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Jonathan Rosenfeld

November 27, 2023

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The legal battle against the Paragard IUD focuses on the grievous harm caused to patients due to device breakage and complications during removal. Rosenfeld Injury Lawyers, LLC, brings a wealth of experience in medical device litigation to this challenging area. Our firm is steadfast in its pursuit of justice for clients, striving to achieve comprehensive compensation for their injuries and related damages.

Paragard IUD, a long-term birth control device, has become the subject of numerous lawsuits. These legal challenges primarily focus on the alleged failure of the device, with claims that the Paragard IUD broke or failed within the body, causing harm to users.

Often, these cases involve IUD product liability litigation, a complex area of law where patients seek justice for injuries caused by defective medical devices. The rise of Paragard IUD defect lawsuits and the concerns regarding the copper IUD’s safety profile have prompted patients to seek accountability from manufacturers through the legal system.

Using Paragard IUDs

The Paragard IUD, a copper intrauterine device, is marketed as a non-hormonal birth control method. It is designed to prevent pregnancy through the presence of copper, which acts as a spermicide within the uterine cavity.

Despite its effectiveness, there have been reports of copper IUD complications, which have led to pending Paragard IUD lawsuits. The concerns revolve around incidents where the device has allegedly broken during the IUD removal process, leading to additional medical interventions.


The FDA and Paragard Complications

The Paragard IUD received FDA (Food and Drug Administration) endorsement in 1984 and has since been utilized by women nationwide. Cooper Surgical reports that this intrauterine device has maintained a record of efficacy and safety for over three decades.

According to the official product page, Paragard’s IUD is touted for its 99% success rate in preventing pregnancies, surpassing other intrauterine devices with its minimal side effects [1]. Additionally, it boasts a 90% satisfaction rate among users for its contraceptive reliability.

Despite this, there have been numerous reports from women experiencing the breaking of the Paragard IUD during removal, which compromises its contraceptive purpose and leads to harm.

Lawsuits against Paragard’s manufacturers, including Teva Pharmaceuticals, allege that the companies were cognizant of these potential dangers but persisted in distributing these flawed contraceptives [2] without sufficiently informing consumers and medical professionals.

FDA Reports on Paragard Complications

Since 2010, the FDA has cataloged over 1,600 reports concerning Paragard fractures. Below is a synopsis of case excerpts from the medical documentation of individuals who experienced Paragard-related complications:

  • A case involved a woman due for an IUD extraction after 6.5 years. Post-removal, the Paragard was devoid of its arms, and imaging revealed the arms embedded in the myometrium (the middle layer of the uterine wall).
  • Hospital records documented four separate incidents of Paragard removal where the device broke, with three instances occurring within the device’s expected duration of use.
  • One individual experienced discomfort and had her Paragard IUD taken out, only to discover the arms of the device were missing, which was the cause of her Paragard-related injury.
  • Another case saw a woman’s Paragard IUD extraction after 8.5 years, during which the copper coil was absent upon removal.
  • A medical record noted a patient’s IUD extraction where the copper coil was unaccounted for post-removal.

While some issues with Paragard could be addressed with non-surgical methods, numerous cases required surgical intervention to extract the fragmented parts from the individuals’ bodies.

Emerging legal issues have surfaced as more individuals come forward with claims against Cooper Surgical, the manufacturer, and Teva Pharmaceuticals, the marketer. Allegations include severe complications like pelvic inflammatory disease and ectopic pregnancy, often following instances where broken IUD pieces were left in the body post-removal. These issues form the basis of the growing Paragard case litigation, including individual suits and multidistrict litigation.

lawyer for paragard iud injuries

Individuals impacted by the Paragard IUD may initiate legal action against the manufacturer on several grounds, including:

  • Flawed Design: Allegations that the Paragard IUD’s design inherently poses a risk of grave injury and complications [3], regardless of proper usage, due to a fundamental defect.
  • Manufacturing Defect in Paragard IUD: Accusations that Teva, during production, omitted critical information regarding the inherent dangers of the Paragard device.
  • Violation of Explicit Guarantee: Claims against the company for assurances that Paragard would function effectively, safely, and without causing harm to users, allowing for litigation under express or implicit warranty assertions.
  • Inadequate Warnings: Litigants argue that the company failed to adequately disclose the potential adverse effects and hazards of the device’s usage (a claim under defective product liability).
  • Manufacturer Negligence: The claim that the company neglected to supply sufficient instructions and cautions about the side effects related to the employment of the Paragard device.

Manufacturer’s Deceptive or Misleading Marketing Promises

Victims may pursue restitution from Paragard by bringing forth a deceptive marketing lawsuit because of the following:

  • Misleading Promotions: Accusations that the marketing practices of the medical device producers misled them into trusting that Paragard would be a reliable, safe, and non-detrimental choice.
  • Incorrect Labeling: The FDA mandates explicitly labeling all prescriptions and over-the-counter (OTC) drugs, warning of possible side effects. Paragard allegedly failed to provide sufficient instructional warnings or side effects on its labeling.
  • Omission of Adequate Warnings: As stipulated by the Federal Food, Drug, and Cosmetic Act (FDC Act) [4], it’s required that every prescription medication or medical device sold in the U.S. must come with guidance or warnings about potential side effects of its use.
  • Negligence Claims: In civil tort law, a Paragard lawsuit alleging serious harm may be categorized under negligence, which involves four critical components:
    • An obligation to protect customers from potential injury.
    • Injurious actions by the manufacturer that resulted in harm.
    • A direct causative link between the manufacturer’s dangerous actions and the victim’s injuries or losses. Legal representatives will assess whether there was a direct connection to the individual who suffered damages and if the infliction of harm was a foreseeable outcome.
    • A causal relationship between the conduct of the manufacturer and the resultant injury or loss, typically requiring that the actions were characterized by negligence, recklessness, or a blatant disregard for public safety, culminating in a Paragard-related injury.

injury from Paragard IUD attorney

Is There a Recall on Paragard IUD Devices?

There is no recall on Paragard IUD, and the copper IUD device is still being manufactured and sold in the market. However, according to an FDA report, Teva only recalled two Paragard lots in 2014 on claims of failing to prevent pregnancies.

Victims harmed by Paragard IUDs can file a Paragard lawsuit against the device manufacturer by claiming:

  • Design Defect: The design of the Paragard IUD is such that even with all due care, the product will cause serious injuries and other complications because it is defective.
  • Paragard IUD manufacturing defect: When Tevo created the device, they failed to include important information about the dangers associated with the Paragard device.
  • Breach of express warranty: If the company promised that Paragard would be effective, safe, and non-harmful to users (they can sue under an express or implied warranty claim).
  • Failure to provide adequate warnings: Possible side effects and risks associated with the use of the device (a defective product liability claim) were not disclosed.
  • Manufacturer negligence: The company failed to provide reasonable instructions and warnings about side effects associated with using the Paragard device.

A Defective Design

A lawyer representing the injured victim can file a Paragard IUD lawsuit against the manufacturer based on their defective design under strict liability/product liability standards.

The manufacturer is legally responsible for any damages, injuries, or losses associated with their defective product if:

  • The product was in the condition they sold it when the injury occurred or altered through normal wear and tear.
  • It is the design of the Paragard IUD that causes injuries or other dangers to women.
  • Defendants fail to warn consumers about their potential side effects. In this incident, the manufacturer did not provide sufficient instructions and warnings about the side effects associated with the use of their product.

Manufacturer’s Deceptive or Misleading Marketing Promises

Another way a victim can receive justice from Paragard is through a deceptive marketing case, where they can sue for:

  • Deceptive advertising: The medical device manufacturers’ advertisements tricked her and other women into believing that Paragard would be effective, safe, and non-harmful to them.
  • Misleading labeling: The FDA requires that all prescriptions, dangerous drugs, and over-the-counter drugs must have label warnings about potential side effects associated with their use. Paragard did not include appropriate instructions or warnings about its side effects on the product’s label.
  • A failure to warn claim: Under the federal law known as the Federal Food, Drug, and Cosmetic Act (FDC Act), every prescription drug sold in the United States must have instructions or warnings about potential side effects associated with its use.
  • Negligence: Under civil tort law, a Paragard lawsuit involving severe injuries can fall under negligence involving four elements:
    1. A duty of care to keep customers from harm.
    2. Dangerous conduct by the manufacturer caused an injury.
    3. Proximate cause between their harmful behavior and the victim’s injuries or losses. To determine this amount, Paragard lawyers will check if the manufacturer had a direct relationship with the person who suffered damages/injuries and whether it was foreseeable for them to cause harm.
    4. Causation between the manufacturer’s conduct and the injury or loss. Usually, causation means they must have acted with negligence, recklessness, or disregard for other people’s safety and well-being, ultimately leading to a Paragard injury.

Paragard IUD Injury Attorney

Nature of Paragard IUD Litigation

The Paragard IUD litigation encompasses individual cases and consolidated proceedings known as multidistrict litigation (MDL). Unlike a class action lawsuit, where plaintiffs with similar claims are grouped together in a single lawsuit, MDL allows for individual claims to be processed separately while streamlining pretrial proceedings such as discovery and evidentiary challenges.

Class Action Paragard Lawsuit vs. MDL

Understanding the difference between a class action lawsuit and MDL is crucial for affected parties. A class action consolidates plaintiffs into a single group. In contrast, MDL retains individual lawsuits but coordinates them for certain phases of the legal process, often in the Northern District of Georgia for the Paragard cases.

Explanation of MDL (Multi-District Litigation) and its Distinction from Class Action

MDL is a legal procedure designed to expedite the process of handling complex cases, such as those involving defective or failed medical devices like the Paragard IUD. This mechanism ensures:

  • Efficient management of cases that share common factual issues
  • Avoidance of the duplication of discovery
  • Inconsistent pretrial rulings

The current status of Paragard lawsuits reflects an active legal landscape with pending Paragard IUD lawsuits across various jurisdictions. The Northern District of Georgia has been a focal point for many of these cases, particularly the multidistrict litigation overseeing the consolidation of numerous claims.

Total Number of Cases and Updates on the Progress

As of the latest updates, the total number of Paragard cases continues to grow, with new filings adding to the consolidated MDL. The proceedings are under the guidance of a settlement mediator and Paragard class action judge, with bellwether trials planned to help determine the outcomes of future cases.

Here is a comprehensive list of the current status of Paragard MDL lawsuits filed in the Northern District of Georgia as of November 2023:

  • November 2023: The Paragard class action has added over 500 new cases since the start of 2023, averaging 63.5 new cases per month since January. On September 1, 2023, the Judge issued an amended Scheduling Order, delaying dates and deadlines in the slow-moving Paragard lawsuit MDL.
  • October 19, 2023: There are 2,246 pending Paragard lawsuits and a total of 2,323 cases against the company in the federal court under MDL number 2974. The first of the bellwether trial cases [5] will be heard in 2024.
  • September 27, 2023: The Paragard IUD lawsuit MDL is described as the slowest-moving mass tort case followed by the reporting firm.
  • September 1, 2023: The Judge issued An amended Scheduling Order.
  • August 2023: Pending cases in the Paragard IUD lawsuit MDL reached 2,094.
  • July 20, 2023: An order revising Defendants’ Leadership Structure for Paragard lawsuit MDL Proceedings was issued.
  • May 9, 2023: A status conference on Paragard lawsuits was held before Judge Martin May.
  • April 2023: There were over 1,780 pending Paragard IUD lawsuit cases.
  • February 2023: One of the new Paragard lawsuits was selected for the bellwether trials set for 2024.
  • January 2023: Judge Martin May appointed a mediator for Paragard IUD lawsuit settlement discussions.
  • December 2022: The MDL grew, with Paragard IUD lawsuits surpassing 1,500.
  • September 27, 2022: Judge Martin May indicated scheduling the first Paragard lawsuit bellwether trial for January 2024.
  • September 2022: Over 1,300 Paragard IUD lawsuit cases have been filed.
  • July 2022: The number of filed Paragard lawsuits rose to over 1,200.
  • May 2022: More than a thousand Paragard IUD lawsuits were filed as part of the MDL.
  • January 2022: The MDL had more than 700 Paragard IUD lawsuits.
  • Summer 2021: A motion to dismiss the Paragard IUD lawsuit cases based on federal preemption was filed by Teva Pharmaceuticals and CooperSurgical, which was denied by Judge Martin May.
  • February 9, 2021: The Court held its initial conference on the Paragard MDL, assigning liaison counsel and considering the appointment of a Plaintiffs’ Steering Committee.
  • December 2020: The Judicial Panel on Multidistrict Litigation approved the consolidation of Paragard lawsuits into an MDL in Georgia’s Northern District​​​​​.
  • August 2020: Vanesha Johnson filed the initial legal complaint against Teva Pharmaceuticals USA and CooperSurgical.

Core Issues in the Paragard Medical Device Lawsuit: Allegations Against Paragard

The allegations suggest that Paragard IUDs and its manufacturers failed to provide a safe product and adequately inform users of the potential risks. The core issues in the Paragard IUD lawsuit revolve around allegations of the following:

  • Design defects
  • Manufacturing defects
  • Failure to warn
  • Negligence claims

Design Defects and Risks

Design defects in Paragard IUDs are at the forefront of the legal battle, with plaintiffs alleging that the device’s construction is inherently dangerous. This has led to comparing the copper IUD with other intrauterine devices, questioning whether alternative designs could have mitigated the injury and surgical procedure risks.

The specific design flaws that have led to legal action include the tendency of the Paragard IUD to break upon removal, posing risks of injury and necessitating surgical intervention. These flaws are central to the global Paragard settlement discussions and the ongoing litigation.

Comparison with Other IUDs on the Market

In comparing Paragard with other IUDs on the market, legal arguments often center on whether the risks associated with Paragard are higher and if the manufacturer failed to address known design concerns that could lead to Paragard IUD-breaking incidents.

Potential Manufacturing Flaws Contributing to the Lawsuit

The potential manufacturing flaws contributing to the lawsuit are varied, with some plaintiffs suggesting that the quality control measures were insufficient to detect and prevent the distribution of defective devices.

Inadequacies in Warning Healthcare Providers and Patients

Healthcare providers’ inadequacies in warning patientsare a critical point in the litigation, with the argument that had better information been provided, healthcare professionals and patients could have made more informed decisions regarding the IUD device.

Negligence Claims

Paragard IUD litigation claims that manufacturers neglected their duty to produce a safe product by failing to properly test and by disregarding signs that the IUD could break during removal. Claims accuse manufacturers of insufficient risk management and oversight due diligence, potentially allowing unsafe devices into the market.

Duty of Care Breaches by Manufacturers

The breaches of duty of care by the Paragard IUD manufacturers are multi-faceted. These breaches include but are not limited to:

  • Failure to employ state-of-the-art design principles that could prevent the device from breaking upon removal
  • Manufacturers not maintaining rigorous quality control protocols that could have identified and weeded out defective devices before distribution
  • Transparency from the manufacturers in their marketing practices about the potential risks and complications associated with using Paragard

Consequences of Paragard’s Alleged Failings

The consequences of Paragard’s alleged failings are widespread, affecting many users who have experienced a range of physical injuries and complications. The impact of these alleged failings has led to significant legal scrutiny and demands for accountability.

Many users of Paragard have reported various physical injuries and complications, which are central to ongoing Paragard case litigation. While varying in intensity, these injuries typically necessitate medical intervention and can inflict enduring detriment to the affected individuals’ well-being.

Injuries Noted by Paragard Users

Accounts of user-reported injuries include cases where the IUD broke and lodged in the uterine lining, necessitating surgical extraction and the inherent risks that accompany such procedures. Most reported severe injuries linked to the IUD have been during its extraction, with the device breaking and causing numerous health issues.

Cooper Surgical portrays Paragard extraction as a straightforward, in-office, non-surgical procedure that concludes within minutes. Paragard’s intended removal process involves the IUD’s arms collapsing inward, as stated by the manufacturer. Nonetheless, legal claims against Paragard highlight instances of the device’s plastic structure fracturing during the procedure, leaving fragments like the coil’s arms inside patients.

Consequently, surgical intervention is sometimes required to retrieve the remnants of the device. Claimants in Paragard lawsuits frequently cite the following injuries:

  • Remnants of the intrauterine coil that cannot be removed
  • Persistent pain and discomfort
  • Infections due to injuries
  • Potential infertility
  • Displacement of the intrauterine coil within the body
  • Necessary surgeries, including laparotomy or hysterectomy
  • Pieces of Paragard becoming embedded in bodily organs
  • Adverse reactions to residual fragments
  • Inflammation

Although the Paragard IUD is associated with hazardous side effects predominantly during the initial two to three months post-insertion, certain grave side effects persist and demand clinical care. The adverse reactions reported include:

  • Hypersensitivity responses
  • Menstrual pain
  • Intermenstrual spotting
  • Displacement of the device
  • Unusual vaginal secretion
  • Uterine perforation
  • Pelvic inflammatory disease
  • Prolonged and heavier menstrual bleeding
  • Discomfort during intercourse

Some victims are facing long-term health consequences due to their severe injuries, including the potential for ectopic pregnancy and other serious reproductive health issues.

Treatment Challenges and Options

Treatment challenges arise when dealing with Paragard-related injuries, as the removal of broken pieces can be complex and may involve invasive procedures. The medical interventions required for Paragard-related injuries can range from simple outpatient procedures to more involved surgical operations, depending on the nature and location of the broken pieces.

The legal aspects and case developments in the Paragard case litigation are evolving, with case volume trends and bellwether trials shaping the landscape of the lawsuit.

The Path to Compensation

Seeking damages for Paragard-related injuries requires navigating the complexities of product liability law. Plaintiffs must meticulously analyze their cases against strict legal criteria, considering medical evidence and individual circumstances. This challenging process involves both understanding the legal system and a determined pursuit of justice despite the emotional and physical impacts of their injuries.

Expected Paragard Litigation Outcomes and Settlements

An in-depth analysis of potential settlement amounts and structured tiers is currently underway, incorporating a spectrum of factors that influence the legal valuation of each case. This includes the gravity of the IUD injuries, the intricacies of the individual’s experience, and the broader implications of Paragard’s alleged product failure.

Legal analysts and Paragard lawyers meticulously evaluate these elements to establish a framework for potential compensation tiers that reflect the varied impact on plaintiffs’ lives.

Factors Influencing Case Values

The factors that dictate compensation values in Paragard lawsuits serve as benchmarks for assessing the monetary value of claims and determining appropriate recompense for the victims. The criteria are multifaceted and include the following:

  • The extent and permanence of the injury
  • The degree to which the injury has disrupted the plaintiff’s quality of life
  • The financial burdens stemming from ongoing medical care, potential loss of income, and other related expenses

The Paragard IUD lawsuits have been brought forth by numerous women who allege that the device is defective, often breaking upon removal, which can lead to a series of health complications. These lawsuits claim that the manufacturers did not provide adequate warnings about the potential for the device to break. The cases are currently part of an ongoing multidistrict litigation (MDL) process​​​.

Regarding case values, a significant settlement has been reported where Bayer, the company associated with the Paragard IUD, agreed to a $12.7 million settlement covering just over 4,000 cases. This settlement averages out to around $30,000 per claim.

However, it is noted that injured women seek compensation amounts ranging between $75,000 to $100,000 for their injuries, suggesting that case values can vary widely based on individual circumstances and the extent of injuries.

Eligibility for Filing Paragard IUD Lawsuits

To file an IUD lawsuit against Paragard, individuals must prove measurable harm linked to the device, including physical injuries or financial losses like medical expenses and lost wages. Legal claims require evidence connecting the injury to the Paragard IUD. Lawyers with expertise in medical device litigation are crucial in defining eligibility and guiding plaintiffs through the legal process.

Looking Forward: The Road Ahead for Plaintiffs and Defendants

The Paragard litigation’s future is uncertain, with critical legal maneuvers and judicial decisions on the horizon. The outcomes of upcoming bellwether trials will be crucial, potentially setting precedents and shaping resolutions for related cases. A potential global settlement could offer a unified resolution for many claims related to Paragard IUD issues.

Staying abreast of these events is critical for all involved, as they will shape future legal strategies and outcomes. Bellwether trials, in particular, are poised to set precedents that could influence the conduct and resolution of subsequent cases.

Paragard Lawsuit FAQs

Our Paragard IUD lawyers understand that many families have unanswered questions about filing a Paragard lawsuit against the manufacturer or doctor for their damages. A personal injury lawyer has answered some of those questions below.

Call our Rosenfeld law office and speak to a Paragard lawyer today at (888) 424-5757 (toll-free phone call) for a free case review. We specialize in Paragard cases.

When Should I File a Paragard Lawsuit?

If you’ve had complications from the breaking of a Paragard IUD during removal, you may be eligible to file a lawsuit. While there’s no class action, individual Paragard lawsuits have been consolidated in a multidistrict litigation (MDL) in Georgia since December 2020. Our attorneys can file your claim directly into the MDL, seeking compensation for your injuries. Contact us for a free case evaluation.

Are Other IUD Devices Safe?

Paragard and Mirena are IUDs facing safety concerns [6]. Mirena, by Bayer, has had 50,000 complaints since 2000, with issues like displacement causing organ perforations and a brain condition known as Pseudotumor Cerebri [7]. Paragard’s main risk involves breakage during removal, necessitating surgery. Over 2,700 lawsuits link Mirena to Pseudotumor Cerebri, and victims have received over $12 million in settlements for various damages. [8]

What Amount Can I Get in a Paragard Settlement?

The exact compensation Teva Pharmaceuticals may owe for the complications caused by a Paragard IUD is uncertain. Past IUD litigations, like Bayer’s $12.2 million Mirena settlement in 2017, indicate potential substantial payouts. Paragard settlements may vary based on injury severity, with projected ranges:

  • Level 1: $100,000 – $200,000
  • Level 2: $25,000 – $75,000
  • Level 3: Under $25,000

Why Is Paragard Bad?

Paragard is dangerous because it poses complications when removing the intrauterine coil device. Many IUD lawsuits against the company have been filed due to the failure of a Paragard IUD. During removal, broken pieces of the defective intrauterine contraceptive become lodged into the surrounding organs.

The company making Paragard continues to manufacture and sell it in the market despite thousands of complaints about the IUD, with no expectancy of a Paragard IUD recall.

Has a Paragard Class Action Lawsuit Been Filed Because the IUD Breaks Unexpectedly, Requiring Revision Surgery?

A multidistrict litigation (MDL) accuses Teva Pharmaceuticals and Cooper Surgical of not properly warning about risks associated with the Paragard IUD, which may break during removal, leading to pain, infection, and the need for further surgery. The complaint alleges that the defendants concealed these risks in their marketing and labeling, misleading consumers about the device’s safety and efficacy.

attorney for paragard iud lawsuits

The intricate nature of Paragard case litigation accentuates the necessity for competent legal representation. Plaintiffs seeking to navigate the formidable landscape of product liability lawsuits require attorneys with a profound understanding of the law and a keen awareness of the medical intricacies involved in defective Paragard IUD cases. Our counsel of experienced lawyers is indispensable in constructing a robust case and achieving a fair resolution.

Legal representation becomes particularly vital when dissecting the myriad aspects of a product liability case. Our skilled product liability lawyer can offer the following:

  • Adept management of the negotiation process
  • Expert advocating in court
  • Strategic guidance is necessary to maximize the chances of a favorable outcome

For victims of Paragard complications, securing such representation is a critical step toward attaining justice and compensation.

If you’ve suffered due to a Paragard IUD, you’re not alone. Rosenfeld Injury Lawyers, LLC specializes in providing compassionate and effective legal representation in such cases. Our experienced team is here to guide you through every step, ensuring your rights are protected.

Contact our defective medical device lawyers for a free consultation to discuss your case. We operate on a contingency fee basis, meaning there are no fees for our services unless we win your case. Trust us to fight for the justice and compensation you deserve.

Resources: [1] FDA, [2] Teva Pharm, [3] NIH, [4] FDA, [5], [6] Mirena, [7] Johns Hopkins Medicine, [8] Forbes

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