FDA BANS THE USE OF PELVIC MESH PRODUCTS – How Will This Affect The TVM Litigation?

Will this move by the FDA re-ignite the mass tort engine in TVM litigation or possibly force settlement in Ethicon TVM MDL 2327?

By Mark A. York (April 17, 2019)

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Manufacturers of pelvic synthetic surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday. The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  The key issue with the product for many years is the fact that its made from polypropylene, basically the same material as fishing line.

The FDA said it “has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

The FDA said its April 16, 2019 action to remove surgical mesh products from the market is part of its commitment to ensuring the safety of medical devices. In a November statement, the agency said that it “regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide.”

FDA Release January 4, 2019

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

Summary: The U.S. Food and Drug Administration issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

FDA Finally Takes Action

Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina. In the 1990s, gynecologists began implanting surgical mesh for the transvaginal repair of the condition and in 2002, the first mesh device specifically for this purpose was cleared for use by the FDA, according to the agency’s statement.

“We couldn’t assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

For years, medical device companies have stated that the products they are developing and placing into the marketplace are safe and helping patients in the USA and worldwide. That is often not the case and people around the world are suffering.

Medical device makers and compensated doctors have touted FDA approved implants and other devices as the surgical cure for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief and many other afflictions.

2017 Pelvic Mesh Study in England Showed High Number of Adverse Events:

Scientific Reports Volume 7, Article number: 12015 (2017) |

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

Conclusions

Summary: This is the largest study to date of surgical mesh insertions for SUI. It includes all NHS patients in England over an 8-year period. We estimate that 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally, within 30-days or within 5 years of the initial mesh insertion procedure. This is likely a lower estimate of the true incidence. Given concerns about the safety of these procedures, this study provides robust data to inform both individual decision-making and national guidance.

Why Device Makers Tout FDA Approvals

  1. “Medtronic receives FDA clearance for two heart devices”
  2. “FDA approves device to help curb cluster headaches”
  3. MRI approved for young infants in intensive care

Manufacturer headlines like these instill consumer confidence that medical devices are safe and effective. After all, they have the FDA’s stamp of approval, right? NO!

The reality is, the FDA seldom requires rigorous evidence that a device works well–and safely–before allowing it onto the market. Medical devices are the diverse array of non-drug products used to diagnosis and treat medical conditions, from bandages to MRI scanners to smartphone apps to artificial hips.

This low standard of evidence applies to even the highest risk devices such as those that are implanted in a person’s body. Surgical mesh, pacemakers and gastric weight loss balloons are just a few examples of devices that have had serious safety problems.

Devices are subject to weaker standards than drugs because they’re regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA’s approval.

In 2011, an Institute of Medicine panel recommended that the “flawed” system be replaced, because it does not actually establish safety and effectiveness. At the time the FDA said it disagreed with the group’s recommendations.

Defective devices cleared through this system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market. .J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

The FDA forcing mesh manufacturers to stop the use of synthetic mesh is long overdue, and how this action results in renewed interest by mass tort firms across the country, remains to be seen. Regardless, it would seem that Ethicon and the other defendants in the pending TVM litigation that have been unwilling to discuss settlement, may now be forced to deal with the catastrophic consequences of manufacturing and marketing medical devices that have injured untold thousands of patients around the world.

To access the most current TVM case status and other real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

May 31 to June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact  Barbara Capasso 954.383.3932 or Barbara@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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TEXTURED BREAST IMPLANTS – “An Emerging Mass Tort”

 

France and Canada look to banning sale of textured implants-what’s the next move in the USA?

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Recent studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not a breast cancer but a cancer of the immune system. Plastic surgeons have identified at least 688 cases of BIA ALCL worldwide, as of February 2019. The FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia has placed the risk as high as 1 in 1,000.

Nine deaths from a rare form of cancer have been linked to breast implants, the Food and Drug Administration announced as far back as 2017, the US oversight has not taken the warning seriously, however the international oversight apparently has. Countires around the globe are starting to ban the sale of “textured breast implants” based on the emerging clinical linbks to these implants and cancer. .

Red flags were raised as far back as  2011 regarding the safety of breast implants and their possible link to a type of lymphoma, but the FDA has only now updated information on the risk to women with both silicone and saline breast implants.

As of February 1, 2017, the FDA had received a total of 359 reports related to breast implant-associated anaplastic large cell lymphoma — a rare cancer of the immune system — including nine deaths, the agency said in a statement. ALCL is not a form of breast cancer, but it grows in the breast in implant patients.

The FDA says the exact number of cases of the disease remains difficult to determine due limitations in the reporting of breast implant sales data. Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000, according to the Associated Press. The cancer is treatable with the removal of implants, though nearly a dozen deaths have occurred.

Additionally, thousands of women have blamed breast implants for a range of other health ailments, including rheumatoid arthritis, pain and chronic fatigue. In documents released before the meeting, the FDA contends “at the present time, there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue disease diagnoses.”

A recent study published in JAMA Oncology concluded that  found that silicone breast implants with a textured surface are 400-times more likely to cause a rare type of cancer compared to silicone breast implants with a smooth surface.

Approximately 1 out of every 26 women in the United States have breast implants.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC

Sientra, Inc.

Breast augmentation remains the most common cosmetic surgical procedure in the U.S. with more than 300,000 performed each year, according to the American Society of Plastic Surgeons.

The meeting comes a week after the FDA sent warning letters to two breast implant manufacturers for their failure to comply with requirements to conduct long-term studies assessing the safety of silicone gel-filled implants.

International Review

The International Consortium of Investigative Journalists revealed the ongoing health problems plaguing women with breast implants as part of its global Implant Files investigation in November 2018, and has covered breast implant safety extensively in the aftermath. In the wake of the investigation, health authorities from France to Brazil to the United States recently announced initiatives to better protect patient health.

Health Canada is advising a manufacturer of breast implants that it could soon ban the sale of its product in Canada because of a possible link to a

The Biocell implants, manufactured by Allergan, have a slightly textured surface, designed to adhere better to the surrounding tissue. Health Canada intends to remove them from the market as a precautionary measure, to “protect Canadians from the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)” the department wrote in a news releaseThursday.

Of 28 confirmed cases of BIA-ALCL reported to Health Canada, 24 involved that particular implant, the department said.

 Quebec contacting women with textured breast implants to warn of cancer risk

BIA-ALCL is not a cancer of the breast tissue, but rather a rare type of non-Hodgkin lymphoma that can develop months or years after the implants were put in. It usually leads to an accumulation of fluid inside the breast. It’s generally treated by carefully removing the implant and fluid containing the cancerous cells. In some cases, it can spread throughout the body, warranting chemotherapy treatment, according to the World Health Organization.

WATCH: Winnipeg woman says breast implants ruined her life and her health

 

 

 

 

 

 

Health Canada will allow Allergan 15 days to present medical evidence about the implants’ safety. If the evidence isn’t “satisfactory,” Health Canada intends to suspend their medical license, meaning the product would no longer be permitted for sale in Canada.

France also announced that it intends to ban textured breast implants earlier this week.

 Breast implant safety under review by U.S. authorities

Health Canada is currently reviewing breast implant safety and BIA-ALCL and plans to present its entire report by the end of April. A second report looking at other symptoms reported among recipients of breast implants will be released this summer, according to the press release.

 Bowmanville woman wants Health Canada to push awareness of ‘breast implant illness’

If you have breast implants, Health Canada recommends that you speak with your surgeon to find out what type of implant you have received. If you experience any unusual changes to your breasts, you should contact a health-care professional and discuss any decisions about implant removal with them too.

Nearly all the lymphoma cases have occurred in women who had implants with a textured surface, rather than a smooth one. Textured implants made by Allergan, a major manufacturer, were taken off the market in Europe in December. Smooth implants are used more often than textured ones in the United States.

 FDA NOTICE ON TEXTURED IMPLANTS

 

 

 

 

 

 

March 20, 2019

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 of FDA Release

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

Mass Tort Nexus “CLE Immersion Course”

May 31 – June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Barbara Capasso at 954.530.9892 or Barbara@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 com/news and sign up for free access.

 

 

 

 

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THE DEALFLOW LITIGATION FUNDING FORUM

LITIGATION FUNDING FORUM

Why You Should Attend

April 4, 2019 in New York City

MASS TORT NEXUS: A Media Sponsor Of This Event

By Mark A. York

(MASS TORT NEXUS MEDIA) Whether you’re active in litigation funding or a firm exploring outside capital sources to fund your practice, the Litigation Funding Forum April 4th in New York City is where you should be.

Mass Tort Nexus has been invited by DealFlow to meet and discuss the most current issues as well as the forecast for litigation funding in law firm business models. We will be meeting with key members of the industry and asking how the funding world may impact mass torts and other practice areas at law firms.

This includes looking at parties who demand oversight and disclosures to the court when outside capital is used to fund a docket, [not needed from a personal perspective] but there are also those that are demanding more open disclosure. Certain courts including Federal Judge Dan Polster in the Opiate Prescription Litigation MDL 2804, now require firms in that litigation to file disclosures when they are using outside capital to fund their litigation, and this view is being pushed by more defense firms who claim this is needed to show outside interests are involved in ongoing litigation.

This may be a unique trend that goes away once all involved see that securing capital investment in any type of ongoing business is often required for any number of reasons from infrastructure development to business expansion – and why a law firm securing funding from a third party should be viewed any differently seems to be not only intrusive but as interfering with a private business matter. This is an evolving area that may or may not become more open to discussion or it may simply become a non-issue as the parties realize that litigation funding is a regular part of the legal world these days.

The Event

Litigation funding is an increasingly popular way to finance the high cost of a legal action, whether as plaintiff or defendant. Lawyers at the highest ranks of the legal profession are updating their toolkits to perform work in litigation funding, while financiers raise hundreds of millions of dollars to fuel demand.

In an uncertain and complex regulatory environment, The Litigation Funding Forum 2019 is your single greatest resource for getting up-to-the-moment information from the brightest minds in the business.

Groups attending this event include:

  • Specialty Litigation Investment Funds
  • Law Firms
  • Accounting and Financial Advisory Firms
  • Corporate Counsels
  • Brokerage Firms
  • Hedge Funds
  • Private Equity Firms
  • Pension Funds and Endowments

Why Funding May be Needed

Litigation funding offers significant benefits in terms of financial reporting and operations. Funding solutions can create immediate improvements in cash flow, bring greater certainty over forecasts of legal expenditure and divert valuable resources into revenue-generating areas of the business. Critically, third-party funding can enable a law firm to pursue cases that it would not otherwise pursue due to budget constraints, at zero risk and at zero cost.

Generally, these are the financial concerns when expanding a practice, the last three often require outside capital.

  • Executive Summary
  • Company Description
  • Market Research
  • Service/Product Description
  • Management & Operational Infrastructure
  • Marketing & Sales Strategy
  • Financials (Bottom Line)

Seeking a reliable source for capital investment makes sense if there’s a viable model and a plan to enter into a mass tort program or other specialty practice area.  Law firms that use outside funding lee experience increases in their chance of success based on the ability to move faster and develop a timely docket, once capital funding is in place. Often banks and certain investors will keep their wallets closed unless they can see a well-planned and structured method of attack and a stellar credit rating as they are not in the business of working with law firms entering or expanding in to a new practice area. That’s why a fund or capital group that focuses on the legal is now an accepted source of expansion capital or to support and existing firm’s practice.

How Firms Use New Capital:

  • Marketing Campaigns
  • Website launch
  • Social media activity
  • Lead list building
  • Customer retention efforts
  • Potential consumer loyalty programs
  • Intake and verification
  • Securing your docket
  • Managing case docket once filed

What the Defense is Saying:

  • Outside funding views from the defense bar and the U.S. Chamber of Commerce, have called for a nationwide disclosure rule that would lift the veil on the details of litigation finance agreements and reveal the identities of the funders. But the effort has been unsuccessful so far.
  • Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform, wrote in a June 2017 letter that not having a disclosure rule lets funders “continue to operate in the shadows, concealing from the court and other parties in each case the identity of what is effectively a real party in interest that may be steering a plaintiff’s litigation strategy and settlement decisions.”

For more information on the Litigation Funding Forum in New York City this week contact:

Charlie— Charlie@dealflow.com     516 876 8006 ex 20

 TKP CONFERENCE CENTER

APRIL 4, 2019

For this event, DealFlow has contracted to rent the entire 2nd floor to accommodate attendees. The TKP Conference Center is conveniently located within walking distance of Grand Central Terminal, the Port Authority Bus Terminal, and Penn Station.

Web LINK TO LITIGATION FUNDING FORUM EVENT

Location

109 West 39th Street,
New York, NY 10018

 

 

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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

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

Mass Tort Nexus “CLE Immersion Course”

May 31 – June 3, 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 com/news and sign up for free access.

 

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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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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.

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FDA STATEMENT ON BAYER ESSURE SAFETY OVERSIGHT AFTER BAYER STOPS U.S. SALES

 

 

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

For Immediate Release

December 20, 2018

FDA Statement

When new safety concerns arise for particular devices, we’re committed to taking action to develop post-market information that can help patients and providers make more informed decisions and also support regulatory actions that reduce any potential risks to patients. We’ve taken a series of such steps with respect to Essure, a permanent birth control device. The product has been the focus of several important FDA safety actions. We’re announcing some additional steps today to make sure the FDA continues to evaluate the product’s long-term safety profile past its scheduled discontinuation from the U.S. market following a series of earlier regulatory actions that we took apply significant new requirements on its use. This includes the agency’s decision to take the step of making Essure a restricted device.

In July, citing the declining annual number of implantations, the manufacturer of the device, Bayer, announced that Essure will no longer be sold or distributed in the U.S. after Dec. 31, 2018. At that time, I stressed that, even when Essure is no longer sold, the FDA would remain vigilant in its oversight of the device. This includes requiring that Bayer complete the postmarket surveillance study that we ordered in February 2016. I also affirmed that we’d continue to actively communicate with patients and physicians as new information about the device becomes available or as the FDA takes additional regulatory steps.

Today, I’m providing an update on new steps to revise and strengthen the manufacturer’s postmarket study, to make sure we continue to collect long-term safety information following the discontinuation of the product to better evaluate the safety profile of the device when used in the real world.

As part of the revised protocol for the postmarket surveillance study, the FDA has worked with Bayer to see that the manufacturer implements 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 was initially required. This significant extension follows the FDA’s request that the company go beyond the three-year period provided for by law. 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.

Second, we’re requiring 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 whether these findings are associated with symptoms that patients have reported related to Essure.

The FDA is also requiring Bayer to continue to enroll patients who might still opt to receive Essure in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study’s progress and results. Since FDA’s 2016 decision to order Bayer to conduct the postmarket study and then to add a boxed warning and Patient Decision Checklist to the labeling, sales of Essure declined by 70 percent. Earlier this year, the FDA decided to restrict the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and that give patients the opportunity to sign an acknowledgement of understanding before implantation. In view of this decline in sales and the manufacturer’s decision to discontinue sales and distribution at the end of this year, we recognize that Bayer is having challenges reaching the study’s initial sample size that relied on enrolling patients who were newly implanted with Essure until May 2020. We believe that this new, revised study plan will help provide more long-term information regarding complications that may be experienced by patients who have Essure, despite reduced enrollment.

For the past several years, the FDA has been monitoring the progress of an Essure post-approval study that was mandated to gather long-term data on pregnancies occurring in patients who may have received a transvaginal ultrasound in order to confirm that Essure was properly placed in a woman’s fallopian tubes and could be relied upon to prevent pregnancy. The FDA’s Center for Devices and Radiological Health conducted an  analysis of an ongoing post-approval study data to gain a fuller understanding of device removals over time; they also completed their extensive evaluation into a significant collection of medical device reports submitted in 2017 and the first half of 2018 that mentioned issues involving potential device removal to learn more about why women were choosing to have the device removed, which usually requires a surgical procedure. CDRH also spent the past several months actively evaluating more than 15,000 medical device reports submitted to FDA in 2017 through June 2018 on the Essure device. (The majority of these reports referenced an instance in which the device was removed from a patient, and most came from cases that were made available by plaintiff attorneys as part of litigation against the manufacturer Bayer.) CDRH is providing some important new information about the removals of the Essure device learned from this analysis on our website.

Based on this information, the FDA instructed Bayer to extend the postmarket surveillance study from three years to five years to capture longer term information about device removals. We believe it’s important to continue closely monitoring device removals in the postmarket surveillance study to gain greater knowledge of this issue.

Following Essure’s removal from the market, the FDA is committed to continuing to monitor women who have the device implanted. In addition to the post-market surveillance study, the agency will continue its efforts to monitor Essure’s safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. This follows previous actions the FDA has taken, including requiring Bayer to add a boxed warning to the labeling of Essure and issue a Patient Decision Checklist to help women considering Essure to be fully informed about potential risks and the sales restriction that FDA placed on the product.

I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.

We’re also advancing new ways to solidify our monitoring systems to achieve our new goal to consistently be the first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

As we announced when we issued our Medical Device Safety Action Plan in April, we’re working to implement an active surveillance system to help us detect device safety signals faster, including for devices related to women’s health. We’re implementing active surveillance capabilities as part of our National Evaluation System of health Technology, which will leverage a wide range of data systems that could provide real-time information on device safety signals from electronic health information, such as registries and electronic medical records. We’re also continuing our ongoing efforts to strengthen our Coordinated Registry Networks (CRN), which link different real-world data sources to generate clinical evidence about medical devices used by patients.

We’re especially focused on addressing clinical questions for device therapies that address conditions that are unique to women, such as treatment of uterine fibroids, pelvic floor disorders, female sterilization (including the Essure device) and long-acting reversible contraception. To advance these goals, the FDA partnered with the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, the National Library of Medicine and others on this effort, which is known as the Women’s Health Technologies CRN, or WHT-CRN. Once fully implemented, the WHT-CRN can be used to answer crucial questions on medical devices for women’s health to help supplement the evidence we’re gathering from postmarket studies and medical device reports. It could also help us detect safety issues with medical devices faster, enabling us to take actions — like the implementation of special controls — sooner.

We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them. The FDA will continue to collect and review reports of adverse events associated with device removal and is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.

____________________________________________________________________________________________________________________

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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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Why is the US Solicitor General Supporting Merck in Supreme Court Fosamax Preemption Appeal?

WILL BIG PHARMA LOBBYING EFFORTS BE PAYING DIVIDENDS IN 2019?

By Mark A. York (December 7, 2018)

The Supreme Court’s decision involving Merck’s osteoporosis drug Fosamax could have a ripple effect across Big Pharma and Mass Torts.

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The U.S. Supreme Court agreed in June to hear Merck & Co.’s appeal in the long running Fosamax liability litigation, (MDL No. 2243, District Judge: Honorable Joel A. Pisano, USDC New Jersey) where plaintiffs are suing Merck & Co over its osteoporosis drug Fosamax, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

The plaintiffs have requested the U.S. Supreme Court uphold a federal appeals court ruling that allowed their cases to move forward, however acting U.S. Solicitor General Jefferey Wall asked for permission to present oral arguments. It would be a plus for Merck, because Wall has been a major supporter of the Big Pharma position on the issue of preemption, which revolves around the question of whether FDA decisions protect pharma companies from state legal challenges.

How the Court answers this question will no doubt shape the drug and device industry for years to come. Levine provided that a drug manufacturer could not be held liable under a failure-to-warn theory if the FDA had previously considered—and rejected—a proposed amendment to the product’s warning label. But Levine did not clearly define when preemption would apply in these circumstances, and as a result, lower courts have struggled to uniformly apply this rule.  With Albrecht, the Court now has an opportunity to clear up the ambiguities left in Levine’s wake.

On December 3, 2018 the Supreme Court agreed to let the Solicitor General’s office participate in the oral arguments, which probably caused the executive suites at Big Pharma to raise a toast to Jeffrey Wall.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court will hear arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse evenet bieng that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referr[ed] solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury.

Merck said it tried to update the label earlier, but failed because the FDA rejected its proposed wording. Because it was the FDA’s call, pre-emption should apply, Merck claimed and Wall concurred. Now, the Supreme Court will offer 10 minutes for the U.S. to make its case.

“The government has a significant interest in the proper resolution of the case, which concerns the manner in which the scope and effect of an FDA labeling decision is determined in private tort litigation,” asserted Wall in his MOTION OF THE UNITED STATES AS AMICUS CURIAE FOR LEAVE TO PARTICIPATE IN ORAL ARGUMENTS.

At least three court members (Thomas, Gorsuch, and Roberts) appear likely to support preemption under this set of facts, and it would not be unreasonable for Kagan, Ginsburg, and/or Breyer to hold similarly, given that the latter two were both part of the Levine majority, which stated that preemption would apply if there existed “clear evidence that the FDA would not have approved a change[.]” Wyeth v. Levine, 555 U.S. 555, 571 (2009). The odds of a five-justice majority favoring preemption could be buttressed if Kavanaugh is confirmed. Regardless, all one can truly hope for is that the Court avoids a plurality decision, since such an outcome would leave the Third Circuit’s opinion intact and muddy the waters further.

SCOTUS Docket: Merck Sharp & Dohme Corp. v. Albrecht

17-290 3d Cir.  Hearing Date January 7, 2019

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning. CVSG: 05/22/2018.

Date Proceedings and Orders (key to color coding)
Jun 23 2017 Application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, submitted to Justice Alito.
Jun 27 2017 Application (16A1264) granted by Justice Alito extending the time to file until August 22, 2017.
Aug 22 2017 Petition for a writ of certiorari filed. (Response due September 25, 2017)
Aug 31 2017 Waiver of right of respondents Affronti, Joanne, et al. to respond filed.
Sep 11 2017 Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp. on 09/12/2017
Sep 19 2017 Waiver of right of respondents Esther Parker & Pamela Paralikis to respond filed.
Sep 20 2017 Blanket Consent filed by Respondents, Albrecht, Doris, et al. on 09/21/2017
Sep 21 2017 Order extending time to file response to petition to and including October 25, 2017, for all respondents.
Sep 22 2017 Because Justice Alito now realizes that he should have recused himself from consideration of this application, the order of June 27, 2017, is vacated. Pursuant to Rule 22.2, the application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, has been submitted to Justice Sotomayor.
Sep 22 2017 Application (16A1264) granted by Justice Sotomayor extending the time to file until August 22, 2017. (Justice Alito is recused)
Sep 25 2017 Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed.
Sep 25 2017 Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Oct 25 2017 Brief of respondents Doris Albrecht, et al. in opposition filed.
Nov 08 2017 DISTRIBUTED for Conference of 12/1/2017.
Nov 08 2017 Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Dec 04 2017 The Solicitor General is invited to file a brief in this case expressing the views of the United States. Justice Alito took no part in the consideration or decision of this petition.
May 22 2018 Brief amicus curiae of United States filed (to be corrected and reprinted).
May 22 2018 Brief amicus curiae of United States filed (Corrected brief received 5/29/18).
Jun 05 2018 DISTRIBUTED for Conference of 6/21/2018.
Jun 05 2018 Supplemental brief of respondents Doris Albrecht, et al. filed. (Distributed)
Jun 07 2018 Supplemental brief of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Jun 27 2018 DISTRIBUTED for Conference of 6/27/2018.
Jun 28 2018 Petition GRANTED. Justice Alito took no part in the consideration or decision of this petition.
Jul 27 2018 Motion for an extension of time to file the opening briefs on the merits granted. The time to file the joint appendix and petitioner’s brief on the merits is extended to and including September 13, 2018. The time to file respondents’ brief on the merits is extended to and including November 14, 2018.
Jul 27 2018 Motion for an extension of time to file the opening briefs on the merits filed.
Sep 12 2018 Blanket Consent filed by Respondents, Doris Albrecht, et al..
Sep 13 2018 Brief of petitioner Merck Sharp & Dohme Corp. filed.
Sep 13 2018 Joint appendix (2 volumes) filed. (Statement of costs filed)
Sep 17 2018 Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp..
Sep 20 2018 Brief amicus curiae of Washington Legal Foundation filed.
Sep 20 2018 Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Sep 20 2018 Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed.
Sep 20 2018 Brief amicus curiae of United States filed.
Oct 12 2018 Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
Oct 26 2018 Justice Alito is no longer recused in this case.
Nov 14 2018 Brief of respondents Doris Albrecht, et al. filed.
Nov 21 2018 Brief amicus curiae of Public Citizen filed.
Nov 21 2018 Brief amici curiae of Commonwealth of Virginia, et al. filed.
Nov 21 2018 Brief amici curiae of Joseph Lane, M.D., and Vincent Vigorita, M.D. filed.
Nov 21 2018 Brief amici curiae of MedShadow Foundation, et al. filed.
Nov 21 2018 Brief amicus curiae of The Cato Institute filed.
Nov 21 2018 Brief amici curiae of Tort Law Professors John C. P. Goldberg and Benjamin C. Zipursky filed.
Nov 21 2018 Brief amici curiae of Public Law Scholars filed.
Nov 21 2018 Brief amici curiae of Jerome P. Kassirer, M.D., et al. filed.
Nov 21 2018 Brief amicus curiae of American Association for Justice filed.
Nov 28 2018 SET FOR ARGUMENT ON Monday, January 7, 2019
Nov 30 2018 CIRCULATED

The SCOTUS ability to resolve the preemption question could have a ripple effect on the entire pharma industry. The issue generated heated debate a few years back, when a liability case raised questions about whether generics makers can be held responsible for patients’ injuries, given that they must use label language the FDA approved for branded versions of the drugs.

In a close 5-4 decision, the justices ruled that generics makers could not be held liable in those cases.

Initially, it looked as if Merck would prevail in its preemption argument, too, as the  defense had won two bellwether lawsuits filed over alleged Fosamax injuries. Then, in 2014, a federal judge tossed out 5,000 lawsuits from patients who claimed their fractures were caused by Fosamax, followed by a federal appeals court reviving those cases by over-ruling that dismissal.

Lawyers representing the patients in this case have argued that Merck’s preemption argument is faulty because it’s largely based on an internal memo recounting a phone conversation one of its employees had with the FDA.

“Respondents are aware of no other preemption case in which the manufacturer relied on hearsay accounts of informal FDA communications,” the lawyers said in a recent brief.

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

Both Merck and the Solicitor General contend that if the FDA believed there was scientific reasoning to support a labeling change, the agency would have added the warning, because federal laws require it to do so.

As SCOTUS gets set to hear the case, many individuals and organizations have filed briefs in support, urging the justices to uphold the lower court ruling that would allow those thousands of Fosamax suits to go forward. Consumer watchdog group Public Citizen, for example, filed a brief earlier this month suggesting that Merck’s pre-emption argument is invalid because federal statutes do not support the idea that “the FDA’s rejection of a particular proposed warning constitutes a determination ‘that no new labeling language is warranted.’”

Besides, Public Citizen argued (PDF), SCOTUS should preserve patients’ rights to pursue drug liability claims in state courts, and by siding with Merck, the judges might make it much harder for those suits to be filed.

“Allowing patients to pursue tort claims against pharmaceutical manufacturers for injuries caused by inadequate warnings is important as both an incentive for manufacturers to be vigilant about product safety and a means to provide remedies to patients,” Public Citizen wrote. “For this reason, the case has important implications that go well beyond the interests of the parties.”

How Big Pharma’s cadre of lobbyists and congressional insiders appears to be paying major dividends as we approach 2019 remaons to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is apying off very well.

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