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.

Sources:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5220210/
https://www.masstortnexus.com/News/4358/Plaintiff-Scores-Win-in-Cook-IVC-Filter-MDL-Bellwether-Trial
https://www.jvir.org/article/S1051-0443(17)30215-4/pdf

The End of Essure

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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 ClinicalTrials.gov, 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.

Sources:

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452270.htm
http://www.essure.com/what-is-essure
http://birthcontrolproblems.com/wp-content/uploads/Revisiting-Essure_Toward-Safe-and-Effective-Sterilization.pdf
https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/UCM452291.pdf
https://www.washingtonpost.com/sf/style/2017/07/26/essure/?noredirect=on&utm_term=.7faee22dfdc3
http://time.com/5344646/bayer-essure-birth-control-sales/
https://www.modernhealthcare.com/article/20170222/NEWS/170229972