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.

Lawsuits against other morcellator manufacturers are ongoing. Please contact us if you or a loved one had cancer spread throughout your body by a power morcellator.

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.

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California, Washington & Hawaii Take Fight to Corporations

Individual citizens aren’t the only ones fighting back against corporate irresponsibility.

In separate lawsuits that validate and strengthen thousands of plaintiffs’ cases, Hawaii and the Virgin Islands (a U.S. territory) have sued Takata and Honda over their failure to warn residents of fatally defective Takata airbags.

Likewise, Washington State and California have sued Johnson & Johnson for the company’s misrepresentation of the serious risks inherent in its vaginal mesh implants.

These state lawsuits serve as vindication for the thousands of individuals who have filed personal injury and wrongful death lawsuits against Takata, Honda, and Johnson & Johnson.

Join the Lawsuit

For each of these companies, these suits are the latest in a series of blows to its credibility, image, and potentially its financial future.

Takata, in particular, may never recover from its airbag scandal, which has cost at least 13 people their lives (and injured 100 more), cost roughly 77 million Americans their vehicles, and cost the company millions if not billions of dollars.

Johnson & Johnson now faces 35,000 lawsuits over its vaginal mesh implants alone – and tens of thousands more over its talc products and several of its prescription medications. “The Family Company” has paid billions in settlements over the past decade, and will likely owe billions more in the decade to come.

Florida, South Carolina Likely to Follow Hawaii’s Lead

Hawaii was the first state to sue Takata and Honda, but it may not be the last.

The state alleges that Takata covered up a lethal defect and has demanded $10,000 for every affected resident.

Hawaii’s Director of Consumer Protection, Steve Levins, told The New York Times, “We’re not going to sit back and wait for more accidents to happen.” Levins added, “We’re also seeking that consumers be compensated for any losses associated with this incident, whether that’s alternative transportation costs, or a diminished value of their vehicle.”

Because the evidence against Takata is so strong, it stands to reason that other states (in addition to the Virgin Islands) will follow suit and demand accountability on behalf of their citizens.

The airbags are more likely to explode in humid regions like Florida, South Carolina, and Puerto Rico, so these states (and territory) seem the most logical plaintiffs. The defective airbags have also impacted Texas.

The Takata airbag recall grows almost daily. At last count, 77 million cars in America had been recalled.

Hold Takata Accountable

Johnson & Johnson’s Mountain of Litigation Grows

Johnson & Johnson’s credibility is eroding rapidly as lawsuits against the company continue to pile up.

In announcing the suit, California’s Attorney General, Kamala Harris, told reporters that 35,000 women have filed lawsuits against J&J in response to side effects from vaginal mesh implants, including severe pain, sexual dysfunction, urinary dysfunction, and constipation.

Washington’s Attorney General, Bob Ferguson, said, “For many victims, their health and their quality of life were forever changed as a result of this deception. Sitting upright, lying on their side, walking all became incredibly painful… These women were robbed of their ability to live and work in the way they once did.”

Drug Companies Pay Billions in Settlements

In addition to its vaginal mesh implants and other products, Johnson & Johnson is also facing thousands of lawsuits over its Baby Powder’s links to ovarian cancer.

In February, a Missouri jury awarded the family of Jacqueline Fox $72 million in damages after Ms. Fox passed away from ovarian cancer. Ms. Fox had used Johnson’s Baby Powder for feminine hygiene for decades.

In May, a Missouri jury found in favor of Gloria Ristesund, who contracted ovarian cancer after using Johnson’s Baby Powder and Shower to Shower Powder on her pelvic area for many years. (As a result, Ms. Ristesund had to have a hysterectomy and other surgeries.) The jury awarded Ms. Ristesund $55 million.

J&J’s mountain of litigation also includes lawsuits related to Tylenol, Invega, Risperdal, and Propecia.

From 2006 to 2015, Johnson & Johnson paid $2.82 billion in settlements – the third most over this time after GlaxoSmithKline ($7.62 billion) and Pfizer ($3.46 billion).

If you or a loved one have been injured by a vaginal mesh implant, or by shrapnel from a Takata airbag, contact us today for a free, no-obligation case evaluation.

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.

Pursue Justice

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.