Medical devices have transformed the healthcare landscape by saving lives for some and making it easier for others. However, their effectiveness depends upon reliable design, manufacturing, and distribution.
The Food and Drug Administration (FDA) exercises significant control over the approval and commercialization of medical equipment. But, once these products hit the market, it is up to the corporations to take care of patient safety.
In many cases, medical devices are found to be defective or hazardous to health. If so, victims can sue the manufacturer for their injuries, and the product may be later recalled.
In this article, we will discuss three product liability lawsuits related to medical devices. These are currently active across Federal courts and also among the largest in 2023.
Transvaginal Mesh Implant Lawsuit
The transvaginal mesh lawsuit dates back to the early months of 2008. It is associated with a surgically implantable device called the transvaginal mesh. This medical device is a synthetic substance placed in a hammock-like fashion across the urethra to strengthen damaged internal tissues.
Medical practitioners usually use it to treat conditions like pelvic organ prolapse and stress urinary incontinence. Over years following the device’s market approval, it was found that the complications involved far exceeded the product’s benefits.
According to TruLaw, victims have suffered injuries like intense pain, organ perforation, infections, bleeding, and autoimmune problems. The major defendants in this litigation include companies like Johnson & Johnson’s Ethicon, C.R. Bard, Boston Scientific, and American Medical Systems.
In the decade that followed, the first-ever trials for this lawsuit (2012), millions in settlements have been made by the defendants across 48 US states. Currently, there is no class-action multi-district litigation (MDL) since attorneys are aware of expected individual payouts.
As of 2023, nearly 95% of the cases have been settled. Even so, the plaintiff’s counsel is accepting new filings which will be handled separately in the respective district courts.
CPAP Machine Lawsuit
The CPAP machine lawsuit also centers around design defects and deceptive marketing on the manufacturer’s part. This litigation is regarding Philips Respironics’ polyester-based polyurethane foam used in their continuous positive airway pressure (CPAP) ventilator.
The foam used to reduce vibrations was found to be defective in the sense that it degraded into harmful emissions. Back in June 2021, the company recalled its CPAP machines due to the potential health risks involved.
In early 2023, victims came forward to file CPAP machine lawsuits alleging that they suffered injuries like blood and lung cancer and acute respiratory distress. Phillips was accused of concealing the possible complications despite being aware of them.
As of September 2023, the defendant has agreed to pay a partial settlement of $479 million for the device’s design defects. Currently, over 740 cases are pending across Federal courts, and the plaintiff’s counsel is looking forward to Bellwether trials expected to begin as early as 2024.
Exactech Hip and Knee Implant Lawsuit
Exactech is a company that manufactures hip and knee replacement surgical implants. As per the company’s claims, its replacement implants are performed using computer-assisted surgery technology. The company also claims to have helped surgeons carry out implant surgeries within one degree of the optimal position.
However, Exactech’s claims were found to be wanting, primarily since early 2021. The manufacturer even issued safety warnings in June 2021 regarding the polyethylene liners used in the replacement systems.
They were said to degrade prematurely, thereby causing injuries such as osteolysis, cracking sounds in the joint, bone loss, swelling and intense pain, limited mobility, instability, and the need for revision surgeries.
As of March 2023, the FDA has reminded of Exactech’s product degradation due to packaging defects between 2004 and 2021. Over 1,100 plaintiffs have filed this lawsuit against Exactech.
This litigation is still in its early stages and is expected to grow further in 2024. Though the product has not been recalled yet, the company is gradually phasing out its production.
This means Exactech will not be manufacturing any more hip and knee replacement implants in the United States.
To wrap things up, the worldwide medical device market was valued at $512.29 billion in 2022 and is growing at a CAGR of 5.9%. In a highly saturated market, it can be challenging to survive. This is why manufacturers are looking for innovative ways to gain a competitive edge and help patients/physicians.
Amidst fierce competition, it is not uncommon for device defects to go unnoticed or worse yet, intentionally neglected.
