The Complex Legal Issues Surrounding C.R. Bard’s Medical Devices

C.R. Bard, founded in 1907, is a major player in the medical device industry. The company is known for its diverse range of products, including vascular, urology, and surgical devices.

Headquartered in Murray Hill, New Jersey, the company has long been a leader in developing innovative medical technologies aimed at improving patient outcomes.

However, Bard has faced significant legal and regulatory challenges over the years, including high-profile lawsuits. In this article, we will talk about them.

The Transvaginal Mesh Controversy

The transvaginal mesh lawsuits represent one of the most extensive and high-profile legal issues for C.R. Bard. The controversy began in earnest after the FDA issued a warning in 2008 about serious complications associated with these devices. The FDA’s alert spurred thousands of lawsuits, resulting in some of the largest multidistrict litigations (MDLs) in U.S. history.

By 2022, the coordinated litigation involving major manufacturers like Bard, American Medical Systems, and Boston Scientific had expanded to over 100,000 cases. These cases were consolidated into seven MDLs overseen by U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia.

The settlements for these cases have been substantial, with companies paying hundreds of millions of dollars, as reported by Forbes. For example, in 2020, C.R. Bard agreed to a $60 million settlement to resolve claims of deceptive marketing concerning its vaginal mesh products.

Despite the resolution of many cases, new lawsuits continue to emerge. While around 95% of the MDL cases have been resolved or dismissed, ongoing litigation persists.

How does transvaginal mesh work?

The mesh is inserted into the pelvic region to support the organs and tissues that have weakened. In cases of pelvic organ prolapse, it helps to hold the organs in their proper place. For stress urinary incontinence, it provides additional support to the bladder and urethra, reducing involuntary leakage.

The Bard PowerPort Lawsuits

The Bard PowerPort, approved by the FDA in 2000, quickly became a dominant player in the market for implantable catheter devices. The National Law Review reports that Bard enjoyed a 70% market share for these devices. However, as the use of PowerPort devices expanded, so did reports of complications. Issues such as device breakage, bacterial colonization, and blood clots led to numerous lawsuits.

Plaintiffs in the Port Catheter lawsuit argue that the PowerPort devices were defective because they used barium sulfate. If not properly coated, this substance could lead to microfractures and other failures. They allege that Bard misrepresented the safety of the devices and failed to provide adequate warnings about potential risks.

Drugwatch notes that the first group of plaintiffs in the PowerPort MDL began consolidating their cases in May 2023. As of August 2024, there are 336 active lawsuits in the Arizona MDL. These lawsuits aim to secure compensation for the physical and emotional distress caused by the faulty devices, TorHoerman Law notes. Victims hope to drive reforms that improve the safety and reliability of medical devices.

What is a port catheter?

A port catheter is a device inserted beneath the skin to provide simple access to the veins. It is often used for patients who need regular blood tests, intravenous treatments, or chemotherapy.

IVC Filter Lawsuits

C.R. Bard’s inferior vena cava (IVC) filters have been embroiled in extensive legal battles due to allegations of design defects and safety issues. An important vein that carries blood from the lower body to the heart is the inferior vena cava, into which these devices are put. Their purpose is to stop blood clots from reaching the lungs and causing a pulmonary embolism.

Intended to offer protection and improve patient outcomes, these devices have faced significant criticism and legal scrutiny for their failure to perform as expected.

In July 2015, the FDA issued a formal warning letter to C.R. Bard, citing serious violations at two of its facilities. The agency’s concerns included misbranding, quality system regulation infractions, and the manufacturing and selling of non-approved medical devices.

Following this, the legal challenges surrounding Bard’s IVC filters have been substantial. Patients have filed numerous lawsuits claiming severe complications such as device migration, filter fracture, and related injuries. These issues have led to extensive litigation.

Bard has negotiated settlements both individually and through a global settlement for multidistrict litigation (MDL) involving over 8,000 plaintiffs.

As per Consumer Notice, the financial and reputational impacts on the company have been significant. This was highlighted by a notable June 2021 verdict in which a Wisconsin plaintiff was awarded $3.3 million. This substantial award underscored the serious legal and financial risks Bard faces.

What is a pulmonary embolism?

A pulmonary embolism (PE) happens when a blockage forms in one of the arteries supplying the lungs. This is often caused by blood clots that travel from the legs (deep vein thrombosis) or other parts of the body. This obstruction can impede blood flow to the lungs and may become life-threatening if not addressed swiftly.

Overall, these legal battles highlight concerns about medical device safety and efficacy, underscoring the need for strict quality control and regulatory compliance. As consumers, it’s crucial to stay vigilant and demand transparency. We should be informed about the products and companies that impact our health, ensuring they prioritize safety and efficacy.