Medical devices aim to transform the healthcare industry by ushering in innovations and solutions. Every hospital has access to appropriate, good-quality, and affordable medical products. These can be an apparatus, machine, or implant that lets the medical institution provide better care.
Currently, the world has over 2 million medical devices. With these, healthcare professionals can perform fundamental medical functions like diagnosis, implantation, and surgical intervention.
Even though these devices offer advanced medical facilities, the industry is not without challenges. One of the biggest issues is inadequate manufacturing methods and malfunctions.
Some manufacturing companies fail to perform timely and adequate tests to ensure the device’s safety or effectiveness. As a result, the patients pay a life-altering price.
In this blog, we will discuss such instances that led to big lawsuits.
#1. BardPort Lawsuit
Bard manufactured and developed devices for vascular medicine, oncology, and urology. Among them was their implanted port, which gained popularity due to its small structure, resembling the size of a quarter.
This device had a catheter for intravenous medication administration and for drawing blood. However, the manufacturers used an improperly mixed polymer substance to create the catheter, leading to quality issues. It migrated and fractured inside the patient’s vascular system, causing injuries and complications. Examples include blood clots, hemorrhages, heart punctures, etc.
As a result, the victims filed a Bard Power Port lawsuit. This lawsuit claims corporate misconduct and improper testing methods. Currently, there are 50 personal injury and wrongful death lawsuits filed against the manufacturer.
According to TorHoerman Law, anyone with evidence of getting injured due to a Bard PowerPort malfunction is eligible for this lawsuit. The expected settlement amount from this litigation can range between USD 10,000 and USD 250,000. However, it depends on the extent of the proof provided and the injuries sustained.
#2. ParaGard Lawsuit
Teva Pharmaceuticals, later acquired by The Cooper Companies, manufactured the first copper-based T-shaped intrauterine contraceptive device (IUD). According to the Cleveland Clinic, copper IUDs are an effective emergency contraceptive with a 99% success rate. Also, they are long-lasting and low-maintenance.
For many years, women used it as a safe and non-hormonal birth control option. However, they noticed that the ParaGard IUDs were defective and would break inside the uterine wall upon removal. When surgically removed, IUD pieces broke, migrated, and lodged in their organs, leading to infection, pain, and infertility.
The worst part is that the manufacturers knew about this issue and its side effects but didn’t warn the patients or doctors. As a result, 2,094 ParaGard lawsuits were filed by injured victims. The legal industry expects compensation between USD 25,000 and USD 200,000 for this litigation.
#3. Exactech Lawsuit
Exactech is a medical device manufacturing company specializing in orthopedic implant devices and surgical instruments. Their most famous products were the metal-on-polyethylene hip, knee, and ankle replacement implants.
However, eroded and defective liners or inserts in the device caused patients to opt for revision surgery. It happened due to improper packaging. Some defective bags didn’t have oxygen barriers, causing a chemical reaction in the polyethylene implants and degrading the product over time.
Between 2021 and 2022, the manufacturer recalled almost 200,000 implants stored in defective bags. When patients learned about this, they were furious because of Exactech’s negligent behavior.
As a result, victims filed product liability lawsuits to seek compensation for lost wages, suffering, medical bills, and more. The Consumer Notice states that 395 Exactech litigations are pending without trial. However, the settlement is expected to be between USD 100,000 and USD 300,000.
When to File a Medical Device Lawsuit?
In America, the industry leaders believe the medical device market will grow at a 5.9% CAGR, amounting to USD 799.67 billion by 2030. This country alone holds 40% of the world’s medical technology market. It proves that the industry is fast-growing.
But even a fast-growing industry comes with intense legal challenges. According to The Regulatory Review, researchers linked 1.7 million injuries and 80,000 deaths with medical device malfunctions in the last ten years.
These victims can receive compensation for the financial, physical, and emotional turmoil through lawsuits. They should file a case if there are:
- Improper and misleading marketing
- Design inconsistencies
- Manufacturing defects leading to health issues
During the hearing, the plaintiffs must prove the product’s manufacturing defects and allege failure to warn. After filing the claim, the companies might compensate victims for the medical bills, lost wages, and diminished quality of life.
The Bottom Line
The medical device malfunction instances mentioned in this blog beg the question, ‘Are the testing methods adequate?’ Technically, the FDA is responsible for testing and approving these devices.
This government body receives multiple reports of medical device-related injuries and deaths. That’s why they have introduced the Medical Device Reporting (MDR) regulation to monitor device performance, defects, safety issues, and risk assessment. Think of it as post-market surveillance from importers, hospitals, and recipients.
MDRs act as proof needed to build a medical malpractice or product liability case against the manufacturers. These cases can lead to high-profile legal claims like the BardPort, Exactech, and ParaGard lawsuit payouts.