters Should Contact Their Physicians Immediately | 12/21/2018
• Lawsuits Filed Across Wide Variety of IVC Filter Manufacturers | 12/18/2018
• IVC Filter Patients May Be Eligible to File A Claim Against CR Bard | 12/13/2018
• IVC Filter Manufacturers Profit When Patients Misinformed | 12/10/2018
• IVC Filter Litigation is Growing Every Day | 12/7/2018
• Doctors May Be Neglecting IVC Filter Device Patients | 12/4/2018
• CR Bard Forced To Compensate Injured IVC Filter Patients | 11/27/2018
• Judge Confirms IVC Filter Malfunction and Punitive Damages Award | 8/31/2018
• Bellwether Trials Underway For Bard IVC Filters | 8/29/2018
• The Bard IVC Filter May Not Have Been Adequately Tested | 8/27/2018

No-Cost, No-Obligation Bard IVC Filter Lawsuit Case Review for Persons or Families of Persons Who Suffered from Organ Damage, Severe Bleeding, Stroke, or Death

OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.