Thousands of American women filed lawsuits against Bayer after they say Essure caused devastating side effects and ruined their lives. Lawsuits say Bayer failed to report serious side effects such as perforated organs and broken devices to the U.S. Food and Drug Administration and to the public.
For many women, Essure side effects started immediately after implantation. In lawsuits, some say their devices moved out of the fallopian tubes and cut into nearby organs. Others say their device broke into pieces and wreaked havoc on their bodies.
“Women are rightfully suing Bayer for the pain and suffering caused by the Essure device. Jobs and marriages have been lost and lives ruined due to injuries caused by this horrific device, which should have already been removed from the market in this country.”
After women in the Essure Problems group met with the FDA and the agency placed sale restrictions and black box warnings on the device, Bayer announced it would stop selling it on Dec. 31, 2018 in the U.S.
The company denied any wrongdoing and stood by the safety of its product. It intends to vigorously defend against lawsuits.
Though the company denies wrongdoing, its decision to stop selling the device could result in more lawsuits against Bayer, attorney Holly Ennis told Drugwatch. It could also make juries more likely to award punitive damages to punish defendants for especially malicious and negligent behavior, she said.
Lawyers filed all lawsuits in the U.S. as individual cases, and there are no class actions or consolidated federal cases. So far, there are no settlements or jury verdicts, but some courts have begun selecting cases and dates for trial.
Bayer's Defense Tactic
Women and their families continue to file Essure lawsuits in state courts across the country. Despite some setbacks, some courts have made progress and are now moving toward scheduling the first trial dates in 2019 and 2020.
Throughout the litigation process, Bayer has been trying to weed out claims by using a legal defense called preemption.
A preeminent entity — the FDA — approved Essure at the federal level, giving Bayer protection from claims it failed to warn the public of risks, the company argues.
The issue of preemption makes Essure cases more complicated, and some judges have dismissed cases for preemption. But Alameda Superior Court Judge Winifred Smith in California allowed Essure lawsuits to proceed in spite of preemption.
Other judges dismissed cases for failing to meet court requirements. For example, St. Louis, Missouri-based U.S. District Judge Stephen N. Limbaugh Jr. tossed 92 out of 95 plaintiffs from a federal Essure case in January 2018 for this reason.
Bellwether Trial Selection
In spite of past case dismissals, California, Illinois, Pennsylvania courts are now in the process of selecting bellwether trial cases and setting trial dates.
The largest number of cases is pending in California, according to Ennis. As of October 2018, the California court has obtained the most documents and information through discovery. By Nov. 22, 2018, both sides must agree on bellwether cases.
Plaintiffs’ attorneys are hopeful they will get California and Pennsylvania trial dates in 2019, Ennis said. Illinois courts set a trial date for 2020.
Complaints in Lawsuits
Injuries claimed by women in lawsuits range from severe pain to crippling autoimmune conditions. Since the FDA approved Essure in 2002 to January 2018, the agency has received 26,272 adverse event reports about the device, former FDA and CEO of device events analyst Madris Tomes told Drugwatch.
Even after multiple surgeries, many women still live with chronic pain and inflammation from metal fragments of Essure left in their bodies. These women are among the thousands who already sued Bayer.
Women in the Pennsylvania lawsuits said Essure “migrates from the [fallopian] tubes, perforates organs, breaks into pieces, and/or corrodes wreaking havoc on the female body.” Manufacturing defects could cause the device to crack, injuring surrounding tissues and organs, according to one complaint. Plastic fibers and nickel in the device could also lead to autoimmune problems.
According to doctors, injuries have discouraged new patients from receiving the device.
“You put in [an internet search for] Essure, and the first thing that comes up is lawsuits,” Dr. James Greenberg, an OB/GYN at Brigham-Faulkner OB/GYN Associates in Boston, told Modern Healthcare. “That’s not something that makes you super excited to have that done to you.”
Allegations Against Bayer and Conceptus
Lawsuits claim that, instead of working as intended, the device “migrates from the [fallopian] tubes, perforates organs, breaks into pieces, and/or corrodes.” These defects led to severe and permanent injuries. The lawsuits are against Conceptus, the original manufacturer of the device, and Bayer, which bought the company in 2013.
Complaints allege several counts of negligence including failing to warn about the risk of side effects. These counts include negligent training, negligent risk management and express breach of warranty.
- Negligent Training
- Lawsuits say Bayer failed to properly train doctors on how to implant the device. It used “Essure Simulator Training” in lieu of actual hands-on training and did not verify doctors completed training before allowing them to implant devices. It also encouraged unqualified doctors to purchase two device kits per month and “sell” Essure to their patients.
- Negligent Risk Management
- Bayer failed to notify the FDA of adverse events and failed to consider these injury reports in continuing to market the device. They received federal citations for failing to disclose adverse events, including pregnancies, perforations and migrations. Specifically, Bayer failed to disclose 16,047 medical device complaints of suspected device malfunction.
- Express Breach of Warranty
- Bayer falsely made statements about Essure’s effectiveness and safety in its marketing materials and its website.
Women Describe Injuries
Lawsuits say Bayer “conspired to engage in…misconduct…for the purpose of enriching themselves and creating an injustice at the expense of plaintiffs” and their health. Some women lost marriages, family and even died after complications.
For many women, the Essure experience has been long and arduous. They incurred medical bills, scheduled multiple surgeries and suffered poor health for years before they filed lawsuits. The claims of Stephanie Baily, Tanya de la Paz and Heather Walsh are some of the first lawsuits filed and only three out of thousands.
Stephanie Bailey’s husband, Bradley, filed a lawsuit on her behalf in 2016. After Stephanie received Essure in November 2010 she suffered numbness in her extremities, long-lasting migraines, joint pain and severe pelvic pain. She had to have a hysterectomy to remove Essure and subsequently died.
Her husband is seeking damages for loss of love, comfort, care, companionship, affection as well as emergency care, funeral expenses and medical bills.
Tanya de la Paz
Tanya de la Paz filed her lawsuit against Bayer in September 2015. According to the lawsuit, in July 2012, de la Paz had her first Essure procedure. However, one of her fallopian tubes perforated during the procedure. She went to a hospital because of the bleeding. She returned in September 2012 for a second procedure. The doctor implanted the metal coils successfully, but she suffered constant daily pain. When she returned to her doctor three months later for a follow-up, the examination revealed that a coil in her right fallopian tube was broken.
Bayer advised her physician to surgically remove the right fallopian tube and the broken coil. The left coil remained implanted and continued to cause her constant daily pain and heavy bleeding. She also suffered weight gain, stomach issues and mental and emotional anguish. She scheduled surgery to remove the second metal coil in September 2015.
According to her lawsuit, “[Bayer] actively and fraudulently concealed adverse reports of migrations and perforations from the Plaintiff and from the FDA.”
Heather Walsh filed suit against Bayer in 2015. In 2008, she went to her doctor’s office to have the device implanted, according to her lawsuit. After two years and four hospitalizations for severe pain, fainting and fever, she underwent a CT scan. It revealed one of the Essure coils had lodged behind her colon. There were three micro-inserts and not two, as there should have been.
She had to undergo a hysterectomy and an additional surgery to remove the coil in her colon. Now, she is left with a legacy of pain and autoimmune disorders. She said Bayer failed to warn her or train physicians properly.
“Defendant’s conduct was malicious, intentional, and outrageous, and constitutes a willful and wanton disregard for the rights and safety of Plaintiff and others,” Walsh’s lawsuit alleges.
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