IVC Filter Recalls And Lawsuit History
Legally Reviewed and Edited by: Terry Cochran
There have been thousands of IVC filter lawsuits filed, but just a few recalls. The FDA says they’re still overused.
What Is An IVC Filter And Why Is It Used?
The purpose of an Inferior Vena Cava (IVC) filter is to prevent blood clots from going to the heart and lungs. The inferior vena cava is a large vein in the middle of the body, and the filter device is usually put into place during a short surgery called interventional radiology — which is a minimally invasive surgical specialty. The IVC blood clot filter was designed to assist individuals who were immobile, sedentary, or who could not take blood thinners to prevent the movement of blood clots to the lungs and heart and potentially cause a pulmonary embolism.
Because of the faulty design and fracturing of these devices, many people have been injured. When portions of the filter break off and migrate to other parts of the body, or when there is any kind of device migration, vein walls can be punctured as well as other life-threatening complications emerge.
Since first introduced in 2005, there have been complications. In 201o, after the FDA had received almost 1,000 complaints about the devices, the agency reported in a Safety Communication that retrievable IVC filters were designed only for short-term placement, and when left in the body for a long time can have serious adverse health effects. The FDA recommended that unless there was a compelling reason to keep the devices in place, that they should be removed between the 29th and 54th day following implant.
Several clinical studies since 2010 have confirmed the FDA’s findings, including a 2013 study published in the Journal of American Medical Association, that indicated that despite the increased risks, doctors were not removing the devices, leading to venous thrombotic problems, including pulmonary embolisms.
As of 2012, it was believed that almost 260,000 of the devices were in use, and the market value continued to grow. According to a study by the American College of Cardiology (2016), IVC filters were being used for a variety of reasons, and the rate of retrieval was low.
IVC Filter Recalls
- In 2005, there were two recalls issued on Greenfield IVC filters. The first one was issued in August 2005 on the titanium Greenfield filter and was classified by the FDA as a Class 2 recall. The problem was the lack of a taper on the braided sheath of the delivery system. The manufacturer, Boston Scientific Scimed, said this could cause the sheath to catch on a vein and tear it due to the lack of a taper. A Class 2 FDA recall means the device could cause temporary or medically reversible health consequences.
The second recall, a Class 1, was issued in December 2005 for the stainless-steel Greenfield IVC filter because it could detach during implantation. This could cause a clot to get past the device and lead to a pulmonary embolism.
These two Greenfield recalls involved approximately 18,000 devices.
- In 2013, the Food and Drug Administration (FDA) announced the recall of all Cordis IVC filters. This involved 33,000 devices then known to be in use. The FDA cited a problem with the filter’s labeling and implant statements, and involved devices sold between May 6, 2010 and April 2, 2013.
- In 2014, the FDA investigated C.R. Bard and found that this manufacturer was making IVC filters without approval, and in 2015 the FDA sent them a warning. C.R. Bard recalled around 1,200 Denali IVC units that year. Even though there were already hundreds of lawsuits pending that involved C.R. Bard’s Recovery units, they never recalled it — they just renamed it. Bard’s G2 and G2 Express models are now named in thousands of pending lawsuits.
- In 2019, Cook Medical recalled more than 91,000 IVC filters (Gunther Tulip and Celect IVC). A 2015 study found a high perforation rate, with 43 percent of users suffering perforated blood vessels.
Lawsuits and Settlements
In 2015, NBC News reported that there were 39 cases of malpractice litigation against C. R. Bard for their IVC filter products. Immediately after that report, other suits were filed. One IVC filter case filed by Kevin Phillips in Nevada, naming Bard as the defendant, was settled 10 days after filing for an undisclosed amount.
In March 2018, in the federal court, District of Arizona, $3.6 million was awarded to Sherr-Una Booker, who said she had been harmed by an IVC filter made by Bard. In her case, court documents tell us Booker had suffered blood vessel perforation when the IVC filter broke apart and migrated through her bloodstream. The lawsuit also claimed that Bard had failed to warn doctors about the possible risks involved in using their products.
This was the first Bard IVC filter case to make it through the court system, and the jury ordered Bard to pay Booker $1.6 million for failure to warn her about the dangers of the device. That $1.6 million was 80% of the $2 million jurors actually awarded. The balance ($400,000) was determined to be the responsibility and negligence of another third party. Jurors also ordered Bard to pay Booker an additional $2 million in punitive damages.
The Booker trial was what is called a bellwether trial. When large numbers of lawsuits are filed about the same issues, the federal court system may choose to organize them into groups, which is called multidistrict litigation. In this arrangement, the same judge may rule on all pretrial matters and preside over early trials, which are called bellwether trials. It is the outcome of these bellwether trials that guide all settlement negotiations.
Many of the IVC filter cases are in one of two MDLS. The Arizona group (MDL No. 15-02641-PHX-DGC), names C.R. Bard as the defendant, and as of May 31, 2019, was not accepting any new cases. It consists of nearly 8,000 cases. Plaintiffs can still file suit against Bard, but they won’t be joining the Arizona MDL.
The other MDL is in Indiana (MDL No. 1:14-ml-02570-RLY-TAB) and Cook Medical is the defendant. This MDL is ongoing and consists of approximately 6,000 cases.
Other than these two MDLs, there are hundreds of other lawsuits that involve faulty IVC filters in jurisdictions across the country, including several more class-action lawsuits currently underway against Bard in Florida, California, and Pennsylvania. The class in all these lawsuits is everyone who has ever had the Bard devices implanted. Because of the well-known high failure rate with Bard Recovery, G2 IVC filters, and G2 Express Filters, everyone who has one needs constant medical monitoring.
Did Bard Know about Problems?
There are allegations that Bard knew about possible problems before they put their IVC filters on the market, and even forged the signature of a regulatory specialist to get FDA approval for their devices.
Bard was aware of problems as early as 2004, and commissioned a review and evaluation — now known as the Lehman Report — that was conducted by an independent consultant Dr. John Lehmann. This report concluded that the Bard IVC Recovery filter had a very high rate of complications, including filter fractures and migrations. Bard kept the report secret and continued to sell thousands of devices.
When the report became public in an early trial, the company sought to have the report excluded for use in current or future lawsuits under the work product doctrine, which is a law intended to protect a company from the documents it produces in anticipation of future lawsuits being used against them.
Greenfield Filter was Never Fully Evaluated
The safety of the Greenfield IVC filter, manufactured by Boston Scientific, was never independently evaluated by the FDA before it went on the market. Instead, it was approved through the fast-track 510(k) premarket notification process. According to court documents, several patients who received the Greenfield filter implant faced serious injury when it broke, migrated, or fragmented.
Despite the known serious threat, Boston Scientific kept selling them — for years.
Cordis IVC Filters Known to Fracture
Approximately 21 cases against Cordis Corporation — for their defective and dangerous Cordis Optease IVC filter — are currently pending in California. A group of Japanese researchers questioned the clinical trials for the device, and in 2012 reported that the clinical trials were not done correctly and that the Cordis filter showed a 50% fracture risk.
The rate of removal was also very low — at 20% — and in 2013 almost 33,000 were recalled because of mislabeling. Instructions could lead to surgeons to implant the filter backward.
Do You Have IVC Filter Complications?
In 2010 and 2014 the FDA warned doctors about the risks involved, and older patients were particularly vulnerable. While in many cases the filter does its intended job and is removed without a problem. But more than 25% of the time, a patient has experienced some kind of complication.
Signs of a problem are:
- Chest and neck pain
- Nausea, shortness of breath
- Rapid heart rate
- Confusion, lightheadedness, and vertigo
- Pain in the abdomen, back or other parts of the body
If you or a loved one has experienced IVC filter complications or side effects, you may be able to file a claim to recover damages from the manufacturer for the medical costs associated with the defective filter, as well as the nonmedical economic and other losses (pain and suffering) associated with the defective device.
What Kind of Compensation Can You Claim?
The amount of compensation you receive when you pursue an IVC filter claim will depend on many factors, including the attorney and law firm you find to work with you on your case.
In general, the factors considered in personal injury claims like this will include the duration and severity of your complications, the costs associated with additional surgeries and treatments, lost income as a result of complications, and whether the device led to temporary or permanent disability.
These lawsuits also consider other nonmedical impacts on your life, other kinds of losses, that are associated with your IVC filter injuries.
An Attorney Can Help
When you are seriously injured through medical malpractice and/or by a defective product, you may not be in the best place emotionally and physically to be making any important legal decisions about your future — without help. Having an attorney at your side, ready to advise, support, and advocate for you can hopefully provide you and your family with some peace of mind, helping you worry less about the future so you can concentrate on your healing and recovery process.
The legal team at Cochran, Kroll & Associates, P.C. want to hear your story, learn about your situation, and explore possible legal options with you.
Senior Partner Eileen Kroll specializes in medical cases at Cochran, Kroll & Associates P.C., and her medical training as a Registered nurse is invaluable in evaluating your IVC filter injuries, any resulting medical conditions, and the treatment you may need going forward.
Finding an Attorney
- Find someone nearby. When you’re looking for an attorney to assist you with your IVC filter case, look close to home. If court proceedings become necessary, it is advantageous to be working with an attorney and law firm familiar with the court system where your case will probably be heard.
The attorneys at Cochran, Kroll & Associates, P.C. are familiar with the procedures and practices of the local court system throughout Michigan, and with the judges that preside over the personal injury, medical malpractice, and defective product liability cases in that district.
- Research the firm’s track record. Finding the right attorney also means checking out their experience, and track record with cases like yours.
Cockran, Kroll & Associates, P.C. is one of the fastest-growing personal injury and medical malpractice law firms in Michigan. We have worked with individuals and families throughout the state who have been injured through someone else’s negligence, to receive the compensation they need and deserve.
- Does the firm have the capacity you need? Look for a firm that has the capability and capacity to systematically gather evidence, assist you in documenting and calculating losses, and be able to confidently represent your interests with insurance company attorneys at settlement hearings and in court. Ask for references.
At Cochran, Kroll & Associates, P.C. we know how to gather evidence, identify liable parties, secure essential documents, interview relevant individuals and secure depositions, and develop a strong case strategy.
- Are you comfortable? You must find an attorney who makes you feel comfortable, gives you honest and clear feedback and has the resources and capacity to meet the challenges of your case. You need to believe that the attorney you work with will make your case a priority, and be able to respond to your day to day concerns with patience and promptness.
When you work with Cochran, Kroll & Associates, P.C., you’ll feel safe asking questions and sharing personal information. We bring a lot of compassion, as well as legal expertise, to all our client relationships.
Don’t Wait Too Long
According to Michigan law, the statute of limitations for most medical malpractice, personal injury, and product liability lawsuits is three years from the date you became aware of the injury and its relationship to your IVC filter.
An attorney from Cockran, Kroll & Associates, P.C. will be glad to meet with you and your family at a time and place that is convenient and comfortable for you, including your home or some other location. After this free consultation, if we decide to work together, it will be on a contingency fee agreement. This means that we don’t get paid until we get a settlement or jury award for you.
Contact us toll-free (24 hours) at 866-MICH-LAW or use our convenient online contact form to schedule your no-obligation consultation.
Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.