AN EMERGING LITIGATION? “Breast Implants Round II”

 

 

 

 

 

 

FDA News Release March 20, 2019

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

For Immediate Release

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California.  Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.  Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.

Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate.

The FDA’s actions today are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agency’s commitment to take more aggressive actions against manufacturers who fail to comply.

In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updatesto the public regarding BIA-ALCL.

Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA’s headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s MedWatch Adverse Event Reporting program.  The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

End

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FDA Statement March 15, 2019 Re: “Efforts to evaluate materials in medical devices to address potential safety questions”  

 

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

For Immediate Release

March 15, 2019

FDA Statement

We’re in an unprecedented era of innovation in medical devices with advances in materials science that have led to technological breakthroughs such as the 3D printing of medical devices, continuous glucose monitoring patches for diabetes and miniaturized brain implants to treat epilepsy and Parkinson’s disease. Helping to ensure patients have access to safe medical devices that improve function and overall quality of life is a crucial part of the mission of the U.S. Food and Drug Administration. Our regulatory framework is designed to ensure that benefits patients receive from these devices are weighed against probable risks.

The vast majority of patients implanted with medical devices have no adverse reactions. The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.

Materials used in today’s medical devices vary as widely as the devices themselves—whether the material is metal, plastic, silicone, an animal-derived product or some combination of these. Because, in the case of implantable or insertable devices, these materials come into contact with tissue or other parts of the body for sometimes extended periods of time, we do a careful evaluation during our premarket review to determine if there is a potential adverse biological response resulting from contact of the device’s component materials with the body and whether the associated risks are unacceptable.

Specifically, we review information about the materials used in the composition of the device and require companies to include a biocompatibility evaluation or risk analysis, as well as clinical studies, when appropriate. In 2016, we finalized updated guidance for industry laying out what we look for in biocompatibility evaluations in order to ensure device manufacturers have adequately assessed the potential of their device to cause adverse biological responses in patients. By clarifying expectations for all devices requiring premarket submissions, we are helping to ensure that manufacturers are providing evidence that demonstrates that any risk to patient health or safety has been adequately evaluated prior to marketing.

These steps help to address any risks that may be posed by, for example, the potential presence of harmful chemicals or materials that might trigger allergic or other adverse reactions in some individuals. While such testing generally has been a reliable predictor of a material’s safety, we also recognize the importance of advancing the science we rely on to evaluate device materials and patient risk factors both before and after devices enter the market to assure we optimally reduce risks to patients and maximize benefits. Once a device is on the market we have a number of tools in place to monitor a device’s benefit-risk profile as it is used in a real-world setting. In cases where new information about safety or effectiveness becomes available, we can and have taken action to inform patients and health care providers about new risks or safety considerations and how to mitigate those risks. These actions include working with companies to recall and correct issues that arise postmarket, issuing safety communications or other updates for health care providers or patients about safe use of devices, requiring boxed warnings or contraindications be added to labeling, requiring postmarket studies, and up-classifying devices to allow us to regulate them more stringently, as we did with metal-on-metal total hip replacement devices. We are also working to fully implement the National Evaluation System for health Technology (NEST) that will link and synthesize data from different sources including clinical registries, electronic health records and medical billing claims; this will help improve the quality of real-world evidence that will empower the FDA to more quickly identify, communicate and act on new or increased medical device safety concerns.

Our understanding of medical technologies evolves over time. As we learn more about long-term effects of materials and as materials science advances and new innovations become a reality, it’s imperative our regulation of devices evolves along with these advances to ensure patients are protected.

Prior to, and as part of, our April 2018 Medical Device Safety Action Plan, the FDA has been carefully evaluating the body of evidence on this issue. This includes current published studies, and information submitted to us as reports in our public adverse events database or through data from postmarket studies that we required manufacturers to conduct. We also have our own team of FDA scientists and engineers conducting research to better understand device materials in our Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Laboratories (OSEL).

Based on our evaluation and discussions with experts elsewhere in the government and academia, we believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to select materials.

The symptoms some patients experience may be limited to the region where the device is implanted or may be more generalized. Symptoms include but are not limited to fatigue, rash, joint and muscle pain or weakness. Although uncommon and varied, these symptoms may share common underlying immune/inflammatory pathways and mimic more well-established inflammatory conditions.

In the small subsets of patients who have reported these symptoms, the symptoms may not develop for several years following implantation. As a result, they may not be detected even in larger and longer clinical studies. To date, these symptoms have not been reported with most materials used in medical devices, including most metals. Moreover, when reported, they have tended to be limited to small subsets of patients.

As an example, some patients, mostly with a history of pre-existing allergies, may develop allergic skin lesions with certain device use. This risk is usually identified by patch testing for potential device material-related allergens. However, not all device-related reactions are allergic in nature. Therefore, the utility of skin patch testing is limited.

Enhancing our collective understanding of materials science could lead to identifying materials that may cause an exaggerated response in sensitive individuals and advance the development of safer materials. Development of new tests to identify at-risk patients would help ensure they do not receive implantable devices that contain the material to which they are sensitive, therefore further enhancing patient safety and advance a precision medicine approach to the selection of device interventions.

It’s clear more work needs to be done.

To this end, we’re undertaking a broad effort to engage the public, scientists and industry stakeholders to gather information and help us determine the current state of the science, critical gaps in the existing science that need to be addressed, what approaches should be considered to further our understanding of medical device materials and improve the safety of devices for patients.

Breast implants

Breast implants have a silicone outer shell, with either a textured or non-textured surface, and are filled with silicone gel or saline. The FDA has regularly communicated about risks associated with breast implants, such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). More confirmed cases of BIA-ALCL have been reported in patients with textured surface implants than in patients with smooth-surface breast implants. We’ve also heard from patients who are concerned that their implants may be connected to other health conditions that could be associated with their immune system’s response to these devices, resulting in symptoms like chronic fatigue, cognitive issues and muscle pain. While the FDA doesn’t have definitive evidence suggesting breast implants are associated with these conditions, we’re looking to gain a fuller understanding of this issue to communicate risk, minimize harm and help in the treatment of affected patients. This topic will be discussed at our upcoming two-day public meeting of the General and Plastic Surgery Devices Panel on March 25 and 26 and will be informed by our ongoing assessment of the long-term health effects of various materials.

In addition, we’ve been coordinating on two different breast implant registries to learn more about how these devices perform and interact with the body’s tissues at the cellular and organ levels. For instance, we worked with the American Society of Plastic Surgeons/the Plastic Surgery Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE). This registry collects real-world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry as well as from medical device reports submitted to the FDA, medical literature and meetings with patient advocates have contributed to our understanding of BIA-ALCL and our communication updates to the public regarding BIA-ALCL. Additionally, we’re working with multiple stakeholders to advance the development of the National Breast Implant Registry (NBIR) to provide a platform for evaluating real world data on the safety and performance of breast implants. This will help us better evaluate data from providers regarding their patients with breast implants.

We’ll continue to report on significant findings as new information and analyses become available and if any of these findings prompt the agency to issue new recommendations or policies to mitigate risks.

Metals in devices

Metal device implants have been used in patients for more than a century, beginning with bone- stabilizing plates to heal fractures and advancing to state-of-the-art stents, prostheses and implantable defibrillators. Many implants are meant to remain in a patient’s body for years or even a lifetime. During this time, we know that tiny amounts of metals may be gradually released into the bloodstream and surrounding tissues.

The FDA regularly conducts thorough reviews of the latest scientific evidence. We continue to find that most patients experience no adverse health effects from these metals interacting either locally where the devices are implanted or systemically throughout the body. However, after carefully reviewing the current scientific literature, reports in our public adverse event database as well as findings from post-approval and postmarket surveillance studies, we believe there’s a need to evaluate through a comprehensive process concerns that were brought to light with particular devices, such as metal-on-metal total hip replacement devices and the permanent birth control implant Essure, a coiled wire that’s composed of multiple metals, including nitinol (a nickel and titanium alloy) and stainless steel, and is inserted into a woman’s fallopian tubes.

Nitinol in devices

Last December, we announced a revised protocol for the postmarket surveillance study of the Essure device to, in part, better understand how the materials in the device interact with the body’s immune system. The FDA worked with Bayer, the manufacturer of the device, to make sure the company implemented several approved modifications to the study that we believe will strengthen the evidence collected.

First and foremost, women in the study will be followed for five years, rather than the three years that were initially required. This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed. We also required additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation. This could help us better evaluate potential immune reactions to the device and define whether these findings are associated with symptoms that patients have reported in relation to Essure. These reported symptoms include persistent pain and hypersensitivity reactions, headaches, fatigue and cognitive difficulties.

The use of nitinol in other devices has increased—particularly for cardiovascular stents, guidewires and other devices used in minimally-invasive medical procedures. This owes to the metal’s properties. Nitinol is flexible and bendable with the ability to spring back, like a Slinky, into its original shape.

Many of the symptoms reported by some patients who had Essure implanted have not been reported by patients who had other nitinol-containing devices implanted, which could be related to the location of the implants. The particular site in the body where a device is placed may contribute to the potential for the device to cause an immune/inflammatory reaction. In the next few months, we’re planning to publish draft guidance on the use of nitinol in medical devices. This new guidance will include recommendations from the FDA on what manufacturers should include in their premarket submission of a device containing nitinol, including technical testing recommendations, labeling and information on how the device is manufactured and other factors that could affect the breakdown of the material in the body.

Metal-on-metal total hip replacement devices

Three years ago, the FDA strengthened the regulation of metal-on-metal total hip replacement devices requiring that manufacturers submit premarket approval applications to keep their devices on the market. That decision was based on significant safety concerns associated with adverse biological reactions to the metal wear particles and ions generated by the metal ball rubbing the metal socket joint during everyday use. These metal particles were found to have the potential to cause damage to the surrounding bones and soft tissues (including muscle) in some patients leading to pain, device failure and the need for repeat surgery to replace the implant. Some patients also developed severe systemic conditions, including damage to their heart, kidneys and thyroid, from the metal ions entering their bloodstream and reaching distant organs.

There are currently no FDA-approved metal-on-metal total hip replacement devices marketed for use in the U.S. However, many patients still have these devices implanted in their body, and the FDA felt it was imperative that manufacturers continue to meet their obligations for completing their postmarket surveillance studies. Today, we’re sharing interim results from these studies. The results show significantly higher blood levels of metal ions (cobalt and chromium) in patients with metal-on-metal hip implants compared to those without metal implants. While that’s not unanticipated, the data also suggest that the standard blood level threshold measurement of 7.0 parts per billion (micrograms/liter) or higher for metal ions, is not optimal to determine if an implant is functioning safely. Some patients in the postmarket surveillance studies had levels higher than this with no adverse medical complications, while others had severe symptoms with lower ion levels in their blood. This suggests that there are additional factors, besides metal ion levels, that affect which patients experience adverse events from metal-on-metal total hip replacement devices.

In addition to the clinical evaluations, the postmarket surveillance studies included a detailed analysis of more than 2,000 devices from patients who elected to have their implants removed. On average, patients who had their devices removed had higher metal ion levels compared to other patients in the postmarket surveillance studies who didn’t. Also, the wear between the metal ball and metal socket was found to be higher than what was expected based on testing performed on the devices before they were allowed on the market. When considering all devices that were explanted, it appears that certain factors, including those related to the design or surgical placement of the device, may be associated with a higher wearing down of the device and elevated metal ion levels.

Based on these findings, the FDA is working with standards development organizations (such as the American Society for Testing and Materials) to develop new standards to improve how metal-on-metal total hip replacement devices are evaluated and identify additional testing protocols for new metal-on-metal devices that are submitted to the FDA for review.

Advisory panel meeting

To help us gain a broader understanding of nitinol and other metals in devices, we’re announcing today that we plan to hold an advisory committee meeting this fall to discuss metal implants and the potential risk for certain patients to have “hypersensitivity” or exaggerated immune and inflammatory reactions to these metals. We’ve been exploring the link between immune and inflammatory markers and symptoms such as pain, headaches and fatigue in patients who have these devices implanted. This advisory committee meeting is part of our ongoing effort to advance the evaluation of materials used in implantable devices.

The panel meeting will engage experts in the field to provide input on what relevant scientific information the FDA should solicit from manufacturers to be considered in both premarket review and postmarket surveillance. Importantly, we’d like to determine how to identify patients who might be at increased risk of having a hypersensitivity response before they receive a metal implant, so they can consider those risks along with the device’s benefits. An additional purpose of the meeting will be to identify gaps in current scientific knowledge to determine what studies are essential to further expand our understanding of this important public health issue, including to what extent immune/inflammatory responses to certain metals contribute to device-related adverse events and steps we can take to mitigate potential risks.

Prior to this meeting, the FDA will release a peer-reviewed white paper that summarizes the current scientific knowledge regarding different aspects of metal implants, including how the structure and function of these devices are impacted by the body’s tissues, muscles and blood supply and how the metal components dissolve and interact with immune cells.

These efforts are just a few aspects of our ongoing evaluation of the effects of materials in at-risk patients. Our goal in taking these steps is to ensure that the benefits of devices made of metal materials continue to outweigh their risks. For the vast majority of patients this is the case and will remain the case as we go through these steps. However, for certain small subsets of patients who exhibit sensitivities to select materials, we must determine what additional actions we should take to make sure they are protected and understand the unique risks they may encounter.

Animal materials in devices

We’re also making efforts to improve the safety of devices made from animal-derived materials such as additives used on device coatings or heart valves made from pig tissue. We know that animal-derived materials may provide benefits over metal or synthetic materials because they can more closely match the biophysical properties of tissues within the human body. But these materials may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured. Specifically, animal tissues can contain infectious agents known as prions, which cause neurodegenerative disorders such as Bovine Spongiform Encephalopathy (BSE) or Mad Cow Disease. Yesterday, we issued final guidance on Medical Devices Containing Materials Derived from Animal Sources to provide recommendations to device manufacturers for how to minimize the potential risk of transmitting these rare but serious infectious diseases while still providing patients access to beneficial devices made from animal-derived materials.

Research efforts to better understand innovative materials

We’re also beginning to see manufacturers incorporate new types of materials in devices. CDRH’s OSEL has been conducting a wide array of research studies to learn more about the new advances in device materials. For example, our scientists are looking to better understand and characterize an innovative form of carbon called graphene, which has enormous applications in biotechnology and device development because it is lightweight, flexible, a superb conductor of electricity and is many times stronger than steel.

In anticipation of new device applications for, say, graphene-containing drug delivery systems or ultrasensitive biosensors that can be used with diagnostic tests, our scientists are working quickly to characterize and learn more about graphene’s chemical properties—both in terms of how durable it will be in medical devices and how it will interact with the body’s tissues and immune system.

OSEL has also worked on understanding how nanoparticles—tiny particles composed of just a few atoms—in medical devices interact with the immune system and whether they’re causing any toxic effects in the body. While these advances are promising, OSEL researchers are working to ensure that the benefits of the new material outweigh any risks that may come from these particles interacting with human cells.

Next steps

Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requires a multi-step approach. We’ll gather input from patients, device manufacturers, researchers and physicians to learn more about their concerns and ideas for how the FDA should proceed. Any new initiatives we implement must be rooted in putting patient safety first and based on sound science.

More closely evaluating the potential for certain materials to cause immune/inflammatory reactions in a small number of patients may improve our understanding of materials, help uncover ways to identify patients predisposed to these reactions and improve the overall safety and performance of medical devices. This is part of our continuing effort to advance opportunities for enabling modern materials to improve the performance of medical devices while also advancing our assurance of safety for these products. We look forward to providing updates about our progress and ongoing research. We believe our continuing efforts will ultimately provide patients and doctors with better access to more effective and safer medical devices.

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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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DePuy Pinnacle Plaintiffs Request Cases Be Remanded For Trial in Hip Implant MDL 2244

Plaintiffs Request Remaining Pinnacle MDL 2244 Cases Be Remanded For Trial 

Mark A. York (February 9, 2018)

A DePuy Pinnacle Hip Implant Component

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Plaintiffs have asked U.S. District Court Judge Ed Kinkeade, Northern District of Texas, who’s hearing thousands of hip implant lawsuits in the DePuy Orthopaedics’ Pinnacle Hip MDL 2244, to remand their cases to the original court of filing for individual trial dates.

According to the February 5th motion filed with the U.S. District Court, plaintiffs request the Court begin an “orderly and efficient staggered remand process,” where both plaintiffs and defense would select 10 cases each for remand to federal courts in California, New York and Texas, for a total of 60 cases being set for trial starting in 2019.

There were further requests that the Court begin not only the remand process, but start phased MDL discovery as well in peripherally related cases alleging RICO, qui tam and other non-personal injuries as part of the metal-on-poly hip revision lawsuits currently pending in the multidistrict litigation.

DePuy Pinnacle Implants and Metallosis

DePuy Orthopaedics,  a subsidiary of Johnson & Johnson, have been named in more than 9,500 hip replacement lawsuits involving the metal-on-metal Pinnacle hip system, which utilizes the Ultamet liner, pending in the multidistrict litigation (see DEPUY MDL 2244 Pinnacle Hip Implant Briefcase) currently underway in the Northern District of Texas.

Plaintiffs allege that the metal-on-metal design within the Ultamet liner configuration can cause dangerous amounts of toxic metal debris to be released into the joint surround the hip, and into the blood stream resulting in metallosis, causing adverse local tissue reactions, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the DePuy hip implant components.

 DePuy/J&J Loses Bellwether Trials

So far, the Pinnacle hip MDL 2244 litigation has convened four bellwether trials related to the metal-on-metal implants with the trial in October 2014, ending with a verdict for DePuy and Johnson & Johnson, which to date, is the only defense win in this litigation.

In the second trial, plaintiffs were awarded a verdict of $500 million in March 2016, however, Judge Kinkeade ultimately reduced the award to $151 million, based on Texas statutes that limit punitive damages. The third bellwether trial ending in December 2016, resulted in a massive billion dollar verdict, when six Pinnacle recipients who were residents of California were awarded more than $1 billion, with 90 percent of the verdict being punitive in nature, meant to send a clear message to the defendants. California does not have a limit on punitive damages, but the judge reduced the award to $543 million, based on the US Supreme Court ruling limiting excessive punitive damages. The most recent trial resulted in the plaintiff being awarded $247 million in November 2017.

J&J Wants To Avoid More Massive Verdicts

J&J are simply using every legal tool available to them, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip  trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to its various medical device and pharmaceutical product lines.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials. Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the Pinnacle hip system. The New York Times stated that the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

Artificial hips are designed to last for 15 years in the best of situations, often that is not the case with many implants failing after just 10 years, and in the case of design defects such as those alleged in Pinnacle devices and many other hip implants, onset of metallosis and other adverse conditions resulting, as well as the ever present implant mechanical breakdown, which cause life altering health problems for patients.

FDA Issues Pinnacle Warning

The U.S. Food & Drug Administration issued a warning in January 2013, stating that patients receiving metal-on-metal hip replacements were more likely to experience premature device failure compared to those who received other types of implants.

In November 2013, DePuy Orthopaedics announced a $2.5 billion settlement in the DePuy ASR Hip Impant MDL2197 ( MDL 2197 DePuy Orthopaedics, Inc. ASR Hip Implant Briefcase), related to the ASR line of metal-on-metal hip implant components. DePuy ended sales of the all-metal Pinnacle hip system that same year, purportedly due to “low clinician use”. However, the company has so far declined to settle the Pinnacle hip litigation.

J&J Facing Many Legal Hurdles

Johnson & Johnson has been hit with numerous large jury verdicts across all areas of the J&J pharmaceutical and medical device operations, with plaintiff trial verdicts Risperdal, Ethicon TVM, Talcum Powder, Xarelto and other products, where recent combined trial verdicts have easily exceeded an additional $200 million. J&J and it’s subsidiaries are now facing more than 100 thousand lawsuits over it’s drug and medical device product lines, in both federal and state courts across the country. To complicate matters further for J&J, the recently started Opiate Prescription MDL 2804 (MDL 2804 Re: NATIONAL PRESCRIPTION OPIATE LITIGATION MDL 2804 Briefcase) names Johnson & Johnson as a defendant in suits filed by more than 400 cities, counties and states across the country.

 They Have Opioid MDL Issues Too

Perhaps J&J should look at settling some of the cases they’ve defended so aggressively over the last 5 years, such as the Pinnacle MDL 2244 to prepare for the Opioid Crisis litigation, which is now looking to displace Tobacco Litigation as far as size and scope as well as the massive multi-billion dollar settlements and years of ongoing litigation that came from lawsuits filed initially by governmental entities.

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WEEKLY MDL UPDATE by MASS TORT NEXUS for Week of November 13, 2017

The week in mass torts around the country:

By Mark York, Mass Tort Nexus (November 16, 2017)

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MASS TORT NEXUS

 Verdicts on November 16, 2017: 

J&J gets hit hard again, in a $247 million Pinnacle hip implant verdict, DePuy Orthopaedics Pinnacle Implant MDL 2244, in bellwether trial of 3:15-cv-03489 Alicea et al v. DePuy Orthopaedics Inc et al. (DePuy Pinnacle Hip Implant MDL 2244 Briefcase)

Drug maker Auxilium won a defense verdict in their Testim product bellwether trial, where plaintiffs claimed it caused a heart attack in a verdict reached in the US District Court Northern District of Illinois, Judge Kennelly, in MDL 2545 Testosterone Replacement Therapy. (Testosterone Therapy MDL 2545 USDC ND Illinois)

Johnson & Johnson Wins a Defense Verdict in Los Angeles Court Talcum Powder Mesothelioma Trial, Jury Finds J&J Not Liable in Tina Herford et al. v. Johnson & Johnson Case number BC646315, consolidated in LAOSD Asbestos Cases, case number JCCP4674, in the Superior Court of the State of California, County of Los Angeles.  (J&J Talcum Powder Cancer Litigation Briefcase)

Senator Bob Menendez  judge declares a mistrial in New Jersey federal court trial, after a hung jury cannot agree unanimously on charges. Question is- Are the Senator and his doctor friend in Florida, just that-were they just friends or was there active bribery taking place?

Recent Case Updates:

>Plaintiff in DePuy Pinnacle Hip Implant Trial Asks Texas Jury For A Hundred Million + In Punitive Damages

At the close of arguments in the latest DePuy MDL 2244 trial on Monday November 13, 2017, six New York plaintiffs asked a Texas federal jury to hit Johnson & Johnson and it’s DePuy subsidiary, with at least a nine-figure punitive damages award. Attorneys asked that J&J and DePuy be punished for making and marketing their Pinnacle model hip implants, an alleged defective line of metal-on-metal hip implants, that have caused many thousands of injuries to unsuspecting patients. If this jury follows suit on prior Pinnacle bellwether jury awards, then J&J and DePuy should be ready for a massive verdict, as the last jury awarded California plaintiffs over one billion dollars in December 2016, sending a clear message that the company’s Pinnacle design and subsequent marketing policies have failed.

METALLSOIS DAMAGE

Closing arguments wrapped up on the two-month bellwether trial, where plaintiffs claimed they suffered “metallosis” which caused tissue damage and negative reactions to the Pinnacle Ultamet line of metal-on-metal hip implants made by J&J’s DePuy Orthopaedics Inc. unit. Depending on the jury verdict, perhaps J&J will consider coming to the settlement table if another massive verdict is awarded, or they may continue the aggressive “we’ve done no wrong stance” resulting in more plaintiff verdicts in the future..

 >Travelers Insurance Wins Declaratory Judgment Suit Over Defense Coverage In Orange County and Chicago Opioid Lawsuits:

“California Appeals court says Watson not covered”

Watson Pharma, Inc. and it’s parent Activis, Inc. were denied insurance coverage in a November 6, 2017 ruling by the California State Court of Appeals in the 2014 Declaratory Judgment action filed by Travelers Insurance in an Orange County, CA court where Travelers successfully asserted claims that they were not required to defend or indemnify Watson in the underlying opioid based litigation filed by Santa Clara and Orange County against opioid manufacturers, due to Watson’s “intentional bad conduct” in their business practices related to sales and marketing of it’s opioid products. The Appeals Court also excluded Watson’s coverage in a similar opioid lawsuit against them in a Chicago, Illinois federal case where the City of Chicago filed similar claims against Watson over opioid marketing abuses in 2014. Perhaps other insurance carrier will take notice and look closer at denying policy coverage for many other opioid manufacturers who have been sued across the country in cases with almost the exact claims as those alleged by Santa Clara County and the City of Chicago.

>NEW XARELTO TRIAL:

Former FDA Commissioner Testifies in Philadelphia Xarelto Trial-

“Xarelto Warnings Are Inadequate”

— Former head of the Food and Drug Administration, Commissioner David Kessler testified during the first state court trial in Philadelphia, telling the jury on Tuesday that “warning labels for the blood thinner Xarelto failed to provide adequate information to doctors and consumers about the risk of bleeding that some patients could face when using the drug”.

David Kessler, FDA Commissioner under President George H.W. Bush and President Bill Clinton, told jurors that Bayer AG and Johnson & Johnson’s warning labels for the medication understated the risk of significant bleeding events that had been seen in television and print ads across the country for years, and failed to disclose the true risks associated with prescribing the blockbuster drug. This trial, expected to take six weeks, is the first state court bellwether trial for the blood thinner Xarelto, in the Philadelphia Court of Common Pleas, the prior trials took place in federal courts in Louisiana and Mississippi where the defense prevailed in all 3 trials earlier this year. Those trials were all bellwether trials, as part of the Xarelto MDL 2592 in front of Judge Eldon Fallon, US District Court, ED Louisiana. Will the change of venue to Pennsylvania State Court have a different outcome than the three prior Xeralto trial losses?

>Luzerene County, Pennsylvania Files RICO Suit Over Opioid Marketing Against Drug Makers

Luzerne County in Northeast Pennsylvania has filed a federal RICO based lawsuit accusing pharmaceutical companies including Purdue, Pharma, Endo, Janssen and Teva of violating the Racketeer Influenced and Corrupt Organizations Act by illegally marketing highly addictive painkillers that have contributed to a costly national opioid epidemic. The suit filed in US district Court of Pennsylvania by Luzerne County is one of many cases opioid drugmakers and distributors are facing as state and local governments seek to recoup costs they’ve incurred in the increased marketing and prescribing of opioid painkillers, and the resultant spikes in addiction and overdose.

OPIOID MARKETING ABUSES

“The manufacturers aggressively pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction,” the complaint, which was filed on Wednesday, said. “These pharmaceutical companies … turned patients into drug addicts for their own corporate profit.”
“The lawsuit accused the drugmakers of using false and deceptive marketing practices over the course of the last two decades, including pushing the opioid painkillers for treatment of chronic pain, to boost prescriptions for the drugs

COMMON CLAIMS AGAINST ALL OPIOiD MAKERS

Among the companies’ primary claims, cited by Luzerne county and others, evidence the manufacturers intentionally misled consumers, was that the drugs were not addictive when prescribed to treat legitimate pain. This is one of the key claims used by all parties filing suit against the opioid manufacturers, across the entire country.

Case heading is: Luzerne County v. Purdue Pharma LP et al., case number 3:17-cv-2043, in the U.S. District Court for the Middle District of Pennsylvania.

>Opioid Litigation Roundup: An Overview Of Recently Filed Cases and MDL 2804

In addition to the many counties and other communities from across the country that have filed lawsuits against opioid manufacturers in MDL 2802, set for a JPML consolidation hearing November 30, 2017 a new group of plaintiffs have joined the increasing pool of parties filing suit against Big Pharma opioid manufacturers and their distributors. Unions are now joining in the suits alleging that the business practices of the opioid makers and distributors caused catastrophic healthcare and related labor problems everywhere in the country over the last 15 years. Locals from the Electrical Workers; Commercial Food Service and Teamsters are now plaintiffs in the MDL 2804, which if approved at the upcoming JPML hearings in St Louis, will probably cause a flood of additional filings by unions across the country.

State attorneys general, a Native American tribe and individual consumers are among the ever increasing pool of plaintiffs who’ve brought lawsuits against drugmakers, pharmacies and distributors allegedly responsible for epidemic levels of opioid abuse. As word spreads among the network of local governments, and discussion take place about the municipal opioid lawsuits being filed, there will be a flood of new complaints filed, that will match or exceed the number of cases filed in the massive “Tobacco Litigation” which is quickly gaining comparison as the opioid case filings are looking to be comparable in size and probably exceed the tobacco litigation in damages.

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JOHNSON & JOHNSON ACCUSED OF WITNESS TAMPERING IN TWO DIFFERENT TRIALS CURRENTLY UNDERWAY

Does Win At Any Cost Apply to J&J Legal Strategy Even At Trial?

By Mark York (November 7, 2017)

 

 

 

 

 

(Mass Tort Nexus)  Federal Judge Edward Kinkeade has requested the US Attorneys Office and the Federal Bureau of Investigations (FBI) open an investigation and question witnesses regarding potential witness tampering in a currently underway DePuy Pinnacle hip implant trial. The trial is taking place in the US District Court of Texas in Dallas. The trial is the third bellwether trial in Multidistrict Litigation No. 2244, where thousands of plaintiffs have filed suit in the DePuy Orthopaedics MDL 2244 Pinnacle Hip Implant Litigation. The last trial resulted in a massive initial verdict of $1 billion, subsequently reduced by Judge Kinkeade to just over $500 million.

DePuy, a subsidiary of Johnson and Johnson, has been sued along with J&J for their metal-on-metal Pinnacle hip devices, due to the release of cobalt and chromium metals into a patient’s body, resulting in the onset of metallosis, pseudotumors, and other adverse medical conditions which require surgery to remove the defective device, as well as ongoing treatment to address the related side effects.

As to J&J’s alleged witness tampering, Judge Kinkeade stated the potential witness tampering was “disturbing and disconcerting to me”. The issue revolves around interaction between am upcoming trial witness Dr. David Shein and a sales representative for DePuy. Dr Shein claims that during a surgical procedure he was warned of business ramifications,  in connection with his planned appearance as a witness during the DePuy Pinnacle trial.

Lead plaintiff trial attorney Mark Lanier noted:

“It is extremely concerning to me when there are requirements under the federal law, as well as state law, that witnesses not be tampered with, that—that it’s a serious felony, that it involves prison time, that it cuts to the core of who we are as a people and what our courts are about”

In the other witness tampering allegation during a current trial, J&J subsidiary Janssen Pharmaceuticals is accused of interfering with a treating physician and witness in the just started Xarelto trial in the Philadelphia Court of Common Pleas, see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court). This trial is the first state court Xarelto trial, where plaintiff Lynn Hartman filed suit against Janssen and Bayer over claims that Xarelto caused a major gastrointestinal bleed. The trial start was delayed by word that a meeting took place between a key witness, Dr. Timothy Aldridge, the plaintiff’s treating physician, and a Janssen sales representative.

Hartman’s lawyers said that scheduled testimony from Dr. Aldridge had essentially changed from indicating that Hartman had suffered a gastrointestinal bleed complicated by Xarelto, to denying whether he knew Hartman had suffered from a gastrointestinal bleed and being hostile to Hartman’s attorney.

Janssen claimed the meeting was routine, but opposing counsel claims that this contact, as well as the DePuy Pinnacle trial witness contact show a pattern of interference and a willingness of Johnson & Johnson employees to attempt to influence legal proceedings in ways that are often consider illegal.

In unsuccessful legal maneuvering, J&J requested a gag order to prevent the public from knowing about the DePuy trial witness tampering issue, but the judge denied their request. Prior verdicts against DePuy for Pinnacle Hip Implant cases included jury awards of $1.4 billion and $498 million in the two prior bellwether trials. The Xarelto trial tampering issue is still being reviewed by the court.

 

 

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Johnson & Johnson and DePuy Pinnacle Hip Implant Trial Continued Until September 18th Based on Appeal

Johnson & Johnson and DePuy Orthopaedics Latest “Pinnacle Hip Implant Trial” Continued Until September 18th Based on Fifth Circuit Appeal 

  • By Mark A. York (September 15, 2017)

  • Mass Tort Nexus

 

 

 

 

 

The latest bellwether trial in the  DePuy Pinnacle MDL 2244 (see DePuy Pinnacle Hip Implant MDL 2244 Briefcase) litigation has been postponed until September 18th, based on the U.S. Court of Appeals for the Fifth Circuit ruling, just days before the trial was to start, where they cited “grave error” by the sitting US District Court judge, in requesting a trial delay. The trial start date was September 5th, where eight plaintiffs from New York were part of the DePuy Pinnacle MDL 2255 multidistrict litigation, who are now facing jurisdictional issues based on the June 2017 SCOTUS “Plavix Ruling” that restricts jurisdiction over plaintiffs who are residents of another state, SCOTUS Plavix Jurisdictional Ruling Strikes Non-Resident CA Plaintiffs. The Plavix ruling forced thousands of non-California residents to determine if and where they can refile their claims against Bristol-Myers Squibb. DePuy Orthopaedics and it’s parent Johnson & Johnson (J&J) are asserting the Plavix ruling by stating that the New York residents are not subject to jurisdiction of the US District Court ND Texas and the trial should be stopped. This seems to fly in the face of the justification of certain tenants of the Joint Panel on Multidistrict Litigation rules of procedure, which assigned the DePuy Pinnacle Hip Implant cases to the Texas court to consolidate the many thousands of cases across the country.

 J&J Wants To Avoid More Massive Trial Verdicts

J&J are simply using evry legal tool available, in an attempt to avoid another massive jury verdict like the one in the December 2016 Pinnacle Hip Implant trial, where California plaintiffs were awarded $1 billion in punitive damages, which the court subsequently reduced to $500 million on appeal. DePuy and J&J want to restrict plaintiffs in any way they can, as J&J is facing massive verdicts in other ongoing federal and state court cases related to it’s various other medical device and pharmaceutical product lines.

Appeals Panel Denies Writ of Mandamus Petition

On August 23rd, the Fifth Circuit panel denied Johnson & Johnson’s and DePuy Orthopaedics’ petition for writ of mandamus, which sought to halt the upcoming trial. However, two of the three panel members found that the judge proceeding over the consolidated DePuy Pinnacle litigation in Texas had allowed certain trials to take place before him which a “judicial error” including the one that as scheduled to begin yesterday where plaintiffs were New York residents. On September 1st, U.S. District Court Judge Ed Kinkeade of the Northern District of Texas issued an Order delaying the next DePuy Pinnacle hip replacement trial until September 18, 2017.

DePuy Pinnacle Hip Verdicts

The multidistrict litigation underway in the Northern District of Texas, DePuy Pinnacle MDL 2244, currently involves more than 9,000 hip replacement lawsuits related to the metal-on-metal version of DePuy Orthopedics’ Pinnacle hip system that utilizes the Ultamet liner. Plaintiffs claim that this configuration is defectively designed, as it sheds toxic metals into the joint surround the hip, as well as the blood stream, causing adverse local tissue reactions, metallosis, pseudotumor formation, and other complications that necessitate the need for revision surgery to replace the joint.

As of August 2017, MDL 2244 Pinnacle hip litigation has convened three bellwether trials. The first concluded in October 2014, with a verdict for DePuy and Johnson & Johnson.

In March 2016, five plaintiffs were awarded a total of $500 million at the close of the second DePuy Pinnacle trial, where the judge overseeing the case reduced the award to $151 million, in order to comply with Texas law governing punitive damages.

The largest hip implant trial verdict anywhere to date was in the DePuy MDL’s third bellwether trial which ended December 2, 2016, where six Pinnacle implant recipients, who were California residents, were awarded more than $1 billion in punitive damages, see $1 billion DePuy Hip Implant Verdict in MDL 2244, with the judgment later reduced to $543 million, by Judge Kinkeade.

DePuy Metal-on-Metal Hip Implant Issues

In January 2013, the U.S. Food & Drug Administration warned that metal-on-metal hip replacements were associated with higher rates of early failure compared to those constructed from other materials.  Last year, the FDA finalized a new regulation requiring the manufacturers of two types of metal-on-metal hips to submit a premarket approval (PMA) application if they wanted to continue marketing their current devices and/or market a new implant.

In August 2010, DePuy Orthopaedics announced a recall of its ASR metal-on-metal hip replacement system, after data indicated the hips were associated with a higher-than-expected rate of premature failure.  Plaintiffs who have filed Pinnacle hip lawsuits question why the company has not taken similar action in regards to the Pinnacle/Ultamet liner combination.

In May 2013, DePuy Orthopaedics did announce that it would phase out metal-on-metal hip implants, including the device named in Pinnacle hip replacement lawsuits. According to The New York Times, the company cited slowing sales, as well as the FDA’s changing regulatory stance on all-metal hip implants, as factors in its decision.

 

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DePuy Pinnacle Hip Implant Trial Set for Today Delayed Based on Appellate Ruling of “Grave Error” By Sitting Judge

DePuy Pinnacle Hip Implant Bellwether Trial Set For September 5th Delayed After Appeals Court Cites Grave Error By Judge

 

 

 

 

 

DePuy Orthopaedics, Inc a subsidiary of Johnson & Johnson

By Mark A. York (September 5, 2017)

Federal Judge Ed Kinkeade has delayed the next DePuy Pinnacle hip implant bellwether trial that was set for today, Sept. 5, 2017 until later this month after a split federal appeals panel requested that he halt the proceedings due to a “grave error.”

In the August 31st opinion, two of three judges on a panel of the U.S. Court of Appeals for the Fifth Circuit refused to grant a petition for writ of mandamus filed by DePuy Orthopaedics Inc. to halt the trial. But two of the three also concluded that U.S. District Judge Ed Kinkeade, who is presiding over 9,300 cases alleging DePuy’s Pinnacle hip implants are defective, committed a “grave error” in allowing certain trials to take place before him, including the one scheduled this month on behalf of eight New York plaintiffs.

Opinion Outline

The opinion stated “despite finding serious error, a majority of this panel denies the writ that petitioners seek to prohibit the district court from proceeding to trial on plaintiffs’ cases,” wrote Circuit Judge Jerry Smith. “A majority requests the district court to vacate its ruling on waiver and to withdraw its order for a trial beginning September 5, 2017.”

Skadden, Arps, Slate, Meagher & Flom lead counsel for Johnson & Johnson, DePuy’s parent company, called on Judge Kinkeade to halt the trial, which is the fourth bellwether in the multidistrict litigation over the DePuy Pinnacle hip implant. This may help DePuy and J&J avoid a repeat of the last Pinnacle verdict in the prior bellwether trial where a Dallas jury awarded over $1 billion in damages, subsequently reduced by Judge Kinkeade, see DePuy Pinnacle Hip Implant Dec 2016 Trial Verdict Halved to Just $500 million in December 2016, which DePuy-J&J are appealing.

“We are pleased that the Fifth Circuit has determined that the MDL court does not have jurisdiction to conduct its planned trial of the claims of eight New York plaintiffs in a Texas courtroom,” Beisner wrote in an emailed statement after the ruling.

Plaintiff Counsel Surprised

Lead plaintiffs attorney Mark Lanier called it the “wildest opinion I’ve ever seen.”

“What this small panel has tried to do is change the law in the Fifth Circuit on a mandamus record, and that’s really frowned about,” said Lanier, of The Lanier Law Firm in Houston, who was joined in the appeal by former U.S. Solicitor General Kenneth Starr.

In addition to this month’s trial, the ruling could impact a separate case before the Fifth Circuit in which Johnson & Johnson has raised the same venue arguments in appealing a $1.04 billion verdict in the most recent Pinnacle trial. Oral argument on that appeal hasn’t yet been scheduled.

“Why this court issues an order on another court’s case, which is just an advisory opinion, is just absurd,” said Lanier. “It’s judicial activism.”

Lanier filed a petition for rehearing en banc on Friday. Later that afternoon, Kinkeade ordered the trial delayed until Sept. 18.

Final Bellwether trial

Kinkeade appeared to anticipate the Fifth Circuit’s intervention. On Aug. 25, he ordered that this month’s trial would “be the final bellwether case tried in the Dallas division of the Northern District of Texas” under which both sides have waived venue.  This was an unexpected ruling for the Pinnacle litigation, where Johnson & Johnson has appealed two other verdicts in Kinkeade’s courtroom, both involving consolidated cases that led to major awards in 2016,. Johnson & Johnson won the first verdict in 2014. But a second trial ended with a verdict of $502 million awarded to five Texas plaintiffs, while the third gave $1.04 billion verdict to six California plaintiffs.

All DePuy Hip Implant Litigation

These cases are part of the 8,707 actions consolidated before Judge Kinkeade in MDL 2244, In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, Case No. 3:11-md-02244, Northern District of Texas in Dallas.

Juries have found that DePuy and J&J have negligently designed the hip implant, failed to warn surgeons about dangerous conditions related to the implant, and concealed its risks. J&J stopped selling the devices in 2013 after the FDA issued a safety communication about artificial-hip damages.

Separately, DuPuy is facing 1,458 product liability actions consolidated before US District Judge Jeffrey J. Helmick in MDL 2197, In re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation in Toledo, Ohio.

J&J prevailed in the first Pinnacle hip case to go to trial in October 2014 after a jury rejected a Montana woman’s claims that the devices were defective and gave her metal poisoning. In March 2016, a Dallas jury ordered J&J to pay $502 million to a group of five patients who accused the company of hiding defects in the hips. A judge cut that verdict in July to about $150 million.

DePuy Claims “Lexecon” Error

DePuy and Johnson & Johnson have argued that Kinkeade lacked jurisdiction over the trials involving California and New York plaintiffs. MDL judges are assigned to oversee pretrial matters with the intention of sending cases back to their original courts for trial. But defendants often waive that right under the U.S. Supreme Court’s 1998 holding in Lexecon v. Milberg Weiss Bershad Hynes & Lerach, which allows bellwether trials to proceed before an MDL judge.

Johnson & Johnson claims it waived that right as to the first and second trials, but not the third or fourth. Plaintiffs’ attorneys have insisted that Johnson & Johnson agreed to a global waiver over all the trials.

Mass Tort Nexus will provide additional details of the ongoing trial dispute as information becomes available.

 

 

 

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5th Circuit Denies Motion to Hear DePuy Hip Appeals Together

DePuy Pinnacle metal-on-metal hip
DePuy Pinnacle metal-on-metal hip

The 5th US Circuit Court of Appeals denied the motion of eight successful plaintiffs who last year obtained a combined total of $646 million in damages against DePuy Orthopaedics Inc. in two jointly-tried cases where juries found that the company knowingly sold a defective hip replacement.

On Jan. 6, five plaintiffs obtained a $146.2 million judgment against DePuy in a consolidated Pinnacle hip bellwether trial had filed a motion asking the Fifth Circuit to consolidate their appeal with that of a $500 million judgment in a subsequent multi-plaintiff bellwether trial.

They argued that the cases were very similar except that the law of Texas governed the second trial, and the law of California governed the third.

The court said no in a one-page order. The case is In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, No. 16-11051 in the 5th Circuit. There are 8,751 cases consolidated in MDL 2244 before US District Judge James Edgar Kinkeade in the Northern District of Texas in Dallas.

DePuy is also facing 1,480 lawsuits in MDL 2197 before US District Judge Jeffrey J. Helmick in DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation.

In the Texas MDL:

  • J&J prevailed in the first Pinnacle hip case to go to trial in October 2014.
  • In the second bellwether trial, a jury awarded $502 million to five of the patients in March 2016. The court cut the award to $150 million.
  • In the third bellwether trial, a jury awarded $1.04 billion in December 2016. The judge cut the punitive damages portion of the award in half.

Design flaws

The plaintiffs were implanted with the hip devices and experienced tissue death, bone erosion and other injuries they attributed to design flaws. Plaintiffs claimed the companies promoted the devices as lasting longer than devices that include ceramic or plastic materials.

The evidence demonstrated that:

  1. The Pinnacle Ultamet was defectively designed and marketed by Defendants.
  2. Defendants failed to provide adequate warnings for the device.
  3. Defendants failed to test the device in people before putting it on the market.
  4. Defendants knew or should have known of the dangers of metal-on-metal hip implants.
  5. Defendants misrepresented or concealed material facts about the device.
  6. Defendants polluted the scientific literature with fraudulent studies and biased doctors.
  7. Defendants routinely used improper consulting agreements to induce orthopedic surgeons to use and market their products.
  8. Defendants routinely prioritized marketing and sales over product safety.

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Plaintiffs in DePuy Hip Cases Ask 5th Circuit to Hear Appeals Together

depuy-asr-hip-replacementEight successful plaintiffs in In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation have called on the Fifth US Circuit Court of Appeals to consolidate all the appeals from two jointly-tried cases where juries found that the company knowingly sold a defective hip replacement.

Citing Fed. R. App. P. 3(b)(2) allowing appeals to be joined, the plaintiffs point out that the cases have the same MDL, defendants, lawyers, plaintiff injuries, evidence and witnesses. The appeals arise out of the second and third bellwether trials in MDL 2244 before US District Judge James Edgar Kinkeade in the Northern District of Texas. A total of 8,707 lawsuits are pending against DePuy in case No. 3:11-md-02244.

  • J&J prevailed in the first Pinnacle hip case to go to trial in October 2014.
  • In the second bellwether trial, a jury awarded $502 million to five of the patients in March 2016. The court cut the award to $150 million.
  • In the third bellwether trial, a jury awarded $1.04 billion in December 2016. The judge cut the punitive damages portion of the award in half.

The only difference is that the law of Texas governed the second trial, and the law of California governed the third.

Design flaws

The plaintiffs were implanted with the hip devices and experienced tissue death, bone erosion and other injuries they attributed to design flaws. Plaintiffs claimed the companies promoted the devices as lasting longer than devices that include ceramic or plastic materials.

The evidence demonstrated that:

(i) the Pinnacle Ultamet was defectively designed and marketed by Defendants.

(ii) Defendants failed to provide adequate warnings for the device.

(iii) Defendants failed to test the device in people before putting it on the market.

(iv) Defendants knew or should have known of the dangers of metal-on-metal hip implants.

(v) Defendants misrepresented or concealed material facts about the device.

(vi) Defendants polluted the scientific literature with fraudulent studies and biased doctors.

(vii) Defendants routinely used improper consulting agreements to induce orthopedic surgeons to use and market their products.

(viii) Defendants routinely prioritized marketing and sales over product safety.

The motion was filed by Kenneth W. Starr; The Lanier Law Firm, PC (W. Mark Lanier, Kevin Parker, M. Michelle Carreras); Fisher, Boyd, Johnson & Huguenard, LLP (Wayne Fisher, Justin Presnal); Neblett, Beard & Arsenault (Richard J. Arsenault, Jennifer M. Hoekstra); Simmons Hanly Conroy (Jayne Conroy, Andrea Bierstein), counsel for Plaintiffs-Appellees.

 

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