Medical devices help patients recover and regain their quality of life after dealing with a serious injury or medical condition. Unfortunately, some medical devices will actually hinder your recovery rather than aid it because of design or manufacturing issues. Companies or physicians that distribute defective medical devices can be held legally responsible.
The U.S. Food and Drug Administrating (FDA) is tasked with regulating medical devices through extensive testing before the product is released to the market. Despite these safety precautions, dangerous medical devices still slip through the cracks and into the medical community.
If you were suffered because of a defective medical device, then you could be legally entitled to a monetary settlement for your injuries.
Product Liability Lawyer for Medical Devices in Chicago, Illinois
Patients with defective medical devices implanted could face serious complications afterwards. In some cases, a faulty medical device could worsen your condition or even be fatal. If the device is jeopardizing your health, you may require additional surgery and medical bills.
If you’ve suffered from medical malpractice, then contact Susan E. Loggans & Associates. We are a group of product liability attorneys who are passionate about defending people who were injured by the health care system. We want to help you recover through quality legal service.
Call us today at (312) 201-8600 to schedule a free consultation. Our lawyers practice throughout the Cook County area including Evanston, Des Plaines, Schaumburg, and Chicago.
Overview of Defective Medical Devices in Illinois
- Examples of Defective Medical Devices in the U.S.
- How Does the FDA Allow Defective Medical Devices?
- Who’s Liable in a Medical Device Liability Case?
- Should I File a Claim for a Defective Medical Device?
- Additional Resources
Examples of Defective Medical Devices in the United States
Medical devices are any type of tool used to aid in a person’s recovery or during surgery. They can range from a scalpel for surgery to a life support system. These devices must be tested and approved by the FDA before hitting the shelves, but they can sometimes still have design or manufacturing defects such as:
- Pacemakers that administer electrical shocks or fail altogether;
- Failing insulin pumps causing conditions such as hypoglycemia and ketoacidosis;
- Artificial joints that break down over time and leak toxic substances;
- Blood clot filters that break down and puncture organs or blood vessels;
- Transvaginal mesh that’s eroded over time and perforated organs such as the bladder;
- Leaking or ruptured breast implants;
- Collagen that causes an infection or allergic reaction; or
- Surgical instruments that don’t function properly such as an endoscope
How Does the FDA Allow Defective Medical Devices?
All medical devices are regulated by the U.S. Food and Drug Administration (FDA). Before a product is released, it must undergo extensive testing by the FDA. So, how do defective medical devices get past the FDA’s regulations? The answer is because the FDA adopted a speedier approval process called 510(k) in 1976.
The 510(k) approval process allows medical devices to be administered a lot quicker if it’s similar to an existing product. For example, if new pacemaker is coming out and an existing model of a pacemaker exists, then the newer model will undergo less testing. This is a quicker and less expensive way to get products onto the market but increases the chances of possible defects in either design or manufacturing.
Who’s Liable in a Lawsuit for a Defective Medical Device?
Product liability concerning defective medical devices can be complicated. Finding fault can be an issue because multiple entities could be responsible depending on the situation. Typically, the manufacturer is held responsible if they didn’t inform the physician of the risks or hidden dangers of using the medical device. It can also be the manufacturer if you directly purchased the device yourself, such as type of medication.
The physician who recommended the device could also be held legally responsible if they knew of the device’s hidden dangers but chose to not inform you of them. This means the doctor failed to act as a “learned intermediary,” and did not notify you of the device’s possible defects.
In addition, hospitals or retail sellers can be liable if they had any part of the device’s creation or sale. These entities can include pharmacies, laboratories, and licensed distributors.
Should I File a Claim for a Defective Medical Device?
If you were injured because of a defective medical device, then it’s highly recommended you file a claim for damages. You could be entitled to compensation for your losses including medical bills and rehabilitation costs. It’s recommended you hire skilled legal representation to assist you with drafting and filing your claim.
Once the claim is filed, the defendant will be legally obligated to respond. If your claim is ignored, then the court will grant you a settlement. However, most defendants contest civil claims in hopes of avoiding a settlement.
You must then collect evidence such as medical records and testing information to prove the following elements:
- The medical device had a dangerous defect that occurred during the product’s design, manufacture, shipping or handling;
- You used the product just how the manufacturer or physician told you to;
- The defect caused serious injury; and
- You suffered as a result of the injury
If you win your case, a settlement will be granted to you. The settlement should cover all your damages, which are any losses you may have sustained because of the injury. These can be financial such as medical bills or emotional such as loss of quality of life.
Listed below are some damages your settlement may cover.
- Medical expenses;
- Rehabilitation costs;
- Handicap installations;
- Loss of wages;
- Pain and suffering;
- Loss of enjoyment for life; and
- Loss of consortium
2019 Medical Device Recalls – Visit the official website for the U.S. Food and Drug Administration (FDA) to access a list of 2019 medical device recalls. Access the site to learn which devices are currently being recalled, why, and resources for medical device safety.
FDA Regulations for Medical Devices – Visit the official website for the U.S. Food and Drug Administration (FDA) to learn more about their regulations for medical devices. Access the Code of Federal Regulations to see how products are examined and tested before they are put out on U.S. shelves.
Medical Devices Lawyer in Cook County, Illinois
Have you been injured because of a medical device? You could be legally entitled to compensation for your injuries. Learn more by contacting Susan E. Loggans & Associates for a free consultation surrounding your case. Our product liability lawyers have handled any type of design or manufacturing device case ranging from a contaminated prescription to a broken pacemaker.
Call us now at (312) 201-8600 so we can set up your appointment today. Susan E. Loggans & Associates represents people throughout the greater Chicago metropolitan area including Evanston, Arlington Heights, Des Plaines and Schaumburg.
This article was last updated on May 31, 2019.