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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  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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(Disclaimer: Excerpts in this document and media content may have originated in other media publications)

 

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“Simon Nitinol IVC Filters” Now Included In BARD IVC FILTER MDL 2641 Claims

“Simon Nitinol IVC Filters” Included In BARD IVC FILTER MDL 2641 Claims

By Mark A. York (January 29, 2019)

SIMON NITINOL IVC FILTER

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Recent pleadings in the Bard IVC Filter MDL 2641 reflect Bard’s Simon Nitinol IVC Filters now being included in the types of IVC filters permitted in claims. The Simon IVC filters being allowed in the litigation is based on motions by Bard that were deemed moot and had also included a Bard request for a separate MDL for Simon Nitinol Filters, which was denied. See Bard IVC MDL 2641 Joint Report Re Bard Simon Nitinol Filters part of MDL (Jan 28, 2019) also referenced in the January 2, 2019 JPML order JPML Order Re: Simon Nitinol IVC Filters Included in MDL 2641.

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.

Bard is currently involved in MDL 2641 Bard IVC Filter Litigation in US District Court -Phoenix, Arizona. For further information, see Mass Tort Nexus Briefcase BARD-IVC-Filters-MDL-2641-Product-Liability-Litigation Briefcase.

Bard IVC filter models include:
  • Simon Nitinol IVC Filter
  • Recovery Filter System
  • G2 Vena Cava Filter
  • G2 Express Vena Cava Filter
  • Eclipse Vena Cava Filter
  • Meridian Vena Cava Filter
  • Denali Vena Cava Filter

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.

                  Two of Bard IVC Filter Products

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.

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.

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

 “Caval Penetration by Inferior Vena Cava Filters”

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

Zhongzhi Jia, Alex Wu, Mathew Tam, James Spain, J. Mark McKinney, Weiping Wang    Originally published13 Jul 2015

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

 Abstract:

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.

Conclusions—

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.

Introduction

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

Clinical Perspective

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.

 Search Strategy

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.

Data Extraction

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

Results

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]

_____________________________________________________________________________________________________

WHAT DID BARD KNOW AND WHEN?

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.

To access the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

March 8-11, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
  2. To obtain our free newsletters that contains real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

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The FDA 510(k) System Overhaul -Process For Medical Device Approval: Is this a win for Big Pharma?

 

IS BIG PHARMA LOBBYING DICTATING FEDERAL REGULATORY POLICY IN WASHINGTON D.C. NOW?

By Mark A. York (December 5, 2018)

 

 

 

 

 

 

 

Official FDA announcement: FDA changes 510(k) program for approval and review of medical devices Nov. 26, 2018

(MASS TORT NEXUS MEDIA) On November 26, 2018 the FDA announced an overhaul of the 510(k) system that is meant to prompt manufacturers to base new products on technologies that are 10 years old or less. Almost 20% of the products currently cleared by the system were based on devices older than 10 years. For consumer safety, the FDA is considering whether to publicize the manufacturers and their devices that are based on older products.

The FDA is supposed to protect the interests of the general public and ensure that new devices, as well as existing ones are functioning as designed. More often that is not the case, as the FDA either fails to review medical device failures or simply ignores them.

The FDA has a reporting and tracking database that permits the public to review and see what devices are unsafe or causing adverse events, see FDA Medical Device Adverse Event Report Database.

Now there seems to be an effort by the FDA to pull back on the reporting functions in their official oversight duties. This includes the reporting requirements for problematic medical devices.

But earlier this year, the FDA made a rule change that could curtail that database, which was already considered to be of limited scope by medical researchers and the FDA itself.

For the FDA Medical Device Reporting Program (MDR): FDA.gov/MedicalDevices/Safety/ReportaProblem

BIG PHARMA LOBBYING INFLUENCE

Pharmaceutical companies and medical device makers, collectively Big Pharma, spend far more than any other industry to influence politicians. Big Pharma has poured close to $2.5 billion into lobbying and funding members of Congress over the past decade.

Hundreds of millions of dollars flow to lobbyists and politicians on Capitol Hill each year to shape laws and policies that keep drug company profits growing. The pharmaceutical industry, which has about two lobbyists for every member of Congress, spent $152 million on influencing legislation in 2016, according to the Center for Responsive Politics. Drug companies also contributed more than $20m directly to political campaigns last year. About 60% went to Republicans. Paul Ryan, the former speaker of the House of Representatives was the single largest beneficiary, with donations from the industry totaling $228,670.

Over the past decade, manufacturers have also paid out at least $1.6 billion to settle charges of regulatory violations, including corruption and fraud, around the world, according to the consortium, which published its report findings on November 26, 2018.

The new FDA rule, which had been sought by medical device manufacturers, opens the door for a decrease in reported information for nearly 9 out of 10 device categories, a recent review found. It could allow manufacturers to submit quarterly summarized reports for similar incidents, rather than individual reports every time malfunctions occur, meaning there will be much less detail about individual cases.

As part of the worldwide scrutiny of medical devices and at times, the  affiliated dangers, a massive investigation known as “The Implant Files” was undertaken by a group of journalists around the world.  Led by editors and reporters from the International Consortium of Investigative Journalists, it took a year to plan and another year to complete

ICIJ partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored. This included an analysis of more than 8 million device-related health records, including death and injury reports and recalls.

The Implant Files review encompassed more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years, and reported to the U.S. alone.

Like the rest of Big Pharma, the medical device manufacturers have created an intricate web of corporate and political influence including at the Federal Drug Administration, where the FDA is charged with oversight of medical devices.

The new rule is one of several regulatory changes favoring the medical device industry that have been proposed and enacted since the beginning of the Trump administration. They are part of a decades-long campaign to decrease U.S. regulation of the pharmaceutical and medical device industry, which is a massive global business that has existed for years with minimal international scrutiny.

A recent analysis of the 10 largest publicly traded medical device companies in the U.S. found that since the start of the Trump administration, the companies have spent more than $36.5 million on efforts to influence rules and legislation. Some of these companies manufacture a variety of medical products, including pharmaceuticals and lab equipment, but four of the 10 exclusively manufacture devices and lobbying disclosures for all 10 emphasize efforts to influence policy around devices.

BUYING A PRESENCE IN WASHINGTON

The medical device industry was worth $405 billion worldwide in 2017, according to an Accenture market analysis. Despite its size, the medical device industry has only a patchwork of international oversight, even though when things go wrong with a device, the consequences can be serious.

But the single largest medical device market in the world is the U.S., worth an estimated $156 billion in 2017, according to the U.S. Department of Commerce. As the medical device market has boomed over the past several decades, the industry has built a sizable presence in Washington, D.C.

Many medical device companies have built sophisticated lobbying arms, often employing their own team of lobbyists in addition to hiring outside firms for specific issues. Several of the largest companies used between 15 and 50 lobbyists in 2017 alone, an analysis by the Center for Responsive Politics (CRP) found.

There are also two main trade groups for the industry to which device makers contribute membership fees to, both of which pack a hefty lobbying punch on their own. Since the start of 2017, the Advanced Medical Technology Association (AdvaMed), the older and larger group, has spent more than $6 million and the Medical Device Manufacturers Association (MDMA) has spent nearly $2.6 million. The groups’ policy goals echo those that individual companies list on their lobbying disclosures, among them: decreasing taxes on devices, increasing insurance coverage and reimbursement and the FDA’s approval process for bringing a device to market.

The medical device lobbying effort is vast, with lobbyists seeking to be heard on Medicare and Medicaid reimbursement codes, device purchasing policies at the Veterans Administration, even cybersecurity and trade issues. Companies regularly lobby Congress and target agencies and offices across the executive branches in D.C., from the FDA to the Center for Medicare and Medicaid and the National Security Council.

Altogether, the industry has spent more than $20 million per year for the past five years lobbying the federal government, according to an analysis of campaign finance and lobbying data from CRP.

With the change in administration in 2017, that spending increased to more than $26 million, $2.2 million more than its highest level in any of the previous four years. Based on disclosures from the first three quarters of the year, medical device lobbying in 2018 is on pace to exceed 2017 levels.

An industry spokesperson noted that the U.S. pharmaceutical industry spends more heavily on lobbying than the device industry. Big Pharma-pharmaceuticals, which was worth more than $453 billion in the U.S. in 2017, spent more than $171 million the same year, more than six times as much as the device industry, according to a Statista market analysis.

The lobbying resources of the device industry far outweigh those of consumer and patient advocates, which are often on the other side of regulatory debates on Capitol Hill.

Very few advocacy groups spend time lobbying on devices, said Dr. Diana Zuckerman, a former HHS official under Obama and president of the National Center for Health Research, a nonprofit advocacy organization based in Washington.

“When we’ve talked to congressional staff about this,” she said, “they say things like, ‘Well, we’re getting calls every day, all day long from various device companies or their lawyers,’ and the nonprofits are basically going to the Hill for visits a few hours a year.”

Zuckerman’s group is one of about a half dozen to lobby on devices over the past few years. Each of the largest spends no more than a few-hundred-thousand dollars annually to lobby on devices and all other consumer issues, according to their federal lobbying disclosures.

Trial lawyer groups, which the device industry spokesperson noted often sue device makers, also spent less than one third of what the device industry did in 2017, a CRP analysis found.

Three companies that spent the most on lobbying in the past five years were  ask about their lobbying efforts. Baxter International and Abbott Laboratories did not comment. Medtronic said, “Despite the company nearly doubling in size, our lobbying-related efforts over the last 10 years have remained relatively stable.”

Previously, Abbott, Medtronic and a half-dozen other international device makers told the International Consortium of Investigative Journalists that they conduct business with the highest ethical standards, adhere to all laws and have rigorous programs to prevent employee misconduct.

In a statement, Mark Leahey, president of MDMA, said, “As millions of Americans benefit daily from the more than 190,000 different medical devices available and in use in the United States, our members continue to work with patient groups and policy makers to advance policies that promote improved access for patients and providers. This dynamic innovation ecosystem remains committed to developing the cures and therapies of tomorrow, while reducing adverse events and learning from ongoing research and each patient’s experience.”

OBAMA – TRUMP COMPARISON

During its eight-year tenure, the Obama administration permitted some deregulation but also instituted the first FDA product ban since the 1980s.

Beginning in 2014, warning letters to industry began to drop steeply and approval of new devices to rise. By 2017, the number of FDA warning letters to device manufacturers about product safety had dropped to nearly 80 percent less than those issued in 2010, while approval numbers for new devices were more than three times as high as at the beginning of the decade. The FDA says the decrease in warning letters is due to a more interactive approach to working with violative companies, and the uptick in approvals is due to an increase in staffing and efficiency.

Under Obama, some FDA regulators responsible for overseeing the device industry pushed for deregulation. Administrators largely kept it in check, said Peter Lurie, an FDA associate commissioner during the Obama administration.

“It was accompanied by very heavy lobbying on Capitol Hill as well,” said Lurie. Priorities included faster device approval times and decreasing taxes.

During Obama’s final year in office, the FDA banned its first device in more than 30 years, a type of surgical glove and proposed a ban on a home shock collar for behavior modification. That ban is still pending.

The industry successfully pushed for changes in a proposed regulation on unique device identifiers, the identification codes for individual devices, similar to automotive vehicle identification numbers, and won the suspension of a tax on medical devices created to help fund the Affordable Care Act.

“Now with the advent of the Trump administration,” said Lurie, “the deregulatory gloves are off and we’re seeing a number of the device industry’s most desired objectives come to fruition.”

President Trump vowed to cut regulations across the government by 75 percent when he came into office.

In 2002, Congress instituted a program in which the device industry pays “user fees” to fund the FDA office that oversees it, amounts which are agreed upon in negotiations between industry and the regulator every five years. In its first year, the fees provided 10 percent of funding for the device center, but by 2018, the fees brought in more than $153 million, providing more than 35 percent of the center’s budget.

“It’s carefully negotiated for weeks and months at a time,” said Jack Mitchell, former director of Special Investigations for the FDA. “And there’s a laundry list of things that the industry gets FDA to agree to and that they’re paying for.”

If the most recent agreement, negotiated in 2017, had not gone through by the deadline, the agency would have legally been required to temporarily layoff at least one third of its device center staff. The final agreement included a decrease in approval time for certain devices.

“We do not believe user fee funding has influenced our decision making,” the FDA said in a statement, noting that other parts of the FDA are also funded by user fees.

The agency also noted that it held meetings with patient stakeholders in addition to industry when negotiating the user fee agreement, saying, “Patients are a critical part of the user fee process.”

The FDA emphasized that it does not always agree with the industry, citing as examples its support of legislation that makers of reusable devices provide instruction on how to prevent bacterial contamination, and including device identifier codes in insurance claims forms.

MAKING FDA APPROVAL EASIER FOR BIG PHARMA

The changes to how adverse events are reported was seen as an overwhelming industry success.

The FDA database in which surgical complications are entered is known as the Manufacturer and User Facility Device Experience Database (MAUDE), which includes more than 750,000 incidents per year. The adverse events range from minor malfunctions to patient deaths linked to products being used around the world.

Despite its size, it’s widely accepted that the database is only a rather limited record of the full scale of medical device complications and adverse events.

The rule went into effect in August. The FDA said in a statement in November that though the reports are valuable, they were never meant to be sole source for determining if a device is causing harm.

“This type of reporting system has notable limitations,” said the FDA, “including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”

Patients are able to report adverse events to the database themselves, but few know to do so. Companies are required to report the events, once they are notified., which they don’t always do. The FDA said thirty-three percent (33%)  of all FDA warning letters to device makers were to companies that failed to meet rules for reporting complications with devices.

The more companies that fail to file properly, the less the database accurately reflects what is happening to patients with devices.

Under the rule change, companies could be allowed to submit quarterly summarized reports for similar incidents, rather than individual reports each time malfunctions occur. Previously, qualified manufacturers could submit summarized reports if they filed a request with the agency. Now they can do so without making a request.

“[The database] is the way we’ve learned about some very serious health issues,” said Rita Redberg, a cardiologist at the University of San Francisco who studies adverse events like Hershey’s. “It’s the most widespread and publicly available database for adverse events, which is extremely important for patient safety.”

In a public comment in support of the rule change, AdvaMed called the change a “commonsense approach” that will reduce the volume of reports manufacturers need to submit to the FDA and streamline the information the FDA receives about malfunctions.

“This process will actually make it easier for third parties to assess the malfunction data in [the database],” said Greg Crist, a spokesperson for AdvaMed. “Comparing the old alternative summary reporting program to this new initiative is comparing apples to oranges.”

In response to public comments that critical report information would be lost with the change in reporting, the FDA wrote in the published rule that, “We do not believe there will be an adverse impact on the content of information provided to FDA.”

In a statement, the agency said the new program “streamlines the process for reporting of device malfunctions and allows us to more efficiently detect potential safety issues and identify trends. It also frees up resources to better focus on addressing the highest risks.”

But Redberg, is worried that the new rule change will make searching an already unwieldy database more difficult, decreasing the ability of researchers and the public to search for misfiled reports or see accurate numbers of adverse events.

“It makes things easier for industry, it makes things worse for patients,” she said. “I really think it’s a public health crisis. We have more and more devices in use, and for many of them we really have no idea how safe they are because we don’t have accurate reporting.”

How these changes are affecting medical care in the US, and more importantly the publics right to be informed of adverse events and problems with medical devices, their approval process and who’s lobbying who and for what in the FDA should be open and transparent.  

(Certain images and text excerpts in this article were reprinted from third party media sources)

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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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