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Jonathan Rosenfeld

March 2, 2023

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The combination of lax regulation and medical appliance makers focused on profits leaves tens of thousands of people each year at risk of serious injury from dangerous medical devices. Serious injuries can have life-altering consequences for the person hurt and their family, which is why you might need a defective medical device attorney.

You have legal rights when a faulty device has caused severe injuries. At Rosenfeld Injury Lawyers, LLC, our personal injury attorneys are legal advocates for injured patients harmed by medical appliances, and we can help you too.

You can file defective medical device lawsuits against the company that designed and sold a dangerous medical device.

Contact our Chicago, IL, product liability lawyers at (888) 424-5757 to learn more about your legal options to file a defective medical device lawsuit during a free case review.

All confidential or sensitive information shared with your attorney about your severe complications remains private through an attorney-client relationship.

Defective Medical Device Lawyer

Chicago Defective Medical Device Attorneys Helping Injured Patients

You may be entitled to substantial financial compensation if you are one of the thousands of people each year injured by a defective med device (metal hip implants, other hip implants, etc.).

However, you need an experienced product liability attorney who can navigate a legal system built to protect these medical device manufacturers that sell faulty appliances.

Faulty medical device manufacturers could face massive liability if users experience complications, life-threatening injuries, or severe harm due to a defect.

Medical Product Liability Claims Against a Manufacturer

One common misconception is that medical appliances are large implants, such as a pacemaker or the Medtronic insulin pump.

However, a defective medical device could be any appliance implanted in the body or used outside the body for medical purposes.

Many medical devices fail. For example, a medical product is the hernia mesh implanted to stabilize and repair the pelvic muscles. It means that the universe of possible faulty devices is vast. There are many medical device recalls that happen every year.

Who is Liable for Defective Medical Devices?

Medical device makers and distributors face several legal obligations under product liability laws. These include warning patients and doctors about potential dangers, providing instructions, and ensuring that devices meet FDA standards.

In addition, manufacturers and distributors may be liable for injuries caused by defective devices.

Under strict liability, manufacturers or sellers of defective devices are held accountable for the harm caused by those products. It includes situations where the manufacturer knew or should have known the product was dangerous. Watch out for any medical device recalls.

Product liability law applies to most medical devices, including surgical tools, implants, prosthetics, and other equipment.

Manufacturers and distributors must provide adequate warnings about the possible hazards of their products, ensure that they comply with federal regulations, and ensure that their products function correctly.

Defective Medical Device Claims Against a Manufacturer

A lawsuit against a manufacturer alleges that it failed to warn consumers about potential risks associated with a medical device, in this case, a pacemaker.

The plaintiff claimed that they suffered injuries due to a malfunctioning device.

The plaintiff sued the manufacturer for negligence, strict liability, breach of warranty, and violation of consumer protection laws.

The defendant moved to dismiss the case based on preemption under the Medical Device Amendments of 1976.

Food and Drug Administration (FDA) Recalling Defective Medical Devices

The FDA regulates medical devices under Title 21 of the Code of Federal Regulations [1] Part 820. Under Section 521(a), the agency must approve each device before they are marketed.

Manufacturers must comply with specific requirements outlined in the regulations.

For example, manufacturers must submit detailed information regarding the intended use of the device, how the device works, what risks might arise from using the device, and whether there are alternative treatments for similar conditions.

They must also provide reports on adverse events that occur during clinical trials. In addition, the agency requires labeling the device containing instructions for safe and effective use.

Failing to Meet Federal Standards

In addition, the agency enforces compliance with the Food, Drug, and Cosmetic Act (FDCA) [2]. If a manufacturer fails to meet federal standards, the agency may take regulatory action, such as imposing recalls, issuing fines, or revoking approval.

Under the FDCA, the statute of limitations for bringing a claim is three years.

However, some states have enacted statutes extending the limitation period beyond the general rule.

Some state statutes allow plaintiffs to bring suit within six years of the date of injury.

Other states do not limit the time frame a plaintiff may file a legal claim.

Defective Medical Device Lawyers

Why There Are Thousands of Defective Medical Device Cases in the US

The United States is the largest worldwide market for medical devices, creating appliances that repair hernias, replace joints, prevent blood clots, expand blood vessels, and correct other conditions.

In the US, 6,500 medical device companies have sold recalled devices that caused adverse health consequences.

The litigation does not include foreign companies that sell products to US consumers. In 2017, the American medical device industry generated over $150 billion.

Dangerous medical devices could include:

  • Surgical robots help medical professionals reach difficult areas during medical procedures
  • Transvaginal mesh used in pelvic organ prolapse surgery
  • Exactech knee or hip implant
  • Biomet hip replacement
  • Hernia mesh lawsuits
  • IVC filters
  • DePuy orthopedics hip replacement
  • Allergan breast implants
  • Stryker hip lawsuit
  • Stryker Shapematch knee replacement
  • Surgical staplers that help health care providers close wounds after surgery
  • Intrauterine devices
  • Implantable contraceptives
  • Cochlear ear lawsuit
  • CPAP lawsuits
  • Blood pressure cuffs used in the doctor’s office
  • Hair Relaxer Lawsuits

The lowest-risk medical devices, such as bandages, are a Class I recall. Medical appliances with higher health risks are categorized as Class III.

This defective device has the highest chance of causing severe injury when malfunctioning.

Defective product recalls are all too familiar in the United States. There were reports of over 1.7 million serious injuries caused by implanted devices. Many implanted appliances cause medical issues due to improper or insufficient testing.

Often the patient’s health is compromised when defective medical devices fail without appropriate warnings that would have prevented problems caused by design, the manufacturing process, or medical malpractice

Contact our defective medical device lawyers for a free consultation to discuss your defective device claim.

Why You Need an Experienced Defective Medical Devices Attorney

Unfortunately, the US Food and Drug Administration is an ineffective regulator of the medical appliance industry, allowing companies to self-regulate.

The FDA approval process 510(k) [3] allows many dangerous medical products to be sold in the medical marketplace without rigorous FDA testing.

Over a ten-year period, 161 medical appliances in this category were recalled. Approximately 98% of the recalled devices were approved through the 510(k) process.

A defective recalled device could have several negative medical consequences.

In fact, there are many defective products that haven’t beed recalled but were found to cause severe medical issues, as claimed in Bard PowerPort lawsuits, for example.

Even if the patient is not injured, they may need to go through the trouble and expense of replacing the medical appliances.

Defective Medical Device Attorney

What Medical Device Companies Must Pay You in a Lawsuit

Examples of recoverable damages (also referred to as compensation) in a case against the medical device manufacturer include:

  • Medical expenses, including the cost of past emergency care
  • Future medical bills
  • Lost wages
  • Wrongful death damages

What do you do if a defective medical device has injured you? All injured parties need a medical diagnosis to begin the lawsuit process for medical products.

You should see a medical professional immediately to get treatment and correct the problem.

Since some medical device injuries can be life-threatening, you should see a medical provider immediately if you suspect something is wrong.

Manufacturers Must Report

Manufacturers must inform the FDA about death or severe injury caused by any medical product.

Medical device manufacturers initiate the most defective product recalls. In some medical device lawsuit cases, the FDA will force the recall.

When you are ready to file a dangerous medical product recall lawsuit, consult an attorney at an experienced law firm.

Some medical malpractice lawsuits may be preempted, meaning the manufacturer cannot be sued for product liability claims when following federal Food and Drug Administration regulations.

Our attorneys use successful strategies and legal theory to argue medical malpractice cases for clients when the defendant wants to be exempt from a lawsuit.

Schedule a free case review to discuss how our medical device attorneys seek compensation for our clients.

Defective Medical Device Attorneys

Defective Medical Device Attorney FAQs

Our law firm understands that many families have unanswered questions about filing a medical device claim after suffering severe harm from a faulty product.

Our attorney has answered some of those questions below. Contact us at (888) 424-5757 for additional answers or to schedule a consultation.

How long do I have to contact a defective medical device lawyer?

The statute of limitations restricts your time to file a defective medical device lawsuit.

In most cases, you have two years from the date of purchase to sue. However, some states have longer statutes of limitations.

For example, Illinois has a two-year statute of limitations for faulty medical equipment claims. However, some situations may extend the period beyond two years.

An attorney can help determine the expiration date of your legal product liability claim based on the statute to ensure you file your case documents as quickly as possible for your compensation.

How do you prove a product is defective?

To establish a defective medical device lawsuit for a faulty product, you must show that the product was manufactured or sold unsafely. The product could have performed better when it left the manufacturer’s hands.

The plaintiff must also demonstrate that the defendant knew about the defect at the time of sale.

For example, if you underwent a hernia repair, the surgeon implanted mesh material, but the mesh tore after only two years.

You would have grounds to sue the manufacturer for failing to warn you of the risk of tearing.

Similarly, if you received a central line catheter that did not work correctly, you might be able to sue the manufacturer for selling an unsafe product.

In addition, the plaintiff must show that the defect caused serious harm or a family member’s wrongful death. It requires proof that the injury would not have happened without the defective product.

If the injury was caused by something else, like medical complications, you could not recover damages from the manufacturer. A lawyer can help recover your damages.

The plaintiff can use several types of evidence to support their case. These include:

  • Expert testimony
  • Consumer complaints
  • Product Literature
  • Testimony from other patients who suffered similar problems
  • Records showing how many times the product has been recalled
  • Evidence that the product was tested before being released
  • Documents show that the company knew about the problem before releasing the product
  • A history of similar products with similar problems
  • An analysis of the product design
  • An analysis of industry standards
  • A comparison of the product to competing products
  • All medical expenses associated with the device-related health problems

What are the categories of medical devices?

These devices are designed to diagnose, treat, cure, mitigate, prevent, or improve a disease or condition. Examples of defective medical equipment might include:

  • Surgical meshes used in hernia repair surgeries
  • Central venous catheters
  • Pacemaker leads
  • Intrauterine devices
  • Artificial joints
  • Full hip implant devices
  • Partial hip replacement components
  • Orthopedic braces
  • Blood transfusion medical equipment
  • Ventilators
  • Dialysis machines
  • Infant feeding pumps
  • Oxygen concentrators
  • Respiratory therapy equipment
  • Tissue expanders
  • Wound closure devices
  • Cardiac pacemakers
  • Breast implants
  • Implants used to correct vision defects
  • Intermittent pneumatic compression (IPC) devices that prevent blood clots
  • Composite and ceramic hip implant devices
  • Implantable defibrillator
  • Arteriovenous fistulas
  • Glaucoma drainage devices
  • Catheters
  • Urinary catheters
  • Stents
  • Prosthetic heart valves
  • Joint replacements
  • Coronary artery bypass grafting (CABG)
  • Laparoscopic surgical procedures
  • Transurethral prostatectomy
  • Gastric banding
  • Vaginal mesh repairs
  • Vascular access devices
  • Facial prosthetics
  • Other dangerous medical products

What should you do if you have a recalled device?

The Food and Drug Administration (FDA) [4] recently announced that it had received reports of 2,933 adverse effects related to surgical mesh products.

It includes medical products for treating hernia, pelvic organ prolapse, incontinence, fistulas, and vaginal vault prolapses.

In addition to the recent recall of over 30 different transvaginal mesh products, other major medical product brands include Bard Mesh, Cook Surgical Inc., Gynemesh, Gynecare Prolift, and Johnson & Johnson.

The FDA has recalled many hip implant devices due to defects causing erosion, device fracturing, metallosis (metal poisoning), and other severe conditions.

Typically, surgeons will recommend hip implant replacement surgery. In most cases, the newly replaced hip implant is fabricated with different materials than the original.

Contact an experienced medical device attorney at (888) 424-5757 to schedule a free case evaluation if you believe you have been harmed due to one of these medical devices.

You are likely entitled to compensation for medical expenses, lost earnings, pain, suffering, and temporary/permanent disability.

Hire a Defective Medical Device Lawyer Concentrating on Dangerous & Recalled Devices

Were you injured, or was a loved one a victim of wrongful death by a defective medical device (metal hip implants, other hip implants, and defective medical devices)? If so, you have legal rights to seek compensation for your damages through a product liability claim.

The maker of that medical product causing severe injuries could be liable to pay you substantial financial compensation to cover past medical costs, future medical care and physical therapy, and additional surgeries.

Let a personal injury attorney from our law firm help you recover compensation if your legal issue involves medical malpractice, a malfunctioning medical product, or another medical issue.

Call the defective medical product lawyers of our Chicago, IL law firm at (888) 424-5757 (toll-free phone number) or use the contact form to schedule a case evaluation.

Our personal injury attorneys provide legal representation throughout Illinois.

At Rosenfeld Injury Lawyers, LLC, you pay no out-of-pocket expenses and owe your experienced defective medical device lawyer nothing until your attorney settles your case.

All confidential or sensitive information you share with your personal injury attorney remains private through an attorney-client relationship during the legal process.

Resources: [1] FDA, [2] FDA, [3] FDA, [4] FDA

Client Reviews

Jonathan Rosenfeld was professionally objective, timely, and knowledgeable. Also, his advice was extremely effective regarding my case. In addition, Jonathan was understanding and patient pertaining to any of my questions or concerns. I was very happy with the end result and I highly recommend Jonathan Rosenfeld.

- Michonne Proulx

Extremely impressed with this law firm. They took control of a bad motorcycle crash that left my uncle seriously injured. Without any guarantee of a financial recovery, they went out and hired accident investigators and engineers to help prove how the accident happened. I am grateful that they worked on a contingency fee basis as there was no way we could have paid for these services on our own.

- Ethan Armstrong

Jonathan helped my family heal and get compensation after our child was suffered a life threatening injury at daycare. He was sympathetic and in constant contact with us letting us know all he knew every step of the way. We were so blessed to find Jonathan!

- Giulia

This lawyer really helped me get compensation for my motorcycle accident case. I know there is no way that I could have gotten anywhere near the amount that Mr. Rosenfeld was able to get to settle my case. Thank you.

- Daniel Kaim

Jonathan did a great job helping my family navigate through a lengthy lawsuit involving my grandmother's death in a nursing home. Through every step of the case, Jonathan kept my family informed of the progression of the case. Although our case eventually settled at a mediation, I really was impressed at how well prepared Jonathan was to take the case to trial.

- Lisa
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