What You Need to Know About IVC Filter Complications

Inferior vena cava, or IVC, filters are used when a patient is at risk for pulmonary embolism. Pulmonary embolisms happen when a blood clot travels into the lungs, and they are extremely dangerous. IVC filters work to prevent embolisms by capturing clots before they can travel to the lungs, keeping them in a safer place, such as the abdomen.

Because IVC filters can prevent life-threatening health events, their risks are generally accepted. However, some case studies suggest that new materials used to make filters, and/or certain manufacturers of filters, are causing increased complications—including deadly ones. This means that some patients with IVC filters may be at more risk than others.

Here are some of the risks associated with IVC filters, according to Seminars in Interventional Radiology:

Problems During Placement

The procedure for inserting an IVC filter is relatively noninvasive. Surgery is not required; rather, a simple nick in the skin provides enough access for placement.

Despite this simplicity, complications can occur, according to Seminars in Interventional Radiology. IVC filters are tiny, delicate structures that expand into the inferior vena canal where they are placed to catch clots. It isn’t uncommon for legs of the filter to get crossed, or for expansion to be incomplete. If this occurs, then the filter cannot properly do its job. It is also possible for the filter to be improperly placed, or malpositioned, which would also affect its function.

Less common complications include the same risks as other, similar procedures: bleeding, hematoma, arterial puncture, and infection.


While IVC filters catch clots, they unfortunately also increase the chances of forming clots, known as thrombosis. It has been recorded that a number of patients develop deep vein thrombosis (DVT) after IVC filter insertion.

Another possible problem, though rare, is that the filter may capture so many clots that blood flow past the filter is impeded. This can cause swelling in the legs and is probably more likely in patients who develop DVT after placement.


An additional potential issue is that the IVC filter struts, or “legs,” can penetrate the wall of the inferior vena canal where the filter is placed. While this sounds frightening, it rarely creates any symptoms, and possibly even occurs in the majority of IVC filter recipients.

When perforation does create symptoms, they can include internal bleeding, but again, this is rare.


IVC filter fractures occur when a part of the filter breaks off. Because filter parts are so small, they are likely to travel through the cardiovascular system when this occurs, winding up in the heart, lungs, or another blood vessel.

Fortunately, most people who experience a filter fracture don’t even realize it has happened. These fractures rarely cause symptoms and often go unnoticed until a patient is scanned for a different health issue. In one case, a woman who was experiencing shortness of breath was discovered to have an IVC filter strut in her heart, according to an article in a 2015 issue of Respiratory Medicine Case Reports. It wasn’t causing any additional symptoms, however, and was left in without issue. Some research cited in her case study suggested that certain manufacturers may produce IVC filters which are more likely to fracture.


Migration is perhaps the scariest of possible IVC filter complications. Rather than a small fragment of the filter traveling through the cardiovascular system, the entire structure may move. It can wind up in some dangerous places, such as the heart or pulmonary outflow tract, or wind up malpositioned somewhere else in the inferior vena canal. Left unnoticed, a poorly positioned filter will fail to do its job, quietly putting the patient back at risk for pulmonary embolism.

It’s possible that newer materials being used by IVC filter manufacturers are responsible for a recent increase in filter migration. This puts patients at a very dangerous increased risk, as a filter in the heart can cause tachycardia. Tachycardia is when the heart beats too fast, over 100 times per minute, and it can lead to cardiac arrest.

In many cases, migrated IVC filters can be retrieved through a non-surgical procedure similar to the one used for placement. However, removal, especially from the heart, can still be difficult and dangerous. In one man’s case, nonsurgical removal left damage to the heart. His case study cited research suggesting that newer construction of filters may contribute to rising migration rates.

In some cases, nonsurgical removal of an IVC filter is impossible, requiring open-heart surgery. In others, a filter in the heart leads to death.


Sadly, for some patients who accept the above risks in exchange for safety from pulmonary embolisms, the IVC filter simply does not work. Studies have revealed that up to 5.6% of patients who have a filter implanted experience a pulmonary embolism despite it, with 3.7% of patients dying as a result.

What Do These Risks Mean for Patients?

Despite these risks, IVC filters continue to be placed in patients who would otherwise likely experience a dangerous traveling blood clot. With concerns surrounding the materials used to make them and quality of manufacturers, it’s important for patients to get as much information as they can if a doctor recommends an IVC filter implantation.

Injured by an IVF Filter?

People are actively filing IVF filter lawsuits. If you or a loved one were injured by an IVC filter, contact our attorneys for a free, no-risk case evaluation. We have decades of experience trying mass torts such as these and have a legal team ready to investigate if you have a case.

How Secure Is Your Medical Device Really?

Pacemakers that fail to send electrical pulses to a patient’s heart when they need it the most; vital signs that are altered, resulting in unnecessary treatment; or insulin pumps that fail to administer insulin. These are all scenarios that hackers say are possible, because they’ve tried it themselves and know it can be done.

We spoke with Christian Espinosa, a white hat hacker, sometimes referred to as an “ethical hacker,” who has decades of cybersecurity experience. He is currently the CEO and Founder of Alpine Security, and cyber security instructor at Maryville University. Along with his team at Alpine Security, Christian hacks into medical devices in order to help manufacturers identify security vulnerabilities before someone with malicious intent catches on.

In the interview below, Christian explains why the medical industry is so ripe for cybersecurity attacks, and just how serious—and complicated—the problem is.

Could you provide an overview of the cybersecurity threats the medical field faces? How big is this problem?  

Medical devices have largely been neglected from a cybersecurity perspective. Many of these devices run legacy operating systems, are full of vulnerabilities, and were

Christian Espinosa, CEO and Founder of Alpine Security

not intended to be connected to hospital networks. For ease of management, data access, updates, etc., many medical devices are now connected to hospital networks, which have connections to the Internet.

Hospital networks are inherently unsecure; any threats to a hospital network are transferred to connected medical devices. Threats to implantable devices are primarily due to unsecure wireless communications. Implantables were designed to be easy to monitor and update via wireless technology. It is too risky to perform heart surgery every time a pacemaker or implantable cardioverter defibrillator (ICD) needs to be updated, for example.

The threats to medical devices are a big problem with severe and potentially lethal consequences.

As a white hat hacker, what’s your process for identifying security vulnerabilities? Do you try to hack everything and anything, or do you gravitate towards particular types of devices or networks?

Our process depends on the scope of the engagement. If we are asked to assess a medical device, we typically have several main phases—1) we perform a discovery to learn more about the device; 2) we define a security boundary for the device; 3) we perform a risk assessment of the device; 4) we identify all possible entry points in the system/device; 5) we develop attack trees and assess all entry points into the system using penetration testing and other techniques; 6) based on the results of 1-5, we determine a mitigation strategy; 7) we generate the report.

As for hacking everything and anything, the process I just mentioned applies a risk-based approach to our assessment. We focus on the big-ticket items first with the highest risk to patient safety, emphasizing how the device could be misused and the effect of attacks on data confidentiality, integrity, and availability. We work with manufacturers and providers to fix the most critical items first, then work down a prioritized list, based on the risk. We also run validation tests to ensure remediation steps worked.

How receptive are companies when you do identify a vulnerability? Do they usually address the issue?

Some are more receptive than others. Sometimes we are met with resistance, such as “there’s no way someone would think of doing that.” Most often though, our findings are well-received.

Unfortunately, company bureaucracy, cost, timelines, and other factors present obstacles to fixing devices under development or devices deployed in the field. It is very costly for medical device manufacturers to fix devices that are deployed across the world, or ones that are in the middle of development.

What do you think makes medical devices and hospital networks so appealing to hackers?

“If you can hack into a medical device, you can directly affect a person’s physical state and well-being.”

A couple reasons. One is that PHI (protected health information) is more valuable than other types of information. Patient records sell for more than other types of stolen sensitive data on the black market.

Another reason is the physical effects that can be caused by hacking medical devices. Normally, if you steal credit card data from a web application, you may inconvenience someone—that’s an indirect effect to the person. If you can hack into a medical device though, you can directly affect a person’s physical state and well-being.

What is the one type of security vulnerability that keeps you up at night?

There’s not one that keeps me up at night. I’ve come to terms with the fact that it’s just a matter of time before something catastrophic happens. There’s already been many warning signs, yet there is a head-in-the-sand mindset still. Almost like “if we pretend it’s not there, the threat doesn’t exist.”  

“I’ve come to terms with the fact that it’s just a matter of time before something catastrophic happens.”

If I had to pick one threat that would keep me up at night though, it is the threat of weaponized medical nanotechnology, a form of biomedical hacking. 

Nanotechnology, or “nanotech,” are basically extremely small computers, smaller than a pinhead. Nanobots can be used in the human body for items such as targeting cancer cells to destroy them by delivering chemotherapy to only cancer cells. These nanobots can also be used to deliver lethal toxins or carry out specific missions in the human body, such as making your arms temporarily unmovable, or similar. The scary thing is they can be introduced to the human body very easily. You could breathe them in and not even know.

Do you think the FDA is doing enough to prevent and respond to cyberattacks?

I think the challenge is identifying who is ultimately responsible for medical device security—the device manufacturer, the user, the hospital, clinic, the Department of Homeland Security, the FDA, the doctor, patient, etc.?

The FDA has basically issued premarket and postmarket guidance for medical devices and passed the responsibility to healthcare delivery organizations (HDOs). According to the FDA, “HDOs are responsible for implementing devices on their networks and may need to patch or change devices and/or supporting infrastructure to reduce security risks.  Recognizing that changes require risk assessment, the FDA recommends working closely with medical device manufacturers to communicate changes that are necessary.” 

We recently spoke with a medical professional who told us that “doctors don’t become doctors to protect data.” What role does the average doctor play in maintaining secure medical devices and networks?

I agree with this statement. Doctors have enough to worry about. They should be given a list of “approved medical devices” that they can use and recommend. These devices should be thoroughly vetted for cybersecurity vulnerabilities. Penetration testing and other methods should be used.

The challenge becomes where does this “approved list of medical devices” come from? Who has the approval authority? This is not a simple problem to solve, because medical devices are complex systems with many vulnerabilities, both known and unknown. What is approved today, could be recalled tomorrow. This should not be the responsibility of the doctor.

‘We Have Won’: Women Celebrate the End of Essure

Bayer claims they are withdrawing Essure due to “inaccurate and misleading publicity,” but the number of Essure adverse events tell a different story.

On July 20, 2018, Bayer announced they would stop selling Essure, their permanent birth control device. The U.S. is currently the only country where the device is sold.

Some women claim their lives were turned upside down after they opted to receive Essure—a non-surgical alternative to tubal ligation that involves inserting a nickel-titanium coil into each fallopian tube. They’ve shared horrific stories of constant pain after the coils fractured, corroded, or migrated elsewhere in their bodies, sometimes perforating their organs in the process.

While Bayer claims their decision was due to “inaccurate and misleading publicity,” the number of adverse events women have reported to the FDA tell a different story. More than 25,000 women have complained of complications after being implanted with the device.

Women have reported a number of Essure-related side effects, like back pain, abdominal pain, severe cramping, pelvic pain, headaches, menstrual changes, and painful intercourse. Some women have developed allergic reactions to the nickel-based coils. What makes these complications especially devastating is that often the only way to remove the device and put an end to the patient’s suffering is by performing a hysterectomy.

E-Sisters Celebrate the End of a Long Battle

Bayer’s announcement was a long time coming. Women have been shouting about the dangers of the device for years, asking for a ban and for Bayer to be held accountable for putting their health at risk.

We spoke to Angie Firmalino, founder of the Essure Problems Facebook group—a group that provides support and community to more than 36,000 women who have allegedly been injured by the device—about what this announcement means to them.  

“Women will not be harmed by this device anymore. We have won, we have finally won.”

“Seven long years of fighting to get Essure removed from the United States market has finally paid off. Friday’s announcement that Bayer will be halting the sales and distribution of Essure has brought us all to our knees in gratitude, relief, and celebration. Women will not be harmed  by this device anymore. We have won, we have finally won.”

Firmalino and her fellow “E-sisters” have campaigned hard, rallying in front of FDA headquarters, meeting with FDA commissioner Scott Gottlieb, and sharing their stories with the media, including Netflix’s new documentary The Bleeding Edge, which exposes how dangerous devices like Essure gain FDA approval.

“These last few weeks leading up to the Netflix premiere of The Bleeding Edge have been a whirlwind,” said Firmalino. “The Tribeca Film Festival premiere, all of the screenings, the rally at Bayer headquarters, Connecticut Medicaid withdrawing coverage of Essure, our recent email to FDA commissioner Gottlieb, I believe it all contributed to the market withdrawal.”

Essure’s Tumultuous History: A Timeline

Essure’s long-awaited withdrawal from the market didn’t happen easily or quickly. Here are the most notable Essure-related safety warnings and scandals.


Essure gains FDA approval and hits the market. It was initially sold by Conceptus, which is now a subsidiary of Bayer.


FDA adds a nickel sensitivity warning to Essure. Conceptus lobbies FDA to remove the contraindication, and the FDA complies.


Angie Firmalino creates the Facebook group Essure Problems where women hurt by Essure can share their experiences. It now has more than 36,000 members.


The FDA orders Essure to carry a warning about chronic pain and device migration.

April 2014

A study suggests that women who use Essure are more than 10 times likely to become pregnant than women who receive the traditional laparoscopic sterilization method.

September 2015

The FDA Obstetrics and Gynecology Devices Panel issues recommendations for Essure, warning that some women with nickel allergies, chronic pelvic pain, autoimmune disorders, or prior uterine surgery should not use the device.

February 2016

The FDA orders Bayer to conduct a new post-marketing safety study “designed to provide important information about the risks of the device in a real-world environment.”

November 2016

The FDA orders stronger black box warnings—the highest warning it can issue—for Essure “designed to call attention to serious or life-threatening risks.”

September 2017

Bayer announces they will stop selling Essure everywhere outside the U.S. The announcement comes after recalls in Brazil and Australia earlier in the year.

December 2017

The FDA receives 11,854 adverse event reports for Essure in 2017, more than double the 5,019 reports in 2016.

February 2018 

Five women from Essure Problems, including Founder Angie Firmalino, meet with FDA Commissioner Scott Gottlieb to ask that Essure is temporarily removed from the market. They present survey results, images, and stories from fellow members illustrating the dangers of the device.

April 2018

FDA requires healthcare providers and facilities to provide patients with brochures and info on possible Essure complications prior to device implementation

July 20, 2018

Bayer announces they will stop selling Essure in the U.S. by end of 2018. The company claims their decision was based on declining sales and “inaccurate and misleading publicity.”

July 27, 2018

Netflix documentary “The Bleeding Edge” premieres.

CNN publishes an analysis of federal data showing that Bayer allegedly paid doctors $2.5 million for Essure-related consulting fees and other services between August 2013 and December 2017.

Thousands of Women Are Suing Bayer

More than 16,000 women in the U.S. have filed lawsuits against Bayer. The lawsuits allege that Essure is defective and unreasonably dangerous, and that Bayer failed to comply with federal safety laws.

If you were implanted with Essure and experienced severe side effects, like abdominal pain, irregular menstruation, or device migration, you may be eligible to file a lawsuit. An Essure lawsuit may be able to help you recover compensation for medical bills, pain and suffering, and more.

You can contact us for a free, no-obligation legal review to see if you may have a case.

Essure Adverse Event Reports Doubled Last Year

In 2017, the FDA received 11,854 adverse event reports for Essure. 

Thousands of women are submitting complaints, filing lawsuits, and even meeting with lawmakers and the FDA in Washington, D.C. in order to ban a popular form of permanent birth control.

Essure, made by Bayer, is a non-surgical alternative to tubal ligation (having one’s tubes tied). It consists of two nickel-based coils inserted into the fallopian tubes which cause scar tissue to build up, preventing egg fertilization.

Since 2002, thousands of women have complained of life-altering chronic pain after receiving Essure, including painful intercourse, painful menstruation, pelvic pain, and back pain. Women have also reported unwanted pregnancies and pregnancy losses, and fractured and migrated coils. In 2016, the FDA issued a black box warning for the device—the highest level of warning it can bestow for the most severe side effects and complications.

Despite greater awareness of potential Essure complications, complaints continue to climb year after year as the birth control remains on the U.S. market.

Majority of Injury Reports Reference Device Removal

In 2017, the FDA received 11,854 adverse event reports for Essure. In 2016, they received less than half that: 5,019 reports. To date, more than 25,000 women have complained about the birth control device.

“The increase in reported adverse events no doubt reflects a greater awareness by doctors, as well as by patients—primarily through social media and litigation—of the widespread problems caused by this dangerous medical device,” said attorney Michael Goetz, head of the Mass Tort Section of the Morgan & Morgan Complex Litigation Group.

The vast majority of complaints received in 2017—92.7 percent—referenced device removal, the FDA reported.

The procedure to remove Essure can be complicated since the coils may break into multiple pieces, drift away from the original location, and even embed into the fallopian tubes, uterus, and other organs. Some women require hysterectomies in order to rid themselves of the device.  

Women who receive Essure are more likely to need surgery afterwards than women who receive tubal ligation, according to a study published in the British Medical Journal. After one year, 2.4 percent of Essure patients required follow-up surgery, compared to only 0.2 percent of women who underwent tubal ligation surgery.

Bayer Stops Sales Outside U.S.

“The fact that Bayer has discontinued sales of Essure in all countries other than the U.S. tells you all you need to know about Bayer’s disregard for the safety of women in this country.”

Today, Essure is only sold in the United States.

In February 2017, Bayer announced a recall in Brazil, and in August of that year, a recall in Australia. In September, they announced that they would stop all Essure sales outside of the U.S.

Bayer denied the move was due to mounting litigation or safety concerns, saying it was a “commercial decision.” But, even though they claimed their decision was merely about numbers, Bayer instructed the National Health Service (NHS) in the U.K. not to use remaining stock of the device. It seems like an odd instruction if safety concerns weren’t an issue like they claimed.

“The fact that Bayer has discontinued sales of Essure in all countries other than the U.S. tells you all you need to know about the device and about Bayer’s disregard for the safety of women in this country—women who trusted the Bayer name and who now find themselves facing unanticipated surgeries and other medical problems,” said Michael Goetz.

Women Share Their Stories with Head of FDA

Despite the fact that Essure sales continue in the U.S., its future doesn’t look bright—not if you look at the thousands of American women who are demanding that the FDA ban the birth control device.

In February, five members of the Essure Problems Facebook group met with FDA Commissioner Scott Gottlieb. They came armed with survey results, images, and stories from their members in order to argue for Essure’s temporary removal from the market.

Shortly after their meeting, Gottlieb issued a public statement on Essure. In it, he outlined the steps the FDA is taking to evaluate Essure’s safety, including ordering Bayer to conduct a 522 Postmarket Surveillance (PS) Study to assess the device’s safety among women who currently use it. The postmarketing study will include data from 2,800 women, but the results won’t be available until 2023.

“While the FDA continues to believe that Essure may be appropriate for some women based on our current information, the agency also recognizes that serious problems have been associated with its use,” said Gottlieb.  

Angie Firmalino, founder of Essure Problems, was one of the women who met with Gottlieb. We spoke with her about what the group’s goals were for the meeting and whether or not the FDA met them.

“Our goal for the meeting with FDA commissioner Scott Gottlieb was to ask for the suspension of Essure until the newly ordered postmarket clinical trials are completed,” Firmalino told us. “After the commissioner released his most recent public statement, we feel that he has made the decision to leave the device on the market, even after we provided him with new evidence and more information.”

FDA Presents a “Façade That They Care”

“The FDA has chosen the side they wish to protect. Sadly, that side is industry.”

Few medical devices have inspired the formation of patient advocacy groups like Essure Problems, a social media community that fights on behalf of women whose lives have been disrupted because of the device. But even though thousands of women are raising their voices, the FDA doesn’t appear to be listening.

“I believe our social media presence and our advocacy have pushed the FDA to publicly acknowledge us and our concerns, but I think that is all it has been, and ever will be—just acknowledgment,” Firmalino told us. “A façade that they care, and that they are listening, and that they are actually investigating the real world damage this device has caused.”

“If they truly were doing their jobs to protect the American citizens, this device would have been taken off the market long ago. The FDA has chosen the side they wish to protect. Sadly, that side is industry.

Bayer Faces Thousands of Lawsuits

Keeping pace with the number of adverse event reports piling up are the number of lawsuits filed against Bayer. As of October 2017, 10,600 women had sued Bayer over Essure.

Essure is a class III medical device, which means that it has federal immunity from lawsuits that allege defective or dangerous manufacturing and design. Women have teamed up with lawmakers to get around this, most recently by introducing bills like the Medical Device Safety Act of 2017 which would remove immunity for class III devices.

Despite this hurdle, many lawsuits have survived federal preemption. These lawsuits allege Bayer failed to report thousands of complaints to the FDA and that the company failed to adequately train doctors on how to implant the device.

If you or a loved one were injured by Essure, you may be eligible for a lawsuit. Contact our attorneys for a free, no-obligation legal review.

One-Third of Medical Errors Caused by Poor Labeling

Labeling and packaging issues are the leading cause of medication errors.

If you’ve ever thought that the instructions and warnings that come with your medications and medical devices required a medical degree to understand, you aren’t alone.

In fact, an Institute of Medicine study found that labeling and packaging issues (particularly confusing instructions) were the leading cause of medication errors (33%) and deaths from medication errors (30%). Medical devices trend the same way. The FDA’s Center for Devices and Radiological Health reports that one-third of the roughly 100,000 medical device event reports they receive each year are attributed to use error.

Part of the problem is that there is a lack of consistency across labeling. While manufacturers are required to include important warnings and dosage information in their packaging, the format and symbols can vary between products. And, if a physician can’t find information on a label quickly, or if a patient can’t understand how to use their medical device or drug at home, it can result in serious complications.

Only 15% of Pharmaceutical Drugs Follow FDA Standards

The FDA realizes the medical industry is suffering from weak labeling regulations, but fixing the problem has proven to be a decade-long process.

Currently, there is no standard for medical device labeling or instructions. While manufacturers are required to include certain information in those materials, there is no format for them to follow, nor is there a set of common terminology to use.

In 2006, the FDA addressed this problem with pharmaceutical drugs. The Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, or the Physician Labeling Rule, established standards for everything from what information should be highlighted, to what size font should be used and what should be bolded.

Though the standards have existed for more than 10 years, only 15% of pharmaceutical drugs follow the labeling rule.

Confusing Labeling Can Result in Drug Overdosing

Every 21 seconds, someone in the U.S. calls the Poison Control Center because of a medication error.

In 2006, drug officials stated that the U.S. spent $4 to $4.8 billion on medical errors that could be prevented if drug manufacturers improved the information they provided to doctors.

But this isn’t just a financial problem; it’s a public health issue.

A 2017 study reported that every 21 seconds, someone in the U.S. calls the Poison Control Center because of a medication error. Medication misuse, they found, has increased 100% since 2000.

Henry Spiller, one of the study’s authors and the director of the Central Ohio Poison Center, emphasized the role that drug manufacturers and pharmacists play in reducing medication errors.

“There is room for improvement in product packaging and labeling,” he said in a statement. “Dosing instructions could be made clearer, especially for patients and caregivers with limited literacy or numeracy.”

Labeling confusion recently resulted in a number of patients overdosing on the antibiotic Zerbaxa. The FDA warned that Zerbaxa’s vial and carton listed the strength of each ingredient, rather than the strength of the dose. This caused some patients to receive 50% stronger doses than they should have.

Hernia Mesh Manufacturers Accused of “Extreme Underreporting”  

Medical device manufacturers are just as guilty of providing weak labeling and instructions.

In a recent study published in the Journal of the American College of Surgeons, researchers found that the majority of hernia mesh labels were missing important information:

  • 67% of hernia mesh labels did not provide information on the device composition.
  • 69% of hernia mesh instructions did not provide information on the device mechanics.
  • 89% of hernia mesh instructions did not provide information on the device thickness.

There is an extreme underreporting and lack of consistency of clinically important mesh properties,” concluded researchers. More standardized information and terminology, they claimed, would improve physician decision making during hernia repair.

The complete lack of information available to physicians is astounding given how common hernia mesh injuries are. Thousands of lawsuits that have been filed against manufacturers alleging that the mesh migrated and stretched in their bodies, causing internal injuries and ultimately requiring revision surgery.

In 2011, C.R. Bard offered to pay $184 million to settle 2,600 lawsuits for its Composix Kugel Mesh. And Ethicon—whose Physiomesh was recalled in July of 2016 for its high complications risk—faces its first trial in January 2018.

Medical Device Manufacturers Fight Labeling Database for Patients

As part of their effort to reduce confusion and medical device use error, the FDA is piloting an electronic database for medical device labeling. Because medical devices are typically used for years, patients often discard or misplace the original packaging and instructions, and may not know if the manufacturer has issued new warnings. 

Since 2007, the FDA has required medical device manufacturers to submit their device registration information electronically, but not the labeling. Currently, there is no easy way for patients to find the original labeling and instructions for their medical devices.

Astoundingly, manufacturers claimed that a database for medical device instructions would actually negatively affect patient safety.

But not everyone is eager to improve communication with patients. AdvaMed, the trade association for medical device manufacturers, went so far as to claim that a database for medical device instructions would actually negatively affect patient safety.

“An online medical device repository would pose numerous problems, including risk to patient safety due to the number of medical devices and the frequency of which patient labeling may be updated,” AdvaMed claimed.

Their reasons? Because if people go online, they may not pick up the phone to call customer service.

“An online repository for all medical devices may divert users from human interaction with Customer Service personnel trained in the operation and maintenance of their devices,” they stated.

It’s an extremely weak attempt to fight regulations which will enable patients to easily find vital safety information.

This isn’t the first time that manufacturers have resisted recommendations to improve patient safety, nor will it be the last. If you or a loved one were injured by a medical device or medication, contact us for a free, no-obligation legal review.

Senators Introduce Bill to Eliminate Billions in Medical Waste

A bipartisan pair of senators may have just charted a path to $765 billion.

On October 31, Amy Klobuchar (D—Min.) and Chuck Grassley (R—Iowa) introduced the Reducing Drug Waste Act of 2017. The cosponsors of the bill are Dick Durbin (D—Ill.) and Jeanne Shaheen (D—NH).

In a press release, Sen. Klobuchar said, “With the skyrocketing costs of prescription drugs, American taxpayers shouldn’t be footing the bill for medicine going to waste. Our bipartisan legislation would begin to address the problem of millions being spent on discarded drugs.”

“American taxpayers shouldn’t be footing the bill for medicine going to waste.”

Sen. Grassley cited a report which “indicated that Medicare and private insurers waste nearly $3 billion a year on cancer drugs that are distributed in vials that hold too much medicine for most patients.”

The act proposes that the U.S. Food and Drug Administration (FDA) team with the Centers for Medicare and Medicaid Services (CMS) to curb waste and “better manage costs with respect to vial sizes and other drug delivery systems like eye-drops.”

The impetus for the bill was a series of reports by nonprofit newsroom ProPublica, which found that medical waste costs taxpayers billions of dollars a year.

Droppers Dispense Twice as Much Liquid as Needed

In one striking example, ProPublica found that oversized eyedrops cause consumers’ prescriptions to run out much sooner than they should, forcing them to buy another vial. Most eyedroppers release far more liquid than the eye can hold; the excess liquid runs down the person’s cheek or is absorbed by the tear ducts.

Physicians have long known about this waste.

The drops can be twice as large as they need to be—which means the bottle runs out twice as fast and costs the patient twice as much.

Physicians have long known about this waste. A 1992 study in the American Journal of Ophthalmology found that microdrops were as effective as large drops, reduced side effects, and were the preferred treatment of patients.

Bill York, who helmed the study while working for eye care company Alcon, lobbied his employers for “microdroppers,” to no avail. Dr. Alan Robin, an ophthalmologist in Baltimore who consulted on the microdrop study, says he cried tears of joy when he learned of the Reducing Drug Waste Act.

“I’m literally crying with joy,” Dr. Robin told NPR. “I’m very concerned about both the cost issues associated with the waste, the side effects on patients, and also the environmental impact of waste.”

Last year several glaucoma patients filed a class action lawsuit against Alcon, Allergan, Bausch & Lomb, Merck, Pfizer, and Prasco alleging financial harm as a result of this industry-wide system of producing oversize droppers. That lawsuit was certified as a class action last year, then tossed before being revived two weeks ago.

The plaintiffs say these oversize droppers cost them thousands of dollars and amount to “an unfair and unscrupulous scheme.”

Healthcare System Wastes $765 Billion a Year

Eyedroppers aren’t the only case of squandered resources, unfortunately. The ProPublica series has brought to light a jaw-dropping amount of medical waste:

  • Hospitals throw away countless perfectly good, usable instruments (surgical staplers, surgical masks, catheters, ventilators, etc.). The article notes a 2012 study which estimated that our healthcare system wastes $765 billion a year.
  • Nursing homes toss, flush, or burn leftover prescription drugs at an alarming rate. One employee estimated that dozens of nursing homes destroy about 20 percent of the drugs they receive.
  • Drug makers often combine two cheap, generic drugs; slap a brand name on it; and sell it at an exponentially higher cost. One example, Vimovo, cost $3,252 for a month’s supply—versus $40 for the two drugs it combines, Aleve and Nexium.
  • Perhaps least surprising (but no less frustrating), several studies show that many drugs remain safe and effective long after their “expiration dates.” Reevaluating how we set these dates could save hospitals, pharmacies, and consumers billions of dollars.

The question, of course, is whether Congress can weather the flood of cash from Big Pharma and hold its ground. Last year drug makers spent $246 million on lobbying—the most of any industry.

That strategy has worked up until now (it usually does), but with soaring drug and healthcare costs rattling more and more consumers, the tide may turn.

FDA-Mandated Essure Study Fails to Get Off the Ground

This post was written by Jay W. Belle Isle, the Editor in-Chief for LegalReader.com, a legal news and commentary site. Jay has a degree in Business Administration from Cleary University and a Juris Doctor from Thomas M. Cooley Law School. He has covered the Essure issue extensively and advocates for the device’s removal from the market.


Bayer is removing the controversial Essure birth control device from foreign markets due to “commercial concerns,” but it remains available in the U.S. despite an ever-increasing number of serious complications. Through grassroots efforts, the women of the Essure Problems Facebook group (known as E-Sisters) have succeeded in getting the U.S. Food and Drug Administration (FDA) to take some action.

However, that action continues to have limited results. One such example is the FDA-mandated 522 Postmarket Surveillance (PS) Study. According to the FDA, this study “helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.”

It appears that the Essure PS study is fulfilling the “least burdensome” goal of the program, at least for Bayer. The FDA mandated the study more than a year and a half ago, on February 29, 2016. At that time Dr. William Maisel, the Deputy Director for Science for the FDA’s Center for Devices and Radiological Health (CDRH), told the media:

“We expect Bayer to submit a study protocol to us within 30 days. By law, they must begin their clinical trials within 15 months. And failure to do so could result in the agency taking action such as issuing a warning letter and declaring their device misbranded. We have taken those actions in the past and we will do so in the future if Bayer does not meet its requirements.”

Bayer submitted its study protocol and the FDA approved the plan. The study should have started in May of this year. But as of October 3, 2017, the study has barely gotten off the ground.

FDA Satisfied with Bayer’s Lack of Progress

Angie Firmalino, founder of the Essure Problems group, sent the FDA a letter earlier this year requesting an update on the study. The agency’s response was not encouraging.

“Regarding the 522 study,” the agency wrote, “the FDA approved the study plan on September 2, 2016. Since then, as the 522 website states, Bayer has begun its postmarket study. As of May 3, 2017, 60 sites had been selected for participation, 31 sites had submitted IRB applications, 24 sites had central IRB approval and 3 sites had been enrolled. Site and patient enrollment is a continuous process.”

There is only one patient enrolled out of the required 2,400.

So, by the FDA’s own admission, the study had only three enrolled sites by the time the clinical trials were to begin. According to the FDA page, not only has that enrollment not changed, but there is only one patient enrolled out of the required 2,400. (This data was updated October 2, 2017.)

Have Dr. Maisel and his cohorts at the FDA issued the warning letter he referenced in 2016? No. Has the Agency declared Essure misbranded? No. What has happened?

In short, nothing.

Essure Still on Market with FDA’s Blessing

The FDA concluded that Bayer has begun the study because it’s made the effort to enroll study sites and patients. Even though the number of each hasn’t changed in five months, the FDA is satisfied with Bayer’s approach. The final report from the study is due September 2023.

The author submitted a Freedom of Information Act (FOIA) request for the six-month study report in May 2017. That information was finally provided last month. Interested parties can access the reports via links at the bottom of the Agency’s FOIA page.

The heavily-redacted report didn’t provide positive news for those concerned with the dangers of Essure. As seen in the “Timeline for Study Implementation” above, the 36-month study won’t begin in earnest until May 2020, the “expected date of enrollment completion.”

Granted, the one patient currently enrolled may be providing data, and subsequent enrollees between now and May 2020 may do the same. However, the fact remains that Essure, a dangerous medical device, will not only remain on the market until completion of the study but will do so with the FDA’s full blessing.

Women Left to Fend for Themselves

Women in the U.S. are left to fend for themselves. Those who are dealing with Essure-related injuries continue to support each other and fight for justice, both in the courtroom and in Congress. They also continue to educate women who are considering Essure on the potential risks.

That education is crucial. New patients are reporting that they were never shown the black box warning or the patient checklist issued by the FDA. Essentially, they never had the opportunity to make an informed decision.

Sources such as Essure Problems, Legal Reader, ClassAction.com, and physician advocates such as Dr. Julioa Novoa (see video above) are dedicated to providing useful information. Furthermore, the Washington Post published a detailed article on Essure in July, and Consumer Reports released a Consumer’s Guide to Essure in August.

Bayer continues to stand by Essure as a safe and effective option for birth control, and the FDA doesn’t seem inclined to do anything until 2023. Until then, it’s up to the people to spread the word.

Injury Risk Rises the Longer IVC Filters Are in Place

A medical device that is supposed to prevent blood clots from reaching the heart and lungs may put patients at risk of potentially fatal injuries like perforated blood vessels or organs.

Inferior vena cava (IVC) filters are metal, cage-like devices that are implanted in the body’s largest vein (the inferior vena cava). The device’s long legs catch blood clots and stop them from traveling to the heart or lungs where they can be deadly.

If the device is left inside patients longer than necessary though, it can cause a number of medical complications of its own. And, removing the potentially dangerous device can be more difficult and susceptible to complications the longer the filter is in place.

FDA Says Filters Should Be Removed within Two Months

Dozens of deaths and nearly 1,000 FDA-reported adverse events have been linked to IVC filters.

Patients have reported cases of the device migrating from its original position, sometimes embedding itself in the inferior vena cava. Other reports describe the device fracturing, causing metal fragments to float in the body until they allegedly pierce the heart, lungs, or blood vessels.

The FDA initially approved IVC filters as a permanent medical device that could remain in place indefinitely. However, in 2010, after receiving hundreds of incident reports, they warned that the device should be removed once it is no longer necessary for the patient’s health.

Temporary retrievable filters are now available, but there’s a short window of time between when the device provides life-saving benefits until it may cause life-threatening complications. The FDA recommends that for patients who are no longer at a high risk for blood clots, retrievable IVC filters should be removed between 29 and 54 days after insertion.

But, a JAMA Internal Medicine study revealed that the majority of physicians aren’t following up with patients who have this high-risk medical device, causing temporary IVC filters to become permanent. The study found that successful IVC filter retrieval rates were as low as 8.5%. Overall, only 24% of patients underwent a retrieval attempt of some sort, putting many patients at risk of serious medical complications.

A study found that successful IVC filter retrieval rates were as low as 8.5%.

The health consequences for this medical oversight are serious. A study from Northshore University in Illinois found that because most retrievable IVC filters aren’t actually retrieved, their complication risk was higher than permanent filters: an 8.9% complication rate compared to 2.9%. 

Waiting too long to remove an IVC filter doesn’t just increase the chance of the device fracturing, migrating, or perforating an organ or blood vessel; it also increases the likelihood that a physician will need to use advance retrieval techniques, or that they won’t be able to remove the filter at all.

Study Finds 40% Chance of Retrieval Failure After Seven Months

Researchers from Northwestern University Feinberg School of Medicine examined 762 IVC filter retrieval procedures from January 2009 to April 2015 for a study published last month. The procedures involved a variety of devices, but primarily Cook Medical’s Celect IVC filter.

Researchers found that the longer the device had been implanted, the likelier standard retrieval procedures would fail.

At seven months, the failure rate for a standard IVC filter removal procedure was 40.9%. And, the failure rate only increased after this point, researchers noted.

“Because of low retrieval rates, any potential benefit of a device optimally designed for limited use may be offset by the increased risk of complications.”

“Because of low retrieval rates, any potential benefit of a device optimally designed for limited use may be offset by the increased risk of complications associated with prolonged or often indefinite implantation,” the report says.

Lead researcher Dr. Kush Desai told tctmd, “These devices were designed originally to be potentially retrievable but could be left in place. But nobody really knew what was going to happen over months and years, well past their intended application.”

Researchers recommend that physicians refer patients who have had IVC filters for seven months or longer to clinics that are equipped in advanced retrieval techniques. Even then though the decision to operate is dependent on if and where the device migrated. If the filter is in an abnormal position, particularly near vital organs and blood vessels, removing it may be more risky than leaving the filter in.

Hundreds File Lawsuits for IVC Filter Complications

The potentially fatal complications associated with IVC filters have prompted hundreds of patients and families to sue manufacturers. Manufacturers C.R. Bard and Cook Medical face the majority of lawsuits. Some lawsuits allege that manufacturers were aware of the device’s safety risks, but they hid them from the public to make a profit.

Class action lawsuits against Bard have been filed in Florida, Pennsylvania, and California. Class members seek the establishment of a medical monitoring fund to offset the costs of ongoing safety monitoring for patients with the device.

Multidistrict litigation (MDL) lawsuits have also been filed in Indiana and Arizona against Cook Medical and C.R. Bard respectively.

If you or a loved one were injured by an IVC filter, contact us today to find out if you are eligible for a lawsuit. A lawsuit can help recover compensation for medical expenses, lost wages, pain and suffering, and more.

Has Bayer Stopped Downplaying the Risks of Essure?

Dr. Julio Novoa is an OBGYN (obstretrician-gynecologist) based in El Paso, Texas. He has more than 20 years of experience in the medical field and is the founder of Novoa Medical Services, which provides healthcare for women and teens in the El Paso area. Dr. Novoa is also an outspoken critic of Bayer’s marketing of the Essure procedure and a frequent contributor to the Essure Problems website.

Dr. Novoa wrote the following open letter to further raise awareness of the Essure controversy and of the sway Big Pharma sales representatives can have over doctors such as himself.


To my peers in the medical field:

I write to express my profound concern for the sway that medical industry sales representatives have over doctors, especially when it comes to the Essure sterilization device.

Doctors are intelligent, but we are only human. That makes us just as persuadable—and gullible—as the next person. Considering the possibility of making thousands of dollars per year for using a medical device in your own office, any new FDA product can develop a cult following of doctors blinded by some combination of ignorance and greed.

This is one weakness of our system: Product device representatives disproportionately present the pros of their medical devices and downplay the cons when trying to sell their products to doctors. This is a well-known marketing tactic used to maximize sales in a short period of time.

Those who become experts in this technique are rewarded by their companies with higher commissions, bonuses, and promotions. Those who fail are reprimanded and eventually terminated.

The average doctor doesn’t have time to research and check everything that a medical rep says about the product he or she is selling.

The average doctor doesn’t have time to research and check everything that a medical rep says about the product he or she is selling. Thus, in this realm of “Sell or be fired,” doctors often hear only a product’s advantages.

Sales representatives also offer doctors free training, discounted or free products, and assistance on how to bill the maximum amount possible to insurance companies when using medical devices they buy from the reps.

This is why we doctors must stop acting like naive customers at a used car lot and start actively checking the facts about a medical device or product before recommending it to our patients. Doctors must always be proactive rather than passive, skeptical rather than impressionable.

Above all else, doctors should never allow financial benefit or greed to influence our decision-making in the care of any patient.

Due to the incredibly high rate of compensation as compared to traditional tubal ligation, the Essure sterilization device can put a significant strain on the ethical standards of some OBGYN doctors.

For example, when one factors in the time and effort spent performing a traditional tubal ligation, a GYN doctor may be paid about $100 per hour. By comparison, a doctor may earn $100 per minute for performing the Essure procedure in their office instead of doing a traditional tubal ligation in the hospital. The eye-popping difference in these rates of pay may be too great a temptation for some doctors to recommend the safer and more effective tubal ligation.

A doctor may earn $100 per minute for performing the Essure procedure.

With or without a financial conflict of interest, many doctors have accepted the promotional information presented by Bayer and its reps at face value, without doing their due diligence.

As previously stated, Bayer has promoted Essure by overstating its benefits and downplaying its problems. Much of the information available originated from biased or poorly designed clinical studies. This is why it has taken years to gather “real world” data rather than small, edited, and/or redacted research to see the significantly high failure and complication rates that occur with Essure.

To this day, Bayer still has not fully acknowledged the potential links of the Essure device to Systemic Nickel Allergy Syndrome (SNAS) or Essure-induced polyester-fiber systemic, inflammatory, foreign body reactions—which mimic a variety of autoimmune diseases such as Lupus, Rheumatoid Arthritis, or Sjorgan Syndrome.

Much of the credit for getting the word out about the problems with the Essure device goes not to Bayer or doctors but to advocacy groups such as the Essure Problems forum on Facebook, which applies constant pressure on the FDA to make formal changes regarding Essure, with the ultimate goal of removing the device from the worldwide market.

Despite being on the market for 15 years, it was less than six months ago that Bayer removed language describing Essure as “non-surgical,” which many people consider to be deceptive advertising.

Prior to 2017, Bayer consistently marketed the Essure as non-surgical, confusing patients who considered it to be a safer option than tubal ligation. Earlier this year, after more than a decade, Bayer finally changed the description of the Essure procedure to “a minimally invasive procedure.”

Still, despite this significant change, Bayer could have done more by at least publicly acknowledging that the placement of the Essure device is more than just a simple procedure. Rather, it is an actual surgery with all the risks associated with surgery, including the death of the patient.

I fear that the only way to remove the Essure device from the market is through litigation.

Has Bayer learned its lesson and stopped downplaying the risks of the Essure procedure, or dare we say, Essure surgery? I think not. I fear that the only way to remove the Essure device from the market is through litigation and million-dollar jury verdicts against Bayer and the surgeons who implant it.

In the meantime, it is up to us doctors to exercise the utmost caution and responsibility in the treatments we recommend to our patients. By doing so, we may spare countless people the pain and trauma that occurs when devices like Essure malfunction.

Dr. Julio Cesar Novoa, M.D.

Bayer Loses $413M for Essure as Lawsuits Pile Up

Bayer faces 3,700 lawsuits for Essure complications. Injured women, physicians, and politicians are lobbying Congress to pull the device from the market.

Essure, a permanent form of birth control, has resulted in reports of nearly 15,000 adverse events and 30 deaths. In 2016 alone, the FDA received 5,016 incident reports for the device.

The number of Essure-related complications prompted the FDA to issue a black box warning November of last year, the highest-level of warning for a medication or medical device.

Essure is made of two nickel-based coils which are inserted in the fallopian tubes. Over a period of three months, the coils create a layer of scar tissue that is supposed to prevent egg fertilization.

But, not only can Essure fail to prevent pregnancyit has a 9.6% failure ratethe coils can also corrode, migrate through the fallopian tubes, perforate the uterus and other organs, and cause pelvic pain, irregular bleeding, allergic reactions, and other serious side effects.

Essure manufacturer Bayer now faces thousands of lawsuits for the device, while injured women, physicians, and politicians lobby Congress to pull Essure from the market.

A Physician Issues a “Public Call to Arms”

Though the device is intended to be permanent, debilitating pain and complications have forced some women to undergo surgery to remove the device. In fact, research from Yale shows that women who receive Essure are 10 times more likely to require revision surgery than women who undergo tubal ligation (having one’s tubes tied).

We reached out to Dr. Julio Novoa, an OBGYN that performs Essure removal surgeries and advocates on behalf of injured women, about the unique risks of Essure. He assured us that the device, which often necessitates a hysterectomy to remove, is not the simple outpatient procedure Bayer made it out to be.

“Prior to 2017,  Bayer marketed Essure as non-surgical, thus confusing many patients who considered it to be a safer option as compared to tubal ligation which has always been correctly described as surgical. Bayer could have done more by at least publicly acknowledging that the placement of Essure is more than just a simple procedure, rather, that it is an actual surgery with all risks associated with surgery, including the death of the patient,” he explained.

“Product device representatives disproportionately present the pros of their medical devices and downplay the cons when trying to sell their products to doctors.”

And, it’s not just Bayer who is responsible for misleading patients. Dr. Novoa thinks doctors need to be more proactive by researching the device themselves. 

Product device representatives disproportionately present the pros of their medical devices and downplay the cons when trying to sell their products to doctors. The average doctor doesn’t have the incentive or time to research everything that a medical rep says about the product they are selling,” Dr. Novoa told us.

“I fear that, only through litigation and million-dollar jury verdicts against Bayer and the surgeons that place Essure, will the medical community and Bayer finally do right by their patients and pull Essure off the market.”  

Bayer Loses $413 Million; Faces Thousands of Lawsuits

Though there haven’t been any settlements or verdicts yet for Essure victims, Bayer is already taking a financial hit for its dangerous birth control device.

In their 2016 financial report, Bayer disclosed losing roughly $413 million USD for Essure, and revealed that as of January 2017, they faced lawsuits from 3,700 patients for Essure complications.

But because Essure is a Class III medical device, among the highest-risk devices which require the strictest FDA pre-market approvals, it complicates how patients are able to hold Bayer accountable for their injuries. Class III medical devices receive FDA immunity from lawsuits that allege defective or dangerous manufacturing and design.

FDA immunity and regulations trump state laws in court. In order to proceed, lawsuits must rely on parallel state laws that don’t impose stricter standards than what federal law requires.

Lawsuits alleging that Bayer is liable for defective device design and for failing to provide sufficient physician training on Essure implantation have so far been dismissed, most recently by Pennsylvania Judge Padova in February.

However, a judge in California allowed lawsuits filed by 14 women against Bayer for failure to warn—the lawsuits allege that Bayer didn’t report more than 32,000 complaints to the FDA—because they rely on a California law that doesn’t preempt federal law. Lawsuits alleging breach of warranty, fraud, and negligent representation in advertising and marketing have similarly withstood federal preemption.

Injured Women Lobby Congress to Reform FDA Regulations

A Facebook group for injured victims, “E-Sisters,” formed a nonprofit to lobby Congress to pull Essure off the market and revoke its pre-market approval.

More than 30,000 injured women have united on Facebook to share resources and fight for justice. A Facebook group for injured victims, “E-Sisters,” formed a nonprofit ASHES—Advocating Safety in Healthcare E-Sisters. The nonprofit is lobbying Congress to pull Essure off the market and revoke its pre-market approval, which would allow women to file lawsuits.

ASHES reports that next week, they will join Congressman Brian Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) as they introduce the Medical Device Safety Act of 2017. If passed, ASHES reports, it would remove federal immunity for all FDA class III medical devices, including Essure, making it easier for victims to hold manufacturers accountable. 

Congressman Fitzpatrick’s predecessor, his brother Mike Fitzpatrick (R-PA), introduced the “E-Free Act” (H.R. 3920) in 2015 that sought to revoke FDA’s Essure approval. It was recommended to a committee but never voted on.

This isn’t the first time the E-Sisters have taken matters into their own hands to force the FDA to act. They also helped educate thousands of women in their Facebook group of the importance of filing adverse event reports.

The spike in reported Essure injuries forced the FDA to review Essure’s safety. Last year, the agency ordered Bayer to conduct an ongoing study of 1,400 women to better determine the long-term risks of Essure.

Did you or a loved one suffer complications from Essure?

Bayer shouldn’t be allowed to freely walk away from the thousands of women who were allegedly injured from Essure. If you or a loved one suffered medical complications from the Essure device, our attorneys want to hear from you.  

In a free, no-obligation case review, our team will help determine if you are eligible for a lawsuit. 


Hernia Mesh Leads to “Horrible Pain,” Lawsuits

Patients across North America continue to attribute painful side effects to hernia mesh, particularly Ethicon’s Physiomesh and Atrium’s C-QUR products, each of which is now the subject of lawsuits.

Last month a group of Canadians filed a complaint against Johnson & Johnson (which owns Ethicon) over debilitating health issues they say were caused by the mesh. The alleged side effects include perforations, abscesses, and infections. Many plaintiffs say they required revision surgeries to correct these issues.

Thirty-four-year-old Colleen Copland claims her mesh stretched, triggering a recurrence of her hernia. She tells CTV News, “The pain is always there. It feels like my insides are going to explode… It is a horrible pain, to be honest.”

Free Legal Consultation

“You Couldn’t Even Touch Me”

Ivan Richardson echoed Ms. Copland’s claims, saying, “You couldn’t even touch me, I would cry, I mean literally cry and I went to the doctor and they kept saying they couldn’t find nothing.”

Mr. Richardson said that when the doctors cut him open to investigate, they found that the hernia mesh he’d received had rolled up inside his torso.

It’s estimated that 30,000 Canadians received a Physiomesh implant before Ethicon issued a worldwide recall of the product in May 2016.

In a statement, Ethicon said, “At Ethicon, our first priority is to our customers and their patients, and that includes the safe and effective use of our products. Ethicon will defend itself against lawsuits concerning the use of our hernia mesh products.”

Health Canada has recalled or removed from market 12 types of hernia mesh since 2000.

U.S. Mesh Patients File Lawsuits, Too

Hernia mesh products have generated lawsuits in the United States, as well. In addition to Ethicon’s Physiomesh, Atrium’s C-QUR faces at least 21 lawsuits from patients who say they experienced side effects resulting from C-QUR’s fish oil coating. These alleged side effects include the following:

  • Pain
  • Inflammation
  • Adhesions
  • Infections
  • Foreign body reactions

Like Ivan Richardson, U.S. plaintiff Theresa Callaway alleges that her mesh “folded up” and became “bunched up in layers,” leading to pain, nausea, vomiting, infections, and revision surgeries.

These kinds of problems have long plagued surgical mesh. In 2011, C.R. Bard offered to pay $184 million to settle 2,600 surgical mesh lawsuits filed in a Rhode Island multi-district litigation (MDL).

See Our Hernia Mesh Infographic

In October 2012, the U.S. Food and Drug Administration (FDA) warned Atrium about its C-QUR mesh’s potential for infections and its sterility complaints. In July 2013, the FDA issued a Class 2 device recall of the C-QUR Edge Mesh.

In January 2017, a man named James Brown filed a lawsuit against Atrium alleging that he was implanted with the C-QUR mesh in a hernia repair surgery in 2013 but continued to suffer abdominal pain. Mr. Brown says he underwent revision surgery in January 2016 to remove the mesh, during which doctors discovered he suffered from a “foreign body giant cell reaction” and scarring of the surrounding tissue.

In July 2013, the FDA issued a Class 2 device recall of the C-QUR Edge Mesh.

Earlier this year, Mr. Brown’s case and 20 others were consolidated into a federal multi-district litigation (MDL).

Meanwhile, the first Ethicon Physiomesh lawsuit in the U.S. is scheduled for January 2018 in Illinois’ Southern District.

Mesh Complications Dampen Financial Forecast

In its five-year forecast of the marketability of hernia repair devices, Research and Markets notes

operation failure and recurrence of hernia in obese and Geriatric patients and also the risks and complications associated with hernia repair surgery and mesh are negatively influencing the expansion of hernia repair devices’ global market.

To pinpoint and avoid exactly these types of complications, yesterday Tela Bio announced that it would conduct a post-market clinical study of its OviTex biological mesh, which is used primarily for hernia repair and abdominal wall reconstructions.

Tela Bio will conduct a post-market clinical study of its OviTex biological mesh.

In a press release, chief medical officer Dr. Maarten Persenaire said, “Surgeon feedback on OviTex performance and surgical handling has been positive so far, and we are excited to initiate a formal clinical data collection program that will support future efforts to refine surgical mesh design and develop new clinical protocols for hernia repair.”

This is a welcome step on Tela Bio’s part, as surgical mesh could absolutely use more scientific scrutiny and design refinements.

If you or a loved one underwent hernia repair surgery and suffered complications from mesh, contact us for a free, no-obligation legal consultation.

Breast Implants May Cause Rare Type of Lymphoma

Breast augmentation surgeries have seemingly gotten safer in recent years, but a potentially lethal health risk now looms for those with textured implants.

Earlier this week the U.S. Food and Drug Administration (FDA) announced that it has received 359 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. Nine of these 359 women died from the disease.

Of the 359 cases the FDA knew about as of February 1st, 231 noted the type of implant. Of these 231, the vast majority—203—had textured surfaces, while 28 had smooth.

This data mirrors a January 2017 study which found that the incidence of ALCL in breasts with textured implants is 67.6 times higher than the incidence of breasts with no implants.

The material of the implants does not seem to affect the incidence rate. Of the 312 reports that included the material, 186 were silicone and 126 were saline.

FDA First Noted ALCL Link in 2011

The FDA first noted a potential link between breast implants and ALCL in 2011, but at that point it had not received any reported fatalities. It also lacked a strong enough body of evidence to establish a solid connection.

That changed over the past six years, as the agency received more reports of BIA-ALCL, some of them fatal. The incidents were common and concerning enough that the FDA issued a statement, noting

…we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants.

The FDA stated that it would continue to monitor MDRs, to review medical literature and data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE Registry), and to collaborate with “international regulators and health experts.”

The FDA states, “All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.”

According to the Plastic Surgery Foundation, there were 290,647 breast augmentation surgeries in 2016—which means there could be many more of these BIA-ALCL incidents that have yet to be reported.

About ALCL and Its Symptoms

ALCL is a rare form of non-Hodgkin’s lymphoma (NHL), comprising just one percent of NHL cases and just 16 percent of all T-cell lymphomas, according to the Lymphoma Research Foundation.

It can take up to ten years for ALCL to develop, which helps explain why it took several years for the FDA to go from a potential link to an established one.

Symptoms of BIA-ALCL may include the following:

  • Breast lump or lumps
  • Pain
  • Swelling
  • Fluid buildup

With regard to ALCL treatment options, the LRF says, “If the disease is confined to a single lesion or area, radiation therapy or surgical excision will result in complete remission in approximately 95 percent of patients.”

It can take up to ten years for ALCL to develop.

This aligns with the FDA’s statement on BIA-ALCL, which says that the majority of these cases can be treated by removing the breast implant and surrounding tissue. The FDA does note, however, that some patients may also require chemotherapy and radiation.


FDA Approves New Power Morcellator Despite Cancer Risks

The U.S. Food and Drug Administration (FDA) has approved a new surgical tool used in minimally invasive gynecological procedures months after it discouraged use of the device over cancer concerns.

Power morcellation has been shown to spread undetected cancer in patients.

Olympus America Inc.’s Contained Tissue Extraction System, a type of laparoscopic power morcellator, was cleared through FDA’s controversial 510(k) program, which requires no testing on human subjects.

Olympus received clearance from the FDA on November 16 for the company’s next-generation laparoscopic PK Morcellator, even though power morcellation has been shown to spread undetected cancer in patients.

Power Morcellation Can Spread Cancerous Tissue

Laparoscopic power morcellation is a surgical procedure for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy). During the procedure, a power morcellator–a device resembling a handheld drill–is inserted through a small incision. It then grinds up tissue into small pieces for removal.

Hysterectomies and myomectomies via power morcellation are associated with fewer complications than the same procedures performed via surgical incision into the abdominal cavity.

But there’s a catch: power morcellation has been shown to spread undetected cancer (uterine sarcoma) in patients. This has led to hundreds of lawsuits filed by affected patients.

Most women will develop uterine fibroids at some point in their lives. While many fibroids are benign, approximately 1 in 350 women have unsuspected uterine sarcoma hidden within fibroids. Power morcellation has the potential to disperse cancerous tissue beyond the uterus, substantially worsening the patient’s long-term survival outlook.

FDA Discourages Power Morcellation for Hysterectomies

In April 2014, the FDA issued a safety communication discouraging use of laparoscopic power morcellation for removal of the uterus or uterine fibroids.

“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” said Chief Scientist William Maisel. “Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

Since the safety communication was issued, rates of power morcellation use for hysterectomy and myomectomy have decreased significantly.

According to a study in the Journal of the American Medical Association (JAMA), the percentage of women undergoing hysterectomy via power morcellation decreased from 13.7% in the fourth quarter of 2013 to 2.8% in the first quarter of 2015. A study reported at the American Society for Reproductive Medicine 2016 Scientific Congress found a 63.9% drop in all myomectomies (both laparoscopic and abdominal) following FDA’s warning.

“Many of the existing studies evaluating the impact of the FDA warning against power morcellation have shown a decrease in use of power morcellation,” Dr. Deirdre Lum told Medscape Medical News.

Dr. Lum suggested that the FDA’s warning may have raised fears about tissue disruption in general, steering patients and their doctors towards other fibroid treatment options.

Olympus Morcellator Cleared Based on “Substantial Equivalence”

The Olympus PK Morcellator is designed for the very same surgeries that the FDA warned against. But whether the PK Morcellator poses equivalent cancer-spreading risk is difficult to determine, because the device did not undergo human testing.

The FDA approved Olympus’ morcellator under its 510(k) program, which allows device makers to forego human testing if the new product is “substantially equivalent” to already-approved devices (so-called “predicate devices”).

FDA documents show few design differences between the PK Morcellator and its predecessor. For example, the PK and its predecessor have the same dimensions, mode of tissue dissection, and sterilization.

New for the PK is a “peeling” method of tissue morcellation, compared to a “coring” morcellation technique used in the predicate. The PK also is designed to be used with the “first of its kind” PneumoLiner containment bag—a device designed to contain morcellated tissue

The FDA, however, acknowledges that “the PneumoLiner device has not been proven to reduce the spread of potentially cancerous tissue during power morcellation.”

PneumoLiner was cleared through FDA’s de novo classification process. Although different than the 510(k) process, de novo classification similarly allows devices to escape the much more rigorous premarket approval process.

Neither the PK Morcellator nor its containment bag underwent human testing.

Research published in The Journal of Minimally Invasive Gynecology found that approximately 1 in 10 morcellation containment bags leaked and spread tissue.

There have been calls for power morcellators to be pulled from the market, or at the very least, classified as high-risk devices, which would necessitate premarket approval testing.

Johnson & Johnson’s Ethicon unit withdrew its morcellators from the market following the FDA’s warning. In March 2016, J&J settled the majority of the morcellator lawsuits it is facing for $100,000 to $1 million per case.

Johnson & Johnson Can’t Win in Court

The hits keep coming for pharmaceutical titan Johnson & Johnson, which has suffered a series of huge legal and financial blows in 2016. A slew of jury awards and settlements have cost the company hundreds of millions of dollars and severely damaged its credibility in the court of public opinion.

J&J is struggling to fight three mammoth legal battles at once, and the strain is showing both in its courtroom performances and in its bank account.

View Our J&J Infographic

J&J Will Try—Again—to Move Talc Cases Out of St. Louis

After three massive awards for plaintiffs who claimed they contracted ovarian cancer from using Johnson & Johnson’s talc-based products, J&J will attempt to move future talc cases out of Missouri. They tried this once before, last August, arguing that the company and plaintiffs had no ties to St. Louis. The judge dismissed the motion.

The most recent jury award, in October, was $70 million to Deborah Giannecchini. Five months prior, a Missouri jury awarded Gloria Ristesund $55 million.

The first big win for plaintiffs, in February 2016, went to the family of Jacqueline Fox, a woman who passed away from ovarian cancer after a lifetime of using Johnson & Johnson’s Baby Powder for feminine hygiene. Ms. Fox’s family received $72 million.

There are more than 1,000 talcum powder lawsuits pending in St. Louis, and 200 more awaiting their day in New Jersey courts.

Attorney Jere Beasley, whose firm filed the three Missouri cases and hundreds of others, told Fortune, “If I were representing them [Johnson & Johnson], I would say, folks, we need to sit down and regroup and start trying to settle these cases.”

But as of this writing, J&J seems more concerned with upholding its image as a wholesome family company than admitting wrongdoing and reimbursing the hundreds of women who say they have contracted ovarian cancer from using talc products.

J&J Settles Another Risperdal Lawsuit, Avoiding Trial

Talcum powders aren’t the only Johnson & Johnson products that have spawned a mountain of litigation. The antipsychotic drug Risperdal has allegedly caused many young boys to grow breasts, a condition known as gynecomastia. Hundreds of these boys have filed Risperdal lawsuits against J&J, and so far, they have been very successful in obtaining relief.

In July, a Philadelphia jury awarded Andrew Yount a staggering $70 million, ruling not only that J&J had failed to warn Mr. Yount of the risks in taking Risperdal, but that the company had concealed or destroyed evidence related to the case. Mr. Yount, of Tennessee, started taking Risperdal when he was just five years old.

A Philadelphia jury found that J&J had concealed or destroyed evidence related to the Andrew Yount case.

Mr. Yount’s award was the latest in a string of wins for Risperdal plaintiffs. Nicholas Murray was awarded $1.75 million in November 2015, and Austin Pledger was awarded $2.5 million in February 2015.

Perhaps still smarting from all of those losses, earlier this month Johnson & Johnson reached an undisclosed settlement to end a Risperdal case filed by a man who started taking the drug at age seven to manage symptoms brought on by his Asperger’s syndrome. According to court documents, the plaintiff developed permanent gynecomastia.

That is one of dozens of Risperdal cases that J&J has opted to settle out of court.

In November 2013, Johnson & Johnson paid a $2.2 billion fine to settle a Justice Department investigation into its promotion and marketing of Risperdal. This was one of the largest such fines in American pharmaceutical history.

There are 1,500 Risperdal lawsuits still pending in U.S. courts.

Hip Replacement Cases Cost $4.15 Billion and Counting

The most expensive legal battle of all, though, keys on Johnson & Johnson’s defective hip implants. In 2013, J&J settled thousands of claims about its Depuy ASR implants for an estimated $4 billion.

That model is not the only one creating pains for patients and headaches for J&J, though. Johnson & Johnson’s Pinnacle hip implant has generated 8,400 lawsuits, the vast majority of which are currently pending in multi-district litigation (MDL).

A bellwether Pinnacle case recently made it to trial, where a jury awarded plaintiffs $500 million in damages.

One bellwether case, though, recently made it to trial, where a jury awarded five plaintiffs $500 million in damages. (A Texas judge later cut that award to $151 million.) Another bellwether Pinnacle trial went to court in September; there has been no word yet on a verdict. Legal experts feel that another loss for J&J could prompt the company to settle the remaining 8,400 suits.

If you or a loved one have suffered unforeseen physical or financial harm because of Johnson & Johnson hip implants, talc products, or its drug Risperdal, please contact us today to explore your options. Don’t wait; you could qualify for compensation.

Hospital Failures Undermine FDA Device Safety Efforts

Hospitals and manufacturers routinely fail to report medical device-related deaths, injuries, and other safety data to the Food and Drug Administration, in violation of federal rules and to the detriment of medical device safety monitoring. FDA fecklessness often compounds these issues, leading to avoidable patient harm.

ClassAction.com wants to remind consumers that you can report medical device problems directly to the FDA through its website.

You can also report problems to ClassAction.com and find out if you have a legal cause of action against a device manufacturer.

Hospitals and Manufacturers Play Key Roles in Data Collection

The FDA is tasked with balancing the need to quickly bring new, life-enhancing technology to market with the need to ensure device safety and effectiveness prior to marketing. Accordingly, FDA relies on both premarket evaluation (including clinical studies) and post-market surveillance (monitoring devices once they are cleared for sale).

FDA relies on premarket and post-market data to evaluate medical device safety.

Medical device reporting is among the post-market surveillance tools available to the FDA. Federal law requires that hospitals notify the manufacturer within 10 days of a serious injury possibly related to a medical device and notify both the manufacturer and the FDA of a possible device-related death. Hospitals must also submit annual reports to the FDA at the start of each calendar year.

Device manufacturers have reporting duties as well. A manufacturer must file FDA reports within 30 days of learning about an injury or death linked to one of its products.

FDA Inspections Reveal Reporting Lapses

In response to a number of high-profile device safety issues associated with power morcellators and duodenoscopes that hospitals failed to report, the FDA performed inspections at 17 hospitals where issues with those devices allegedly occurred.

The inspections revealed reporting issues at prominent medical centers, the FDA disclosed in October 2016, including at Massachusetts General Hospital in Boston, New York Presbyterian Hospital, and the Ronald Reagan UCLA Medical Center.

Issues uncovered in the inspections include failure to submit required reports, inadequate reporting procedures, and a lack of reporting requirements awareness and training on the part of hospital staff.

Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, addressed these reporting lapses in a blog post and said that while certain hospitals were singled out, the issues are widespread.

“We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals. We want to work with all hospitals to address these issues,” said Mr. Shuren.

The FDA will hold a workshop in December to discuss ways to improve hospital-based surveillance efforts.

Patients interested in taking a proactive role in medical device adverse event reporting can submit reports online through MedWatch.

FDA Medical Device Oversight Criticized

The FDA’s hospital inspections were driven by criticism that the agency is not doing a good enough job tracking medical devices.

A Senate investigation into superbug outbreaks at hospitals linked to duodenoscopes—tube-like medical devices inserted through the mouth into the stomach and intestine for minimally invasive procedures—found that poor FDA oversight was to blame.

Device manufacturers’ main goal is to quickly get new products to market—not to protect patient health.

“This investigation clearly demonstrates the inability of FDA’s current device surveillance system to accurately identify the extent of device problems when they occur, which poses an unacceptable risk to patients,” concluded the Senate in its January 2016 report.

The report recommends that FDA make changes to its 510(k) approval process, a fast-track process that allows devices to be cleared for sale without rigorous premarket testing if they are “substantially equivalent” to devices already sold. FDA clears dozens of high-risk medical devices each year through the 510(k) process. Many of the most high-profile product defect lawsuits in recent memory have involved 510(k)-approved devices, including metal hips, transvaginal mesh, and power morcellators.

A 510(k) submission is also required when a manufacturer modifies a medical device in a way that might impact safety or effectiveness.

According to the Senate report, manufacturers of duodenoscopes blamed for spreading antibiotic-resistant infections between 2012 and 2015 made substantial design changes to the devices that affected their decontamination specifications, but failed to submit relevant 510(k) applications. By the time the FDA determined applications should have been submitted, the devices had been in use—and spreading infections—for years. At least one manufacturer was aware of contamination problems but failed to disclose them.

The Senate report notes it is up to manufacturers to determine if and when a 510(k) application is warranted. Yet this creates a strong conflict of interest, since manufacturers’ main goal is to quickly get new products to market.

In fact, an over-reliance on manufacturers and hospitals to self-report device safety information places consumers at the mercy of organizations that have incentives not to make rapid and robust disclosures for fear of costly litigation.

While a stronger FDA can help to protect patient safety, patients should take steps to help themselves, such as reporting directly to the FDA and holding companies accountable.

The Trouble with Stryker Hip Implants

Stryker Orthopaedics recently issued a hazard alert warning doctors and patients of potential side effects that may be caused by seven models of Stryker V40 femoral heads, which are used in metal-on-metal (MoM) hip replacement procedures.

These types of procedures have generated many such alerts from health organizations. They have also spawned thousands of lawsuits filed by patients who exhibited severe side effects and/or had to undergo revision surgery as a result of MoM complications.

Hold Stryker Accountable

The side effects cited in the most recent Stryker alert include the following:

  • Loss of mobility
  • Pain
  • Inflammation
  • Adverse tissue reaction
  • Dislocation
  • Joint instability
  • Broken bones
  • Leg length discrepancy
  • Need for revision surgery

Though the alert is not technically a recall, it could certainly discourage surgeons and patients from pursuing total hip replacements that include a Stryker V40 femoral head.

Many companies have ceased producing MoM hip replacements altogether because of the kinds of risks outlined in the alert. When the metal head rubs against the metal socket, metal particles can be released into the bloodstream, leading to cobalt chromium poisoning.

As a result, drug and health agencies worldwide have issued warnings about MoM replacements since as early as 2010.

FDA, Other Agencies Warn of “Unique Risks”

“Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants.”

In the spring of 2010, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning about MoM hip replacements. In this alert the MHRA advised patients to get blood tests and imaging to ensure they didn’t have metal poisoning. Two years later, the MHRA issued a follow-up with guidelines on monitoring and caring for MoM hip patients.

In 2012, Health Canada issued an alert containing important safety information for MoM hip replacement surgeons and patients. This alert noted:

In recent years, there has been an increase in awareness of pain, implant loosening and significant soft tissue reactions thought to be the result of increased levels of metal (cobalt and chromium) ions in the surrounding joint tissue. Soft tissue reactions can range from fluid collection to more extensive necrotic and “pseudotumor” reactions and can necessitate device revision.

Health Canada also reported that “14.2% of revised MoM hip implants exhibited soft tissue reactions.”

Furthermore, the U.S. Food and Drug Administration (FDA) states on the Metal-on-Metal Hip Implants section of its website, “Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants.”

The FDA advocates the following measures for any patient experiencing symptoms that suggest their implant is not functioning as it should:

  • Joint aspiration (removing fluid from around the joint)
  • Soft tissue imaging
  • Blood tests, including checking metal ion levels

The FDA adds that MoM patients should be extra-aware of their general health, as some medical literature suggests MoM hip implants can lead to systemic reactions elsewhere in the body.

Among these potential reactions are skin rash and hypersensitivity, cardiomyopathy, neurological changes, renal function impairment, depression or cognitive impairment, and thyroid dysfunction.

Stryker Hip Implants Lead to $1.4 Billion Settlement

Given the startling health risks laid out by the FDA, MHRA, Health Canada, and Stryker itself, it should come as no surprise that a Rhode Island judge recently denied Stryker’s motion to dismiss a lawsuit pertaining to its Trident hip replacement system.

In fact, the corporation is no stranger to litigation. In the fall of 2014, Stryker agreed to pay $1.43 billion to settle thousands of lawsuits concerning its ABG II and Rejuvenate hip stems. Under the settlement, each plaintiff could receive as much as $600,000 in damages.

If you have experienced metal poisoning, dislocations, pain, inflammation, or broken bones, and you require(d) revision surgery as a result, please contact us today to learn your rights. You may qualify for a lawsuit that could help you pay medical bills and other expenses related to your device’s unforeseen side effects.

Essure Lawsuits Explained in the Context of Federal Preemption

Since it was approved in 2002 about 900,000 women have been implanted with the Essure permanent contraception device. Manufacturer Bayer has acknowledged receiving over 30,000 reports of Essure adverse events, while the FDA has received around 10,000 Essure complaints. A Facebook support group for women suffering from Essure-related health problems—which asks “Has your life become a living hell since having the Essure procedure done?”—has more than 30,000 members.

Federal preemption, Bayer claims, makes it immune to injury lawsuits. But this isn’t necessarily the case.

To date, however, only about 1,000 women have stepped forward and filed Essure personal injury lawsuits.

Clearly, the number of reported Essure problems doesn’t correlate well with the number of Essure lawsuits. A big reason for this is something called “federal preemption” that, according to Bayer, makes it immune from Essure injury claims.

But recently, and in opposition to Bayer’s legal arguments, judges have allowed certain Essure claims to proceed. ClassAction.com takes a look at what federal preemption means for women seeking redress for alleged Essure injuries, why some claims have been allowed to proceed, and why Essure may serve as a springboard for a broader preemption discussion.

Federal Preemption

Federal preemption is a legal concept rooted in the U.S. Constitution’s Supremacy Clause (Article VI, Paragraph 2), which establishes that the federal constitution (and federal laws in general) are the supreme law of the land. In other words, where state and federal statutes, regulations, and common law civil actions come into conflict, federal law takes precedence.

There are two types of federal preemption: explicit and implicit. Explicit preemption occurs when a federal statute expressly reserves to the federal government an area of legislation. Federal law can also preempt state law implicitly, even if it does not do so explicitly, if the enforcement of state law interferes with federal purposes.

Lawmakers don’t have perfect foresight. New legislation as well as societal changes (particularly technological ones) make it necessary at times for courts to interpret whether there is a genuine conflict between a state law and a federal law on the same subject. These interpretations create precedents that come to bear on relevant future questions of federal preemption.

Hold Bayer Accountable

FDA Authority

The Federal Food, Drug, and Cosmetics Act (FDCA), passed in 1938, authorized the Food & Drug Administration (FDA) to oversee food, drug, and cosmetics safety. Its passage, prompted by the poisoning death of 107 people from a legally marketed toxic elixir, gave the FDA authority to demand safety evidence for new drugs.

Congress added the requirement in 1962, through the Kefauver-Harris Amendments, that FDA demand evidence of product effectiveness, in addition to evidence of safety. The 1976 passage of the Medical Device Amendments (MDA), which followed a Senate finding that faulty medical devices were responsible for more than 700 death and 10,000 injuries, extended safety and effectiveness standards to new medical devices.

MDA also contains an express preemption clause (21 U.S.C. §360k) that says state device requirements for safety and effectiveness cannot trump federal (FDA) requirements. Importantly, however, the clause does not prohibit states from imposing standards that run parallel to federal law, does not expressly prohibit medical device lawsuits based on state tort claims, and only applies to Class III medical devices (the highest-risk medical devices, subject to the highest level of regulatory control).

Riegel v. Medtronic

A Supreme Court ruling in a 2008 case involving the question of federal preemption created the precedent that is currently making it difficult for women harmed by Essure to file personal injury lawsuits.

Courts cannot enforce state laws on medical devices with Premarket Approval, unless the regulations are the same as corresponding FDA regulations.

In Riegel v. Medtronic, Charles Riegel brought suit under New York law against device manufacturer Medtronic after a catheter—an FDA-approved Class III medical device—burst in his coronary artery during surgery. Medtronic argued that because the device was subjected to FDA approval requirements, letting the case proceed would impose state requirements and undermine FDA power.

The court agreed but Riegel challenged the ruling. Eventually the issue was put before the Supreme Court, which upheld the decision. Riegel v. Medtronic thus established that federal preemption applies to devices determined to be safe and effective by the FDA through its rigorous premarket approval (PMA) process (although devices approved through the less-stringent 510(k) process are a different story).

As a result, courts cannot enforce state regulations on medical devices with PMA, unless the restrictions are the same as corresponding FDA restrictions. This caveat provides a small window of opportunity for plaintiffs to bring state law medical device claims against PMA-approved devices.

Essure Lawsuits

A recent California state judge ruling has given some hope to women with Essure injury claims.

On August 2 Alameda County Judge Winifred Smith ruled that a narrowed set of claims from 14 women could proceed against Bayer because they sought to impose a parallel standard (rather than a different or tougher standard).

Smith said that the women’s failure to warn claims, which allege that Bayer did not report more than 32,000 Essure complaints to the FDA, were not preempted under California law. Also not preempted were breach of warranty, fraud, and negligent misrepresentation claims over advertising and promotional materials not subject to FDA approval. Plaintiff claims for manufacturing defect and negligent training of physicians, however, are preempted, Smith ruled.

A Pennsylvania federal judge similarly ruled earlier this year that a narrow set of claims, including those for negligent misrepresentation and negligent failure to warn, could proceed. But a different California judge ruled in February that an Essure lawsuit could not proceed due to federal preemption. These different outcomes reveal the significance of state law, as well as the importance of judicial interpretation of those laws, when it comes to preemption.

Bills Seek to Undo Preemption

The 1976 Medical Device Amendments was not intended to grant manufacturers of defective medical devices immunity from personal injury lawsuits. Yet thanks to the Supreme Court’s ruling in Riegel v. Medtronic, that is precisely what has happened.

Rep. Mike Fitzpatrick has introduced two bills that would make Essure lawsuits easier.

In 2012 the Supreme Court declined a petition to review a case (Walker v. Medtronic) decided by the U.S. Court of Appeals which had confirmed MDA preemption as interpreted in Riegel v. Medtronic. The Supreme Court’s refusal to review the decision preserves the current preemption analysis being implemented by the federal courts. This has led to legislative efforts aimed at stripping device makers of the preemption defense.

Rep. Mike Fitzpatrick (R-PA), working closely with Essure victims, introduced in November 15 the “E-Free Act” (aka H.R. 3920). If passed, the Act would withdrawal FDA approval of Essure, thereby making the federal preemption argument irrelevant.

Fitzpatrick also introduced H.R. 5403 (Ariel Grace’s Law), a bill that would amend section 360k of the Food, Drug, and Cosmetics Act so that “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”

Both of Fitzpatrick’s bills were sent to committee in June 2016.

FDA Medical Device Standards Fail to Protect Public

Giving the FDA the last word on medical device safety may not be the wisest idea, considering the agency’s track record of approving devices based on questionable evidence.

Essure is a textbook example of FDA approval shortcomings. A Northwestern University study published in 2016 looked at 18 Class III devices approved by the FDA from 2000 to 2015 and found that 22% were given market clearance despite a failure to show effectiveness during clinical trials. The study authors noted that Essure approval was based on short-term evidence and insufficient post-market follow-up.

Of the PMA process in general, the study’s lead author said, “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affection millions of women worldwide, the evidence leading up to approval has a lot of weaknesses.”

FDA did finally order Bayer to conduct a postmarket surveillance study about Essure’s benefits and risks—more than 14 years after it was initially approved, and only after tens of thousands of women filed adverse event reports. FDA additionally ordered a “black box” warning be added to Essure based on concerns over serious complications such as abnormal bleeding, autoimmune reaction, and tearing of the uterus or fallopian tube. Again, this move was too little too late for women who would have benefited from a stronger warning in the first place.

If the FDA cannot ensure the safety and effectiveness of medical devices, then injured patients at the very least need a clear path to personal injury lawsuits. Absent corrective legislation, medical device users will continue to be at the mercy of an organization that has shown it is incapable of protecting the public health.

Attorney Choice Matters in Essure Lawsuits

Courts’ interpretation of medical device preemption laws make it very difficult—but not impossible—to successfully bring Essure lawsuits.

Plaintiffs have a narrow window through which to assert their Essure injury claims. Their arguments and the evidence used to support them must be extremely solid. For these reasons, it is of the utmost importance to work with an experienced, knowledgeable personal injury attorney who can craft a legal strategy that survives Bayer’s dismissal efforts.

To learn more, schedule a free case review with ClassAction.com.

Free Case Review

Northwestern Medicine Study Highlights Flaws in FDA Device Regulation

Most women probably assume that medical devices used in obstetrics and gynecology are thoroughly tested before introduction to mainstream medicine. However, a new study out of Northwestern Medicine shows why faith in the regulatory process is misplaced and demonstrates how dangerous devices can make their way onto the market and into women’s bodies.

“Despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”

Several obstetrics and gynecology medical devices—including Essure permanent birth control, laparoscopic power morcellators, and transvaginal mesh—have been the subject of recent controversy (as well as lawsuits) due to high rates of complications. These devices have a common link, according to researchers at Northwestern University: they were approved by the FDA based on flawed data.

The researchers looked at 18 high-risk OB/GYN medical devices approved from 2000 to 2015 and found that:

  • Four devices were approved despite failure to demonstrate efficacy in clinical trials.
  • Six devices were not required to undergo postmarketing surveillance to measure ongoing safety.
  • Nearly half of the devices were approved based on nonrandomized controlled trials (the randomized controlled trial is considered the “gold standard” of clinical trials).
  • Three devices were withdrawn from the market; of these, two were not reviewed by experts on the FDAs obstetrics and gynecology advisory committee, and the other was reviewed by the panel but not recommended for approval.

“We looked at the class of devices with the highest potential risk to patients—the devices that had to go through the most rigorous pre-market approval process,” said Dr. Steve Xu, the study’s senior author. “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”

Researchers Point to Failings of Essure

The researchers used Bayer’s Essure permanent birth control as an example of how weaknesses in the FDA medical device approval process can lead to patient harm.

Essure was approved in 2002 based on short-term evidence and inadequate post-market follow-up, the study authors said. It has been linked to more than 10,000 injuries, including severe pain, organ damage, and unintended pregnancy.

“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices.”

In one premarket study used to approve Essure, 9% of women reported adverse events, but the device was approved based on the fact that no pregnancies were reported during testing. Although the FDA ordered post-approval studies for Essure, these studies were found by the New England Journal of Medicine to have serious limitations, such as short follow-up periods, the exclusion of key data, and a lack of a comparison group (i.e. a controlled study).

Independent, controlled testing has found that Bayer’s Essure device has a much higher failure rate than pre and post-marketing data indicate.

FDA ordered in March 2016 that a “black box” warning be added to Essure and additionally called for Bayer to conduct new studies of the device.

“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices,” said Dr. Xu. There are much higher standards for the approval of new drugs. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”

File an Essure Lawsuit

More Stringent Device Regulation Needed

The research team emphasized the need for greater scrutiny of medical devices, even as legislation opposed to this is making its way through Congress.

The 21st Century Cures Act, an industry-friendly bill that contains a broader definition of “valid scientific evidence,” passed the House of Representatives in May 2015 and is currently before the Senate.

“Our concern,” said study author Jessica Walter, “is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective.”

Walter and Xu suggested that both physicians and the FDA have a role to play when it comes to bringing higher quality studies into the device approval process. They added that evidence shows more regulation doesn’t necessarily mean less innovation.

“Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems” is published in the June 2016 edition of Obstetrics and Gynecology.

Judge Allows Philadelphia Essure Suit to Proceed

In a major victory for five plaintiffs who allegedly suffered serious injuries after receiving Bayer’s Essure sterilization device, a Pennsylvania judge has allowed their case to proceed.

Bayer had asked Judge John R. Padova to throw the case out because Essure received pre-market approval (PMA) from the FDA in 2002. But, in yet another blow to the reeling pharmaceutical giant, Judge Padova allowed the case to continue on two counts: Bayer’s use of deceptive advertising, and its failure to warn consumers of Essure’s risks.

Hold Bayer Accountable

The Essure procedure, which is irreversible, involves implanting two tiny nickel-titanium coils into the fallopian tubes to prevent fertilization. Despite Bayer’s claims that it is 99% effective, there have been thousands of Essure-related adverse events since it hit the market in 2003.

Among the Philadelphia plaintiffs is Heather Walsh, who said her Essure coils migrated to her uterus, triggering serious health complications, hospitalizations, and eventually a hysterectomy.

Sadly, there are thousands more stories like Ms. Walsh’s. Complications are so rampant among Essure users that they spawned a support group on Facebook called Essure Problems. Since its 2011 founding, the group’s membership has grown to 28,000.

Across the country, hundreds of Essure users have filed lawsuits against Bayer. Because the Philadelphia case is the farthest along, legal experts, attorneys, and plaintiffs are monitoring it closely for the precedent it will set.

A Brief History of Essure

When it first hit the market in 2003, Essure was hailed as a safe, painless, and less invasive alternative to tubal ligation (having one’s tubes tied). The pre-market studies went well, and early on, women reported very few side effects.

As time went on, though, it became clear that Essure was not as safe or painless as Bayer claimed.

The studies conducted before Essure hit the market were mostly short-term, and many were deeply flawed.

From November 2002 to October 2013, there were 943 adverse event reports related to Essure: an average of roughly 86 per year. In 2013 alone, the number jumped to 817. The next year, it skyrocketed to 2,259.

In 2011, Angie Firmalino founded the Facebook group Essure Problems, and later, a nonprofit group called ASHES: Advocating Safety in Healthcare E-Sisters. (Essure victims call themselves E-Sisters.) In 2014, famed consumer advocate Erin Brockovich joined the fight, launching a website where women can tell their stories and sign a petition calling for a ban of Essure.

The following year, a study of more than 50,000 women found that those with Essure were ten times more likely to need a follow-up operation versus those who opted for surgical sterilization.

Last month, the FDA ordered stronger “black box” warnings for Essure, which will “Note the types of significant and/or common adverse events that may be associated with the device and its insertion and/or removal procedures,” and “Include a statement noting that these risks should be conveyed to the patient during the woman’s decision-making process.”

The FDA also asked Bayer to conduct new studies of the device to more accurately assess its risks and complications.

But for E-Sisters, doctors, and lawmakers who have called for an outright ban, the new FDA guidances feel like half-measures. To date, the FDA has received more than 5,000 complaints of Essure adverse events.

Bayer Facing Hundreds More Lawsuits

Naturally, given the thousands of complaints and serious side effects, Bayer is now mired in hundreds of lawsuits nationwide. Though the Philadelphia case is the farthest along, it is just the first in a giant wave of litigation that Bayer hopes to beat back. Judge Padova’s ruling does not bode well for Bayer’s odds of quashing these lawsuits before they reach trial.

Hold Bayer Accountable

The severe and debilitating nature of the injuries sustained by plaintiffs won’t help Bayer’s case, either. Many women have reported becoming pregnant while on Essure; some have miscarried or given birth to children with defects. Some of the other side effects reported include:

  • Pain/Abdominal Pain
  • Menstrual Irregularities
  • Headache
  • Fatigue
  • Bloating
  • Bleeding
  • Weight Fluctuations
  • Patient Device Incompatibility (e.g., possible nickel allergy)
  • Migration of the Device or Device Component
  • Device Operating Differently Than Expected
  • Device Breakage
  • Malposition of the Device
  • Organ Perforation
  • Dyspareunia (difficult or painful sexual intercourse)

If you have used Essure and would like to explore your legal options, ClassAction.com can help.

Our attorneys have decades of experience fighting for the rights of victims who encountered surprising and unwanted side effects from drugs and medical devices. We have fought large pharmaceutical and medical corporations on behalf of our clients and have won millions of dollars in the past.

Contact us for a free evaluation to determine whether you might be entitled to compensation.

FDA Issues New Black Box Warnings for Essure

The U.S. Food and Drug Administration (FDA) has ordered stronger “black box” warnings for Essure, the surgery-free sterilization procedure sold by Bayer since its FDA approval in November 2002.

The new guidances ask that the boxed warning “Note the types of significant and/or common adverse events that may be associated with the device and its insertion and/or removal procedures,” and “Include a statement noting that these risks should be conveyed to the patient during the woman’s decision-making process.”

The FDA has also asked Bayer to conduct new studies of the device to more accurately assess its risks and complications. These guidances arrive in the wake of more than 5,000 Essure-related adverse events, and a 2015 study that found that women who received Essure instead of having their tubes tied were ten times more likely to need a second operation.

Hold Bayer Accountable

Congresspersons like Mike Fitzpatrick (R—PA) and Rosa DeLauro (D—CT), consumer groups like Public Citizen, advocates like Erin Brockovich, and thousands of women have long pushed for an outright recall of Essure. Many expressed disappointment in the FDA’s decision not to ban the procedure.

Sara Sorscher, an attorney for Public Citizen, said, “The FDA unacceptably puts patients at risk by allowing the device to continue to be marketed as this surveillance study proceeds.”

The FDA’s deputy director for science in the center for devices and radiological health, Dr. William Maisel, told reporters, “The agency continues to believe the product should remain available to women who are informed of the risks.”

What Is Essure?

Essure, which hit the market in 2002, is the only permanent, nonsurgical birth control method in the United States. The procedure involves implanting two tiny nickel-titanium coils into the fallopian tubes to prevent fertilization. It takes just 10-15 minutes, and most women go home within an hour after the procedure. About three months later, they can stop using traditional birth control and rely on Essure.

For years, the device seemed like an affordable, safe, and highly effective alternative to tubal ligation (having one’s tubes tied). But most early studies were short-term, and in recent years, reports of severe side effects have soared.

Complications range from pain and bloating to coils breaking and piercing organs. Many women say the procedure—which is irreversible—ruined their lives.

Bayer maintains that, when used properly, Essure is extremely safe and effective (99%, according to them). But tens of thousands of women disagree, and the new FDA warnings seem to vindicate their claims.

Adverse Events Skyrocketed from 2012 to 2015

The new study will involve more than 2,000 women who will be monitored for at least three years. Past studies were not so extensive and followed a relatively small number of women for a relatively short period of time. For example:

  • Seventy-five percent of the 745 women studied before Essure hit the market were not consulted two years after having the device implanted.
  • In a five-year study conducted shortly after Essure became available, nearly a third of women were not followed up with through the end of the study.
  • A 2009 study, which determined that “Only a few small risks are associated with the procedure,” was also short-term.

The length of these studies is crucial because side effects often don’t manifest for years. From November 2002 to October 2013, there were 943 adverse event reports related to Essure: an average of roughly 86 per year. In 2013 alone, the number jumped to 817. The next year, it skyrocketed to 2,259.

Pursue A Lawsuit

Complications are so rampant among Essure users that they spawned a support group on Facebook. Angie Firmalino founded Essure Problems in 2011; its membership has since grown to over 27,000. Firmalino has also created a nonprofit group called ASHES: Advocating Safety in Healthcare E-Sisters.

In 2014, famed consumer advocate Erin Brockovich joined the fight, launching a website where women can tell their stories and sign a petition calling for a ban of Essure.

Many Patients Exploring Legal Options

Despite thousands of complications, Essure remains on the market. Patient health has been put at risk; some of the serious side effects reportedly caused by Essure include:

  • Pain/Abdominal Pain
  • Menstrual Irregularities
  • Headache
  • Fatigue
  • Bloating
  • Bleeding
  • Weight Fluctuations
  • Patient Device Incompatibility (e.g., possible nickel allergy)
  • Migration of the Device or Device Component
  • Device Operating Differently Than Expected
  • Device Breakage
  • Malposition of the Device
  • Organ Perforation
  • Dyspareunia (difficult or painful sexual intercourse)

If you have used Essure and would like to explore your legal options, the attorneys at ClassAction.com can help.

Our attorneys have your best interests at heart, and the experience and skills to win in court. We stand ready to evaluate your case and determine whether you are entitled to compensation for any injury or medical costs related to your use of Essure.