Want to checkout our Free Trial?

M

Nexplanon Lawsuits: Know the Horrific Nexplanon Side Effects

by | Feb 21, 2024 | Mass tort, Medical Malpractice, Product liability

In an era of advancing medical innovation, it can be dreadful to realize that progress often comes with unforeseen challenges and controversies. Nexplanon, the much-hyped up birth control implant, is not an exception. It is now under scrutiny with Nexplanon lawsuits asserting that its manufacturers have compromised the health and choices of countless women worldwide.

This blog aims to explore this sobering reality, course of ongoing legal battle and highlight the importance of medical record review services to assist in bolstering Nexplanon lawsuits by digging out the traces of Nexplanon side effects.

Want to gain the edge you need for successful Nexplanon litigation?

Want to maximize your case strength?

Get in-depth medical record review

Start your journey now!

creative cta - LezDo TechMed Blog

Nexplanon Implant- a Rundown

YouTube video

Before diving into the lawsuits, it’s essential to understand what Nexplanon is and how it functions.

Nexplanon is a long-lasting, reversible birth control device, which claims to offer 99% effectiveness. It is much-desired by women, due to its convenience of usage unlike other IUD contraceptives. Women can regain fertility soon after the removal of the device.

This thin, rod-like implant can be placed sub dermally into a woman’s upper arm. Once implanted, the device releases etonogestrel (progestin) continuously for three years to prevent conception.

The released progestin prevents the release of ovum from the uterus, thickens the mucus plug in the cervix and prohibits the sperms from reaching the uterus. It also thins down the endometrial linings to reduce the possibility of fetus embedding on the uterus wall.

However, the device will be less effective in women with high body mass index (BMI).  People with the below-listed signs should not receive the device.

  • Allergies to the device components
  • Blood clots
  • Liver disease
  • Irregular menstrual bleeding
  • Progestin-related cancer
  • Tumors

Reported Adverse Nexplanon Side Effects

Adverse-side-effects-of-Nexplanon-leads-to-Nexplanon-lawsuits

How common are Nexplanon complications?

The product label lists out the possible Nexplanon side effects as follows:

  • Menorrhagia (more bleeding during one’s period)
  • Amenorrhea (Absence of menstrual period)
  • Spotting between periods
  • Oligomenorrhea (Irregular menstruation intervals)
  • Mood swings
  • Weight increase
  • Headaches
  • Acne
  • Depression

Some women may experience other Nexplanon symptoms like

  • Vaginitis
  • Pain in the breast, stomach, back and at the insertion site
  • Nausea
  • Dizziness
  • Viral infections
  • Painful menstruation

Do you have a Nexplanon implant? Are you experiencing any unusual symptoms? If so, it’s crucial to seek immediate medical attention and consider seeking legal guidance.

Medical record review services play a pivotal role in shaping these lawsuits. By meticulously reviewing your health records, these experts can help identify links between your Nexplanon implant and any resulting health issues, effectively bolstering your legal case.

Medical Record Review:

Key to Strengthening Your Nexplanon Lawsuits

Why to wait?

creative cta button - LezDo TechMed Blog

FDA Regulations and Nexplanon Implants

This soft, flexible and matchstick-sized implant is manufactured and marketed by Organon USA Inc., a subsidiary of Merck & Co.

Organon USA got the Food and Drug Administration (FDA) approval for Implanon, a thin plastic etonogestrel-releasing rod in 2006. The approval came with an order to conduct a post-market study as the FDA regarding suspected the device’s efficacy.

Out of the 1000 women included in the study, more than 300 U.S. women were there. Most of them dropped themselves out of the study due to adverse birth control implant side effects as follows:

  • Irregular bleeding- 36%
  • Mood swings- 6.1%
  • Depression- 2.4%
  • Weight gain- 13.7%
  • Headaches- 2%
  • Vaginal infection- 14.5%

In 2011, the manufacturer replaced Implanon with Nexplanon, as Implanon was associated with menstrual disruption.

The below video will enlighten you on how implant and removal of the device is done.

YouTube video

Nexplanon came with a special feature of being radiopaque (can be seen in X-ray, as it has barium), and also with an insertion device to reduce implantation errors.

Merck provides clinical training to physicians on implanting Nexplanon. The device can be easily located by palpating the arm before removal.

Don’t think that Organon was the first one to introduce a sub dermal contraceptive. The FDA gave approval to Norplant, manufactured by Leiras Oy in 1990 itself. It had six capsules with levonorgestrel and designed to be effective for five years. However, in 2002, due to complications and lawsuits, the distributor Wyeth-Ayerst stopped the supply.

Wyeth-Ayerst settled Norplant lawsuits filed by around 36,000 American women for $50 million.

What controversy sprinted the Nexplanon lawsuits?

Nexplanon is linked to life-altering ramifications like blood clots, deep vein thrombosis, ectopic pregnancy, vascular damages and heart attacks.

The deep vein thrombosis (blood clots) usually occurs in the larger veins in the legs. When these blood clots burst and reach the lungs (pulmonary embolism), it can damage the lung tissues and lead to death. It can also block the blood circulation or cause heart attacks or strokes.

Nexplanon comes with a 40% risk of pulmonary embolism. These blood clots can be detrimental in damaging the blood vessels and tissue and end up in organ failures.

Though the manufacturers has listed some contraceptive implant side effects, they failed to warn the detrimental side effects of contraceptive implant such as blood clots to the consumers until after 2015. Then, in 2016, the product label was updated again to include the potential side effects of device migration, which could cause the implant to move to the arm.

Why is Nexplanon getting sued?

Nexplanon implants are alleged to cause adverse implant birth control side effects other than those noted in the label. They are

  • Infection
  • Inflammation, pain, edema, or bruising at the insertion site
  • Numbness and tingling at the point of insertion
  • Scarring, especially a thick keloid scar formation surrounding the insertion site
  • Scar tissue may grow around the implant, making removal difficult.

There are vital evidence of Nexplanon risking women’s health.

Danish study on blood clot:

A Danish study published in 2012 in the British Medical Journal indicated a higher risk of blood clots for women who use subcutaneous contraceptive implants like Nexplanon. The researchers noted that these contraceptives and other oral contraceptives cause a 40% risk of blood clots.

The study conducted between 2001 and 2010, in Danish women aged 15 to 49 revealed the blood clot risks. The participants had no past blood clots or cancer occurrences and were not pregnant. The IUD was discovered to be a safe hormonal contraception that was not related to the elevated risk of blood clots. Skin patches and the vaginal rings were connected with a 7.9-fold and 6.5-fold increase in risk respectively.

Case Studies

Peripheral nerve injury from Nexplanon removal

A 21-year-old woman wanted to remove her Nexplanon implant and visited her clinic for removal. However, neither she nor her nurse practitioner could be able to palpate the device. They did not perform any imaging studies to locate the device.

During the attempt to remove the device, the provider could not locate it. During the attempt, the provider accidentally grasped another “structure” in her arm, which damaged her peripheral nerve. The patient started losing strength in her arm and her she noted wasting of her arm muscles.

According to the Bio Med Central, when the woman was presented, the device was found lodged deep within the brachial fascia of her arm, dangerously close to the ulnar nerve. The damaged ulnar nerve was shrouded with scar tissues.

The surgeons removed her implant and had to remove the scar tissues and do nerve graft to cure her. Still she has not recovered fully from her ulnar nerve-related weakness.

Implant migration

A 17-year-old woman had the Nexplanon implant for some time. Later, due to her irregular bleeding patterns, she wanted to remove the implant. However, the implant could not be located either in palpation or in X-ray of the upper arm.

According to the BMJ case reports, the implant was located in chest X-ray and CT at the left lower lobe of the pulmonary artery. It was embedded in the arterial wall. Trying to remove the implant via interventional radiological technique or open surgery was considered to be risky as it could damage the arterial wall.

The surgeons decided to leave the implant in her body until it creates any health issues to the patient. Intravascular migration of the Nexplanon implant in her case was a rare complication added to the existing list.

The Pursuit of Justice: Legal Battles and Settlements

South Carolina woman:

This Beaufort woman became the unwitting recipient of a Nexplanon implant in January 2014. Though it was intended to help, it became a source of unending anguish instead in her case. She found herself frequenting the stark corridors of her clinic more often than she could ever have anticipated.

The implant, though eventually removed, left a lasting trail of permanent nerve damage in her. The jury, moved by her sufferings, awarded her a hefty $600,000 to compensate for her sufferings and life-altering disability.

Angela Lauderdale:

Angela Lauderdale is fighting for her precious daughter, Ms. Addison Cook.

In February 2019, Ms. Cook made an inquiry about Nexplanon, seeing the ads about the product. With an affirmation from Dr. Jason Hurt, the device was implanted.

The scene changed on December 6, 2019, as Ms. Cook found herself gasping for breath in the ER, clutching her chest in agony. CT scans revealed bilateral multiple pulmonary emboli. She battled it out and was discharged on December 10, but fate dealt her a cruel blow just a week later. Brought back to the ER, now battling a deadly Venous Thromboembolism (VTE), she tragically lost her fight four days later.

With a heart heavy with grief and a spirit fuelled by a desire for justice, Ms. Lauderdale launched a lawsuit against Nexplanon and Merck. She accused them of negligence, failing to warn physicians about the potential VTE risks of Nexplanon, especially in African-American or obese women.

But the pharmaceutical giant, Merck, is no stranger to legal battles. Journalist Tina Vasquez highlights that there are two ongoing product liability litigations concerning device migration issues with Implanon.

Furthermore, there are more than 50 unfiled cases revolving around Implanon, with an additional 18 pending cases related to both Implanon and Nexplanon.

Unveiling the Allegations: What Went Wrong?

The emergence of Nexplanon lawsuits has unmasked a range of serious allegations on Nexplanon complications and health risks. Plaintiffs claim that they were not adequately informed about potential Nexplanon implant side effects and in some cases, medical professionals may have failed to follow proper insertion and removal procedures. Some common allegations include:

  1. a) Migration and Device Breakage: There have been reports of the implant migrating from its intended location or breaking, potentially causing pain, injury, or difficulties during removal.
  2. b) Inaccurate Insertion and Removal: Improper insertion or removal techniques may result in injury, nerve damage, or scarring.
  3. c) Failure to Warn: Lawsuits argue that the manufacturers of Nexplanon failed to provide sufficient warnings regarding dormant side effects of implants, leaving patients unaware of the risks involved.

Liability in Nexplanon lawsuits include:

  • The medical facility or the physician who recommended the implant
  • The physician or nurse practitioner who installed the implant
  • The manufacturer

We have seen the complications and risks of Nexplanon implant so far. Now let’s analyze how attorneys can steer the Nexplanon lawsuits to success.

The Role of Medical Experts in Nexplanon Lawsuits

Medical experts play an influential role in Nexplanon lawsuits, often serving as a cornerstone to the case. To build a convincing lawsuit, the following should be considered

  • Medical Causation: Medical experts are called upon to establish a causal link between the Nexplanon implant and the adverse effects experienced by the plaintiff. This involves a detailed analysis of the plaintiff’s medical records, symptoms, timeline, and the known side effects of Nexplanon.
  • Standard of Care Analysis: Medical experts witnesses can provide essential insights into whether the healthcare provider who prescribed and/or implanted Nexplanon adhered to the accepted standard of care.
  • Explaining Complex Medical Issues: Medical experts can effectively translate complex medical terms, conditions, and processes into simpler language that the jury can understand.
  • Testimony: If the lawsuit goes to trial, medical experts may be called to testify. The expert opinion of a credible medical expert witness carries considerable weight with juries in influencing the lawsuit’s outcome.
  • Critiquing the Defense’s Medical Expert: The medical expert can also critically evaluate and respond to the testimony or reports presented by the defense’s medical experts to challenge the defense’s counterclaims about Nexplanon.

The credibility and expertise of the medical expert are thus fundamental in demonstrating the legitimacy of the plaintiff’s claims and grounding the legal arguments in sound medical science.

Legal Strategies for Representing Nexplanon Plaintiffs

Representing plaintiffs in Nexplanon lawsuits requires specific strategies to convincingly present their case and secure a favorable outcome. Here are some key legal strategies that attorneys often employ:

  • Understanding of Medical Aspects

Attorneys should have a thorough understanding of the medical aspects of Nexplanon, including its intended use, how it works, and hidden side effects of the implant. This knowledge will help in constructing compelling arguments about the product’s risks and its impact on the plaintiff’s health.

  • Gathering Evidence and Examination

Collate all possible evidence, including medical records, testimonies from physicians, any communication regarding Nexplanon between healthcare providers and the plaintiff, as well as any records of reported Nexplanon birth control side effects from the manufacturer or FDA. A thorough record review of these documents can help substantiate the plaintiff’s claims.

  • Demonstrating Causation

It’s essential to establish a clear link between the Nexplanon implant and the health problems experienced by the plaintiff. This often involves expert medical testimony, as mentioned earlier.

  • Sub-Standard Care and lack of Informed Consent

Investigate whether the physician involved followed the standard of care when prescribing and implanting Nexplanon. If the provider adequately informed the plaintiff about possible risks and implant contraceptive side effects (informed consent), it could form the basis for a negligence claim.

  • Product Liability Claims

Nexplanon lawsuits attorneys would need to demonstrate that the product is inherently dangerous, defective, or was marketed without adequate warnings.

  • Damage Calculation

Accurately calculate and present the damages suffered by the plaintiff. This could include medical expenses, lost wages, future medical costs, pain and suffering, emotional distress, and in some cases, punitive damages.

  • Leveraging Previous Cases

Previous lawsuits and settlements involving Nexplanon can provide valuable insights into successful strategies and potential weaknesses in the defense’s arguments.

By implementing these strategies, attorneys can effectively represent Nexplanon plaintiffs and maximize their chances of securing a favorable outcome.

Intersection of Personal Injury and Product Liability Laws

In Nexplanon lawsuits, two areas of law often intersect: personal injury and product liability. Understanding how these two areas connect is crucial for attorneys in these cases.

Personal Injury Law

Personal injury law pertains to legal solutions for a wrongful conduct. In the context of Nexplanon lawsuits, it could involve a medical malpractice claim against the healthcare provider who prescribed or implanted the Nexplanon device, if there is evidence they failed to meet the standard of care, or did not obtain informed consent.

If the incorrect implant or removal of the device caused injury, this could also give rise to a personal injury claim.

Product Liability Law

Nexplanon lawsuits could involve claims against the manufacturer on the basis of defective design, manufacturing defects, or failure to provide adequate warnings about the product’s potential risks.

If Nexplanon device was proved to be inherently dangerous, even when used as intended, a product liability claim based on defective design could be made. If the manufacturer did not provide sufficient warnings or instructions about the potential risks of using Nexplanon, a claim could be based on failure to warn.

If you’re representing women impacted by Nexplanon’s unforeseen implant contraceptives side effects, the time for action is now. Let us help you navigate the path towards justice.

Our dedicated team of medical record review professionals is ready to dive deep into the plaintiff’s health history, connecting the dots between the Nexplanon implant and any adverse health events. Your journey towards justice begins with us.

Unlock the full potential of your legal strategy with us!

cta button - LezDo TechMed Blog

Nexplanon Lawsuits and the Impact on Contraceptive Industry

The ongoing Nexplanon lawsuits are expected to bring some crucial changes in the policies and standards in the contraceptive pills and device manufacturing industry.

  • Increasing Scrutiny:

We can expect increased scrutiny on the part of regulatory agencies like the FDA, leading to stricter regulations and guidelines for the approval, manufacturing, marketing, and post-market surveillance of contraceptive implants.

  • More Comprehensive Risk Disclosure:

Manufacturers may respond to lawsuits by providing more comprehensive information about the underlying risks and side effects of implant family planning, both to meet potential new regulations and to minimize their liability exposure.

  • Product Innovation and Safety Improvements:

Lawsuits often drive manufacturers to make their products safer. Future may see improved versions of Nexplanon or alternative contraceptive implants eliminating the adverse effects.

  • Impact on Prescribing Practices:

Healthcare providers may become more cautious in their prescribing practices. This could result in more thorough patient consultations and a preference for alternative contraceptive methods with lower risk profiles.

  • Increased Patient Awareness:

Nexplanon lawsuits through media will increase public awareness about the potential risks associated with contraceptive implants, influencing patient choices, and driving demand for safer contraceptive products or methods.

  • Rise in Legal Actions:

Significant compensations in Nexplanon lawsuits may encourage more victims to come forward with their own legal actions, potentially leading to a rise in such lawsuits.

Medical Record Review Bolsters Nexplanon Lawsuits

A comprehensive medical record review can reveal inconsistencies in implanting or removing the implant, or undisclosed arm implant birth control side effects that can be critical in building your case. It also forms the foundation for expert medical testimony, which can be pivotal in persuading the jury.

If you don’t have the time or resources to conduct a comprehensive review, consider partnering with experienced medical record review professionals. Their expertise can help you navigate through the maze of medical jargon, identify key pieces of information, and assist in developing a strong, evidence-based legal strategy.

Utilizing comprehensive medical record reviews maximizes your chances of securing justice for those affected by Nexplanon implants.

Leverage Medical Record Reviews to Strengthen Your Nexplanon Lawsuits

The emergence of Nexplanon lawsuits is not only a way to get reparation for the victims. It is also expected to create awareness among the physicians and people on the risks underlying the sub dermal contraceptive before going for one.

Affected people may come forward to fight for justice. By stepping forward, they’re not just advocating for themselves, but potentially protecting other women from the same adverse experiences. Stricter regulations by the FDA may lead to safer contraceptive products from the manufacturers.

Was Nexplanon recalled? Despite all these controversies, the manufacturers had not initiated any Nexplanon recall 2023 so far for the Nexplanon implant side effects.

Investigations are going on to identify the possibility of a Nexplanon class action lawsuit.

Let’s hope women can make their choice of motherhood with a safer contraceptive option in the future.

Follow us to know more updates on Nexplanon lawsuit 2024.

Trending Posts

Get our trending newsletter delivered straight to your inbox.

error: Content is protected !!