Recent $3 Million Win in Cook IVC Case Could Kickstart Settlement Talks

For patients suffering from deep vein thrombosis (DVT) who are not suitable candidates for anticoagulant treatments, inferior vena cava (IVC) filters have provided an alternative treatment for reducing the risk of harmful and potentially fatal pulmonary embolism.  Unfortunately, many patients have suffered a variety of serious medical problems related to these devices as they’ve gained popularity over the years.

First introduced in 1979, when an estimated 2,000 devices were placed, IVC filters steadily gained popularity, with an estimated 50,000 placed in 1999.  However, usage saw a significant uptick in the early 2000s with the introduction of retrievable filters (as opposed to permanent placement devices).  The low-profile design of such devices appeared to present fewer risks than those perceived to accompany older model, permanent IVC filters, and by 2008, an estimated 65,000 devices were placed annually just for Medicare patients.

Over time, however, significant risk factors with these devices became apparent, including filter penetration, migration, and fracturing, as well as problems with placement of devices.  These outcomes have led to such complications as bleeding, infection, allergic reaction, blood vessel damage (especially at insertion site), blood flow blockage (and subsequent leg swelling), piercing of the inferior vena cava (potentially harming organs), migration to the heart or lungs (potentially resulting in death), and continued risk of pulmonary embolism, which the IVC filter is supposed to mitigate.

Not surprisingly, this has led to an increasing number of lawsuits, now numbering over 9,000, against major manufacturers of IVC filters, including Indiana-based Cook, Inc. and New Jersey-based C.R. Bard, which collectively control 80% of the market for these devices.  Also under litigation are a number of lesser manufacturers, including B. Braun, Cordis Corporation, Johnson & Johnson, and Rex Medical, among others.

To date, several bellwether trials have taken place to determine whether litigation will move forward with other cases, if settlement negotiations will begin, or if either side will rethink their position.  The recent case of Tonya Brand against Cook resulted in $3 million in damages.  What does this mean in the landscape of pending IVC filter litigation?

What is a Bellwether Trial?

bellwether trial, generally speaking, is a trial meant to act as an indicator of how further trials might proceed.  In mass torte and multi-district litigation (MDL) scenarios, or situations in which several similar cases spread across multiple districts arise, a limited number of sample cases indicative of the larger group are selected to be presented to a panel of select judges from different jurisdictions, with pretrial proceedings held at an agreed-upon MDL venue before cases return to their original district for jury trial.

In essence, bellwether trials give attorneys on both sides the opportunity to try out their legal strategies and see which way the wind blows.  If plaintiffs are primarily triumphant in bellwether trials, defendants may decide to try to settle a class action lawsuit rather than facing a costly, protracted legal battle that could end in a much higher payout for plaintiffs.

If defendants are largely triumphant, they may try to devalue pending cases, forcing plaintiffs to drop out rather than risk losing at trial, or alternately, take much lower settlement amounts.  In cases where bellwether trials are inconclusive, with wins on each side, attorneys may have to rethink their legal strategies in order to ensure better results in further trials.  In all cases, valuable information is gained and all parties involved can gain insight into how best to move forward with additional cases.

Previous IVC Bellwether Trials

In the last year, several IVC bellwether trials have been conducted – three against Bard (with a fourth scheduled) and three against Cook.  In March 2018, the Booker case against Bard resulted in a $3.6 million verdict for the plaintiff, but the Jones case, tried in June 2018, ended in a win for Bard, as did a third case, the Hyde trial, in October.

Two other cases slated for trial were granted summary judgments, in one case because the statute of limitations had expired, and in the other because the case was too similar to one that had already been decided.  The Tintin case, which is the final bellwether trial against Bard, is scheduled for May 2019.

As for Cook, two bellwether trials were dismissed due to the statute of limitations expiring, and the third resulted in a $3 million judgment for the plaintiff, Tonya Brand, in January 2019.  A separate lawsuit against Cook was filed in a Texas state court in March of 2018 and resulted in a $1.2 million judgment for the plaintiff, although the verdict is currently being appealed.

Tonya Brand v. Cook

In the case of Tonya Brand, the plaintiff received a Celect IVC filter that subsequently deteriorated, broke apart, and migrated to other areas of her body, resulting in an incident where she was actually able to pull part of the filter out of her thigh in 2011.  In addition, several pieces of the filter remain lodged throughout her body in areas where they cannot be removed.

In this case, the jury determined that the filter was defective and awarded Brand a $3 million verdict, although they declined to add punitive damages to the judgment.  In response to the verdict, Brand’s trial counsel, Misty Farris of Fears Nachawati, stated, “we are happy with the jury verdict and are encouraged that the Celect IVC Filter was recognized as being defectively designed”.

While there are no further bellwether trials scheduled against Cook, Farris continued on to say that the legal team, including Ben Martin of the Law Offices of Ben C. Martin, Denman Heard of the Heard Law Firm, Laura Baughman of Baron & Budd, and Joseph Williams of Riley, Williams & Piatt, were looking forward to the next trial.  She also said, “We believe this was the right verdict and perhaps the defense may consider this when determining whether or not to begin settlement discussions.”

Outlook for IVC Filter Cases

The bellwether trials conducted to date have delivered mixed results, leaving no clear winners.  While some of the more than 9,000 cases are probably beyond the statute of limitations at this point, there are doubtless still thousands that are eligible to go to trial.  The question then becomes whether or not these trials move forward.

The risk is high for both sides.  Although IVC filter manufacturers Bard and Cook collectively won more than they lost in bellwether trials to date, the fact that juries ruled in favor of plaintiffs in two of six cases, resulting in awards totaling $6.6 million in damages, should be enough to give manufacturers pause when it comes to taking further cases to trial.

While there’s a chance they could win some, or even the majority of case, the legal fees and a handful of losses could end up costing more than simply settling before trial.  On the other hand, plaintiffs emboldened by a couple of big-ticket wins in bellwether trials could push for higher settlement amounts or elect to go to trial.

At this point, there are likely to be further MDL trials against Cook.  Until the bellwether trials have concluded, both sides will do their best to hone their legal strategies and ensure favorable outcomes.  Once the bellwether trials are complete, each side will assess their position and determine whether to move ahead with trials or negotiate settlement terms.


The End of Essure


Family planning has become big business as more and more women and couples seek control over exactly when they choose to have children, in keeping with their life plan.  Responsible adults want to ensure that they are well-prepared if and when they bring a child into the world, and drug companies are happy to accommodate with a slew of pharmaceuticals and medical devices designed to give women options for family planning.

Some women use pharmaceuticals like the birth control pill, while others seek more convenient long-term solutions or even methods of permanent contraception.  The Essure System, a product introduced by Conceptus in 2002 (a company later purchased by Bayer), was designed as a permanent sterilization alternative to surgical procedures like laparoscopic surgery (a minimally-invasive procedure using tiny cameras), which was considered the standard of care to that point.

Unfortunately, a series of incomplete studies and omitted data led to reporting problems that allowed for this device to remain available on the U.S. market for nearly 16 years, despite a number of reported adverse effects that eventually led the product to be removed from the market.  While Bayer claims the discontinuing of the product is due to declining sales, women negatively affected by the product have called it unsafe.

How did Essure make it to market?  How has it adversely affected patients?  What is the current state of affairs for this product and women affected by it?

Initial FDA Approval

The innovation of Essure was that it provided women with a convenient and non-invasive (i.e. non-surgical) method of permanent sterilization.  The procedure, performed in a doctor’s office, involves no anesthesia, no cutting, and no visible scars.  Instead, a soft, flexible coil device is inserted into fallopian tubes with the intention of causing fibrosis (thickening/scarring of surrounding tissue).  Within about three months, the barrier formed by this procedure should stop sperm from reaching eggs, effectively preventing pregnancy.

The procedure became a popular alternative to laparoscopic surgery and hormonal birth control methods, with an estimated 750,00 plus women choosing Essure since it was approved by the FDA for sale in 2002.  This Class III device was approved by the FDA under the Pre-Market Approval (PMA) process, which included two pre-market clinical trials, and as a condition of approval, the completion of two post-approval studies, including:

– A 5-year follow-up on participants from pre-market clinical trials

– Evaluation of the bilateral placement rate for newly trained physicians

What happened with these studies?  The problems began with the pre-market clinical trials, which were nonrandomized, nonblinded studies featuring no comparator group.  Further, the findings only included women involved in the study who successfully underwent the implantation procedure and then had 3-month follow-up results showing correct coil placement and tubal occlusion.  The resulting conclusion by the FDA that the device would reliable for 97% of women was therefore flawed.

Not all results were included in the final findings and of those study participants who underwent the procedure, only 85% were followed-up with after one year to determine safety and effectiveness of the product, with only 25% included in a 2-year follow-up.  The 5-year follow-up study, which included only 71% of women (and excluded women who did not have successful implantation, who became pregnant within 3 months of implantation, or who subsequently underwent hysterectomy), claimed a 100% success rate at preventing pregnancy.

The second required FDA study (evaluation of the bilateral placement rate for newly trained physicians) included 514 participants and was stopped early.  Results indicate an 89% success rate for bilateral placement of devices, 38 device malfunctions, and 13 adverse events (perforation, pelvic pain, bleeding, and more).  No follow-up was reported for this study.  Still, the device was deemed safe.

New Model Approval

Under FDA guidelines, changes to devices that have undergone the PMA process require additional approval, which Essure sought in 2007 and received under the condition of a new post-marketing study.  This supplemental study, which was supposed to include 800 participants, ultimately included only 578 patients that underwent the procedure.  The trial was stopped early, no follow-up was conducted, and the study was never registered at, despite requirement to do so by the 2007 FDA Amendments Act.

Updates to Labeling

Although the results of pre- and post-marketing trials for Essure are spotty, the FDA did elect to make adjustments to warning labels for the product several times, including the following:

– 2011 – warning for contraindication to nickel (i.e. nickel sensitivity) added

– 2012 – results of 5-year follow-up to Phase II and pivotal trials added, along with information related to pregnancies outside the clinical trials

– 2013 – warning for risks of chronic pain and device migration added

– 2016 – boxed warning label and Patient Decision Checklist added

– 2018 – restriction on sale and distribution of product to limited doctors and hospitals added

MAUDE Database Submissions and Lawsuits

The FDA provides a Manufacturer and User Facility Device Experience (MAUDE) database where consumers may report on their own experience with devices.  As of June 2015, nearly 6,000 adverse-event reports had been made to MAUDE, relating to myriad safety concerns such as incomplete procedures, tubal perforations, pain and bleeding (in some cases leading to hysterectomies), unintended pregnancies, possible device-related deaths, and more.

The number of complaints rose to more than 16,000 by mid-2017, including over 9,000 cases of surgical removal of the device, frequently by hysterectomy.  As of early July 2018, more than 16,000 lawsuits had been filed against Bayer alleging harm related to use of the Essure device.  According to Bayer’s annual report for 2016, lawsuits related to Essure cost the company roughly $413 million that year alone.

Essure Removal from the U.S. Market

As of December 31, 2018, Bayer halted the sale and distribution of Essure in the U.S., although healthcare providers may still implant devices for up to a year following the purchase date of the device, in keeping with FDA regulations.  Sale and distribution were also halted in Canada and many countries in Europe, Latin America, and Asia Pacific.  According to the company, discontinuation is due to falling sales (which have dropped 70% in the U.S. since 2010), not safety issues.  Many lawsuits against Bayer in relation to Essure are still pending.


IVC Litigation Update

There are now more than 8,000 IVC filter lawsuits pending in two federal courts.  The lawsuits all claim that the manufacturers of various IVC filters were both negligent in the design and manufacturing of the filters as well as failed to warn patients of the dangers of IVC filters. The largest two manufacturers of IVC filters are C.R. Bard Inc. and Cook Medical.  There are also two smaller manufacturers named Cordis Inc. and Argon/Rex Medical Inc.

All of the cases against Bard and Cook Medical have now been centralized in what is called a multidistrict litigation (MDL) before Judge Young in Indianapolis, Indiana (Cook IVC MDL) and Judge Campbell in Phoenix, Arizona (Bard IVC MDL).  The Cordis cases are filed in state court in California and the cases against Argon/Rex Medical are filed in state court in Philadelphia.

A bellwether trial is a case that the court and the parties select to test their arguments, with the goal of moving the overall litigation towards resolution.  Bellwether cases generally have facts that are typical and representative of other cases in the wider litigation, and the outcome of a bellwether trial often informs the parties on whether they will continue to litigate or settle their claims.  The court selects a bellwether case from a pool of cases that each side proposes. If these bellwether trials result in verdicts for the plaintiffs, they may set the stage for potential settlement discussions, but there is no guarantee this will occur.  If the bellwether trials result in verdicts in favor of the defendant, the defendants usually argue that the cases are not as valuable as an individual plaintiff may have previously thought.

On March 30, 2018, the first bellwether trial involving an IVC filter was tried before a jury in Phoenix, Arizona.  The Phoenix jury awarded $3.6 million in damages to the plaintiff in the first C. R. Bard IVC bellwether trial (the case was Booker v. Bard).  The second Bard bellwether trial took place a few weeks later, and on June 1, 2018, a jury ruled in Bard’s favor. Finally, Bard was granted summary judgement in the third bellwether trial because the judge determined the statute of limitations had expired on the plaintiff’s claim (i.e., they waited too long to file their lawsuit after suffering an injury and the case was dismissed in favor of Bard).

In the Cook MDL, the first and second bellwether trials were dismissed because the judge ruled the plaintiff had waited too long after surgery to file suit.  A third bellwether trial against Cook goes to trial in January 2019.  In March 2018, a separate lawsuit against Cook that was filed in state court in Texas returned a $1.2 million dollar verdict against Cook which is now being appealed.  In short, Cook has been fairly successful at getting the bellwether cases dismissed before trial but will likely need to try a few more cases in the federal MDL before any talks of a settlement are likely.

Moze Cowper named to the Plaintiffs’ Steering Committee in the Eastern District of Pennsylvania Essure litigation

On March 27, 2018, Moze Cowper and Cowper Law LLP were named as one of six law firms in the country to serve on the Plaintiffs’ Steering Committee in the Eastern District of Pennsylvania (“EDPA”) before Judge Padova.  There are currently over one thousand five hundred Essure cases filed in the EDPA and over sixteen thousand cases filed across the United States.

Moze Cowper Brought in as Co-Counsel by Hausfeld in Foreign Exchange Antitrust Litigation

On March 10, 2016, Moze Cowper was brought in as co-counsel with Hausfeld and Scott + Scott to assist in the settlement of The Foreign Exchange Benchmark Rates Antitrust Litigation.  The complaint alleges that the world’s largest financial institutions conspired to manipulate prices paid in the $5.3-trillion-per-day foreign exchange market from 2003 to present. The case is currently pending before Judge Lorna G. Schofield in the United States District Court for the Southern District of New York.

On December 15, 2015, Judge Schofield granted plaintiffs’ motion to preliminarily approve nine settlements in the case. These settlements with Bank of America, Barclays, BNP Paribas, Citi, Goldman Sachs, HSBC, JPMorgan, RBS, and UBS recover more than $2 billion for the plaintiff class.

Mr. Cowper was brought in as an expert in European data privacy and international e-discovery in order to assist in the preliminary settlement approval process and help build a legitimization plan for the transfer of certain information sought by the plaintiffs that is also governed by data privacy laws abroad.

Mr. Cowper is a Senior Editor on the Sedona Conference’s publication: International Principles on Discovery, Disclosure & Data Protection: Best Practices, Recommendations & Principles for Addressing the Preservation Discovery of Protected Data in U.S. Litigation.  He has also authored numerous articles on international discovery and has been a faculty member for the Sedona Conference for over a decade.

Dr. Steven Wang’s Recent Study on IVC Filters

On April 5th, 2016, Dr. Steven Wang presented at the annual Society of Interventional Radiology in Vancouver, Canada. Dr. Wang is an interventional radiologist from Palo Alto, California and is affiliated with Kaiser Permanente. In a retrospective study involving 96 patients he sought to understand the prevalence of long-term (greater than 46 month) complications of both permanent and retrievable IVC filters (IVCFs).Screen Shot 2016-03-13 at 11.57.34 AM

The study looked at all inferior vena cava filters implanted in patients from January 2007 through December 2009 at multiple health care facilities across the United States. Dr. Wang then identified all patients who had imaging of the filter taken at four years or more after implantation.  Of those patients (96), he then evaluated the imaging to determine whether or not the IVC filter had malfunctioned.

After reviewing the data, the authors concluded that device complications at four or more years after implantation “are relatively common.”  They also found that the Cordis OptEase and Trapease IVC filters suffered fracture rates of 37.5% and 23.1%, respectively.

Cowper Law has filed over a dozen lawsuits against the manufacturers of IVC filters in the last month.  A growing body of scientific research indicates that the risks of IVC filter implantation far outweighs any benefits.  If you have been implanted with an IVC filter, please call us at 877.LAW.3707 so we can discuss filing a lawsuit on your behalf.

NBC News Special Report — IVC filters

In a follow up to their earlier investigation, NBC Nightly News reported last week that IVC filters manufactured by CR Bard continue to cause patients to suffer major injuries.

What was most compelling about the report, though, was the interview with Dr. William Kuo at Stanford. Dr. Kuo has gained a reputation in the vascular surgery world as being one of the only surgeons willing to remove IVC filters that have become deeply imbedded in the vena cava — and which other surgeons are unwilling to remove for fear of losing the patient. He has never testified on behalf of a plaintiff and yet he had incredibly strong words for the manufacturer of the G2 filter.

“All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications,” said Dr. William Kuo. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”


The report went on to find that: “confidential company records obtained by NBC News show that New Jersey-based medical device giant C.R. Bard was concerned about reports of failures for its G2 series filters, designed to replace the company’s Recovery filter, within four months of being cleared to sell the G2 by the Food and Drug Administration. A company that made a blood-clot filter associated with 27 deaths and hundreds of problems replaced the device with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market. But instead of recalling the G2 filter, and the virtually identical G2 Express, the medical device manufacturer decided to keep them on the market for five years, until 2010, selling more than 160,000 of them.”

To read the full report, click here:

A confidential memo written in December 2005 by a Bard vice president soon after the G2 was cleared by the FDA shows his concern about “problems with…migration,” “tilting” and “perforation.” The Bard executive also noted that Bard had another filter on the market that had virtually no complaints. “Why shouldn’t doctors be using that one rather than the G2?” he asked.

If you have been injured by an IVC filter, please contact Cowper Law at 877.LAW.3707. This firm has recently filed a dozen lawsuits against both C.R. Bard and Cook Medical Inc. in both MDL proceedings. We are very active in this litigation. Email Moze Cowper at: to discuss your potential claim.

Click here to watch the NBC report:

LA’s Best Friends Board raises over $109,000 for after school program

Moze Cowper is a member of the LA’s Best Friends Board. This blog post was shamelessly and proudly posted by him.

The 6th annual CYCLE 4 LA’s BEST fundraising event took place over the weekend at Esperanza Elementary on April 26th, 2015. The Sunday fundraiser, sponsored by Wendy’s of LA, was a HUGE success, as we surpassed our goal of $100,000 thanks to the tireless efforts of more than 100 dedicated LA’s BEST supporters who cycled to raise money for the organization.LA’s Best Cycle Event

Led by the Cycle Committee and our BEST Friends Board, CYCLE 4 LA’s BEST teams pedaled for 50 minutes in 90-degree heat as funds from their supporters continued to roll in throughout the day, and by Monday, the event raised over $109,000 for LA’s BEST After School Program!

When teams weren’t pedaling, the participants enjoyed a reception sponsored by a variety of companies, including BUICED, Just Chill, Clif Bar, Simply Salad, Invigorade, WTRMLN WTR, Le Bon Garcon, and Aquahydrate. LA’s BEST students also were in attendance and joined in the fun, cheering on the cyclists and participating in fun physical activities led by BEST Fit, the nutrition and physical fitness program of LA’s BEST.

In between cycling, participants, supporters and kids enjoyed music from our very own DJ AmRo and even had the chance to strike a pose at the step and repeat!

You can continue to donate towards CYCLE 4 LA’s BEST by clicking here:

Moze Cowper Moderates Panel on Changes to the Federal Rules at Georgetown Law

On November 19th, 2015, Mr. Cowper moderated a panel on proportionality and e-discovery at Georgetown Law’s Advanced E-discovery Institute. The Panel was comprised of John Rosenthal (Winston & Strawn), Aaron Crews (AGC at Walmart), Ariana Tadler (Milberg LLP) and U.S. Magistrate Judge Craig Shaffer.

The Advanced eDiscovery Institute has gained a reputation among judges, practitioners, and vendors as the leading eDiscovery conference of its kind in the United States. Now in its twelfth year, this program, planned by a national Advisory Board, gives attendees access to more federal judges than any similar program and provides the opportunity to learn at an advanced level from the leading eDiscovery practitioners and academics from across the country. A combination of plenary sessions and targeted break-out sessions allows attendees to craft your their learning experience. Attendees will be exposed to the latest case law, trends in all aspects of eDiscovery, and judicial and practitioner perspectives on where this fascinating world is heading in the next few years.

Check out:

NBC News Report raises Serious Questions about C.R. Bard’s IVC Filter

Following a year-long investigation, an NBC Nightly News two-part report has raised significant questions about medical device manufacturer C.R. Bard, Inc.’s decision to continue to market and sell its inferior vena cava (IVC) filters, even after it became aware that its filters were failing and causing death and other serious injuries at higher rates than other similar devices.

The NBC report, titled “Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?”, associated 27 deaths and 300 problems to failures associated with C.R. Bard, Inc.’s Recovery model IVC filters. The report also questioned why Bard did not recall the Recovery filters once a confidential study commissioned by Bard “urgently” urged further investigation of the device’s performance. Instead of informing the public about these problems or issuing a recall, Bard put profits over people, hiring a PR firm that circulated a crisis management plan warning about unfavorable press damaging Bard’s stock prices. A link to the NBC report is here:

The second part of the report, “Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?”, raises serious questions about how Bard obtained FDA clearance for the Recovery filter. It details how the Recovery filter was originally rejected for FDA clearance, causing Bard to hire Kay Fuller, a veteran FDA specialist, to help Bard re-submit its FDA clearance application. After Bard failed to give her important performance safety test results, and following results from a small human clinical trial which raised red flags, Fuller grew concerned. Fuller told her boss she would not sign Bard’s FDA application until her concerns were addressed. Nevertheless, the report continues, her signature is on the FDA application. Fuller claims the signature on the application which was represented to be hers is not, in fact, hers, and was signed and submitted without her knowledge. A link to the second part of the report is here:

Cowper Law currently represents a number of individuals implanted with Bard IVC filters who have suffered injuries as a result. It is believed that over 20,000 people remain implanted with Bard Recovery filters, or the G2 model which replaced the Recovery. If you or a loved one have been injured as a result of being implanted with a Bard IVC filter, please contact Cowper Law at:


We are here to fight for you.