Greenfield Vena Cava Filter Lawsuit Filed Against Boston Scientific Over Perforation

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Boston Scientific faces a product liability lawsuit brought by the family of Ohio woman, which alleges that problems with a Greenfield Vena Cava filter caused severe internal injuries and death.

The complaint (PDF) was filed in the U.S. District Court for the Southern District of Ohio on January 12, by Julia and Raylyn Ratliff, administrators of the estate of Cinthia K. Ratliff.

Ratliff had the inferior vena cava (IVC) filter implanted in April 2004, for treatment of deep vein thrombosis (DVT). The small, spider-like filter is designed to “catch” blood clots that may break free, preventing them from traveling to the lungs and causing a pulmonary embolism.

According to allegations raised in the wrongful death lawsuit, design defects with the Boston Scientific Greenfield Vena Cava filter caused the device to fail and perforate her vena cava, resulting in severe internal bleeding, from which Ratliff died on May 3, 2013. According to an autopsy performed, the immediate cause of death was determined to be “Perforation of Inferior Vena Cava by Greenfield Filter with Retroperitoneal Hemorrhage.”

The family indicates that Boston Scientific knew or should have known that its Greenfield Vena Cava filter posed a risk of breaking free from its implantation site, migrating, perforating the vena cava and causing serious injury or death, according to the complaint.

IVC Filter Long-Term Risks

Amid hundreds of adverse event problems involving problems with retrievable IVC filters, the FDA issued a warning in August 2010, urging doctors to remove the devices once the danger of a pulmonary embolism has passed. One of the most common complications reported by the FDA involved IVC filters fracturing or breaking, allowing small pieces to migrating through the patient’s body and pose a potentially life-threatening risk.

In May 2014, the FDA issued an updated safety statement indicating that patients may face an increased risk of problems with IVC filters the longer they remain in place, advising doctors that the ideal time for removal appears to be between 29 days and 54 days after implantation.

A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.

The Boston Scientific lawsuit over the Greenfield Vena Cava filter joins a growing number of claims brought against manufacturers of IVC filters in recent years, alleging similar design defects with products like the Bard Recovery IVC Filter, Bard G2 IVC Filter, and Cook Celect or Gunther Tulip IVC Filters.

Amid a growing number of complaints filed against Cook Medical, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an order in October, consolidated all Cook IVC filter lawsuits pending throughout the federal court system before U.S. District Judge Richard L. Young in the Southern District of Indiana.


68 Comments


Helen
I had after cancer surgery a PE they put an ivc filter in. So far it is still in place. I asked after the coma regarding if they can travel or fall apart and hospital staff ensured me they were very safe. A freind told me about the recent lawsuits. I have been getting over the last few years chest x rays, which will show the tiny filter and you can count if all his tiny legs are still attached. I try to not crush it, nt to bend to far, no trauma to the chest and be very carful. I also take a baby aspirin, and have to be for the rest of my life on I urban to keep my lungs working. Hope this post helps somebody. Chest x rays will show the filter

Antonio
I have had 2 clods 1 n my legs and n my lungs I have had the Greenfield filter put n 2008 just now hearing about these problems

Kim
I had my greenfield filter put in in 1997. I was in a coma for a month and my lungs kept collapsing so I guess they had no hesitation at that time. A few months ago I saw on the news that there were lawsuits against Bard filters. I got concerned. My sister is a nurse and said it’d be more dangerous to remove it. I don’t know, I’ll probably look into getting it checked to see if it’s moved. I’ve never had any problems though

Cheryl
I had the Greenfield filter put in in 2012 and after that immediately I had pains in my left thigh, and ever since have had a hard time walking it’s like one leg is longer than the other. Plus I am on Zarylto(spelling wrong and I have had 1 clot in each lung even after having that put in. I still have a lot of pain and I need to stop the Zarylto because I could bleed to death.

Mike
Mine has been in place since 2003. It appears that the Greenfield IVC manufactured before March 10, 2004 was included in a FDA Class I Recall. Class I is the most urgent recall. I knew nothing about this until I saw ads on TV about class action lawsuits and started researching it on the web. I’m not sure, but I don’t believe that the Greenfield IVC is included in the lawsuit. However, I’m definitely going to talk to my doctor about it.

Barbara
I had a Greenfield ivc filter placed in 2011. I had multiple PE’s DVT’s arm leg lungs aortic track. I also have ITP which caused a SAH. I WAS GIVEN A NEW DRUG CALLED N-Plate which caused all the blood clots. The filter was placed just before a large clot broke loose in my leg. It plugged the ivc filter which caused me to have compartment syndrome. I had a double fasciotomy done to my right leg which I now have to wear a custom made hose for life as well as be on warfarin for life. Dangerous drug when you have ITP. Now this with the filter which I still have. No one has checked it since it was placed. What should I do now.

Ellen
I’ve had a Greenfield Filter since 1996. I’ve had numerious DVT’s and a Massive Pulmunary Embolism. Now recently I was in the hospital with an Hemotoma the size of a softball on my right kidney. When the filter was put in they were supposed to check and make sure it was still in place. They have only checked it once in 19yrs. My Sister is in Florida she sent me info about a class action law suit against these type of filters. i fully plan on calling tomorrow to see if the Greenfield filter in included in this lawsuit . The worst they can tell me is no. If your curious type in Greenfield Filter and you’ll see info from January of 2015. It has me scared a lot. The funny thing is the Dr who put it in swore the thing was safe. Hopefully I get some peace of mind soon about this stupid filter one way or the other.

Sharon
I had a greenfield filter placed in 1999 December, prior to gastric bypass. I asked the hospital for the card to carry that stated what kind of filter and the company name twice, with out getting it. Surgery,bypass, was Jan. 2000, I was doing well when in July ,2000, I went to hospital with deep vein thrombosis, and two small clots to my lung. I told them how many clots had gone there and that it was my left lung wich they concured. I always thought that I was grateful for the filter but now I wonder? Why would they not give me the card and why did they not take the filter out later.

ARCHIE
MY FILTER HAS BEEN IN SINCE 1998. I HAVE BREAKING PROBLEMS. PAIN IN LEFT SHOULD AND LEGS ARE SWOTTEN

Melissa
Currently, I have a non-removable IVC Greenfield Filter. This is a recalled filter. This was placed in 2005 during a hospital stay for a DVT. All together I’ve had 4 blood clots; 2 Pulmonary Embolisms, 1 DVT, and a blood clot in my right hand. The 2 PE’s occurred prior to the placement of the filter. According to a recent study, my filter is now tilted and has a chronic blood clot between the filter and vein wall. I wasn’t made aware, at the time it was implanted, that this is a non-retrievable filter; nor was I educated on the types of filters available. It was rushed. When the DVT occurred, I had an 8.1 INR; that is 5.1 higher then what it was supposed to be. My blood was so thin, yet I was told that I was still clotting, (which is why I had a DVT); they said this was highly unusual – they had to give me plasma in order to place the filter. My doctor, back then, did not monitor my Warfarin intake; which is why my blood was so thin. I had to demand to be admitted to the hospital. My doctor argued that my lungs didn’t show sign of a pulmonary emboli, and that my air saturation was normal. I continued to tell him that I knew I had a DVT, told him my symptoms, and informed him that if I wasn’t admitted it could become a PE. He had the hospital look at me, and of course I was diagnosed with a DVT. I’m not sure if I have to wait until something bad happens in order to take action; but it’s scary knowing that it’s tilting and that it is moving. 🙁

Jennifer
Please look up dr. William Kuo out of Stanford hospital intentional radiology He was able to successfully remove imbedded greenfield IVC filters I highly recommend as he developed the technique to remove permanent filters.

James
I’ve had a Greenfield since 2006. I’ve recently experienced pain from the bottom of my left knee going downward and bruising in the area. I can’t help but to be a little worried after reading this article !

Jonah
I’ve had one since 1995. The doctor’s say I’m fine… derp 🙂

Lisa
I’ve had mine since May 1996 also….been having health issues……

andy
I have one since 97 and I have been,told it moved

Holly
I have had a greenfield filter since 1999. This is very disturbing to think about 🙁

Karen
I have had one since 1994 – this is the first I have heard of a problem.:(

Michael
I have a greenfield vena cava filter and I am scared because It has been since 1996

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