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?
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
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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Bard-Davol is attempting to consolidate MDL 2641 IVC Filter litigation cases now that settlement discussions seem to be starting in earnest and having all their filters in this MDL makes good business sense.
Bard’s history includes being known as the company that manufactured IVC filters associated with at least 27 deaths and hundreds of related problems when they replaced the initial IVC device with a modified version, that it knew had similar and potentially fatal flaws soon after it was put on the market.
Company records have shown that New Jersey based 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.
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.
At least 12 deaths and hundreds of problems are now linked to the G2 series filters, according to Bard and FDA records.
“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, a interventional radiologist who runs Stanford Health Care’s IVC Filter Clinic, which specializes in removing failed blood clot filters. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
The spider-shaped Bard filters, implanted in the largest vein in the body (the inferior vena cava) were designed to stop blood clots from moving to the heart and lungs, where they could be fatal.
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. Bard is one of 11 manufacturers that make these devices.
Bard had hoped to gain a new foothold in the lucrative filter market when it introduced the Recovery filter. But after it received FDA clearance to market the device in 2002, reports of deaths and injuries associated with it moving and breaking steadily climbed.
A confidential study commissioned by Bard showed that the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all of its competitors. An outside doctor hired to conduct the study wrote that “further investigation…is urgently warranted.”
But Bard decided not to recall the Recovery from the market. In 2005, after the device had been sold for three years, the company replaced it with the similar G2 series of filters. Internal Bard records and hundreds of reports to the FDA show that the G2 series did not solve the filter’s problems.
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.” He 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.
Another document written later that includes data through 2010 showed the G2 series filters had more fractures, migrations and reported problems than any of its competitors.
Clinical Research Shows IVC Filter Dangers Were Known
Limited penetration into the caval wall is an important securing mechanism for inferior vena cava (IVC) filters; however, caval penetration can also cause unintentional complications. The aim of this study was to assess the incidence, severity, clinical consequences, and management of filter penetration across a range of commercially available IVC filters.
Methods and Results—
The MEDLINE database was searched for all studies (1970–2014) related to IVC filters. A total of 88 clinical studies and 112 case reports qualified for analysis; these studies included 9002 patients and 15 types of IVC filters. Overall, penetration was reported in 19% of patients (1699 of 9002), and 19% of those penetrations (322 of 1699) showed evidence of organ/structure involvement. Among patients with penetration, 8% were symptomatic, 45% were asymptomatic, and 47% had unknown symptomatology. The most frequently reported symptom was pain (77%, 108 of 140). Major complications were reported in 83 patients (5%). These complications required interventions including surgical removal of the IVC filter (n=63), endovascular stent placement or embolization (n=11), endovascular retrieval of the permanent filter (n=4), and percutaneous nephrostomy or ureteral stent placement (n=3). Complications led to death in 2 patients. A total of 87% of patients (127 of 146) underwent premature filter retrieval or interventions for underlying symptoms or penetration-related complications.
Caval penetration is a frequent but clinically underrecognized complication of IVC filter placement. Symptomatic patients accounted for nearly 1/10th of all penetrations; most of these cases had organ/structure involvement. Interventions with endovascular retrieval and surgery were required in most of these symptomatic patients.
The inferior vena cava (IVC) filter is a device that is implanted in the IVC to prevent lower-extremity deep venous thrombosis from causing life-threatening pulmonary embolism. The IVC filter achieves this by catching the embolizing thrombus between metal struts. Therefore, it is critical that the IVC filter maintains its position once implanted to fulfill this filtration function. Limited penetration of the filter into the caval wall is needed to secure the filter to the caval wall, so penetration is considered pathological only when the limb protrudes >3 mm beyond the caval wall.1 Over the last decade, as more patients with optional filters have returned for filter retrieval, penetration has been increasingly recognized as a frequent finding, particularly with conically shaped filters.2 Although most cases of penetration are asymptomatic and regarded as incidental findings on imaging studies, penetrations may be clinically significant when they involve the adjacent organs or structures. In such cases, filter penetration may require intervention.3
The purposes of this study were to conduct a literature review on the frequency and severity of caval penetration for commercially available IVC filters and to discuss the potential mechanisms, risk factors, treatment, and prevention strategies for filter penetration.
Institutional Review Board approval was not required for this literature review. The MEDLINE database was searched (search parameters: PubMed from 1970–2014, English language) for terms describing IVC filters (key words: inferior vena cava, filter, and perforation or penetration). Prospective clinical trials, retrospective studies, case reports, and series with IVC filter placement and subsequent radiographic imaging or surgical follow-up were included in this review for analysis. We excluded studies of IVC filter placements without either imaging or surgical follow-up, review articles, animal studies, laboratory investigations, duplicated case reports or clinical studies, and other unrelated articles such as editorials, guidelines, response letters, commentaries, or special communications.
Articles that met the inclusion criteria were reviewed. A standardized data extraction database was created by tabulating the following information: first author; year of publication; title; journal; study design (prospective, retrospective, or case report); number and model of IVC filters; number of patients with imaging or surgical follow-up; cases of penetration; imaging findings; clinical symptoms; interventions; and clinical outcomes. Two investigators conducted the literature search independently to verify data accuracy and completeness, with a third reviewer resolving any uncertainties. The formal definition of penetration provided by Society of Interventional Radiology guidelines (the extension of a limb >3 mm beyond the cava wall) was used in this study.1 Major complications of IVC penetration were defined as admission to a hospital for therapy (for outpatient procedures), an unplanned increase in the level of care, prolonged hospitalization, permanent adverse sequelae, or death after filter placement.1 The quality of clinical studies and case reports was assessed with the Grading of Recommendation, Assessment, Development and Evaluation (GRADE), with study and report quality categorized as high, moderate, low, or very low.4
The initial search for “IVC” and “filter” yielded 1511 English reports from January 1, 1970, to December 31, 2014. Of the 1511 reports, a total of 1311 studies were excluded, which included 146 review articles, 1158 studies unrelated to penetration, 1 duplicated clinical study, and 6 duplicated case reports (Figure 1). Ultimately, a total of 88 studies (14 prospective clinical trials and 74 retrospective studies) and 112 case reports were included in this study. The quality of evidence was as follows: high, n=9; moderate, n=44; low, n=34; and very low, n=113. The total number of filter placements qualified for analysis was 9002 (8833 from clinical studies and 169 from case reports; Figure 1). Fifteen types of filters exhibited caval penetration (Table 1); the basic shape of each involved filter is illustrated in Figure 2. Penetration segregated by filter type according to longitudinal studies is shown in Table 2. The incidence of caval penetration was 21% (973 of 4694) for conical filters and 4% (34 of 799) for nonconical filters (P<0.01). The incidence of caval penetration in prospective trials was 9.8% (105 of 1076) and for retrospective studies was 20% (902 of 4417). [end]
Bard kept the G2 series filters on the market until 2010, the same year that Chris Svedise had a Bard G2 Express implanted in him because he was prone to blood clots. Svedise, 69, a manager at a wholesale fish company in San Francisco, asked his doctor last October to check on the filter. He was alarmed to learn it had moved.
“He said, ‘It is dangerously close to your heart,’” Svedise said.
After two surgeons declined to remove the filter because of its precarious position, Svedise turned to Dr. William Kuo, whose team has developed an advanced technique to remove failed filters and filter pieces.
Dr. William Kuo of Stanford Health Care’s IVC Filter Clinic.
During emergency surgery, Kuo discovered three legs had already broken off of Svedise’s filter and traveled to his lungs. Kuo also said that two partially broken legs completely broke away during the operation. One, he said, could have killed Svedise.
“It floated off right in front of our eyes,” Kuo said. “First into the right atrium and then into the right ventricle. He’s very lucky.”
Kuo estimates that in the last 10 years he has removed 1,000 failed filters. Many of the cases were referred to him by other surgeons who deemed the procedure too complex and dangerous. Kuo said he has removed more Bard filters than any other single type.
The Recovery and G2 series filters should have been pulled from the market, “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled,” he added.
Kuo said that along with device companies, the FDA also needs to take stronger action to protect patients.
“What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices,” he said.
Sen. Charles Grassley (R-Iowa), chairman of the Senate Judiciary Committee, sent a letter to the FDA inquiring about the agency’s oversight of the filter. One of his questions was about the actions the agency takes when new information about the performance of an already cleared medical device becomes known.
“FDA’s only got one responsibility. It’s not the company, it’s John Q. Public — to protect the American public from two standpoints: safety and effectiveness,” Grassley said.
Grassley then issued a statement that the FDA’s response was incomplete and he has more questions as he decides what steps to take next.
Asked about Grassley’s concerns and why Bard’s Recovery and G2 filters were not recalled, the FDA declined to answer. The agency said in a statement that it has “investigated the risks of all of these devices,” not just Bard’s, and “issued safety communications” about “risks associated with IVC filters.”
In 2010 and 2014, the agency recommended in those safety alerts that doctors should consider removing the filters from patients as soon as protection from blood clots is no longer needed.
The Society of Interventional Radiologists, Society for Vascular Surgery, and blood clot filter manufacturers, including Bard, have started a large clinical trial called PRESERVE to examine how safe and effective filters now on the market are. The study, which the FDA helped organize, is expected to enroll 2,100 patients over the course of five years, the most ambitious filter study ever in the U.S.
In the meantime, Kuo worries about the steady stream of patients coming into his clinic whose filters have failed and risk injury or death. ”It’s upsetting to see the patients who have actually suffered from a system that appears to be broken,” he said.
As of January 2, 2019 when the JPML issued the Simon Nitinol related order, there were 85 Simon IVC filter related cases directly filed in to MDL 2641, and how many more of these claims will be filed is unknown, as many Simon Nitinol cases have been historically declined by firms due to not being part of Bard MDL 2641.
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Litigation involving Cook and Cordis IVC Filters is now the hot, trending practice area for mass tort lawyers, with hundreds of cases already filed, and hundreds of thousands of potential clients nationwide who need attorneys.
“These devices cause the one thing they are design to prevent — blood clots,” says said Troy Brenes of Aliso Viejo, California, a lawyer who is active in IVC Filter litigation. “They cause the development and increase risk of thrombosis and pulmonary embolism.”
The cause of the litigation is the rapacious greed of the two companies competing to get market share, rolling out one defective product after another for the last 16 years, brushing aside reports of patient deaths and lying to the FDA about it.
Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. The federal district court has created a short form complaint.
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,” says Mass Tort Consultant John Ray.
Brenes and John Dalimonte of Boston spoke on a recent webinar about the litigation sponsored by the Consumer Attorney Marketing Group.
The number of potential plaintiffs is immense: Since 2000, Cook has sold 264,006 Tulip Filters and 129,089 Celect Filters. Attorneys Brenes and Dalimonte estimate that 200,000 Cordis filters have been inserted into patients.
Settlement values of the cases are unknown, and a settlement conference on June 7 with Cook “went nowhere.” The first bellwether trials are scheduled for next year.
IVC filters are small, cage-like devices that are inserted into the inferior vena cava – a major vein leading directly to the heart. They were supposed to capture blood clots and prevent them from reaching the lungs.
However, Dalimonte identified three issues with the Cook Tulip and Celect IVC Filters:
Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.
“There are a lot of cases out there,” Dalimonte says, because the manufacturers conducted off-label marketing directly to bariatric patients, trauma patients and orthopedic surgery patients.
Brenes and Dalimonte will be speaking at the upcoming AAJ annual convention, July 22-25 in Los Angeles.
Fast forward to 3:40 in the video to see John H. Weiland, President, CEO and Director of CR Bard Inc., flee an NBC reporter with questions about the company’s defective IVC filter.
At least 27 deaths have been associated with Bard’s Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade, according to NBC News. Government data shows approximately 300 other non-fatal problems have also been reported with the Recovery.
Even as death and injury reports were climbing, the company decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.
Multi District Litigation
Lawsuits from across the country have been consolidated in MDL 2641 docket in Arizona federal court. Fact discovery is under way. The parties reported that they have scheduled seven depositions and are in the process of scheduling more.
Each year, about a quarter of a million blood clot filters are implanted in patients who can’t tolerate blood thinners, most without incident. Eleven companies sell them in the U.S., but Bard’s Recovery filter stood out early as a risky device.
Bard officials declined NBC News’ requests for interviews but in a statement said all its filters have been “appropriately cleared by [the] FDA based on required and accurate documentation and that when used as instructed they demonstrate “significant benefits to patients.”
03/30/2016 – Plagued with mounting allegations and evidence of wronging relatedto various IVC Filter Devices C. R. Bard, Inc. made an announcement in recent10q filingswith the SEC that we interpret as Bard announcing an Intent to settle many, if not all lawsuits, related to certain Inferior Vena cava (IVC) Filters.
In the same 10q disclosuresin which Bard informed stockholders that certain complaints over their IVC Filter product line had been consolidated in a Multidistrict Litigation in Arizona, Bard also inserted language indicating they intended to settle complaints related to their IVC line, adding that they would fight any claim that did not settle. We found the last comment interesting as we are unsure what other alternative Bard would have other than to fight claims that did not settle.
Although the indication of a desire to settle claims at such an early stage of Bard IVC Litigation did not surprise many of those following the litigation, it is safe to say that such an early stage settlement indication is extremely unusual. It is more common for defendants in case like the Bard Litigation to at least provide some pretense of defense to their stockholders early such a litigation.
Bard Has a Great Deal They Seem to Want to Hide
One possible explanation for Bards indication of early settlement may stem from Bard exectives concluding that the cost of paying claims will be less damaging to their image and stock price than what may come out in discovery if the litigation goes to forward.
Bard has filed motions to suppress a great deal of evidence, claiming that the evidence is protected work product or shielded from discovery for other reasons.
Some of the evidence Bard has moved to suppress include:
1: The Lehmann Report. The Lehmann Report was issued by John Lehmann MD in 2004. It appears that Dr. Lehmann was hired by Bard to conduct research ostensibly intended to demonstrate the Safety and Effectiveness of certain Bard IVC Filter Products. What Dr. Lehmann ultimately reported in what is now referred to as the Lehmann report was not what Bard had hoped for. The report did not support the Safety and Effectiveness of Bard Products in the manner Bard undoubtedly hoped.
Plaintiffs’ Counsel seeks to have The Lehman Report entered into evidence, Bard Counsel seeks to suppress the Lehmann Report as protected work product.
One argument Plaintiffs lawyers have to counter defense arguments related to the Lehmann report being Confidential and Privilege work product arises from the fact that Bard did not diligently protect this supposedly Confidential Work Product.
NBC News was easily able to obtain a copy of The Lehmann report which it featured in a series of reports related to Bards beleaguered IVC products. Mass Tort Nexus investigators were also able to obtain a copy of The Lehmann Reportfrom public sources with little difficulty. Arguably, Bard did not meet the necessary burden of keeping its confidential document, confidential.
Other documents Bard has moved to suppress include:
Again Plaintiffs’ counsel may argue that Bard has failed in their diligence to maintain allegedly confidential documents confidential as both NBC news was able to obtain many of the documents Bard wishes to suppress. Additionally, Mass Tort Nexus was able to obtain copies of the majority of the documents Bard wishes to suppress from public sources.
Copies of many of the documents Bard wishes to suppress may be found at the following link:
Another factor which may contribute to Bard desiring to end the IVC Filter Litigation sooner rather than later stems from the shellacking they received at the hands of plaintiff attorneys Raymond Lopez and Julia Reed Zinc in a case tried in Arizona before the Bard MDL was formed.
These two capable attorneys took on the giant medical device manufacturer in Phillips v Bardan Arizona case. The documents and transcripts from that case clearly show why Bard decided to settle that case before it went to a jury. Raymond and Julia deftly pressed Bard insiders, who appeared to have been coached by a leading member of the actor’s guild, bringing to light truths that Bard would likely have preferred remain in the dark.
Ramon Lopez is now co-lead counsel in the Bard MDL, Julia Reed Zinc also serves in a Plaintiffs Leadership positon. Richard North, Bards defense attorney in Phillips v Bard heads up Bards defense team in the MDL.
Incidentally, Bard now announces the following on its website:
Bard no longer manufactures or sells the Meridian®, Eclipse®, G2X®, G2®, and Recovery™ Filters.
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