An IVC filter lawsuit is a legal claim by a patient who underwent implant surgery and subsequently suffered serious complications. These lawsuits claim that the manufacturer made a defective product and/or failed to warn blood clot patients of foreseeable risks and complications.
At this time, there are thousands of inferior vena cava filters plaintiffs. And many are part of a federal multi-district litigation (MDL) mass tort case.
Shouse Law Group is a California-based personal injury law firm. We represent victims of IVC filters injuries nationwide. Our mission is to recover the highest financial reward possible.
IVC Filter Manufacturers Sued for Defective Products
- Cook Medical
- Boston Scientific (Greenfield)
Common IVC Filters Injuries
- Device migration, causing the filter to compromise the veins and organs it travels to (internal bleeding and organ damage);
- Filter fracture, causing pieces of the filter to pierce and perforate veins or organs (organ perforation);
- Pulmonary embolism, if the filter has migrated and is no longer in place to prevent a blood clot from traveling up the inferior vena cava vein;
- Deep vein thrombosis (DVT), as the IVC filter can cause other veins to be partially blocked with blood clots (including lower limb DVT);
- MRI complications, if the filter materials interfere with the magnetic resonance imaging;
- Cardiac tamponade, which is fluid buildup that occurs when filter fragments travel to the heart;
- Clogging of the filter often with blood clots or debris;
- Removal, retrieval and revision surgeries for IVC filters; and
- Replacement surgery to replace a defective IVC filter with an alternative filter
Financial Damages for IVC Filters Injuries
- Economic damages: compensation for lost wages, loss of future earnings, doctor bills and medical expenses, and other out-of-pocket expenses;
- Non-economic damages: pain and suffering, mental anguish, and loss of consortium
- Punitive damages: if the case goes to trial and the plaintiff wins, the jury can order the manufacturer to pay punitive damages as a punishment to the manufacturer
Below our experienced IVC filters lawyers discuss:
- 1. What are the grounds for an IVC filter lawsuit?
- 2. Who are the defendants being sued?
- 3. What money can victims recover?
- 4. Is the IVC filter litigation individual lawsuits or class actions?
- 5. Have IVC filters been recalled?
- 6. How long do I have to file a lawsuit?
1. What are the grounds for an IVC filter lawsuit?
There are four potential claims:
- Defective design,
- Manufacturing defect, and/or
- Failure to warn/ improper labeling
The victim is the “plaintiff.” The filter manufacturer is the “defendant.”
There are four elements in negligence claims. Plaintiffs have to prove all of them to win:
- The defendant(s) owed the plaintiff a duty of care;
- The defendant(s) breached that duty of care;
- This breach of duty caused the plaintiff’s injuries; and
- The plaintiff’s injuries caused money damages
Medical device makers owe a “duty of care” towards patients. This duty comprises such reasonable measures as:
- Creating safe and functional devices;
- Providing adequate instructions to the medical providers;
- Sufficiently outlining all the side effects and potential hazards; and
- Receiving all the necessary FDA (U.S. Food and Drug Administration) clearances
It is a breach to fall short of these duties. An IVC filter caused the plaintiff’s injury is this statement is true: He/she would not have suffered complications but for the filter.
Finally, victims need to prove they lost money. Evidence typically includes:
- Medical bills;
- Past paychecks. These show what earnings patient lost from being too injured to work; and
- Anything else that can show “pain and suffering”
1.2. Defective design
A defective design means the IVC filter is inherently dangerous. A medical device manufacturer is liable when:
- A design defect posed a foreseeable risk; and
- The device was manufactured and used as intended
This type of liability is called “strict liability.” All the plaintiff has to show is the device failed. Plaintiffs do not have to prove negligence. (Plaintiffs may have to show the manufacturer could have designed a less risky filter. It depends on the state.)
These defects may manifest right after implantation. Or weeks or months may pass before patients feel symptoms. One IVC filter design defect is “fracturing.” In other words, these defective medical devices are prone to falling apart.
A 2010 article studied patients with a Bard Recovery filter. It reported that 25% of them experienced fracturing.1 Once these cage-like devices break apart, the pieces can travel. They migrate to other parts of the patient’s body. And they can cause IVC perforation, embolisms, and/or death.
Typical evidence to show defective devices include:
- The original filter design schematics; and
- Expert testimony about the design problems
1.3 Manufacturing defects
A good IVC filter design can fail due to poor construction. The equipment could be faulty or substandard and at high risk for a malfunction. And human error could have played a part.
Typical evidence of these defects include:
- Testimony from people who made the filters; and
- Expert testimony about the filters’ defects
Proving medical device makers made a mistake is difficult. They keep their operations very secret. And it may be hard to gather enough evidence.
1.4. Failure to warn (marketing defects, improper labeling)
Medical manufacturers have many responsibilities. This includes instructing doctors on how to use their products safely. And they must disclose their potential complications and health risks. This is especially true for any hidden dangers.
Warning labels on the packaging for medical devices should be:
- Easy for doctors to understand;
- Specific; and
- Placed conspicuously where the doctor can see it
Typical evidence to show marketing defects includes:
- The warning labels; and
- Other information included with the device packaging
2. Who are the defendants being sued?
IVC filter victims typically sue the manufacturer. There are more than a dozen types of filters. But the three main manufacturers include:
- Cook Medical
- Boston Scientific (Greenfield)
Bard manufactures or has manufactured:
- Bard Recovery Filter
- Bard G2 Filter
- Bard G2 Express / G2x Filter
- Eclipse Vena Cava Filter
- Meridian Vena Cava Filter
- Denali Vena Cava Filter
- Simon Nitinol Vena Cava Filter
One of the metals in Bard IVC filters is Nitinol. This is an alloy of nickel and titanium.
The FDA issued a Warning Letter to Bard on July 13, 2015. The FDA discussed several concerns:
Bard did not establish procedures to evaluate complaints about certain filters. And Bard did not report information about malfunctioning devices.
2.2 Cook Medical
Cook Medical manufactures or has manufactured:
- Günther Tulip Vena Cava Filter
- Cook Celect Vena Cava Filter
- Cook Celect Platinum
One of the metals that Cook uses is Conichrome. This is an alloy of cobalt, chromium, nickel, molybdenum, and iron.
The FDA received multiple adverse event reports. Two examples are here and here.
2.3 Boston Scientific (Greenfield)
Boston Scientific makes the Greenfield Filter. It is meant to be permanent (so they are not retrievable IVC filters). It is for patients facing pulmonary embolism. The FDA recalled it for almost a year for a defect.
3. What money can victims recover?
IVC filter victims can sue for both:
- Economic damages (such as medical bills); and
- Non-economic damages (such as pain and suffering)
If plaintiffs win at trial, the jury decides the reward. But most cases settle through negotiation with IVC filter settlements.
3.1. Types of compensation
3.1.1. Economic Damages
Economic damages have a monetary value attached to them. Examples include:
- Medical bills. This includes rehab and home health care (past and future);
- Lost wages while the plaintiff was too ill to work;
- Loss of earning capacity while the plaintiff is too ill to work; and
- Other out-of-pocket expenses that there are receipts for
Some economic damages can be “capped” at a maximum. Every state’s law is different.
3.1.2. Non-Economic Damages
Non-economic damages are hard to calculate. They comprise intangible injuries. Examples include the plaintiffs’:
- Mental anguish and emotional distress the filter caused, and
- Pain and suffering. This includes physical pain from injuries and revision surgeries.
The plaintiff’s spouse may also be able to sue. Spouses would claim “loss of consortium.” This is when the injury had a direct and negative marital impact. Examples are if the filter caused:
- Anxiety, and/or
- Sexual dysfunction
Factors that help determine non-economic damages are:
- The plaintiff’s prognosis;
- The type and seriousness of the injuries;
- How long the recovery will take, if ever;
- Whether there are permanent injuries;
- Whether there is chronic pain;
- The extent the injuries compromise daily activities; and/or
- The extent the injuries impact family and friends
Some non-economic damages can be “capped” at a maximum. Every state’s law is different.
3.1.3. Punitive damages
Punitive damages factor in when there is a trial. If the plaintiff wins, the jury can award punitive damages.
Economic damages pay back plaintiffs for their injuries. So do non-economic damages. But punitive damages are different.
Punitive damages punish the defendants (medical device makers). And they deter other device makers from acting like the defendants.
Punitive damages can be very high. States have their own rules about caps.
3.2. Sample jury awards in IVC filters trials
- $3.6 million by an Arizona jury: A woman sued Bard for her fractured filter (March, 2018).2
- $3 million by an Indiana jury: A woman sued Cook Medical for her fractured filter (March, 2019) [2020 UPDATE: The court vacated this verdict and ordered a new trial].3
- $1.2 million by a Texas Jury: A man sued Cook Medical following organ and blood vessel perforations from his filter (May, 2018).4
4. Is the IVC filter litigation individual lawsuits or class actions?
Victims sue individually. But they get joined in a multidistrict litigation (MDL). MDLs are different from class action lawsuits.
MDLs help streamline the pretrial process for all IVC filter cases. But unlike in class actions, each plaintiff keeps his/her attorney. And each case gets transferred back to its original court.
A few MDL cases do go to trial. These are called “bellwether” trials. The results give both sides a starting point for negotiations. Current IVC Filter MDLs include:
- Cook Medical, MDL No. 2570, in the Southern District of Indiana Court (1:14-ml-2570-RLY-TAB)
- Bard, MLD no. 2641, in the District of Arizona Court (2:15-md-02641-DGC)
- Rex Medical and Argon Medical (regarding Option and Option Elite IVC Filters), in the Pennsylvania Court of Common Pleas, which is state court (“complex litigation” instead of an MDL)
Recently, an IVC filter class action from Arizona was joined into an MDL. (Case No. 2:16-cv-01374).
5. Have IVC filters been recalled?
Some have. The Food & Drug Administration (FDA) should not have cleared many of them in the first place.
5.1. The FDA approval process for IVC filters
The FDA uses the 510(k) clearance process to approve or deny IVC filters. The manufacturer does not have to provide clinical or laboratory studies to demonstrate the filter’s safety. Instead, the manufacturer has to demonstrate that:
- There already exists a similar filter on the market; and
- The new filter has the same intended use as the one currently on the market; and
- If there are technical differences between the two filters, they do not call into question the safety and effectiveness of the new one
The 501(k) process is efficient. But it has potential pitfalls. If the FDA approves a new IVC filter based on a current IVC filter that then turns out to be defective, chances are the new IVC filter may be defective as well.
5.2. The FDA’s monitoring process for IVC filters’ safety
Once the FDA approves an IVC filter for commercial use, it relies on patients and doctors to notify the FDA when the device fails. This notification is called an “adverse event report.”
If these adverse event reports indicate that the device may be defective, the FDA will send the medical manufacturer a “warning letter.” (See a sample of a warning letter to Bard.)
If it turns out the filter is defective, the FDA will recall the device until it gets fixed. (Manufacturers can voluntarily recall their devices as well.)
In 2010, the FDA issued a “safety communication” recommending that IVC filters be removed as soon as the risk of pulmonary embolism is lifted. Following this communication, the use of these filters substantially declined.5
Current and past IVC filter recalls include:
|Date Posted||Recall |
|IVC Filters Product||Reason for recall||Termination Date||510(k)?|
|12/2/05||1||Greenfield Vena Cava Filter System||Reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before March 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization.||4/2/2007||Yes|
|8/5/05||2||Greenfield Vena Cava Filter||Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.||3/18/16||Yes|
|9/27/13||2||Cordis OPTEASE Vena Cava Filter||Error in labeling||9/23/14||Yes|
|3/15/15||2||Bard Denali Filter||Labeling change control||2/1/16||Yes|
|2/9/16||2||Denali Filter Femoral Delivery System||Component design/selection||5/13/16||Yes|
|10/6/06||3||MediTech Stainless Steel Greenfield Vena Cava Filter||One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.||7/3/12||Yes|
|10/30/07||2||B. Braun (BIS) VenaTech LP Vena Cava Filter System||Packaging process control||3/2/08||Yes|
|3/29/13||1||OptEase Vena Cava Filter||Labeling design||10/27/14||Yes|
|2/25/19||3||Gunther Tulip Vena Cava Filter Sets||Labeling Change Control||ongoing||Yes|
|2/25/19||3||Cook Celect Platinum Vena Cava Filter Set||Labeling Change Control||ongoing||Yes|
5.3. When the FDA recalls your IVC filters
A patient’s case is much stronger if his/her attorney can say that the FDA recalled the very device that injured the patient. But even if the FDA has not recalled a particular filter, a plaintiff may still be able to prove that it malfunctioned or was otherwise defective. Relevant evidence would include the plaintiff’s medical records and expert medical testimony.
There may also be evidence of shady practices by the manufacturer that suggest it was covering up its knowledge of the filters’ risks and complications. (For an example, read the NBC News article, “Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?” (September 3, 2015).)
6. How long do I have to file a lawsuit?
Each state has its own statute of limitations. In most states, victims have two years after the IVC filter complications to file suit. But it could be less.
Therefore, victims should seek legal counsel from personal injury lawyers as soon as possible. Otherwise, they risk losing out on financial damages.
Call our IVC Filters Attorneys for a Free Consultation
Our medical device lawyers are here for you. We do everything to investigate, litigate, and negotiate your case. And we fight for the highest financial rewards possible for you or a loved one.
Phone us for a case consultation. Our IVC filter lawyers are here 24/7 to discuss your legal options. Everything is confidential. We offer a free case evaluation and case review.
We represent clients throughout the United States.
- Nicholson W, Nicholson WJ, Tolerico P, Taylor B, Solomon S, Schryver T, McCullum K, Goldberg H, Mills J, Schuler B, Shears L, Siddoway L, Agarwal N, Tuohy C, “Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade,” Archives of Internal Medicine 170(20):1827-31 (November 8, 2010); also see Durack JC, Westphalen AC, Kekulawela S, Bhanu SB, Avrin DE, Gordon RL, Kerlan RK, “Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filters,” Cardiovascular Interventional Radiology 35(2):299-308 (April 2012)(regarding Celect IVC filters); Jose Pablo Morales, MD, Xuefeng Li, Ph.D., Telba Z. Irony, Ph.D., Nicole G. Ibrahim, Ph.D., Megan Moynahan, MS, cand Kenneth J. Cavanaugh Jr, Ph.D., “Decision analysis of retrievable inferior vena cavafilters in patients without pulmonary embolism,” Journal of Vascular Surgery (April 22, 2013); Shayna Sarosiek, MD; Mark Crowther, MD; J. Mark Sloan, MD, “Indications, Complications, and Management of Inferior Vena Cava Filters: The Experience in 952 Patients at an Academic Hospital With a Level I Trauma Center“, JAMA Internal Med (April 8, 2013). Note that IVC filters are often given as an option to patients who cannot take anticoagulants.
- James Humann, “UPDATE: Arizona Jury Orders C.R. Bard to Pay $3.6 Million in First Bellwether Trial,” The Legal Examiner (April 3, 2018); Booker v. C.R. Bard, Inc. (In re Bard IVC Filters Prods. Liab. Litig.), MDL 15-02641-PHX-DGC No. CV-16-00474-PHX-DGC in U.S. District Court (Booker needed heart surgery from his Bard filter; the Bard recovery was large.) Note that the Boston Scientific (Greenfield Vena Cava Filter) MDL has closed.
- Greg Land, “Indiana Jury Awards $3M in Bellwether Trial of Cook IVC Filters,” Law.com (February 7, 2019); Federal Court Vacates Judgment in IVC Filter Litigation Case, Cook Medical Continues Fight for Physician Access to Life-Saving Filter Technology, Businesswire (January 7, 2020).
- “Cook Medical faces $1.2 Million Verdict,” PRNewswire (May 29, 2018). Note that Cordis was recently sued in Palm Beach Circuit Court in Florida.
- “Notable decrease in… usage after FDA advisory Significant decrease in inferior vena cava filter implantation following FDA safety communication. implantation rates remain high compared to rates in Europe,” Science Daily (July 10, 2017).