Plaintiff Scores Win in Cook IVC Filter MDL Bellwether Trial

Indiana Jury Awards Tonya Brand $3 million In Damages

By Mark A. York (February 6, 2019)

 

(MASS TORT NEXUS MEDIA) A federal jury awarded plaintiff Tonya Brand $3 million in the most recent Cook MDL 2570 IVC Filter bellwether trial on February 1, 2019 in Indianapolis. See Tonya Brand v. Cook IVC Filter Jury Verdict Form Feb 1, 2019 , where the jury determined that the design of the Cook Celect IVC Filter was defective and returned a verdict of $3 million dollars.

The jury declined to award punitive damages against Cook Medical, Inc. with Ms. Brand’s trial counsel, Misty Farris offering “we are happy with the jury verdict and are encouraged that the Celect IVC Filter was recognized as being defectively designed, as far as punitive damages not being awarded—we respect the jury decision to not award punitives and look forward to the next trial.” See Tonya Brand v Cook Punitive Jury Instructions Feb 5, 2019.

Ms. Farris further added, “We believe this was the right verdict and perhaps the defense may consider this when determining whether or not to begin settlement discussions,” as there are no other bellwether trials scheduled in the Cook MDL 2570 following the Tonya Brand trial. Will this verdict move Cook Medical and its legal team toward the start of settlement negotiations?

The Brand trial is just one of the more than 5,000 cases filed against Cook Medical, Inc. and its affiliates, where plaintiffs are alleging its blood clot filters were defectively designed. Ms. Brand’s attorneys offered to the jury that she pulled a part of her Cook IVC filter out of her thigh in 2011 after it broke up and deteriorated, while pieces of the device remain lodged in in other areas of her body and are unable to be removed. For additional information on the Cook IVC Filter MDL 2750 docket see Cook-Medical IVC-Filter-MDL-2570-Docket Briefcase, by Mass Tort Nexus.

In addition to Misty Farris, of Dallas-based Fears Nachawati, the trial team consisted of Ben Martin of  the Law Offices of Ben C. Martin; Denman Heard, of the Heard Law Firm; Laura Baughman, with Baron & Budd and Joseph Williams of Indiana-based Riley Williams & Piatt, with a sincere congratulations to the entire team on their trial victory!

The Brand jury verdict came in the third bellwether trial in the Cook IVC MDL 2750, after two previous cases selected for trial resulted in wins for Cook.

Cook promoted its Celect IVC filter which was implanted into Ms. Brand as retrievable, but the filters often tilt and pierce the inferior vena cava, or pieces break off and may travel to the duodenum and aorta as well as other parts of the body, resulting in metal fragments pressing against the spine and other critical areas and organs, making it impossible to remove without major surgery. Many times the filter migration requires multiple attempts at surgical removals which fail due to the location of where the metal IVC filter fragments have migrated to.

What is an IVC Filter?

An inferior vena cava (IVC) filter is a small device surgically inserted into the inferior vena cava, the largest vein in the body. These devices, resembling a cage with spindly legs, are designed to trap blood clots from traveling to the lungs and causing a pulmonary embolism. A pulmonary embolism is a potentially fatal blockage of an artery that carries blood from the heart to the lungs. The idea is that the clots will dissolve naturally once trapped in the filter. Some filters are permanent, but otherwise the U.S. Food and Drug Administration (FDA) recommends removing the filter between the 29th and 54th day after the filter is implanted, unless the threat of pulmonary embolism hasn’t subsided. The FDA concluded this specific time span based on a mathematical model they developed using available medical data. When the agency discovered this, they did issue a safety notice in 2010 and again in 2014 outlining the risks of leaving the devices in for too long.

Plaintiff claims include that Cook knew its Celect IVC filter had perforation problems before it was cleared by the FDA, yet pushed it to the market anyway. There are independent studies that found Celect had a perforation rate of greater than 79 percent, while the Cook-sponsored study the company presented to the FDA prior to Celect’s 510(k) clearance in 2008 showed a zero percent perforation rate.

Over 9000 IVC Filter Claims Filed

Since 1979 when IVC filters were first introduced, hundreds of thousands of IVC filters have been implanted in patients. In August 2010, the FDA issued a safety communication stating IVC filters “are not always removed,” and known long term IVC filter risks include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation. There are now over 9,000 IVC filter lawsuits pending against Cook Medical, Johnson & Johnson, C.R. Bard, Cordis Corporation, B. Braun, Rex Medical, and other manufacturers in state and federal courts.

What are the risks of an inferior vena cava filter placement?

  • Infection
  • Excess bleeding
  • Allergic reaction
  • Damage to the blood vessel at the insertion site
  • Blockage of blood flow through the vena cava, which can cause leg swelling
  • A filter that travels to the heart or lungs, causing injury or death
  • A filter that pierces through the inferior vena cava, causing pain or damage to other organs
  • Problem with placement of the filter
  • Continued risk of a blood clot that travels to the lungs

Clinical Research Shows IVC Filter Dangers Were Known

 “Caval Penetration by Inferior Vena Cava Filters”

https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.115.016468

Zhongzhi JiaAlex WuMathew TamJames SpainJ. Mark McKinneyWeiping Wang    Originally published13 Jul 2015

https://doi.org/10.1161/CIRCULATIONAHA.115.016468 Circulation. 2015;132:944–952

Blood clot filters are implanted in an estimated 250,000 people in the U.S. each year, most without incident. In the last decade, millions of filters have been implanted in Americans and Cook Medical, Inc. is justone of 11 manufacturers that make these devices and are involved in litigation pending in both federal and state court dockets across the country.

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(Disclaimer: Excerpts in this document and media content may have originated in other media publications)

 

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C. R. Bard, Inc., Hit With Multimillion Dollar IVC Filter Jury Verdict in Arizona Federal Court

Plaintiff Wins the First Bellwether Trial in Bard IVC Filters Products Liability Litigation MDL 2641

By Mark A. York (March 30, 2018)

Bard G2 Inferior Vena Cava Filter

 

 

 

 

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media)  A Phoenix federal jury awarded $2 million in compensatory damages on Friday to plaintiff Sherr-Una Booker, in the first bellwether trial against IVC filter maker Bard, Inc. and affiliate company Bard Peripheral Vascular, Inc. finding that the clot-stopping vein filter known as a G2 model IVC filter, (an Inferior Vena Cava filter) manufactured by Bard broke apart in her body, and returned a verdict citing that the device maker was responsible for 80 percent of the harm. They also said that Bard is liable for punitive damages in addition to the $2 million in actual damages award, with the hearing on punitive damages taking place right after the initial verdict announcement.

The punitive damages phase of the first bellwether over the IVC device began immediately after the early Friday verdict in the Sherr-Una Booker v. C.R. Bard, Inc et al, Case No. 16-CV-0474-PHX-DCG litigation, US District Court of Arizona in front of Judge David G. Campbell.  The Booker trial is the first “bellwether trial” in the more than 3,500 other IVC filter lawsuits pending in the Bard IVC Filters Litigation MDL 2641, before Judge Campbell. The verdict came fairly quickly after just six-and-a-half hours of deliberations that started Thursday. The jury said Bard was not liable for strict liability, which will probably be appealed by Ms. Bookers counsel. We will update this article with the results of the punitive damage hearing as soon as they become available.

BARD IVC FILTER PROBLEMS

Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of over 3,500 injury claims in the Bard IVC Filters Products Liability Litigation MDL 2641 currently pending before the court in the District of Arizona. The thousands of lawsuits  filed against the two Bard companies claim they concealed dangerous side effects associated with their retrievable IVC filters – including filter migration, fracture, organ perforation, embolization, and inferior vena cava punctures – and failed to warn doctors and patients about these risks. In addition to the Bard MDL 2641 cases, there is other litigation against smaller IVC manufacturers, Cordis Corporation Rex Medical, Argon Medical, and B. Braun who are all facing  IVC lawsuits in state and federal courts across the country.

BARD FAILURE TO WARN

IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.

Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.

The FDA has issued two safety alerts about using retrievable IVC filters.

  • The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
  • The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.

“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”

Additional research has shown in the last 30 years an estimated 30,000 IVC filters have been implanted. But it wasn’t until 2010, after they’d received thousands of adverse event reports, that the FDA finally issued a warning citing the risk of retrievable filter injuries. It took another four years for the FDA to strengthen the warning when in 2014 they implored doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has lessened.

BARD KNEW OF DANGERS

In 2015 after the FDA issued the second IVC warning, a bombshell media report claimed C.R. Bard continued to market and sell their inferior vena cava (IVC) filters even after the company became aware the filters were failing and causing serious injuries and even death. The report went on to link at least 27 deaths and more than 300 injuries to failures associated with C.R. Bards Recovery Model IVC filters. The investigative report also uncovered that IVC devices made by C.R. Bard and Cook Medical had been linked to hundreds of adverse event reports where they punctured the vena cava, tilted out of position or migrated or broke apart and caused metallic fragments to travel to the heart or lungs – a condition known as embolization. Even after C.R. Bard was warned about the problems, they continued to sell the devices, without warning the doctors of the defects and injuries.

With 3,500 additional cases remaining the the Bard IVC Filter litigation docket, it seems that the Bard entities may need to prepare for a long and protracted legal fight, unless they determine settlement discussions are the best legal strategy to prevent future plaintiff wins.

 

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FDA Warns Public about Dangerous IVC Filter Side Effects

Bard Denali IVC Filter 2013
Bard Denali IVC Filter 2013

In a public safety communication, the U.S. Food and Drug Administration (FDA) says it has received approximately 920 adverse event reports related to the use of IVC filters, It issued a public report to inform medical professionals and patients about the potential risks associated with using the small, cage-like device. Adverse events reported by the FDA include:

  • Filter fracturing of the device
  • Migration of the pieces
  • Embolization of fractured device or device components
  • Tearing of the inferior vena cava vein.

Cordis IVC Filter Litigation is consolidated in California State Court. Bard IVC Filter Litigation is consolidated in MDL 2641. Cook Medical IVC Filter Litigation is consolidated in MDL 2570.

There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” said Mass Tort Consultant John Ray.

According to one of the many product liability cases filed against IVC Filter manufacturers:

“Defendants knew or should have known that its Cook Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”

The case is Olenda Homes et al. v. Cook Medical Inc. et al. (Case No. 5:16-cv-00066).

Patients who cannot use traditional blood-thinning drugs are usually the typical users of IVC filters. The devices are surgically implanted into a patient’s inferior vena cava vein and are designed to catch blood clots from the legs before they migrate to the heart and lungs, which could cause a pulmonary embolism if it reached these important organs. The filters are meant to only be used temporarily, according to the FDA, and hold the clot until it naturally disappears and until the threat of blood clots is no longer an issue.

IVC filters have come under more intense scrutiny and have been the subject of many lawsuits due to allegations that they have fractured with pieces subsequently migrating away from the original insertion point to other parts of the body. The pieces can tear veins and organs, and embed in other “high risk” areas of the body where they cannot be surgically removed, thus causing significant and long-term risks for the patient.

In its report, the FDA identifies a number of potential symptoms of migrating pieces that patients should be on guard for that include out of the ordinary heart rhythms, dizziness, fainting, heart palpitations, and chest pain.

 

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