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More IVC Filter Lawsuits Added to MDLs

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Boston, MATwo IVC filter makers face numerous lawsuits alleging adverse events linked to the use of IVC filters. Lawsuits against both Cook Medical and Bard allege their inferior vena cava (IVC) filters caused harm to patients who were not able to use anticoagulant medications. Among the harm reportedly linked to the use of IVC filters is migration, fracture, and tilting and perforation.

According to reports on multidistrict litigation, there are 56 lawsuits sitting in MDL 2641 (In Re: Bard IVC Filters Products Liability Litigation) as of October 15, 2015. That’s up from 50 lawsuits sitting in the multidistrict litigation as of September 15, 2015. Meanwhile, there are 133 lawsuits against Cook Medical in MDL 2570 (In Re: Cook Medical, Inc., IVC Filters Marketing, Sales, Practices And Products Liability Litigation) as of October 15, up from 120 as of September 15. Consolidation of lawsuits into a multidistrict litigation is acknowledgement that they share similar questions of fact but is not a comment on the merits of the lawsuit.

Retrievable IVC filters are used to prevent blood clots from traveling to a patient’s lungs in patients who cannot use anticoagulant medications. Some filters, however, have been linked to failure of the struts, in which the struts break off the filter potentially leading to perforation of a major blood vessel. In 2010, the US Food and Drug Administration (FDA) released a Safety Communication warning that it had received more than 900 reports of adverse events linked to the filters. The same communication noted that long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion.

“The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides,” the FDA noted.

In September 2015, NBC News published a report on IVC filters, noting that 27 deaths were linked to the Recovery filter in 10 years. Among people reportedly injured by the filter was Dodi Froehlich, 45, who had a filter implanted after a car accident increased her risk of a blood clot. Four months after receiving the filter, Dodi suffered a severe headache and found out she would need open-heart surgery because a piece of the filter had perforated her heart.

According to NBC News, a confidential study found that Bard’s Recovery filter had a higher rate of failure than its competitors’ filters, but no recall was announced. Bard has said its filters were appropriately approved by the FDA and still have significant benefits for patients.

Whether patients and the courts agree with those significant benefits remains to be seen.

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READER COMMENTS

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My Brother-Has a completely occluded-and is alive only do to collateral circulation-my sister an MD just had hers removed-I am an RN and KNOW I will loose my Brother early due to the filter-sure-He may have needed it-bout not removed-for months-(He had had brain bleed-'fixed' then 'Fell coded in Calif-Then filter put in-I am horrifically upset-Primarily that My MIT Grad and IVY League Med School Sis? Was unable;e-or unwilling-To explain the pros and cons of the device-was NEVER given a brochure regarding the device (I would have researched it) She Blindly Trusted her MD-and THAT? Is wrong a top doc? Should give all available medical device info to patient as is done for cash payment Cosmetic Sure Patients-Why are MD s so LAX and uninformed about the Failure of So many 'Medical Devices'? I'll tell you MONEY! Where is the list of Company payouts to MDs ? Where is the Disclosure info?— People do NOT know the questions to ask-Legal Nurse Consultants? Are Educators by Training-Un-used by the Facilities they are employed by-It is horrible for me personally as I was recently faced with a dozen family and friends/Professionals-Angry at my questions-and The MDs ? Played that-as They-are the ones implanting these devices-If the patients do not Leave surgery with written info regarding the implanted device-along with their POA..? I believe this is 'Failure to Warn' 'Breech of Duty' and MORE—Sometimes it is hateful to be the ONLY one informed—My brother is still alive-but in California—but the Filter-has become so Blocked by clots? It cannot be removed—I fear -- My nephew may loose his father--and already has been traumatized-although it is not the #1 problem-My brother cannot be doing well-and I am sick at the thought--It would be better if I knew he had understood-or his wife had-I inquired-about the protocol-when he was to have it checked or removed—Being on the East Coast? He is in UC Davis area CA—Then my sister had back surgery and had a filter placed due to-'brothers' need---Thankfully she had it removed-0But I refused to take her to have it removed and Her husband drove -- I Knew despite the 'Outpatient' act 'no big deal' It was a VERY Big deal-and I was not about to play ER communicator to POA--when sh@# 'Could' happen AND I was angry that given my brothers-NOW blocked Vena Cave??? WHERE IS THE 'Informed Part?? Of Informed consent??? I would consider myself pretty liable if I did implant devices-that patients did not thoroughly understand pros and cons--If the DR wants to use a filter to 'Avoid a lawsuit'? They will not do that-long—As I NOW hear all I would expect regularly PROBLEMS—and my understanding? Is that there is a markup of 75% way more than any Apple Computer-An actual QUALITY product--Hospitals?--?? Make a pile of profit on this 'grandfathered in crap'--It sickens me--Especially when it is the third family member harmed by a Top Hospital--In the last decade--Our system is not broken for the people reaping in profits fort this continued problem-DRS are Not Harvard Business School Grads-And Harvard Business Grads are not Doctors (Add generally to both statements)Put the 2 together and -PROBLEMS as each is really NOT primarily focused on improvement-a great DEAL of the time--Medical Devices can TOO Cheaply and easily be put on market-FDA?? Spends little money---add the crisis in CRAP non tested Generics..? I just Had to go bvack to Health and Fitness-as I have seen too Little hope of improvement ESPECIALLY in Hospitals That-continue to USE a non profit status-When they are ANYTHING but not for profit--Show me the Payoffs by these Companies to MDs? Hospitals-Full disclosure? HARDLY- It will CONTINUE because as a 'Public' We are Un informed EXCET by Advertising PAID for by the very people selling snake oil at BEST and dangerous unproven devices-Even the MDs are Un informed enough to KNOW-They need to understand 'Manufacturing-(SH#$..Happens REGULARLY) and Must educate or HIRE a Licensed Certified Nurse Educator (not a medical device Sales Rep) if they want to stay out of court---It is SAD that is what it takes-Taking LIVES until--Enough People suffer--And until they stop selling unproven poorly manufactured and unexplained devices are planted into their body—Only the corner (if they look) will see Real Cause of death-nob wonder cremation is so 'Popular'---Am I angry. sure And it is not going to improve when my phone rings--AGAIN--WITH MY PREVIOUSLY WORLD CLASS CREW AND FOOTBALL PLAYING BRO-? BECOMES MORE HARMED THAN HE EVEN KNOWs -Quite frankly? The harm it has caused me-? Has been significant-and As u should not be your own Lawyer? Unfortunately peole pay and listen for a MD ort Lawyer---But no one will pay to Educate Peole-So Apparently These are the people that will need to anser-and risk Liability if they do Not Provide 'UnBiased' Education-...Sure I have stong opinions-I have seen things that turn my stomach-and its NOT getting better-The more this stuff is swept uinder the rug-The more pthe money is noir Folloewd? The more danger we are all in-Its a gamble-If you do not need-it--Wait till they get the bugs out-and THEY HAVE'nt!!---If they Have? Show me the Data---I have asked and asked and the Anger??? At my Questions? Is unreal-If someone will NOT give Me infor? That is about MY HEALTH ? Hello---RUN---When did we all go mute? Speak up speak up Speak up-And -I know WELL-Expect-Resistance---because --There is information that Is being kept from the public--and shaming Me? Into silence? Is NOT EVER going to work!

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