A lawyer's guide to lawsuits for injuries caused by a defective IVC filter

 

Patients injured by an inferior vena cava filter (IVC filter) can bring IVC filter lawsuits against the medical manufacturer that created the device. These lawsuits claim that the manufacturer made a defective product and/or failed to warn blood clot patients of foreseeable IVC filter risks and complications. At this time, there are thousands of inferior vena cava filters lawsuits, 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 that represents victims of IVC filters injuries nationwide. Our mission is to recover the highest financial reward possible for these victims, including compensation for medical bills, lost wages, pain and suffering, and punitive damages.

IVC Filters Manufacturers Sued for Defective Products

Common IVC Filters Injuries

  • Migration, causing the filter to compromise the veins and organs it travels to;
  • Fracture, causing pieces of the filter to pierce and perforate veins or organs;
  • DVT, since the filter is no longer in place to prevent the preexisting blood clot from traveling;
  • 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; or
  • Removal, retrieval and revision surgeries for IVC filters

Financial Damages for IVC Filters Injuries

  • Economic damages: lost wages, loss of future earnings, doctor bills, 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

Continue reading if you are seeking information on types of inferior vena cava filters, related injuries, manufacturer liability, FDA recalls, suing for inferior vena cava filter injuries, and how our experienced IVC filters lawyers will manage your personal injury lawsuit:

filter
Recently, victims of IVC filters have been awarded million dollar verdicts.

1. Filing an IVC Filters Lawsuit

Patients injured by IVC filters ("plaintiffs") may be able to recover substantial money damages from the manufacturers ("defendants") by suing for either:

  1. negligence,
  2. defective design,
  3. manufacturing defect, and/or
  4. failure to warn/ improper labeling

1.1. Negligence

In order to prevail on a negligence claim, plaintiffs need to prove all of the following elements:

  1. The defendant(s) owed the plaintiff a duty of care;
  2. The defendant(s) breached that duty of care;
  3. This breach of duty of care directly and proximately caused the plaintiff's injuries; and
  4. The plaintiff's injuries are financially quantifiable.

As with any medical manufacturer, the companies which produce inferior vena cava filters owe a "duty of care" towards the patients who will be implanted with them. This duty comprises such reasonable measures as:

  • creating IVC filters that are safe and functional;
  • providing adequate instructions to the medical providers who will be using the IVC filters;
  • sufficiently outlining all the side effects and potential hazards of the IVC filters; and
  • receiving all the necessary FDA clearances

If the manufacturer falls short in any of these duties, it is in breach. Patients implanted with defective IVC filters are eligible to sue for neglgience only if this breach caused them harm. A shorthand way to determine whether a filter resulted in a patient's injury is if the following statement applies:

“I would not have suffered my complications or injuries but for the IVC filter."

Finally, IVC filters patients need to be able to show proof of the financial damages they sustained due to their injuries. Proof typically includes:

  • medical bills;
  • past paychecks to 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 that the inferior vena cava filter is inherently injurious and problematic no matter how carefully it was manufactured. Sometimes these defects become clear shortly after the implantation surgery. Other times, weeks or months pass before the patient experiences pain or other potentially dangerous symptoms.

A common example of an IVC filter design defect is that they are prone to falling apart ("fracturing"). A 2010 article reported that 25% of patients studied who had a "Bard Recovery" filter experienced fracturing.1 Once a filter breaks apart, the pieces can travel to other parts of the patient's body and cause perforation, embolisms, and possibly death.

A filter manufacturer is liable when a design defect posed a foreseeable risk if the device was manufactured and used as intended. This type of liability is called "strict liability" because all the plaintiff has to show is that the device failed, not that the manufacturer was also negligent. Depending on the state, plaintiffs may also have to show that the manufacturer could have reasonably and feasibly designed an alternative filter that was less risky.

Typical evidence to show design defects include the original filter design schematics as well as experts who can attest to the design's problems.

1.3 Manufacturing defects

A manufacturing defect occurs when the design for an inferior vena cava filter is sound, but the manufacturer failed to build the device correctly. An example of a manufacturing defect is using the wrong materials or broken equipment to build an IVC filter.

If a patient gets implanted with a poorly manufactured IVC filter for its intended purpose of managing a blood clot, the manufacturer should liable for the patients' ensuring injuries. Typical evidence to show manufacturing defects include testimony from people who made the filters as well as experts who can attest to the filters' defects.

Although manufacturers have "strict liability" for their defective products, in practice it is difficult to gather enough evidence to prove a manufacturing defect.

1.4. Failure to warn (marketing defects, improper labeling)

Medical manufacturers have the responsibility not only to design and build working devices. They also have the responsibility to instruct doctors on how to use them and what complications they may carry. Specifically, IVC filters manufacturers are required to both:

  • warn doctors of hidden or non-obvious dangers that may be caused by the filter; and
  • instruct doctors how to use and manage a filter so that they and their patients can avoid any dangers

Warning labels on the packaging for medical devices should be:

traveling filter
A "failure to warn" about risks and complications can form the basis of a personal injury lawsuit.
  • 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. Defendants in IVC filter lawsuits

Victims of defective inferior vena cava filters typically sue the manufacturer which made the filter. There are more than a dozen types of filters, but the three main manufacturers include:

  1. Bard
  2. Cook Medical
  3. Boston Scientific (Greenfield)

2.1 Bard

The inferior vena cava filters Bard manufactures or has manufactured include:

  • Bard Recovery IVC Filter
  • Bard G2 IVC 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 that Bard uses is Nitinol, an alloy of nickel and titanium.

The FDA issued a Warning Letter to Bard on July 13, 2015. Among the concerns were that Bard did not establish procedures to review and evaluate complaints for certain filters, and it did not report information about the devices malfunctioning.

2.2 Cook Medical

The inferior vena cava filters that Cook Medical manufactures or has manufactured include:

  • Günther Tulip Vena Cava Filter
  • Cook Celect Vena Cava Filter
  • Cook Celect Platinum

One of the metals that Cook uses is Conichrome, an alloy of cobalt, chromium, nickel, molybdenum, and iron.

Multiple adverse event reports have been filed with the FDA. Two examples are here and here.

2.3 Boston Scientific (Greenfield)

Boston Scientific makes the Greenfield Vena Cava Filter, which is usually used for permanent implantation in patients facing a risk of pulmonary embolism. The device was recalled by the FDA for nearly a year due to a defect.

3. Compensation for IVC filter injuries

Victims of inferior vena cava filter injuries can sue for both economic damages (such as medical bills) and non-economic damages (such as pain and suffering). Most cases settle out of court through negotiation. But if the case goes to trial and the plaintiff wins, a jury would determine the financial reward.

3.1. Types of compensation

3.1.1. Economic Damages

Economic damages have a ready monetary value attached to them. Common examples include:

  • medical bills, including 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

Every state has its own laws regarding whether economic damages can be "capped" at a maximum amount.

3.1.2. Non-Economic Damages

Non-economic damages are not easily calculable like economic damages. This is because non-economic damages refer to intangible injuries such as the plaintiff's:

  • pain and suffering (physical pain from the IVC filter complications and revision surgeries), and/or
  • mental anguish or emotional distress caused by the filter

The plaintiff's spouse may also be able to sue for the derivative claim of "loss of consortium." Loss of consortium is when the plaintiff's IVC filter injury has had a direct and negative impact on their marriage, such as by causing:

  • depression,
  • anxiety, and/or
  • inability to enjoy physical intimacy

Common considerations that factor into determining the monetary amount of non-economic damages include:

filter lodged near spine
Victims are eligible to recover money for pain and suffering.
  • The plaintiff's prognosis;
  • The kind and seriousness of the IVC filter's complications and injuries;
  • How long the recovery will take (if ever);
  • Whether the plaintiff will suffer permanent disabilities, chronic pain, scars, and/or disfigurement;
  • The extent that the injuries compromise daily activities; and/or
  • The extent that the injuries compromise familial relationships and friendships

As with economic damages, every state has its own laws regarding whether non-economic damages are "capped" at a certain amount.

3.1.3. Punitive damages

If an IVC filters case goes to trial and the plaintiff (victim) wins, the jury can elect to award the plaintiff punitive damages.

The purpose of economic and non-economic damages is to compensate the plaintiffs for their injuries. In contrast, the purpose of punitive damages is to punish the defendants (the medical manufacturers) for their actions which caused the injuries. Punitive damages are also meant to deter other people from engaging in the same wrongful behavior.

Punitive damages are often much larger than compensatory damages. States have their own rules regarding the maximum amounts available for punitive damages.

3.2. Sample jury awards in IVC filters trials

  • $3.6 million by an Arizona jury: A woman sued Bard for her fractured IVC filter (March, 2018).2
  • $3 million by an Indiana jury: A woman sued Cook Medical for her fractured IVC filter (March, 2019).3
  • $1.2 million by a Texas Jury: A man sued Cook Medical following organ and blood vessel perforations from his IVC filter (May, 2018).4

4. Types of IVC Filters Lawsuits

Anyone injured by an inferior vena cava filter should consider consulting with an attorney about filing a claim. Currently, there are thousands of lawsuits pending against IVC filter manufacturers. Plaintiffs may the option of either:

  1. filing an individual lawsuit;
  2. joining an MDL (multi-district litigation); or
  3. joining a class action

4.1. Solo IVC filters lawsuits

An IVC filter lawsuit is where the victim plaintiff (usually through a personal injury attorney) files a claim against the device's manufacturer (the defendant).

The plaintiff would allege that the filter was defectively designed or manufactured by the defendant, and/or that the defendant failed to warn about all the possible complications. The plaintiff would also ask that the defendant compensate him/her for all his/her economic and non-economic damages.

(Depending on the circumstances of the case, plaintiffs may also file medical malpractice and negligence claims against their doctors or hospitals.)

Although IVC filter lawsuits typically involve a lot of time, paperwork, and "David against Goliath" legal tactics, plaintiffs should never have to pay a dime unless they win the case. This is because any reputable personal injury attorney works on a "contingency fee" basis.

IVC filter lawsuits may progress through the following stages:

  1. Complaint. The plaintiff's attorney thoroughly investigates the case and composes a "complaint" to file against the medical manufacturer in court. This complaint outlines all the factual and legal allegations and what economic relief the plaintiff wants. Once the complaint gets filed, the manufacturer has a limited amount of time to file an "answer."
  2. Pretrial Discovery. During this pretrial period, both the plaintiff and defense attorneys will be amassing information by subjecting key witnesses to "depositions" and "interrogatories." Depositions are like cross-examination interviews done under oath and with a court reporter; and interrogatories are written questions that witnesses are required to answer in writing under oath. In addition, the attorneys will file motions with the court in attempt to clarify procedural issues or exclude ("suppress") certain evidence. Meanwhile, the attorneys on both sides may be trying to negotiate a settlement in an effort to avoid trial.
  3. Trial. If the two sides do not agree to a settlement, the case will go to trial. The attorneys for the plaintiff and the defendant will admit evidence, make arguments, and examine and cross-examine witnesses. Afterwards, the jury will deliberate and deliver a verdict. If the plaintiff wins, the jury will determine the financial reward. Meanwhile, the trial can stop at any time if the two sides agree to a settlement.
  4. Post-Verdict/Appeal. Both sides have various legal avenues to contest a verdict. For instance if the jury finds against the defendant, the defendant can file a motion to set aside the verdict and/or appeal. Medical manufacturers usually try every stalling tactic available to delay giving plaintiffs their money; but the plaintiffs' attorneys will stay on their case in an effort to expedite the process and have the compensation paid as soon as possible.

Note that some plaintiffs' IVC filter lawsuits are automatically joined with similar lawsuits under an MDL (multi-district litigation), discussed below.

4.2. MDL IVC filters lawsuits

filter lodged near spine
Many IVC filters lawsuits automatically join an MDL lawsuit, which helps expedite litigation.

When there are several plaintiffs with similar lawsuits against the same medical manufacturer, courts may combine these lawsuits into a multi-district litigation (MDL). And while an MDL is ongoing, anyone who files a similar lawsuit will automatically have that case consolidated with the MDL.

The main advantage of an MDL is that one court makes all the pretrial decisions, which streamlines the litigation process. Meanwhile, each plaintiff gets to keep his/her attorney. And once these pretrial proceedings have finished, each case gets transferred back to its original court.

In every MDL, there are a few cases that the judge allows to go to trial first. These are called "bellwether" trials. The results of these trials help the plaintiffs and defendants gauge how all the other cases are likely to resolve. And this information, in turn, can help the remaining plaintiffs decide whether to go to trial themselves or to pursue a settlement.

Current IVC Filter MDLs include:

4.3. Class action IVC filters lawsuits

Class actions are very different from MDLs. The three main distinctions are:

  1. Whereas MDL join similar cases during only pretrial proceedings, class actions join similar cases from start to finish.
  2. Whereas MDL plaintiffs can each have their own trial or settlement, class action cases have only one trial or settlement.
  3. Whereas plaintiffs are automatically joined with existing MDLs, plaintiffs can always opt-out of class actions.

In order for a class action lawsuit to proceed, the court has to certify all the plaintiffs as a single "class." Some of the criteria this group of plaintiffs has to meet include the following:

  • There are so many plaintiffs that it is impractical for courts to hear the cases individually;
  • The plaintiffs have similar injuries from the same defendant; and
  • The "named representatives" of the class represent and can protect the interests of all the plaintiffs

Class actions are often difficult to certify since every plaintiff is unique. And even if there is a class action, the class action itself could get joined with an ongoing MDL. This recently happened with an IVC Filter class action case in Arizona (Case No. 2:16-cv-01374).

An experienced IVC filter personal injury attorney would talk with victims about all their options for bringing a lawsuit: Depending on the manufacturer and the nature of the injuries, the victim may need to be the sole plaintiff in the lawsuit. Otherwise, the victim may elect to join a class action or be required to join an MDL.

5. The Food & Drug Administration (FDA) and IVC filters consumer safety

All inferior vena cava filters must be approved by the Food & Drug Administration (FDA) before they can go on the market. Once IVC filters get approved, the FDA monitors whether any problems with them arise. If they do, the FDA may recall the filter from the market until the problem is fixed.

5.1. The FDA approval process for IVC filters

The FDA employs the relatively quick 510(k) clearance process to approve or deny inferior vena cava 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 IVC filter on the market; and
  • the new IVC filter has the same intended use as the one currently on the market; and
  • if there are technological differences between the two filters, they do not call into question the safety and effectiveness of the new one

Although the 501(k) process is efficient, 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 concerning an IVC filter.)

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 IVC filters substantially declined.5

Current and past IVC filter recalls include:

Date Posted

Recall
Class

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 IVC 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

When patients sue a medical manufacturer over a defective IVC filter, it is always helpful evidence if the FDA ended up recalling that particular model and make of filter. Put another way, 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. What to do if an IVC filter is causing your pain and suffering

Please go to a doctor if your IVC filter may be causing you problems. Remember, complications and injuries do not always manifest themselves shortly after surgery. It may take much longer for patients to feel the effects of a fractured or traveling IVC filter.

Once you get the medical help you need, there is nothing to lose by seeking out an attorney as well. A good IVC filters lawyer will not charge you for an initial consultation. And you can discuss all of your legal options and chances of success in confidence.

Should you choose to go forward with a lawsuit, you should not have to pay a cent upfront because most IVC filters attorneys work on a contingency fee basis. That means that the only time you pay is if you win your case and receive a financial reward (either through a settlement or a trial).

Just be sure to speak to an attorney sooner rather than later. Each state has its own IVC filter statute of limitations that restricts how long you have to bring a suit against medical manufacturers for a defective device. (Most states' statute of limitations is only two years.) If you wait too long to file suit, you lose your chance to recover financial damages.

Male receptionist waiting for your call.
Call our IVC Filter attorneys at (855) 396-0370 for a FREE consultation.

Call our IVC Filters Liability Attorneys for a Free Consultation

Our medical device lawyers will do everything to investigate, litigate, and negotiate your case in pursuit of the highest financial rewards possible. Phone us now at (855) 396-0370 to have a case evaluation, to learn more about IVC filter lawsuits, and to talk about all your legal options. We are here 24/7, everything is confidential, and there is never a charge for the initial consultation.

We have offices throughout California, Colorado, and Nevada for IVC filters victims, though we represent clients in mass tort litigation all over the United States.


Legal References

  1. 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 Inverventional Radiology 35(2):299-308 (April 2012); Jose Pablo Morales, MD, Xuefeng Li, PhD, Telba Z. Irony, PhD, Nicole G. Ibrahim, PhD, Megan Moynahan, MS, cand Kenneth J. Cavanaugh Jr, PhD, "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 Inernal Med (April 8, 2013).
  2. James Humann, "IVC FILTER UPDATE: Arizona Jury Orders C.R. Bard to Pay $3.6 Million in First Bellwether Trial," The Legal Examiner (April 3, 2018).
  3. Greg Land, "Indiana Jury Awards $3M in Bellwether Trial of Cook IVC Filters," Law.com (February 7, 2019).
  4. "Cook Medical faces $1.2 Million Verdict," PRNewswire (May 29, 2018).
  5. "Notable decrease in IVC filter 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).

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